1333ND21QNB640296 STATEMENT OF WORK.pdf

STATEMENT OF WORK

Manufacturing and Testing of a Master Cell Bank and a Working Cell Bank

I. BACKGROUND

The Biomolecular Structure and Function (BSF) Group in the Biomaterials Measurement Division (BMD) of the Material Measurement Laboratory (MML) at the National Institute of Standards and Technology (NIST) (1) advances novel measurement methods and models for the determination and analysis of the structure and function of biological macromolecules, including lipids, DNA, RNA and proteins and macromolecular complexes and assemblies formed by these molecules;

(2) advances methods to determine the physical and chemical factors which determine the specific interactions of macromolecules with cofactors and ligands; (3) studies the relationships between biomolecular structure, dynamics, function and energetics using computational, biophysical and biochemical techniques; (4) develops reference databases for these properties;

and, (5) advances measurement methods for engineering complex biological systems.

The BSF Group intends to qualify a clonal Chinese hamster ovary (CHO) CHO-K1 strain cell line producing a non-originator version of the NISTmAb molecule as a NIST Reference Material (RM).

Among the goals for this NIST RM is comparability of the material to cell lines used by biopharmaceutical manufacturers in the production of biologics. As such, the BSF Group requires the manufacturing and testing of a master cell bank (MCB) and a working cell bank (WCB) performed in accordance with current good manufacturing practices (cGMP), national and international safety and quality guidances and biopharmaceutical industry standards of practice.

II. SCOPE OF WORK

The NIST BSF Group will provide to the Contractor within 180 calendar days of contract award a Cell Substate in the form of two (2) vials of a research cell bank (RCB) for MCB manufacture, MCB testing, WCB manufacture, and WCB testing. Each vial will contain ≥ 0.9 mL of a cryopreserved cell suspension containing ≥ 5.0 x 106 CHO-K1 CHOZN® GS-/- cells. The RCB will be accompanied by a statement from the third-party responsible for cell line development that the RCB has (1) been developed without the use of products of animal origin (animal-origin free; AOF) and (2) been tested for sterility and mycoplasma contamination by non-compendial and/or PCR-based methods. The RCB will be conveyed to the Contractor directly from the third-party responsible for cell line development within 180 calendar days of contract award. The NIST Contracting Officer’s Representative (COR) will provide documented Cell Substrate media requirements (using commercially available media), manipulation protocols, coding DNA sequence for NISTmAb heavy chain product and coding DNA sequence for NISTmAb light chain product within 180 calendar days of contract award. The Contractor shall agree to use the RCB for only the scope of work defined herein and governed by any resultant contract. Prior to contract award, NIST will provide the Contractor with certain terms governing the use of the Cell Substrate and RCB, in order to ensure that the Contractor will fully comply with such terms. The Contractor shall agree not to grant material access to the RCB, MCB, WCB or any documentation concerning the RCB, MCB or WCB to any party other than those parties listed herein, a Subcontractor engaged to perform activities within the Scope of Work defined herein or a party named to the Contractor by the COR.

The Contractor shall adhere to any Quality Agreement enacted between NIST and the Contractor for the Scope of Work described herein.

The Contractor shall, if requested by the COR within 90 calendar days of contract award, allow a documentary and/or physical (on-site) review by NIST personnel, named by the COR, of the Contractor’s scientific and quality procedures and processes. The Contractor shall accommodate such review(s), if requested by the COR, to commence within 120 calendar days of contract award. Such review would occur concurrently without any pause to other timelines described herein.

The Contractor shall manufacture, test and ship to NIST one (1) MCB having a deliverable quantity of 200 vials and a deliverable report of analysis transmitted as an electronic PDF document to the

COR.

The Contractor shall manufacture, test and ship to NIST one (1) WCB having a deliverable quantity of 800 vials and a deliverable report of analysis transmitted as an electronic PDF document to the

COR.

The Contractor shall be responsible for the physical transfer to NIST of the MCB vials and of the WCB vials while maintaining suitable cryogenic temperature (≤ -150 °C) of the vials.

The MCB report of analysis and WCB report of analysis shall not include any information restricted from public disclosure by NIST in accordance with any confidentiality and/or non-disclosure agreement(s) executed between NIST and the Contractor. If confidential information must be provided to satisfy the deliverable MCB report of analysis or the deliverable WCB report of analysis for scientific or quality purposes, the Contractor may provide such report(s) of analysis with all confidential information clearly indicated and shall also provide (a) confidentiality unrestricted (redacted) version(s) of the report(s) to the COR for the report of analysis deliverable(s) to be satisfied.

