Attach_3_of_4_CGMP_IDIQ_SOW.pdf

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IDIQ STATEMENT OF WORK

PREVENT Cancer Preclinical Drug Development Program: Preclinical Services for Biopharmaceutical Product Development and Manufacturing

Independently and not as an agent of the Government, the Contractor shall furnish all the necessary services, qualified personnel, materials, equipment, and facilities, not otherwise provided by the Government, as needed to perform the Statement of Work.

1) SCOPE

This Statement of Work directly supports the PREVENT initiatives, as necessary, to help the Program achieve its mission. The Preclinical Services for Biopharmaceutical Product Development and Manufacturing Program will provide the PREVENT initiatives with a broad and flexible range of timely, proactive and development-oriented capabilities to provide preclinical product development and manufacturing support for promising biopharmaceutical products and diagnostic reagents.

2) GENERAL TASK ORDER REQUIREMENTS

The Technical Task Area(s) identified under each specific Task Order will depend on the status of the candidate agent(s) as part of an overall product development plan and/or regulatory submission plan to the U.S. Food and Drug Administration (FDA). Tasks shall be conducted in accordance with quality oversight that is appropriate to the phase of the specific task and within all applicable and current federal, state, and local laws, codes, ordinances and regulations, as well as all applicable Public Health Service (PHS) Safety and Health provisions.

Note to Offerors: Task Orders shall range in duration from 1 to 3 years. For proposal purposes, Offerors shall assume that each Task Order will involve no more than three (3) biopharmaceutical products or reagents.

The following requirements shall apply to each Task Order:

2.1 PROJECT MANAGEMENT

1. Task Order Initiation Meeting and/or Teleconference: Within 10 calendar days after the effective date of the Task Order or before the start of any tasks, the Contractor shall plan for and participate in a Task Order Initiation Meeting or Teleconference to review the Task Order requirements and timelines, discuss Task Order technical plans and approaches, and identify any anticipated problems/obstacles to completing the Task Order requirements. The Task Initiation Meeting shall be attended by Contractor key personnel (including subcontractor personnel as appropriate), the Contracting Officer’s Representative (COR), and other representatives at the discretion of the COR (e.g., CO, Subject Matter Experts, investigator representatives).

2. The Contractor shall provide and maintain an acceptable Project Management Plan (PMP)

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depicting overall project management and implementation plans including coordination and integration of task activities to be conducted under the Task Order to meet all Technical Requirements. The PMP shall clearly delineate all the roles and responsibilities of key personnel and site(s) involved on the Task Order and any preparation and/or planning to be done prior to performance of the tasks. The PMP shall be provided to the Contracting Officer’s Representative (COR) describing proposed project management of all proposed tasks for each Task Order including:

a. Project Management

1) Project Organization

2) Roles and Responsibilities of Personnel and Staffing Plan

3) Project Deliverable Tracking including Acceptance Criteria

4) Subcontract Management (if applicable)

5) Communication Approach

6) Risk Management Approach

7) Quality Management Approach

b. Technical Approach

c. Project Monitoring and Control

1) Schedule including Gantt chart(s)

2) Budget: task-linked budgets will be required under any cost-reimbursement task orders that separate costs for each milestone, while for any fixed-priced task orders, payments will be tied to receipt and approval of task order deliverables to facilitate tracking and reporting costs with regards to progress made and activities accomplished;

3) On-time submission of Project Reports as outlined in the Task Order

4) Tracking of action items

4. The Contractor shall develop, monitor, and modify the timelines, tasks, budgets, objectives and milestones as discussed with and/or prioritized by the COR before and during the performance of activities under the Task Order. If changes need to be made to the technical protocol at any time, the Contractor shall provide updates to the CO and COR immediately by teleconference or email and also document the change in the monthly progress reports for each Task Order. The CO and COR must provide written concurrence and approval prior to Contractor implementing any proposed change(s). These updates shall include changes made and current project rationale.

5. The Principal Investigator (or equivalent) shall be responsible for overall compliance with quality requirements, project management and communication, tracking performance, monitoring and reporting on project status and progress, and recommending modifications to project requirements and timelines, including projects undertaken by subcontractors.

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6. Key personnel or other senior staff coordinator(s) shall be available for ad hoc meetings/teleconferences with the COR immediately upon a meeting request.

