Attachments 0001-0003 - W911QY-21-R-0021.pdf

STATEMENT OF OBJECTIVES (SOO): Stability testing of rBV A/B and rF1V critical materials

Purpose

In order to maintain critical capability to respond to potential emergencies, the United States Government (USG) is seeking commercial sources capable of performing stability testing for its recombinant Botulinum A/B (rBV A/B) program and recombinant Plague F1V (rF1V) program. This includes critical material lots and reagents in anticipation of ongoing and future activities.

Scope

The purpose of this contract is to continue stability testing of rBV A/B and rF1V critical material lots and reagents in anticipation of ongoing and future activities. Testing of critical material includes the continued testing of several lots of cGMP drug product (DP), cGMP drug substance (DS), associated reference materials, and other critical reagents. Refer to tables 1.1 - 1.4 for full list of lots for continued stability testing. The scope of this effort includes activities such as program management, review and approval, contracting appropriate subcontractors for the work, setup and execution, and delivery of presentations, reports, and certificates of analyses. JPM CBRN Medical will review and approve of all work plans prior to initiation of any activities.

JPM CBRN Medical will provide the necessary drug product, drug substance, reference material, and critical reagents to be placed on continued stability testing.

Period of Performance: The entirety of this effort is projected at 5 years; comprised of an 8 month base period, 4 month optional period, followed by Four – 12 month optional periods.

The timeline allows for the prime contractor to contract any subcontractors for testing, protocol development, review, and all necessary approvals such as the One Network of Excellence for Regulatory Affairs (ONE-RAQA), the Institutional Animal Care and Use Committees (IACUCs) and Animal Care and Use Review Office (ACURO). Due to funding limitations the Government anticipates evaluation of all optional efforts and may decide to exercise optional effort at time of award. The anticipated delivery date for each item is delineated at Section F.

Background

The JPM CBRN Medical’s rF1V vaccine is intended to protect adults from aerosolized pneumonic plague caused by inhalational exposure to Yersinia pestis. Vaccine potency (for stability) is tested using the validated relative potency assay. Refer to tables 1.1 and 1.2 for list of lots for continued stability testing and tables 1.5 and 1.6 for a list of stability tests.

The JPM CBRN Medical’s rBV A/B vaccine is intended to protect adults from fatal botulism caused by inhalational intoxication from exposure to Botulinum neurotoxin (BoNT)/A1 and BoNT/B1. Neutralizing antibody-combined (NAC) and vaccine potency (for stability) are tested using validated mouse bioassays.

Refer to tables 1.3 and 1.4 for list of lots for continued stability testing and tables 1.7 and 1.8 for list of stability tests.

The vaccine programs are in advanced development, having completed safety and efficacy studies through a Phase 2 human clinical trial. Newly manufactured lots of rBV A/B and rF1V were completed in late 2020 and early 2021. The intent of the work described here is to continue stability testing for these

Attachment 0001 - Statement of Objectives newly manufactured lots, previously manufactured lots, and critical materials associated with these programs.

Constraints

Data generated under this contract are considered Department of Defense Controlled Unclassified Information (CUI) and fall under ITAR 120.10 whose export is restricted by the Arms Export Control Act (Title 22, U.S.C. Sec 2778, et seq.) Violations of United States export laws are subject to severe criminal penalties.

Table 1.1 – Material for continued stability testing – Test sites identify the current test performers.

Note: Yellow shaded cells are currently contemplated as optional items/time points.

