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Complaint in THE REGENTS OF THE UNIVERSITYOF CALIFORNIA, a CaliforniaCorporation,Plaintiff,V.PAUL S. AISEN, an individual;JEREMY PIZZOLA, an individual;DEBORAH TOBLAS. an individual;GUSTAVO JIMENEZ-MAGGIORA, anindividual; PHUOC HONG, an individual;HONG MEI QIU, an individual;STEFANIA BRUSCHI, an individual; RASINGSO, an individual; MAYYANESSIRIO, an individual; UNIVERSITYOF SOUTHERN CALIFORNIA, aCalifornia Corporation; and DOES 1-25,Inclusive,
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7/21/2019 Regents of the University of California v. Aisen (USC) - Complaint
http://slidepdf.com/reader/full/regents-of-the-university-of-california-v-aisen-usc-complaint 1/87
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CROWELL
MORNG LLP
J. Daniel Sharp (SBN 131042)
dsharNi,
crowell.com
27 5 Battery Street, 23rd Floor
San Francisco, CA 94111
Telephone:
15.986.2800
Facsimile:
15.986.2827
Mark A. Romeo (SBN 17 3007)
mromeoCii;crowell.com
Derek Hecht (SBN 273039)
dhechtgcrowell.corn
3 Park Plaza, 20th Floor
Irvine, California 92614-8505
Telephone:
49.263.8400
Facsimile:
49.263.8414
I
F
L
E
D
Clerk of
the Superior
Court
JUL
0 2 2 0 1 5
9
10
Attorneys for Plaintiff
THE REGENTS OF THE U NIVERSITY OF CALIFORNIA
1 1
12
1 3
SUPERIOR COURT OF THE STATE OF CALIFORNIA
COUNTY OF SAN DIEGO
14
15
16
17
18
19
2 0
21
22
23
2 4
2 6
THE REGENTS OF THE UNIVERSITY
OF C ALIFORN IA, a California
Corporation,
Plaintiff,
V.
PAU L S. AISEN , an individual;
JEREMY PIZZOLA, an individual;
DEBORA H TOBLAS. an individual;
GUSTAVO JIMENEZ-MAG GIORA, an
individual; PHUO C H ON G, an individual;
HON G M EI QIU, an individual;
STEFANIA BRUSC HI, an individual; RA-
SING SO , an individual; MAYYA
NESSIRIO, an individual; U NIVERSITY
OF SOUTHERN CALIFORNIA, a
California Corporation; and DOES 1-25,
Inclusive,
Defendants.
Case No
37-2015-00022082-CU
BT
-
CTL
COMPLAINT FOR MONEY DAMAGES
AND EQUITABLE RELIEF FOR:
1.
BREACH OF FIDUCIARY DUTY;
2 .
BREACH OF DUTY OF LOYALTY BY
EMPLOYEE;
3.
INTERFERENCE WITH UirsITRACT;
4 .
INTERFERENCE WITH
PROSPECTIVE ECONOMI
ADVANTAGE;
5 .
CONVERSION;
6.
COMMISSION OF COMM I
CRIMES;
7 .
CIVIL CONSPIRACY
DEMAND FOR JURY TRIAL
27
28
C:wwELI
MoK;Nc; 1.1.P
ArTkNF)c AT LAS
SFACTIVE-90372830 1.1
COMPLAINT FOR MONEY DAMAGES AND EQC:TABLE RELIFF
7/21/2019 Regents of the University of California v. Aisen (USC) - Complaint
http://slidepdf.com/reader/full/regents-of-the-university-of-california-v-aisen-usc-complaint 2/87
Plaintiff The Re gents of the University of California alleges upon know ledge as to its own
actions, and upon information and belief as to all other m atters, against Defendants Paul S. A isen,
Jeremy Pizzola, Deborah Tobias, Gustavo Jimenez-Magg iora, Phuoc Hong, Hong M ei Qiu,
Stefania Bmschi, Jia-S ing So, and Mayya Nessirio and the University of Southern California as
follows:
THE PARTIES
1.
The Regents of the University of California ("The Regents" or "Plaintiff') is a
California corporation doing business in the County of San Diego, State of C alifornia.
2.
Defendants Paul S. Aisen ("Aisen"), Jeremy Pizzola, Deborah Tobias, Gustavo
Jimenez-Maggiora, Phuoc Hong, Hong Mel Qiu, Stefania Bruschi, Jia-Sing So, and Mayya
Nessirio (sometime s collectively referred to as "Individual Defendants") are and w ere at all
relevant times individuals residing in the C ounty of San Dieg o, State of California.
3.
Defendant U niversity of Southern California ("USC ") is a California corporation
doing business in the Counties of Los Ang eles and San Diego, State of C alifornia.
4.
Plaintiff is informed and b elieves and thereon alleges that each of the D efendants
fictitiously sued hereunder as Does 1 through 25 are in some manner responsible for the
occurrences alleged hereunder and the damag es which Plaintiff alleges hereunder, and that at all
times, each of said Does w ere acting as the agent for each other or the Defendants w ithin the
scope and capacity of said ag ency. Plaintiff is ignorant of the true nam es and capacities of such
Defendants sued herein as Does 1 through 25 inclusive and therefore sues these Defendants by
such fictitious names for the sam e acts and causes of action alleged against D efendants. Plaintiff
w ill seek leave of Court to am end this Com plaint to allege the true nam es and capacities of said
Defendants at such time as they may b e ascertained.
JURISDICTION AND VENUE
5.
The conduct alleged herein occurred w ithin the County of San Diego, State of
California, and jurisdiction and venue is proper w ithin this County.
2
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1
ROWELL
MORING
LLP
ATTORNEYS AT LAW
SFACTIVE-90372830 I. I
COMPLAINT FOR MONEY DAMAGES AND EQUITABLE RELIEF
7/21/2019 Regents of the University of California v. Aisen (USC) - Complaint
http://slidepdf.com/reader/full/regents-of-the-university-of-california-v-aisen-usc-complaint 3/87
GENERAL ALLEGATIONS
The Regents and the ADCS
6.
The R egents is a California corporation authorized and empow ered to administer a
public trust known as the University of California ("UC" or "(he University"). Under Article IX,
section 9, of the California Constitution, the Regents is vested w ith full powers of organization
and governm ent over the University, including all powers necessary or convenient for the
effective administration of the public trust and the advancem ent of the tripartite mission of the
University: to provide excellence in teaching , research, and pub lic service.
7.
The Regents maintains a campus in this county known as the University of
California, San Diego ("UCSD"). UCSD operates a School of Medicine as well as the UC San
Diego H ealth System, w hich is the region's only academ ic health system and provides patient
care, conducts me dical research, and serves as a training ground for health care professionals.
8.
Since 1991, UCSD has managed a research enterprise known as the Alzheimer's
Disease Cooperative Study ("ADCS") under a cooperative agreement with the National Institute
on Aging ("NIA"), which is an agency of the federal government and one of the National
Institutes of Health ("NIH"). The ADCS facilitates the testing of new drugs for the treatment of
Alzheime r's disease, particularly drugs that mig ht not otherwise be tested b y private industry. To
this end, ADC S coordinates clinical trials and other research activities at approximately 7 0
academic medical centers and research clinics in the United States and Canada. The ADCS is in
he nature of a joint venture, but instead of operating for profit, it operates for the advancemen t of
the missions of the NIA and The Regents with respect to medical education, research, and public
service.
9.
The work of the ADCS is funded primarily by the federal government and private
companies pursuant to the terms of written contracts entered into by The Regents. These
contracts are sometim es colloquially referred to as "g rants," and typically carry titles such as
"Collaborative Study Agreement" and "Clinical Trial Research Collaboration Agreement." The
value of the grant funding is in exc ess of $100 m illion. This funding finances research activity as
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1 1
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CROWELL.
dr MORING LLP
ATTORNEYS AT LAW
2
COMPLAINT FOR MONEY DAMAGES AND EQUITABLE RELIEF
5EACTIVE-903728301.1
7/21/2019 Regents of the University of California v. Aisen (USC) - Complaint
http://slidepdf.com/reader/full/regents-of-the-university-of-california-v-aisen-usc-complaint 4/87
we ll as administrative costs, including the salaries of the approximately 80 em ployees and
2 administrators who run the ADCS at UCSD.
3
CSD Entrusted Defendant Aisen with the Directorship of the ADCS
4
0.
rom the time that the ADCS was established in 1991 until February 2007, the
5 Director of the ADCS was Leon Thal, M.D., a Distinguished Professor and Chair of
6 Neurosciences at UCSD. Dr. Thal had joined the UCSD faculty in 1985 and over the years
7
ecame the acknowledged leader in the development of drug therapies for Alzheimer disease. In
8
ebruary 2 007 , he was tragically killed in a plane crash.
9
1.
ollowing the death of Dr. Thal, UCSD conducted a search for a new Director of
10 the ADC S and hired Defendant Paul Aisen, M.D. in November 2 007. D r. Aisen became
11 employed by The Regents as a Professor of Neurology and Medicine at UCSD and was appointed
12 Director of the ADCS. A s such, Defendant Aisen was the agent of T he Regents and its fiduciary
13
n effectuating UCSD's participation in the ADCS venture. As an employee of The Regents,
14
efendant Aisen ow ed a duty of loyalty to the U niversity during his tenure, including a duty to
15
efrain from actions that are inimical to the interests of The R egents, and to avoid g iving
16
reference to his own interests, or those of a rival employer, at the expense of The R egents and
17
CSD . The position of Director of the AD CS is one of prestige and influence in the field of life
18
ciences, and UCS D placed trust and confidence in Defendant Aisen to discharge his obligations
19
o The Reg ents with honesty and candor.
20
21
Defendant Aisen and Defendant IJSC Conspire to Misappropriate IJCSD's Role in
the ADCS
22
2 .
ithin the past week, The R egents has learned that, beginning at least as of April
23 2015, Defendant Aisen and Defendant USC began to conspire with one another to displace UCSD
24 in the ADCS, to interfere with The Regents' contractual and economic relationships with ADCS
25
inders, to interfere with the Regents' relationships with UCSD employees engaged in work on
26
ehalf of the ADC S, and to usurp the beneficial opportunities available to The Regents through
2 7
CSD's role in the ADCS. The Regents do not presently have access to all of the facts showing
2 8
he extent of the conspiracy and the w rongful acts done in furtherance of their comm on design,
3
COMPLAINT FOR MONEY DAMAGES AND EQUITABLE RELIEF
CRO1VELL
MoRirm LLP
ATTOINEVS AT LAW
SFACTIVE-903728301.1
7/21/2019 Regents of the University of California v. Aisen (USC) - Complaint
http://slidepdf.com/reader/full/regents-of-the-university-of-california-v-aisen-usc-complaint 5/87
and w ill require discovery to present such facts at trial. How ever, the facts set forth below have
2
een learned within the past week.
3
3.
n April 2015, Defendant Aisen reached out to USC Provost Michael Quick to
4
esume discussions, begun a t some earlier time, regarding the potential for Defendant Aisen to
5 join the faculty at USC, w hich operates the K eck School of Medicine ("K eck") near downtown
6 L os Angeles. K eck has an A lzheimer's Disease Research Center, also located near downtown
7 Los Angeles.
8
4 .
or reasons known best to Defendants, the discussions between Defendants Aisen
9 and USC soon centered on making arrangem ents for Dr. Aisen to remain in the vicinity of La
10
olla, where USC has no facilities of any kind. Defendants agreed to create a brand new
1 1
Institute" in San Diego by hiring away the necessary UCSD employees who serve the ADCS,
12
nd seeking to supplant UCSD as the contracting party in connection W ith research contracts and
1 3
ther agreeme nts related to ADCS , including the lease for the office space that houses the
14 UCSD/ADCS staff. Defendants Aisen and USC thus planned to cripple UCSD's ability to
1 5
erform its cooperative agreement with the NIA to administer the ADCS.
16
5 .
efendant Aisen demanded, and Defendant USC agreed to provide, significant
17 incentives for Dr. Aisen to betraithe trust reposed in him by UCSD. Among other things, USC
18
n or about May 2 015 offered Aisen a guaranteed salary of $5 00,000 per year through 2 02 0, and
19
oth interest-free and low- interest financing on a new home, w ith forgiveness of at least half the
20
ebt over time. The terms offered by USC were expressly set forth with the expectation that
21
isen's salary would be paid by "ex tramural research funding you
[i.e.,
Aisen] obtain." Thus,
2 2
hanks to Defendant U SC, D efendant Aisen has a strong personal financial incentive to interfere
2 3
ith The Regents' contractual relationships with UCSD's research sponsors.
2 4
6.
efendants further agreed that USC w ould provide a "start-up loan" of up to $8
2 5
illion to finance the creation of the new "Institute" in San Dieg o. In making these financial
2 6
rrangements, Defendant USC expressly stated its expectation that Aisen would arrange a
2 7
transition to USC" of existing research activities administered by UCSD, and that the new
28
Institute" would incur real estate remodeling expenses only "if a relocation from current [UCS D-
4
COMPLAINT FOR MONEY DAMAGES AND EQUITABLE RELIEF
CROWELL
MORING LLP
ATTORNEYS AT LAW
SFACTIVE-903728301.1
7/21/2019 Regents of the University of California v. Aisen (USC) - Complaint
http://slidepdf.com/reader/full/regents-of-the-university-of-california-v-aisen-usc-complaint 6/87
leased] facilities is required." Thus, thanks again to Defendant USC, Defendant Aiscn had a
2
trong financial incentive to interfere with The Reg ents' relationships with the UC SD faculty and
3 employees who staffed the ADCS.
4
7 .
he terms of Defendant USC's May 2015 offer to Defendant Aisen called for
5
isen to join USC as of September 1, 2015. In accordance with the incentives he anticipated to
6
eceive from US C, Dr. Aisen, w hile still employed by T he Reg ents, and in violation of his duties
7
f loyalty and fidelity, began to recruit other UCSD employees to join him in his schem e to
8
nterfere with the contractual relationships between UCSD and research sponsors, and to attempt
9 to interfere with UC SD's performance of its agreements both w ith the NIA and w ith private
10 sponsors of the ADCS.
1 1
8.
n May 2015, after entering into the conspiracy with USC, Defendant Aisen, using
12
he authority of his position as director of the ADCS, summoned all ADCS employees to a
13 meeting and told them that he would likely be moving to USC, that the ADCS grants would move
14 with him, and falsely advised that none of the employees working on behalf of ADCS would have
15 jobs at UC SD. Aisen told the ADC S staff that USC w ould offer all of them jobs if they left -
16 UCSD. This conduct by Defendant Aisen created fear and unrest and concern among UCSD's
17
mployees and disrupted their relationships with The R egents.
1 8 9.
efendants Jeremy Pizzola, Deborah Tobias, Gustavo Jimenez-Maggiora, Phuoc
19 Hong, Hong Mei Qiu, Stefania Bruschi, Jia-Sing So, and Mayya Nessirio, were UCSD employees
2 0
ho agreed to join Defendant Aisen in a conspiracy to act as "double agents"— ostensibly
21
mployed by The Regents but in reality working to undermine UCSD, to advance their own
2 2
ersonal interests, and to serve the interests of Defendant USC , in violation of their obligations
23
nder California Labor Code 2863, which states "An employee who has any business to transact
2 4
n his own acc ount, similar to that entrusted to him by his em ployer, shall always g ive the
25
reference to the business of the employer."
2 6 0.
or example, Defendants Aisen, Pizzola, and Tobias, while still employed by The
27 Regents, attempted to pressure and persuade Toyama Chemical Company ("Toyama"), a research
2 8
ponsor and party to a Collaborative Study with the R egents, to terminate its contractual
5
COMPLAINT FOR MONEY DAMAGES AND EQUITABLE RELIEF
CROWELL
M O R
ING LLP
ATTORNEYS AT LAW
FACTIVE-90372830 I. I
7/21/2019 Regents of the University of California v. Aisen (USC) - Complaint
http://slidepdf.com/reader/full/regents-of-the-university-of-california-v-aisen-usc-complaint 7/87
arrangement with The R egents and form a new contract with USC. O n May 30, 2 015 , Defendant
2 Pizzola wrote to Toyama.
3
e believe that Paul [i.e., Defendant Paul A isen] can affiliate w ith
USC and form a new institution that would reside here in San
4
iego. The new institute will hire on all of the staff members
currently working for Paul. We have discussed with USC and they
5
ave indicated that they can issue replacem ent contracts to all
TC AD sites [i.e., research facilities under contract with The
6
egents] simultaneously with precisely the same terms and
conditions. ... This w ould need to be very carefully timed w ith
7
oyama as we believe Toyama could chose to cancel its agreement
8
ith UCSD with 30 days notice.
In short we be lieve that we can have essentially the same people
9
illing the same roles in the TCAD study simply under a new
institutional affiliation.
10
11
1.
oyama's representatives responded to Defendants Aisen, Pizzola, and Tobias on
12
une 3, 2015 , stating in part, "Have you already discussed these with UCSD and NIH? It is
13
mportant for Toyama to confer directly with UCSD to make sure that Toyama honors all of its
14 obligations to UCSD and complies w ith all applicable laws." How ever, rather than advise UCSD
15
f Toyam a's inquiry, Defendant Pizzola replied "w e do not think it is time to discuss anything
16 w ith UCSD," and told Toyama "w e don't know w hat's going to happen with 11CSD."
17
2 .
n June 8, 2015, Toyama wrote directly to Defendant Aisen, stating in part:
18
fter carefully considering the actions that Jerem y
[i.e.,
Defendant
Pizzola] and you have recently requested of us, we find that the
19
omplex ity of these requested actions raises a series of significant
logistical, contractual, and regulatory compliance issues.
20
esolution of these issues, from both business and leg al
perspectives, requires us to consult with UCSD and its counsel. We
21
hus request that, in addition to the project m eeting scheduled for
next w eek in San Diego, that you kindly arrange for us and our
22
ounsel to meet separately with the appropriate representatives of
UC SD and its counsel so that this consultation can occur.
23
2 4 Notwithstanding this explicit request from Toyama, Defendant Aisen concealed the
2 5
omm unication from UCS D and its counsel, and accelerated Defendants' planned transition to
26 USC.
2 7
3.
n or about June 18, 2015, while travelling and away from San Diego, Dr. Aisen
28
ent an email announcing that he would be resigning from UCSD effective July 1, 2015, to take a
CROWELL
Moncc LLP
ATTORNEYS AT
LAW
SFACTIVE-903728301. I
COMPLAINT FOR MONEY DAMAGES AND EQUITABLE RELIEF
7/21/2019 Regents of the University of California v. Aisen (USC) - Complaint
http://slidepdf.com/reader/full/regents-of-the-university-of-california-v-aisen-usc-complaint 8/87
position at USC. That same day, UCSD Campus Counsel Dan Park sent Aisen a letter
2
ongratulating Aisen on his job offer from U SC, and rem inding Aisen of hit fiduciary duties as
3
irector of the ADCS , and an em ployee's duty of undivided loyalty to Ins employer during the
4
erm of employment. Park's letter further stated:
In addition to avoiding any action that could disruptUC San
Diego's contractual relationships, you should be sure not to rem ove
6
rom UC San Diego's possession or control any equipment, records,
electronic data, or software that w ere purchased or created for the
7 j
DCS at UC San Diego. All such items are the property of UC San
Diego, the taking of w hich without UC San Diego's express
8
ermission w ould be an illegal conversion.
Burlesei v . Petersen
(1998) 68 Cal.App.4th 1062. Conversion is a strict liability tort,
9
mean ing questions of the defendant's good faith, lack of
know ledge, and m otive are ordinarily imm aterial." Id. Similarly,
10
ou should not attempt to delete or destroy any records or
documents, w hether electronic or physical.
In summary, UC San Diego w ill be pleased to provide you w ith
1 2
ssistance as you make you r transition to your new position. At the
same time, UC San Diego hopes that you will provide similar
1 3
ssistance to ensure the continued smooth functioning of the ADCS
14
t UC San Diego as w e prepare to search for a new director.
15
4 .
fter receiving Park's letter requesting Aisen's compliance with legal obligations
16
nd cooperation in transition, Defendant Aisen chose a diametrically opposite course. Without
17
aving returned from his travels, on Sunday, July 21, 2015, Aisen sent an email stating, "Because
1 8
f the tone and implications of the letter I received on 6/18/15 from U CSD general counsel, as
19
ell as threatening statements made by UCSD leadership, it is untenable for me to remain at
2 0
CSD through my planned resignation date. I resign immediately, effective today, 6/21/15."
2 1
5 .
efendant Aisen refused to consent to an exit interview w ith any of his former
2 2
olleagues at UC SD, and m ade no arrangem ents for the transition of his responsibilities as
2 3
irector of the ADCS, despite multiple requests from UCSD.
2 4
6.
efendant Aisen and other Individual Defendants arranged for the return of the
25 laptop computers that had been issued to them and which w ere owned by The R egents. Each
26
aptop had been wiped of all data, notwithstanding The Regents' ownership of the data.
27
7 .
orse, upon their departure, and through the present, Defendant Aisen and the
28
ndividual Defendants have exerted dominion and control over the ADCS data that has been
CROW ELL
MORING LLP
AITOIM0Y5
AT
LAW
7
COMPLAINT FOR MONEY DAMAGES AND EQUITABLE RELIEF
SFACTIVE-903728301.I
5
1 1
7/21/2019 Regents of the University of California v. Aisen (USC) - Complaint
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entrusted to UCSD as a participant in the ADCS, 'and have failed and refused to provide UCSD
with account data, passwords, and access credentials to enable UCSD to maintain administrative
control of ADCS data, as set forth below.
Defendants Arrogate Control over ADCS Data After Resigning from The Regents
28.
One of the core functions that UCSD performs in connection with the ADCS is to
receive, monitor, and analyze clinical data from clinical trials and research studies that AD CS
administers. Such clinical data includes medical records of the individuals who have volunteered
to participate in a clinical trials of new drugs, and o ther information of a sensitive, confidential,
and proprietary nature. Such data is typically transmitted to ADC S from the various sites at
which clinical studies are conducted via an intend website with a unique U RL and stored on
computer servers. UCSD sometimes contracts with comm ercial vendors such as Amazon to host
ADC S data on their computer servers, colloquially referred to as "the Cloud."
29.
Maintenance of da ta pertaining to clinical trials is subject to detailed regulations
promulgated by the federal Food and Drug Administration (FDA). Maintenance of study data is
also subject to contractual obligations set forth in the contracts betw een The R egents and the
compan ies and governm ent agencies that sponsor clinical trials. Such contracts specify that all
data created or captured by UCSD related to the ADCS program will be jointly owned by The
Regents and the sponsors, and will be maintained by UCSD.
30.
For example, The R egents entered w ritten agreements with Eli Lilly and Company
("Lilly"), and the Toyama Chemical Company ("Toyama") with respect to research studies that
were ongoing at the time of Defendant Aisen's resignation, and remain ongoing today. A true and
correct copy, without exhibits, of The Regents' agreement with Lilly is attached hereto as Exhibit
"A" (the "Lilly Agreement"). A true and correct copy, without exhibits, of The Regents'
agreement w ith Toyama is attached hereto as Ex hibit "B" (the "Toyama Agreement").
31.
None of the Defendants are parties to the Lilly Agreement or the Toyama
Agreement.
32.
Pursuant to Section 18.1 of the Lilly contract, UCSD is required to create and
maintain all records required by the Agreement, and Section 16.1 provides that Study Data will be
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CROW ELL
MORING LLP
ATTORNEYS AT
LAW
COMPLAINT FOR MONEY DAMAGES AND EQUITABLE RELIEF
8
5FACTIVE-903728301. I
7/21/2019 Regents of the University of California v. Aisen (USC) - Complaint
http://slidepdf.com/reader/full/regents-of-the-university-of-california-v-aisen-usc-complaint 10/87
captured by UCSD and maintained jointly by Lilly and UCSD .
See Exhibit A. Pursuant to
2
ection 16.2, the study data is jointly owned by Lilly and UCSD.
3 3.
ursuant to Section 8(C)(i) of the Toyama A greem ent, Clinical Study results shall
4 be jointly ow ned by Toyam a (and its parent company) and The R egents.
See
Exhibit B. Pursuant
5
o Section 8(C )(iii), all joint intellectual property created as a result of the clinical studies w ill
6 belong jointly to Toyama (and its parent company) and The Regents.
Id.
7
4 .
he AD CS w as also partially funded by an aw ard from Department of Health and
8 Human Services, through the National Institutes of Health ("NN"), The terms of this funding are
9 set forth in the Notice of Award ("NOA") issued by NH on December 8, 2014. A true and
10
orrect copy, without exhibits, of the NOA is attached hereto as Exhibit "C." (The financial
1 1
nformation on this copy was redacted by the University's Department of Contracts and Grants in
12 connection w ith making the NO A publicly available.) Pursuant to the NOA, UCSD is expressly
13
dentified as the grant recipient, and funding provided by the N IH is to be received by D efendant
14 Aisen "on behalf of UCSD."
See
Exhibit C at A ttachment B, p. 3. Further, the NOA expressly
15
rovides that a principal investigator such as Defendant Aisen m ay not transfer the ADC S project
16
o another host institution w ithout first securing advance approval from the N IH and a w ritten
17
elease by 1JCSD approving the transfer.
Id.
at Attachment B, p. 13. Representatives of NIH
18
ave confirmed, following Dr. Aisen's resignation, that "UCS D is the grant holder and retains
19
ustody of the data."