The Contractor shall, within 30 calendar days of final receipt and acceptance of all deliverables by NIST, destroy by incineration or steam sterilization any remaining viable material derived from the RCB unless the Contractor is specifically instructed otherwise by the COR. The Contractor shall, in the event of termination of the resultant contract for any reason, within 30 calendar days destroy by incineration or steam sterilization any remaining viable material derived from the RCB unless the Contractor is specifically instructed otherwise by the COR.

III. SPECIFICATIONS

Requirements for the Performance of the Scope of Work

1. The Contractor shall perform all manufacturing and testing work with the Cell Substrate in accordance with United States National Institutes of Health (US NIH) biosafety practices, aseptic processing procedures, and all applicable cGMP and current good laboratory practices (cGLP) including those defined in 21 CFR §211 Current Good Manufacturing Practice for Finished Pharmaceuticals and defined in 21 CFR §58 Good Laboratory Practice for Nonclinical Laboratory Studies.

2. The Contractor shall perform all open manipulations of the Cell Substrate in the lineage of the deliverable MCB units and/or the deliverable WCB units in a cleanroom suite satisfying, at minimum, International Standards Organization (ISO) 14644-1:2015 Class 7 specifications in operation and in which no exogenous Cell Substrates are undergoing open manipulations.

The Contractor shall perform validated decontamination of the designated suite, and equipment contained within, prior to beginning open manipulations with the Cell Substrate.

3. The Contractor shall perform all open manipulations of the Cell Substrate in a suite and using equipment that is free of components of animal origin.

4. The Contractor shall only use animal-origin free (AOF) components in the manufacture of the deliverable MCB units and the deliverable WCB units.

5. The Contractor shall, at all times, maintain unique and unambiguous identification of the Cell Substrate in each of its respective forms including RCB, WCB and MCB.

6. The Contractor shall deliver to the COR copies of any quality-related documentation (in electronic PDF format) regarding MCB manufacture, MCB testing, WCB manufacture and/or WCB testing that are necessary to satisfy terms of any Quality Agreement enacted between NIST and the Contractor.

7. The Contractor shall accept a label design provided by the COR and print and apply such label to the WCB units according to the following.

7.1. The Contractor shall, within 30 days of contract award, provide to the COR the physical dimensions and allowable graphic and/or alphanumeric content of the Contractor’s preferred label and label printing method. The Contractor shall also provide any related requirements as to the design of a label for the WCB units such as preferred electronic file format for printing method, preferred monochrome and/or color formatting, any graphic or alphanumeric content required to be included in the label design by the Contractor, etc.

7.2. The COR shall, within 30 days of receiving the information described in 7.1, provide a label design, in electronic file format, to the Contractor for use in manufacturing the

WCB.

Protection of Human Subjects

8. Historically, use of pre-existing de-identified human cell lines not collected from subjects for the purposes of the specific project has been deemed as not human subject research;

however, depending on the Contractor’s technical quotation, may be subject to Institutional Review Board (IRB) review.

9. The Contractor may utilize commercial or in-house pre-existing sources of human cell lines, without identifiers, in the production and/or testing of the MCB and/or WCB. A list of all such human cell lines with the source/vendor must be provided to the COR within 60 calendar days of contract award.

Protection of Live Vertebrate Animals

10. The Contractor shall assure compliance with the Animal Welfare Act as amended and implementing regulations (7 USC 2131 et seq., 9 CFR Parts 1,2, and 3), and other Federal statutes and regulations relating to activities with live vertebrate animals for testing, training, and research.

11. Specifically, for testing to be conducted under the contract that involves live vertebrate animals within the meaning of 7 USC 2131 et seq. and 9 CFR Parts 1,2, and 3, Contractor agrees to take all steps required to assure compliance with 9 CFR Parts 1,2, and 3 and other Federal statutes and regulations. The Contractor certifies that testing, or research involving live vertebrate animals, shall not begin until documentation of the review and approval by the Contractor’s or subcontractor’s cognizant Institutional Care and Use Committee (IACUC) for the required procedures have been provided to the COR and approved by NIST’s Research Protections Office (RPO). This documentation may include an IACUC approval document for either: a specific protocol for this contract, or the applicable Standard Operating Procedure (SOP) for such testing. The COR may request a copy of the specific protocol, or the appliable sections of the SOP.

