20
1 Projekt pn. "Rozwój i skalowanie innowacyjnego procesu wytwarzania terapeutycznego, rekombinowanego przeciwciała monoklonalnego, w celu umożliwienia przemysłowego wdrożenia pierwszego polskiego leku biotechnologicznego do terapii onkologicznych oraz autoimmunologicznych" jest współfinansowany ze środków Europejskiego Funduszu Rozwoju Regionalnego w ramach poddziałania 1.1.1 POIR na lata 2014-2020. . Konstantynów Łódzki, date: 15.06.2018 MABION S. A. ul. Gen. Mariana Langiewicza 60 95-050 Konstantynów Łódzki Contact person's details: Patrycja Pietraszek e-mail: [email protected] phone no.: +48422077890 MODIFICATION ON 03.07.2018 THE DEADLINE FOR SUBMISSION OF OFFERS HAS BEEN EXTENDED TO THE DATE 20.07.2018 REQUEST FOR TENDER no. 2/06/2018/CD20 Project name: " Development and scaling up of an innovative production technology of a therapeutic, recombinant monoclonal antibody, in order to launch commercial manufacturing process of the first Polish biotechnological drug product for oncologic and autoimmune therapies". The procedure to select the best tender is conducted in observance of the rules of fair competition, openness and transparency. The provisions of the Act of 29 January 2004 Public Procurement Law do not apply to this procedure. I. PARTICULARS OF CONTRACTING ENTITY MABION Spółka akcyjna with its registered office in Konstantynów Łódzki [95-050] at Langiewicza 60, entered in the Business Register kept by the District Court for Łódź- Śródmieście in Łódź, 20 th Commercial Division of the National Court Register, under KRS number: 0000340462, NIP: 7752561383, REGON: 100343056, with a share capital of PLN 1,372,077.20 [in words: one million three hundred seventy two thousand seventy seven zlotys 20/100], fully paid up.

MODIFICATION ON 03.07.2018 THE DEADLINE FOR SUBMISSION … · 2018-07-03 · Regionalnego w ramach poddziałania 1.1.1 POIR na lata 2014-2020. . 8. Viscose swabs with transport buffer,

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Page 1: MODIFICATION ON 03.07.2018 THE DEADLINE FOR SUBMISSION … · 2018-07-03 · Regionalnego w ramach poddziałania 1.1.1 POIR na lata 2014-2020. . 8. Viscose swabs with transport buffer,

1 Projekt pn. "Rozwój i skalowanie innowacyjnego procesu wytwarzania terapeutycznego, rekombinowanego przeciwciała

monoklonalnego, w celu umożliwienia przemysłowego wdrożenia pierwszego polskiego leku biotechnologicznego do terapii onkologicznych oraz autoimmunologicznych" jest współfinansowany ze środków Europejskiego Funduszu Rozwoju

Regionalnego w ramach poddziałania 1.1.1 POIR na lata 2014-2020. .

Konstantynów Łódzki, date: 15.06.2018

MABION S. A. ul. Gen. Mariana Langiewicza 60 95-050 Konstantynów Łódzki Contact person's details: Patrycja Pietraszek e-mail: [email protected] phone no.: +48422077890

MODIFICATION ON 03.07.2018

THE DEADLINE FOR SUBMISSION OF OFFERS HAS BEEN EXTENDED TO THE

DATE 20.07.2018

REQUEST FOR TENDER

no. 2/06/2018/CD20

Project name: " Development and scaling up of an innovative production technology

of a therapeutic, recombinant monoclonal antibody, in order to launch commercial

manufacturing process of the first Polish biotechnological drug product for oncologic and

autoimmune therapies".

The procedure to select the best tender is conducted in observance of the rules of fair

competition, openness and transparency.

The provisions of the Act of 29 January 2004 Public Procurement Law do not apply to this

procedure.

I. PARTICULARS OF CONTRACTING ENTITY

MABION Spółka akcyjna with its registered office in Konstantynów Łódzki [95-050]

at Langiewicza 60, entered in the Business Register kept by the District Court for Łódź-

Śródmieście in Łódź, 20th Commercial Division of the National Court Register, under KRS

number: 0000340462, NIP: 7752561383, REGON: 100343056, with a share capital of PLN

1,372,077.20 [in words: one million three hundred seventy two thousand seventy seven

zlotys 20/100], fully paid up.

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2 Projekt pn. "Rozwój i skalowanie innowacyjnego procesu wytwarzania terapeutycznego, rekombinowanego przeciwciała

monoklonalnego, w celu umożliwienia przemysłowego wdrożenia pierwszego polskiego leku biotechnologicznego do terapii onkologicznych oraz autoimmunologicznych" jest współfinansowany ze środków Europejskiego Funduszu Rozwoju

Regionalnego w ramach poddziałania 1.1.1 POIR na lata 2014-2020. .

II. OBJECT OF THE CONTRACT

1. Description of product

a. The aim of contract is successive supply of usage materials and regents. List

of materials and regents is presented in table below:

No Product Amount Unit

1.

Tryptic Soy Broth on 90 mm Petri dishes, optionally containing neutralizers, medium specification: storage temperature 15-25°C; closed dishes (screwed or click-safe closure); agar quantity of 25 ml min. per Petri dish; packed in three sleeves (without counting the packaging); validity of at least 6 months up to the production date; composition compliant with EP / USP; it is allowed to pack 100 items together

18000 dishes

2.