Product Description Test Sites

Storage Condition

Tests Time point

Time point

Time point

Time point

Time point

Time point

Time point

Time point rF1V DP GMP2 JHS/II

TRI/K

BI/EL

LI

4 °C Refer to table 1.2

5/20

8/20

2/20

8/20

8/20

8/20

8/20 rF1V DP GMP1 JHS/II

TRI/K

BI/EL

LI

4 °C Refer to table 1.2

5/20

8/20

2/20

8/20

8/20

8/20 rF1V DP GMP3 JHS/II

TRI/K

BI/EL

LI

4 °C Refer to table 1.2

6/20

9/20

3/20

9/20

9/20

9/20

9/20 rF1V DS 1 FDBU -70 °C Refer to table 1.3

1 mo post awar d

3/20

3/20

2/20

2/20 rF1V DS 2 FDBU -70 °C Refer to table 1.3

8/20

8/20

8/20

8/20 rF1V DS3 FDBU -70 °C Refer table 1.3

8/20

8/20

8/20

8/20 rF1V DP Phase 2b JHS/E

LLI

4 °C Refer to table 1.2

1 mo post awar d

3/20

3/20

3/20

3/20 rF1V DP Ref. Std. IITRI 4 °C Refer table 1.2

2/20

2/20

2/20

2/20 rF1V DS Ref. Mtrl. FDBU -70 °C Refer table 1.3

9/20

9/20

9/20

9/20

9/20 rF1V DS Ref. Std. Qual IITRI DVC-

RPA-

NLT

12/2

Anti F1 IgY FDBU 1 mo post awar d

4/20

4/20

4/20

4/20

Anti F1V IgY FDBU 1 mo awar d

4/20

4/20

4/20

Anti V IgY FDBU 1 mo awar d

4/20

4/20

4/20

HRP-conj. 1° rabbit antibody

FDBU 1 mo post awar d

4/20

4/20

4/20

Rabbit Anti F1V FDBU 1 mo awar d

4/20

4/20

4/20 rBV DP GMP 1

JHS/

Batte lle/K

BI

4 °C Refer to table 1.4

6/20

9/20

12/2

12/2

12/2

12/2

12/2 rBV DP GMP 2

Batte lle/K

BI

4 °C Refer to table 1.4

6/20

9/20

12/2

3/20

3/20

3/20 rBV DP GMP 3

Batte lle/K

BI

4 °C Refer to table 1.4

6/20

9/20

12/2

3/20

3/20

3/20 rBV DP D1200138

Batte lle/K

BI

4 °C Refer to table 1.4

10/2

10/2

10/2

10/2 rBV A DS GMP 1

FDBU

/Batt elle/

KBI

-70 °C Refer to table 1.5

1 mo post awar d

10/2

10/2

10/2

10/2

10/2 rBV A DS GMP 2

/Batt elle/

KBI

-70 °C Refer to table 1.5

5/20

11/2

11/2

11/2

11/2 rBV B DS GMP 1

/Batt elle/

KBI

-70 °C Refer to table 1.5

1 mo post awar d

4/20

4/20

4/20 rBV B DS GMP 2

/Batt elle/

KBI

-70 °C Refer to table 1.5

6/20

6/20

6/20

6/20

6/20 rBV A DS GMP 3

/Batt elle/

KBI

-70 °C Refer to table 1.5

8/20

8/20

8/20

8/20 rBV A DS GMP 4

/Batt

-70 °C Refer to

9/20

9/20

9/20

9/20

9/20 elle/

KBI

table 1.5 rBV B DS GMP 3

FDBU

/Batt elle/

KBI

-70 °C Refer to table 1.5

5/20

5/20

5/20

5/20

5/20 rBV B DS GMP 4

/Batt elle/

KBI

-70 °C Refer to table 1.5

5/20

5/20

5/20

5/20 rBV A Ref. Mtrl.

/Batt elle/

KBI

-70 °C Refer to table 1.5

5/20

5/20

5/20

5/20 rBV B Ref. Mtrl.