20
5 .
n short, the contracts governing the ADCS make it abundantly clear that the data
21
enerated by ADCS studies is to be maintained under the control of UCSD for the benefit of the
22
tudy sponsors and The Regents, who are the owners of the data. There is no plausible
23
nterpretation of the governing contracts that would accord D efendant Aisen or any of the
2 4
ndividual Defendants the right, privilege, or pow er to assume control of AD CS data after
25
evering their employment from UCSD, but this is exactly what Defendants have done.
2 6
6.
hile still employed by U CSD , Aisen and one or m ore of the Individual
2 7 Defendants, conspired to arrange for ADC S data to be hosted on an Amazon accou nt in the name
2 8
f a party other than UCSD , presumab ly one or more of the Individual Defendants, or persons
9
COMPLAINT FOR MONEY DAMAGES AND EQUITABLE RELIEF
CROWELL
MORING LLP
ATIOPNEY9 AT LAW
SFACTIVE-903728301. I
7/21/2019 Regents of the University of California v. Aisen (USC) - Complaint
http://slidepdf.com/reader/full/regents-of-the-university-of-california-v-aisen-usc-complaint 11/87
under their control. The account bears Amazon Account No. 67 5 7 1342 864 6. According to
UCSD accounting records, Amazon had invoiced UCSD , and The R egents has paid,
approximately $96,000 for the m aintenance of this account.
37.
After the resignations of Defendant Aisen and the other Individual Defendants,
representatives of UCSD made repeated requests that the Defendants turn over to UCSD all
account data, passw ords, and access credentials for any and all repositories holding AD CS data,
including Amazon Account No. 67 5 7 1342 864 6. The Individual Defendants failed to respond in
any substantive or meaning ful way, and have failed and refused to relinquish control of ADCS
data.
38.
On Sunday, June 28, 2 015, UCSD Dean and Associate Vice Chancellor Gary S.
Firestein, M.D., sent an urgent message to his counterpart at USC, Associate Dean for Clinical
Research Thomas Buchanan, stating, "Since Dr. Aisen is now an employee and agent of USC , w e
fomially request your assistance in directing D r. Aisen to turn over to UCSD all account data,
passw ords, and access credentials for any and all repositories holding A DC S data, of wha tever
kind or nature." Dr. Firestein's message was referred to USC Provost Michael Quick for
response. Mr. Quick responded on Monday, June 29, 2 015 , "I w ill assume that this issue of
access to data, etc., will get resolved today," but took no steps to do so, and the D efendants
continue to assert dominion and control over ADCS data.
39. UCSD has attempted to gain access to the Account No. 67 5 7 1342 864 6 through
Amazon; however, Amazon advised that, because the account is not held in the name of UCSD,
that Amazon regarded the account as "owned" by someone else, and Amazon's internal policies
prevented Amazon from identifying the "account holder," permitting UCSD to reset the password
to the account, or granting UCSD administrative control over the account. Amazon suggested
that UCSD either obtain the password from the "account holder," or get a court order. UCSD has
continued to work with Amazon in an attempt to gain full access and control over the account.
40.
The Defendants' exercise of dominion and control over ADCS data, including
Amazon Account No. 675 7 1342 864 6, causes harm to The Regents and to the ADCS in the
following ways:
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CROWELL
MORING LLP
ATTORNEYS AT LAW
COMPLAINT FOR MONEY DAMAGES AND EQUITABLE RELIEF
10
5FACTIVE-903728301.1
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a.
ecurity patches and other maintenance operations such as software
upgrades cannot be conducted.
2
b. ystem m onitoring is not possible, increasing the risk of hacker attacks and
3
ata breaches.
4
.
anagement of user accounts including the creation of new accounts,
updating permissions for existing accounts and rem oval of deprecated
5
ccounts is not possible leading to potential security vulnerabilities.
d.
Randomization codes may not be accessible, safety monitoring can be
compromised.
e.
Access to the ba ckend database is not possible, thus restricting reports to
8
hose that can be obtained through the existing web- based system.
9
.
he codeba se cannot be inspected for potential security vulnerabilities
including potential backdoors into the system.
10
g.
he type or amount of services procured from Amazon cannot be
1 1
ontrolled hence leading to potential abuse of acc ount billing.
12
.
ll data are at risk for irreversible m anipulation, duplication and/or
deletion and the creation of local snapshots for data backup/history is not
1 3
ossible.
41.
As a result of the conduct alleged herein, The Regents have suffered damages, and
will continue to incur damag es, in ways that w ill be subject to proof at trial.
FIRST CAUSE OF ACTION
(BREACH O F FIDUCIARY DUTY - AGAINST DEFENDANT AISEN)
42.
The R egents incorporates herein, by w ay of reference, all other paragraphs set forth
in this Com plaint in support of this cause of action.
43.
By virtue of being entrusted to act as The R egents' agent in serving as Director of
the ADCS, Defendant Aisen was a fiduciary to The Regents and owed fiduciary duties.
44.
Defendant Aisen breached his fiduciary duties by committing the acts complained
of herein.
45.
As a direct and proxim ate result of Defendant Aisen's w rongful and tortious
conduct, Defendant Aisen has becn unjustly enriched at the expense of The Regents, and The
Reg ents has suffered, and will continue to suffer, substantial damag es including, but not limited
to, costs incurred recovering data ow ned or controlled by The R egents, the loss of property owned
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ROWELL
MORING LLP
ATToRNEts Ai LAW
COMPLAINT FOR MONEY DAMAGES AND EQUITABLE RELIEF
5FACTIVE-903728301.I
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THIRD CAUSE OF ACTION
(INTERFERENCE WITH CONTRACTUAL RELATIONS - AGAINST
AISEN, PIZZOLA, TOBIAS, USC, AND DOES 1-2 5 )
50.
The R egents incorporates herein, by w ay of reference, all other paragraphs set forth
in this Com plaint in support of this cause of action.
51.
Valid contracts existed between The Regents and ccrtain third parties.
52.
Defendants knew of the existence of said contracts.
53.
Defendants intended to disrupt the performance of the contracts between The
Regents and certain third parties.
54.
Defendants' conduct made it more expensive and difficult for The Regents to
perform under its contracts w ith third parties, and, unless corrective action is taken by the court,
The R egents w ill likely be unable to perform at all under its contracts.
55.
By way of specific example, but not limitation, by exercising dominion and control
over Cloud-based storage accounts and preventing The Regents from exercising administrative
control over the data contained therein, Defendants h ave m ade it m ore difficult, if not impossible,
for The Regents to comply with Sections 16.1 of the Lilly Clinical Trial Agreement, which
requires UCSD to capture and maintain Study Data jointly with Lilly. Further, Defendants'
actions have made it difficult, if not impossible for The Regents to comply with Section 17.3 of
the Clinical Trial Agreem ent, which forbids either party from disclosing the confidential
information of the other.
56.
Defendants engaged in independently wrongful acts of conduct which violated
common and statutory law and which interfered with performance of the contracts and made The
Regents performance more expensive and burdensome. The full extent of Defendants' wrongful
conduct w ill be show n at trial after the opportunity for discovery,
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ROWELL
& MORING LLP
AMAMI Ai LAW
SFACTIVE-903728301.1
COMPLAINT FOR MONEY DAMAGES AND EQUITABLE RELIEF
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FOURTH CAUSE OF ACTION
(INTENTIONAL INTERFERENCE WITH PROSPECTIVE ECONOMIC
ADVANTAGE — AGAINST ALL DEFENDANTS)
57.
The R egents incorporates herein, by w ay of reference, all other paragraphs set forth
in this Com plaint in support of this cause of action.
58.
Economic relationships existed between The Regents and the sponsors of the
ADCS, including Lilly, Toyama, and the NIA, containing a past and probable future economic
benefit or advantage to The Reg ents.
59.
Defendants knew of these relationships.
60.
Defendants intended to interfere with these relationships in order to foster their
own relationship with the AD CS sponsors, and the relationship between the Individual
Defendants and Defendant USC.
61.
As described m ore fully above, Defendants engaged in tortious and wrongful
conduct, including the conversion of UCSD property, damage to UCSD's network and systems.
62.
As a result of Defendants' tortious conduct, The Regent's relationship with the
ADC S program sponsors w as disrupted and UCSD has been harmed in w ays that will be shown at
t
rial. Defendants' conduct was a substantial factor in causing The Regent's harm.
FIFTH CAUSE OF ACTION
(COMMISSION OF COMPUTER CRIMES PURSUANT TO CALIFORNIA PENAL
CODE SECT ION 502 (C) AGAINST ALL DEFENDANTS)
63.
The R egents incorporates herein, by w ay of reference, all other paragraphs set forth
in this Complaint in support of the above- referenced cause of action.
64.
The acts described above, including the know ing and unauthorized actions and
attempts to access and download from The Regents' databases and other information stored on
The R egents' computers and com puter systems by D efendants, constitute a violation of one or
more of the following provisions of the California Penal Code, Section 502, which imposes
liability on one w ho:
• K nowingly accesses and w ithout permission alters, damages, deletes, destroys, or
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CROW ELL
MORING LLP
ATTOIMEt9 AT LAW
COMPLAINT FOR MONEY DAMAGES AND EQUITABLE RELIEF
14
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otherwise uses any data, computer, computer system, or computer network in order
2
o either (A) devise or execute any scheme or artifice to defraud, deceive, or extort,
3
r (B) w rongfully control or obtain m oney, property, or data;
4
nowingly accesses and without permission takes, copies, or makes use of any
5
ata from a computer, computer system, or computer network, or takes or copies
6
ny supporting docum entation, whether ex isting or residing internal or external to
7
computer, computer system, or computer netw ork;
8
nowingly and without permission uses or causes to be used computer services;
9
K nowingly accesses and w ithout permission adds, alters, damages, deletes, or
10
estroys any data, computer software, or computer programs winch reside or exist
1 1
nternal or external to a computer, computer system, or computer network;
12
nowingly and without permission provides or assists in providing a means of
1 3
ccessing a com puter, computer system , or computer netw ork in violation of this
14
ection;
1 5
nowingly and without permission accesses or causes to be accessed any
16
omputer, computer system, or computer network; or
17
nowingly introduces any computer contaminant into any computer, computer
18
ystem, or computer network.
19 5 .
s a direct and proximate result of Defendants' wrong ful conduct, Defendants
20 have been unjustly enriched, and The Regents has been harmed and The Regents has sustained
21
amag es in an amount to be proven at trial.
2 2
6.
he Reg ents also has suffered irreparable harm as a result of Defendants' activities
2 3
nd w ill continue to suffer irreparable injury that cannot be adequately rem edied at law unless
2 4
efendants, and their officers, agents and employees, and a ll other persons acting in conceit with
25
hem, are enjoined from eng aging in any further such acts.
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1 5
COMPLAINT FOR MONEY DAMAGES AND EQUITABLE RELIEF
CROwEic
& MORtNG LLP
Al7ORNEIS AT LAW
SFACTIVE-903725301.1
7/21/2019 Regents of the University of California v. Aisen (USC) - Complaint
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SIXTH CAUSE OF ACTION
(CONVERSION- ALL DEFENDANTS)
67.
The R egents incorporates herein, by w ay of reference, all other paragraphs set forth
in this Complaint in support of the above-referenced ca use of action.
68.
The Regents owned all data related to the ADCS project, as well as the data and
contents of Amazon Account No. 675 7 1342 864 6, and the data contained on the UCSD laptop
computers issued to the Individual Defendants ("the ADCS Data").
69.
The Defendants, and each of them, have wrongfully exercised dominion and
control over the ADC S Data, and have intentionally and substantially interfered w ith The
Regents' ownership of the ADCS Data, as more fully in paragraphs 28-40 of this Complaint.
70.
As a direct and proxim ate result of the wrongful and tortious conduct of
Defendants as alleged herein, Defendants have been unjustly enriched and The Regents has
suffered, and w ill continue to suffer, substantial dama ges including, but not lim ited to, costs
incurred recovering data owned or controlled by The Regents, the loss of property owned by the
Regents, and costs incurred with repairing and monitoring UCSD's network, and in other ways
t
hat will be shown at trial. Defendants' actions were a substantial factor in causing The Regents'
harm.
SEVENTH CAUSE OF ACTION — ADDENDUM TO ALL CAUSES OF ACTION
(CIVIL CONSPIRACY — ALL DEFENDANTS)
71.
The R egents incorporates herein, by w ay of reference, all other paragraphs set forth
in this Complaint in support of the above- referenced cause of action.
72.
Defendants, and each of them, were aware the Defendant Aisen and Defendant
USC planned to interfere with The Regents' contractual and economic relations with the NIA,
with ADCS sponsors, and with UCSD employees, and that they planned for Dr. Aisen to act as a
double-agent by advancing his personal interests and those of USC while he was still employed
by The R egents.
73.
Defendants, and each of them, with full knowledge and intent and without
justification, agreed to act in concert with Defendants Aisen and USC to commit the tortious acts
CROWELL
&MORINO LLP
ATTOANLY3 AT LAW
16
COMPLAINT FOR MONEY DAMAGES AND EQUITABLE RELIEF
5FACTIVE-903728301.1
7/21/2019 Regents of the University of California v. Aisen (USC) - Complaint
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against The R egents described in this C omplaint in order to further their personal financial gain
2 and to aid in the formation of their new 'venture, and to harm T he Regents and U CSD .
3
4 .
s a result of the w rongful and tortious conduct of Defendants as alleged herein,
4 Defendants have been unjustly enriched and The R egents has suffered, and will continue to suffer,
5
amages in ways and amounts that will be shown at trial.
6
HERE FORE , The R egents prays for Judgment against Defendants and each of them as
7 ollows:
8
.
or compensatory damag es, according to proof;
9
.
or preliminary and perm anent injunctive relief;
10
.
or restitution and/or disgorgement of profits;
1 1 .
or attorneys' fees;
12
.
or costs of suit incurred herein;
13
.
or a trial by jury; and
14 .
or such other and further relief as the Court m ay deem proper.
15
ATED: July 2 , 2 015
ROWELL 8 c MORING LLP
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y:
J. Daniel Sharp
18
ark A. Romeo
Derek S. Hecht
19
Attorneys for Defendant
The R egents of the University of California
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R O W E L L
Moinyc LLP
ATTORNEYS AT LAW
COMPLAINT FOR MONEY DAMAGES AND EQUITABLE RELIEF
5FACTIVE-903728301.1
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EXHIBIT A
7/21/2019 Regents of the University of California v. Aisen (USC) - Complaint
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Clinical Trial Research Collaboration Agreement
This Clinical Trial Research Collaboration Agreement ("Agreement") is entered into between Eli Lilly
and Company, an Indiana corporation ("Lilly"), and The Regents of the University of California, on
behalf of the University of California-San Diego Campus, on behalf of the Alzheimer's Disease
Cooperative Study) ("UCSD").
Introduction and Scope
WHEREAS, Lilly is committed to research and development in various therapeutic areas, including
Alzheimer's disease ("AD");
WH EREAS, U CSD possesses the comm itment and expertise to plan, engage in, and oversee the conduct
of research studies related to AD;
WHEREAS, UCSD and Lilly desire to work cooperatively in order to advance research in the AD field
by combining each party's expertise and commitment to making strides in this challenging disease state;
WHEREAS, UCSD and Lilly intend to work as partners throughout the clinical research contemplated
under this Agreement, including study design, study conduct, and data analysis;
WHEREAS, the clinical research contemplated under this Agreement is intended to involve Lilly's
investigational drug product solanezumab and Florbetapir F18 Injection, and Lilly will serve as the
regulatory sponsor of the study under applicable laws and regulations;
WHEREAS, the clinical research contemplated under this Agreement will be funded by a number of
public and private sources, including the National Institutes of Health ("NIH "), Lilly, and several
philanthropic organizations; and
WHEREAS, the clinical research contemplated under this Agreement is of mutual interest and benefit to
Lilly and UCSD and will further the research and development objectives of both parties.
NOW THEREFORE, in consideration of the mutual covenants contained in this Agreement, and other
good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the
parties, intending to be legally bound, agree as follows:
Section 1
efined Terms
1.1
apitalized terms are defined in the attached Exhibit A.
1.2
or the purposes of this Ag reement, Lilly includes Avid R adiophannaceuticals, Inc, a
wholly owned subsidiary of Eli Lilly and Company.
Section 2
ackground
2.1
illy is a research-based company that develops, manufactures, markets, and sells
pharmaceutical and animal health products.
2.2
he Alzheimer's Disease Cooperative Study ("ADC S") is a cooperative agreement
betw een the National Institute on Aging and the University of California, San Diego.
ADCS works to facilitate the discovery, development and testing of new drugs for the
treatment of AD.
Page 1 of 40
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2.3
illy and UCSD wish to enter into this Agreem ent in order to facilitate a clinical research
study involving the Study Drugs in the field of AD, especially in brain amyloid elevated,
preclinical AD.
2.4
illy will serve as the regulatory sponsor for the Study for purposes of interacting with
regulatory authorities, and UC SD and L illy will be jointly conducting the study. The
nature of the collaboration is further outlined in the joint leadership group mem o, which is
attached as Exhibit F.
2.5
tudy Leadership. The A4 Partnership Leadership Team shall govern the study and shall
endeavor to reach con sensus on all decisions w ithin its jurisdiction, as further described in
Exhibit G.
Section 3
cope of Agreement
3.1
ssignment of Ob ligations. This Agreement serves to assign to Lilly and to UCSD certain
responsibilities imposed by applicable regulations that are outlined in this Agreeme nt and
its exhibits in connection with the conduct of the Study. UCSD and Lilly plan to work as
partners throughout the Study, including study design, study condu ct, and data analysis.
3.2
erformance Period. The effective period of this Agreement w ill be from the date of
execution of this Agreemen t until completion of the obligations established in this
Agreement and the Protocol, unless otherwise terminated in accordance with Section 11.
The effective period may be ex tended by the m utual written consent of the parties hereto.
3.3
ther Parties. Additional parties may provide in-kind and/or philanthropic support for the
Study only upon approval by Lilly, which may be withheld only in the event support would
jeopardize or conflict with Lilly's responsibilities as the regulatory sponsor or w ould result
in a conflict of interest. In addition, such support shall not be accepted from any
individuals, groups, or entities that appear on any go vernment list of restricted, sanctioned,
denied, or debarred parties.
UCSD's Rights and Obligations
Section 4
CSD's General Obligations
4.1
rotocol. UCSD s hall exercise reasonable efforts to conduct and manage the multi-c enter
clinical study as set forth in the Protocol, which w ill be agreed to by Lilly and UCSD as
soon as possible after this Agreement is signed and w hich will be attached as Ex hibit H
("the Protocol"). In the event of inconsistency between this A greement and the Protocol
and Study Operations Manuals, the terms of this Agreement shall govern, except that the
terms of the Protocol and Study O perations Manuals shall govern w ith respect to matters of
science, medical practice, and subject safety. In the event of inconsistency betw een the
Protocol and Study O perations Manuals, the Protocol shall govern.
4.2
hanges to Protocol and Operations Manuals. Unless there is an amendment needed for
urgent safety reasons, changes in the Protocol and Study Operations Manuals may be made
only through prior written agreement between Lilly and UCSD and, in the case of the
Protocol, may be implemen ted only after approval is granted by the applicable Institutional
Review Board ("TRW'). All changes to the Protocol and Study Operations Manuals
necessary for the safety of subjects shall be implemented immediately upon A4 Partnership
Leadership Team instruction and the applicable IRB approval.
Page 2 of 40
Ex.
A ,
Pg. 19
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4.3
CSD sh all conduct the Study under the direction of Clinical Investigator, in accordance
with the Protocol, the terms and conditions of this Agreement, and all Applicable Laws.
4.4
he roles and responsibilities of UCSD in conducting and managing the Study are set forth
in Exhibit B . UC SD shall m ake available all personnel, facilities, and resources necessary
to efficiently and expeditiously accom plish its responsibilities under this Agreem ent.
4.5
harmacoviailance. UCSD will fulfill pharmacovigilance responsibilities listed in Exhibit
B and detailed in the Safety Plan (Exh ibit [J]), which w ill be in place prior to Study
enrollment. Obligations include notification of Lilly within twenty- four (24 ) hours of
receiving notification of any Serious Adverse Event (SAE) experienced by a subject
participating in the Study and receiving the Study Drug s.
4.6
linical Investigator. The Clinical Investigator is Paul Aisen, M.D., w ho w ill serve as
Investigator for the Study, as defined in 21 C .F.R. § 312 .3. The Clinical Investigator is
responsible for the management and direction of the Study in accordance with the Protocol,
and all Applicable Laws.
4.7
f for any reason, Dr. Aisen is unwilling or unable to continue to serve as C linical
Investigator and a successor who is acceptable to both Lilly and UCSD is not available, this
Agreem ent may be terminated as provided in Section 11. Prior to the comm encement of
the Study, UC SD shall provide to Lilly true, complete and correct copies of Dr. Aisen's
investigator statement on FDA Form 15 7 2 and curriculum vitae.
4.8
f for any reason the intended Project Director, Dr. Reisa Sperling, is unwilling or unable to
continue to serve as Project Director and a successor w ho is acceptable to both L illy and
UCSD is not available, this Agreement may be terminated as provided in Section 11.
4.9
CSD may contract with Participating Sites and sub-Investigators to conduct the Study.
Any Participating Site and sub- investigator used shall be subject to all of the terms and
conditions of this Agreement applicable to UCSD, and UCSD shall ensure that each
Participating Site and sub-investigator is aware of such terms and conditions. UCSD shall
ensure that each contract w ith a Participating Site and sub -Investigator includes a
representation that the Participating Site or sub- Investigator is not subject to any
obligations that would prevent it from complying with the applicable terms of this
Agreem ent. UCSD shall also ensure that each Participating Site signs the Investigator
Letter UCSD shall ensure that any sub-award contracts with Participating Sites and sub-
investigators are consistent with the relevant terms of this Agreem ent.
4.10
nstitutional Review Board. UC SD shall provide to Lilly documentation verifying review
and approval by the ap plicable IRB of the information to be provided to p otential subjects
of the Study to secure their informed consent, including information ab out any
compen sation being provided to Sub jects for participation in the Study, and the Protocol.
UCSD shall ensure that any applicable IRE(s) continues to monitor the Study during the
term of this Agreement in accordance with Applicable Laws and in any event at least once
per year and shall provide Lilly with docum entation of any applicable IRB's continuing
review contem poraneously therewith. UCSD shall promptly notify Lilly if any IRB takes,
or proposes, threatens or gives notice of its intent to take, any action that could reasonably
be expec ted to affect any duties or clinical activity under the Study , including the safety or
welfare of any Subject.
4.11
nformed Consent. UCSD shall obtain the informed consent of each Subject participating in
the Study in accordance w ith 21 C.F.R. parts 50 and 5 6, including the completion of an
informed consent form. Such form shall be reviewed and approved in advance by UC SD,
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Lilly, and the appropriate IRB, prior to any Subject's screening o r participation in the
Study. Each informed c onsent shall include (a) safety profiles for the Study Drugs, as
provided by Lilly unless an IRB requires changes, and Lilly consents to such ch anges, (b) a
description of the situations under which Subjects w ill be reimbursed for treatment of
injuries related to their participation in the Study, and (c) data privacy terms that secure
access and usage rights to Study Data and biological samples as described in Sections 16
and 17.
4.12
inancial Disclosure Information. At Lilly's request, UCSD shall cause Clinical
Investigator to promptly provide to Lilly (a) financial disclosure statements in com pliance
with 21 C.F.R. Part 54, in the form required by Lilly and (b) such other financial
information as Lilly m ay reasonably request for the sole purpose of fulfilling its regulatory
responsibilities, including information docum enting the am ounts paid to each Investigator
participating in the Study. During the term of the Study and for a period of one (I) year
thereafter, UCSD shall cause Clinical Investigator and any Sub-Investigators to promptly
notify Lilly in writing of any substantive changes to su ch financial information.
4.13
roject Personnel. UCSD shall ensure that its personnel receive appropriate training,
including any training required by Applicable Laws or consistent with established ADCS
SOP, and the specifics surrounding the confidentiality obligations stated under Section 17 .
UCSD shall maintain accurate and current records of all training activities and retain such
records in accordance with the terms of this Agreement.
4.14
hanges in Services or Deliverables. If A4 Partnership Leadership Team ag rees to make
changes to the Study that alters the scope of work required under this Agreement or
otherwise makes modifications hi the Services or Deliverables being provided by UCSD,
UCSD and Lilly shall agree in writing on the resulting change an d the related costs or
savings, if any.
4.15
rants. UCSD shall be prohibited from establishing a clinical grant with an Investigator on
the behalf of Lilly that uses the outcome of the Study as a basis for com pensation or
requires payments to a spouse or dependent children.
4.16
onditions of NIH Funding. UC SD shall have sole responsibility for ensuring that the
conduct of the Study meets any requirements imposed by the NIH as a condition of
receiving a grant for partially funding the Study.
4 .17
nti-Bribery/Foreign Corrupt Practices A ct. In carrying out its responsibilities under this
Agreement, UCSD agrees to comply with all applicable anti-bribery laws in the countries
where UCSD has its principal place of business and where UCSD conducts activities under
this Agreement. Additionally, UCSD understands and agrees to comply w ith the U.S.
Foreign Corrupt Practices Act, as revised, w hich generally prohibits the offer, promise,
paym ent or giving of anything of value either directly or indirectly to any governm ent
official for the purpose of obtaining or retaining bus iness or any improper advantage. For
purposes of this section, "g overnment official" m eans any official, officer, representative,
or employee of, including any doctor employed by, any non-U.S. government department,
agency or instrumentality (including any government-owned or controlled commercial
enterprise), or any official of a pub lic international organization or political party or
candidate for political office. Additionally, if UC SD or any of its owners, directors,
employees, agents, and consultants are government officials, UCSD agrees that Lilly's
payment of UCSD in connection with this Agreement is not intended to influence any
decision that any individual may m ake in his or her capacity as a governm ent official.