Tryptic Soy Broth on 55 mm Petri dishes (imprint plates), specification: storage temperature 15-25°C; closed dishes (screwed or click-safe closure); agar quantity of 25 ml min. per Petri dish; medium with neutralizers (lecithin, polysorbate 80, histidine, sodium thiosulphate), packed in three sleeves (without counting the packaging); a separating grid inside the plate; composition compliant with EP / USP’ it is allowed to pack 100 items together

17000 dishes

3.

Sabouraud medium with dextrose (4%) and agar (1.5%) on Petri dishes 90 mm, optionally containing neutralizers, medium specification: storage temperature 15-25 ° C; packaged in a minimum of two sleeves (not including the packaging); composition compliant with EP / USP; it is allowed to pack 20 items together

900 dishes

4.

Sabouraud medium R2A on Petri dishes 90 mm, specification: storage temperature 15-25 ° C; packaged in a minimum of two sleeves (not including the packaging); composition compliant with EP / USP

3600 dishes

5. THIO medium for sterility testing, specification: storage temperature 15-25 ° C; capacity 100 ml; packaging with septum; composition compliant with EP / USP

120 bottles

6. TSB medium for sterility testing, specification: storage temperature 15-25 ° C; capacity 100 ml; packaging with septum; composition compliant with EP / USP

120 bottles

7. Rinse A for sterility testing, specification: storage temperature 15-25 ° C; capacity 600 ml; packaging with septum; composition compliant with EP / USP

80 bottles

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3 Projekt pn. "Rozwój i skalowanie innowacyjnego procesu wytwarzania terapeutycznego, rekombinowanego przeciwciała

monoklonalnego, w celu umożliwienia przemysłowego wdrożenia pierwszego polskiego leku biotechnologicznego do terapii onkologicznych oraz autoimmunologicznych" jest współfinansowany ze środków Europejskiego Funduszu Rozwoju

Regionalnego w ramach poddziałania 1.1.1 POIR na lata 2014-2020. .

8.

Viscose swabs with transport buffer, capacity 5 or 10 ml; swab adapted to take samples of environmental cleanliness, with transport liquid containing neutralisers of disinfectants, with the consistency of the fluid enabling the membrane filtration analysis. The Ordering Party requires that the swabs be at least double packed

4300 swabs

9. Plastic sterile heads, packed in a minimum of 2 sleeves (not including the packaging); adapted to the SAS super ISO device

2680 heads

10. Biochemical test for Bacillus identification with the reagents enabling the determination to be made

1120 strips

11. Biochemical test for cocci identification with the reagents enabling the determination to be made, it is allowed to pack 20 items together

1120 strips

12. Biochemical test for identification of gram negative, oxidase negative rods with the reagents enabling the determination to be made, it is allowed to pack 25 or 60 items together

760 strips

13. Biochemical test for identification of gram negative, oxidase positive rods with the reagents enabling the determination to be made, it is allowed to pack 25 or 24 test items together

220 strips

14. Biochemical test for yeasts identification with the reagents enabling the determination to be made

80 strips

15a. Set of reagents for gram staining (crystal violet, Lugol's liquid, alkaline fuchsin, acetone) in bottles with dispenser capacity of each reagent 100 ml or

40

set

(a set of four bottles

of reagents)

15b. Set of reagents for gram staining (crystal violet, Lugol's liquid, alkaline fuchsin, acetone) in bottles with dispenser capacity of each reagent 200 ml or

20

Set

(a set of four bottles

of reagents)

15c. Set of reagents for gram staining (crystal violet, Lugol's liquid, alkaline fuchsin, acetone) in bottles with dispenser capacity of each reagent 250 ml

16

Set

(a set of four bottles

of reagents)

16.

Sodium chloride with peptone for microbiology with composition potassium dihydrogen phosphate 3,6g/l; disodium hydrogen phosphate dihydrate 7,2 g/l; sodium chloride 4,3g/l; peptone from meat 1,0g/l) a package capacity of 500 g is allowed

20000 g

17. Oxidase detection strips it is allowed to pack 50 items together 3600 strips

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4 Projekt pn. "Rozwój i skalowanie innowacyjnego procesu wytwarzania terapeutycznego, rekombinowanego przeciwciała

monoklonalnego, w celu umożliwienia przemysłowego wdrożenia pierwszego polskiego leku biotechnologicznego do terapii onkologicznych oraz autoimmunologicznych" jest współfinansowany ze środków Europejskiego Funduszu Rozwoju

Regionalnego w ramach poddziałania 1.1.1 POIR na lata 2014-2020. .

18.

Filter units consisting of 100 ml sterile funnel and 47 mm filter with 0.45 μm pore size (white filters made of cellulose extracts (MCE)) compatible with EZ Stream Pump and EZ FIT Mainfold handle

4500 funnels

b. Material supply shall result from each order previously submitted by the Ordering

Party. Total pool of materials presented in the chart will be split into regular

deliveries, according to the schedule below.

