Master Alliance Provisions Guide (MAPGuide)

Shionogi – GARDP, Cefiderocol License Agreement

  • Term & termination | Term of agreement
  • Term & termination | Termination & withdrawal

This License and Technology Transfer Agreement is made and entered into as of the 15th day of June, 2022 (Effective Date)…[.]

12. TERM AND TERMINATION

12.1 Term 

This License Agreement will commence as of the Effective Date and, unless sooner terminated in accordance with the terms of this License Agreement or by mutual written consent, will expire upon the expiration of the last-to-expire of the patents set forth on Schedule B in the last country in the Territory in which there is such a patent; provided that, with respect to any and all countries in the Territory in which any Sublicensee is pursuing the Commercialization of Licensed Product at such expiry date, the License Agreement will survive for so long as the Commercialization of Licensed Product is being pursued in such country(ies) (the period from the Effective Date until such last patent expiry date or as applicable the date on which the Commercialization of Licensed Product is no longer being pursued, being the Term, subject to early termination as contemplated below).

12.2 Termination by either Party 

Either Party will have the right to terminate this License Agreement, at its sole discretion, upon delivery of written notice to the other Party, upon the occurrence of any of the following:

(a) the other Party becomes bankrupt or insolvent, or cannot pay its debts when due; or 

(b) a material breach of this License Agreement by the other Party that is not cured within ninety (90) days after written notice of such breach is given.

12.3 Additional termination rights 

(a) Shionogi has the right to terminate this License Agreement upon delivery of written notice to GARDP upon the occurrence of any of the following: 

(i) the failure of GARDP to use reasonable best efforts to conduct the activities and achieve the objectives for which it is responsible in the Market Access Plan with the objective of promoting affordable access to the Licensed Product through its Sublicensees in the countries in the Territory selected pursuant to the Market Access Plan; 

(ii) the failure of GARDP to comply with Shionogi’s reasonable requests in connection with a breach under Sections 2.3(n) through (q); 

(iii) any failure by GARDP of ensuring compliance with relevant OFAC regulations under Section 2.9 of this License Agreement; or 

(iv) if, in the reasonable opinion of Shionogi, control (through ownership or otherwise) of GARDP changes.

(b) GARDP will have the right to, and will at Shionogi’s request, terminate any Sublicense Agreement, by delivery of written notice to the relevant Sublicensee(s) upon the occurrence of any of the following: 

(i) the occurrence of any material safety issue that Shionogi reasonably believes makes it inadvisable to proceed or continue with the Commercialization of the Licensed Product in the Territory; 

(ii) without prejudice to Section 2.7(c), a cross-border diversion of the Licensed Compound and/or Licensed Product whereby any Sublicensee (directly or indirectly or through a Third Party, located in or out of the Territory) uses, offers for sale, sells, or has sold Licensed Compound and/or Licensed Product for use in any country outside of the Territory; 

(iii) any failure by the Sublicensee to comply with the quality requirements under Section 6.2 of this License Agreement for any Licensed Product that is Commercialized or intended for Commercialization; 

(iv) the failure by the respective Sublicensee to file for registration of the Licensed Product in at least one country in the Territory within four (4) years of the start of technical transfer pursuant to Section 4.2 to the Sublicensee or if there is no technical transfer to the Sublicensee, within four (4) years of the Effective Date of the applicable Sublicense Agreement;

(v) the occurrence of a direct or indirect change of control of Sublicensee (with control having the meaning set out in the definition of Affiliate in Section 1.1), unless Shionogi and GARDP have previously confirmed in writing that they would not terminate the Sublicense Agreement based on such change of control; and/or

(vi) in the event of any serious or intentional violation of any laws and regulations or intentional misappropriation of a Third Party’s intellectual property rights by a Sublicensee anywhere in the world which, in Shionogi’s and GARDP’s judgment, may reflect unfavorably on Shionogi, GARDP, their reputation or the Licensed Product.

(c) GARDP will have the right to terminate this License Agreement upon sixty (60) days advance written notice to Shionogi if it is unable despite its reasonable best efforts to raise required funding for the performance of GARDP’s obligations under this License Agreement and the Collaboration Agreement, and such termination in and of itself shall not constitute a breach of GARDP’s obligations under the Agreement or give rise to the payment of damages; provided, however, that the foregoing shall not relieve GARDP of liability in respect of any other breach or noncompliance with this Agreement or affect any other right or remedy available to Shionogi with respect thereto.