UCSD further represent that neither UCSD nor any of its owners, directors, employees,
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agents, or consultants w ill directly or indirectly offer to pay, promise to pay or give
anything of value to any g overnment o fficial for purposes of (a) influencing any act or
decision of such governm ent official in his official capacity; (b) inducing such governm ent
official to do or omit to do any act in violation of the law ful duty of such official; (c)
securing any imp roper advantage; or (d) inducing such gove rnment official to use his
influence with the governm ent or instrumentality thereof to affect or influence any act or
decision of the governm ent or such instrumentality w ith respect to any activities undertaken
relating to this Agreement. Additionally, UCSD will make reasonable efforts to comply
with requests for information, including answering questionnaires and narrowly tailored
audit inquiries, to enable Lilly to ensure compliance w ith applicable anti-bribery laws and
any applicable provisions of the Anti Bribery Commitments as revised by Lilly from time
to time and pub lished at http://supplierportal.lillv.com
or otherwise made available to
UC SD, to the extent consistent with UC policies. UC SD agrees that Lilly's payment to
UCSD in connection with the Services or Deliverables to be provided under this Agreement
is not intended to influence any decision UCSD may make regarding the prescription of
Lilly medicines or to otherwise influence any pend ing or future Lilly business.
Section 5
CSD's Certifications, Representations and Warranties
5.1
CSD certifies that:
5 .1.1 Neither UCSD nor any other Person who provides Services or Deliverables for
Lilly or satisfies any other obligation of UC SD under this Ag reement is prohibited
from doing so by any legal obligation or restriction, including any Applicable Laws
or contractual comm itment.
5 .1.2 U CSD's performance under this Agreement com plies with all Applicable Laws and
with any relevant description or specification in this Agreement.
5 .1.3 Services and Deliverables will be rendered w ith at least that degree of skill and
competence reasonably expected of, and in accordance with any codes of conduct
commonly recognized by, Persons who perform similar Services in the country in
which the Services are performed.
5.1.4
bligations of Clinical Investigator. Clinical Investigator is, and at all times during
the course of the Study shall be, qualified, by training and experience, and w ith
appropriate expertise to conduct the Study. UC SD shall cause C linical Investigator
and Participating Sites and sub-investigators to perform the Study appropriately,
professionally and efficiently, which includes: (a) exercising independent medical
judgment as to the compatibility of each Subject with the Protocol requirements;
(b) ensuring that each Subject is provided with information about the Study, has
been given an opportunity to ask questions about the Study and his involvement,
and has received answers to all such questions; (c) ensuring that UCSD has
obtained the informed conse nt of each of the Subjects participating in the Study;
(d) reviewing all case report forms for accuracy and com pleteness; (e) submitting
all Study Data in a timely manner; (f) notifying UCSD's IR B imm ediately of any
unanticipated or serious adverse reactions to the Study Drug; (g) m aintaining
adequate and correct records of Subject identification, clinical observations,
laboratory tests and drug receipt and disposition; (h) cooperating w ith Lilly in all of
its efforts to monitor the Study; and (i) notifying UCSD immediately of any SAEs.
5 .1.5 Licenses, Approvals and Certifications. UCSD and Clinical Investigator have, and
at all times during the course of the Study shall have, the appropriate licenses,
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Section 6
approvals and certifications necessary to safely, adequately and law fully perform
the Study.
5 .1.6 Absence of Conflicts. No UCS D personnel or Clinical Investigator or any other
person involved in performing the S tudy is, or at any time du ring the course of
their involvement with the Study shall be, subject to any conflicting obligations or
is party to any conflicting arrangements that might interfere with the performance
of the Study or that might impair the acceptance of the resulting data by the FDA.
5 .1.7 U CSD and Clinical Investigator are entering into a collaborative arrangement w ith
Lilly to conduct the Study b ased on the scientific merits of the project and not, in
any w ay, as an inducem ent to, or in return for, past, present or future prescribing,
purchasing, recommending, using, dispensing or granting preferential formulary
status for any Lilly product.
5 .1.8 Privacy and H 1PAA. U CSD represents, warrants and covenants that it and Clinical
Investigator are "Covered Entities" under the provisions of the Health Insurance
Portability and Accountability Act of 1996 and any regulations and official
guidance promulgated thereunder ("HIPAA" ). UCSD shall, and shall cause
Clinical Investigator to, handle all Study Data (including Subjects' me dical
records) in accordance with HIPAA requirements and all other Applicable Laws
and shall ensure that they obtain from each Sub ject a valid authorization that
complies with HIPAA, and is, in form and substance, acceptable to Lilly,
permitting UCSD and Clinical Investigator to provide Lilly with the Study Data as
contemplated hereby and to satisfy their other obligations under this Agreement
with respect to the Study D ata or with the applicable provisions of Lilly's Vendor
Privacy and Security Standard as revised by Lilly from time to time and published
at htto://supolierportal.com
or otherwise made available to UCSD and to the extent
consistent with UC policy. UCSD acknowledges and agrees that no component of
Lilly or any of its affiliates that will be performing Lilly's obligations under this
Agreement (a) is a "Covered Entity" for purposes of HIPAA, (b) will become a
"Business Associate" of a Covered Entity for purposes of HIPAA by performing its
obligations under this Agreement, or (c) is otherwise governed by HIPAA.
Debarment and Exclusion from Certain Health Care Programs
6.1
CSD represents and warrants that it has not been:
6.1.1 Debarred by the FDA under any provision of the Generic Drug Enforcement Act;
6.1.2 E xcluded by the O ffice of the Inspector General of the United States Department of
Health and Human Services, or by any other authority, from participating in any
health care program (such as Medicare or Medicaid) funded by any Governmental
Authority; or
6.1.3 . Deb arred or disqualified from participating in clinical research by any other
Governmental Authority.
6.2
CSD agrees that no Person who has been debarred or excluded as described above will
furnish any of the Services or Deliverables or perform any of UC SD's obligations under
this Agreement.
6.2.1 UCSD will immediately notify Lilly in writing of any actions taken or proceeding
pending that threatens or confirms a debarment or exclusion of any such Person.
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Lilly's Rights and O bligations
Section 7
illy's General Obligations
7.1
illy shall be the Sponsor of the Study, as defined in 2 1 C.F.R . § 312 .3. For the purpose of
the study UCSD and Lilly plan to work as partners throughout the A4 study, including
study design, study conduct, and data analysis.
7 .2
he roles and respon sibilities of Lilly are set forth in E xhibit B.
7.3
ubject to UCSD's material compliance with its obligations under this Agreement, Lilly
will provide partial funding in support of the Study in accordance w ith Exhibit I.
7 .4
illy shall be responsible for obtaining all necessary reg ulatory approvals for the condu ct of
the Study. Lilly will keep UC SD informed regarding the status of regulatory approvals.
7.5
illy shall be responsible for com plying w ith applicable requirements to register the Study
and results on clinicaltrials.gov
or any other database for w hich registration is required by
Applicable Law s. Any such results will be calculated using a mutually agreed upon
statistical analysis plan.
7.6
illy may contract w ith contract research organizations or other third parties to conduct the
Study. Any vendor or CR O used shall be sub ject to all of the terms and conditions of this
Agreement applicable to Lilly, and Lilly shall ensure each is aware of such applicable terms
and conditions.
Section 8
rovision of Study Drugs
8.1
erms of Supply. Lilly shall provide UCSD w ith the Study Drugs free of charge, in
accordance w ith the Protocol, solely for UCS D's performance of the Study. Lilly retains
all right, title and interest (collectively, "Rights") in and to the Study D rugs. UC SD shall
not, without L illy's prior written permission, (i) use the Study Drugs for any purpose other
than the performance of the Study, (ii) provide the Study Drugs to any third party (except a
contract research organization or other third party receiving Study Drugs und er the
Protocol), or (iii) take the Study Drugs to any location other than an investigational study
site. UCSD shall not, and shall cause Clinical Investigator not to, modify or alter the Study
Drugs in any m anner. Upon termination or completion of the Study, UC SD shall, at Lilly's
direction, either return to Lilly any quantities of unused Study Drugs, or dispose of the
same, in any event in accordance w ith Lilly's written instructions. UCSD shall m aintain
comp lete and accurate records relating to the disposition of all Study Drugs supplied to
UCSD.
8.2
isclaimer. Without limiting Lilly's obligations under section 22 , LILLY DOES HEREB Y
DISCLAIM ANY AND ALL WARRANTIES, WHETHER W RITTEN OR ORAL,
EXPRESS OR IMPLIED, WITH RESPECT TO THE STUDY DRUG, INCLUDING ANY
WARRANTY OF QUALITY, PERFORMANCE, MERCHANTABILITY OR FITNESS
FOR A PARTICULAR USE OR PURPOSE, OR THAT THE USE OF THE STUDY
DRUG (FOR PURPOSES OTHER THAN THOSE CONTEMPLATED BY THIS
AGREEMENT) WILL NOT INFRINGE THE RIGHTS, PATENT OR OTHERW ISE, OF
ANY THIRD PARTY.
Section 9
illy's Representations and Warranties
9.1
illy represents and warrants that:
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9.1.1 Neither Lilly nor any other Person who performs any obligation of Lilly under this
Agreement is prohibited from doing so by any: (a) Applicable Laws; (b) covenant
not to com pete; (c) contract to deal exclusively with another Person; or (d) other
legal or professional obligation or restriction.
9.1.2 T he performance of Lilly's responsibilities under this A greement and Lilly's use of
the Services and Deliverables comply with all Applicable Laws.
Payments
Section 10 UCSD's Invoices
10.1
chedule. Except to the extent provided by the Statement of Work (Exhibit B) or the
Budget (Exhibit I), UCSD will submit invoices on the following schedule:
10.1.1 For hourly fees, for unit-based fees, and for reimbursement of expenses: once a
month, as accrued or incurred.
10.1.2 For fixed fees: after Lilly has received and accepted all Services and Deliverables
subject to the fixed fee.
10.2
orm and Supplemental Information. Each invoice submitted by UCSD must comply with
Lilly's standard forms and procedures (as changed from time to time), to the extent
consistent with UC SD's standard invoice, and published on the intemet at
lutp://supplierportaLlilly.com
and with any specific requirements in this Agreement. Lilly
may at any time request additional invoice information as needed. As requested, each
invoice will be hccompanied by any information required by this Agreement or that Lilly
may reasonably request, including detailed information for any amounts of Taxes UCSD is
collecting from L illy.
10.3
urrency. Invoices will be stated in United States Dollars.
10.4
ayment Term s. Payment w ill be due sixty (60) days after Lilly's Accounts Payable
Department receives an invoice that complies with the requirements of this Agreement,
except that Lilly may withhold payment of any amount that it may reasonably dispute in
good faith until such dispute is resolved. Payment by electronic transfer will be made on
the payment date. Payment by check w ill be mailed on the payment date.
10.5
urrency. Payment w ill be in United States Dollars.
10.6
he funding agreed to by Lilly pursuant to this Agreement is based on 1,000 subject
enrollment only. Any increase to the subject population due to sample size re-estimation
will be made only by written agreement between Lilly and UCSD. Additional funding by
Lilly as a result of this re-estimation will occur only by written agreement between Lilly
and UCSD.
Right to Terminate
Section 11 Termination of Agreement
11.1
his Agreement may b e terminated by either party upon thirty (30) days' prior Niiritten
notice if the other party m aterially breaches any of its obligations or p rovisions of this
Agreement and has not cured the breach during such period.
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11.2
CSD may terminate this Ag reement on ninety (90) days' prior written notice if it is not
financially, adm inistratively, or scientifically feasible for UCSD to continue the S tudy.
11.3
illy may terminate this Agreem ent on ninety (90) days' prior written notice if for any
reason Lilly deem s its sponsorship of the S tudy no long er financially or scientifically
feasible, including if UCSD fails to timely obtain N11-1 funding in the amount of $36
million or if Lilly determines, as a result of a pre-Study enrollment audit, that UCSD does
not possess the necessary facilities, personnel, or abilities to adequately perform its
obligations under this Agreement.
11.4
his Agreement may be terminated immediately: (a) for safety reasons as in good faith
determined by either UCSD or L illy, (b) if the FDA requests the Stud y be terminated, (c) if
UC SD's IRE orders the Study terminated, or (d) the Drug Safety M onitoring Board
recommends this course of action in accordance with the charter.
11.5
pon termination for any reason, Lilly shall promptly provide paym ents for all work
completed and non cancellable costs incurred by UCSD in accordance with Exhibit I.
Upon termination for any reason, UCSD shall (a) promptly refund any amounts paid to
UCSD that exceed L illy's obligation to pay for work ac tually performed, (b) provide a
summary status report of the Study, including subjects enrolled, statement of work, and
summ ary of data collected; and (c) deliver to Lilly all unused Study Drug s and any other
information or property in the possession or control of UCSD that was su pplied by Lilly or
derived from the Study that Lilly may request under the terms of this Agreement.
11.6
n the event that the Study is terminated under this Section, the A4 Partnership Leadership
Team shall determine an appropriate course of action with regard to winding down the
Study or w hether the Study shall continue. Except in the case of termination as a result of
an uncured breach of this Agreement by UCSD, Lilly shall reimburse UCSD for its
reasonable and verifiable direct costs incurred in connection w ith any such transfer or
winding down of the Study.
11.7
ermination of this Agreem ent by any pa rty shall not affect the rights and obligations of the
parties accrued prior to the effective date of the termination. The rights and duties under
sections 12 through 17, 19, and 22 survive termination or expiration of this Agreement.
Information and Property Rights
Section 12
ublications
12.1
illy encourages the pub lication of Study Data in reputab le scientific journals and at
seminars or conferences. UCSD has the sole and irrevocable right, consistent w ith
academic standards, to pub lish the first manuscript containing results of the Study. This
sole right to publish the Study Data shall survive the agreem ent if Lilly should choose to
sell or otherwise relinquish its rights and property to another entity. UC SD shall be
responsible for facilitating timely disclosure of the p rimary publications reporting results of
the Study, and it is anticipated that the results of the Study w ill be published in a joint
multi-center prim ary publication including Lilly authors, as scientifically appropriate, and
consistent with the publication plan. UCSD will prepare a proposed disclosure plan for the
primary m ulticenter publication, including proposed title or topic, journal or congress, and
subm ission date for the primary multicenter publication disclosures and provide to Lilly
before database lock. UCSD will coordinate the publication of the primary manuscript to
simultaneously occur w ith the first disclosure of primary Study results at a scientific
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meeting. Submission of the primary publication is to occur no later than 6 months, unless
mutually agreed to be extended by the parties, following the Study database lock if
simultaneously pub lication and presentation is not feasible. The primary publication shall
include the results of the primary efficacy measures as prespecified in a m utually agreed
upon statistical analysis plan and may co ntain other key secondary efficacy m easures if the
parties mutually agree to such secondary efficacy measures and whether to include them
within the primary publication.
12.2
rior to submission for publication or presentation, UCSD shall provide Lilly with at least
thirty (30) days for review and com ment on the m anuscript. Lilly has the right to review all
proposed UCSD publications, manuscripts, and presentations of the results of the Study and
to require (1) the deletion of Lilly Confidential Information and/or (2 ) postponem ent of the
publication, manuscript, or presentation for no m ore than 90 days in order to protect the
Intellectual Property Rights of either party. The parties will work coo peratively to ensure
the accuracy of statem ents in registries, publications, m anuscripts, and presentations
relating to the Study Drugs.
12.3
f UCSD seeks to register the Study or publish the Study results on a web-based registry
other than clinicaltrials.gov or any other database for w hich registration is required by
Applicable Laws, UCSD shall provide Lilly with the proposed registration or publication
information at least thirty (30) days in advance, and Lilly shall have the right to review
such information and to req uire (1) the deletion of Lilly Confidential Information and/or (2 )
postponement of the release of such information for no more than 90 days in order to
protect the Intellectual Property Rights of either party.
12.4
ubject to the same review process in Section 12.2, Lilly and UCSD will each have the
right to make follow-up publications, and the parties will exercise good faith efforts to
coordinate such pu blications in order to avoid identical or overly sim ilar publications.
UCSD will provide to the A4 Partnership Leadership Team a record of all planned platform
presentations, poster presentations, or publications. Similarly, Lilly w ill provide to the A4
Partnership Leadership Team a list of all presentations or publications planned by L illy
employees at scientific meetings or in scientific journals. The A4 Partnership Leadership
Team or their designees will review and discuss the publication plans of Lilly and UCSD
on an as needed basis. A L illy publication coordinator will assist the A4 Partnership
Leadership Team and authors in com plying with any applicable Lilly publication
procedures and processes.
Section 13
illy Property
13.1
CSD a cknow ledges that Lilly ow ns the entire rights, title and interest in Lilly Intellectual
Property and certain processes, know-how, trade secrets, improvements, Records,
Confidential Information, other assets, including but not limited to, the Stud y Drug
compounds, database design and an interactive voice study drug randomization system to
assign treatments, dispense drugs, monitor clinical supply inventories and obtain data
during clinical studies (collectively "Lilly Property"). UC SD, as w ell as its Affiliates,
agents, and ven dors, shall be bound to the terms of confidentiality as set forth in this
Agreement with regard to such Lilly Property and shall not share such Lilly Property with
other sponsors for whom they may later perform w ork or other third parties. Nothing
contained in this Agreement shall be construed as a license to UCSD to any proprietary
rights of Lilly, including but no t limited to, patent rights to mak e, sell, reverse engineer, or
prepare derivative works based upon the L illy Property, or any part thereof, outside the
purposes contemplated by this Agreement.
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Section 14 UCSD Property
14.1
illy acknowledges that UCSD possesses certain processes, know-how, trade secrets,
methods, approaches, analyses, improvements, Records, Confidential Information, and
other assets, including but not limited to, clinical trial manag ement analyses, analytical
methods, procedures and techniques, computer technical expertise and proprietary
software, and technical and conceptual ex pertise in the area of conducting clinical trials, all
of which have been developed independently by UCSD without the benefit of any
information provided by Lilly (collectively "UCSD Property"). Lilly agrees that any
UCSD Property or improvements thereto which are used, improved, modified or further
developed by UCSD under or during the term of this Agreement are the sole and exclusive
property of UCSD. Ex cept as provided below, nothing contained in this Agreem ent is to be
construed as a license to Lilly under any proprietary rights of UCSD, including bu t not
limited to patent rights to make , use, sell, reverse engineer, or prepare derivative works
based upon UCSD Property, or any part thereof, outside the purposes contemplated by this
Agreement.
Section 15
ntellectual Property Rights
15.1
illy shall maintain ownership of its ex isting intellectual property related to Study Drugs
and its method of use, whether patentable or not.
15.2
o the extent legally possible, Lilly shall be granted a worldwide, non-exclusive, royalty-
free license, to any patents and patent applications that necessarily use, incorporate, or are a
result of the Study Drugs provided by Lilly pursuant to this Agreement, including any
patents or patent app lications filed by third parties as a result of acce ss to Study Data
pursuant to Section 15 .5 of this Agreement.
15.3
illy shall be free, in its sole discretion, to distribute the Study Drugs to othe rs and to use
them for its own purposes.
15.4
CSD shall use reasonable efforts to assist Lilly in complying w ith the requirements of
The Bayh-Dole Act of 1980 (Public Law 96-5 17; 35 U.S.C. §§ 200-2 12).
15.5
ubject to Sections 12, 13, 14, 16, 17, and 18 of this Agreement, and its obligations to
maintain patient confidentiality, UCSD shall have the right to m ake available, in whole and
in part, any final Study Data to third parties. Such disclosure shall not occur before
publication of the primary manuscript referenced in Section 13. Consistent w ith NIH data
sharing policies and precedents, UCSD may make the Study Data available only upon a
written request containing a prohibition on using su ch data as part of a filing with a
regulatory authority, whether for a marketing ap plication or supplement or investigational
drug application. Such written request must also contain an acknowledgement that Lilly
will retain rights to the patents and patent applications as outlined in Section 15 .2 o f this
Agreement.
Section 16 Rights to Study Data
16.1
tudy Data will be captured by UCSD and maintained jointly by Lilly and UCSD.
16.2
tudy Data w ill be jointly ow ned by Lilly and UC SD. Lilly has the right to obtain a copy
of the Study Data, as well as copies of all regulatory-required Study documentation,
including, but not lim ited to, any IRB approval notifications, investigator qualifications,
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and Study subject records, as needed to support a regulatory application or submission in
relation to Study drugs or for use as outlined under this Agreement and for other reasonable
purposes.
16.3
iological samples taken during the course of the Study w ill be retained by U CSD or Lilly
for future research purposes. Biological samples related to treatment response shall not bp
provided to any third-party without the prior w ritten authorization of Lilly which shall not
be unreasonably withheld. UCSD shall ensure that the informed consent form for the Study
informs Subjects that such samples w ill be retained by UC SD or Lilly and used for further
research but only if the Subjects opt-in for the future use. Lilly and UC SD shall have the
right to access and perform research under this Agreement on the samples related to
treatment response with prior w ritten notice to the other party. Any publications arising out
of the biological samples shall follow the pub lication process outlined in Section 12 of this
Agreement. UC SD and Lilly agree to further work through the specifics surrounding the
biological samples through amending the Statement of W ork or entering into a W ork Plan
process as outlined in this Agreement. A ny disputes related to the biological samples shall
be vetted through the A4 Partnership Leadership Team as further described in Exhibit G.
16.4
otwithstanding any provision in this Agreement to the contrary, data and publication
rights w ill be governed by the N ational Institutes of Health's Grants Policy (dated Octob er
2011), including the requirement that N IH be given a royalty-free, nonexclusive, and
irrevocable license for the U .S. Federal government to reproduce, publish, or otherwise use
the Study Data and to authorize others to do so for Federal purposes. Consistent w ith this
policy, each publication, press release, or other public document about the S tudy shall
contain an acknowledgment of N IH support and a disclaimer stating that the content does
not represent the official views of the NIH.
Section 17
onfidential Information
17.1
illy shall only disclose confidential information necessary for Institution's performance of
the Study. "C onfidential Information" shall m ean and include all data and other
information which are disclosed by Lilly to UCSD for the purposes of conducting the Study
which is marked as "C onfidential" at the time of disclosure, or (i) in the case of oral
disclosures, identified at the time of such oral disclosure as confidential and reduced to
writing and m arked as "Confidential" within thirty (30) days of oral disclosure; (ii) if not
marked, regarded as confidential if a reasonable person in the relevant field would consider
such information to be the Company's confidential information given its content and the
circumstances of the disclosure. The parties anticipate that each party has already or m ay
acquire or have access to C onfidential Information ow ned by the other party, including but
not limited to the following types: research and developm ent plans and results; new
compounds and processes; evaluation procedures (including clinical and field testing);
product formulations; manufacturing methods; applications to g overnment authorities;
pricing or cost; c onstruction plans; sales, marketing, and advertising studies and plans;
customer lists; computer information and softw are; special techniques unique to each
party's business; information subject to a right of privacy; and information each party
maintains under a system of protection against unauthorized access. The parties w ill
cooperate to ensure that C onfidential Information does not inhibit or prevent publication
including publication required by any Federal sponsor.
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17.2
he Confidential Information provided to the receiving party w ill remain the p roperty of
the disclosing party.
17.3
illy and UCSD will neither:
17.3.1 disclose the other party's Confidential Information except as authorized below or
by the other party in w riting; nor
17.3.2 use the other party's Confidential Information for any purpose other than the
purpose of this Agreement.
17.4
n executing the o bligations in this Section 17 , each party shall use a standard of care at
least as stringent as each party uses to protect its ow n Confidential Information and in any
event, using no less than a reasonable standard of care.
17.5
ach party shall restrict the dissemination of the Confidential Information w ithin its own
organization to only those persons who have a need to know it, and shall ensure that all of
its employees and representatives involved in carrying out this Agreement and the Study,
including Clinical Investigator, (a) are aw are that the Confidential Information is
confidential and (b) are bound by obligations of confidentiality and non-use at least as
protective of the Confidential Information as those set forth in this Agreem ent.
17.6
ach party may disclose the other party's Confidential Information only (a) to ADCS
employees, (b) to those other persons who require access in order to perform obligations
required under this Agreement and who have contractual obligations that prohibit any
disclosure and use of the Con fidential Information prohibited by this Agreeme nt, or (c) to
the extent compelled by Applicable Law s. If permitted by Applicable Law, each party w ill
provide the other w ith reasonable advance notice of the disclosure.
17.7
he obligations of confidentiality in this Section 17 sha ll not apply to information that: (a)
is published or otherwise ge nerally available to the public at the time of disclosure other
than by reason of breach of the provisions of this Agreement; (b) becomes publicly known
subsequen t to disclosure by either party other than by reason of b reach of the provisions of
this Agreement; (c) either party can demonstrate by competent evidence was in its
possession at the time of disclosure and was n ot acquired directly or indirectly from the
other party; or (d) either party can demonstrate by competent evidence was developed by
the party without the use of, and independent from, any information received from the other
party.
17.8
romptly upon termination, expiration, or cancellation of this Agreement, each party will
delete or destroy all Records of the other party's Con fidential Information in each party's
possession or control (if such Records are not the property of the other party). For the
purpose of Electronic Records, "destroy" includes destroying the physical medium on
which a Record is stored or completely and permanently removing a Record from its
storage medium.