12. The Contractor may utilize pre-existing commercial or in-house sources of vertebrate animal cell lines in the production and/or testing of the MCB and/or WCB. A list of all such vertebrate animal cell lines with the source/vendor shall be provided to the COR within 60 calendar days of contract award.

Acceptance by the Contractor of the Cell Substrate RCB

13. The Contractor shall accept into their facility the Cell Substrate in the form of a RCB composed of two (2) vials shipped directly from the third-party responsible for cell line development.

Each vial will contain ≥ 0.9 mL of a cryopreserved cell suspension containing ≥ 5.0 x 106 CHO- K1 CHOZN® GS-/- cells. The RCB will be accompanied by a statement from the third party responsible for cell line development that the RCB has (1) been developed without the use of products of animal origin (animal-origin free; AOF) and (2) been tested for sterility and mycoplasma contamination by non-compendial and/or PCR-based methods.

Contractor Pilot Expansion of the RCB

14. The Contractor may, if deemed necessary by the Contractor, on the basis of the RCB description provided in 13, conduct a pilot scale expansion of the RCB and/or testing for bacteriostasis, fungistasis and/or mycoplasma contamination for the purposes of (1) to satisfy manufacturing and/or testing requirements prior to the start of MCB manufacturing and/or

(2) testing Cell Substrate proliferation characteristics.

Contractor Manufacture of the MCB

15. The Contractor shall manufacture a MCB of the Cell Substrate using the provided RCB.

16. The Contractor shall manufacture sufficient units of the MCB so that a quantity of 200 units can be delivered. Each MCB unit shall contain > 0.90 milliliters of cell suspension having at least 5.0 x 106 cells exhibiting post freeze recoverable viability ≥ 90.0%.

17. The Contractor shall provide to the COR documentation in electronic format describing the validated vials used in the packaging of each MCB unit.

18. The Contractor shall print and apply to each MCB unit a label suitable for long term (≥ 5 calendar years) storage at cryogenic temperatures (≤ -150 °C). The text of each applied label shall include the phrase “cNISTmAb CHO MCB”.

19. The Contractor shall, upon completion of MCB manufacturing, store and maintain all deliverable MCB units at appropriate cryogenic temperatures (≤ -150 °C) until final delivery of the MCB.

Contractor Testing of the MCB

20. The Contractor shall test the MCB for sterility using (a) compendial assay(s) (or method(s)) that is/are compliant with the current U.S. Pharmacopeia.

21. The Contractor shall test the MCB for mycoplasma by direct agar assay, media assay and by indicator co-culture assay as described by Attachment #2 of the Points to Consider in the Characterization of Cell Lines Used to Produce Biologicals (1993), Center for Biologics Evaluation and Research, U.S. Food and Drug Administration.

22. The Contractor shall test the post-freeze recoverable cell viability of the MCB using (an) assay(s) or method(s) validated according to International Committee on Harmonization (ICH) Quality Guidelines.

23. The Contractor shall test the species of origin of the Cell Substrate within the MCB using (an) assay(s) or method(s) validated according to ICH Quality Guidelines.

24. The Contractor shall test the MCB for adventitious viral contamination using in vitro culture of indicator cell lines including, at a minimum MRC-5, VERO and CHO lines, according to (an) assay(s) or method(s) validated according to ICH Quality Guidelines.

25. The Contractor shall test the MCB for adventitious viral contamination using in vivo inoculation of suckling and adult mice and embryonated hen eggs according to (an) assay(s) or method(s) validated according to ICH Quality Guidelines.

26. The Contractor shall test the MCB for contamination by adventitious viruses of bovine origin to satisfy the applicable requirements prescribed in 9 CFR § 113 using (an) assay(s) or method(s) validated according to ICH Quality Guidelines.

27. The Contractor shall test the MCB for contamination by adventitious viruses of porcine origin to satisfy the applicable requirements prescribed in 9 CFR § 113 using (an) assay(s) or method(s) validated according to ICH Quality Guidelines.

28. The Contractor shall test the MCB for contamination by Vesivirus/Calcivirus 2117 using (an) assay(s) or method(s) validated according to ICH Quality Guidelines.

29. The Contractor shall test the MCB for contamination by the Minute Virus of Mice (MVM/MMV) using (an) assay(s) or method(s) validated according to ICH Quality Guidelines.

30. The Contractor shall test the MCB with (a) mouse antibody production (MAP) assay(s) or method(s) including choriomeningitis virus (LCMV) challenge meeting applicable requirements of ICH Q5A Guideline and validated according to ICH Quality Guidelines.

