A simplified guide to conducting research within the DoD

(San Antonio Edition)

ContentsPreface........................................................................................................................................................3

Getting Started............................................................................................................................................4

Financial Considerations..............................................................................................................................5

Funding Source........................................................................................................................................5

Core Funding.......................................................................................................................................6

Extramural Awards and the Broad Agency Announcement (BAA).......................................................6

Grant Cycle..............................................................................................................................................6

Preparing your application......................................................................................................................7

Required Registrations........................................................................................................................7

The Proposal........................................................................................................................................7

Scoring.................................................................................................................................................9

Contract Negotiations............................................................................................................................10

Regulatory Considerations........................................................................................................................11

Credentials.............................................................................................................................................12

Application............................................................................................................................................12

Review...................................................................................................................................................12

Dissemination Approval.........................................................................................................................12

Technology Transfer..................................................................................................................................12

Cooperative Research and Development Agreement (CRADA).............................................................13

Material Transfer Agreements (MTAs)..................................................................................................13

Patent License Agreements (PLA)..........................................................................................................13

Interagency Agreement.........................................................................................................................14

Frequently Asked Questions......................................................................................................................14

Preface

This guide is primarily written as a requests from colleagues with a genuine interest to perform research within the DoD medical community but are frustrated by the relative lack of transparency. Indeed, this information is neither unique nor proprietary and if someone had the time to attend the appropriate research seminars or even sit in front of the internet for a few hours, he/she would probably be able to understand this process. I make no claim that this is an “all inclusive” guide. I know that there’s much information missing but this hopefully serves as a place to get you started.

I intend for this guide to evolve with your input. This is published in print but also available on the web and as part of an iPhone/Android app. The forums will be a good place to get unanswered questions answered which in turn may improve future editions.

I hope you the best of luck with your research endeavors.

Rodney Chan

Getting Started

Whether you are thinking of doing a retrospective study, an animal experiment or a multi-centered clinical trial, you will need to consider ways of financing your work and to make sure that your work is in regulatory compliance. Below are two simplified flow charts to put these two parallel processes into perspective. BLUE represent steps to secure funding. GREEN represent steps to achieve regulatory compliance. Each of these topics will be approached sequentially but feel free to skip ahead.

Financial ConsiderationsFunding Source

The Defense Health Program (DHP), administered by the Defense Health Agency (DHA), was established within the DoD with responsibility for ten shared services (Facility Planning, Medical Logistics, Health Information Technology, TriCARE health plan, Pharmacy, Budget and Resource Management, Contracting/Procurement, Public Health, Medical Education and Training and RESEARCH and DEVELOPMENT). DHA support the business or clinical operations for all three Service Branches.

Within the US Army Medical Department (AMEDD), the US Army Medical Research and Materiel Command (USAMRMC) is charged with responsibility for medical research, development, and acquisition and medical logistics management from DHA. The Command is headquartered at Fort Detrick, MD, with 12 subordinate commands located throughout the world. The Command manages both intramural and extramural research programs in five basic areas: military infectious diseases, combat casualty care, military operational medicine, chemical biological defense, and clinical and rehabilitative medicine. The command is also the research manager for the DoD Blast Injury Research Program Coordinating Office and the Armed Forces Institute of Regenerative Medicine. (Office of Naval Research (ONR)/BUMED, Air Force equivalent.)

The USAMRMC has also been entrusted by Congress to manage and execute appropriated funds for Congressional Special Interest (CSI) medical research. The CSI appropriations are not part of the President's budget request; they are added to the Department of Defense budget by Congress. The majority of USAMRMC CSI appropriations are executed through one of the following offices or Commands within the USAMRMC: Congressionally Directed Medical Research Programs, Telemedicine and Advanced Technology Research Center, US Army Medical Materiel Development Activity, US Army Medical Materiel Agency. CSI efforts which may be directly relevant to existing Department of Defense or Army medical research and development programs may be directly managed by/or are provided additional scientific guidance and direction from the USAMRMC science and technology research programs and/or advanced development program managers. The currently funded research programs are: Alcohol and Substance Abuse, Amyotrophic Lateral Sclerosis, Autism, Bone Marrow Failure, Breast Cancer, Defense Medical Research and Development, Duchenne Muscular Dystrophy, Gulf War Illness, Joint Warfighter Medical (Coming Soon), Lung Cancer, Military Burn (Coming Soon), Multiple Sclerosis, Neurofibromatosis, Neurotoxin Exposure Treatment Parkinson's Research, Orthotics and Prosthetics Outcomes, Ovarian Cancer, Peer Reviewed Alzheimer's, Peer Reviewed Cancer, Peer Reviewed Medical, Peer Reviewed Orthopaedic, Prostate Cancer,

Psychological Health/Traumatic Brain Injury, Spinal Cord Injury, Trauma Clinical Research Repository (Coming Soon), Tuberous Sclerosis Complex, and Vision.