17.9
otwithstanding anything to the contrary in this Agreement, each party may make and
retain one (1) Record of the other party's Con fidential Information so lely for its legal
archives.
17.10
he prohibitions on disclosure and use of C onfidential Information shall survive for seven
(7) years after the end o f the study, termination, or cancellation of this Agreemen t or after
UCSD returns or destroys all Records of the relevant Confidential Information in its
possession or control, whichever is later. The foregoing notw ithstanding, the restrictions
on prohibition or use of Lilly's Trade Secrets shall survive for as long as the information
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satisfies the definition of Trade Secret, provided that Lilly informs UC SD in w riting at the
time of disclosure that the information constitutes a T rade Secret.
Section 18 Records and Audits
18.1
ecords That Must Be C reated and Maintained. UCSD w ill create and maintain all
Records: (a) required by this Agreement and Applicable Laws that relate to this Agreement
and to UCSD's performance under this Agreement; and (b) sufficient to enable Lilly to
comply with Applicable Laws and other legal obligations, to the extent that UCSD has or
reasonably should have knowledge of those Applicable Laws and other legal obligations.
18.2
eriodic Reports. UC SD shall, and shall cause C linical Investigator to, provide Lilly, in
writing, w ith data and results arising from the performance o f the Study, at such intervals as
Lilly shall reasonably request. Lilly shall have free access to all Study D ata, provided,
how ever, that the confidentiality of Subjects' identifiable health information shall be
maintained to the extent required by Applicable Laws.
18.3
ecord Retention Periods. The Records required to be maintained under this Agreement
shall be retained by UCSD for fifteen (15) years commencing upon conclusion or
termination of the Services. After the applicable Records retention period ends, at the
request of UC SD and at Lilly's direction, such Records shall be delivered to Lilly, be
destroyed, or be retained by UCSD for a standard storage fee to be agreed upon by the
parties.
18.4
ccess to Participating Sites and R ecords. Lilly or its authorized representatives or
designees shall have the right, w ith reasonable advance no tice, at Lilly's cost, and during
business hours, to audit Participating Sites and Study Records at reasonable times and with
reasonable advance notice for regulatory purposes, for ensuring that UCSD is in
compliance with the terms of this Agreement.
18.5
IH Records and R eports. UCSD shall have sole responsibility for maintaining any
Records that are required as a con dition of the grant received by UC SD to partially fund the
Study. UCS D shall also have sole responsibility for any comm unications with NIH,
including reports on the Study. Lilly shall have the right to review reports related to the
study before submission to NIH.
Section 19 Nondisclosure, Publicity, and Use of Lilly Name or Trademarks
19.1
either party shall use the name, insignia, sym bol, trademark, trade name or logotype of
the other party in any press release, advertising or m aterials distributed to p rospective or
existing customers, annual reports or any other public disclosure, except with the other
party's prior written authorization or as required by Applicable Law s. To the extent
allowed by Applicable Laws, each party will provide copies of any proposed disclosure for
prior review and comment by the other party no less than ten (10) days prior to disclosure.
19.2
oth Lilly and UCSD agrees to confer with the other before responding to inquiries by
journalists or financial analysts related to the Study and ag ree upon a m utual external
communication coordination process within a reasonable time after execution of this
Agreem ent. In responding to such inquiries, the parties will endeavor to distinguish
betw een the roles and responsibilities of various entities. In particular, when discussing
interactions with regulatory authorities (such as IND filings, safety reports, etc.), it may b e
helpful to note that Lilly is the regulatory sponsor of the Study under A pplicable Law s.
When discussing the overall management and conduct of the Study, it may be helpful to
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note that the A4 ADC S/Lilly Partnership w ill be jointly conducting the Study. Finally,
whe n discussing financial support for the Study, it may b e helpful to note that NIH, L illy,
and m ultiple philanthropic organizations have provided funding for the Study.
19.3
n no event will UCSD:
19.3.1 represent, directly or indirectly, that any product or service provided by U CSD has
been approved, recommended, certified or endorsed by Lilly; or
19.3.2 use Lilly's name, logo, or other trademarks on any business cards, letterhead, or
similar m aterials.
19.4
illy may, in its sole discretion, revoke any authorization or consent given under this
Section 19.
. R isk A llocation
Section 20 Remedies
20.1
he naming of a specific remedy does not preclude any other remedy unless this
Agreement clearly states that the specified remedy is the sole or exclusive remedy.
20.2
CSD acknowledges that monetary damages are inadequate to protect Lilly from a breach
or threatened breach of UC SD's duty to protect Lilly's Confidential Information and that
any such breach w ill cause irreparable harm to Lilly. Accordingly, Lilly may seek an
injunction restraining any breach or threatened breach without having to prove the
inadequacy of monetary dam ages or irreparable harm.
20.3
illy acknowledges that monetary damages are inadequate to protect UCSD from a breach
or threatened breach of Lilly's duty to protect UC SD's Confidential Information and that
any such breach will cause irreparable harm to UCSD. Accordingly, UCSD may seek an
•
njunction restraining any breach or threatened breach without having to prove the
inadequacy of monetary damages or irreparable harm.
Section 2 1
nsurance
21.1
CSD and Lilly will satisfy the requirements of the Insurance Exhibit.
Section 22
ndemnification
22.1
y Lilly. Lilly agrees to indemnify, defend, and hold harmless UCSD and its officers and
administrators, trustees, directors, employees and agen ts, including Clinical Investigator
(collectively, the "UCSD Indemnitees"), from and against any and all claims, damages,
liabilities, losses, costs and ex penses (collectively, "Claims" ) for any personal injury
(including death) to Subjects directly arising from the adm inistration or use of the Study
Drugs or any clinical intervention or procedure provided for or required by the Protocol to
which Subjects would not have been exposed but for their participation in the Study
pursuant to the Protocol, except to the extent that such C laims arise from: (a) the violation
by any UCSD Indemnitee of the Protocol; (b) the breach by any UCSD Indemnitee of the
terms of this Agreement, including UCSD's failure to obtain from each of the Subjects
participating in the Study the informed consent described; (c) the violation by any UCSD
Indemnitee of any Applicable Laws; (d) the negligence, recklessness or willful misconduct
of any UCSD Indemnitee; (e) any natural processes or complications of an underlying
illness, or any other illness or injury the Subject m ay experience during the co urse of the
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Study, unless such illness or injury is a Study-related injury (i.e., any illness or injury
caused by activities described in the Protocol that are different from the m edical
management the Subject would have received if he had not participated in the Study); or (f)
injuries resulting from the use of any drug (including biological m aterial) or device
supplied by any third party.
22 .2
y UCS D. UCS D shall defend, indemnify and ho ld harmless Lily, its directors, officers,
agents and em ployees ("Lilly Indemnitees") from an d against any and all claims, liabilities,
expenses (including reasonable attorneys' fees) actions or demands that may be made or
instituted against any of them b y reason of injury (including death) to any person or
damage to property, arising out of or in connection with the Study ("Claims") but only in
proportion to and to the extent such Claims are caused b y or result from the negligent or
intentional acts or omissions of, or the breach of this Agreem ent by, UC SD, its directors,
officers, agents or employees, including Clinical Investigator.
22.3
rocedures for Indemnification
2 2 .3.1 If an indemnitee becom es aware of a third-party Claim that (if successful) will
result in indemnification under this Section, the indemnitee will promptly notify
the indemnitor in w riting (with a copy of the notice to the indem nitor's legal
counsel). Failure or delay in giving suc h notice w ill not affect the right to be
indemnified except to the ex tent that it prejudices the defense of the Claim. If the
indemnitor acknow ledges that the Claim (if successful) will result in
indemnification under this Section, it may assume the defense within fifteen (15)
days after receiving the notice of the Claim. In the m eantime, the indemnitee may
take any action that it deems appropriate to protect its interests or those of the
indemnitor, provided it is not prejudicial to the indem nitor.
22 .3.2 If the indemnitor acknowledges its obligation to indemnify and assumes the
defense, it will have both the duty to d efend and the right to control the defense.
The indemnitor will conduct the defense in a prudent manner and will keep the
indemnitee reasonably informed as to the s tatus of the defense. The indemnitee
will cooperate with the defense and may retain separate counsel at its own expense
to participate in, but not control, the defense. Neither party may settle a C laim
without the consent of the other, and that consent may not be unreasonably
withheld or delayed.
2 2 .3.3 If the indemnitor does not timely assume the defense, the indemnitee will have the
right (but no duty) to defend or settle the Claim at the risk of the indemnitor. The
indemnitor w ill reimburse the indem nitee for its expenses (including reasonable
attorney's fees) of defending or settling the C laim
22 .4
ubject Injury Reimbursem ent. In addition to any amounts listed in Exhibit I, Lilly will
pay UCSD on a cost pass through basis without mark-up or overhead for any reasonable
expenses incurred in reimbursing Investigators for costs incurred related to the diagnosis
and/or treatment of an injury to a Subject directly arising from the proper adm inistration or
use of the Study Drug s or any clinical intervention or procedure provided for or required by
the Protocol to which Subjects would not have been exposed but for their participation in
the Study pursuant to the Protocol. In order for Lilly to comply w ith reporting
requirements under the Centers for Medicare and Medicaid Services (CMS) Section 111 of
the Medicare, Medicaid and SCHIP Extension Act of 2007 (MMSEA 111), UCSD shall
submit, upon request, documentation required by Lilly regarding any request for payment
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of subject injury costs. Such docum entation must be provided to Lilly prior to Lilly
making any such payment.
Section 23 Exclusion of Certain Damages
23.1
either party (nor any of its Affiliates) is required to pay, or to indemn ify any Person for,
consequential, indirect, incidental, punitive, or special damages, including loss of reven ues
and lost profits, arising from or relating to:
2 3.1.1 any breach of any provision of this Agreement, except any provision relating to
Confidential Information or Intellectual Property Rights, or
2 3.1.2 any negligence in its performance under this Agreement, except gross negligence
or intentional misconduct.
General Terms and Condit ions
Section 24 Work Plans
24.1
uring the course of the Study, the parties may develop w ritten plans designed to further
specify the responsibilities of the parties ("Work Plans") w hich may be tied to the
Statement of Work. These Work Plans will be management tools designed to improve
coordination. The Work P lans will provide additional detail regarding Services to be
performed by UCS D and Lilly as outlined in the Statement of Work. The Work Plans are
not associated with an increase to funding by Lilly and w ill not constitute a written
amendment to this Agreement unless the intention to amend is expressly stated in writing
and the W ork Plan signed by a du ly authorized representative of each party to this
Agreement.
Section 25 Taxes
25.1
ayment of Tax es. Each party w ill be responsible for its ow n taxes, including Property
Taxes on property it owns or leases, Income Taxes on its business, and any other Taxes
incurred by such party in connection w ith its business and with perform ing its obligations
hereunder. Lilly will be responsible for any Transaction Tax es properly collectible from
Lilly under Applicable Laws. UC SD w ill be responsible for payment of any Transaction
Taxes that are, under Applicable Laws, properly borne by UCSD . The calculation of Taxes
shall not include, and Lilly shall not pay, any Taxes that are related to intra-corporate
transfers or intermediate supplies of the Services betw een UC SD and its Affiliates or
betw een UCS D's Affiliates and related entities.
25 . 2
ithholding Taxes. If any payments made by the parties under this Agreement becom e
subject to w ithholding taxes under Applicable Law s of any state, federal, provincial or
foreign government, each party shall be authorized to withhold such Taxes as are required
under Applicable Laws, pay such Taxes to the appropriate Governmental Authority, and
remit the balance due to the other party net of such Taxes. The party paying the taxes to
the Governm ental Authority shall secure and deliver to the other party an official receipt
for Taxes paid.
25.3
eports Regarding A pplication of Funds. In order that Lilly may comply w ith applicable
federal tax laws and regulations, UCSD agrees that if requested by Lilly, UCSD will report
to Lilly within sixty (60) days after the close of each calendar year the dollar amoun t of
expenses which UCSD has incurred during the year but has not yet billed to Lilly on
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activities covered by this Agreement. In order to assist UCSD in completing the statement,
Lilly will endeavor to provide UCSD with a summary of payments made to it during such
year for all Lilly studies or activities conducted by it during such yea r.
2 5 . 4
ax Docum ents and Information. Each party shall provide and make available to the other
party any ex emption certificates, resale certificates, information regarding out of state or
out of country sales or use of equipm ent, materials or Services, and any other information
reasonably requested by the other party to support the provisions of this Section 25,
including the appropriate organization of invoice formats and supporting documents.
25 . 5
ax Filings and Audits or Proceedings. Eac h party represents, warrants, and covenants that
it will file appropriate tax returns and pay ap plicable Taxes ow ed and arising from or
related to the provision of the S ervices in applicable jurisdictions.
Section 26 Independent Contractors
26.1
n performing their obligations under this Agreement, Lilly and UCSD act solely as
independent contractors. This Ag reement does not create a partnership, joint venture, or
any similar relationship between Lilly and UC SD. Neither UC SD nor Lilly has any
authority (a) to bind, incur any liability on behalf of, or otherw ise comm it the other or; (b)
to act in any other manner as agent or representative of the other.
26.2
either UCSD nor any persons employed by UCSD to perform any obligations under this
Agreem ent are employees of Lilly for any purpose. Lilly will not withhold any taxes, pay
any Social Security taxes, pay unemployment compensation, furnish worker's
compensation insurance, or provide any employment benefits for UCSD such persons.
Section 27 Delegation and Assignment
27.1
either party may assign its rights or delegate its obligations under this Agreement, except
that:
2 7 .1.1 Property rights acquired under this Agreement m ay be freely assigned unless this
Agreement expressly prohibits the assignment.
27 .1.2 A ccounts receivable may b e assigned in accordance with Applicable Law s.
2 7.1.3 UC SD m ay engage one or more Subcontractors to perform its obligations under
this Agreement, but only with Lilly's prior written consent; however, UCSD will
remain fully responsible to Lilly for the performance of all obligations delegated to
the Subco ntractor.
27.1.4 Lilly may assign any or all of its rights or delegate any or all of its obligations
under the Agreement to any of its wholly ow ned Affiliates. Lilly may assign any
or all of its rights or delegate any or all of its obligations under the Agreem ent to
any of its other Affiliates, but only with UCSD's prior written consent; however,
Lilly will remain fully responsible to UCSD for the performance of all obligations
delegated to the Affiliate.
Section 28 Regulatory Agency Visits
28.1
isitation. At Lilly's request, a representative of UCSD s hall accompany Lilly to meet
with representatives of the FDA, U.S. Environmental Protection Agency ("EPA"), or
similar domestic or foreign regulatory agencies (collectively "Reg ulatory Authority") to
explain or discuss any and all aspects of Services provided under this Ag reement. Such
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visit or visits to the Regulatory Authority shall be arranged at times mutually agreeab le to
Lilly and UCSD. A ll reasonable travel and living expenses incurred by UC SD in
connection with such visits shall be reimbursed by Lilly.
28.2
otification. Either party shall imm ediately notify the other of any request from a
Regu latory Authority, other federal or state agencies or any other third-party to inspect or
otherwise g ain access to the information, data or m aterials pertaining to the responsibilities
assigned under this Agreem ent. Notification of such requests shall be prior to permitting
any third-party access, unless prior notice is not possible. Both parties shall have the right
to be present at and to p articipate in any such inspection or regulatory action with respect to
the Study. The contacted party shall provide the other party with c opies of all pertinent
information and documentation issued by any Regulatory Authority and any proposed
response. Both parties shall have the right to review and approve in advance any responses
that pertain to the Study.
28.3
nspection. UCS D agrees to perm it inspection of such information, data and materials by
authorized representatives of the Regulatory Authority and as otherwise required by
Applicable Law s. During such inspections, UC SD shall provide appropriate scientific and
quality assurance support for its Services and D eliverables. Lilly reserves the right to
provide additional scientific and qua lity assurance support during regulatory inspections as
related to the Services and Deliverables.
28.4
indings By Reg ulatory Authorities. UCSD w ill imm ediately notify Lilly Medical Quality
Assurance if it receives a formal report from a Reg ulatory Authority (including but not
limited to FDA- 4 83s) regarding significant findings by a Reg ulatory Authority resulting
from an inspection, review or audit of UCSD and/or any Investigators participating in
Lilly-sponsored Studies. UCSD w ill provide Lilly with its response to such finding and
Lilly shall be given the opportunity to provide assistance to UCSD in responding to any
such review, audit or inspection. UC SD shall provide Lilly with the ultimate resolution of
such findings.
Section 29
ompliance with Law, Regulations and Lilly Policies
29.1
n the performance of its Services and obligations under this Agreement, UCSD shall
comply with all Applicable Laws, regulations, and professional standards, including, but
not limited to:
29.1.1 .
• Any instructions or po licies set forth by L illy which relate to com pliance by Lilly or its
Affiliates with any US or other Government Authority mandates, settlements or
adjudications, including the Corporate Integrity Agreement (the "CIA") between Lilly
and the Office of Inspector General, US Department of Health and Human Services,
dated January 14, 2009, and any disclosure requirements set forth thereunder; UCSD
acknowledges that it or certain of its employees are deemed by Lilly to be Covered
Persons under the terms of the CIA . Supplier agrees to perform the ac tivities set forth in
Exhibit D and any other obligations required by Lilly to ensure full compliance with the
CIA."
29.1.2 Applicable clauses set forth in the U .S. Federal Acquisition Regulation ("FAR")
FAR 52.244-6(c)(I) as set forth at http://supplieroortal.lillv.com
and such other
provisions as may be required by Applicable Laws to allow the sale of Products to
the U.S. Government from time to time by Lilly; and
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29.1.3 Paragraphs (1) through (3) of 29 C.F.R. Part 471, Appendix A to Subpart A
regarding the posting of certain notices pertaining to em ployee rights under the
National Labor Relations Act available at
lutp://www.gooaccess.gov/fr/.
29.2
otwithstanding anything in this Agreement, the parties expressly agree that the provisions
of the Uniform Computer Information Transaction Act and the United Nations convention
on Contracts for the International Sale of Goods (including any p rovision of any state law
adopting exactly, or in modified form, such laws) shall not apply to this Agreement, Work
Order, Purchase Order, Work Product, Deliverables, software services, or products
provided hereunder and that both parties waive any and all rights arising from such laws.
29.3
he parties acknowledge that each maintains its own financial authorization policies on
ensuring requisite corporate authority has been given for specific transactions. The parties
therefore agree that any communications between the employees of the parties that may
impact previously agreed upon financial, economic or legal expectations under this
Agreement, must be approved by the authorized individuals of both parties. The parties
further agree to periodically meet a nd/or enter into discussions to identify authorized
individuals as well as take any corrective actions necessary for any pa st discrepancies in
order to m eet appropriate financial expectations for potential future transactions.
29.4
ll the requirements of this Section 2 9 are in addition to all of UCSD's other obligations
under this Agreement.
Section 30 Regulatory Submissions
30.1
illy shall have responsibility for subm itting to the FDA or any other federal, state or
foreign agency all docum ents required under any applicable federal, state or foreign laws or
regulations, including annual reports and safety reports. UCSD shall provide Lilly with
relevant information for and assist Lilly in the preparation of any required documen ts,
including annual reports and safety reports and shall respond to any and all questions
regarding such reports at costs mutually agreed to by the parties in writing in advance.
30.2 mutua lly agreed upon statistical analysis plan shall be used for regulatory purposes.
Section 31
everability
31.1
f a provision of this Agreement is held to b e unenforceable, the other provisions w ill
remain in effect. If possible, the offending provision w ill be modified to the slightest
degree necessary to m ake it enforceable, remaining as close as p ossible to the parties'
original intent for the provision. If not possible, the offending provision will be stricken.
Section 32
ontract Interpretation
32.1
he meaning of a provision of this Agreement will be considered in context with other
provisions of this Agreement.
312
he following principles apply to the construction of this Agreem ent unless the
construction is plainly contrary to the intent of the parties:
32.2 .1 "Including" m eans "including but not limited to."
32.2 .2 Language that has a g enerally prevailing m eaning is given that meaning unless this
Agreement expressly assigns a different one.
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32 .2 .3 Technical terms used in the technical field of the subject of this Agreement are
given their technical meaning.
32.2.4 Singular words may be treated as plural, and plural words may be treated as
singular.
32.2.5 The masculine gender may be treated as feminine, and the feminine gender may be
treated as masculine.
32.3
n computing any period of time under this Agreement, the day of the act, event, or default
from w hich the designated period of time begins to run is not included. If this Agreement
specifies that a period is to run for a certain number of business day s, only business days
are included in the count, and the period may not end on any other day.
Section 33
urvival
33.1
he expiration, termination or cancellation of this Agreem ent will not extinguish the rights
of either party that accrue prior to ex piration, termination or cancellation or any ob ligations
that extend bey ond termination, exp iration or cancellation, either by their inherent nature or
by their express terms.
Section 34 No Waiver
34.1
o provision of this Agreement is w aived unless the waive;is in writing and signed by the
party granting the waiver.
34.2
o delay in exercising any right, power or privilege under this Agreement will operate to
waive co mpletely or partially any present or future exercise of that right, power or
privilege.
Section 35
otice
35.1
nless specifically directed otherwise in this Agreement, whenever written notice is
required by this Agreement, it must be delivered to the applicable address indicated below
by:
35.1.1 Certified mail, postage pre-paid, return receipt requested;
35.1.2 Hand delivery;
35 .1.3 Comm ercial overnight delivery Service such as Federal Express or United Parcel
Service;
35.1.4 Email; or
35.1.5 Facsimile.
35.2
ither party may chang e its address for notices by w ritten notice to the other.
35.3
otice is effective when received. If delivery of any written notice under this Agreem ent
cannot be m ade despite the exercise of diligent efforts, the requirement to give notice is
excused.
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Address for Notices to Lilly:
ddress for Notices to Lilly's Legal C ounsel (if
required):
Eli Lilly and Company
Lilly Corporate Center
Indianapolis, IN 462 85
Attention: Director — LRL Global Procurement
Telephone: (317) 276-2000
Address for Notices to UCSD:
8950 Villa La Jolla Drive, Ste C-2 27
La Jolla, CA 92037-1712
Alzheimer's Disease Cooperative Study
[Address]
Attention:
Telephone:
58
246-1313
Facsimile:
(858) 24 6 -1414
Email:
; wizzolasuesd.edu
Eli Lilly and Company
Lilly Corporate Center
Indianapolis, IN 462 85
Attention: General Counsel's Office
Address for Notices to IJCSID's Legal Coun sel (if
required):
Office of Contract and Grant Administration
95 00 Gilman Drive
La Jolla, CA 92093-0924
Attention: Rachel SievertTelephone: 858-5 34- 3335
Email: [email protected]
Nancy Bastian
Section 36 Integration and Amendments
36.1
his Agreement, its exhibits and attachments are the final, complete and exclusive
expression of all the statements, promises, terms and conditions within its scope and
supersedes any prior written or oral agreements within its scope. In making this
Agreement, neither party relies on any promise or statement made by the other party, other
than those contained in this Agreement, its exhibits or attachments.
36.2
o amendment to this Agreement will be binding on either party unless it is in writing and
signed by each party or executed in another manner expressly provided by this Agreement.
Such an amendment does not require the consent or agreement of any third party, even if
the third party is beneficiary of this Agreem ent.
36.3
n the event of a conflict betw een the provisions of the exhibits or the attachmen ts to this
Agreem ent and the provisions of this Agreem ent itself, the conflicting provision(s) of this
Agreement shall control over the language in the exhibit or attachments, unless otherwise
agreed by the parties.
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Section 37 ignatures
37.1
his Agreement is legally binding when, but not until, each party has received from the
other a counterpart of this Agreement signed by an authorized Representative. The parties'
Representatives may sign separate, identical counterparts of this document; taken together,
they constitute one agreement. A signed counterpart may be delivered by any reasonable
means, including facsimile or other Electronic transmission.
ELI LILLY AND COMPANY
Name:
?
1
6
6
O Farrell
Title:
friiP
Date:
THE
HE REGENTS OF THE UNIVERSITY OF
CALIFORNIA; UNIVERSITY OF CALIFORNIA, SAN
DIEGO
Name:
inda Collins
Title:
irector, Office of
Contracts & Grants Admin.
Date
August 30, 2013
cf 34. Cab/
Page 23 of 40
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By signing here, I
conditions of this
)reSent that I have carefully read and understand all of the provisions and
cement and their potential impact on me,
Bv:
Name: • D r . P a u l A i s e n .
Title: °Loa cdtr
Date:
441
1
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EXHIBIT B
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COLLABORATIVE STUDY AGREEMENT
This Agreement by and between Toyama Chemical Co.,
Ltd.,
a company organized under the laws of Japan
("Toyama" or "Company") and The Regents of the University of California; University of California, San
Diego ("Institution") ha‘
ing a place of business at 9500 Gilman Drive, Mail Code 0687. La Jolla. California
92091-0687 is made and effective as oldie date of execution that the last party signs below (hereinafter
"Effective Date").
Background
W I IEREAS,
Institution, through the activitie, of the Alzheimer's Disease
Co()Nrative Study ("ADCS"),
established through a cooperative agreement between the
ational Institute on Aging and Institution, and
Institution's employee Dr. Paul S. A isen (
-
Principal Investigator" and Director
of
the ADCS), have experience
in conducting Multi-Center Alzheimer's Disease clinical study programs.
