5. Statutory and NIH Requirements and Reserved Government Rights
5.1 Upon request and prior to the First Commercial Sale, the Licensee agrees to require the Sublicensee to provide IC with reasonable quantities of Licensed Products or materials made through the Licensed Processes for IC research use.
8. Record Keeping
8.1 The Licensee agrees to keep accurate and correct records of Licensed Products made, used, sold, or imported and Licensed Processes practiced under this Agreement by each Sublicensee appropriate to determine the amount of royalties due IC. These records shall be retained for at least five (5) years following a given reporting period and shall be available during normal business hours for inspection, at the expense of IC, by an accountant or other designated auditor selected by IC for the sole purpose of verifying reports and royalty payments hereunder. The accountant or auditor shall only disclose to IC information relating to the accuracy of reports and royalty payments made under this Agreement. If an inspection shows an underreporting or underpayment in excess of five percent (5%) for any twelve (12) month period, then the Licensee shall reimburse IC for the cost of the inspection at the time the Licensee pays the unreported royalties, including any additional royalties as required by Paragraph 9.7. All royalty payments required under this Paragraph shall be due within sixty (60) days of the date IC provides 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 IC with the WHO C–TAP Development Plan in Appendix E, under which the Licensee and its Sublicensees intend to bring the subject matter of the Licensed Patent Rights to the point of Practical Application. This WHO C–TAP 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 Sublicensee product development progress or efforts to commercialize under the WHO C–TAP 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, marketing, importing, and sales during the preceding calendar year, as well as plans for the present calendar year. IC also encourages these reports to include information on any of the Licensee’s public service activities that relate to the Licensed Patent Rights and Licensed Materials. If reported progress differs from that projected in the WHO C–TAP Development Plan and Benchmarks, the Licensee shall explain the reasons for such differences. In any annual report, the Licensee may propose amendments to the WHO C–TAP Development Plan, acceptance of which by IC may not be denied unreasonably. The Licensee agrees to provide any additional information reasonably required by IC to evaluate the Licensee’s performance under this Agreement. The Licensee may amend the Benchmarks at any time upon written approval by IC. IC 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 WHO C–TAP Development Plan and toward bringing the Licensed Products to the point of Practical Application.
9.3 The Licensee shall report to IC the dates for achieving Benchmarks specified in Appendix D and the First Commercial Sale in each country in the Licensed Territory within thirty (30) days of such occurrences.
9.4 The Licensee shall submit to IC, within sixty (60) 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 Licensee’s Sublicensee(s) 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 earned royalties due. If no earned royalties are due to IC for any reporting period, the written report shall so state. The royalty report shall be certified as correct by an authorized officer of the Licensee and shall include a detailed listing of all deductions made under Paragraph 2.18 to determine Net Sales made under Article 6 to determine royalties due.
10.4 The Licensee agrees to require each of its Sublicensee(s), after that Sublicensee’s First Commercial Sale and as part of its marketing and product promotion, to develop educational materials (e.g., brochures, website, etc.) directed to patients and physicians detailing the Licensed Products or medical aspects of the prophylactic and therapeutic uses of the Licensed Products.
10.5 The Licensee agrees to supply IC, at the mailing address listed for notices, with inert samples of the Licensed Products or Licensed Processes or their packaging for educational and display.
13. Term, Termination, And Modification Of Rights
13.9 Within ninety (90) days of expiration or termination of this Agreement under this Article 13, a final report shall be submitted by the Licensee. Any royalty payments, including those incurred but not yet paid (such as the full minimum annual royalty), and those related to patent expense, due to IC shall become immediately due and payable upon termination or expiration. Unless otherwise specifically provided for under this Agreement, upon termination of this Agreement, the Licensee shall return all Licensed Products or other materials included within the Licensed Patent Rights to IC or provide IC with written certification of the destruction thereof. The Licensee may not be granted additional IC licenses if the final reporting requirement is not fulfilled.