Core FundingIntramural funds support research efforts within the DoD. Each institution may differ but intramural laboratories are often segregated by task area of research interests.

The task areas at USAISR are Blood Research, Clinical Trials, Combat Critical Care and Engineering, CranioMaxillofacial, Damage Control and Resuscitation, Extremity and Regenerative Medicine, Ocular Trauma.

Each task can receive funds from the various Program Area Directives (PADs) at MRMC (MID, CCC, MOP, CBD, CRM) and with few exceptions, all funds are appropriated to a peer reviewed research proposal submitted through each task area’s manager (TAM). TAMs determine the focus of their research programs based on the proposals they select to submit for review and funding. Each task area may also receive additional intramural Congressional Special Interests (CSI) funds and expiring funds through unfunded Requests for Proposals (UFRs). TAMs are the best avenues to approach with novel ideas to be included as a part of their research portfolios.

Extramural Awards and the Broad Agency Announcement (BAA)Extramural awards are open to competition from any organization, including DoD investigators. In fact, DoD investigators are encouraged to seek these prestigious extramural awards to augment their core funding. The BAA is the mechanism by which extramural awards are granted. The BAA announces an agency's research interests including criteria for selecting proposals and soliciting the participation of all offerors capable of satisfying the government's needs. Each BAA packet will include details about the solicitation and it is important to determine the topic areas, the funding level, the funding period as well as the maximum of funds requested per proposal along with the deadlines for pre-proposal and full proposal submission. Investigators are encouraged to seek assistance at an early stage in order to maximize the chance of a successful submission.

Grant CycleFirst an opportunity is identified and a proposal is written. Depending on the award (this assumes that we are talking about extramural BAA solicitations), a pre-proposal and/or a QUAD chart may be required. The details of the pre-proposal is documented in the solicitation but it is generally an abbreviated grant application that is less than 3 pages. A Quad chart allows the reviewer to rapidly understand your proposal and the gap that it fulfills. The pre-proposal application is submitted to a program manager can determine whether the proposal fulfills

the basic requirements of the solicitation. After the invitation for a full proposal, the program manager

also assigns the proposal for peer review. In general, two levels of review is performed (scientific review and programmatic review). Once the proposal is recommended for funding, the award still has to be negotiated before research can begin. In general, funds do not get dispersed until the necessary animal or human research protocols are approved by the institutional IACUC (animal)/IRB (human) as well as by the funding agency ACURO (animal)/CIRO-HRPO (human) – a part of RCQ (Regulatory Compliance and Quality). Finally, your research can begin. Administrative and fiscal monitoring, reporting and compliance still has to be carefully adhered prior to close-out of the award.

Before submitting a proposal, it is to your best interest to get to know the program manager/science officer. Using CDMRP as an example, the Science Officer, a member of the CDMRP staff, is also known as the Grants Officer's Representative (GOR). The CDMRP Science Officer/GOR is a doctorate level scientist or clinician in the Grants Management Division with whom investigators will discuss the details of the solicitation, scientific aspects of their award, also later with respect to milestones and changes in the scientific design. He or she will assist you to ensure that your needs and the needs/requirements of USAMRMC are met. The Science Officer/GOR assists and advises the USAMRAA Contracting Office, and serves as a liaison between investigators and representatives at USAMRAA, Regulatory Compliance and Quality (RCQ), and other offices at USAMRMC. In addition, he or she serves as an ombudsman who can provide you with or direct you to sources for answers to your questions. Remember that the science officer will often not reach out to you – that’s your responsibility.