WHEREAS,
Company desires to collaborate with Institution to conduct a clinical study of the Drug (as defined
herein) according to a protocol and any related amendments thereto (the "Protocol") entitled "A Phase 2
multi-center, randomized. double blind, placebo-controlled. parallel group study to evaluate the efficacy
and
safety of T-81 7MA in patients with mild to moderate Alzheimer's I )isease (US202)
-
(the "Study"), attached
hereto as Exhibit "A" and incorporated herein by reference.
WHEREAS,
Company and Fujitilm Corporation are Affiliates (as defined herein) of each other and each has
rights to develop and commercialize the Drug in various regions of the world:
WHEREAS. Institution through the AD( 'S and its other resources is equipped, has the expertise, and desires to
undertake the Study in collaboration with Company, under the terms and conditions hereinafter set forth.
NOW, TIIER [WORE,
in consideration of the premises and the mutual promises and covenants expressed
herein, and for other good and valuable consideration. the sufficiency and receipt of which is hereby
acknowledged. the Parties agree as follow
s:
I.
efinitions.
A.
"Affiliate" means. with respect to either Party or other entity. any person or emits that, directly or
indirectly, controls, is controlled by or is under common control with such Party or other entity. As used
in this definition, "control" means (a) in the case of corporate entities, direct or indirect ownership of
more
than fifty percent (50''))) of the stock or shares having the right to vote for the election of directors
of such entities. and (b) in the case of non-corporate entities, the direct or indirect power to manage.
direct or cause the direction of the management and policies of the non-corporate entity or the power to
elect more than fifty percent (5(1%) of' the members of
overning, body ofsuch non-corporate entity.
For the avoidance of doubt, the Company. Fujitilm Holdings Corporation (a corporation organized
under the laws ofJapan), Fuji film Corporation (a corporation organized under the laws of Japan). and
Fuji film Pharmaceuticals U.S.A.. Inc. (a corporation organized under the law of the Commonwealth of
Massachusetts) are Affiliates of each other.
B.
"Applicable Law" or "Applicable
Laws
means any and all laws, rules, regulations, guidelines and
ethical standards including but not limited to Good Clinical Practices ("G('Ps"), and including law
s .
regulations and guidelines governing data protection and pH\ acv (including. but not limited to. the
IIIPA A. the Fitropean Union Data Protection Directive and the guidelines of the International
Conference on I larmonisation of Technical Requirements for Registration of Pharmaceuticals For
I
human ( :se
''ICI I"), and those regarding the sourcing, handling, storage, banking. transport. use,
disposal. releasing. transierring. import or export of I human Biologic Materials and associated data,
each as may be amended from time to time, and as appropriate to the pertbrmance of the Study under
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this iNgreement.
"Case Report Forms (CRF)" means the form, in electronic: or paper fonnat, which may consist of
multiple pages. and is jointly developed by Company and Institution for
the
purposes of the Study to
collect Subject data reporting.
I). "Clinical Study Results" means any and all CR Es prepared in part or in whole to record the results of
the Study and the data contained therein, deliverables under the Protocol, any results arising from the
conduct of the Protocol. compilations and analyses of the data set forth in such CREs. reporv, in respect
of the Study. including, in each case, without litnitation, written. printed, graphic, or video material, and
information contained in any computer data base or computer readable form implemented or maintained
in connection with the Study by the Institution. Principal Investigator. or
the Company in the course of
conducting the Study, and specifically excludes Institution Data and Direct Identifiers.
E.
"Company Confidential Information" has the meaning given to that term in Section 8(1).
F.
"Company Intellectual Property" means
any
Intellectual Property made in the direct performance of
the Study that is invented solely by employees. officers, agents. or other persons on behalf of Company
or other isc acquired or licensed by Company from one or more third parties.
G.
"De-Identified Human Biologic Materials" means HUIrlan Biologic Materials and associated data that
do not include the 18 identifiers of Protected Health Infomiation as
set
forth by I IIPAA in the 11 IPAA
Privacy Rule and which I Inman Biologic Materials and associated data are coded and labeled so as to be
linked to the CRLs in respect of the Subjects from whom such I luman Biologic Materials have been
obtained.
II. "Direct Identifiers" means information that directly identities a Subject, including, but not limited to.
Subject's name, birth date, street address, telephone. social security, medical record, or health plan
beneficiary numbers.
I. "Drug" means that certain drug called
-
1-81 7mA ( -1342(
I
-benzothiophen-5-y1) ethoxy
propyl ;-3-azetidinol maleate; "1-8I7) under development by Company as a pharmaceutical to treat
Aliheimer's Disease.
"Effective Date" has the meaning given to that term in the first paragraph
of
this Agreement.
K. "FDA" neamis the U.S. Food and Drug Administration and any successor thereto.
I.. "Fundamental Structural Change" means (a) when used with respect to (.'ompany, any materially
adverse change in the business, assets, liabilities, results ofoperations, condition (financial or otherwise)
or prospects of Company taken as a whole (excluding, however. changes in general economic
conditions or financial markets) or (b) when used with respect to Institution. iii any materially adverse
chance in the legal authority of Institution to perform its respective obligations under this Agreement
due to any statute, law. rule, regulation, judgment. order, decree, permit, license or injunction of any
governmental authority that is applicable to or binding upon Institution or any of its properties. ()i) any
materially adverse chance in the operations of Institution taken as whole that will jeopardize or disable
continuation of the Study. caused by compliance with any order or regulation or ally government entity
(such as the National Institute on Aging) acting lawfully within Institution's power, or (iii) any event
bey (ind the reasonable control of Institution that in the reasonable judgment of Institution acting in good
faith and after
consullinu,
with Company prevents, restricts, interferes or delays Institution from being
able to satisfy its obligations under this Agreement, provided that Institution, where reasonably possible.
has used its reasonable best efforts to avoid or remove such cause, and in each case not caused by the
negligence, intentional conduct or misconduct of Institution.
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M .
"Ilealib Authority" means the governmental agency in each jurisdiction \vhere the Study is conducted
responsible for regulating. M s uch jurisdiction the conduct of hum an clinical trials ol
.
medicinal products,
including, without limitation, the FDA.
N.
"IIIPAA" means the U.S. Health Insurance Portability and Accountability Act of {9% and any
regulations and official guidance documents promulgated thereunder, including, without limitation, the
IIPAA Privacy Rule and the HIPAA Security Rule.
0. "Illl'AA Authorization" means the authtvimtion required to be obtained pursuant to HIPA A from
Subjects pursuant to .45 CI...R. Part 164 in the U.S. Code of' Federal Reenlat ions.
P.
"Duman Biologic Materials" may include, but are not limited to. blood, urine, saliva, or other bodily
fluids. products of conception, excess pathology tissue, surgical tissue and any other human tissues.
Q.
"Informed Consent Form" means the form of informed consent agreed upon by Company and IRB
and to be signed by each Subject print to Subject's participation in the Study.
R.
"Institution Data" means source documents. Subject medical records, and raw data generated or
collected from Subjects during the performance of the Study,
S.
"Institution Intellectual Property" means any Intellectual Property discovered, conceived, reduced to
practice or developed by Institution employees (including, without limitation, the Principal
Investigator) arising from the Stud y that are neither Com pany Intellectual Property nor Joint Intellectual
Property.
T.
"Institutional Review Board" or "IBB" means the institutional review board from w Inch Institution
shaII seek approval of the Protocol and the Informed Consent Form.
U.
"Intellectual Property" means collectively inventions, discoveries. products, mechanisms, substances.
formulae, and methods, including improvements.
V.
"Joint Intellectual Property" means any Intellectual Property invented, conceived, and reduced to
practice jointly by Company and Institution employees (including. without limitation. the Principal
Investigator), as determined by U.S. Patent I ,a w , in the conduct of the Protocol or directly resulting from
the scope of the Study that is neither C ompany Intellectual Property nor Institution Intellectual Property.
W.
"Option" has the meaning given to that term in Section /it(
X.
"Party" means Institution, or Company, as applicable. and "Parties" means. collectively. Institution
and Company.
Y.
"Principal investigator" means the Institution's employee who will personally supervise the Study
and may not delegate this duty. Principal Insestigator may, however, delegate other duties to qualified
personnel in accordance with the Protocol and regulatory requirements.
Z.
"Protocol" has the meaning given to that term in the Recitals.
AA. "Samples" has the meaning given to that term in Section 5(A).
RR. "Site" means the physical locations where the Study is conducted and includes, among other locations.
hospital. outpatient, community and other clinics, and physician's offices.
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CC."Study" has the meaning given to that term in the Recitals.
1)1). Stud Stall'
means Principal Investigator and any other employee, contractor, or agent performing or
assisting with the study on behalf of the Institution,
EE. "Sub-Ins estigator" has the meaning given to that term in Section 2(C).
FE.
Subject
means each human subject participating in the Study.
GC."Subsequent Derived Intellectual Property" means any Intellectual Property directly arising from
the use of the Clinical Trial Results or Joint Intellectual Property tOr academic non-commercial research
purposes by Institution and Principal Investigator.
1111."Term" has the meaning given to that term in Section 7(A 4
2 .
erformance of Study.
A.
Compliance With This Agreement. Institution and Principal Investigator agree to perform the Study
in strict accordance with the Protocol, including any subsequent Protocol amendments thereto, all
Applicable Laws and the terms and conditions of this Agreement. In the event that Institution and/or
Principal Investigator use the services of Sub-Investigators, investigational staff. or others to conduct a
portion of the Study, Institution and Principal Investigator shall be responsible for ensuring that all are
appropriately licensed and credentialed and in compliance with the terms of this Agreement. Institution
and Principal Investigator shall refrain from, and shall cause any other member of the Study Staff to
refrain from, using the Drug in any manner that is contrary to the provisions of, or outside the scope of.
the Protocol or that is contrary to Applicable
I a W
or written instructions from Company. Institution. or
Principal Investigator, as applicable. Institution shall be liable kir any breach of this Agreement by such
individuals to the extent the breach is caused by or results from the Institution's negligent or intentional
acts or omissions.
B . R ep la ce me nt
of Principal Investigator. In the event that the Principal Investigator becomes no longer
affiliated with Institution. Institution shall designate another individual to serve as Principal Investigator
and provide written notice to Company within three (3) days of such departure and designation.
Company shall have the right to approve any new Principal Investigator designated by Institution.
Institution shall require such new Principal investigator to agree in writing to abide by the terms and
conditions of this Agreement. In the event Company does not approve such new Principal Investigator.
Company may terminate this Agreement in accordance with the Section 70.31 (Termination) below and
Institution shall comply with the provisions of Section 7(11;4v) related to such termination.
C.
Delegation of Investigator Duties.
Institution may not replace Principal Investigator or substantially
reduce Principal Investigator's role in the Study without Company's prior written approval. If
-
Principal
In\ estigator is to be temporarily absent from Institution for more than fifteen 15) business days.
Institution shall designate a sub-investigator ("Subinvestigator' 110 temporaril) supervise the Study on
the Principal Investigator's behalf and inform Company of such designation in writing at least 14 days
prior to such absence. Institution shall document this designation.
l). Audits by Company.
t I) Institution
shall make
available to Company {or its agent). to the extent allow able under Institution's
policies mid procedures, and, subject to applicable law relating to patient confidentiality. all Study
documents and Institution Data upon reasonable advance notice from Company and during regular
business hours, to allow Company (or its agent) to conduct audits from time to time to confirm that the
Study is being conducted in conformance with the Protocol and in compliance with this Agreement and
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Applicable Laws. Except as provided in Section 2(D)( 3) of this Agreement, Company shall have a right
to conduct up to three (3) audits under this Section 2(D) during the term of this Agreement.
(2) If Company determines based on any such audit, that the conduct of the Study violates or is
otherwise not in compliance with the Protocol, this Agreement, or Applicable Laws, Company shall
notify the Principal In estioator and Institution to such effect. Upon receipt of any such notice, the
Principal Investigator and Institution shall promptly act to cure any circumstances giving rise to such
violation or noncompliance. To the extent any such violation or noncompliance was the d irect result of
Institution htiling to adhere to GCP, the cure shall be at the expense of Institution. which shall be
accounted ft
-
ir as an offset against payments owed by Company" to Institution hereunder. Company shall
provide such reasonable and necessary assistance as is requested by the Principal Investigator and
Institution in order to effect such cure and shall work w ith Institution to determine how the expense shall
be covered when not the direct result of Institution faili4,
to adhere to (iCP.
(3 t Company shall have the right to conduct audits as needed for the purpose set forth in Section 2(1))(1)
above and in response to any violations or noncompliance by Institution and Principal Investigator of or
with the terms and conditions of this Agreement or the Protocol. A pre-qualification audit will he
conducted as mutually agreed to between the Parties.
E.
Inspections. Each Party acknowledges that the other ()arty may respond independently to any
regulatory correspondence or inquiry in which such Party or its A Ifiliates is named. Each Party,
however, shall notify the other Party promptly of any FDA or other governmental or regulatory
inspection or inquiry concerning any matter relating to the Study. During any such inspection or inquiry.
the Parties agree to make reasonable efforts to disclose only the information required to he disclosed.
F.
Source Documents Verification. Institution shall enter into an agreement w ith each Site pursuant to
which such Site shall be contractually required to respond promptly to any request from Company for
verification of any source documents in respect of any Subject treated at such Site in connection
With the
Study by providing to Company such documents and information as are necessary for such purpose.
3.
nstitutional Review board (IRB)- Informed Consent — Authorizations.
A.
Approvals. Institution shall be responsible for obtaining IRB approval of
-
the Protocol, the Informed
Consent Form. Study advertisements (natty), any alteration to or waiver of any subject authorization
permitting the disclosure of confidential subject information in connection with the Study
, and any
matter involving
questions of
human subject protections, from the IRI3 prior to commencement °land
during the performance of the Study.. In the event the IR1.3 requires changes in the Protocol or any
substantive and material changes in the Informed Consent Form, such changes shall not be implemented
until Company is notified and gives its written approval. The Protocol, the Informed Consent Form, and
any Study
advertisements each in their original form and prior to commencement of the Study shall be
mutually agreed upon by Institution and Company. and each shall not he rev ised without the prior
written agreement of Company and the Principal Investigator. Amendments shall be approved by the
IR R prior to implementation. Institution shall conduct the Study in a manner consistent with the
Informed Consent Form as so approved and all other applicable consents.
B.
Signed Informed Consent Forms and IIIPAA Authorizations, Institution shall be responsible for
obtaining the Informed Consent Form validly signed by or on behalf of each Subject and appropriately'
doknimented prior to the Subject's participation in the Study.
C.
Subject Medical Information. The Informed Consent Form shall include the right for Company and
its designees and applicable government authorities to review raw Study data, including original Subject
records, and all monitoring and auditing activities required to ensure quality assurance and compliance
with the Protocol as well as all legal and regulatory requirements. Company may' copy such original
Subject records and records relating to such monitoring and
auditing
activities to the extent permitted by
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the express authorization in the Informed Consent Form and HIPAA Authorization signed by each
Subject and to the extent that Company complies with all Applicable Laws regarding the confidentiality
of Subjects medical records and other health information. including. without limitation. holding each
Subject's personal identifying information in confidence.
D.
RH Letter of Approval. If requested by Company. Institution and Principal Investigator shall provide
Company with copies of the letter of approval from the IRB, the approved Informed Consent Form and
any relevant communications with the MB, which includes, but is not limited to. information which
may
affect
the conduct of the Study.
E.
HIPAA Matters. Institution represents and covenants that (a) it is a "covered entity'' under the
provisions of HIPAA. and (b) Institution shall handle all Study records and Institution Data in
accordance with HIPAA and other Applicable Law. Such compliance shall include. in each case when
required, obtaining from each Subject a HIPAA Authorintion or obtaining a waiver valid under 45
C.F.R. See. 164.512(1) that permits the disclosure and
use
of data collected from the applicable Subject
in accordance with the Protocol. Institution acknowledges that Company is not a "covered entity'' (as
defined by HIPAA ) and will not become a "business
associate"
(as defined by IIIPAA) of a covered
CiitiiV h
performing its obligations under this Agreement.
4 . Adverse Event Reporting.
Institution and Principal Investigator shall be solely responsible for complying, within the required
timelines. with any safety reporting obligations to the competent I.lealth Authorities. the Bit and the
participating (co- or sub-) investigators, as defined in the Applicable Law. Principal Investigator and
Institution also agree to notify Company within a reasonable time period as written in the Study Scope
of Work set fOrth in Nxhibit 11 attached to this Agreement. Safety Plan and the Protocol of any serious
and or unexpected adverse events (as defined in the Protocol)
at lectity
any Subject in the Study .
5 .
Transfer of Iluman Biologic Materials.
A.
Generally.
Institution shall comply with Applicable law in the collection, storage, and transfer of
any I luman Biologic Materials taken from Subjects in the perlortnance Study, and shall obtain any
informed consents required from Subjects for the use of such materials in accordance with the
Protocol and such other uses as set forth in such informed consents. During the course of the Study,
Institution will coordinate with Company to transfer the De-Identilled Human Biological Materials
taken from the Subjects in the perfiwinance of the Protocol (
-
samples-
) to a third party entity for
storage, management, and use in accordance with Section b.
B.
Reimbursement. As part
of Company's financial support of this Agreement. Company shall. in
accordance with the Reimbursement Schedule set
out
at Fixhibit C, reimburse Institution for its
reasonable and documented out-of-pocket expenses inclined
in
connection with technical and
logistical activities associated with de-identification. sourcing. handling, preparing, storing and
transferring the Samples as required under this Agreement. Institution acknowledges and agrees that
all sums paid by Company under the terms of this Agreement are solely for the performance of the
Study and the reimbursement of expenses incurred by Institution in connection with its obligations
under this Agreement. Institution certifies that:
I .
he sums payable under this Agreement represent the fair market value for the Institution's
services and expenses in the conduct of the Study; and
ii.
t has the right under Applicable Law to receive the payments contemplated under this
Agreement, and
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no sums under this Agreement are designed to compensate for the sale or purchase of
I luman Biologic klaterials; and
iv.
he Parties specificallv intend to comply with all Applicable Laws, including. without
limitation, the U.S. federal anti-kickback statute (42 U.S.C. 1320a-7b), the related sate
harbor regulations and the limitation on Certain Physician Relemds. also reterred to as the
"Stark Law" (42 U.S.C. 1395 (n)). Accordingly, no part of any consideration paid
hereunder is a prohibited payment for the recommending or arranging for the referral
of
business or the ordering
of
items or services: nor are the payments intended to induce
illegal referrals of business.
6. Permitted Uses of Inman Biologic Materials.
A.
Right to Use. Company and its officers. employees, agents or their Affiliates have the right to use the
Samples. including related data, according to the terms of this Agreement for the Study and
for
other
research, development and commercial uses that are consistent with the informed consent and
Applicable Law. Institution, its officers, agents and employees shall have the right to use any lluman
Biological Materials and Samples. including related data, according to the terms of this Agreement for
the Study and for other research. education, treatment of subjects who are participating or have
participated in the Study and related non-commercial purposes that are consistent with the informed
consents and Applicable Law,
B.
Obligations. Institution agrees to handle and maintain any Human Biologic Materials and related data
collected by Institution in accordance with the terms of this Agreement and Applicable Law. Company
agrees to handle and maintain the Samples in accordance with this Agreement and Applicable Law.
Company and Institution agree that reasonably promptly following the execution of this Agreement
they shall agree upon a set of procedures for managing the storage and use of the Human Biologic
Materials tbr purposes beyond those contemplated by the Protocol and the Study ("Post-Study
Uses"). Such procedures shall have as their purpose the optimal use and stewardship of the Human
Biologic Materials in order to satisfy the requirements of the Protocol and the Study and any Post-Study
l;ses. Such procedures shall include, among other things, periodic consultations between the Parties as
to Post-Study Use s by either Party, maintenance of an intim/1;Mo ) system containing data on the types
and quantities of I
illITIall
Biologic Materials in storage, and shall comply with all Applicable I .aws and
applicable Informed Consent Forms. Post-Study Uses shall indude Company further do, elopment and
commercial uses and shall include Institution further acadonie non-commercial research and
educational uses.
C.
Agreements with Non-Affiliated Third Parties. Subject to its obligations under Section NB). the
Parties shall fully document by a written agreement any transfer or disclosure of the {Rattan Biologic
Materials and any related data to any third party that is not an Affiliate of the Parties and to include in
any such agreement restrictions and obligations on the third party substantially- in accordance with the
obligations of this Agreement,
7. Term and Termination.
A.
Term. The term of this Agreemenu
-
Term") shall begin on the Effective Date and shall end on the later
of ti May 31, 201g, or (ii) upon Company's agreement that the milestone captioned "Completion of
CSR Res iew and signing by Principal Investigator" in Exhibit C has been satisfactorily completed and
Company's receipt of the final Study report as so signed by Principal Investigator, as required pursuant
to the Scope of Work. The Parties agree that the Term may be extended by mutual written agreement.
B.
Termination.
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1 )
otwithstanding the provisions set forth in Section 7(A) and in addition to those events described
elsewhere in this Agreement as permitting immediate termination of this Agreement, this
Agreement may be terminated by Company at any time in the exercise of its sole discretion upon
thirty (30) days prior w ritten notice to Institution and Principal Investigator.
(ii)
n addition, this Agreem ent may be term inated by either Party upon written notice to the other Party
if any of the following events occur: (a) after prior consultation w ith the other Party. the term inating
Party' reasonably believes in good faith that there are valid scientific or ethical reasons not known
before execution of this Agreement for not commencing or discontinuing, as applicable, the Study;
(b)
after prior consultation with the other Party. the terminating Party reasonably believes in good
faith that commencement or continuation, as applicable, of the Study will compromise patient
safety or result in a material v iolation of data integrity. Good C linical Practices. or Applicable Law s;
(c)
the non-terminating Party fails or is unable to remedy within thirty (30i days of prior written
notice of a material violation
or
this Agreement by the terminating Party: or td) either Party seeks
termination not earlier than one-hundred twenty (120) days follos ing prior written notice to the
non-terminating Party that a Fundamental Structural Change with respect. ni the terminating Party
will render the terminating Party unable to satisfy. its obligations under this Agreement.
(iii)
pon receipt of such notice in respect of the circumstances described in clauses (a) and (b) of
Section 7(3)(ii), the Parties agree to work together to promptly' terminate conduct of the Study. to
the extent medically permissible, for all Subjects. Upon receipt of such notice in respect of the
circumstances described in clause (c) of Section 7t 131(u). the Parties agree to continue the Study in
accordance with this Agreement until a final resolution of the relevant dispute.
(iv)
n the event of termination hereunder, other than as a result of a material breach by Institution or
Principal Investigator, the total stints payable by Company pursuant to this Agreement shall he
equitably prorated for actual work performed to the date of termination, with any unexpended funds
previously paid by Com pany
.
to Institution being refunded to UoMpany.
(s
)
lpon the termination of this Agreement by Company pursuant to Section 703)(i i)1ct or by
Institution pursuant to 7(B)(ii)(d) or following the delivery of the termination notice, as applicable,
each of the following provisions shall take effect:
(I) within thirty (30) days
of
the date of such notice, to the extern feasible. Institution shall
complete the do-identification of any Human Biologic Materials then in the possession of
Institution or any Site and deliver to Company such De-Identified I luman Biologic Materials.
and the rights of Institution (provided that prior to the liate of such notice all data from the
Study has been reviewed and all queries and issues about that data have been resolved and the
database containing that data is closed to further entries or revisions (the "Database Lock")),
Company and its Affiliates to use such De-Identilied Human Biologic Materials in accordance
with Section 6(A) shall survive termination of this Agreement, and Institution's use rights shall
continue in the event of pre-Database Lock termination to the extent it is determined. alter
consultation with Company. that the use is not ad
crse to the Study goals and objectix es:
(2 )
within ten ( 10) days of the date of such notice, to the extent feasible by Institution and the Sites,
but in no event more than thirty (30) days
or
the date of such notice. Institution and the
applicable Site shall complete and deliver to Company any and all CRIs then outstanding in
respect of any Subject;
(3 )
within thirty (30) days of the date of such notice, Institution, Principal Investigator, and any
Site shall deliver to Compan• a report of Clinical Study Results other than CRI's (which are
addressed in subclause (2) of this Section 7(111)(v));
Ex. B,
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(4 )
Institution shall deliver to Company, upon request. invention disclosures lot any Joint
Intellectual Property and Institution Intellectual Property conceived and reduced to practice
prior to the termination:
(5 )
the rights and obligations of Company and Fujifilm Corporation and the rights and obligations
of Institution and Principal Investigator under Section 8t l))( iii) shall survive termination or this
Agreement: neither Institution nor Principal Investigator shall thereafter use any Company
Intellectual Property for any purpose whatsoever. other than to fulfill Institution's or Principal
Investigator's obligations under Section 8(l)) iii); and w ithin ten (10) days following the
completion of any assistance from Institution and Principal Investigator requested by Company
under Section St WHO, Institution and Principal Investigator shall deli‘er to Company any and
all manifestations of Company Intellectual Property then in the possession of Institution or
Principal Investigator, as applicable;
((i) within thirty (30) days of the date of such notice, each of Institution and Principal Investigator
shall provide Company w ith copies ()fatly
and all writings that are the subject of Copyrights
referenced in Section 8(11). and the rights of Institution. Company and Fujiiihn Corporation
under Section 8111 ) shall survive termination of this Agreement:
(7 )
the rights of Company under Section 2(D) in respect of any and all Institution Data shall
survive termination of this Agreement and within thirty (30) days following the date of such
notice, Institution shall, to the extent permissible under Applicable Law and the Informed
Consent Form, deliver to Company copies of any and all Institution Data and Company shall
have the right to use the Institution Data for purposes of continuing the undertaking of the
Protocol and the Study, and any further research and development of the Drug and successor
compounds thereto:
(8)
The rights of Company and Fuji film Corporation rights under Section 8(G) in respect of any and
all Institution Intellectual Property and Section 8(C)i iv) in respect of any and all Subsequent
Derived Intellectual Property shall survive termination of this Agreement and within thirty (30)
days following the date of such notice, Institution shall, to the extent permissible under
Applicable Law, disclose any Institution Intellectual Property and Subsequent Derived
Intellectual Property to Company, and unless the Database Lock has occurred prior to the date
of such notice, from and after the date of such notice. Institution shall cease an work or further
research that involves the Clinical Study Results: and
(9 )
the rights of Institution, Company and Fuji tilm Corporation to Joint Intellectual Property under
this Agreement (including, without limitation. Section 81F)(iii)) shall survive termination of
this Agreement: and within thirty (30)days Ibllowing the date of such notice. InstitutiOn shall
deliver to Company Joint Intellectual Property disclosures.