/Batt elle/

KBI

-70 °C Refer to table 1.5

5/20

5/20

5/20

5/20 rBV Anti-rBoNTA KBI 6/20

6/20

6/20

6/20 rBV Anti-rBoNTB

KBI 6/20

6/20

6/20

6/20 rBV A Assay Ctrl

KBI -70 °C 1 mo post awar d

3/20

3/20

3/20 rBV B Assay Ctrl

KBI -70 °C 1 mo post awar d

3/20

3/20

3/20

(BoNT/A1)

Batte lle

1 mo post awar d

3/20

3/20

3/20

(BoNT/B1) Batte lle

6/20

6/20

6/20

6/20

1 The Contractor shall perform or have a subcontractor perform the required testing at the anticipated time points identified in the above tables 1.1 and in accordance with the specifications provided at tables 1.2 – 1.5, below:

Table 1.2 rF1V DP stability tests

DP Stability Study Methods

Name SOP # Test Site Degree of Coloration

JHS

303.218

JHS

Clarity and Degree of Opalescence

JHS

303.218

JHS

Visible Particles

JHS

303.218

JHS

pH

JHS

303.218

JHS

LDS-PAGE

JHS

303.218

JHS

Western Blot

JHS

303.218

JHS

Osmolality

JHS

303.218

JHS

RP-HPLC

ATM-0847-

KBI

Unbound Protein

LLI-0761 ELLI

Total Protein

(AAA)

LLI-0761 ELLI

Mouse Relative Potency

DVC-RPA-

IITRI

Table 1.3 – rF1V DS stability tests:

DS Stability Study Methods

Name SOP # Test Site Western Blot TM-0023445 FDBU Nu-PAGE® TM-0023442 FDBU Total Protein Concentration (A280)

TM-0023441 FDBU

RP-HPLC (purity) TM-0028645 FDBU

SEC-MALS LL-0709 FDBU

rF1V ELISA TM-0028735 FDBU

RP-HPLC (% monomer) TM-0029989 FDBU

Visual Appearance TM-0024472 FDBU pH TM-0023115 FDBU

Table 1.4 – rBV A/B DP stability tests

DP Stability Study Methods Name SOP # Test Site Clarity and Opalescence

GTM-0294 KBI

Degree of Coloration

GTM-0295 KBI

Visible Particulates

GTM-

0033/GTM-

KBI

pH GTM-0015 KBI

HIC-HPLC ATM-0001 KBI

fHIC-HPLC ATM-0074 KBI

Total Protein Concentration

(BCA)

ATM-0138 KBI

SDS-PAGE ATM-0004 KBI

SDS-CGE ATM-0283 KBI

CEX-HPLC

(Characterization)

ATM-0242 KBI

Vial Integrity TP67450 JHS Sterility <USP 71> JHS Mouse Potency Assay

BBRC.X-169 Battelle

Table 1.5 rBV DS stability tests:

DS Stability Study Methods Name SOP # Test Site pH TM-0047632 FDBU Color and Appearance TM-0047633 FDBU Total Protein Concentration (A280)

TM-0047634 FDBU

CEX-HPLC (Purity) TM-0047638 FDBU

SDS-PAGE TM-0047639 FDBU

CEX-HPLC

(Characterization)

ATM-0242 KBI

SDS-CGE

(Characterization)

ATM-0283 KBI

Western Blot ATM-0007 KBI Mouse Potency Assay BBRC.X-169 Battelle

SEC-HPLC

(Characterization)

TM-0047640

TM-0048494

1.1 Testing of critical material, drug product, and drug substance lots may utilize the existing testing facilities and protocols.

1.2 JPM CBRN Medical shall provide drug product, drug substance, reference material and critical reagents to be place on continued stability testing

2 Task 2: Program Management

2.1 Schedule

2.1.1 Current estimated period of performance is 8 months commencing in May 2021. There is optional scope to include continuation of annual testing for these lots, to be consider at the end of the base period. The timeline allows for all necessary approvals (e.g. IACUC, ACURO, ONE-RAQA). Progress will be evaluated monthly or more frequently as necessary and agreed-on by all parties.