7. Progress Review Meetings and Teleconferences

a. The Contractor shall plan and participate in Progress Review Meetings or Teleconferences, which shall be attended by Contractor key personnel (including subcontractor personnel as appropriate), the COR, the Contracting Officer, and other individuals designated by the COR (e.g., Subject Matter Experts, investigator representatives), as necessary, at monthly intervals or as issues arise. The purpose of these meetings/teleconferences shall be to review and discuss:

1) ongoing and planned activities, protocols and associated data;

2) timelines for task initiation and completion, submission of data and other information;

3) any problems or deficiencies identified with respect to the accuracy, timeliness and completeness of data submitted; and

4) any other matters relevant to the technical and financial administration of the task.

8. The Contractor shall be responsible for the following:

a. preparing and distributing meeting/teleconference agendas and background materials at least one business day prior to each meeting/teleconference; and

b. preparing and submitting to the COR written summaries of all major decisions and action items resulting from such meetings and teleconferences within seven calendar days after each meeting/teleconference.

The following Quality Management requirement shall apply and be provided at the base IDIQ level:

2.2 QUALITY MANAGEMENT

1. The Contractor shall be responsible for the quality and applicable regulatory compliance of the materials and documentation generated per this Statement of Work (SOW). The Contractor shall ensure the products meet the stated Current Good Manufacturing Practice (CGMP) quality standards specified in each Task Order.

2. The Contractor shall maintain an acceptable Quality Management Plan (QMP), outlined in the Final Proposal Revision, that describes how quality assurance is addressed within the organization, including quality management responsibilities, resources, training program, oversight of all subcontractors if applicable, and communication processes including timelines. The Quality Management Plan shall include any Quality Agreements (QA) between the Prime Contractor and any subcontractors which clearly delineates:

responsibilities, communication processes including timelines, personnel, production and process controls, facilities, equipment, laboratory controls, training, materials management, N01CN77019-18 2/7/2018 packaging and labeling, records and documentation, plans for routine and “for cause” audits of the subcontractor facility(s), participation in and/or communication of audit findings with Government personnel, and deviations, corrective and preventive action (CAPA), and out of specification (OOS) documentation. The Contractor shall also ensure adequate environmental controls are in place to prevent cross-contamination in any multiproduct manufacturing environment. If changes need to be made to the QMP or QA, the Contractor shall provide updates to the CO and COR immediately by teleconference or email. The CO and COR must provide written concurrence and approval prior to Contractor implementing any proposed changes.

2.3 FACILITIES, EQUIPMENT AND OTHER RESOURCES

As outlined in the Task Order:

1. The Contractor shall provide facilities, equipment, space, training and other resources to conduct work with potentially hazardous chemical and biological materials in compliance with all federal and NIH regulations in accordance with the following guidelines where applicable:

a. “Biosafety in Microbiological and Biomedical Laboratories”, Centers for Disease Control and Prevention, and the National Institutes of Health, Fifth Edition 2009 (http://www.cdc.gov/biosafety/publications/bmbl5/index.htm)

b. NIH Guidelines for Research involving Recombinant or Synthetic Nucleic Acid Molecules (http://osp.od.nih.gov/sites/default/files/NIH_Guidelines.html)

2. The Contractor shall provide facilities, equipment, space and other resources to conduct work in a manner to prevent cross-contamination with other materials.

3. All personnel, equipment and facilities shall be compliant with applicable regulatory agency requirements in effect throughout the entire period of performance. The Contractor shall maintain quality assurance (QA) documentation to support adherence to these areas.

2.4 STORAGE AND SHIPPING

As outlined in the Task Order:

1. The Contractor shall be responsible for the overall management and conduct of the receipt, storage, retrieval, packaging and shipping of products, materials, and specimens, including obtaining appropriate licenses and permits, where applicable.

2. The Contractor shall receive and record products, materials, reagents, and specimens.

3. The Contractor shall store products, materials, and test samples at the specified temperature range and conditions in a secure area. Specific temperature ranges include but are not limited to liquid nitrogen, -70°C +/- 10°C, -20°C +/-5°C, 2-8°C, room temperature.

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4. The Contractor shall monitor and document the conditions in all controlled temperature chambers as appropriate for the level of regulatory compliance, under which each product is produced: specific procedures should be proposed by the Contractor and will be reviewed and approved by the COR.

5. The Contractor shall qualify or validate temperature chambers as proposed by the Contractor and reviewed and approved by the COR.