31. The Contractor shall test the MCB with (a) hamster antibody production (HAP) assay(s) or method(s) meeting applicable requirements of ICH Q5A Guideline and validated according to ICH Quality Guidelines.

32. The Contractor shall use transmission electron microscopy (TEM) to test cellular morphology and the appearance and/or production of retrovirus-like particles (VLPs) using (an) assay(s) or method(s) validated according to ICH Quality Guidelines.

33. The Contractor shall test the MCB for retrovirus contamination using product-enhanced reverse transcriptase (PERT) using assay(s) or method(s) validated according to ICH Quality Guidelines.

34. The Contractor shall test the MCB for retrovirus contamination by co-culture with Mus dunni cells and subsequent testing for ecotropic viruses and/or murine leukemia viruses (MuLV) using (an) assay(s) or method(s) validated according to ICH Quality Guidelines.

35. The Contractor shall test the MCB for retrovirus contamination by co-culture with feline S+L-cells and subsequent assay for amphotrophic viruses using (an) assay(s) or method(s) validated according to ICH Quality Guidelines.

36. The Contractor shall test the MCB for retrovirus contamination by co-culture with mink S+L-cells including extend focus forming assay and subsequent assay for xenotropic viruses using

(an) assay(s) or method(s) validated according to ICH Quality Guidelines.

37. The Contractor shall determine the nucleic acid sequence of the mRNA (cDNA) present in the Cell Substrate corresponding to the heavy chain of the “NISTmAb” product using (an) assay(s) or method(s) either qualified or validated according to ICH Quality Guidelines.

38. The Contractor shall determine the nucleic acid sequence of the mRNA (cDNA) present in the Cell Substrate corresponding to the light chain of the “NISTmAb” product using (an) assay(s) or method(s) either qualified or validated according to ICH Quality Guidelines.

39. The Contractor shall use restriction digest and blotting to test the integrity of the “NISTmAb” heavy chain transgene within the Cell Substrate genomic DNA using (an) assay(s) or method(s) either qualified or validated according to ICH Quality Guidelines.

40. The Contractor shall use quantitative polymerase chain reaction (qPCR) to determine the genomically-integrated copy number of the “NISTmAb” heavy chain transgene, the “NISTmAb” light chain transgene and/or the recombinant vector carrying both “NISTmAb” transgenes using (an) assay(s) or method(s) either qualified or validated according to ICH Quality Guidelines.

Contractor Manufacture of the WCB

41. The Contractor shall manufacture a WCB of the Cell Substrate using a single, homogeneous culture or cell pool, seeded from one (1) vial of the manufactured MCB and using documented Cell Substrate media requirements and manipulation protocols provided by the COR.

42. The Contractor shall manufacture sufficient units of the WCB so that a quantity of 800 units can be delivered. Each MCB unit shall contain > 0.90 milliliters of cell suspension having at least 5.0 x 106 cells exhibiting post freeze recoverable viability ≥ 90.0%.

43. The Contractor shall provide to the COR documentation in electronic format describing the validated vials used in the packaging of each WCB unit.

44. The Contractor shall print and apply to each WCB unit a label suitable for long term (≥ 5 calendar years) storage at cryogenic temperatures (≤ -150 °C). Per 7-7.2 above, the COR will provide the design for the WCB unit label in an electronic format.

45. The Contractor shall, upon completion of WCB manufacture, store and maintain all deliverable WCB units at appropriate cryogenic temperatures (≤ -150 °C) until final delivery of the WCB.

Contractor Testing of the WCB

46. The Contractor shall test the WCB for sterility using (a) compendial assay(s) (or method(s)) that is/are compliant with the current U.S. Pharmacopeia.

47. The Contractor shall test the WCB for mycoplasma by direct agar assay, media assay and by indicator co-culture assay as described by Attachment #2 of the Points to Consider in the Characterization of Cell Lines Used to Produce Biologicals (1993), Center for Biologics Evaluation and Research, U.S. Food and Drug Administration.

48. The Contractor shall test the post-freeze recoverable cell viability of the WCB using (an) assay(s) or method(s) validated according to International Committee on Harmonization (ICH) Quality Guidelines.

49. The Contractor shall test the species of origin of the Cell Substrate within the WCB using (an) assay(s) or method(s) validated according to ICH Quality Guidelines.