( o) Notwithstanding the foregoing, Institution shall retain its rights to Institution Intellectual
Property, Joint Intellectual Property, and Institution Data for its ow n internal and
non-commercial research, teaching, and education purposes to the extent the parties determine
in good faith that Institution retaining its rights will not be detrimental to completing the Study.
Institution will cooperate with Company as needed to assist in transfer of the Study so it may
continue post-termination.
(11)1. Ipon completion of the above, Institution shall have
110
further obligation to Company with
respect to disclosing intellectual property, delivering results, or data and Company shall
provide institution with written confirmation that all
actions under this section have been
completed and that Institution has no further obligations to Company under this Section 7( )(v)
unless and until a separate written agreement is entered into between the Parties.
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(I 2)The Parties agree that Company, Fujitilin Corporation and their licensee:: and assignees, as
licensee or assignee of all rights under this Ag reemen t, shall retain and may fully exercise all of
such rights atter the termination.
(vi)
otw ithstanding the foregoing, the Parties shall take reasonable steps to resolve via the dispute
resolution provisions of this Agreement any conflicts prior to terminating. For the sake of clarity.
those provisions stated in Section 23 or otherwise stated to survive shall continue to have effect.
C.
Disposition of Company Confidential Information. Institution and Principal Investigator shall
account for and return to Company. or otherwise dispose of iii accordance with Company's instructions.
all Company Confidential Information upon request of Company or at the earlier of the conclusion of
the Study or termination of this Agreement.
D.
Final Accounting. Institution shall deliver to Company, by the earlier to occur 01(i) sixty (6(1) days
after Company's approval of the final study report and (ii) ninety (90) days after termination or
expiration, as applicable, of this Agreement. a final accounting of amounts due (and reasonable
supporting documentation, which requirement shall be satisfied by properly completed Case Report
forms as to completed visits by Subjects). taking into account payments made and not yet made under
the pay men
t schedule, and expenses reimbursable pursuant to Section 7(B). from one Party to the other
Party
. Undisputed amounts due shall
he paid within sixty (60) days therealler.
8. Intellectual Property, Copyright, and Confidentiality.
A. Separate Property.
Intellectual Property that either Party owned prior to the execution of this Agreement, or develops
independently of this Study and the other Party's Confidential Information, is that Party's separate
property. It is not affected by this Ag reement. N either Party has any claim to or right in such Intellectual
Property of the other Party
.
l.
Institution Data Ownership.
(it
wnership. The Institution owns all Institution Data. Company and Institution inay freely use
Institution Data in a manner consistent with such Informed Consent Form and 110.1 approval
iiS
provided fir in Section 3(A).
(ii)
Ise by Company and Fujililm Corporation. Subject to the provisions olthe preceding Section
i Company and Fujifilm Corporation shall have full, unrestricted access and use rights to any
Institution Data for lawful purpo ses (provided that all protected health information contained in the
Institution Data is either authorized to be disclosed to Company or de-identified at Company's
expense) and may make use it (inside and outside the United States) or transfer to one or more
Affiliates or third parties the Institution Data without accounting or further consideration to and
without co nsent from Ins titution or Principal Investigator pm )\ ided that such use thereof shall not
be deemed to restrict Institution's publication rights in accordance with Section 9 of this
Agreement.
Notices. Institution and the Principal Investigator shall from time to time promptly disclose to
Company any and all Company Institution Data discovered, conceived, reduced to practice, or
otherwise developed by Institution and/or Principal Investigator.
C. Clinical Study Results.
Ownership. 'Du; Clinical Study Results shall be jointly and severally owned by Company. Fujifilm
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Corporation, and Institution.
(ii)
Use by Company and Fujifilm Corporation. Subject to the provisions of this Section 8, and to
the extent allowed by law, Company and Fujifilm Corporation shall have full. unrestricted access
and unlimited use rights to any Clinical Study Results for lawful purposes (provided that all
protected health information contained in the Clinical Study Results is either authorized to be
disclosed to Company or de-identified at Company's expense) and may make use of (inside and
outside the United States) or transfer to one or more Affiliates or third parties engaged in bona tide
research, development and/or commercial activities the Clinical Study Results without accounting
or further consideration to and without consent from Institution or Principal Investigator: provided
that such use thereof shall not be deemed to restrict Institution's publication rights in accordance
with Section 9 of this Agreement.
(iii)
Use by Institution and Principal Investigator. Subject to Sections 8(C ii). 8(C)(iv) and 8(D(iii),
Institution and Principal Investigator shall have the full, unresuicled right to use the Clinical Study.
Results for the purpose of conducting academic. non-commercial research, for teaching purposes
and for treating patients.
(iv)
Subsequent Derived Intellectual Property. Any Subsequent Derived Intellectual Property
derived from the use of the Clinical Study Results shall he subject to the Option granted to
Company. Fujifilm Corporation. and their sublicensees in Section 8(C).
0
otices. Institution and Principal Investigator shall from time to time provide Company with
reasonably prompt notice ails becoming aware of the discovery. conception, reduction um practice.
development or the like of any Clinical Stud) Results and any Subsequent Derived Intellectual
Property derived from Institution's or Principal Investigator's use of any Clinical Study Results.
D.
ompany Intellectual Property.
(i)
Ownership. All right, title, and interest to any Company Intellectual Property shall be solely
owned by Company and Pujilihn Corporation.
(ii)
Any information about Company Intellectual Property shall be deemed to be Company
Confidential Information.
(iii)
Assignment by Principal Investigator and Institution; Further Assurances, Fat+ of Institution
and the Principal Investigator agrees to cooperate with Company. at Company's reasonable
expense. in preparing, filing, and prosecuting any and all patents claiming Company Inventions,
and, at the reasonable request of Company, to execute and deliver such other instruments and do
and perform such other acts and things as may be reasonably necessary or desirable tor perfecting,
and
conveying to Company ownership in and to the Company Intellectual Property as contemplated
hereby.
E. oint Intellectual Property.
(i)
Ownership. All right, title, and interest to any Joint Intellectual Property shall be
O‘Nned jointly
and severally by Company, Fujitilm Corporation, and Institution. Subject to Section 8(1i)(iv). each
owner of any Joint Intellectual Property may dispose of its rights therein without accounting or
compensation to the other co-owners .
(ii)
Notices. Each Party shall from time to time provide the other Party with reasonable prompt notice
of its becoming aware of the discovery, conception, reduction to practice. development or the like
of any joint Intellectual Property.
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iii) Patents and Further Assurances.
Company, at its expense. shall have the right to prepare. tile. and
prosecute on behalf of Company. Institution, Principal Imestigator, and any other applicable inventors
any and all patent applications claiming Joint Intellectual Property with the cooperation of Institution
and Principal Investigator, it being understood that Institution and Com pany (or Fujifilm Corporation, as
the case m ay be) are co- applicants on any such patent application. How ever, in the case that (a)
Com pany, upon request of Institution, prepares, files., and prosecutes a patent application in respect of
any such Joint Intellectual Property or ( b) Institution and Company ag ree upon the necessity of preparing,
tiling, and prosecuting any such patent application, Institution and Company shall determine hy mutual
agreement x) the P arty which shall be responsible for and shall control the preparation, tiling, and
prosecution of such patent application and the maintenance and enforcement of any patent granted in
respect thereof and (y) the allocation to Institution and Company
(or Fujitilm Corporation, as the case
may be) attic responsibilities iOr, and ex penses ol
. such actions in respect of suc h patent applications
and patents.
iv) Use by Company and Fujifilm Corporation.
Subject to the provisions of this Section 8. and to
the extent allowed by law. Company and Fujifilm Corporation shall ha
% e full, unrestricted access
and unlimited use rights to any Joint Intellectual Property for lawful purposes and may make use of
(inside and outside the United States) or transfer to o ne or mo re Affiliates or third parties ownership
and/or use of the Joint Intellectual Property without accounting or further consideration to and
without consent from Institution or Principal Investigator.
V)
se by Institution.
To the ex tent allowed by law , Institution shall have full, unrestricted access and
unlimited use rights to any Joint Intellectual Property fur lawful. non-commercial purposes and may
make use or transfer to one or more Affiliates or third parties ow nership andfor use ofJoint
Intellectual Property for lawful and non-commercial purposes without accounting to or further
consideration to and without consent from Company, provided that Institution shall obligate
transferee to comply with this Section and Institution shall remain responsible tor providing
reasonable assistance to the Company in ensuring that such transferee comply with its obligations
under this Section after such transfer.
Institution Intellectual Property; Subsequent Derived intellectual Property.
Ownership.
All right, title, and interest to any Institution Intellectual Property and Subsequent
Derived Intellectual Property t whether derived from Clinical Study Results or Institution
Intellectual Property) shall be owned by Institution.
(ii)
Notices. Institution and Principal Investigator each shall from time to time provide Company with
reasonable prompt notice outs becoming aware of the discovery, conception, reduction to practice.
developme nt or the like of any Institution Intellectual Property and Subsequen t Derived Intellectual
Property.
iii)
Patent Applications.
Institution agrees to prepare, tile, and prosecute all patent(s) on any
I list ilution Invention
and
any invention comprising Subsequent Derived Intellectual Property,
pursuant
to the request of Company, provided Company pay s all reasonable costs and expenses
directly related thereto.
G .
icense and Option.
(i)
rant of Non-Exclusive License. To
the extent legaI.Le
to do
so.
Institution shall grant to
Company and Fujitilm Corporation a royalty-free, non-exclusive, worldwide license to make or
have made, use or have used, and import or have imponed with a right to sublicense to Affiliates of
Company' and
Fujifilm Corporation and third parties objects or methods embodying Institution
Intellectual Property and Subsequent Derived Intellectual Property for purposes of the Study and
any other internal research and development programs directly relating to Drug. Further, to the
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extent legally able to do so. Institution shall grant and agrees to grant to Com pany and Fujifilin
Corporation a royalty-free, non-exclusive, world wide license to make or have m ade, use or have
used, and import
or have
imported W
ith a right to sublicense. to bona fide research. development.
and com merciali/ation third parties, Affiliates olCom pany and kn ifilm C orporation. all
Intellectual Property that necessarily and effectively use or incorporate the Drug and are conceived
and reduced to practice in the course of the work performed by Institution and Principal Investigator
under this Agreem ent. For this purpose. Institution and the Principal Investigator shall from t ime
to time prom ptly disclose to Comp any any and all Intellectual Property conceived, reduced to
practice or otherw ise
invented by Institution and/or Principal Investigator in the course ofthe work
performed
by Institution and Principal Investigator under this Agreement,
(ii)
Grant of Option.
To the extent legally able,
Institution hereby grants to Compan and Fujifilin
Corporation an exclusive option the
-
Option") to negotiate a royalty-bearing, exclusive,
worlds ide license
to make or
have made. use of
have used. sell or have
sold,
import or have
imported
with a right to sublicense to A ffiliates of
Company and Fujifilm
Corporation and third
parties engaged in bona
tide research,
development, tin,For commercial activities objects
or
methods embodying Institution Intellectual Property.. Institution's interest in
Joint Intellectual
Property and Subsequent Derived Intellectual Property for the diagnosis,
treatment, or prevention
of Al/heimer's disease and other diseases. Such Option shall be conditioned upon Company or
Fuji film Corporation paying the reasonable expenses of such patent protection including, but, not
hinned to,
preparation, filing, and prosecution.
(iii)
Term of Option.
With respect to any item of Institution Intellectual Property and Subsequent
Derived Intellectual Property in respect of which Institution has granted
the Option to Company and
Fujildni Corporation, the Option shall expire if not exercised by Company or Fujifilin Corporation
within ninety (90) day s alter receipt
or institution's notice of
iscovery. conception, reduction to
practice, or development thereof
(iv)
Negotiation of Exclusive License. Following notice to
Institution of the exercise of the O ption,
Com pany and Fujifilm C orporation (the "Toyam airuiililm P arties') and Institution, shall
negotiate
commercially reasonable terms for the
exclusive license contemplated by the Option w ithin ninety
(90) days, such terms to be embodied in a separate license agreement, and Institution shall not
commence license negotiations with any third party relating to such
Instit
ution Intellectual Property.
Institution's Interest in Joint
Intellectual Property or Subsequent Derived Intellectual Property. If
such negotiations are unsuccessful and are terminated by one side or the other, and tithe
Toyama/Fuji film Parties shall have made a written offer for such license prior to the termination of
such negotiations. then for a period of twelve months after such termination. Institution may not
grant such a license to a third party on terms which, taken as a whole, are substantially similar or
more favorab le to the third party
than those offered hr the ToyainalFujitilm
Parties in its final offer
in respect of such negotiations, without first
offering the Toyama/FLO
-
11m Parties an opportunity to
obtain the license on those similar or more favorable terms. Institution shall hold open such offer
tor the To )
arnarl'utifilin Parties lir at least sixty (60)
days.
tithe Toy amaflujifilm Parties reject
the offer or such sixty {OW day period expires bet
Ore the Toy arnaTujifilm Parties elect to obtain
such license on such terms, Institution shall have no further obligation to the ToyamalFujifilm
Parties with respect to such exclusive license.
l
or the avoidance ot doubt, the foregoing release of
obligation allows Institution to license to another com mercial entity and
the non
-
commercial nature
of Institution's future use rights shall not im pede this ability to the extent that the O ption has
expired and
the Toyama/Fuji film Parties and Institution have not successfully concluded a license
agreement.
II. Copyrights. Title to, interest in. and the right to determine the disposition of any copyrights or
copy rightable
material first authored by Principal Investigator or Institution in connection with the
performance of the Study other than contributions to any Study reports prepared for regulatory purposes
and except as provided in Section 8{..1)
), shall remain with Principal Iiisestigator and Institution or be
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jointly and severally owned by Company, Principal Investigator and Institution, if jointly authored by
Company together with Principal Investigator and/or other Institution personnel. Institution will grant to
Company, Fujitilm Corporation and their licensees a royalty-free. non-exclusi
4 :
right and license under
such copyrights on the Clinical Study Results as owned by Principal Investigator or Institution to use,
reproduce. display, distribute, make derivative works of and perform all such copyrighted and
copyrightable materials only for all developing, marketing and promotional materials related to the
Drug prepared by
Toyama. Fujifilm Corporation and their licensees. Each ow tier of any jointly owned
copyrights or copyrightable material may dispose of its rights therein without accounting or
compensation to any other. subject to 3n irrevocable, royalty-free. non-transferable, except to a
successor in interest of Company's rights and obligations under this Agreement, non-exclusive right and
license granted to Company. Fuji film Corporation and their licensees to use, reproduce. display,
distribute, make derivative works of. and perform all such copyrighted and copyrightable materials.
Company Confidential Information. In order to carry out the Study under this .Agreement. it may be
necessary for Company to disclose to and provide Institution with certain technical or other confidential
information relating to the Study thereinafter collectively referred to as "Company Confidential
Information") which Company considers confidential and proprietary. To be deemed Company
Confidential Information for the purposes of this Agreement such information must be clearly marked
as such and if orally disclosed clearly marked as Confidential Information within thirty (30) days of
disclosure. Institution agrees to keep any Company Confidential Information
Which
comes into its
possession in strict confidence and not to disclose or otherwise use such Company Confidential
Information for any purpose other than for the performance of the Study without the prior written
consent of Company, subject to the right of Institution to publish as provided in Section 9 of this
Agreement. The definition of -
Company Confidential Information shall include (i) subject to the right of
Institution to publish as provided in Section 9 of this Agreement. the Clinical Study Results. and (ii)
unmarked information that a reasonable person in the relevant ticld would judge as confidential. The
obligations under this section shall not apply to information:
that is in the public domain as of the Effective Date or subsequently enters the public
domain through no fault of Institution, Principal Investigator or other Study Staff.
that is known as Of the Effective Date becomes know n to Institution from its Own
independent sources as evidenced by contemporaneous written records; or
that Institution receives l`rorn any third party not under obligation to keep such information
confidential.
Compelled Disclosures. In the event Institution as the recipient or any Company Confidential
Information tor any person to whom Institution has transmitted the Company Confidential Information
received by Institution hereunder) is required by law or legal process to disclose any of such Company
Confidential Information, the Institution or such receiving person. its applicable. will (i) provide
Company with prompt notice of such event so that Company may take appropriate steps, including
intervening, to protect the confidentiality of the Company Confidential Information and (ii) use
reasonable efforts to obtain assurance that confidential treatment will be accorded to the Company
Confidential Information to be disclosed.
K. The Institution, as an instrumentality of the State ofCalifOrnia. is subject to certain state regulations and
resolutions regarding access to the Institution's records, including the requirement that the Institution
make available the terms and conditions olcontracts. 'Hie actual contract agreement must be released
upon request. although portions oldie document may be withheld when redaction meets one of the legal
exemptions under the California Public Records Act. As Such, the general terms and conditions of this
Agreement will be released to the public tipon request, with prompt notification to Company of such
release. "lo the extent disclosure of other records, including the Protocol, terms of compensation and
related documents, is requested. the Institution will use reasonable efforts to provide notice to Company
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prior to disclosure and work with Company to redact material which can be withheld from disclosure, to
the extent permitted by law and at Company's request and reasonable expense. Furthermore. for the
avoidance of doubt, the Institution maintains a publicly accessible listing of all proposals and awards.
The listing includes the name of the campus, sponsor. a \
ard amount, dates, principal investigator and
co-investigators name, project ly pe, award instrument, indirect cost rate, account and fund number.
department and academic
9. Publication.
A. Multi-Center Primary Publication. The Parties, recognizing the importance of communicating the
results
of
the Study to the public and to the medical and scientific communities in an accurate and
complete manner, intend for the first publication about the results of the Study 10 include the results
from all of the Sites and for such first publication to appear in a peer-reviewed scientific journal, in
accordance with the Protocol. Accordingly, Institution has first and sole right (which shall be
irrcv (+cable for so long as Institution is not in breach of its obligations under this Ag reement) to publish
the Study results in a joint multi-center primary publication IblION‘ log com pletion or termination of the
Study and sub ject to Section 8(1). Section 8(J) and this Section 9. For purpos es of this Section 9 and the
avoidance of doubt, the term "publish
-
includes the t011ow Mg: presentation and/or submission for
presentation in a peer-reviewed scientific or medical journal of any Section, manuscript, abstract. report.
poster. presentation. or other material (each a "publication
-
) that includes: (i) an analysis of the results
of the Study: (ii) a summary of the Protocol; and/or (iii) data supporting such analysis generated by the
Study: and tiv identifying information regarding the Drug. fixcept as otherwise provided in this
Agreement, nothing in this Agreement is intended to limit Institution's ability to publish about the
results of the study .
R. Follow-II) Publications.
Institution and Company \kill
each have the right to make follow-up
publications, and the Parties will exercise good faith efforts to coordinate such publications in order to
av old duplication.
C.
Review. Company has the right to review proposed publications about the results of the Study authored
by employee of the Institution and/or members of the Study
Staff and to require I, I ) the deletion of
Company Proprietary Information and (2) postponement of the publishing of any such item for no more
than ninety (90) days in order to protect Company's intellectual property rights
or
to avoid m aterial
adverse effect on development, manufacture and marketing of the Drug by Company, Fujitilm
Corporation and their licensees. The Parties will work cooperatively to ensure the accuracy of
statements in any such publication relating to the Study.
10. Prevention of Commingling. Institution will use reasonable efforts to ensure the ('ompany's support of the
Study is not commingled with other sponsored projects andi'or other federally'
funded research projects.
I.
Compliance with Applicable Laws,
A.
Applicable Laws. Principal Investigator and Institution agree to conduct the Stud) and maintain
records and data during and atter the Term in compliance with the Protocol and
all
Applicable Law s.
B.
Privacy Laws.
i.
he Parties agree that Institution's use and disclosure of Subject health and medical
information is subject to compliance with
applicable national, state, and local privacy.. and
security laws and regulations in the jurisdictions where the Study is conducted. The
Parties, therefore,
agree
to take all reasonable steps to protect the confidentiality of any
Subject health and medical information that it has access to and comply with all such
applicable privacy
and security laws and regulations. The obligations set forth in this
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Section shall survive the termination or expiration of this Agreement.
ii.Iiistitution agrees to obtain or cause Principal Investigator to obtain 11
.
0111 each Subject
participating in the Study a validly signed Informed Consent Form and a IIIPAA
Authorization as required in Section 3(C) of this Agreement.
C.
Study Noncompliance. In the event that
any part of this Agreement is determined to violate any
Applicable I.aws. the Parties agree to negotiate in good faith revisions to the provision or provisions that
are in violation.
D.
Principal Investigator Notice.
Institution shall inform the Principal Investigator and any other key
Study Staff', that Company may collect the following personal identifying information about such
personnel: name. hospital or clinic address and phone number, and curriculum vitae, and may transfer
this information to Company's Affiliates and their respective agents worldwide for internal study
management purposes. Nonetheless. Company and its Affiliates and its agents and business partners
will apply adequate privacy safeguards to protect such information. Company tri,1 its A Itiliates and its
agents and business partners may also use and disclose personal information as required by individual
regulatory agencies or Applicable Law. Upon written request. Company will provide the Principal
Investigator and any other k.ey Study Staff with reasonable access to such individual's personal
information that is held by. Company. Such individual may also request correction
of information
that
such individual demonstrates to be inaccurate or incomplete.
F. Compliance With Third Party health Insurance Pr(4..Ira
ms. It is Institutions policy to conduct
activities in accordance with applicable state and federal laws and regulations regarding Medicare.
Medicaid, and other third party payer programs. Therefore, Institution certifie
s that:
i. To the best of Institutions knowledge. neither Institution nor any of its Affiliates providing
services pursuant to this Agreement is excluded from participation in any state or federal
healthcare program in the l .:ni ted States, as defined in 42 USC Sec t ion 1.1 20.1-
7 b( ti or the
provision of items or services for which payment may be made by a I 5. federal healthcare
program:
Institution has not contracted for the performance of any services or supplies required tbr th
performance of this Agreement xvith any employee, contractor, agent, vendor or vendor's
Affiliate. knowing that the contracting party is excluded from participation in any state or
federal healthca re program: and
No final adverse action, as defined in 42 USC Section 1320a-7e tata I ) and 42 USC Section
1320a-7iug), has occurred or is pending against Institution or its Affiliates or, to the best
knowledg,e of Institution, contractors providita:. ser‘ ices pursuant to this Agreement.
By signing this Agreement. Institution aurees to notify Company of any ilwd adverse action, discovery
of contract with an excluded entity or individual or exclusion (as described in clauses (i). (ii) and (iii) of
this Section 10(1)) within thirty (30) days of such action.
F. No Participation of Excluded/ Debarred Persons in Performance of this Agreement.
Institution
shall not employ. contract with or retain any person directly or indirectly to perform the Study under this
Agreement if such a person is
(i) excluded from a Federal health care program as outlined in Sections I I2g and
1156 or the
Social Security Act (see the Office of Inspector General of the Department of I lealth and
I Ionian Seta ices List, of Excluded Individuals/Entities at
http://www.nig.11
hs.govifraud/exelusions/exelusions_list.asp;
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(ii)
debarred by the FDA under 21 U.S.C. 335a (see the FDA Office of Regulatory Affairs
Debarment List at
http://www.fda.gov/ICECl/Enforccmcnt
Actions/FDA t)eI iruicnt Listidefault.htm; or
(iii)
excluded from contracting with the federal gt)
anment (see the Excluded Parties Listing
System at lit tps://epls.arnet.gov
Upon written request from ('ompany. Institution shall, within ten (10) day s. provide written
confirmation that it has complied with the foregoing obligation. In the
ent that Institution becomes
aware that any person identified above becomes excluded or debarred or receives notice of the threat of
an action with respect to such exclusion or debarment. Institution shall promptly provide Company with
written notice. Upon receipt of such notice, Company shall have the right to terminate this Agreement
immediately.
G. Representations and Warranties and Covenants: Conflict of Interest Obligations,
(I)
here the study binding under this Agreement is subject to professional amPor employment rules
such as conflicts of interest or ethics policies) established by Institution or a prcifessional organimtion
or other institution with which the Principal Investigator or any Sub-Investigator is affiliated.