Preparing your applicationRequired RegistrationsIn order to apply to the government (BAA/CDMRP/NIH) for funding, in general, both you and your organization will need to be registered with the electronic systems that are involved in receiving and processing your grant applications, Grants.gov and the eRA Commons. Regardless of whether your application is submitted electronically or by mail, as PD/PI, you will need an eRA Commons Account to monitor its status in the application process. Remember that only an organization can submit a grant application on behalf of an individual so each organization much have completed all registrations including a Data Universal Numbering System (DUNS) number, an identifier government vendors need to register their organization in the System for Award Management (SAM) so they can apply for a federal grant. PI/PDs should ensure that the applicant organization creates an eRA Commons account for you at least one month before the application is to be submitted. Ask your eRA Commons signing official (SO) to register you and associate your profile with your organization in the system. (This individual is typically someone in your central grants office.) All of the above is usually taken care of by your institution’s sponsored research office. However, as a DoD investigator applying for an extramural award, your institution may not have the ability to manage the above. In other circumstances, more involved awards that such those that involve more than just your institutions, the involvement of a consultant or the handling of expiring funds may also go beyond the capability of your parent institution. Remember to do this essential background work early in the application process.

The Proposal

It is beyond the scope of this handbook to teach practices that enhances your grant proposal. However, these are some tips that several investigators have found helpful. Early preparation and expert critiques prior to submission cannot be overly emphasized.

Significance. Does the project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

Investigator(s). Are the PD/PIs, collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? For Early Stage Investigators or New Investigators, or those who are in the early stages of independent careers, it is important to provide the reviewers evidence that you have the appropriate experience and training for the size and scope of the project. If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?

Innovation. Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?

Approach. Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? If the project involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed?

Environment and Institutional Support. Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements? Letters of reference and institutional commitment are important. Mention any start-up funds, support for a technician, etc. This is a positive indicator of institutional commitment to the peer reviewers. Understand the level of resources needed to compete. Conduct an organizational assessment. Determine what resources and support your organization has and what additional support you'll need. Consider whether the available equipment and facilities are adequate and whether the environment is conducive to the research. Applicants should clearly state that they have the appropriate resources to conduct the research, such as adequate equipment and laboratory space.

Collaborators Determine the expertise needed to strengthen your research study team (individuals, collaborating organizations, resources, etc.). Most scientific work requires collaboration among researchers, and DoD/NIH is dedicated to fostering such relationships. If you have identified collaborators, you will need to include letters of commitment in your application that clearly state their roles. The grant application should contain a signed letter from each collaborator to the applicant that lists the contribution he or she intends to make and his or her enthusiasm for the work. These letters are often crucial information for the reviewers. Investigate opportunities for collaborating with more experienced, well-known grantees, or a

known laboratory. Collaborators can fill gaps in your own expertise and resources and can assure reviewers of the competence of your proposed team.

Begin to assemble the research study team early. Sufficient information must be included to demonstrate to reviewers and NIH staff the high quality of the PD/PI, the co-investigators, available research resources, and the applicant institution and its support of the project. When possible, include letters of commitment for resources, such as particular pieces of equipment or lab space, or letters from collaborators stating their willingness to participate in the research.

For consultants, you will need to include letters that reflect the rate/charge for consulting services.

Consider a Multiple PD/PI Model: If your work includes multidisciplinary efforts and collaboration where a team science approach could be more effective, then you should consider the multiple-PI model. The format, peer review and administration of applications submitted under the multiple-PI model do have some significant differences from the traditional single-PI model which will need to be taken into consideration as you plan. Therefore, as with the preparation of any research proposal, it is essential that you consider all aspects of the funding mechanism before submitting an application. All applicants proposing team science efforts are strongly encouraged to contact their NIH program officials at the earliest possible date to discuss the appropriateness of the multiple-PI model for the support of their research.

ScoringNIH SystemThe NIH utilizes a 9-point rating scale (1 = exceptional; 9 = poor) for all applications; the same scale is used for overall impact scores and for criterion scores.

Before the SRG meeting, each reviewer and discussant assigned to an application gives a separate score for each of (at least) five review criteria (i.e., Significance, Investigator(s), Innovation, Approach, and Environment for research grants and cooperative agreements). For all applications the individual scores of the assigned reviewers and discussant(s) for these criteria are reported to the applicant.In addition, each reviewer and discussant assigned to an application gives a preliminary overall impact score for that application. The preliminary scores are used to determine which applications will be discussed in full at the meeting. For each application that is discussed at the meeting, a final impact score is given by each eligible committee member (without conflicts of interest) including the assigned reviewers. Each member's score reflects his/her evaluation of the overall impact that the project is likely to have on the research field(s) involved, rather than being a calculation of the reviewer's scores for each criterion.