2.2 Deliverables :

2.2.1 Final documentation of Standard Operating Protocols (SOPs) shall be provided as supporting documentation.

2.2.2 Testing results shall be reviewed and signed by testing facilities’ quality assurance units as necessary and provided to JPM CBRN Medical for review and approval prior to final payment.

2.2.3 Biweekly meetings for status updates from subcontractors (JPM CBRN Medical to attend in listening mode) and Report, record of meeting agenda/minutes with subcontractor.

2.2.4 Monthly progress, status, and management report of effort

3 Task 3: Regulatory

3.1 Objectives

3.1.1 All facilities shall follow standard GLP for testing, re-testing, and reporting, as necessary. In case of a protocol deviation or testing failure, notification shall be provided to JPM CBRN Medical within 2 business days.

DEPARTMENT OF THE ARMY

U.S. ARMY CONTRACTING COMMAND

ABERDEEN PROVING GROUND

NATICK CONTRACTING DIVISION

1 KANSAS STREET

NATICK, MA 01760-5011

REPLY TO

SUBJECT: Offeror Past Performance Assessment in Support of Request for Proposal

(RFP) W911QY-21-R-0021

Dear Sir/Ma’am, The US Army Contracting Command – Aberdeen Proving Ground (ACC-APG) – Natick Division – Frederick Branch is currently conducting a competitive source selection to evaluate offerors on the subject RFP. As part of this evaluation, we have requested that the offerors provide information about their past performance on same or similar federal, state, or local government or commercial contracts as compared to the North American Industry Classification System 541715.

Your assessment of their performance is extremely valuable to our evaluation.

Please complete the enclosure and return to the undersigned, prior to the closing date of the solicitation. Submit your completed questionnaire to the undersigned at Scott Hoffman scott.i.hoffman2.civ@mail.mil, with the subject line: W911QY-21-R- 0021_Name_Date. You may also cc the the offeror to confirm the questionnaire has been sent.

Your cooperation is greatly appreciated. Questions may be directed to the Contract Specialist at scott.i.hoffman2.civ@mail.mil.

Sincerely, Scott Hoffman Contract Specialist

Performance Assessment Questionnaire

Please provide your candid responses. The information that you provide will be used in the awarding of federal contracts. Therefore, it is important that your information be as factual, accurate and complete as possible to preclude the need for follow-up by the evaluators. If you do not have knowledge of or experience with the company in question, please forward this Questionnaire to the person who does (and/or) notify the Contracting Officer. Please return the completed Questionnaire to the Contracting Officer identified in the cover letter within the stated timeframe.

Rating Definitions:

Substantial Confidence: Performance meets contractual requirements and exceeds many requirements that benefit the end user. Work was accomplished with few, if any, minor problems for which corrective actions taken by the contractor were highly effective. The offeror has been highly successfully in performing the required effort.

Satisfactory Confidence: Performance meets contractual requirements and exceeds some requirements that benefit the end user. Work was accomplished with some minor problems for which corrective actions taken by the contractor were effective. The offeror has successfully performed the required effort.

Limited Confidence: Performance does not meet some contractual requirements.

Serious problems with contractor performance were experienced for which the contractor has either not yet identified corrective actions or the corrective actions taken appear only marginally effective. The offeror has had little success performing the required effort.

No Confidence: Performance does not meet most contractual requirements. Serious problems with contractor performance were experienced for which the corrective actions were ineffective. The offeror has not successfully performed the required effort.

PART I. (To be completed by the Offeror)

A. CONTRACT IDENTIFICATION

Contractor/Company Name/Division:

Address:

Program Identification/Title:

Contract Number:

Contract Type:

Prime Contractor Name (if different from the contractor name cited above):

Contract Award Date:

Forecasted or Actual Contract Completion Date:

Nature of the Contractual Effort or Items Purchased:

Total Contract Value:

Attachment 0002 - Past Performance Questionnaire

B. IDENTIFICATION OF OFFEROR’S REPRESENTATIVE

Name:

Title:

Date:

Telephone Number:

Address:

E-mail Address:

PART II. EVALUATION (To be completed by Point of Contact – Respondent) *Note: rationale is required for each response.