6. The Contractor shall be responsible for retrieving, packaging, and shipping of materials to various domestic and international locations. If not provided by the Government, detailed shipping instructions shall be supplied by the Contractor as appropriate, at the time of shipment. The Contractor shall also be responsible for establishing and following a documented shipping procedure compatible with CGMP regulations when appropriate;

capturing and documenting temperatures maintained during shipping and storage; and adhering to U.S. and international standards for packaging.

2.5 TRANSITION

At the completion of each Task Order or at any point as determined by the COR, the Contractor shall deliver to the Government the following items:

1. all data obtained from all work carried out under each Task Order by the Contractor, all subcontractors, and all third parties as designated by the COR;

2. all products remaining from the work carried out under each Task Order by the Contractor, all subcontractors, and all third parties as designated by the COR;

3. any critical reagents (such as proteins, peptides, molecular constructs, vectors, viruses, cell banks; also see 3.3.3), test results, reference standards or materials developed under each Task Order by the Contractor, all subcontractors, and all third parties as designated by the COR; and

4. all files pertaining to each Task Order generated by the Contractor, all subcontractors, and all third parties as designated by the COR.

3) TECHNICAL TASK AREAS

Services to be performed under this contract have been assembled into the following Task Areas:

Task Area A – Product Development Planning and Evaluation Task Area B – Analytical Assay Development and Product Characterization Task Area C – Process Development and Related Activities Task Area D – CGMP Manufacture, Related Activities and Documentation

For the purposes of this contract:

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Biopharmaceutical Products are defined as materials that are derived from biotechnology processes including, but not limited to, recombinant proteins derived from traditional and non-traditional expression systems; peptides; nucleic acid based materials (such as RNAs and plasmids); vaccine adjuvants and delivery systems; and other biotechnology or cell-derived products.

Contractors may need to be supported to a certain extent by the expertise and resources of other organizations or persons through consortia agreements, partnerships, subcontracts, and/or consultants. However, the Prime Contractor shall be responsible for ALL work to be performed, including project planning, initiation, implementation, management and communication;

evaluation, selection, and management of subcontractors; and for all deliverables specified in this contract and each awarded Task Order.

Scope and Requirements for each Technical Task Area

The Technical Requirements for each Technical Task Area are considered applicable to all Task Orders, unless otherwise indicated in the specific Task Order. Similarly, all Technical Task Areas are considered applicable to all Task Orders, unless otherwise indicated in the specific Task Order.

3.1 Task Area A: Product Development Planning and Evaluation

Scope of Task Area A:

Task Area A will support the assessment of products with respect to feasibility of design, development, manufacture, assay development and stability testing for the preparation of Preclinical, Phase I - III clinical trial materials, and materials for diagnostic purposes; developing and writing Preclinical and/or Product Development Plans for specified products; and conducting, reviewing and evaluating technical and/or facility audits of potential subcontractors.

Technical Requirements for Task Area A:

1. The Contractor shall conduct an evaluation of the current status and overall scientific feasibility of the project as determined by: 1) product development history, if applicable, including all current scientific documents related to the project, laboratory notebooks, publications, and any ancillary documentation, plus all regulatory documentation; 2) the manufacturing feasibility and traceability of all project reagents; and 3) the financial feasibility of the project.

2. The Contractor shall develop and/or update Pre-clinical and/or Product Development Plans for candidate products in collaboration with the product investigator and COR. The plans shall include regulatory, pre- clinical, clinical, non-clinical, and manufacturing activities to be undertaken for a product. Anticipated minimum timelines for completion of tasks related to the activity shall be provided via the use of Gantt charts or other appropriate project management tools.

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3. The Contractor shall develop Concept Development Plans for COR-designated products and/or their manufacturing process and related safety studies needed to achieve desired outcomes for the product and shall determine whether proposed studies are acceptable for the given phase of product development.

4. The Contractor shall develop Informational Reports for COR-designated services, products, processes and/or technologies using market surveys and/or literature review of scientific and industry publications. The Contractor shall utilize public databases for identifying and comparing potential products, and prepare reports of product characteristics that can be used to identify and support the selection and prioritization of candidate preventive agents or diagnostic products.