No

materials/

regents

Total

amount

Quarter number

III

(2018)

IV

(2018)

I

(2019)

II

(2019)

III

(2019)

IV

(2019)

1. 18000 4740 4740 2130 2130 2130 2130

2. 17000 4440 4440 2030 2030 2030 2030

3. 900 150 150 150 150 150 150

4. 3600 600 600 600 600 600 600

5. 120 20 20 20 20 20 20

6. 120 20 20 20 20 20 20

7. 80 14 14 14 14 14 10

8. 4300 1000 900 600 600 600 600

9. 2680 640 640 320 360 360 360

10. 1120 200 200 180 180 180 180

11. 1120 200 200 180 180 180 180

12. 760 140 140 120 120 120 120

13. 220 40 40 40 40 30 30

14. 80 ND 20 20 20 20 ND

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5 Projekt pn. "Rozwój i skalowanie innowacyjnego procesu wytwarzania terapeutycznego, rekombinowanego przeciwciała

monoklonalnego, w celu umożliwienia przemysłowego wdrożenia pierwszego polskiego leku biotechnologicznego do terapii onkologicznych oraz autoimmunologicznych" jest współfinansowany ze środków Europejskiego Funduszu Rozwoju

Regionalnego w ramach poddziałania 1.1.1 POIR na lata 2014-2020. .

15a. 40 8 8 6 6 6 6

15b. 20 4 4 3 3 3 3

16. 20000 5000 5000 3000 2000 2000 3000

17. 3600 600 600 600 600 600 600

18. 4500 900 900 600 600 750 750

c. The Ordering Party permits for derogations from the schedule while keeping the total

amount of material/ reagent being the subject of the tender procedure. .

d. Materials shall be protected with a package, which guarantees a possibility to deliver

and store them with no risk of damage or their quality worsening.

2. Common Procurement Vocabulary (CPV): 33696500-0: Laboratory regents;

3. The time of offer validity period – 90 days;

4. Validity of the contract – from the date of conclusion by 31.12.2019;

5. Place of realization of order: Konstantynów Łódzki.

III. FORMAL REQUIREMENTS FOR TENDERS

1. Each tenderer may submit only one tender.

2. Tenderer must submit an offer using the template attached as Annex 1, the list

of parameters for the device template enclosure in Annex 2 and the conditions of free

warranty service template enclosure in Annex 5 to the present Request for Tender. The

offer should be accompanied by a statement on the lack of personal or capital links,

constituting an Annex 3 and a declaration on the fulfillment of the formal conditions

of participation in the procedure constituting Appendix 4 to this Offer Request. The

contractor forbids any modification of the contents of the documents, except for places

to fill the content of the offer or statements.

Page 6: MODIFICATION ON 03.07.2018 THE DEADLINE FOR SUBMISSION … · 2018-07-03 · Regionalnego w ramach poddziałania 1.1.1 POIR na lata 2014-2020. . 8. Viscose swabs with transport buffer,

6 Projekt pn. "Rozwój i skalowanie innowacyjnego procesu wytwarzania terapeutycznego, rekombinowanego przeciwciała

monoklonalnego, w celu umożliwienia przemysłowego wdrożenia pierwszego polskiego leku biotechnologicznego do terapii onkologicznych oraz autoimmunologicznych" jest współfinansowany ze środków Europejskiego Funduszu Rozwoju

Regionalnego w ramach poddziałania 1.1.1 POIR na lata 2014-2020. .

3. The Contracting Entity calls the Tenderers who did not submit required statements

or who submitted the aforementioned statements and documents, containing errors

or incomplete or that raise Contracting Entity’s doubts as to its submission, completion

or correction them within the 3 working days as indicated in point VII. 1, or to give

explanations, unless the submitted tender would be subject to rejection or the whole

proceeding is to be declare void. If the Tenderer fails to submit the tender

or to complete or correct the aforementioned statements or documents within the

period predescribed, its tender shall be rejected.

4. The tender must include:

a. full name of the tenderer or tenderers (if they submit the tender jointly);

b. Tenderer's address or registered office, NIP number [or equivalent tax identification

number];

c. name, phone number and e-mail of the contact person who handles the tender;

d. the overall price for the tender proposed by Tenderer, given in PLN or EUR, filled

in using digits and words [the price should be stated inclusive of the tax

on goods and services (VAT) unless the tender is submitted by a foreign entity which

is not required to pay VAT in Poland on the basis of separate provisions. Tenders

submitted by such Tenderers should state the price net of VAT]. In the event that the

tender contains an ambiguity in relation to the tender sum, the amount in words shall

prevail.

e. The unit prices for individual materials given in PLN or EUR, filled in using digits [the

price should be stated inclusive of the tax on goods and services (VAT) unless the

tender is submitted by a foreign entity which is not required to pay VAT in Poland

on the basis of separate provisions. Tenders submitted by such Tenderers should

state the price net of VAT]. In the event that the tender contains an ambiguity

in relation to the tender sum, the amount in words shall prevail.

f. Time of processing the order which was submitted according to the schedule –

deadline, before which the order shall be delivered to the Ordering Party – shall not

Page 7: MODIFICATION ON 03.07.2018 THE DEADLINE FOR SUBMISSION … · 2018-07-03 · Regionalnego w ramach poddziałania 1.1.1 POIR na lata 2014-2020. . 8. Viscose swabs with transport buffer,

7 Projekt pn. "Rozwój i skalowanie innowacyjnego procesu wytwarzania terapeutycznego, rekombinowanego przeciwciała

monoklonalnego, w celu umożliwienia przemysłowego wdrożenia pierwszego polskiego leku biotechnologicznego do terapii onkologicznych oraz autoimmunologicznych" jest współfinansowany ze środków Europejskiego Funduszu Rozwoju