A. Compliance of Products, Services, Documents, and Related Deliverables to Specification Requirements and Standards of Good Workmanship

Substantial Confidence Satisfactory Confidence Limited Confidence No Confidence

Rationale: _________________________________________________________

B. Effectiveness of Project Management (to include use and control of subcontractors).

Rationale: __________________________________________________________

C. Timeliness of Performance for Services and Product Deliverables.

D. Effectiveness in Forecasting and Controlling Estimated Costs (Use this Question on Cost Reimbursement Type Contracts Only).

E. Commitment to Customer Satisfaction and Business-like Concern for its Customers’ Interest

F. General Comments. Provide any other relevant performance information.

Comments: _________________________________________________________

G. Other Information Sources. Please provide the following information:

Are you aware of other relevant past efforts by this company?

If yes, please provide the name and telephone number of a point of contact:

Point of Contact (Name): __________________________________________ Telephone Number: ______________________________________________

H. Respondent Identification. Please provide the following information:

Organization:

Name:

Title:

Date:

Telephone Number Address:

E-mail Address:

PART III. RETURN INFORMATION

Please return this completed Questionnaire to the Contracting Officer identified in the cover letter.

Thank you for your assistance.

Quality Assurance Surveillance Plan (QASP)

1. Vision In order to maintain critical capability to respond to potential emergencies, the contractor is required to continue stability testing of recombinant Botulinum A/B (rBV A/B) program and recombinant Plague F1V (rF1V) program critical material lots and reagents in anticipation of ongoing and future activities.

2. Mission The mission of this contract is to continue stability testing of rBV A/B and rF1V critical material lots and reagents in anticipation of ongoing and future activities.

Testing of critical material includes the continued testing of several lots of cGMP drug product (DP), cGMP drug substance (DS), associated reference materials, and other critical reagents. The contractor shall be required to maintain the required level of quality in their program management, testing, data reporting and tracking and trending data to the requirements listed below in the QASP.

3. Purpose

This Quality Assurance Surveillance Plan is a government-developed document used to determine if the contractor’s performance meets the performance standards contained in the contract. The QASP establishes procedures on how this assessment/inspection process will be conducted. It provides the detailed process for a continuous oversight process:

• What will be monitored

• How monitoring will take place

• Who will conduct the monitoring

• How monitoring efforts and results will be documented

The contractor is responsible for implementing and delivering performance that meets contract standards using its Quality Control Plan. The QASP provides the structure for the government’s surveillance of the contractor’s performance to assure that it meets contract standards. It is the government’s responsibility to be objective, fair and consistent in evaluating contractor performance.

The QASP is not part of the contract nor is it intended to duplicate the contractor’s quality control plan. This QASP is a living document. Flexibility in the QASP is required to allow for an increase or decrease in the level of surveillance necessary based on contractor performance.

Attachment 0003 - Quality Assurance Surveillance Plan (QASP)

The government may provide a copy of the QASP to the contractor to facilitate open communication. In addition, the QASP should recognize that unforeseen or uncontrollable circumstances might occur that are outside the control of the contractor.

Bottom line, the QASP should ensure early identification and resolution of performance issues to minimize impact on mission performance.

4. Authority

Authority for issuance of this QASP is provided under Part 46 of the Federal Acquisition Regulation, Inspection of Services clauses, which provides for inspection, acceptance and documentation of the service called for in the contract or order. This acceptance is to be executed by the contracting officer or a duly authorized representative.

5. Roles and Responsibilities

The following personnel shall oversee and coordinate surveillance activities.

