Provision Language
5. Statutory And NIH Requirements And Reserved Government Rights
5.1 Prior to the First Commercial Sale, the Licensee agrees to provide the IC with reasonable quantities of Licensed Products or materials made through the Licensed Processes for the IC’s 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 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.
8.2 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.
8.3 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.
9. Reports On Progress, Benchmarks, Sales, And Payments
9.1 Annual Reporting. 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.
(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 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:
(i) summary of work completed;
(ii) key scientific discoveries;
(iii) summary of work in–progress on research and development, status of applications for regulatory approvals, manufacture;
(iv) current schedule of anticipated events or Benchmarks;
(v) market plans for introduction of Licensed Product(s); and
(vi) status of marketing, importing, and total Net Sales during the preceding calendar year as well as, plans for the present calendar year.
(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 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 performance under this Agreement.
(c) Commercial Development Plan Amendments. In any annual report, the Licensee may propose amendments to the Commercial Development Plan and Benchmarks. The IC shall not unreasonably withhold approval of any request of the Licensee to amend the Commercial Development Plan or Benchmarks if Licensee’s 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. At IC’s discretion, amendments to change the Commercial Development Plan or Benchmarks (or both) may include amendment royalties. In determining whether or not to impose an amendment royalty, IC shall consider in good faith any information provided by Licensee demonstrating that a performance delay is due to inaction or delayed action by a regulatory agency and not by inaction or intentional or avoidable action by Licensee.
9.2 The Licensee shall report to the IC the date of achievement of each Benchmark specified in Appendix D and the First Commercial Sale in each country in the Licensed Territory within thirty (30) calendar days of such occurrence.
9.3 Semi-annual Sales Reports. Following the date of the First Commercial Sale, Licensee must submit to the IC , within sixty (60) calendar days after each calendar half-year ending June 30 and December 31, a written sales report, as described in the example in Appendix F, setting forth for the preceding half-year period the amount of the Licensed Products sold 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 sales report, the Licensee shall submit payment of earned royalties due for that reporting period. If no earned royalties are due to the IC for any reporting period, the written report shall so state. The sales report shall be certified as correct by an authorized officer of the Licensee and shall include the information identified in Appendix F and shall make clear the following information:
(a) gross receipts from Final Sales of Licensed Products for which an earned royalty is payable under Paragraph 6.3;
(b) any deductions from gross receipts used to arrive at Net Sales ; and
(c) Licensee’s computation of the aggregate earned royalties payable to IC . Licensee agrees to provide a copy of sales report information in electronic spreadsheet format (e.g., Microsoft Excel) when submitting sales reports by electronic mail.
10. Performance And Diligence Obligations
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10.3 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.
10.4 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.