Regionalnego w ramach poddziałania 1.1.1 POIR na lata 2014-2020. .

be longer than 5 working days from the moment of submitting a single order by the

Ordering Party in case of an order submitted according to the schedule. Working days

shall be understood as days from Monday till Friday, with the exceptions of public

holidays.

g. The Ordering Party allows for the possibility of submitting orders in dates other than

indicated in point II.1.b. In such cases, time of processing the order submitted

as a derogation from the schedule – deadline, before which the order may

be delivered to the Ordering Party – shall not be longer than 10 working days from

the moment of submitting a single order by the Ordering Party in case of an order

submitted independently from the schedule (refers to point 1c). Working days shall

be understood as days from Monday till Friday, with the exceptions of public

holidays.

h. Conditions of material delivery – during each transport of materials no. 1-7 and 10-14

defined in the tender procedure, it is required to control temperature with the use

of a calibrated temperature recorder. The rest of materials require a statement of the

Tenderer that transport temperature does not influence the quality of materials.

5. Costs of materials delivery are covered by the Tenderer.

6. The tender shall contain an attached folder (advertising, propaganda, informative

leaflet, usually with descriptions, photos, maps or data concerning offered products

or services) or a brochure (propaganda article or essay, published as a separate

publication) for the offered material, which – with the description of the object of order

– confirms the requirements set out by the Ordering Party.

7. The offer and all attachments should be signed by an authorized representative of the

Tenderer. All changes to the text of the tender must be initialed by the person who signs

the Tender.

8. The offer, together with the accompanying documents, should be prepared in Polish

or in English language.

Page 8: MODIFICATION ON 03.07.2018 THE DEADLINE FOR SUBMISSION … · 2018-07-03 · Regionalnego w ramach poddziałania 1.1.1 POIR na lata 2014-2020. . 8. Viscose swabs with transport buffer,

8 Projekt pn. "Rozwój i skalowanie innowacyjnego procesu wytwarzania terapeutycznego, rekombinowanego przeciwciała

monoklonalnego, w celu umożliwienia przemysłowego wdrożenia pierwszego polskiego leku biotechnologicznego do terapii onkologicznych oraz autoimmunologicznych" jest współfinansowany ze środków Europejskiego Funduszu Rozwoju

Regionalnego w ramach poddziałania 1.1.1 POIR na lata 2014-2020. .

9. The Ordering Party allows for submission of partial tenders. Tenders shall be submitted

for the entire item indicated in the subject of the order. It is not allowed to submit

tenders for delivery of a part of materials or reagents indicated in a given item.

10. Contracting Entity doesn’t accept variant offers.

11. During the tender procedure, only materials and reagents meeting requirements

of specification provided in the subject of the order will be considered.

12. Tender that not satisfy the requirements referred to in the points 1, 5, 9, 10 shall

be subject to rejection, in the points 2, 4, 6-8,11 shall be subject to complement.

IV. FORMAL REQUIREMENTS FOR PARTICIPATION IN THE PROCEDURE

A tender may be submitted by any entity that has appropriate knowledge and experience

which enable it to perform the contract in accordance with the highest standards and whose

financial situation ensures that the contract will be performed in full.

In order to confirm the fulfilment of the above mentioned conditions the Tenderer is obliged

to provide, together with the offer a Declaration stated on the Annex no. 4. Tenderer who

fails to comply with any of the requirements mentioned will be excluded

from the proceedings.

V. EXCLUSIONS

1. To avoid a conflict of interest, public contracts may not be awarded to any entities that

have personal or capital links with Contracting Entity. Capital or personal links are

understood as mutual ties between Contracting Entity or persons authorised

to bind Contracting Entity or persons who act on behalf of Contracting Entity

in connection with preparing and conducting the procedure for selection

of a contractor, and the contractor, which are in particular the following:

a. participation in a partnership as a partner of a civil law partnership or general

partnership;

Page 9: MODIFICATION ON 03.07.2018 THE DEADLINE FOR SUBMISSION … · 2018-07-03 · Regionalnego w ramach poddziałania 1.1.1 POIR na lata 2014-2020. . 8. Viscose swabs with transport buffer,

9 Projekt pn. "Rozwój i skalowanie innowacyjnego procesu wytwarzania terapeutycznego, rekombinowanego przeciwciała

monoklonalnego, w celu umożliwienia przemysłowego wdrożenia pierwszego polskiego leku biotechnologicznego do terapii onkologicznych oraz autoimmunologicznych" jest współfinansowany ze środków Europejskiego Funduszu Rozwoju

Regionalnego w ramach poddziałania 1.1.1 POIR na lata 2014-2020. .

b. holding a least 10% of shares;

c. serving as a member of a supervisory body or a managing body, acting as a registered

representative (prokurent) or an attorney;

d. being a spouse, a relative by lineal consanguinity or affinity, by collateral consanguinity

to the 2nd degree or affinity to the 2nd degree, or a person linked by way of adoption,

custody or legal guardianship;

2. Tenderer is required to submit, along with its tender, a statement attached

as Annex 3 to this Request for Tender.

