Master Alliance Provisions Guide (MAPGuide)

MSD – MPP, Molnupiravir License Agreement

  • Term & termination | Termination & withdrawal

MSD-MPP Agreement

6. Term And Termination

6.2 This Agreement may be terminated by MSD upon written notice to MPP with immediate effect in the event of any of the following:

(a) If, prior to obtaining US FDA approval, MSD stops development of the Substance or Product related to COVID-19 treatments;
(b) MSD no longer retains the rights necessary to sell the Product in the Territory or to license such rights to third parties;
(c) With respect to the Product, MSD determines at its sole discretion that the continued sale of such Product would not be medically appropriate or would otherwise harm MSD’s business reputation;
(d) If MSD does not file the Product with any health authority by 31 December 2021, or such other later dates as MSD may determine in its sole discretion;
(e) If MPP had not entered into any Sublicense with any Sublicensee within six (6) months from the execution of this Agreement;
(f) If MSD does not get any regulatory authorization or approval for the Product within 12 months of filing;
(g) if MPP, its subsidiaries, Affiliates or Sublicensee acting at the instance or with the support of MPP or its Affiliates, challenges the validity, enforceability or scope of any claim within the Patent in a court or other governmental agency of competent jurisdiction, including in a re- examination or opposition proceeding, or as a defense to enforcement of this Agreement or the terms of this Agreement, including applicable payment obligations. The Parties understand that this right of termination is required pursuant to MSD’s upstream contractual obligations. To the extent that this Section 6.2(g) is deemed invalid or unenforceable in any jurisdiction, this Section 6.2(g) is intended to be severable without affecting the validity of the rest of this Agreement.
(h) If no patent has granted on any patent application filed in the Territory and all patent applications filed in the Territory have lapsed; or
(i) If MPP is in breach of Section 4.4.

6.3 Termination for Breach. A Party (“non-breaching party”) shall have the right to terminate this Agreement in the event the other Party (“breaching party”) is in material breach of any of its material obligations under this Agreement. The non-breaching party shall provide written notice to the breaching party. The breaching party shall have a period of 30 days after such written notice to cure such breach, or to provide a timeline to cure such breach to the satisfaction of the non-breaching party. If such breach is not cured within the 30 day period or in accordance with the timeline, this Agreement shall automatically terminate 30 days after the date of a written notice of termination by the non- breaching party. Any termination pursuant to this Section 6.3 will not (1) relieve either Party of any obligation or liability accrued; (2) impair any accrued rights of either Party (3) or rescind anything done by either Party hereunder prior to the time of such termination becoming effective.
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6.5 Insolvency. Either Party may terminate this Agreement in the event that the other Party becomes insolvent, makes an assignment to the benefit of creditors, or has a petition in bankruptcy filed for or against it.

Form of Sublicense Agreement

10. Term And Termination

10.2 Termination for Breach. A Party (“non-breaching party”) shall have the right to terminate this Agreement in the event the other Party (“breaching party”) is in material breach of any of its material obligations under this Agreement. The non-breaching party shall provide written notice to the breaching party. The breaching party shall have a period of 30-days after such written notice is provided to cure such breach, or to provide a timeline to cure such breach to the satisfaction of the non-breaching party. If such breach is not cured within the 30-day period or in accordance with the timeline, the non-breaching party shall have the right to terminate this Agreement immediately in the sole discretion. Any termination pursuant to this Section 10.2 will not (1) relieve either Party of any obligation or liability accrued; (2) impair any accrued rights of either Party (3) or rescind anything done by either Party hereunder prior to the time of such termination becoming effective. In the case where the breaching party is Licensee, such termination shall not relieve Licensee of its obligation to pay any royalty or other fees owing at the time of such termination.

10.3 MPP Right to Terminate. MPP shall have the right to terminate this Agreement, either in whole or in relation to a particular Patent, with immediate effect by notice in writing to Licensee if:

(a) Licensee breaches any of the anti-diversion provisions of Section 4;
(b) MPP becomes aware of any action (including any official notifications or communications) taken by any regulatory authority involving a determination of Licensee’s failure to comply with good manufacturing practices as prescribed in the applicable legal or regulatory standards in connection with for the manufacture and handling of the Products, or otherwise reasonably determines that, due to material deficiencies in Licensee’s compliance, or repeated failure to comply, with the quality requirements of Section 3.2, Licensee is unable to reliably and consistently manufacture Substance or Product in accordance with such quality requirements;
(c) Licensee fails to comply with the obligations contained in Section 3.3 of this Agreement;
(d) Licensee repeatedly fails to comply with or to timely provide MPP with the reports contemplated under Sections 3.4 and 9.2 of this Agreement; or
(e) Licensee fails to file for WHO Pre-Qualification of the Product within six months of a WHO Expression of Interest for the Product or such other time as may be mutually agreed between the Parties.
(f) The legal or beneficial ownership of Licensee or any of its Affiliates changes in such a manner as MPP after consulting with Licensee reasonably determines to be significant and adversely impacts the ability of the Parties to achieve the objectives of this Agreement.
(g) if Licensee, its subsidiaries or Affiliates challenges the validity, enforceability or scope of any claim within the Patent in a court or other governmental agency of competent jurisdiction, including in a re-examination or opposition proceeding, or as a defense to enforcement of this Agreement or the terms of this Agreement, including applicable payment obligations. The Parties understand that this right of termination is required pursuant to MSD’s upstream contractual obligations. To the extent that this Section 10.3(g) is deemed invalid or unenforceable in any jurisdiction, this Section 10.3(g) is intended to be severable without affecting the validity of the rest of this Agreement.

10.4 Failure to Promote Access. If, in the reasonable opinion of the MPP, the Licensee fails to promote access or appears in MPP’s reasonable opinion, will fail to promote access to the Products in the Territory in accordance with this Agreement, the MPP shall give notice to the Licensee requiring it to cure such failure. If, in the reasonable opinion of the MPP, the Licensee fails to present an acceptable plan within 60 days and report reasonable progress within 180 days after receiving written notice with respect to the default, the MPP shall have the right to terminate this Agreement with immediate effect by giving written notice to the Licensee. In making such determination of reasonable progress, the MPP shall take into account the period within which the relevant authorities provide the necessary approvals and normal development lead time for the Products, and progress reported by Licensee in its quarterly reports and meetings provided under Section 3.4 of this Agreement.

10.7 Termination by Licensee. Licensee may terminate this Agreement at any time by providing 30 days written notice to MPP. Any termination pursuant to this Section 10.7 by the Licensee will not relieve Licensee of any obligation or liability accrued hereunder prior to such termination or rescind anything done by Licensee or any payments made to MSD hereunder prior to the time such termination becomes effective, and such termination will not affect in any manner any rights of MPP arising under this Agreement prior to such termination.

10.8 Insolvency. Either Party may terminate this Agreement in the event that the other Party becomes insolvent, makes an assignment to the benefit of creditors, or has a petition in bankruptcy filed for or against it.