50. The Contractor shall test the WCB for adventitious viral contamination using in vitro culture of indicator cell lines including, at a minimum MRC-5, VERO and CHO lines, according to (an) assay(s) or method(s) validated according to ICH Quality Guidelines.

Transfer of Materials and Documentation from the Contractor to NIST

51. The Contractor shall arrange for transportation and/or shipping of the MCB units, while maintaining the MCB units at appropriate cryogenic storage conditions (≤ -150 °C), to the NIST Office of Reference Materials (ORM) facility in Gaithersburg, MD. The Contractor shall maintain responsibility for the quality of the MCB units until these are officially received by

NIST ORM.

52. The Contractor shall arrange for transportation and/or shipping of the WCB units, while maintaining the WCB units under cryogenic storage conditions (≤- 150°C), to the NIST ORM facility in Gaithersburg, MD. The Contractor shall maintain responsibility for the quality of the WCB units until these are officially received by NIST ORM.

53. The Contractor shall deliver, as (an) electronic PDF document(s), to the COR a protocol for NIST BSF scientists to follow when thawing MCB and/or WCB units, recovering and assaying for viability per Acceptance Requirement Summary below.

54. The Contractor shall deliver, as (an) electronic PDF document(s), to the COR a compiled report of analysis of the MCB including the results of all tests performed according to the specifications in above sections.

55. The Contractor shall deliver, as (an) electronic PDF document(s), to the COR a compiled report of analysis of the WCB including the results of all tests performed according to the specifications in above sections.

IV. PLACE OF PERFORMANCE

All work shall be completed at the Contractor’s facility or at a Subcontractor facility qualified as suitable by the Contractor. All MCB deliverable units and all WCB deliverable units shall be transferred to the NIST ORM facility with mailing and delivery address of Office of Research Materials, NIST, 100 Bureau Drive, Gaithersburg, MD 20899. Normal duty hours are Monday through Friday, 8:30 am to 5:00 pm with the exception of Federal holidays.

V. GOVERNMENT FURNISHED PROPERTY, DATA AND/OR INFORMATION

No government property will be furnished to the Contractor. The RCB will be conveyed directly to the Contractor from the third-party responsible for cell line development. The COR will provide documentation as to Cell Substrate media requirements, manipulation protocols and “NISTmAb” heavy chain product and “NISTmAb” light chain product coding DNA sequence information. The COR will provide, as an electronic document, the label design to be used in the manufacture of the WCB as described in above SPECIFICATIONS.

VI. DELIVERABLES

Description Quantity Due Date Description of WCB label specifications and printing requirements (electronic format)

One (1) set Per contract and within 30 calendar days post award

A list of human cell lines with the source/vendor One (1) list Per contract and within 60 calendar days post award A list of vertebrate animal cell lines with the source/vendor

One (1) list Per contract and within 60 calendar days post award

IACUC approval document for either: a specific protocol for this contract or the applicable SOP for such testing

One (1) IACUC approval document

30 days before the activities with live vertebrate animals is scheduled to begin

Specifications of vials used for MCB manufacture (electronic format)

One (1) set Per contract and within 6 months post award

Specifications of vials used for WCB manufacture (electronic format)

One (1) set Per contract and within 6 months post award

MCB deliverable units 200 vials Per contract and within 24 months post award

MCB report of analysis (electronic PDF document(s)) One (1) document or set Per contract and within 24 months post award

WCB deliverable units 800 vials Per contract and within 24 months post award

WCB report of analysis (electronic PDF document(s)) One (1) document or set Per contract and within 24 months post award Protocol for MCB and/or WCB unit thaw, recovery and viability assay

One (1) protocol Per contract and within 24 months post award

Copies of Quality Documentation for MCB manufacture, MCB testing, WCB manufacture and WCB testing (electronic PDF documents)

One (1) set Per contract and within 24 months post award

VII. ACCEPTANCE REQUIREMENT SUMMARY

1. MCB report of analysis will be accepted once it has been received by the COR and reviewed by NIST BSF Group biologists to verify the findings listed below. Report review will be completed within 15 working days of receipt of the MCB report of analysis. NIST reserves the right to address scientific or quality questions to authorized quality and/or scientific Contractor representatives, as described in any Quality Agreement(s), and to pause the 15 working day review period while awaiting Contractor response to such questions.

1.1. The MCB is sterile as determined by the reportable results of Specifications described in the section “Contractor Testing of the Master Cell Bank”.

1.2. The MCB is free of mycoplasma as determined by the reportable results of Specifications described in the section “Contractor Testing of the Master Cell Bank”.