VI. EVALUATION CRITERIA FOR SELECTION OF TENDER

1. When selecting the best Tenderer, Contracting Entity will take into consideration the

following criteria:

L.p. Name Maximal score Weight [%]

1. Net price 100 55

2. Delivery time accordance with the schedule

100 20

3. Delivery time out of schedule 100 25

TOTAL 300 100

The evaluation among groups of products of the Tenderers who have completed

requirements will be made on the basis of following criteria:

1. Net price (“P”) – 100 point (weight of criteria 65%)

Purchaser in the calculation of this criterion will take into account net price of 1 piece in PLN

for a given materials or regents. If price is in EUR, the Offer will be taken into consideration

after price calculation according to NBP exchange rate with of on the opening day of the

offers.

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10 Projekt pn. "Rozwój i skalowanie innowacyjnego procesu wytwarzania terapeutycznego, rekombinowanego przeciwciała

monoklonalnego, w celu umożliwienia przemysłowego wdrożenia pierwszego polskiego leku biotechnologicznego do terapii onkologicznych oraz autoimmunologicznych" jest współfinansowany ze środków Europejskiego Funduszu Rozwoju

Regionalnego w ramach poddziałania 1.1.1 POIR na lata 2014-2020. .

Offer with the lowest price will receive 100 points multiplied by the weight of criterion and

will be adopted as the basis for the study of other offers. The price of the next offer will

be evaluated according to the following formula:

𝐶𝑟𝑖𝑡𝑒𝑟𝑖𝑜𝑛 C = 𝑇ℎ𝑒 𝑙𝑜𝑤𝑒𝑠𝑡 𝑜𝑓𝑓𝑒𝑟𝑒𝑑 𝑝𝑟𝑖𝑐𝑒 (𝑛𝑒𝑡𝑡𝑜 𝑝𝑒𝑟 𝑝𝑖𝑒𝑐𝑒)

𝑂𝑓𝑓𝑒𝑟𝑒𝑑 𝑝𝑟𝑖𝑐𝑒 (𝑛𝑒𝑡𝑡𝑜 𝑝𝑒𝑟 𝑝𝑖𝑒𝑐𝑒)∗ 100 𝑝𝑘𝑡

∗ 65% (𝑤𝑒𝑖𝑔ℎ𝑡 𝑜𝑓 𝑐𝑟𝑖𝑡𝑒𝑟𝑖𝑜𝑛)

2. Delivery time accordance with the schedule – Term “TH” - 100 point (weight

of criteria 20%)

Offer with the shortest execution time in accordance with the schedule (counted in working

days) will receive 100 points and will be on the first place in ranking. If execution time

is presented as a period of time, to evaluate this criteria, Purchaser will take into account the

longest date. Offers with the maximum execution time settled by Purchaser (5 days) will

receive 0 points in this criterion. Every offer providing longer term placing in next position

in ranking of this criterion will receive -10 points (minus 10) less than its predecessor (second

Offer will receive 90 points, third 80 points etc).

The method of calculating the number of points:

Criterion “T” = number of points x 20% (weight of criterion)

3. Delivery time accordance with the schedule – Term “TH” - 100 point (weight

of criteria 25%)

Offer with the shortest execution time out of schedule (counted in working days) will receive

100 points and will be on the first place in ranking. If execution time is presented as a period

of time, to evaluate this criteria, Purchaser will take into account the longest date. Offers

with the maximum execution time settled by Purchaser (10 days) will receive 0 points in this

criterion. Every offer providing longer term placing in next position in ranking of this

criterion will receive -10 points (minus 10) less than its predecessor (second Offer will

receive 90 points, third 80 points etc).

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11 Projekt pn. "Rozwój i skalowanie innowacyjnego procesu wytwarzania terapeutycznego, rekombinowanego przeciwciała

monoklonalnego, w celu umożliwienia przemysłowego wdrożenia pierwszego polskiego leku biotechnologicznego do terapii onkologicznych oraz autoimmunologicznych" jest współfinansowany ze środków Europejskiego Funduszu Rozwoju

Regionalnego w ramach poddziałania 1.1.1 POIR na lata 2014-2020. .

The method of calculating the number of points:

Criterion “T” = number of points x 25% (weight of criterion

Final score will be evaluated by summing all of received points by Offer according

to equation:

Score = Criterion “P” + Criterion “TH” + Criterion “TPH”

1. Purchaser will select the most advantageous tender, which obtains the highest number

of total points.

2. In the case that, during the purchase, the Purchaser will decide between several offers

with equal number of points, the most favorable offer for environmental and climate

impact will be chosen. For this purpose, the Ordering Party has the right to call on the

Tenderers who have received the highest number of points to complete the offer

by giving the information indicated by the Ordering Party regarding the impact of the

object of the offer on the environment.

3. If all tenders contained the price higher than the amount of the money which

Contracting Entity can spend, to finance the contract, Contracting Entetity provides the

ability to negotiate prices with Tenderers.

4. Contracting Entity reserves the right to request from Tenderers some additional

information which it deems necessary to properly evaluate the submitted tenders.

5. Contracting Entity reserves the right to decide that no award will be made in the

procedure and no tender will be selected.

6. Contracting Entity reserves the right to change the announcement or terms of the

inquiry or revocation or proceeding for any reason.

7. Contracting Entity reserves the right to place orders exceeding the number of packages

specified in the table.

