ANNEX 1 to Request for Tender No. 2/10/2017/CD20 Dated 20.10.2017

ANNEX 1 – to Request for Tender no. 2/10/2017/CD20 dated 20.10.2017

FORM OF TENDER

(template)

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

…………………………………

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

…………………………………………

………………………………………..

Information about quality system using in Tenderer’s facility

…………………………………………………………………………………………..

Value of the tender as per the wording of the tender evaluation criterion for price:

Net price: ……………………… [in words: ……………………….]
Gross price: ……………………. [in words: ……………………….]

The date of commencement of work, from the moment of signing the agreement:

………………………………………………(not laterthan 15.11.2017)

Execution time of object of the contract (from analysis performance to final repot delivery) - considered in evaluation criteria (max.120 days starting from the initiation of tests to final report delivery):

………………………………………………………………………………………………………………….………………..

Form and time of payment

………………………(min 30 days) from the date of delivery of VAT invoice to the Contracting Entity

Prepayment (if applicable): ……. (max. 15 % of net price before the delivery of the final report)

I agree to:

a. place the following point to the contract:

-“In case of any error occurring, that may affect final results; the Performer is obligated to find optimal solution that will provide satisfactory results (meeting the initial arrangements). Samples repetition should be carry out without additional quotation for within initial timelines”.

-"ThisContractisgovernedbythePolishlaw"
- "Any disputes which arise due to failure to perform or improper performance hereof shall be referred by the Parties to a court with jurisdiction over the Contracting Entity's seat "

□ YES □ NO

b. allow a delegated person from Contracting Entity Company to carry out visit
to make sure the Tender’s company is able to deliver results of appropriate quality before cooperation starts

□ YES □ NO

In the event my/our tender is awarded a contract, I/we agree to conclude a nondisclosure agreement, including the following clauses:

This Contract is governed by the Polish law
Any disputes between the parties shall be referred by the Parties to a court with jurisdiction over the Contracting Entity's seat
The tenderer shall pay liquidated damages in the amount of PLN 100,000 for each breach of confidential obligation. The Contracting Entity can claim damages exceeding the liquidated damages upon general terms of the Polish civil law.

□ YES □ NO

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

I/we declare that:

1)the following information are company’s secret:

………………………………………………………………………..

…………………………………………………………………………

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

2)explanation of the request for confidentiality of the aforementioned information I/we enclose as attachment to the tender.

Validity of tenders

I decelerate, that following tender is valid for 90 days from the deadline for submission
of tenders.

Place and date: ………………………..

…..………………………………………………………………….…..

Signature of Tenderer or Tenderer's authorised represent

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 no 2 – to Request for Tender no. 2/10/2017/CD20 dated 20.10.2017

Parameters for analytical panel

NO / TEST / METHOD / SAMPLE1 / MEDIUM2 / SAMPLE AND AUXILIARY MATERIALS TRANSPORT / TIMEFRAME FOR TESTING3 / PRICE 14 / PRICE 25
1 / Test for sterility / direct inoculation in accordance with:
- EUP 2.6.1,
- USP <71> / N/D
2 / Test forMycoplasma / Test for mycoplasma including mycoplasmastasis in accordance with:
- EUP 2.6.7,
- USP <63> / N/D
3 / Test for adventitiousagents / IN VITRO ASSAYS:
1.cytopathic assay;
2. haemadsorption end-points assay;
ad 1.&2. at least 3 detector cell lines (MRC-5, VERO, CHO) / N/D

3 / IN VIVO ASSAYS using:
1. embryoanated eggs;
2. suckling mice and;
3. adult mice. / N/D
4 / Test for retroviruses / Detection of murine xenotropic, amphotrophic and MCF retroviruses by:
1. Mus dunni co-cultivation followed by PG4 S+L-;
2. Mink S+L- Focus Assay / N/D
Transmission electron microscopy (TEM) of cell cultures (200 profiles) / N/D
4 / Fluorescent product enhanced reverse transcriptase (F-PERT) assay / N/D
5 / Test for Identity / RAPD
6 / Construct coding region sequence confirmation / mRNA sequencing (Heavy and Light Chain)
7 / Construct coding region 5 and 3 flanking regions sequencing / DNA sequencing (Heavy and Light chain)
8 / Construct DNA size and distribution characterization (restriction enzyme analysis) / Southern blot (analysis carried simultaneously for MCB and EoPCB)
9 / Insert Gene Copy Numer determination / RT-qPCR (together with method design and validation prior to testing; analysis carried simultaneously for MCB and EoPCB)

Number of MCB vials, Number of EoPCB vials
Volume of medium required to Objętość medium hodowlanego niezbędna do hodowania banków
Ramy czasowe, licząc od daty dostarczenia próby po zakończenie analiz liczone w dniach
Cena w przypadku analizy jednej próby (charakterystyka jednego banku)
Cena w przypadku analizy dwóch prób (charakterystyka dwóch banków tej samej linii komórkowej i identycznego konstruktu)

NET PRICE FOR THE COMPLETE ANALYTICAL PANEL (TEST NO.1-9) AND ADDITIONAL SET OF TESTS OF GENETIC IDENTITY AND GENETIC STABILITY (TEST NO.5-9)1

NET PRICE OF THE COMPLETE ANALYTICAL PANEL (TEST NO 1-9)1

Price covers all points indicated in Request for Tender

Place and date: ………………………..

…..………………………………………………………………….…..

Signature of Tenderer or Tenderer's authorisedrepresentativ

ANNEX 3 – to Request for Tender no. 2/10/2017/CD20 dated 20.10.2017

STATEMENT ON THE ABSENCE OF PERSONAL OR CAPITAL LINKS

I, the undersigned ……………………………………………………………………………………………………………....., [name and surname of Tenderer or its authorised representative], declare that …………………………………. [name oftenderer]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:

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

2.holding a least 10% of shares,

2.serving as a member of a supervisory body or a managing body, acting as a registered representative (prokurent) or an attorney,

3.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

ANNEX 4 – to Request for Tender no. 2/10/2017/CD20 dated 20.10.2017

STATEMENT ON FULFILLING THE FORMAL REQUIREMENTS FOR PARTICIPATION IN THE PROCEDURE

have/ has the appropriate knowledge and experience to perform the contract
in the highest standards
have/ has a financial situation that guarantees the performance of the whole order

Place and date: ………………………..

…..………………………………………………………………….…..

Signature of Tenderer or Tenderer's authorised representative