Program/Project Manager (PM) – The PM provides primary program oversight, nominates the COR, ensures the COR is trained before performing any COR duties and supports the COR’s performance assessment activities. While the PM may serve as a direct conduit to provide Government guidance and feedback to the Contractor on technical matters, they are not empowered to make any contractual commitments or any contract changes on the government’s behalf.

Assigned PM: Wai Kwan Chung Organization or Agency: JPEO-CBRND/CBRN Medical Telephone: 301-619-8471 Email: waikwan.chung2.civ@mail.mil

Contracting Officer (KO) – The KO shall ensure performance of all necessary actions for effective contracting, ensure compliance with the contract terms, and shall safeguard the interests of the United States in the contractual relationship.

The KO shall also ensure that the contractor receives impartial, fair, and equitable treatment under this contract. Determine the final assessment of the contractor’s performance.

Assigned KO: Richard Totten Organization or Agency: ACC Natick – Fort Detrick Telephone: 301-619-2446 Email: Richard.w.totten2.civ@mail.mil

Contracting Officer’s Representative (COR) The COR is responsible for providing continuous technical oversight of the contractor’s performance. The COR uses the QASP to conduct the oversight/surveillance process. The COR shall keep a Quality Assurance file that accurately documents the contractor’s actual performance. The purpose is to ensure that the contractor meets the performance standards contained in the contract. The COR is responsible for reporting early identification of performance problems to the KO. The COR is required to provide an annual performance assessment to the KO which will be used in documenting past performance. The QASP is the primary tool for documenting contractor performance. The COR is not empowered to make any contractual commitments or to authorize any contractual change on the Government’s behalf.

Assigned COR: Wai Kwan Chung Organization or Agency: JPEO-CBRND/CBRN Medical Telephone: 301-619-8471 Email: waikwan.chung2.civ@mail.mil

Senior Scientist The senior scientist is responsible for providing technical input and oversight of contractor’s performance. While the Senior Scientist may serve as a direct conduit to provide Government guidance and feedback to the Contractor on technical matters, they are not empowered to make any contractual commitments or any contract changes on the government’s behalf.

Contractor Representatives

The following employees of the contractor serve as the contractor’s Program Manager and Task Manager for this contract. (Complete this section after the contract award)

Program Manager - <upon award, enter name> Telephone: <enter number> Email: <enter address>

Task Manager - <upon award, enter name> Telephone: <enter number> Email: <enter address>

Other Key Contract Personnel - <upon award, enter name or delete these lines if not applicable> Title: <enter title> Telephone: <enter number> Email: <enter address>

6. Performance Requirements and Method of Surveillance

6.1. Contract Surveillance

The goal of the QASP is to ensure that contractor performance is effectively monitored and documented. The COR’s contribution is their professional, non-adversarial relationships with the KO, PM and the contractor, which enables positive, open and timely communications. The foundation of this relationship is built upon objective, fair, and consistent COR evaluations of contractor performance against contract requirements. The COR uses the methods contained in this QASP to ensure the contractor is in compliance with contract requirements. The COR function is responsible for a wide range of surveillance requirements that effectively measure and evaluate the contractor’s performance.

Additionally, this QASP is based on the premise that the contractor, not the government, is responsible for management and QC/QA actions to successfully meet the terms of the contract.

6.2. Surveillance Matrix

The Surveillance Matrix (Attachment 1z`) is the list of performance objectives and standards that must be performed by the contractor. This matrix details the method of surveillance the COR will use to validate and inspect these performance elements. Inspection of each element will be documented in the COR file.

Performance objectives define the desired outcomes. Performance Standards define the level of service required under the contract to successfully meet the performance objective. The inspection methodology defines how, when, and what will be assessed in measuring performance. The Government performs surveillance, using this QASP, to determine the quality of the contractor’s performance as it relates to the performance element standards. The Performance Requirement Summary (PRS) should be used to form the foundation of the COR’s inspection checklist.