The final overall impact score for each discussed application is determined by calculating the mean score from all the eligible members' impact scores, and multiplying the average by 10; the final overall impact score is reported on the summary statement. Thus, the final overall impact scores range from 10 (high impact) through 90 (low impact). Numerical impact scores are not reported for applications that are not discussed (ND), which may be reported as ++ on the face page of the summary statement and typically rank in the bottom half of the applications.

DoD SystemThe DOD plays by different rules than NIH when it comes to what science they are willing to support. Similar to the NIH System, there are two levels of review. The first tier review is Scientific Peer Review.

These reviewers include both scientific and consumer advocates. Panel members were asked to rate each evaluation criterion related to the award mechanism as published in the program announcement on a scale of 1-10 (highest to lowest merit). A global score is then given in the range of 1.0 to 5.0 (1-5, highest to lowest merit). The following adjectival equivalents used to guide reviewers: Outstanding (1.0-1.5); Excellent (1.6-2.0); Very Good (2.1-2.5); Good (2.6-3.5); and Fair (3.6-5.0).

A Second Tier programmatic Review is performed. Participants are a diverse group of experienced basic and clinical scientists and consumer advocates with special expertise and interest in program specific research. The group discusses programmatic agenda, funding mechanism intent and priorities and review grants. Advocates have significant influence on whether a grant is awarded. Members do not have access to full applications so technical and lay abstracts as well as innovation and impact statements are critical. The outcome of this review is funding recommendations.

Their Evaluations is a comparison-based process where one grant is compared to one another. Takes into account scientific evaluations across all disciplines and specialty areas. Does not recommend funding for highly rated proposals automatically; rather, they carefully scrutinized all assigned proposals to allocate the limited funds available for each award mechanism based on relevance to program mission.

The most important criteria (the first three are key decision drivers) are: Innovation – they are looking for “paradigm shifting” studies & new research avenues; Impact – does not need to have immediate impact but must be significant; Adherence to the intent of the award mechanism with respect to research disciplines or specialty areas; Recommendations of peer review; Programmatic relevance and Program portfolio balance.

Approach to DOD Application PreparationGiven the unique aspects of the DOD peer review system – it is important to write clear, detailed innovation and impact statements. Well designed studies but with little impact or military relevance have little chance of getting funding. Utilize entire page limit if needed to make clear that your study is a cut above in these areas. The Abstract should include a very clear description of study, including enough methods for all to understand the experimentation as not all members of group get entire grant. Follow the requisite information requested in the funding announcement. If applying as a Collaborative Idea grant, make sure to team up with an investigator that has obviously distinct expertise. Research plan strategy should be detailed enough to judge feasibility even if for Concept Awards. Do not refer to using all well-established techniques already in use in the lab – panel wants to see that they are being used in a novel way.

Contract NegotiationsUS Army Medical Research Acquisition Activity, also known as USAMRAA or RAA, is the CDMRP's counterpart to your institution's Sponsored Programs Office. Individuals in this office review your grant application for budgetary issues and work with your institution's representatives to develop a mutually agreeable award. You will be involved with two individuals in this office, a Grants Officer (not the same as the science officer) and a Contract Specialist. A USAMRAA Grants Officer has the authority to sign the award document that obligates the federal government to pay your institution to perform the work described in your application. A Contract Specialist assists the Grants Officer. The Contract Specialist assigned to your application will review budgetary issues and communicate with your Sponsored Programs Office. These individuals can be thought of as "Business Specialists" because they manage the

business aspects of the award for the government. Note: When calling any of the above offices, please identify yourself as a CDMRP award recipient or impending recipient and indicate the program (e.g., Breast Cancer, Prostate Cancer, Ovarian Cancer, Neurofibromatosis, or other) and the fiscal year (FY) of the award (e.g., FY03, FY02). In addition, please have your application log number (e.g., PC03xxxx) or award number (DAMD17-x-xx-xxxx) available to facilitate retrieval of information from the information management system.