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12 Projekt pn. "Rozwój i skalowanie innowacyjnego procesu wytwarzania terapeutycznego, rekombinowanego przeciwciała

monoklonalnego, w celu umożliwienia przemysłowego wdrożenia pierwszego polskiego leku biotechnologicznego do terapii onkologicznych oraz autoimmunologicznych" jest współfinansowany ze środków Europejskiego Funduszu Rozwoju

Regionalnego w ramach poddziałania 1.1.1 POIR na lata 2014-2020. .

VII. PLACE, MANNER AND DEADLINE FOR SUBMITTING TENDERS

1. The tender should be delivered in writing by mail, courier service or personally at the

address of Contracting Entity given in Section I of this Request for Tender or send

by e- mail at the following e-mail address: [email protected] by 20.07.2018 the

tender should be received by Contracting Entity. The date of the offer will be the date

of delivery to the Purchaser.

2. The tender should be placed inside a non-transparent and sealed envelope which must

bear the following address details of Tenderer, its name and the following text: "Tender

regarding Request for Tender no. 2/06/2018/CD20 – not to be opened before

23.07.2018 at 09.00 am.” If you submit an offer by an e-mail, the above mentioned text

should be included in the message tittle.

3. The offers will open 23.07.2018 at 9.00 am.

4. Tenders submitted after the deadline will not be considered.

5. The Contracting Entity informs that in accordance with the guidelines on the eligibility

of expenditures under the European Regional Development Fund, European Social Fund

and the Cohesion Fund for the period 2014-2020, the Contracting Entity at the request

of the Tenderer who submitted the tender is obligated to make available to the Tenderer

protocol of tender proceedings, with the exception of parts of tenders which constitutes

the company’s secret within the meaning of the provisions of the Act of 16 April 1993

on Combating Unfair Competition (Dz. U. of 2003 No. 169, item 1650, with amendments).

6. The Contracting Entity recommends to submit the proprietary information which

constitutes the company’s secret in a separate inner envelope marked “company’s

secret” or to bound it (staple) separately from the other public documents. The lack

of a clear indication that the information constitutes a company's secret means that all

the statements made in the course of the present proceedings are open to the public

without any reservation. Request for confidentiality of the information which are not

company’s secrets within the meaning of the Act on Combating Unfair Competition, will

be treated as ineffective and will result its declassification.

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13 Projekt pn. "Rozwój i skalowanie innowacyjnego procesu wytwarzania terapeutycznego, rekombinowanego przeciwciała

monoklonalnego, w celu umożliwienia przemysłowego wdrożenia pierwszego polskiego leku biotechnologicznego do terapii onkologicznych oraz autoimmunologicznych" jest współfinansowany ze środków Europejskiego Funduszu Rozwoju

Regionalnego w ramach poddziałania 1.1.1 POIR na lata 2014-2020. .

7. Tenderer may change, complete or withdraw the tender before the deadline for

submission of the tenders. In the event of correction, completion or withdraw of the

tender, the above mentioned point 2 shall apply accordingly, but with the annotation

on the envelope, respectively: CHANGE/COMPLETION/TENDER WITHDRAW.

8. A decision following a comparison of tenders is final, that is, the results of the tender

procedure conducted by the Contracting Entity cannot be challenged.

VIII. WEBSITE WITH NOTICE OF THE REQUEST FOR TENDER

https://mabion.eu/pl/2/o-mabion/zapytania-ofertowe/

https://bazakonkurencyjnosci.gov.pl/

IX. ADDITIONAL INFORMATION

Additional information on behalf of the Ordering Party is provided by:

Patrycja Pietraszek [email protected]

X. CONTRACT AMENDEMENTS CONDITIONS

The Contracting Entity stipulates the following conditions that may cause necessity

to amend the contract in comparison to the content of the submitted tender, unless they

lead to a change in the nature of the contract:

a) change of time for performance of the subject of the contract due

to circumstances beyond the control of the awarded tenderer;

b) remuneration stipulated in the contract may be changed due to change in the

applicable VAT rate;

c) amendments to general applicable law that may affect performance of the subject

of the contract;

d) Necessity of changing the agreement is caused by conditions which the Contracting

Party – performing its responsibilities with the utmost care – could not predict and

the value of the change is not higher than 50% of the value

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14 Projekt pn. "Rozwój i skalowanie innowacyjnego procesu wytwarzania terapeutycznego, rekombinowanego przeciwciała

monoklonalnego, w celu umożliwienia przemysłowego wdrożenia pierwszego polskiego leku biotechnologicznego do terapii onkologicznych oraz autoimmunologicznych" jest współfinansowany ze środków Europejskiego Funduszu Rozwoju

Regionalnego w ramach poddziałania 1.1.1 POIR na lata 2014-2020. .

of the order originally stated in the agreement

e) total value of changes is less than 209 000 EUR and simultaneously less than

10% of the value of the order that was originally stated in the agreement

f) change of obvious typographical and arithmetical errors.

XI. ATTACHMENTS

Attached to the Request for Tender is the tender form [Annex 1], the statement on the

absence of personal or capital links [Annex 2], the statement on the fulfillment of the formal

conditions for participation in the procedure [Annex 3]

______________________

signature of Contracting Entity

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15 Projekt pn. "Rozwój i skalowanie innowacyjnego procesu wytwarzania terapeutycznego, rekombinowanego przeciwciała

monoklonalnego, w celu umożliwienia przemysłowego wdrożenia pierwszego polskiego leku biotechnologicznego do terapii onkologicznych oraz autoimmunologicznych" jest współfinansowany ze środków Europejskiego Funduszu Rozwoju

Regionalnego w ramach poddziałania 1.1.1 POIR na lata 2014-2020. .