6.3. Performance Rating Definitions

In evaluating the quality of contractor’s performance, the following performance ratings may be used.

[ If your organization requires that you use a different rating mechanism, insert it here. ]

Performance Criteria

Rating Excellent /

Outstanding Performance meets contractual requirements and exceeds many to the government’s benefits. The contractual performance of the element or sub-element being assessed was accomplished with no problems and contractor actions were highly effective.

Very Good Performance meets contractual requirements and exceeds some to the government benefits. The contractual performance was accomplished with few minor problems for which corrective actions taken by the contractor were effective.

Good Performance meets contractual requirements. The contractual performance contains some minor problems for which corrective actions taken by the contractor were satisfactory.

Marginal Performance does not meet some contractual requirements.

The contractual performance reflects a serious problem for which the contractor has not yet identified corrective actions.

The contractor’s proposed actions appear marginally effective or were not fully implemented.

Unsatisfactory Performance does not meet most contractual requirements and recovery is not likely in a timely manner. The contractual performance contains serious problem(s) for which the contractor’s corrective actions appear or were ineffective.

7. Performance Reporting

7.1. Performance Assessment Report

PARs will be used to report ALL minor discrepancies and will be generated by the COR and sent to the contractor for corrective action. Contractors will be given 10 days to correct PARs unless they have requested an extension. If 3 minor discrepancies are found, combine them and process a CAR.

7.2. Customer Complaint Form

The COR must furnish instructions to the customer receiving the contractor’s service. The customer must retain supporting evidence of complaint or feedback.

After the COR validates feedback or complaint demonstrating contractor noncompliance, the COR processes a Performance Assessment Report (PAR) or Corrective Action Report (CAR) to the KO. ALL Customer Complaint forms WILL be validated by the COR prior to notifying the contractor.

7.3. Corrective Action Report (CAR)

The COR will forward the CAR to the KO for action. A copy will be provided to the contractor’s representative by the KO. Most CARs will be corrected within 30 calendar days depending on the complexity of the finding, the contractor may be allowed up to six months (maximum) correcting a CAR. The contractor will be asked the status of the CAR on a monthly basis. The COR will keep an electronic log of all CARs and will keep a hard copy of CARs in the contract oversight file.

7.4. Contract Performance Assessment Reporting System

(CPARS)

CPARS will be initiated annually, documenting contractor performance for this specific contract. More frequent updates may be made as required to document a significant improvement or degradation of the level of contract performance.

Appendix 1 - Surveillance Matrix

PWS

Paragrap h

Performance Objective / Elements

Standards / AQL Inspection Calculation / Ratings What How/ Method When/

Freq SOO Section 1: Contractor shall submit a monthly status report and hold biweekly meetings. The contractor shall provide a written monthly report to provide an update on the data generated and status of deliverables

COR will ensure that monthly reports are received from the contractor that are accurate and complete and will ensure a biweekly status update call occurs

COR will receive monthly reports from the contractor via email and biweekly meetings will occur via teleconference.

IAW CDRL A001 and CDRL A002

Delivery shall be on the 15th day of the month in contractor format.

Contractor shall receive an unsatisfactory rating if reports are received after the 15th of the month without approval or are inaccurate.

SOO Section 1: The Contractor shall submit testing results and the Standard Operating Protocols (SOP) used for each stability time point.

COR will ensure that the testing document will show the stability testing data, quality charts, environmental monitoring records, inspection reports for the entire production process for testing of the required materials and a certificate of analysis all reviewed and signed by contractors QA group. IAW CDRL A003 and CDRL A004

Delivery shall be within 30 days of completion of testing

Contractor shall receive an unsatisfactory rating if reports are delayed without approval or are inaccurate, testing not completed according to SOPs, or missing documentation, signature, or data.

Inspection Metrologies:

M1: Periodic. Periodic surveillance/inspection is the type of surveillance that is based upon selecting samples for evaluation on other than 100% inspection or on a statistically random basis. Periodic surveillance can be accomplished, weekly, monthly or quarterly using a checklist method.

