Draft_SOW_cGMP_N01CN87006-18.pdf

cGMP Base Statement of Work (10/16/2018) 1

STATEMENT OF WORK

PREVENT Cancer Preclinical Drug Development Program: cGMP Production of Vaccines and Biologicals for Cancer Prevention

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) BACKGROUND AND INTRODUCTION

The Division of Cancer Prevention (DCP) is a principal Division of the National Cancer Institute (NCI) devoted to cancer prevention research with the overarching goal of preventing invasive cancer and associated deaths in humans. Research supported by the DCP encompasses a broad range of preclinical and clinical cancer prevention studies, including a better understanding and elucidation of cancer initiation processes, determination of individuals with increased risk of cancer, early cancer detection methodologies, and the development of cancer preventive interventions. The PREVENT Cancer Preclinical Drug Development Program (PREVENT;

http://prevention.cancer.gov/major-programs/prevent-cancer-preclinical) is a peer-reviewed research program that was formally launched by the DCP in 2011 with its primary mission to advance the preclinical development of cancer-preventive interventions and intermediate biomarkers, and to support/enable their clinical translation. The PREVENT Program accepts applications from academia, small businesses, and the pharmaceutical industry, and selects meritorious projects through peer review and organizational prioritization processes. Approved projects are entered into the appropriate stages of the PREVENT pipeline, consisting of early proof of concept studies, secondary testing for validation, and the final steps of applications for Investigational New Drug (IND) enabling studies. Projects are implemented in a milestone-driven manner. Since its inception, the PREVENT Program has partnered with researchers in the extramural community and supported over 60 projects through Task Orders awarded to two separate pools of competitively selected prime contract holders with requisite technical capabilities in the areas of (1) in vivo efficacy testing and biomarker development, and (2) toxicology and pharmacology testing.

The PREVENT Program focuses on anti-inflammatory approaches for cancer prevention, novel molecularly targeted chemoprevention agents, and immunoprevention of cancers of non-infectious etiology. While long term use of anti-inflammatory approaches (e.g. NSAIDs) are considered viable strategies for cancer chemoprevention in certain high-risk cohorts, molecularly targeted chemopreventive approaches and immunoprevention of cancers of non-infectious etiology are relatively new and emerging concepts in the field of cancer prevention research.

Because cancer preventive interventions require long term (possibly life-long) use of preventive agents in healthy subjects, rigorous preclinical studies are necessary for new chemopreventive agents not only to establish their preventive efficacy profiles, but also to demonstrate safety, and thereby to ensure a high benefit/risk ratio, before they can progress to clinical trials. In contrast, cancer preventive vaccines have the potential to provide long-lasting protective immunity virtually in the absence of long-term toxicity concerns. Recent advances in tumor immunology and anticancer immunotherapies have uncovered the host immune system’s capacity to mount effective antitumor immune responses to tumor associated antigens and counter cancer growth.

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When tumor-derived immune suppression is blocked by immune checkpoint inhibitors in the established tumor immune microenvironment, the immune system can exert more robust antitumor immune responses. It is highly conceivable that cancer vaccines targeting certain immunogenic tumor-associated antigens may induce more effective antitumor immunity if given before or early in the tumorigenic process, and thus may prevent or deter the development of malignant lesions.

The development and introduction of cancer immunopreventive agents, such as vaccines, remain one of the highest priorities for the PREVENT Program. As the PREVENT project portfolio matures, multiple immunoprevention projects are expected to progress to the late stage of preclinical development, which will necessitate the supply of clinical-grade vaccines and other immunomodulatory agents in support of IND-enabling studies.

2) SCOPE

This Statement of Work directly supports the PREVENT initiatives, as necessary, to help the Program achieve its mission. To meet the anticipated technical needs in the PREVENT pipeline, the NCI has a requirement for production of vaccines and other biological agents under cGMP conditions. Vaccines can be expected to span the spectrum of vaccine types, ranging from relatively simple peptide vaccines (as will be found in the Initial Task Order SOW) through protein vaccines, DNA or RNA vaccines, and vaccines packaged in viruses or a variety of organisms e.g. Listeria or constituted as virus-like particles. Other biologicals may include antibodies, ligands, cytokines, or growth factors affecting immune targets. Occasionally, preclinical grade products may be required for advanced development studies.