1.3. The MCB is free of adventitious viruses and retroviruses as determined by the reportable results of Specifications described in the section “Contractor Testing of the Master Cell Bank”.

1.4. The MCB is comprised of a Cell Substrate derived from the species Cricetulus griseus as determined by the reportable results of Specifications described in the section “Contractor Testing of the Master Cell Bank”.

1.5. The genetic properties of the MCB have been tested according to Specifications described in the section “Contractor Testing of the Master Cell Bank”.

2. WCB report of analysis will be accepted once it has been received by the COR and reviewed by NIST BSF Group biologists to verify the findings listed below. Report review will be completed within 15 working days of receipt of the WCB report of analysis. NIST reserves the right to address scientific or quality questions to authorized quality and/or scientific Contractor representatives, as described in any Quality Agreement(s), and to pause the 15 working day review period while awaiting Contractor response to such questions.

2.1. The WCB is sterile as determined by the reportable results of Specifications described in the section “Contractor Testing of the Working Cell Bank”.

2.2. The WCB is free of mycoplasma as determined by the reportable results of Specifications described in the section “Contractor Testing of the Working Cell Bank”.

2.3. The WCB is free of adventitious viruses and retroviruses as determined by the reportable results of Specifications described in the section “Contractor Testing of the Working Cell Bank”.

2.4. The WCB is comprised of a Cell Substrate derived from the species Cricetulus griseus as determined by the reportable results of Specifications described in the section “Contractor Testing of the Working Cell Bank”.

3. MCB deliverable units will be accepted once:

3.1. The MCB units have been officially received at the NIST Office of Reference Materials

(ORM) facility.

3.2. The MCB report of analysis has been accepted as described above.

3.3. The MCB units have been verified by visual inspection to be manufactured and labeled according to Specifications described in the section “Contractor Manufacture of the Master Cell Bank”. This verification will be performed within 2 business days of officially receiving the MCB units.

3.4. NIST BSF Group biologists have verified that the post-freeze recoverable cell viability of the MCB is >90% by thawing, culturing and assaying a sample of ≤ 5 MCB units according to the protocol delivered by the Contractor. This testing and a report to the Contractor of the results as well as acceptance or refusal of the MCB will be performed within 20 working days of officially receiving the MCB. NIST will assume the responsibility for maintaining cryogenic storage (≤ -150 °C) and physical integrity of the MCB units received during this confirmation period. NIST reserves the right, during this confirmation period, to address scientific questions regarding cell characteristics to authorized scientific Contractor representatives, as described in any Quality Agreement(s), and to pause the 20 working day confirmation period while awaiting Contractor response to such questions.

4. WCB deliverable units will be accepted once:

4.1. The WCB units have been officially received at the NIST Office of Reference Materials

(ORM) facility.

4.2. The WCB report of analysis has been accepted as described above.

4.3. The WCB units have been verified by visual inspection to be manufactured and labeled according to Specifications described in the section “Contractor Manufacture of the Working Cell Bank”. This verification will be performed within 2 business days of officially receiving the WCB units.

4.4. NIST BSF group biologists have verified that the post-freeze recoverable cell viability of the WCB is >90% by thawing, culturing and assaying a sample of ≤ 10 WCB units according to the protocol delivered by the Contractor. This testing and a report to the Contractor of the results as well as acceptance or refusal of the WCB will be performed within 20 working days of officially receiving the WCB. NIST will assume the responsibility for maintaining cryogenic storage (≤ -150 °C) and physical integrity of the WCB units received during this confirmation period. NIST reserves the right, during this confirmation period, to address scientific questions regarding cell characteristics to authorized scientific Contractor representatives, as described in any Quality Agreement(s), and to pause the 20 working day confirmation period while awaiting Contractor response to such questions.

5. The one set of “Copies of Quality Documentation for MCB manufacture, MCB testing, WCB manufacture and WCB testing” will be accepted once it has been officially received by the COR and reviewed by NIST BSF Group biologists. This review will be completed within 15 business days of receiving the documentation. NIST reserves the right to address scientific or quality questions to authorized quality and/or scientific Contractor representatives, as described in any Quality Agreement (s), and to pause the 15 working day review period while awaiting Contractor response to such questions.

Should any deficiencies be noted prior to final acceptance of VII. 1-5 above, the Contractor will be notified and provided the opportunity to correct these deficiencies, at their expense, IAW the commercial terms and conditions articulated in FAR 52.212-4.