Institution shall cause Principal Investigator and any Sub-Investigator(s) to warrant that he or she shall
comply fully- with such rules, including, as applicable. obtaining any required approval(s) prior to
initiating the Study and making any required reports relating thereto. Further, Institution and
Principal Investigator have received no offer by Company or its affiliates or agents of extra benefit
for participation in the Study, including offers to family members, Institution warrants that it has
policies and procedures with respect to conflicts of interest, and that these policies meet the applicable
FDA requirements, and will promptly report to the Company any such conflicts relating to the
Principal Investigator or any Sub-Investigator(s) duties under this Agreement. Institution will notify
Company in the event a conflict of interest prevents a Principal Investigator or Sub-Investig,ator(s)
from conducting his or her duties and responsibilities under this agreement. Institution policy
information can be tOund it Imp; "Thlink.ucsd.edu
?sponsorleoii
policies.hind
(ii)
Institution represents and warrants that it is under no agreement or obligation to any third
party and has no material conflict of interest that would prevent it from performing its
duties .ind obligations under this Agreement.
(iii)
Institution shall ensure and certifies the billow inc.:
a. Performance of this Agreement by Principal Investigator and other Study
Staff shall
not conflict with, breach. cause a default under, or result in the termination of any
contract, employment relationship, grant or funding, agreement or understanding, oral
or written, with any third party, including without limitation any noncompetition
covenant to which Principal Investigator or other Study Staff
is a party or by which
Principal Investigator or other Study Staff is hound. Neither Principal Investigator nor
Study Staff have any obligation, whether express or implied, to any third party that
would interfere with, hamper or limit its ability to perform such person's duties and
obligations under this Agreement.
I). Principal Investigator is not a federal government employee.
c. Principal Investigator is not a member of a pharmacy and therapeutics committee
CP& I ( 'ommittee") of a health plan, pharmacy benefit manager or other health care
provider or payor,
Whet
her public or Prc•
Ex. B, Pg. 58
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(iv)
nstitution ;
a. shall cause the Principal Investigator to provide to Company a signed, completet form
FDA-1572 and a curriculum vitae or other statement of quail tieations showing the
education, training, and experience that qualities the Pt ineipal Investigator to lead the
clinical investigation of the Drug for the use under the Study
;
b.
shall cause. before the commencement of the Study, during the course of the Study.
and for up to one (1) year after the completion or termination of the Study. at
Company's reasonable request, the Principal Investigator and any Sub-Investigator to
disclose to Company (and afterwards to notify Company of any relevant changes to)
any financial arrangement between Company and the Principal Investigator or
Sub-Investigator, as applicable, and including any spouse or dependent child thereof
(any such person, a "clinical investigator") as to which the value (tithe compensation
could be influenced by the outcome of the Study. any significant payments of other
sorts from Company to any clinical in estigator„tny proprietary' interest in the Drug
held by any clinical investigator, or any significant equity interest in Company held by
any clinical investigator (for purposes tit this Section 10(1l)(v)(b). the terms
"significant equity interests," "proprietary interests," and "significant payment of other
sorts" shall have the meanings set out in 21 (Tit See. 54); and
r. shall comply, and shall ensure that the Principal Investigator and any sub-investigator
comply. with all applicable disclosure requirements related to conflict of interest that
are imposed by the FDA
or other regulatory or govet mental ;inthorities.
I 2. I n dem ti ifica don.
A. Institution agrees to defend, indemnify
and hold harmless Company and its directors, officers.
employees, agents and representatives (each a "Company Indemnified Party") from any loss, claim.
damage or liability of any kind ("1„iability"), which may arise from or in connection w ith (i) the
negligence or willful misconduct of any Institution Indetnnilied Party in its perliumance of its
obligations under this Agreement. except to the extent such Liability arises from a negligent act or the
intentional misconduct of Company: or (ii) any material breach by Institution of this Agreement,
including any representations
and warranties or covenant provided herein but only in proportion to and
to the extent any such Liability is caused by the negligent or intentional acts or omissions of Institution
its officers, agents or employees. Institution's obligation to defend. indemnify and hold harmless a
Company Indemnified Party is conditioned upon the Company Indemnified Party providing to
Institution with prompt notice ofany such Liability and providing all reasonable assistance to Institution
in defending against such Liability. Company shall provide reasonable assistance to Institution in
defending against such Liability. Institution agrees that it will not settle any
chilli
or admit any liability
on behalf of any Company Indemnified Party without the prior written consent of Company. which shall
not be unreasonably \killtheld or delay ed.
It. Company agrees to defend, indemnify and hold harmless Institution and its directors, officers.
employees, agents, representatives, and Sites (each an "Institution Indemnified Party") front any
Liability which may arise from or in connection with (I) the negligence or willful misconduct of any
Company Indemnified Party in its performance of its obligations under this Agreement. except to the
extent such liability arises from a negligent act or the intentional misconduct of Institution; (ii) any
personal injury (including death) to Subjects directly
arising
from the administration or use. of the Study
Drugs or any clinical intervention or procedure provided for or required by the Protocol to which Subjects
would not have been exposed but for their participation in the Study provided, that any such administration
or use of the Study Drugs is in accordance with the Protocol or ( iii) any material breach by Company of
this Agreement, including any representations and warranties or co
% enant pros idcd herein but only in
proportion to and to the extent any snch Liability is caused by the negligent or intentional acts or
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omissions of Company its officers, agents or employees. Company's obligation to defend, indemnify
and hold harmless an Institution Indemnified Party is conditioned upon the Institution Indemnified
Party providing to Company with prompt notice of any such liability and providing all reasonable
assistance to Company in defending against such Liability. Company agrees that it will not settle any
claim or admit any liability on behalf of any Institution Indemnified Party without the prior written
consent of Institution. which shall not be unreasonably withheld or delayed.
Ii.
Insurance.
Institution shall secure and maintain in lull force and effect through the performance of the Study (and
following termination of the Study to cover any claims arising from the Study) self-insurance coverage
for: (i) medical professional and/or medical malpractice liability (ii) general liability: and (iii)
workmen's compensation, each such insurance coverage in amounts appropriate to the conduct of
Institution's and Principal Investigator's business activities and the services contemplated by the Study.
14. Payment.
A. Budget and Compensation.
The compensation and fees to be paid by Company for the Study is
contained in the budget described in Exhibit C. attached hereto and incorporated by reference in this
Agreement. Payment shall be due and payable upon receipt °fan Institution invoice that is in
accordance with the schedule set forth in Exhibit C.
Total contract amount shall not exceed the prior
written consent of Company.
B.
Fair Market N'alue.
The Parties acknowledge and agree that the compensation and support provided
by Company
nstitution pursuant to this Agreement represents the fair market value t
ir Institution
and Principal Investigator's efforts under this Agreement. has been negotiated in an arms-length
transaction, and has not been determined in a manner that takes into account the volume or value of any
referrals or other business otherwise generated between Company.' on
the one hand and Institution and
Principal Investigator on the other hand.
C.
Third Party Payor Billing. Neither Institution nor Principal Investigator shall bill any third party for
any items or services furnished by Company in connection with the Studs, or any services provided to
Subjects in connection with the Study for which payment is made as pan of the Study.
15.
Independent
Contractors.
Institution and Principal Investigator are acting in the capacity of independent
contractors hereunder and not as employees or agents of Company. The Parties will make no claim against
the other for compensation, vacation pay, sick leave, retirement benefits. social security benefits, workers'
compensation, disability or unemployment benefits or employee benefits of any kind.
16. Publicity. Neither Party shall use the name, logo, or trademark of the o ther Party or its employees or
Affiliates far promotional purposes without the prior written consent of the other Party whose name, logo, or
trademark is proposed to be used.
17. Notice. Any notices given hereunder shall
e
deemed given: (i) when delivered personally; iii) one (I) day
after having been sent by
facsimile. w ith a copy sent promptly
by registered or certified mail. return receipt
requested, postage prepaid; (iii) five (5) days
aBer having
been sent by registered or certified mail, return
receipt requested, postage prepaid: or t iv) two (2)
days alter deposit with a nationally recognized overnitzht
carrier. w ith written verification of receipt. Notice shall be given to the addressees below at the respective
addresses indicated (or to such other addressee and/or address as a Party subsequently designates writing to
the other Party pursuant to this Section 16):
Toyama Chemical Co.. Ltd.
2-5, Nishishinjuku 3-chome
Ex. B, Pg. 60
4
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Shinjuku-ku Tokyo 160-0023
Japan
Attention: Ilirohisa Tsuchida, Clinical Planning Group. Clinical Research
Department
Telephone: + 81-3-5381-3827
Facs imi le :
4 -
8
- 3 - 3 3 4 2 - 5 1 4 5
entail: Ill R011 ISA_TSUCLIIDAi,toyalmi-eliemical.co.jp
1'0:
NIVFRS1TY OF CALIFORNIA SAN DIEGO
. •
9500 Gilman Drive
mail Code 0934
1.,a Jol la, CA 92093-0687
States
Attention: Rachel Sievert, Esq.
Telephone: +1-858-534-3335
Facs imi le :
rsieverriOcsd.edu
18 . Force Majeure.
If the performance of this Agreement by Institution or Company is prevented. restricted,
interfered with or delayed, (either totally .
or in pail) by reason of any cause beyond the reasonable control of
either Party or both Party (such as acts of(rod, explosion, fire, disease, weather, flood, earthquake, war,
terrorism, insurrection, civil commotion, strike or other labor disturbances, riots, destruction of facilities
and/or materials, shortage of materials. failure of common carriers, or power failure). the Party so affected
shall, upon giving written notice
to
the other Party. be excused from such performance to the extent of such
prevention. restriction, interference or delay, provided that the affected Party shall use its reasonable best
efforts to a‘ oid or remove such causes of non-performance and shall continue performance with the utmost
dispatch whenever such causes are removed. For purposes of this Section, a lack of funds shall not be
considered a cause beyond the reasonable control of the Part ies.
19 . Agreement Modifications.
This Agreement and any of its Attachments or Exhibits, may not he altered,
amended or modified except by written document signed by both Parties.
2 0.
Assignment.
Company shall has e the right to assign. in whole or in part, this Avreement (i) to Fuidilm
Corporation and other Affiliates of Company upon prior written notice to Insiitution and (ii) to third parties
upon prior written consent of Institution not to be unreasonably withheld or delayed, and Company may. in
whole or in part. delegate its obligations or assign its rights under this Agreement to a contractor, provided
that Company remains liable for the pertOrmance of all such delegated obligations. In all other instances.
neither Party shall assign its rights or duties under this Agreement to another without prior written consent of
the other Party'. Any assignment or delegation of this Agreement not permitted under this Agreement shall
be null and void. Subject to the foregoing. this Agreement shall bind and inure to the beneiit of the
respect ive Part ies and their successors and assigns.
2 1. Conflict with Protocol. If
an provision of this Agreement conflicts with a pro‘ision
or
the Protocol, the
Protocol takes precedence on matters of medicine, science. and conduct of the Study. This Agreement takes
precedence in any other conflicts.
2 2 .
Waiver and Severability.
No waiver by either Party of any breach of any provision hereof shall constitute
a waiver of any other breach of that or of any other provision hereof*.
In
the event that a court of competent
jurisdiction holds any provision of this Agreement to be invalid, such holding shall have no effect on the
remaining provisions of this Agreement, and they shall continue in lull force and effect.
2 3.
Survival.
The rights and obligations of Company and Institution, which by intent or meaning have validity
beyond such termination (including. but not limited to, rights with respect to Section 5, Section O. Section 7
Ex. B. Pg. 61
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(Tenn and Termination). Section 8 (Inventions. Patents, Know-flow. Copyrights. and Confidentiality).
Section 9 (Publication). Section 10 (Compliance with Applicable Law S). Section 1 I (Indemnification). and
Section 12 (Insurance) and Section 16 (Publicity) shall survive the termination of this Agreement. In
addition, any other pros ision which by its terms is stated to survive this Agreement. and .my
other provision
required to interpret and enforce the Parties' rights and obligations under this Agreement (including without
limitation Section 1 (Definitions) and Section 18 (Force Majeure) through Section 31 (Governing 1.aw )).
shall survive to the extent required for the full observation and performance of this Agreement by the
Parties.
24 .
Disclosure of Compensation. The Parties acknowledge that certain states require pharmaceutical
companies to disclose information on compensation, gifts or other remuneration provided to physicians and
other health care professionals. Company may report as required by law. or may
oluntarily disclose or
make public, information about remuneration provided under this Agreement.
25.
Headings. Headings used in this Agreement are ibr the purpose of con enience only
1 1n_ up not ;iffect the
interpretation or construction of the Agreement itself.
26.
Entire Agreement. This Agreement constitutes the entire understanding between the Parties and there are
no collateral, oral or written agreements or understandings. This Agreement supersedes any prior oral or
written agreement or understanding between the Parties.
27.
Authorized Representa(ives. Each signatory to this Agreement pers(mally represents that, such signatory
has authority to legally bind such signatory's respective Part) to this Agreement. The signatories arc not
otherwise Parties to this Agreement. except as elsewhere set forth in this Agreement.
28 .
Counterparts. This Agreement may he executed in two (2) or more counterparts. each of
WhiCh
i s deemed
an original. but all of which together constitutes one instrument.
29.
Interpretation. Unless the context of this Agreement requires otherwise, words of one gender include the
other gender: words using the singular or plural number also include the plural or singular number.
respectively: and the term "including" means "including. without limitation."
3 0.
Dispute Resolution. The Parties will work together in good faith to resolve an disputes that arise under this
Agreement. All disputes may be submitted to arbitration or mediation upon the mutual agreement of
the
Parties.
3 1 .
Governing Law, This Agreement shall be governed by, and construed and enforced in accordance with the
law olCalifornia applicable to contract made and to be performed therein without giving effect to the
principles thereof the conflict of' laws.
[Signatures folhtw on the next page.
Ex. B, Pg. 62
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IN WITNESS WHEREOF,
the Parties
hereto have caused
this Agreeinein to be executed by their duly
authorized representatives.
On behalf of Toyama Chemical Co., Ltd.
Date V
4
Name
Y
S A And
0
Mole- R4 of Devejorent
pit/is:eh
On behalf
of University of California San Diego
n
ate )
t
e
d
v
i
3
Name: Lynelle Gehrke
ThlefDepartment: Associate Director, UCSD O ffice of Contract & Grant Adm inistration
1 q
Read & Agreed,
Signature
ate
t
Paul S Aisen,
Principal investigator
A itaelinif
nts:
Exhibit A: Protocol or protocol summ ary
Exhibit 13: lOtlacr Boatmen tsl,SOW
Exhibit
C: Midget
and Payment Schedule
Ex. B,
P g .
63
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EXHIBIT C
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Notice of Award
RESEARCH PROJECT COOPERATIVE AGREEMENT
Issue Date: 12/08/2014
Department of Health and Hum an Services
National Institutes of Health
NATIONAL INSTITUTE ON AGING
cky.rfist.,
Grant Number:
5U19AG010483-24
FAIN:
19AG010483
Principal Investigator(s):
Paul S. Aisen, MD
Project Title: Alzheimer's Disease Cooperative Study
CONTRACT & GRANT OFF ICER
UNIVERSITY OF CALIFORNIA, SAN D IEGO
OFFICE OF CONTRACT & GRANT ADMIN
9500 GILMAN DRIVE, 0934
LA JOLLA, CA 950930934
Aw ard e-mailed to:
Budget
Period: 12/15/2014 —
11/30/2015
Project Period: 07/01/1997 — 11 /30/2017
Dea r Business O fficial :
The National Institutes of Health hereby awards a grant in the am ount of
see
"Award Calculation" in Section land "Terms and Conditions" in Section OF
CALIFORNIA SAN DIEGO in su pport of the above referenced project. This aw ard is pursuant to
the authori ty of 42 U SC 241 31 U SC 6305 42 CFR 52 and is s ub ject to the requirements of th is
statute and regulation and of other referenced, incorporated or attached terms and c onditions.
Acc eptance of this award including the Terms and Conditions is acknowledged by the grantee
when funds are drawn down or otherwise obtained from the grant payment s ys tem.
Each publication, press release, or other document about research s upported by an NIH award
mus t include an acknowledgment of NIH award support and a disc laimer such as Research
reported in this publication was supported by the National Institute On Aging of the National
Institutes of Health under Award Number U1 9AG01 048 3. The content is s olely the responsibi l ity
of the authors and does not necessari ly represent the off icial views of the National Institutes of
Health. Prior to issuing a press release concerning the outcome of this research, please notify
the NIH awarding IC in advance to allow for coordination.
Award recipients mus t promote objectivity in research by establishing s tandards that provide a
reasonable expec tation that the design, c onduct and reporting of research funded under NIH
awards wil l be free from bias resulting from an Inves tigator's Financ ial Conflict of Interest (FC0 I),
in accordance with the 2011 revised regulation at 42 CFR Part 50 Subpart F. The Institution
shall su bm it all FC0I reports to the NIH through the eRA Com mons FC0I Module. The regulation
does not apply to Phase I Small Business Innovative Research (SBIR) and Small Business
Technology Trans fer (STTR) awards. Consult the NIH webs ite
http://drants.nihmov/orants/policv/coi/
for a link to the reg ulation and ad ditional important
information.
I f you have any questions ab out this award, please contact the individual(s) referenced in Section
IV.
Sincerely yours,
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TRACI LAFFERTY
Grants Management
NATIONAL INSTITUTE ON AGING
Additional information follows
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SECTION I — AWA RE
5U19AG010483-24
Award Calculation (U.S. Dollars)
Salaries and W ages
Fringe Benefits
Personnel Costs (Subtotal)
Consultant Services
Equipment
Supplies
Travel Costs
Oth er Costs
Consortium/Contractual Cost
1
ederal Direct Costs
Federal F A Costs
Approved Budget
Federal Share
TOTAL FEDERAL AW ARD AMOUNT
AMOU NT OF THIS ACTION (FEDERAL SHA RE)
SUMMARY TOTALS FOR ALL YEARS
YR
THIS AW ARD CUMULATIVE TOTALS
24
25
26
R
ecom mended future year total cos t support
sub ect to the availabil i ty of funds and
progress of the project
Fiscal Information:
CFDA Number:
3.866
EIN:
956006144A1
Document Number:
AG010483E
PMS Account Type:
(Pooled)
Fisca l Year:
015
IC
AN
015
016
017
AG 470696
Recomm ended future year total cost support, subject to the availabili ty of funds and s atisfactory
progress of the project
NIH Administrative Data:
PCC:
3CCCTNS / OC: 414P / Released: LAFFERTYT 12/04/2014
Aw ard Processed:
05108/2014 01:52:21 PM
SECTION I I — PAYMENT/HOTLINE INFORMA TION — 5U19A6010483-24
For paym ent and H HS Off ice of Inspec tor General Hotline information, see the NIH Home Page
at
http://orants.nihmov/erants/policv/awardconditions.htm
SECTION III — TERMS AND CONDITIONS — 6U19AG010483-24
This award is bas ed on the application sub mitted to, and as approved by , NIH on the above-tit led
project and is s ubject to the terms and c onditions incorporated either directly or by reference in
the following:
a. The grant program legislation and program reg ulation cited in this Notice of Award.
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b .
Conditions or
ies and expenditure of funds in other sta
equirements, s uch as
those include
L
propriations acts.
c .
45 CFR Part 74 or 45 CFR Part 92 as applicable.
d.
The NIH Grants Policy Statem ent, including addenda in effect as of the beginning date of
the budg et period.
e.
This award notice, INCLUD ING THE TERMS AND CONDITIONS CITED BELOW .
(See NIH Home Page at http://erants.nih.qov/qrants/oolicv/awardconditions.htm
for certain
references ci ted above.)
This institution is a signatory to the Fed eral Demons tration Partnership (FDP) Phas e VI
Agreement w hich requires active institutional participation in new or ongoing FD P dem onstrations
and pilots.
Carry over of an unobligated balance into the next b udget period requires Grants Managem ent
Officer prior approval.
This award is sub ject to the requirements of 2 CFR Part 25 for institutions to receive a Dun &
Bradstreet Universal Numbering Sys tem (D UNS) num ber and m aintain an ac tive registration in
the Central Contractor Registration. Should a consortium/sub award be is sued under this award,
a DU NS requirement must be included. See
http://qrants.nih.gov/qrants/policy /awardconditions.htm
for the full NIH aw ard term implem enting
this requirement and other additional information.
This award has b een ass igned the Federal Award Identif ication Number (FAIN) U1 9AG01 048 3.
Recipients must document the assigned FAIN on each consortium/subaward issued under this
award.
This award is not subject to the Transparency Act sub award and exec utive compens ation
reporting requirement of 2 CFR Part 170.
In accordance with P.L. 110-161, compliance with the NIH Public Access Policy is now
mandatory. For more information, see NOT-OD-08-033 and the Public Ac ces s w ebs ite:
http://publicaccess.nih.qov/.
Treatment of Program Income:
Additional Costs
SECTION IV — AG Special Terms and Conditions — 51.119AG010483-24
NIH is c urrently funded through a Continuing Resolution (see NIH Guide Notice NOT-OD-15 -001)
http://grants.nihmov/erants/quide/notice-f iles/NOT-OD-15-00 1.html
Therefore, NIH will issue
non-competing research g rant awards at a level below that indicated on the mos t recent Notice of
Award. Upward adjus tments to awarded levels w ill be cons idered after our FY 201 5
appropriations are enacted; NIH ex pects institutions to m onitor their expenditures carefully during
this period.
This award includes funds awarded for cons ortium ac tivity with the University of Pennsy lvania,
Seattle Institute for Biomedical and Clinical Research, Columbia University, Regents of the
University of California, Indiana University, New York University School of Medicine, Banner
Alzheimer's Institute, Mayo Clinic, the U niversity of Rochester, W ashington U niversity, Mount
Sinai School of Medicine, University of Southern California, The Brigham and W omen's Hospital,
Georgetown University, University of California - San Francisco, Cas e W estern Reserve
University School Of Medicine and W ake Forest University Health Sciences. Cons ortiums are to
be es tablished and adm inistered as desc ribed in the NIH Grants Policy Statement (NIH GPS).
The referenced sec tion of the NIH Grants Policy Statement, October 201 0 is available at:
http://odoerdb2.od.nih.gov/gmac/nihgps_2010/nihgps_ch15.htm
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The requested budget
onsidered and determined not to represr
i ficant re-budgeting.
Therefore, categorical
nts reflect the direct and facilities and adi.
ative cost (F&A)
levels previously recomm ended for the current year. Funds m ay b e re-budgeted between direct
cos ts and FM c osts, c onsistent wi th applicab le cost pr inc iples and inst i tu tional and pol icy
requiremen ts for prior approval.
The following special terms of award are in addition to, and not in lieu of, otherwise applicable
U.S. Off ice of Management and Budget (OMB) adm inistrative guidelines, U.S. D epartment of
Health and Human Services (DHHS) g rant administration regulations at 45 CFR Parts 74 and 92
(Part 92 is applicable when State and local Governments are eligible to apply), and other HHS,
PHS, and NIH grant adm inistration policies.
For additional information concerning the RFA, please refer to:
http://grants.nih.gov/grants/guide/rfa-files/RFA
-AG -13 -001.html
The adm inistrative and funding instrument used for this program wil l be the cooperative
agreement, an ass istance mec hanism (rather than an acquisition mec hanism), in which
sub stantial NIH programm atic involvement w ith the awardees is anticipated during the
performance of the activities. U nder the c ooperative agreement, the NIH purpose is to s upport
and s timulate the recipients' ac tivities by involvement in and otherwise working jointly w ith the
award recipients in a partnership role; it is not to assume direction, prime responsibility, or a
dominant role in the activities. Consis tent with this c oncept, the dom inant role and prime
responsibi l ity resides with the awardees for the project as a whole, although spec ific tasks and
activities may be shared am ong the awardees and the NIH as defined below.
The PD (s)/P1(s) w ill have the primary respons ibi li ty for
Overall managem ent of the study through the c oordinating center and should ag ree to work
cooperatively with the cores/functions and c linical sites developing and implementing s ys tems
neces sary for comm unications am ong the various s tudy organizational components. The
coordinating center will facilitate the design and refinement of all protocols, manuals of
operations, and forms. All data and s amples that s hall be placed in the public domain and s hared
freely by methods and within time periods to be s pecif ied by the Steering Comm ittee, as a
fundamental purpose of this s tudy is the es tablishment of an unrestricted public databas e.
Awardees wil l retain custody of and have primary rights to the data and software developed under
these awards , subject to Government rights of acces s c onsistent with current DHH S, PHS, and
NIH policies.
NIH staff have subs tantial programm atic involvement that is above and b eyond the normal
stewards hip role in awards, as desc ribed below:
The des ignated NIA Project Scientist, Laurie Ryan, PhD , wil l serve as a mem ber of the Steering
Committee and have sub stantial scientific/programm atic involvement during c onduct of this
cooperative agreement, through technical as sistanc e, advice, and c oordination above and
bey ond normal program stew ardship of grants. The awardee agrees to accept as sistanc e from
the designated NIA Project Scientist. This person will participate, through the Steering
Committee, in the monitoring of issues relating to recruitment, follow-up, and adherence to
protocols and wil l assist in the development and/or adjustment of study protocols.
Additionally, an agency program official or NIA Program Officer, Nina Silverberg, PhD, will be
responsible for the normal scientific and programmatic s tewardship of the award and wil l be
named in the award notice.