5. The Contractor shall deliver to the Government within a mutually agreed upon period prior to the completion of each Task Order, or after completion of specific activities within the Task Order, the following:

a. Audit Reports and Final Audit Reports from initial, follow-up, and/or subsequent audits of a site or facility for a specified product. Final reports shall be a compilation of all audits performed for a given site/facility regardless of product for which the audit was performed;

b. Reports for feasibility assessments performed and recommendations for applicable go-no/go decisions;

c. Concept Development Reports for designated products;

d. Informational Reports for specified biopharmaceutical products and diagnostic reagents;

e. Pre-clinical plans and/or product-specific Product Development Plans for specified biopharmaceutical products and diagnostic products; and

f. All data and/or technical information obtained from the NCI or a third party in preparation for activities performed.

3.2. Task Area B: Analytical Assay Development and Product Characterization

Scope of Task Area B:

Task Area B will support activities required for the design, development, qualification and validation of assays as needed for the characterization of a biopharmaceutical product or diagnostic product to demonstrate safety, identity, potency, purity, and quality; and performance of product characterization tests required for in-process testing and subsequent lot release of produced materials. Other activities under this Task Area include method comparability studies;

redevelopment or improvement of existing assays; and technology transfer of assays to/from

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other facilities.

Technical Requirements for Task Area B:

1. The Contractor shall develop, qualify and validate analytical methods for evaluation of the product. The Contractor shall also identify contaminants in support of product characterization, product potency, in-process tests, lot release, and product stability.

2. The Contractor shall prepare associated documentation for assay development, qualification, validation, and regulatory submissions.

3. The Contractor shall develop, produce, procure, and characterize assay reagents/required components.

4. The Contractor shall develop, produce, procure, and characterize diagnostic reagents.

5. The Contractor shall prepare and document cell-line or clone history for master stocks, cell banks, and/or bacterial or viral clones applicable to the product, including CGMP-grade master stocks, cell banks, and/or bacterial or viral clones [e.g. expansion of cell banks and their characterization to meet regulatory requirements including CGMP-compliant DNA sequencing, restriction analysis, plasmid stability, host stability, host identity, and purity (non-host contamination)].

6. For mammalian and other eukaryotic cells, the Contractor shall perform safety assessment studies such as in vivo and in vitro viral and non-viral adventitious agent detection, tumorigenicity, and karyotyping. The Contractor shall also provide and store characterized research and/or CGMP-grade reagent stocks (e.g. cell banks, and/or bacterial or viral clones).

7. The Contractor shall deliver to the Government within a mutually agreed upon period prior to the completion of each Task Order, or after completion of specific activities within the Task Order, the following items:

a. Assay protocols, Standard Operating Procedures (SOPs), Reports, and Certificate of Analysis (COAs).

b. Development, qualification and validation reports with all related raw data attached as appendices or made available for NCI review.

c. Technology transfer packages.

d. Any remaining Test Samples provided to initiate the Task Order.

e. Critical assay reagents and components specific to the assay and required for successful technology transfer.

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3.3. Task Area C: Process Development and Related Activities

Scope of Task Area C:

Task Area C will support the development and performance of production and purification processes amendable to scale-up for the manufacture of biopharmaceutical products or diagnostic reagents; the production of research-grade products and reagents; performance of CGMP banking (cell/viral) activities; performance of product characterization tests required for in-process testing and subsequent lot release of produced materials. Activities may also include technology transfer of processes to/from other facilities.

Technical Requirements for Task Area C:

1. The Contractor shall be responsible for the overall management and the conduct of process development and production activities.

2. The Contractor shall develop a detailed project plan, budget and Gantt chart for early-to-late-stage process development and manufacture of products prior to undertaking reagent grade or pilot lot CGMP production. This plan shall include written standard operating procedures for all steps in the production and purification process that are used in pilot/engineering production runs.

3. The Contractor shall provide process development, characterization and production of biotechnology products such as, but not limited to, recombinant proteins; peptides; vaccine adjuvants and delivery systems; nucleic acid materials (DNA and RNA based), and other biotechnology or cell-derived products.

4. The Contractor shall establish master and working cell/viral banks. Perform all release testing and provide a COA. The Contractor shall also provide documentation for all submissions (including, but not limited to, an IND and Master File) to Regulatory Agencies.

5. The Contractor shall develop production and purification process steps that are suitable for subsequent use in CGMP operations and are scalable. The Contractor shall also conduct necessary in-process testing to demonstrate process suitability.

6. The Contractor shall produce biopharmaceutical products and diagnostic reagents including production of lots suitable for IND-enabling safety and activity testing, and performance of the necessary characterization tests required for product release.