3) GENERAL TASK ORDER REQUIREMENTS

The Technical Focus Area(s) identified under each Specific Task Orders will depend on the nature of the product requested for development.

Note to Offerors: Task Orders shall range in duration from 1 to 5 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:

3.1 PROJECT MANAGEMENT

1. The Contractor shall provide a Project Management Plan (PMP) depicting overall project management and implementation plans including coordination and integration of task activities to be conducted under the Task Order. 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 cGMP Base Statement of Work (10/16/2018) 3

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

1) Sourcing key materials

2) Production of product(s)

c. Project Monitoring and Control

1) Schedule including Gantt chart(s) with milestones

2) Budget: task-linked budgets that separate costs for each milestone 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

2. 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 an 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 COR, and other representatives at the discretion of the COR (e.g., CO, Subject Matter Experts, investigator representatives).

3. 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. The Contractor shall prepare regular updates to the Project Management Plan and provide updated plans to the COR as part of quarterly progress reports for each Task Order.

4. 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.

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

6. Progress Review Meetings and Teleconferences cGMP Base Statement of Work (10/16/2018) 4

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 quarterly 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.

7. The Contractor shall be responsible for the following for all meetings, including each Task Order Initiation Meeting as well as Progress Review Meetings:

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.

3.2 QUALITY MANAGEMENT

1. The Contractor shall be responsible for the quality and regulatory compliance of the materials and documentation generated per this Statement of Work. The products will be required to meet the stated Current Good Manufacturing Practice (cGMP) quality standards specified in each Task Order. The Contractor shall have a quality management plan that includes management responsibilities, resources, training program, oversight of all outsourced manufacturing operations, and communication processes including timelines.

2. The Contractor shall be responsible for the control of outsourced activities. The Contractor shall have a quality system oversight program that ensures stage-specific cGMP compliance of the outsourced activities. The quality system oversight program must include establishing a Quality Agreement with the subcontractor that clearly delineates the responsibilities of both the Contractor and the subcontractor and describes communication processes including timelines. The Quality Agreement must cover personnel, production and process controls, facilities, equipment, laboratory controls, training, materials management, packaging and labeling, and records and documentation, as well as deviations, corrective, and preventive action (CAPA) and out of specification (OOS) documentation. The Contractor shall ensure adequate environmental controls are in place to prevent cross-contamination in any multiproduct manufacturing environment. When requested, the Contractor shall provide the draft and/or final Quality Agreements to the government.

3.3 FACILITIES, EQUIPMENT AND OTHER RESOURCES

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1. The Contractor shall provide facilities, equipment, space, training, and other resources to conduct work with potentially hazardous 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.

3.4 STORAGE AND SHIPPING

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.

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.

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 Contractors shall qualify and validate temperature chambers as proposed by the Contractor and reviewed and approved by the COR.

6. The Contractor shall be responsible for retrieval, 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.

3.5 TRANSITION

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At the completion of each Task Order or 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, including all subcontractors;

2. all products remaining from the work carried out under each Task Order by the Contractor, including all subcontractors;

3. any critical reagents (such as proteins, peptides, molecular constructs, vectors, viruses, cell banks; also see 4.3.3), test results, reference standards, or materials developed under each Task Order by the Contractor and all subcontractors; and

4. all files pertaining to each Task Order generated by the Contractor, including all subcontractors.

4) TECHNICAL FOCUS AREAS

The requirements outlined in this Statement of Work have been assembled into the following Technical Focus Areas:

Focus Area A – Analytical Assay Development and Product Characterization Focus Area B – Process Development and Related Activities Focus Area C – cGMP Manufacture, Related Activities and Documentation

For the purposes of this contract:

Vaccines for cancer prevention are defined as antigens formulated with or without adjuvant for use as vaccines. Antigens may be comprised of peptides (as illustrated in the Initial Task Order), proteins, or nucleic acids encoding the antigens or viral vectors or virus-like particles. A variety of adjuvants may be combined with antigen to comprise a vaccine.

