ARTICLE 7. Financial Matters
H. Comptroller General Access to Records: To the extent that the total Government payments under this Agreement exceed $5,000,000, the Comptroller General, at its discretion, shall have access to and the right to examine records of any Party to the Agreement or any entity that participates in the performance of this Agreement that directly pertain to, and involve transactions relating to, the Agreement for a period of three (3) years after final payment is made. This requirement shall not apply with respect to any Party to this Agreement or any entity that participates in the performance of the Agreement, or any subordinate element of such Party or entity, that has not entered into any other agreement (contract, grant, cooperative agreement, or “other transaction”) that provides for audit access by a government entity in the year prior to the date of this Agreement. This paragraph only applies to any record that is created or maintained in the ordinary course of business or pursuant to a provision of law. The terms of this paragraph shall be included in all sub-agreements to the Agreement other than sub-agreements with a component of the U.S. Government. The Comptroller General may not examine records pursuant to a clause included in an agreement more than three years after the final payment is made by the United States under the agreement.
ARTICLE 8. Report and Data Requirements
A. Weekly Teleconferences and Communication. Awardee shall conduct weekly teleconferences with the Government throughout the performance of the Agreement to discuss tasks accomplished and direction for the upcoming tasks. The Government anticipates reducing the teleconferences once enrollment executes and again after completion of the trial. Awardee shall provide agendas and read-ahead material as required two days prior to the meetings and shall provide minutes of each meeting to the Government. Awardee shall include key subcontractors as attendees at these teleconferences when applicable. The Awardee shall provide meeting minutes within [***] after each formal scheduled meeting/teleconference conducted with JPEO EB.
B. Quarterly Progress Reports. The Awardee shall submit a Quarterly Progress report within [***] after the end of each quarter of performance. The Quarterly Progress report shall contain the technical progress made during the previous quarter and the updated resource loaded Integrated Master Schedule (IMS) in Microsoft Project format. The schedule update shall include the explanation for any changes in the schedule, and drivers for the changes, as applicable. The report should also address any concerns that would impact the performance, schedule, or cost planned for the effort. The Awardee shall report risk matrix format to include risk mitigation strategies. Note: Any identified changes require formal notification to the OTAO in accordance with the Agreement provisions.
In addition, the Quarterly Progress Report shall contain regular status updates of all Intellectual Property (IP) license(s) related to the effort to ensure that all license(s) are in good standing as the project progresses. In the event of any change in IP license(s) status or potentially imminent change in status, the Awardee shall immediately contact the OTA and GPM in writing.
The Government will have [***] to respond to the report with any comments and the Awardee will have [***] to revise the deliverable or respond to those comments.
C. Quarterly Financial Status Report. The Awardee shall submit a Quarterly Financial Status Report no later than [***] after the end of each quarter of performance. The Government will have [***] to respond to the report with any comments and the Awardee will have [***] to revise the deliverable or respond to those comments. Reports will cover work performed every three (3) months for the duration of the Period of Performance (PoP). In addition, the Quarterly Financial Status Report shall include quarterly expenditure forecasts with both the quarterly planned accrual and the cumulative total. Expenditure forecast submissions shall include analysis of the cost drivers for Estimate to Complete changes, if any, from the previous projection. The Awardee shall provide all submissions in Excel format, including all formulas.
D. Expenditure Forecasts. The Awardee shall submit the first expenditure forecast within thirty (30) calendar days after receiving the project award. An updated forecast shall be submitted within [***] of any project modifications that modify the PoP or the cost of the prototype. Expenditure forecast submissions shall include analysis of the cost drivers for Estimate to Complete changes, if any, from the previous projection. The Awardee shall provide all submissions in Excel format, including all formulas.
E. Final report. A Final Report shall be prepared at the end of the effort by the Awardee. The Final Report shall narrate a complete summary of the project execution and associated results obtained. The narration will include outstanding problems and their potential solutions, problems solved during the course of the agreement, and the solutions to the solved problems. The Final Report shall demonstrate how the prototype was developed and advanced.
The Awardee shall submit a Draft Final Report by the [***] following the end of the project. The Government shall provide comments to the Awardee by the [***] following receipt of the Awardee’s Draft Final Report. The Awardee shall submit the Final Report on the [***] after receipt.
G. Patents – Reporting of Subject Inventions. For purposes of this paragraph, “Subject Invention” is defined as any invention, discovery, or improvement of the Awardee, whether or not patentable, that are conceived of or first actually reduced to practice in the performance of work under this Agreement. The Awardee shall report any OTA Inventions in accordance with the terms and conditions of this Other Transaction Agreement (OTA).
H. All documentation submitted to the government must have quality oversight from an independent quality group not reporting to the executing management group (for example; clinical trials group, data management group, etc)
I. If applicable, the Awardee must submit to the Government all Point Papers, Briefings, Technical Performance Plans (TPP), Program Development Plans (PDP), Regulatory Strategy, Technology Transfer Report and Gap Analysis, Formulation Development, Feasibility and Optimization Reports, United States Army Medical Research and Material Command Animal Care and Use Review Office (USAMRMC ACURO) Approvals, Human Resources Operations Branch (HROB) Approvals, Technical Presentations and Publications, and any formal technical reports that have been prepared for eventual submission to FDA or other regulatory agencies. Examples include the following reports related to: pharmaceutical development, manufacturing development, manufacturing validation, completed batch records, certificates of analysis, analytical development and validation, drug substance and product stability, nonclinical testing, and clinical testing. Examples include clinical performance and clinical quality documentation.
K. Integrated Master Schedule. The Awardee shall provide within [***] after project award an IMS in Microsoft Project format. Any updates to the IMS shall be included in the monthly progress reports. Submission shall be [***] after the end of each month of performance. The Government will have [***] to respond to the report with any comments and the performer will have [***] to revise the deliverable or respond to those comments.
L. Incident Report. The Awardee shall report any incident to the Government that could result in more than a one month delay in schedule from the most recent IMS critical path delivered to the Government. Telephonically contact the GPM within one day of incident. A written summary report shall be submitted within [***] of an incident, to include, what happened, what was the impact, if there are any available corrective actions and a time line for when the corrective actions would be in place.
ARTICLE 11. Intellectual Property Rights
D. Patent Prosecution. Awardee agrees to take responsibility for the preparation, filing, prosecution, and maintenance of any and all patents and patent applications listed as Awardee Background IP that are relevant to the work performed under this Agreement. Awardee shall keep the Government reasonably advised on the status of Awardee Background IP by providing an annual report on the status of Awardee Background IP. Prior to acting on a decision by Awardee to abandon or not file in any country a patent or patent application covering an OTA Invention, which is defined below, Awardee shall so inform the Government in a timely manner to allow Awardee to thoughtfully consider the Government’s comments regarding such a proposed decision. Nothing in this ARTICLE shall restrict the Government in its preparation, filing, prosecution and maintenance of a patent or patent application covering an OTA Invention.
G. Patent Applications. The Parties will respectively have the option to file a patent application claiming any OTA Invention made solely by their respective employees. The Parties will consult with each other regarding the options for filing a patent application claiming a joint OTA Invention. Within thirty (30) calendar days of being notified of the discovery of an OTA invention or filing a patent application covering an OTA Invention, each Party will provide notice of such discovery or filing to the other Party. The Parties will reasonably cooperate with each other in the preparation, filing, and prosecution of any patent application claiming an OTA Invention. Any Party filing a patent application will bear expenses associated with filing and prosecuting the application, as well as maintaining any patents that issue from the application, unless otherwise agreed by the Parties.