ANNEX 1 – to Request for Tender no. 2/06/2018/CD20 dated 15.06.2018

FORM OF TENDER

(template)

I. Name and address of tenderer and its registration details, including NIP (tax ID): ………………………………………………………………………………………………………………………………………………

………………………………………………………………………………………………………………………………………………

………………………………………………………………………………………………………………………………………………

II. Name, phone number and e-mail of the contact person:

………………………………………………………………………………………………………………………………………………

………………………………………………………………………………………………………………………………………………

………………………………………………………………………………………………………………………………………………

III. Unit price for individual materials: *Incuded in the scoring criterion

Material/

Regent Net price per 1 piece* Gross price per 1 piece*

Delivery time TH* Delivery time TPH*

Tryptic Soy Broth on 90 mm Petri dishes

……………………………………….

[in words: ……………………….]

……………………………………….

[in words: ……………………….]

…………………………. days from the date of order delivery

…………………………. days from the date of order delivery

Tryptic Soy Broth on 55 mm Petri dishes

……………………………………….

[in words:……………………….]

……………………………………….

[in words: ……………………….]

…………………………. days from the date of order delivery

…………………………. days from the date of order delivery

Sabouraud medium with dextrose (4%) and agar (1.5%) on Petri dishes 90 mm

……………………………………….

[in words:……………………….]

……………………………………….

[in words: ……………………….]

…………………………. days from the date of order delivery

…………………………. days from the date of order delivery

Sabouraud medium R2A on Petri dishes 90 mm

……………………………………….

In words: ……………………….]

……………………………………….

[in words: ……………………….]

…………………………. days from the date of order delivery

…………………………. days from the date of order delivery

THIO medium for sterility testing

……………………………………….

[in words:……………………….]

……………………………………….

[in words: ……………………….]

…………………………. days from the date of order delivery

…………………………. days from the date of order delivery

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16 Projekt pn. "Rozwój i skalowanie innowacyjnego procesu wytwarzania terapeutycznego, rekombinowanego przeciwciała

monoklonalnego, w celu umożliwienia przemysłowego wdrożenia pierwszego polskiego leku biotechnologicznego do terapii onkologicznych oraz autoimmunologicznych" jest współfinansowany ze środków Europejskiego Funduszu Rozwoju

Regionalnego w ramach poddziałania 1.1.1 POIR na lata 2014-2020. .

TSB medium for sterility testing

……………………………………….

[in words:……………………….]

……………………………………….

[in words: ……………………….]

…………………………. days from the date of order delivery

…………………………. days from the date of order delivery

Rinse A for sterility testing

……………………………………….

[in words:……………………….]

……………………………………….

[in words: ……………………….]

…………………………. days from the date of order delivery

…………………………. days from the date of order delivery

Viscose swabs with transport buffer, capacity 5 or 10 ml

…………………………………….

in words: ……………………….]

……………………………………….

[in words: ……………………….]

…………………………. days from the date of order delivery

…………………………. days from the date of order delivery

Plastic sterile heads, ……………………………………….

[in words:……………………….]

……………………………………….

[in words: ……………………….]

…………………………. days from the date of order delivery

…………………………. days from the date of order delivery

Biochemical test for Bacillus identification

……………………………………….

[in words:……………………….]

……………………………………….

[in words: ……………………….]

…………………………. days from the date of order delivery

…………………………. days from the date of order delivery

Biochemical test for cocci identification

……………………………………….

[in words:……………………….]

……………………………………….

[in words: ……………………….]

…………………………. days from the date of order delivery

…………………………. days from the date of order delivery

Biochemical test for identification of gram negative, oxidase negative rods

……………………………………….

[in words:……………………….]

……………………………………….

[in words: ……………………….]

…………………………. days from the date of order delivery

…………………………. days from the date of order delivery

Biochemical test for identification of gram negative, oxidase positive rods

……………………………………….

[in words:……………………….]

……………………………………….

[in words: ……………………….]

…………………………. days from the date of order delivery

…………………………. days from the date of order delivery

Biochemical test for yeasts identification

……………………………………….

[in words:……………………….]

……………………………………….

[in words: ……………………….]

…………………………. days from the date of order delivery

…………………………. days from the date of order delivery

Set of reagents for gram staining in bottles with dispenser capacity of each reagent 100 ml

……………………………………….

[in words:……………………….]

……………………………………….

[in words: ……………………….]

…………………………. days from the date of order delivery

…………………………. days from the date of order delivery

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17 Projekt pn. "Rozwój i skalowanie innowacyjnego procesu wytwarzania terapeutycznego, rekombinowanego przeciwciała

monoklonalnego, w celu umożliwienia przemysłowego wdrożenia pierwszego polskiego leku biotechnologicznego do terapii onkologicznych oraz autoimmunologicznych" jest współfinansowany ze środków Europejskiego Funduszu Rozwoju

Regionalnego w ramach poddziałania 1.1.1 POIR na lata 2014-2020. .

Set of reagents for gram staining in bottles with dispenser capacity of each reagent 200 ml

……………………………………….

[in words:……………………….]