Proper Grant Number Format

If your application involves the use of human subjects or human anatomical substances and you have submitted your human subjects appendix, the Human Subjects Research Review Board (HSRRB) Log Number (A-xxxxx), if known, is valuable as well. The more information you provide, the quicker you can be connected to the appropriate individual.

If your study involves human subjects, you will need to prepare a human subjects protocol (separate from the application) and informed consent that are specific to the project that is being funded by CDMRP. Please be aware the Army has human subjects' requirements in addition to those in the Common Federal Rule. The protocol and consent form will need review and approval by your local IRB, and then review by the Human Research Protections Office (HRPO). If your study is being conducted at multiple sites, each local site IRB must approve the consent and protocol and each site's documents must be reviewed and approved by the HRPO. HRPO approval is required prior to implementation of the protocol. For each investigation involving human subjects, the Director of ORP will designate as the responsible office, either the ORP Clinical Investigations Regulatory Office (CIRO): or ORP HRPO. This process can be quite time consuming, and the earlier that it is started, the sooner approval will be received.

Regulatory ConsiderationsSome investigators reading this handbook may find topics covered under Financial Considerations irrelevant as you may already have achieved funding or your project (such as case reports, case studies and smaller clinical/animal studies) may not require substantial financial support. Regardless whether you are performing a multi-centered clinical trial or a retrospective analysis, you will have to make sure that you are in complete regulatory compliance.

CredentialsMuch like obtaining credentials to perform clinical work, research credentials much be achieved prior to beginning any work. This are different credentials required for human and animal studies and may even be specific to the species of animal that you are working with. In general, you will be required to submit a CV, obtain occupational health assessment, perform readings and courses that demonstrate your understanding of basic research ethics and obtain approval from the commander.

ApplicationDepending on where your research is being performed and what is being done, it is paramount to obtain the correct application for your sponsoring institution. For human research, this is called an IRB (institutional review board) and IACUC (Institutional Animal Care and Use Committee) for animals. This is different than your grant application as they are less interested in the novelty/impact/scientific validity of your research (though still important) but more interested in the protection of the research subjects. Having an application that you are base your new application off of will be a time-saver. All application will require a budget as well as a literature search (in order to minimize redundancy). Human applications will also require a HIPAA statement as well as informed consent. Most retrospective studies will qualify for a waiver of informed consent as it may be difficult or not feasible to contact every patient. Standard language regarding privacy risks and storage of PII/PHI should be modified to your needs. Few studies are exempt from institutional review with exceptions of single case reports or very small case studies (ie. n <5).

ReviewBefore submission, a series of reviews are required prior to presentation at the review committee meeting. This includes a review with the veterinarians if this is an animal study or a review with RCD for human studies. Almost all studies will require a statistician review. For human studies, the statistician review doubles as one of the two required scientific reviews. Animal studies only require one scientific review. Lastly, the proposal should be vetted by the TAM. Impact statements may also be required.(?) After the application is submitted to the appropriate IRB/IACUC, expect to receive inquiries from a “pre-review”. The actual review is best attended by the principal investigator to answer any questions. If the proposal is a part of a grant, a second level review by the funding agency is often required. For MRMC, RCQ has both a division that reviews animal research (ACURO) and human research (CIPO/HRPO).

Dissemination ApprovalPrior to dissemination of your results either through oral, electronic or written formats, command approval has to be obtained through OPSEC (Operation Security). This process can take up to a week and early planning is encouraged.

Technology TransferTechnology transfer is an important consideration for any researcher. Because no one person has expertise is all areas, collaborations between individuals, government, academia and industry are necessary yet require proper control and management. Further, the ultimate goal of research is to affect human kind and the development and promotion of intellectual property is essential. Several instruments are available to administer the transfer of technology.

Cooperative Research and Development Agreement (CRADA) The preferred vehicle used to transfer technology is a Cooperative Research and Development

Agreement (CRADA). A CRADA provides a great opportunity for the Army investigators to collaborate with scientists in industry and academia to attain a common research goal. CRADAs, have the greatest potential for long-term payoff of any technology transfer mechanism. They allow Army scientists to better understand the technology needs of the commercial sector and facilitate a reverse flow of ideas, resources, and funds into the laboratories, and are the linchpins of the Command's technology transfer program.