Areas of Joint Respons ibi li ty include:
The Steering Com mittee, comprised of the PD (s)/P1(s) of the c ooperative agreem ent, the leaders
of the cores/functions and each of the clinical sites, the bioethicist, the family representative, the
FDA representative, and the NIA Project Scientist will have primary responsibility for finalizing
standard definitions, procedures, and meas ures c omm on for all the protocols. The s teering
comm ittee wil l meet every three to six m onths, or as dictated by the needs of the study . Each full
mem ber of the Steering Com mittee wil l have one vote, and all major scientific dec isions w ill be
determined by majority vote of the Steering Committee. Awardee m emb ers of the Steering
Committee wil l be required to ac cept and implement policies approved by the Steering
Committee. Subcom mittees appointed by the Steering Committee, com prised of appropriate s taff
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from the cores and c11
tes, will be involved in the design of prot
nd manuals of
operations, and in ong,
unctions of the study s uch as preparation
blications.
To oversee the allocation and distribution of biological spec imens generated from the study , the
Steering Com mittee wil l nominate mem bers for the Res ource Allocation Review Comm ittee
(RARC). This group will review applications for use of the biological specimens. The format of the
application and c riteria for the use of repository biological s pecimens wil l be developed by the
RARC with advice and approval from the Steering Committee and made available to all potential
users . Memb ership on this c omm ittee w ill rotate periodically ac cording to a procedure developed
by the RARC. Final approval of members of the RARC and final approval for disposition of
sam ples to investigators following RARC review w ill be m ade b y NIA staff. The primary g overning
body of the study wil l be the Steering Com mittee, which wil l have responsibi l ity for the f inal details
of study des ign and policy decisions and wil l define the rules regarding acces s to data and
samples.
Dispute Res olution:
Any d isagreements that may arise in scientific or programm atic matters (within the scope of the
award) between aw ard recipients and the NIH may be brought to Dispute Resolution. A Dispute
Resolution Panel composed of three mem bers w il l be c onvened. I t will have three memb ers: a
designee of the Steering Comm ittee c hosen w ithout NIH staff voting, one NIH d esignee, and a
third des ignee with expertise in the relevant area who is chos en by the other two; in the case of
individual disagreement, the f irst mem ber may be c hosen by the individual awardee. This spec ial
dispute resolution procedure does not alter the awardee's right to appeal an adverse action that is
otherwise appealable in acc ordance with PHS regulation 42 CFR Part 50, Subpart D and DHH S
regulation 45 CFR Part 1 6.
STAFF CONTACTS
The Grants M anagem ent Specialist is respons ible for the negotiation, award and a dministration of
this project and for interpretation of Grants Administration policies and provisions. The Program
Official is responsible for the scientific, programmatic and technical aspec ts of this project. These
individuals work together in overall project administration. Prior approval requests (signed by an
Authorized Organizational Representative) s hould be sub mitted in w riting to the Grants
Managem ent Specialist. Requests m ay be m ade via e-mail.
Grants Managem ent Specialist: John Bladen
Email: [email protected]
Phone: 301-496-1472 Fax: 301 -402-3672
Program Official: Nina B. Silverberg
Email: si lverbergn@ mail.nih.gov
Phone: 301-496-9350 Fax: 301-496-1494
STAFF CONTACTS
The Grants M anagem ent Specialist is respons ible for the negotiation, award and adm inistration of
this project and for interpretation of Grants Administration policies and provisions. The Program
Official is res ponsible for the scientific, programmatic and technical as pects of this project. Thes e
individuals work together in overall project administration. Prior approval requests (signed by an
Authorized Organizational Representative) should be submitted in writing to the Grants
Management Specia list . Requests m ay be m ade via e-mai l.
Grants Management Specialist John Bladen
Email: bladenj@ nia.nih.gov
Phone: 301-496-1472 Fax : 301 -402-3672
Program Official: Nina B. Silverberg
Email: si lverbergn@m ail.nih.gov
Phone: 301-496-9350 Fax : 301-496-1494
SPREADSHEET SUMMARY
GRANT NUMBER: 5U19AG010483-24
INSTITUTION: U NIVERSITY OF CALIFORNIA SAN DIEGO
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Budget
Year 24
Year 25
Year26 H
Salaries and W ages
Fringe Benefits
I
Personnel Costs (Subtotal)
Consultant Services
I
I
I
1
Equipment
Supplies
Travel Costs
Other Costs
Consortium/Contractual Cos t
I
TOTAL FEDERAL DC
TOTAL FEDERAL F&A
I
OTAL COST
Facil i ties and Administrative Cos ts
Year 24
Year 25 Year 26
F&A Cost Rate 1
I
I
I
I
I
I
I
I
I
F&A Cost Base 1
F&A Costs 1
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alzheirnes
95
association
December 12, 2014
EVISED
Paul S. Aisen, MD
University of California, San Diego
Alzheimer's Disease Cooperative Study
9500 Gilman Drive, Dept 0934
M/C 0949
San Diego, CA 92093-0934
Re: Longitudinal Evaluation of Am yloid R isk and N eurodegeneration (LEA RN)
Dear Dr. Aisen:
The Alzheimer's Association is pleased to inform you that LEARN- 15 -3387 30, "Longitudinal
Evaluation of Amyloid Risk and Neurodegeneration (ADCS)" has been funded. The funding
of
LEARN
comprises three project awards: (1)
Dr. Aisen as listed in this letter (2) LEARN-15-338729, Reisa Sperling, MD.,
Massachusetts General Hospital and (3) LEARN-15 -35 2131, Cohn
L. Masters, MD., Morey Institute of Neuroscience
and Mental H ealth.
The Project will be funded beginning October 1, 2014 .
The Project period is October I, 2 014 to Septem ber 30, 2018.
The total amount of the funding is $7,004 ,76 1.00."
a)Amount
of Funding:
The Association w ill provide University of California, San Diego directly
with funding for the Project, over a period of four (4) years, in the bi -
annual
amount set forward in the project budget.
Payment for the first year (Fall 2014) is guaranteed. Payment for the subsequent years (2015 , 2016, 2 017, 2 018) will
be forthcoming unless the Association advises University of California, San
Diego in w riting by January I' of the
year in which the payment is due, that it has elected to not continue such funding. Ab sent the Association's election to
discontinue funding, the payments will be made accordingly.
Payment Cycle Funding Period Anticipated Budget
I
Fall, 2014 (FY15)
$
86,452
2
Spring, 2015 (FY15)
$
86,452
3
Fall, 2015 (FY 16)
$
71,541
4
Spring, 2016 (FY16)
$
71,541
5
Fall, 2016 (FYI7 )
$ 71,972
6 Spring, 2017 (FY17)
$
71,971
7 Fall, 2017 (FY18)
$ 72 ,416
8
Spring 2018 (FY18) $ 72 ,416
TOTAL
$ 7,004,761
The requirements for this Project are detailed in this document which includes the Award Letter,
Conditions of Award and the Patent Policy as one document. The document must be signed, initialed
where required and uploaded to your online file as a "pdr.
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alzheimer's
93
association'
The Alzheimer's Association also requires the following electronic files to be uploaded to pcCentral at:
httos://Promarentral.altum,com/loainam
•
Signed/initialed Award Letter, Conditions of Award and Patent Policy documentation as a "pd?'
•
A 5" x 7" black and white or color photograph of you in your lab
•
A non-technical abstract of the project as a Word document or "pdf'
All of the above are required and must be submitted electronically to activate the funding.
Hard copies of the
required documents
will not be accepted.
The Alzheimer's Association depends upon private support to meet its goals and to fund research projects. Therefore,
your help and support are very important in the efforts to educate the general public and the scientific community
about the disease and the Association. In accepting this research award, you agree to credit the Alzheimer's
Association for providing funds for this research whenever you present the research or publish Articles about the
project. In addition, your acceptance allows the Alzheimer's Association to use your likeness in presenting your
findings through press releasei, interviews, or other strategic activities. Please note the attached Conditions of Award
for details of this commitment.
It is necessary for both you and a representative from the business office or Office of Sponsored Research from the
applicant Institution, to sign the form below. The signatures verify that the funding is accepted by the Institution with
the attendant requirements and that no part of this research project has been funded from another source. Also,
complete the included form requesting the information for the business official that has fiscal responsibility for this
project.
Please retain a cope
for your
111eA and upload the complete Award Letter, Conditions of Award, and
Patent Polk
,
document to the ocCentral site.
Thank you for your support of the Alzheimer's Association and commitment to research on Alzheimer's disease. If
you have any questions, please call Mary Grilli, Post Award Specialist, Medical and Scientific Relations department at
(312) 335-5727.
Sincerely,
&W/4924
Heather NI, Snyder, PhD.
Director
Alzheimer's Association
Medical & Scientific Relations
Sincerely,
--
)71,24..;-. C.
Cott...zee
Maria C. Carrillo, PhD.
Vice President
Alzheimer's Association
Medical & Scientific Relations
cc:
Deborah Tobias, Director of Administraton, Signing Official
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alzheintes
c o
association '
This FY2015 Research Award is accepted on behalf of University of California, San Diego. The
requirements as specified in the Award L etter documentation
receiving duplicate funding from another source.
The Alzheimer's Association depends on volunteers for its
could not have been funded without the hard w ork of those
want to repay those volunteers by r
ining an active reviewer
respond when called upon to con
e to this support of
are accepted. o part of this project is
exem plary grant review process.
Your grant
volunteers. The Association assumes you
in our system.
It is imperative that you
the Alzheimer's research community.
By signing this document you a gr i
of the above terms and conditions.
Principal Investigator Date 2 hrbq
Institutional Official
Date
will
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alzheimer's
93 association
Conditions of Award I 09/14 (LEARN)
DATA SHARING & GAAIN
The Alzheimer's Association is committed to data sharing for Alzheimer's Association
International Research Grant Program grantees. Data sharing is a necessary means to advance
Alzheimer research results into systemic knowledge, usable products, and research procedures,
leading to the overall improvement of human health. We expect the timely release and the
sharing of final research data from Alzheimer's Association funded research studies at no more
than incremental cost and within reasonable time frame. Included in the "final research data"
are the data, samples, physical conditions and other supporting materials created or gathered
during the course of the work. The rights and privacy of people who participate in Alzheimer's
Association — sponsored research must be protected at all times. When applicable, data
collected during these stud ies and shared for broader use should b e free of identifiers and
variables related to individual subjects.
To that end, the Alzheimer's Association requires the data sharing associated with this grant
award b e connected through the Global Alzheimer's Association Interactive Network
(GAAIN). GAAIN is a federated research repository utilizing a cloud-based, grid network
infrastructure spanning centralized computational facilities in North America and Europe.
GAAIN is led and m anaged by the Alzheimer's Association, Dr. Arthur Toga (USC) and D r.
Giovanni Frisoni (University of Geneva).
Awardees are encouraged to discuss potential impediments or time delays to data sharing with
their Association contact at the time they negotiate grant agreement to accept the Alzheimer's
Association g rant award.
**IMPORTANT NOTE**
Failure to comply with the Alzheimer's Association Data Sharing Policy will result in
termination of the grant funding from the Alzheimer's Association.
5
nitial that you accept the terms stated on this page'
.
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alzheimes
9 5
association -
Conditions ofAw ard — 09/14 (LEA RN)
NOTIFICATION OF PUBLICATIONS
One electronic copy of manuscripts and meeting abstracts reporting research acknowledging
funds from the Alzheimer's Association must be submitted
ELECTRONICALLY
at the time
of publication. This copy will become part of the official file of the grant and will be provided
to the Communications Division to assist in the efforts to further inform the public about the
research program of the Association. These submissions must be made electronically using the
same system outlined above for report submissions.
The Association will provide publicity assistance when the principal investigator notifies the
staff prior to the release of findings in any scientific journal or major meeting presentations and
will work with the Public Relations Officer of the institution to ensure coordination of efforts.
Please contact the Communications Division, Media Relations Department at 312-335-5776 as
early as possible in the process, for instance as soon as the manuscript is accepted for
publication or presentation.
An acknowledgment of support provided by the Association must be included in any responses
to or interviews with radio, television or print journalists when an Association funded grant is
discussed.
ACKNOWLEDGEMENT OF FUNDING SOURCE
An acknowledgment of support provided by the Alzheimer's Association must appear in
publications of any material whether copyrighted or not, if the data is based on or developed
under Association-supported projects. The following wording should be used:
This work was
supported by A nds from the Alzheim er's Association (LEA RN -I5-??????).
In addition, an acknowledgement of support provided by the Alzheimer's Association must
appear in presentations of any material, if the data is based on or developed under Association-
supported PROJECTS.
Whenever the principal investigator is informed of sponsorship through the generosity of a
donor, the specific PROJECT name should be used. For example, the Alzheimer's
Association/Samuel A. Blank Research Grant.
**IMPORTANT NOTE**
Upon completion of projects, the Association encourages award recipients to consider
submitting an article describing results to Alzheimer's & Dementia: The Journal of the
Alzheimer's Association. For submission information, visit
www.elsevier.com/authors.
6
nitial that you accept the terms stated on this page
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alzheimer's
Q s
association
Condiiions
of
Award— 09/14 ILEA RN)
RIGH T TO AUDIT
n
accordance with generally accepted accounting principles, the grantee institution ("Grantee")
shall maintain reasonably full and complete records of the cost and completion of services
performed under this Grant Aw ard and the Conditions of Award A greement (together,
"Agreements"). During the term of the Agreements, and for a period of two years after their
termination or completion, the Alzheimer's Association shall have the right to inspect and/or
audit the Grantee's records as they pertain to the performance of the Agreements at Grantee's
office. Upon five business days written notice from the Alzheimer's Association, Grantee
agrees to make available all records for inspection or audit at its offices during normal business
hours (Monday through Friday, 8 a.m. - 5 p.m. local time).
** IMPORTANT NOTE**
Overlapping finding of more than one Alzheimer's Association grant is not allowed, except in
instances of Special Grant opportunities as designed by Alzheimer's Association staff.
Investigators who currently have an active Association grant may apply for another award in
the last year of their grant if that last year conc ludes by June 30
t h
prior to the start of the new
funding year as ofJulyl.
7
nitial that you accept the terms stated on this page'
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alzbeimes
q s
association
Condit ions ofAward
- 09/14 LEARN )
REQUESTS FOR ADMINISTRATIVE ACTIONS
Subm it requests for adm inistrat ive a ct ions electronical ly through the proposalCEN TR AL
online system used for Interim and Final report subm issions des cribed above). When
the
request has been uploaded , please advise M ary Gri l li , Post Award G rant Special ist that a
request has been fi led (MamGrilliealz.org
).
** IMPORTANT NOTE**
' ALL letters and reports must be submitted electronically (see instructions above in
reporting requirements).
Requests for administrative actions (e.g. re-budgeting, carry-over of unexpended funds,
replacement of principal investigator, transfer of institution, overlap, extension of award,
administrative supplements)
must be submitted electronically via letter
which has been
signed by the principal investigator of the application or grant and the responsible, bonded
business official of the institution. Any request must be submitted 45 days prior to the desired
date of action. Association staff will review draft letters for content and appropriateness prior to
submission of the final signed request. The preliminary review does not indicate advance
approval of the request, rather the preliminary review will ensure that all necessary information
has been included.
Review and approval of requests for administrative actions is the responsibility of the staff of
the Alzheimer's Association. The Association reserves the right to refer a request to the MSAC
for its advice prior to final decision. All requests for adm inistrative supplemental funds w ill be
referred to the MSAC.
Re-budget ing
Requests for re-budgeting of m ore than 10% of the total awarded amount (direct + indirect
costs) for that year
must be submitted electronically
for prior approval to the Alzheimer's
Association. Requests to re-budget must be clearly explained and justified against the timely
achievement of the specific aims of the grant. If possible, re-budgeting requests should be
submitted w ith the interim/non-competing continuation report. If necessary, re-budgeting
requests will be accepted mid-grant year.
Carry over of Unexpended Funds
In general, permission to carry forward unexpended balances into future funding years is
allowed. For exam ple, a $10,000 unexpended balance at the end of the 02 year, of a three year
award, will be carried forward automatically and used to supplement to the $60,000
continuation funding of the 03 year (which would provide the investigator a total of 0,000 for
the 03 year).
Initial that you accept the terms stated on this page
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alzheimer's 9 5 association
Condit ions
of Award-09/14 LEARN)
Replacement of the Principal Investigator
The grantee institution may request the replacement of a principal investigator, except for
principal investigators of Zenith and Pioneer awards. If the principal investigator of a Zenith or
Pioneer award does not wish to complete the grant or leaves research work for some reason, the
grant will be terminated and the remaining funds returned to the Alzheimer's Association.
The request to replace a principal investigator must be submitted electronically (see
instructions above in reporting requirements) by the appropriate faculty mem ber (usually
the Department Chair or Dean) and countersigned by the responsible business official of the
grantee institution. The letter requesting replacement of the principal investigator must contain
a curriculum vita of the proposed replacement principal investigator. Approval of a
replacement principal investigator is the responsibility of the Association and subject to review
by staff.
Transfer of Institution
The Association will consider and approve requests to transfer a grant to another institution
when the principal investigator moves during the award period. The key points in determining
if a request to transfer w ill be approved are (I) if the resources and technical personnel at t he
new institution will adequately support the research through the remaining period of the award
and (2) if both institutions and the principal investigator are in agreement about the
appropriateness of the transfer.
To transfer a grant to a new institution, the following documents are required:
• A release letter from the current institution
• An acceptance letter from the new institution stating their new position and the resources
available to support the Alzheimer's Association funded research
•
A scientific and financial report detailing accomplishments to the date of transfer
• Transfer of all unexpended funds must be m ade back to the A lzheimer's Association, w ho
will in turn make a payment of unexpended funds to the new institution
The request to transfer a grant should be submitted electronically at least 60 days in advance of
the planned move to ensure Association staff have adequate time to review the request and ask
for and receive additional information should it be necessary. You may request a six-month
extension to complete work proposed in the grant for time loss during your move to the new
institution.
Overlap with other Funded Applications
Investigators must inform the Association of any overlap, or concern about possible overlap,
with other grants. Overlap is defined as "tw o or m ore grants by the same principal investigator
which share at least one specific aim". It is not necessary to provide information about
applications that share specific aims with an Association grant. The concern about overlap
arises only when an investigator has been notified that he/she will be awarded a gran
9 nitial that you accept the terms
stated on this page
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alzheinier's c o
association
Condit ions of
Award —
09/14 LEARN
another organization and that application, soon to be awarded, shares specific aim(s) with a
grant from the Association.
Extension of Award
An extension of the term of a g rant without funds (no-cost extension) or with funds remaining
at the end of the grant period (extension w ith cost) may be approved w hen requested
electronically 45 days prior to the grant expiration. Typically, requests range from six to
twelve months however you are allowed a 6 month extension for each year of the award (e.g. a
two year aw ard will be eligible for 2 no-cost extensions, up to 6 m onths each whereas a three
year award w ill be eligible for 3 no-cost extensions, up to 6 months each). The principal
investigator and responsible business official must countersign the letter requesting the
extension, whether the extension is with funds unexpended at the end of the g rant period or at
no cost. Although requests may not be made for the sole purpose of spending remaining funds,
you may expend remaining funds during the no-cost extension period. The duration of the
extension and the expected products/accomplishments must be detailed in the letter. An
extension of term m ay only be requested to complete w ork proposed in the grant.
Administrative Supplemental Awards
The Association, through review and recommendation of the MSAC , may provide
administrative supplemental funds during the period of an ongoing grant. Requests for
administrative supplements will be approved only in rare, compelling circumstances. Funds for
the award of an administrative supplement m ust be taken from the pool of funds for new
competitive grant awards.
Administrative supplemental awards m ay only be requested to (1) address some em ergency that
imperils the completion of the grant as approved and funded and (2) cannot be handled by re-
budgeting available funds. Supplemental funds may not be requested to expand the goals or
scope of the award. Investigators should contact the staff of the Grants Operations office to
thoroughly discuss the circumstances and the possible request for an administrative supplement
prior to submitting the letter.
Investigators w hose requests for administrative supplements are denied by the MSAC may not
appeal the decision.
Change of Names and A ddresses
If an investigator moves while an application is under review by the Association, it is necessary
to submit electronic notification of the new address and the date of the move by updating the PI
profile in proposalCENTRAL. In some instances, great difficulty has been encountered trying
to find an investigator to inform him/her of the award of a grant.
If the business official responsible for the grant or application at the institution is changed, the
investigator and new business official should update information electronically in the
proposalCENT RAL profile as soon as possible.
10
nitial that you accept the terms stated on this page
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alzheimes association
-
Conditions
of Award—
09/14 LEARN)
Prompt online notification through proposalCENTRAL, of changes in names, titles,
addresses, phone and fax numbers, email addresses will help to avoid delays in processing
any actions or requests.
Other Administrative Actions
For other
administrative actions not covered in this document,
the investigator should submit an
electronic letter detailing the request and the rationale.
** IMPORTANT NOTE**
ALL letters and reports must be submitted electronically (see instructions above in
reporting requirements).
11
nitial that you accept the terms stated on this page
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alzheimer's
2 5
association°
PATENT POLICY OF TH E ALZHEIMER'S ASSOCIATION®
The primary purpose of the Alzheimer's Association (the "Association") funding scientifically meritorious research
is to advance its mission to eliminate Alzheimer's disease through the advancement of research; to provide and
enhance care and support for all affected; and to reduce the risk of dementia through the promotion of brain health.
The Association recognizes that patentable Inventions (defined below) having pub lic health, scientific, business or
comm ercial application or value m ay be m ade in the course of research supported by the A ssociation. It is the
desire of the Association that such Inventions w ill be administered in such a m anner that they are brought into
public use at the earliest possible time. The A ssociation recognizes that this may be b est accomplished through the
filing of applications for registration of patents and/or copyrights in such Inventions and the com mercial licensing
of such Inventions to third parties. Discoveries, works of authorship, or Inventions derived from research
performed, supervised or subcontracted for by the grantee institution during the term of the grant w ill be subject to
the Association's Patent Policy as set forth b elow:
1.
"Invention" is any discovery, data, m aterial, method, process, device, product, prog ram, softw are,
proprietary know- how or other work of authorship, whether or not patentable or copyrightable, that is
created, conceived or discovered in the course of research supported in whole or in part by the Association,
and in the case of patentable inventions is capab le of being reduced to practice, either actually or
constructively, during the course of the research.
2 .
All notices of disclosure of Invention patents must be reported in a timely m anner to the Medical &
Scientific Relations Division of the Association. Upon the Association's request, all documentation
relating to the filing or assertion of rights shall b e provided to the A ssociation. The Association shall agree
to m aintain the confidentiality of such documentation by executing a confidentiality agreement mutually
agreed to by the g rantee institution /inventor and the Association. All expenses of the Invention patent
process should be b orne by the grantee institution or individual awardee.
3.
Unless otherwise indicated or requested by the grantee institution, title to any invention shall reside in the
grantee institution.
4.
Distribution of income derived from an Invention shall be according to the policies of the g rantee
institution, except that the Association shall participate in net income derived from the Invention (unless
waived in w riting by the Association) to the extent, and at a rate of remuneration, to be determined by
mutual agreement betw een the grantee institution and the Association at the time a patent application is
filed. If the grantee institution has no established and applicable patent, intellectual property, or technology
transfer policy and procedure for administering Inventions, the Association shall have the sole right to
determine the disposition of the Invention rights in a m anner consistent w ith this Patent Policy.
5. The grantee institution shall use reasonable efforts to notify the Research Department of the Association
prior to abandoning a patent or patent application claiming an invention supported by finds furnished by
the A ssociation.
Initial that you accept the terms stated on this page
Ex. C, Pg. 81
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association®
6.
The grantee institution shall agree that if it has not taken effective steps, within a reasonable time frame for
the research project advancement after a U.S. patent issues on an Invention supported by Association funds
and administered by the institution, to bring that invention to the point of practical application, or has not
made such Invention available for licensing, the Association shall have the right to request grantee
institution terminate the license for lack of diligence, grant title to the Association and to locate and
proceed with another licensee.
7. If any Invention is made with the joint support of the Association and any agency or department of the
United States Government, the Association may defer to the patent policy of that agency or department
upon written statement by the appropriate agency of government notifying the Association of its position
with respect to the Invention in question.
8.
If any Invention is made with the joint support of the Association and some other organization, not an
agency or department of the U.S. Government, that organization, the institution, the inventor(s), and the
Association will confer to arrive at a mutually satisfactory disposition of the Invention rights.
Address all correspondence regarding this policy to:
Alzheimer's Association®
Medical & Scientific Relations—Grant Operations
225 N. Michigan Avenue — 17th Floor
Chicago, 11, 60601-7633
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C
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(2015-0717)
SOW
Longitudinal Evaluation Of Amyloid Risl and Neurodegeneration (LEARN)
The primary goal of the A4 trial is to test the hypothesis that decreasing Al3 burden in the
preclinical stages of AD will slow the rate of clinical decline, as assessed with a sensitive
cognitive composite primary outcome. We will also investigate the impact of anti-amyloid
therapy on multiple imaging modalities and biomarkers, including PET amyloid imaging,
volumetric MRI, and cerebrospinal fluid levels of
Ap,
phospho-tau and total tau in a subset of
participants. The A4 study also incorporates several novel outcomes, including a computerized
cognitive composite (C3) administered on the iPad, participant reported outcomes for self-
assessment of memory function, and functional connectivity MRI to assess impact of anti-
amyloid therapy on brain network function. The A4 study provides a critical opportunity to more
appropriately test the amyloid hypothesis at a stage when Ap may still drive the AD biologic
cascade, and determine the impact of anti-A13 therapy on neuronal loss and cognitive decline,
prior to widespread irreversible damage. The findings from this study should provide decisive
evidence to support (or refute)
Ap
as a viable strategy for disease-modifying therapy, and will
serve to greatly enhance the design, conduct, and efficiency of future early intervention trials.