7. The Contractor shall establish, implement, and oversee formulation studies for manufactured products.

8. The Contractor shall establish and maintain an inventory of test and pilot lots of products that have been produced, and arrange for storage of such lots in a manner that meets regulatory guidelines. The Contractor shall also maintain and operate controlled storage of samples at appropriate temperatures (room temperature through -90°C) with monitoring for equipment

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failure. The Contractor shall also provide liquid nitrogen storage and receive, store, ship and record products, master cell banks, biological agents, reagents, records, and any other materials associated with the products.

9. The Contractor shall perform stability assays throughout process development and pilot manufacture including examination of titer or potency at appropriate intervals. The Contractor shall also implement stability testing programs in parallel with formulation studies of designated products during process development and pilot lot manufacture.

10. The Contractor shall deliver to the Government within a mutually agreed upon period prior to the completion of each Task Order, or after completion of specific activities within the Task Order, the following items:

a. assay protocols, SOPs, Reports, and COAs;

b. any remaining materials provided to initiate the Task Order;

c. all products including master cell banks, bulk products and pilot lots, and any other product made under the Task Order, including the product’s associated data;

d. all data obtained from product characterization tests;

e. data from stability programs and/or formulation studies;

f. labeled and inventoried paper files and computer files covering all aspects of process development and detailed manufacturing information for all product(s) made under the Task Order;

g. a complete list of accurate and updated information regarding design, development and production, including pertinent Contractor activities, computerized data files, original data, and any related information;

h. technology transfer packages; and

i. a complete list of accurate and updated information on subcontract activities.

3.4. Task Area D: CGMP Manufacture, Related Activities and Documentation

Scope of Task Area D:

Task Area D will support the production of CGMP biopharmaceutical products in accordance with relevant FDA guidelines and the performance and documentation of all other related activities including product release assays required for human clinical use. The Contractor shall be responsible for directing and ensuring the successful technology transfer of all materials, assays, methods, and procedures as required for the successful performance of the activities.

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The needs, funding, product maturity, and timelines of the product as specified in the Task Order establishes requirements for compliance with Current Good Manufacturing Practices (CGMP) [21 CFR Parts -11, -210, -211, -600].

Task Area D will support developing a Manufacturing Report; Chemistry, Manufacturing and Controls (CMC) Information; a Master File; and other regulatory documents appropriate for submission to the FDA. Guidance on regulatory requirements can be obtained through the FDA Center for Biologics Evaluation and Research website (www.fda.gov/cber).

The Contractor shall obtain and compile, in consultation with the COR, product sponsors, subcontractors and/or consultants, the nonclinical data, Manufacturing and Controls (CMC), and other appropriate documentation for submission to either the Center for Biologics Evaluation and Research (CBER) or the Center for Drug Evaluation and Research (CDER), FDA, or non-domestic regulatory authorities as applicable.

Technical Requirements for Task Area D:

1. The Contractor shall be responsible for the overall management and the conduct of technology transfer and CGMP production activities.

2. The Contractor shall develop a detailed project plan, budget, and Gantt chart in consultation with the COR for manufacture of each designated product prior to undertaking CGMP production. The project plan shall include written production records for all steps in the production and purification processes for CGMP manufacture as well as the fill/finish of the product.

3. The Contractor shall prepare Master Production Records.

4. The Contractor shall perform CGMP-compliant activities that shall include, but not be limited to, those leading to the production of recombinant proteins, peptides, vaccine adjuvants and delivery systems, nucleic acids (DNA and RNA based), and other biotechnology or cell-derived products.

5. The Contractor shall manufacture biopharmaceutical products under CGMP conditions in compliance with FDA CGMP regulations and guidance for CGMP production, vialing or pre-filled applicator preparation, filling, finishing, packaging, labeling, storage, and shipping of material. The Contractor shall perform all necessary release testing required for clinical use and provide a Certificate of Analysis. The Contractor shall also establish and maintain a stability testing program. Provide documentation for all submissions (including, but not limited to, an IND and Master File) to Regulatory Agencies.

6. The Contractor shall establish and maintain an inventory of all lots of products that have been produced, and store in accordance with regulatory guidelines. The Contractor shall maintain controlled storage of samples at appropriate temperatures (room temperature through -90°C) with monitoring for equipment failure. The Contractor shall also provide liquid nitrogen storage amd receive, store, ship and record products, master cell banks, N01CN77019-18 2/7/2018 biological agents, reagents, records, and any other materials associated with the products.