A CRADA is an agreement between a federal laboratory and one or more non-federal (or sometimes federal) parties. Under a CRADA, the federal laboratory can provide personnel, services, facilities, equipment, and other resources to the other party, but no funding. In contrast, the non-federal party may provide funds, personnel, services, facilities, equipment, or other resources toward the conduct of specified research or development efforts within the laboratory, consistent with its mission.

A CRADA also provides the partner with an option to exclusively license inventions made by the Army investigator under the agreement.

Intellectual property (IP) rights in existence prior to a collaboration are retained by the provider, while any rights to newly created IP are negotiated on a case-by-case basis subject to applicable law and regulation.

Material Transfer Agreements (MTAs) A Material Transfer Agreement (MTA) and a Cooperative Research and Development Agreement for

Material Transfer (CRADA-MT) are short agreements in which scientists can exchange materials/information. As opposed to a full CRADA discussed earlier which is bi-directional in nature, an MTA is unidirectional and no collaboration is contemplated.

Scientists receive or provide materials for completion of a particular experiment or research study. In most instances, the providing party may require that the results of the study be communicated back to them. These agreements may also be used to request special immunization for personnel that would be working at the Army or are affiliated with the Institute.

Patent License Agreements (PLA) Patent License Agreement (PLA) - is a contractual agreement between the licensor (IP owner) and a

licensee to assign, grant, and convey either the whole patent, comprising the exclusive/nonexclusive rights to make, use, develop, and vend the invention throughout the U.S. & abroad in exchange for royalties.

Attributes: o U.S. industry/small businesses preferred o Can be exclusive, nonexclusive (preferred), for specific field of use, or a specific geographic area o Substantial royalties return to the laboratory o Licensee must present plans to commercialize the invention o Government obtains a nonexclusive, royalty-free, worldwide license o Subject to conflict-of-interest rules

Royalties: o The inventor receives the first $2,000 and 20% thereafter up to $150,000/year of any

royalties/payments resulting from commercial licensure. The USAMRMC laboratory receives the residual income, which can be used by the Commander to do any of the following: Reward laboratory employees, including inventors of technology regardless of whether it

has commercial application Fund research projects within the institute

Further scientific exchange among laboratories Educate and train laboratory employees Pay the expenses incidental to the administration and licensing of inventions Support technology transfer marketing activities

Interagency Agreement Interagency Agreements (IAA), Service Agreements (SA), Memorandum of Agreements (MOA),

Memorandum of Understandings (MOU)- These agreements allow two or more federal agencies to exchange information, personnel, equipment, material, resources, and funds.

Non-Disclosure AgreementsNon-Disclosure Agreements (NDA) or Confidential Disclosure Agreements (CDA)

Frequently Asked QuestionsHow can I apply for a license for one of USAMRMC's technologies?Any company interested in acquiring commercial rights to technologies protected by intellectual property by USAMRMC must acquire a license. The first step in doing so is to complete the application for licensure available on the website. The application along with any supplemental information such as recent SEC filings and a business plan should be submitted as described in the template on our website.

How do I know what technologies are available for licensing?The issued patents and published pending patents available for licensing are listed on our website. We continuously strive to update our website in order to provide a complete overview of our technologies. If you are unable to locate a technology, or if you would like to find out more about a specific area, please contact us for further information. Additionally, our issued patents and published pending patents can be found on the USPTO website.

What types of licenses are available?We offer four main types of licenses:Exclusive license - limits the invention to only a single group or entity Nonexclusive license - allows the use of the invention by multiple groups or entities. Commercial evaluation license - grants a nonexclusive right to make and use the technology for the purpose of evaluating the technology internally. These licenses have a limited time span and do not grant any rights to sell the invention. Biological Material License - generally grants a license to technologies that are not protected by any intellectual property.

What if the technology I'm interested in commercializing does not have any protected intellectual property associated with it?Currently, DoD similar to NIH and USDA, executes licenses for nonprotected intellectual property by using either a Biological Material License or a CRADA for commercialization.

What are some of the financial reimbursements that USAMRMC requires for its license?Since each technology is unique, the financial terms for each license are also different. Generally some of our financial terms include, but are not limited to: reimbursement for patent prosecution costs, execution fee, annual minimum royalty, percent sales, sublicensing pass-through fees, and other milestones fees upon attaining regulatory objectives.

References