Biologicals for cancer prevention may include antibodies, ligands, cytokines, or growth factors affecting immune targets.

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 Focus Area

The Technical Requirements for each Technical Focus Area are considered applicable to all Task Orders, unless otherwise indicated in the specific Task Order. Similarly, all Technical Focus Areas are considered applicable to all Task Orders, unless otherwise indicated in the specific cGMP Base Statement of Work (10/16/2018) 7

Task Order.

4.1. Focus Area A: Analytical Assay Development and Product Characterization

Scope of Focus Area A

Focus Area A 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 Focus Area include method comparability studies;

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

Technical Requirements for Focus Area A include:

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 verify authenticity of cells if possible using DNA fingerprinting and perform safety assessment studies such as in vivo and in vitro viral and non-viral adventitious agent detection. 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).

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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.

4.2. Focus Area B: Process Development and Related Activities

Scope of Focus Area B

Focus Area B will support the development and performance of production and purification processes amendable to scale-up for the manufacture of products; performance of cGMP banking (cell/viral) activities; and 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 Focus Area B include:

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

4. As applicable to the individual task order, the Contractors shall establish master and working cell/viral banks. The Contractor shall also perform all release testing and provide a COA. The Contractor shall provide documentation to support submissions (including, but not limited to, an Investigational New Drug [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 Contractors shall produce products including production of lots suitable for IND-enabling safety and activity testing, and performance of the necessary characterization tests required for product release.

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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 failure. The Contractors shall also provide liquid nitrogen storage. The Contractor shall also 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 or to its designee 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. 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;

g. technology transfer packages; and

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

4.3. Focus Area C: cGMP Manufacture, Related Activities and Documentation

Scope of Focus Area C

Focus Area C will support the production of cGMP 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 cGMP Base Statement of Work (10/16/2018) 10 procedures as required for the successful performance of the activities.

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].

Focus Area C 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 Manufacturing and Controls (CMC), and other appropriate documentation in formats acceptable for submission to either the Center for Biologics Evaluation and Research (CBER) or the Center for Drug Evaluation and Research (CDER), FDA, or to non-domestic regulatory authorities as applicable. The actual regulatory submission will be performed by DCP’s Regulatory Support contractor.

Technical Requirements for Focus Area C include:

1. The Contractor shall be responsible for the overall management of the technology transfer process 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 and labeling 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 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 also perform all necessary release testing required for clinical use and provide a Certificate of Analysis. The Contractors shall also establish and maintain a stability testing program.

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 also 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. The Contractor shall also receive, store, ship and record products, cGMP Base Statement of Work (10/16/2018) 11

Master Cell Banks, 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. If requested, the Contractor shall provide all data, information, and records required for preparation of the Chemistry, Manufacturing and Controls (CMC) section of an IND, a Master File, or other regulatory documents related to the manufacturing process to the COR.

The Contractor shall also provide information pertaining to the composition, manufacture, and quality control of the 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 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 or to a Government-designated facility 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;

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

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

g. Government-owned equipment and property.

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12. The Contractor shall prepare and provide the required documentation (e.g., Manufacturing Report; Chemistry, CMC Information; in-process/release testing data) with content and format to support Regulatory Agency submissions (such as Pre-IND, IND, and/or Pre- Submission) to the COR. If invited, the Contractor shall also 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 and submit as required by the individual task order.

14. The Contractor shall provide additional information and amendments as necessary to the COR 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.

15. The Contractor shall submit to the COR all manufacturing data and information required to support a Biologic License Application (BLA) submission when applicable.

16. 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.

5) BASE CONTRACT MANAGEMENT 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: cGMP Production of Vaccines and Biologicals for Cancer Prevention” which occurs independent of other specific Task Orders to be awarded under the contract.

Requirements for Base Contract Management Support 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.