7. Prior to use of a manufactured product in clinical studies, the Contractor shall perform final lot release testing as described for biologics and drugs in applicable FDA or International Conference on Harmonization (ICH) guidance and regulations.

8. The Contractor shall provide all data, information, and records required for the writing and submission of the Chemistry, Manufacturing and Controls (CMC) Information, Master File, and all other documents related to IND submission or for submission to other non-U.S.

regulatory authorities, and to the COR or to a COR-designated third party. The Contractor shall also provide information pertaining to the composition, manufacture, and quality control of the biopharmaceutical product as appropriate for investigations carried out under an IND.

9. The Contractor shall retain all records and samples as indicated under CGMP guidelines, and provide them to the COR upon request.

10. The Contractor shall establish, implement and oversee product specific stability programs that comply with FDA and/or ICH guidelines for CGMP manufactured biopharmaceutical products intended for human use. The Contractor shall also develop and implement plans for stability testing of products including examination of titer or potency at appropriate intervals.

11. The Contractor shall deliver to the Government within a mutually agreed upon period prior to the completion of each Task Order, or after completion of specific activities within the Task Order, the following items:

a. all products including harvest, bulk product substance, final product, and any other products or intermediates made under the Task Order in various stages of production with attached detailed manufacturing information (such as Production Records [Master and Batch] and appropriate SOPs);

b. all data obtained from in-process and release tests;

c. data from stability programs;

d. a complete list of accurate and updated information regarding design, development, and production, including pertinent Contractor activities, computerized data files, original data, and any related information such as the Chemistry, Manufacturing and Controls (CMC) Information for IND, cross-reference to Biologic Master File (BMF) as well as Quality System Regulations (QSR; 21 CFR Part 820);

e. a complete list of accurate and updated information on subcontract activities;

f. labeled and inventoried paper files, if applicable, and computer files covering all aspects of production; and

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g. Government-owned equipment and property.

12. The Contractor shall prepare and provide the required documentation (e.g., Manufacturing Report; Chemistry, CMC Information; in-process/release testing data) to support Regulatory Agency submissions (such as Pre-IND, IND, and/or Pre-Submission). The Contractor shall also transfer Master Files to Regulatory Agencies as required for IND submission. Participate in discussions with the FDA during Pre-IND, IND, and/or Pre-Submission meetings/teleconferences as necessary.

13. The Contractor shall prepare, assemble, edit, paginate, and index the original Manufacturing Report and/or CMC Information. The Contractor shall also forward these documents to the COR or third party as identified by the COR.

14. The Contractor shall obtain authorization for cross-filing of information when appropriate.

15. The Contractor shall file a Master File or international equivalent to support regulatory filings by the NCI or a third party as identified by the COR.

16. The Contractor shall provide additional submissions and amendments as necessary for successful filing of the IND or comparable non-U.S. approval documents. The Contractor shall also prepare an environmental assessment as described in 21 CFR 25.31 if required.

17. The Contractor shall provide regulatory assistance to the manufacturer, any partners or subcontractors performing safety testing, and all others involved in the production and preclinical testing of a product throughout the process of IND submission to the FDA.

18. The Contractor shall submit to the FDA, NCI, or product sponsor all data and information required to support a BLA submission when applicable.

19. The Contractor shall deliver to the Government within a mutually agreed upon period prior to the completion of each Task Order, or after completion of specific activities within the Task Order, all files and/or data pertaining to the activities of the contract.

Base Contract Management Support Activities

These activities support parent contract requirements as stated in the contract. The scope includes management functions performed by the Contractor in support of NCI’s contract entitled “PREVENT Cancer Preclinical Drug Development Program: Preclinical Services for Biopharmaceutical Product Development and Manufacturing” which occur independent of other specific Task Orders to be awarded under the contract.

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Requirements include:

1. Kick off Meeting

The Contractor shall participate in the initial parent contract kick-off meeting to be held in Rockville, Maryland. The kick-off meeting shall be attended by the Principal Investigator and other relevant key Contractor technical and business staff, the COR and his/her designees, and the Contracting Officer and/or his/her designees.

2. Annual Meeting

The Contractor shall participate in an annual meeting to be held in Rockville, Maryland at the COR’s discretion. The annual meeting shall be attended by the Principal Investigator and other relevant key Contractor staff, the COR and his/her designees, and the Contracting Officer and/or his/her designees. Task orders will be issued for this meeting on an annual or semi-annual basis during the contract period of performance.