Provision Language
8. RECORD KEEPING
8.1 [***] These records shall be retained for at least five (5) years following [***]. The accountant shall only disclose to the NIAID information relating to the accuracy of royalty payments made under this Agreement. If an inspection shows an underreporting or underpayment in excess [***] five percent (5%) for any twelve (12) month period [***], then the Licensee shall reimburse the NIAID for the cost of the inspection at the time the Licensee pays the unreported royalties, including any additional royalties as required by Paragraph 9.8. All royalty payments required under this Paragraph shall be due within sixty (60) days of the date the NIAID provides to the Licensee notice of the payment due.
9. REPORTS ON PROGRESS, BENCHMARKS, SALES, AND PAYMENTS
9.1 Prior to signing this Agreement , the Licensee has provided the NIAID with the Commercial Development Plan in Appendix E, under which the Licensee intends to bring the subject matter of the Licensed Patent Rights to the point of Practical Application . This Commercial Development Plan is hereby incorporated by reference into this Agreement. Based on this plan, performance Benchmarks are determined as specified in Appendix D. [***]
9.2 The Licensee shall provide written annual reports on its product development progress or efforts to commercialize under the Commercial Development Plan for each of the Licensed Fields of Use within sixty (60) days after December 31 of each calendar year. These progress reports shall include, but not be limited to: progress on research and development, status of applications for regulatory approvals, manufacture and status of sublicensing, marketing, importing, and [***] during the preceding calendar year, as well as, plans for the present calendar year. The NIAID also encourages these reports to include information on any of the Licensee’s public service activities that relate to the Licensed Patent Rights. If reported progress differs from that projected in the Commercial Development Plan and Benchmarks, the Licensee shall explain the reasons for these differences. In the annual report, [***] the Licensee may propose [***] amendments to the Commercial Development Plan, acceptance of which by the NIAID may not be denied unreasonably. The Licensee agrees to provide any additional information reasonably required by the NIAID to evaluate the Licensee’s performance under this Agreement. The Licensee may amend the Benchmarks at any time upon written approval by the NIAID. The NIAID shall not unreasonably withhold approval of any request of the Licensee to extend the time periods of this schedule if the request is supported by a reasonable showing by the Licensee of diligence in its performance under the Commercial Development Plan and toward bringing the Licensed Products to the point of Practical Application as defined in 37 C.F.R. §404.3(d). The Licensee shall amend the Commercial Development Plan and Benchmarks at the request of the NIAID to address any Licensed Fields of Use not specifically addressed in the plan originally submitted.
9.3 [***]
9.4 The Licensee shall report to the NIAID the dates for achieving the First Commercial Sale in each country in the Licensed Territory within [***] days of such occurrences.
9.5 [***], the Licensee shall submit to the NIAID, within [***] days after each calendar half-year ending June 30 and December 31, a royalty report, as described in the example in Appendix F, setting forth for the preceding half-year period [***] the amount of the Licensed Products sold or Licensed Processes practiced by or on behalf of the Licensee in each country within the Licensed Territory [***], the Net Sales and the amount of royalty accordingly due. With each royalty report, the Licensee shall submit payment of royalties due. The royalty report shall also identify the site of manufacture for the Licensed Products sold in the United States.
10. PERFORMANCE
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10.5 The Licensee agrees to supply, to the Mailing Address for Agreement Notices indicated on the Signature Page, the Office of Technology Transfer, NIH with inert samples of the Licensed Products or the Licensed Processes or their packaging for educational and display purposes only.