M2: Inspection of Reports. All reports shall be reviewed upon receipt. The reviewer will report any flaws in the document and categorize the flaws (Editorial, Format, and/or Substance).

M3: Technical Inspection: Surveillance/inspection is the type of surveillance that will be performed as specified on the project schedule by actually looking at the work being done.

M4: Non-Service Summary. Assessment of Non-SS Items: All other tasks required under the CET may be inspected on a random basis at a frequency determined by the Functional Commander/Functional Director (FC/FD), CO, and/or COR per the Inspection of Services Clause in the contract. Non-SS Items will be verified by the COR at least quarterly or on an event basis as required.

0BCORRECTIVE ACTION REPORT (CAR)

(If more space is needed, use reverse and identify by number)

1. CONTRACTOR

2. CONTRACT NUMBER

3. TYPE OF SERVICES

4. FUNCTIONAL AREA

5. SUSPENSE DATE

6. CONTROL NUMBER

7. DEFICIENCY MAJOR MINOR

FINDING:

FINDING IMPACT:

Please respond with a written corrective action plan that details the corrective action of the cited deficiency, the cause of the deficiency, and actions taken to prevent recurrence by Suspense Date in Block 5. If date was not entered in Block 5, the contractor is not required to provide a response.

5B8. QUALITY ASSURANCE PERSONNEL (COR)

6BTYPED NAME AND GRADE

7BSIGNATURE AND DATE

8B9. ISSUING AUTHORITY

9BTYPED NAME AND GRADE

10BSIGNATURE AND DATE

10. COR RESPONSE TO CONTRACTOR CORRECTIVE ACTION AND ACTION TAKEN TO PREVENT RECURRENCE

11. COR DETERMINATION

ACCEPTED REJECTED

12. CLOSE DATE

CUSTOMER COMPLAINT RECORD

DATE/TIME OF COMPLAINT

SOURCE OF COMPLAINT

ORGANIZATION

BUILDING NUMBER

INDIVIDUAL

PHONE NUMBER

NATURE OF COMPLAINT

CONTRACT REFERENCE

VALIDATION

DATE/TIME CONTRACTOR INFORMED OF COMPLAINT

ACTION TAKEN BY CONTRACTOR

RECEIVED/VALIDATED BY

1BPERFORMANCE ASSESSMENT REPORT (PAR)

(If more space is needed, use reverse and identify by number)

1. CONTRACT/TASK ORDER NUMBER 2. CONTRACTOR 3. TYPE OF SERVICES

2B4. QUALITY ASSURANCE PERSONNEL (COR) SIGNATURE AND DATE 3B5. COR PHONE 4B6. SUSPENSE DATE

11BI. PERFORMANCE

7. DEFICIENCY (CHECK ALL BOXES THAT APPLY)

NEW

REPEAT

NO DEFICIENCY NOTED

8. SERVICES SUMMARY or PWS PARAGRAPH ITEM REVIEWED

9. BRIEF DESCRIPTION OF DEFICIENCY (IF DEFICIENCY BOX WAS

CHECKED)

10. DETAILED PERFORMANCE ASSESSMENT

12BII. CONTRACTOR VALIDATION

11. CONTRACTOR REPRESENTATIVE CONCUR NON-CONCUR 12. CORRECTIVE ACTION ESTIMATED COMPLETION DATE

13. CONTRACTOR REPRESENTATIVE CORRECTIVE ACTION AND PREVENTION OF RECURRENCE OR REASON FOR NON-

CONCURRENCE OF COR CITED DEFICIENCY

13BIII. ACTION CORRECTED

14. CONCUR NON-CONCUR COR SIGNATURE AND DATE

15. COR REMARKS (REQUIRED)

6. CONTRACTOR REPRESENTATIVE REMARKS