Provision Language
<p><span style=”text–decoration: underline;”><strong>8. Record Keepingstrong>span>p>
<p><span style=”font–weight: 400;”><strong>8.1strong> The Licensee agrees to keep accurate and correct records of Licensed Products made, used, sold, or imported and Licensed Processes practiced under this Agreement appropriate to determine the amount of royalties due to the IC. These records shall be retained for the term of this Agreement and for at least five (5) years from the last day of the final reporting period and shall be available during normal business hours for inspection, at the expense of the IC, by an accountant or other designated auditor selected by the IC for the sole purpose of verifying reports and royalty payments hereunder. span>p>
<p><span style=”font–weight: 400;”><strong>8.2strong> If an inspection shows an underreporting or underpayment of royalties due to the IC in excess of five percent (5%) for any twelve (12) month period, then the Licensee shall reimburse the IC for the cost of the inspection at the time the Licensee pays the unreported royalties, including any additional royalties as required by Paragraph 9.6. All royalty payments required under this Paragraph shall be due within sixty (60) calendar days of the date the IC provides notice to the Licensee of the payment due.span>p>
<p><span style=”font–weight: 400;”><strong>8.3strong> Licensee agrees to conduct, or to arrange and pay for the cost of, an independent self–audit of sales and royalties at least every two (2) years if annual sales of Licensed Product are over Five Million Dollars ($5,000,000). The audit will address, at a minimum, the amount of gross sales by or on behalf of Licensee or any Affiliate during the audit period, the amount of funds owed to IC under this Agreement, and whether the amount owed has been paid to IC and is reflected in the records of Licensee. Licensee will submit the auditor’s report promptly to IC upon completion. Licensee will pay for the entire cost of the audit.span>p>
<p><span style=”text–decoration: underline;”><strong>9. Reports On Progress, Benchmarks, Sales, And Paymentsstrong>span>p>
<p><span style=”font–weight: 400;”><strong>9.1 Annual Reporting.strong> Prior to signing this Agreement, the Licensee has provided the IC with the Commercial Development Plan in Appendix E, under which the Licensee intends to bring the subject matter of the Licensed Patent Rights and Materials 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. span>p>
<p style=”padding–left: 25px;”><span style=”font–weight: 400;”>(a) The Licensee shall provide to IC written annual progress reports on its product development progress or efforts to commercialize under the Commercial Development Plan for each of the span><span style=”font–weight: 400;”>Licensed Fields of Use within sixty (60) calendar days after December 31 of each calendar year. These progress reports shall be signed by an officer of Licensee and shall include, but not be limited to, at least the following topics: span>p>
<p style=”padding–left: 35px;”><span style=”font–weight: 400;”>(i) summary of work completed; span>p>
<p style=”padding–left: 35px;”><span style=”font–weight: 400;”>(ii) key scientific discoveries; span>p>
<p style=”padding–left: 35px;”><span style=”font–weight: 400;”>(iii) summary of work in–progress on research and development, status of applications for regulatory approvals, manufacture; span>p>
<p style=”padding–left: 35px;”><span style=”font–weight: 400;”>(iv) current schedule of anticipated events or Benchmarks; span>p>
<p style=”padding–left: 35px;”><span style=”font–weight: 400;”>(v) market plans for introduction of Licensed Product(s); and span>p>
<p style=”padding–left: 35px;”><span style=”font–weight: 400;”>(vi) status of marketing, importing, and total Net Sales during the preceding span>p>
<p style=”padding–left: 35px;”><span style=”font–weight: 400;”>calendar year as well as, plans for the present calendar year. span>p>
<p style=”padding–left: 25px;”><span style=”font–weight: 400;”>(b) The IC also encourages Licensee to include in progress reports information on any of the Licensee’s public service activities that relate to the Licensed Patent Rights and Licensed Products. If span><span style=”font–weight: 400;”>reported progress differs from that projected in the Commercial Development Plan and Benchmarks, the Licensee shall explain the reasons for such differences. Licensee agrees to provide any additional information reasonably required by the IC to evaluate Licensee’s span><span style=”font–weight: 400;”>performance under this Agreement.span>p>
<p><span style=”text–decoration: underline;”><strong>10. Performance And Diligence Obligationsstrong>span>p>
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<p><span style=”font–weight: 400;”><strong>10.3strong> The Licensee agrees, after its 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. span>p>
<p><span style=”font–weight: 400;”><strong>10.4strong> The Licensee agrees to supply, to the Office of Technology Transfer, NIH and Technology Transfer and Intellectual Property Office (TTIPO), NIAID with insert samples of the Licensed Products or Licensed Processes or their packaging for educational and display purposes only.span>p>
