13. Term, Termination, And Modification Of Rights
13.1 This Agreement is effective when signed by all parties, unless the provisions of Paragraph 14.14 are not fulfilled, and shall extend on a country–by–country basis to the later of (a) twenty (20) years from the First Commercial Sale where no Licensed Patent Rights exist or have ceased to exist, or (b) to the expiration of the last to expire of the Licensed Patent Rights unless sooner terminated as provided in this Article 13.
13.2 In the event that the Licensee (or its Affiliate(s)) is in default in the performance of any material obligations under this Agreement , including but not limited to the obligations listed in Paragraph 13.5, and if the default has not been remedied within ninety (90) calendar days after the date of notice in writing of the default, the IC may terminate this Agreement by written notice and pursue outstanding royalties owed through procedures provided by the Federal Debt Collection Act.
13.3 In the event that the Licensee becomes insolvent, files a petition in bankruptcy, has such a petition filed against it, determines to file a petition in bankruptcy, or receives notice of a Third Party’s intention to file an involuntary petition in bankruptcy, the Licensee shall immediately notify the IC in writing.
13.4 The Licensee shall have a unilateral right to terminate this Agreement completely or in any country of the Licensed Territory by giving the IC sixty (60) days written notice to that effect.
13.5 The IC shall specifically have the unilateral right to terminate or modify, at its option, this Agreement, if the IC determines that the Licensee (or its Affiliate(s)):
(a) is not executing the Commercial Development Plan submitted with its request for a license and the Licensee cannot otherwise demonstrate to the IC’s satisfaction that the Licensee has taken, or can be expected to take within a reasonable time, effective steps to achieve Practical Application of the Licensed Products or Licensed Processes;
(b) has not achieved the Benchmarks as may be modified under Paragraph 9.1;
(c) has willfully made a false statement of, or willfully omitted, a material fact in the license application, negotiation of this Agreement, or in any report required by this Agreement;
(d) has committed a material breach of a covenant or agreement contained in this Agreement;
(e) is not keeping Licensed Products or Licensed Processes reasonably available to the public after commercial use commences;
(f) cannot reasonably satisfy unmet health and safety needs;
(g) cannot reasonably justify a failure to comply with the domestic production requirement of Paragraph 5.2, unless waived;
(h) has not provided timely annual progress or semi-annual royalty reports to IC under Article 9; or
(i) has not made timely royalty payments to IC under Article 6.
13.6 In making the determination referenced in Paragraph 13.5, the IC shall take into account the normal course of such commercial development programs conducted with sound and reasonable business practices and judgment and the annual reports submitted by the Licensee under Paragraph 9.3. Prior to invoking termination or modification of this Agreement under Paragraph 13.5, the IC shall give written notice to the Licensee providing the Licensee specific notice of, and a ninety (90) day opportunity to respond to, the IC’s concerns as to the items referenced in 13.5(a)-13.5(g). If the Licensee fails to alleviate the IC ’s concerns as to the items referenced in 13.5(a)-13.5(g) or fails to initiate corrective action to the IC ’s satisfaction, the IC may terminate this Agreement
13.7 The IC reserves the right according to 35 U.S.C. §209(d)(3) to terminate or modify this Agreement if it is determined that the action is necessary to meet the requirements for public use specified by federal regulations issued after the date of the license and these requirements are not reasonably satisfied by the Licensee.
13.8 Within thirty (30) calendar days of receipt of written notice of the IC’s unilateral decision to modify or terminate this Agreement, the Licensee may, consistent with the provisions of 37 CFR §404.11, appeal the decision by written submission to the designated the IC official. The decision of the designated IC official shall be the final agency decision. The Licensee may thereafter exercise any and all administrative or judicial remedies that may be available.
13.9 Within ninety (90) calendar 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 the IC shall become immediately due and payable upon termination or expiration.
13.10 Unless otherwise specifically provided for under this Agreement, within thirty (30) calendar days of termination, cancellation or expiration of this Agreement, the Licensee shall return all Materials, Licensed Products or other materials included within the Licensed Patent Rights to the IC or provide the IC with written certification of the destruction thereof. The Licensee may not be granted additional HHS licenses if the final reporting requirement is not fulfilled.
14. GENERAL PROVISIONS
14.14 The terms and conditions of this Agreement shall, at the IC’s sole option, be considered by the IC to be withdrawn from the Licensee’s consideration and the terms and conditions of this Agreement, and the Agreement itself to be null and void, unless this Agreement is executed by the Licensee and a fully executed original is received by the IC within sixty (60) days from the date of the IC signature found at the Signature Page.