……………………………………….

[in words: ……………………….]

…………………………. days from the date of order delivery

…………………………. days from the date of order delivery

Set of reagents for gram staining in bottles with dispenser capacity of each reagent 250 ml

……………………………………….

[in words:……………………….]

……………………………………….

[in words: ……………………….]

…………………………. days from the date of order delivery

…………………………. days from the date of order delivery

Sodium chloride with peptone for microbiology

……………………………………….

[in words:……………………….]

……………………………………….

[in words ……………………….]

…………………………. days from the date of order delivery

…………………………. days from the date of order delivery

Oxidase detection strips

……………………………………….

[in words:……………………….]

……………………………………….

[in words: ……………………….]

…………………………. days from the date of order delivery

…………………………. days from the date of order delivery

Filter units ……………………………………….

[in words:……………………….]

……………………………………….

[in words: ……………………….]

…………………………. days from the date of order delivery

…………………………. days from the date of order delivery

IV. Value of the tender a. Net price:…………………………. [in words: …………………………] b. Gross price:………………………..[in words: ………………………..]

V. Date of payment:

………………………..days from the date of delivery of the invoice to the Purchaser (min 30 days)

VI. Declaration of the Tenderer about the company’s secret (if applicable):

I /we declare that:

1. The following information are company’s secret (if applicable)*:

………………………………………………………………………………………………………………………………………

………………………………………………………………………………………………………………………………………

*(the Tenderer shall indicate documents containing the company’s secret)

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18 Projekt pn. "Rozwój i skalowanie innowacyjnego procesu wytwarzania terapeutycznego, rekombinowanego przeciwciała

monoklonalnego, w celu umożliwienia przemysłowego wdrożenia pierwszego polskiego leku biotechnologicznego do terapii onkologicznych oraz autoimmunologicznych" jest współfinansowany ze środków Europejskiego Funduszu Rozwoju

Regionalnego w ramach poddziałania 1.1.1 POIR na lata 2014-2020. .

2. Explanation of the request for confidentiality of the aforementioned information

I/we enclose as attachment to the tender.

VII. Other statements by the Tenderer:

I declare, that:

- I am bound by this offer for a period of 90 days from the deadline of submission

of offers

- I accept to cover the cost of delivery

Place and date: ………………………..

…..………………………………………………………………….…..

Signature of Tenderer or Tenderer's authorised representative

and company seal (if Tenderer is an entity that runs business activity)

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19 Projekt pn. "Rozwój i skalowanie innowacyjnego procesu wytwarzania terapeutycznego, rekombinowanego przeciwciała

monoklonalnego, w celu umożliwienia przemysłowego wdrożenia pierwszego polskiego leku biotechnologicznego do terapii onkologicznych oraz autoimmunologicznych" jest współfinansowany ze środków Europejskiego Funduszu Rozwoju

Regionalnego w ramach poddziałania 1.1.1 POIR na lata 2014-2020. .

ANNEX 2 – to Request for Tender no. 2/06/2018/CD20 dated 15.06.2018

STATEMENT ON THE ABSENCE OF PERSONAL OR CAPITAL LINKS

I, the undersigned …………………………………………………………………………………………………………….....,

[name and surname of Tenderer or its authorised representative], declare that

…………………………………. [name of tenderer] has / I have no personal or capital links with

Contracting Entity.

Capital or personal links are understood as mutual ties between Contracting Entity

or persons authorised to bind Contracting Entity or persons who act on behalf of Contracting

Entity in connection with preparing and conducting the procedure for selection

of a contractor, and the contractor, which are in particular the following:

a. participation in a partnership as a partner of a civil law partnership or general

partnership,

b. holding a least 10% of shares,

c. serving as a member of a supervisory body or a managing body, acting as a registered

representative (prokurent) or an attorney,

d. being a spouse, a relative by lineal consanguinity or affinity, by collateral

consanguinity to the 2nd degree or affinity to the 2nd degree, or a person linked by

way

of adoption, custody or legal guardianship.

Place and date: …………………

…..………………………………………………………………….…..

Signature of Tenderer or Tenderer's authorised representative

and company seal (if Tenderer is an entity that runs business activity

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20 Projekt pn. "Rozwój i skalowanie innowacyjnego procesu wytwarzania terapeutycznego, rekombinowanego przeciwciała

monoklonalnego, w celu umożliwienia przemysłowego wdrożenia pierwszego polskiego leku biotechnologicznego do terapii onkologicznych oraz autoimmunologicznych" jest współfinansowany ze środków Europejskiego Funduszu Rozwoju

Regionalnego w ramach poddziałania 1.1.1 POIR na lata 2014-2020. .

ANNEX 3 – to Request for Tender no. 2/06/2018/CD20 dated 15.06.2018

STATEMENT ON FULFILLING THE FORMAL REQUIREMENTS FOR PARTICIPATION IN THE PROCEDURE

I, the undersigned …………………………………………………………………………………………………………….....,

[name and surname of Tenderer or its authorised representative], declare that

…………………………………. [name of tenderer]

1) have/ has the appropriate knowledge and experience to perform the contract

in the highest standards

2) have/ has a financial situation that guarantees the performance of the whole order

Place and date: ………………………..

…..………………………………………………………………….…..

Signature of Tenderer or Tenderer's authorised representative

and company seal (if Tenderer is an entity that runs business activity)