A27 - STO 1- Kickoff and Project Management Plan.pdf

Sample Task Order #1 - Statement of Work

Project Management Plan and Kick-Off Meeting for Manufacturing and Nonclinical Studies Support Services for the Development of Therapeutic Biotechnology Products (Biologics) Contract

SECTION B - SUPPLIES OR SERVICES AND PRICES/COST

ARTICLE B.1. PRICES

a. The total fixed price of this contract is $TBD.

b. Upon delivery and acceptance of the services described in SECTION C of this task order and identified in the schedule of charges below, the Government shall pay to the Contractor the unit price(s) set forth below:

SCHEDULE OF CHARGES FOR THE TASK AWARD PERIOD

Description of Service Quantity (Units)

Unit Price ($)

Extended Price ($)

Total ($)

Project Management Plan and Contract Kickoff Conference In-person and/or Video Webinar

ARTICLE B.2. ADVANCE UNDERSTANDINGS

a. Contract and Task Order Number Designation On all correspondence submitted under this TO, the Contractor agrees to clearly identify the base contract and TO numbers as follows:

Base IDIQ Contract Number: TBD Task Order Number: TBD

SECTION C - DESCRIPTION/SPECIFICATIONS/WORK STATEMENT

ARTICLE C.1. STATEMENT OF WORK

1. Comprehensive Project Management Plan

Comprehensive Project Management Plan – The Contractor shall deliver a comprehensive project management plan, including work breakdown structures, timelines, key milestones and deliverables, Go/No-Go decision points, resource allocation, budget, intellectual property terms, and a risk mitigation plan. The Contractor shall develop an overarching Project Plan for all in-house and subcontracted activities outlining but not limited to the following:

The Project Management Plan shall describe the Contractor’s understanding of its contract management responsibilities and the approach it will use to: 1) keep the projects on track; 2) ensure risks are understood and managed; 3) handle changes to scope; and 4) communicate in

Attachment #27 a timely manner with stakeholders. The Project Management Plan shall be kept current and updated throughout the contract period of performance and shall address, but is not limited to, the following:

1. Team organization and responsibilities

2. Identification of suitable subcontractors

3. Oversight of subcontractors

4. Project execution

5. Project constraints and assumptions

6. Project schedule and milestones

7. Project risks identification and management

8. Budgeted costs

9. Project monitoring

10. Quality control and assurance

11. Independent audits including internal and at subcontractor facilities

12. Contract Management, including plan to effectively and efficiently manage cost, schedule, and performance under this contract by using integrated program management processes across all aspects of performance and in a manner that yields cost savings and/or performance efficiencies throughout the execution of all TOs issued to the Contractor under this Contract

2. Contract Kick-off Meeting

The Contractor’s Key Personnel shall participate in a contract kick-off meeting in-person and/or by video conference call. The meeting shall be between 2-3 hours long and shall not exceed 4 hours. The conference call shall be scheduled at a date and time mutually agreed upon by the Government and Contractor that is within thirty (30) days of the base Indefinite- Delivery, Indefinite-Quantity (IDIQ) contract effective date. The Government will provide an agenda before the meeting and there will be time for questions and answers (Q&As) regarding the contract and its related projects.

The Contractor shall prepare a presentation outlining the following:

1. Overview of Key and support personnel assigned to the various areas that will conduct in-house and/or subcontracted execution for Manufacturing and/or Nonclinical Study related Task Orders.

2. Contractor Key Personnel reporting structure and point(s) of contact with the Government

3. Overview of Communication plan including subcontractor(s) and Government; project planning, execution, delivery of reports, and communication with the NIH Contracting Officers (COs), Contracting Officer Representatives (CORs), and other stakeholders

4. Overview of how Manufacturing studies will be subcontracted, scheduled, overseen and executed

5. Overview of how Nonclinical studies will be subcontracted, scheduled, overseen and executed

6. Overview of in-house and subcontractor facilities that will be devoted to Manufacturing and/or Nonclinical Study related Task Orders

7. Overview of Quality systems at Contractor and subcontractor facilities

8. Overview of data security, storage, access and transfer to the NINDS

9. Overview of the Project Management Plan including:

a. Scheduling and oversight of in-house execution of Manufacturing and/or

Nonclinical Study related Task Orders

b. Scheduling and oversight of Subcontracted execution of Manufacturing and/or Nonclinical Study related Task Orders

10. Overview of risk assessment and mitigation plans for overall Contract activities

ARTICLE C.2. REPORTING REQUIREMENTS

No additional requirements beyond those of the base contract.

SECTION D - PACKAGING, MARKING, AND SHIPPING

No additional requirements beyond those of the base contract.

SECTION E - INSPECTION/ACCEPTANCE

No additional requirements beyond those of the base contract.

SECTION F - DELIVERIES OR PERFORMANCE

ARTICLE F.1. TASK ORDER PERIOD OF PERFORMANCE

a. The anticipated period of performance of this TO is three months.

ARTICLE F.2. TIME OF DELIVERY

No additional requirements beyond those of the base contract.

SECTION G - CONTRACT ADMINISTRATION

ARTICLE G.1. CONTRACTING OFFICER’S REPRESENTATIVE (COR)

a. The following Contracting Officer's Representative (COR) shall represent the Government for the purpose of this TO:

TBD

b. All other terms and conditions of the base contract ARTICLE G.1. CONTRACTING OFFICER’S REPRESENTATIVE (COR) shall be considered to apply to this TO.

ARTICLE G.2. KEY PERSONNEL

a. The following individuals are considered to be essential to the work being performed hereunder for this TO:

Name Title Principal Investigator Senior Research Scientist Program Manager

b. All other terms and conditions of the base contract ARTICLE G.2. KEY PERSONNEL shall be considered to apply to this TO.

ARTICLE G.3. INVOICE SUBMISSION/CONTRACT FINANCING REQUEST AND

CONTRACT FINANCIAL REPORT

a. Invoice Submission

The Contractor shall submit invoices in accordance with ARTICLE G.4. INVOICE SUBMISSION/CONTRACT FINANCING REQUEST AND FINANCIAL REPORT of the base contract number.

SECTION H - SPECIAL CONTRACT REQUIREMENTS

No additional requirements under SECTION H beyond those of the base contract.

SECTION I – GENERAL CONTRACT CLAUSES

No additional requirements beyond those of the base contract.

SECTION J – LIST OF ATTACHMENTS

No additional attachments beyond those of the base contract.

END OF SCHEDULE