Common use of MPP Right to Terminate Clause in Contracts

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 5 of this Agreement; (b) MPP becomes aware of any action (including any official notifications or communications) taken by any Agency involving a determination of Licensee’s failure to comply with cGMP in connection with for the manufacture and handling of the Licensed 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 9.1, Licensee is unable to reliably and consistently manufacture Compound or Licensed Product in accordance with such quality requirements; (c) Licensee fails to comply with the obligations contained in Section 3.7 of this Agreement; (d) Licensee fails to comply with the obligations contained in Section 3.12 of this Agreement; (e) Licensee repeatedly fails to comply with, or to timely provide MPP with the reports contemplated under this Agreement, including, but not limited to, the reports required under Sections 3.4, 3.8, 3.9, 4.5 and 11.2 of this Agreement; (f) Licensee fails to file for WHO Prequalification of the Licensed Product within six (6) months of a WHO Expression of Interest for the Licensed Product or such other time as may be mutually agreed between the Parties; (g) any material safety issue that Pfizer or MPP reasonably believes makes it inadvisable to proceed or continue with the Commercialization of Licensed Product in the Territory; (h) the legal or beneficial ownership of Licensee or any of its Affiliates changes, directly or indirectly, without the prior written consent of Pfizer and MPP in accordance with Section 14.8; (i) any serious or intentional violation of any Applicable Law or misappropriation of a Third Party’s intellectual property rights by Licensee anywhere in the world, which in Pfizer’s and MPP’s judgement, may reflect unfavorably on Pfizer, MPP, their reputation or Licensed Product; or (j) Licensee is in breach of Section 8.3, Section 8.4 or Section 8.5 of this Agreement.

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 5 of this Agreement4; (b) MPP becomes aware of any action (including any official notifications or communications) taken by any Agency regulatory authority involving a determination of Licensee’s 's failure to comply with cGMP good manufacturing practices as prescribed in the applicable legal or regulatory standards in connection with for the manufacture and handling of the Licensed 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 9.13.2, Licensee is unable to reliably and consistently manufacture Compound Substance or Licensed Product in accordance with such quality requirements; (c) Licensee fails to comply with the obligations contained in Section 3.7 3.3 of this Agreement; (d) Licensee repeatedly fails to comply with the obligations contained in Section 3.12 of this Agreement; (e) Licensee repeatedly fails to comply with, or to timely provide MPP with the reports contemplated under this Agreement, including, but not limited to, the reports required under Sections 3.4, 3.8, 3.9, 4.5 3.4 and 11.2 9.2 of this Agreement;; or (fe) Licensee fails to file for WHO Prequalification Pre-Qualification of the Licensed Product within six (6) months of a WHO Expression of Interest for the Licensed Product or such other time as may be mutually agreed between the Parties;. (gf) any material safety issue that Pfizer or MPP reasonably believes makes it inadvisable to proceed or continue with the Commercialization of Licensed Product in the Territory; (h) the The legal or beneficial ownership of Licensee or any of its Affiliates changes, directly or indirectly, without changes in such a manner as MPP after consulting with Licensee reasonably determines to be significant and adversely impacts the prior written consent ability of Pfizer and MPP in accordance with Section 14.8; (i) any serious or intentional violation of any Applicable Law or misappropriation of a Third Party’s intellectual property rights by Licensee anywhere in the world, which in Pfizer’s and MPP’s judgement, may reflect unfavorably on Pfizer, MPP, their reputation or Licensed Product; or (j) Licensee is in breach of Section 8.3, Section 8.4 or Section 8.5 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.

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 the Licensee if: (a) Licensee breaches any of the anti-diversion provisions of Section 5 of this Agreement; (b) MPP becomes aware of any action (including any official notifications or communications) taken by any Agency involving a determination of Licensee’s 's failure to comply with cGMP in connection with for the manufacture and handling of the Licensed Products, or otherwise reasonably determines that, due to material deficiencies in Licensee’s 's compliance, or repeated failure to comply, with the quality requirements of Section 9.1, Licensee is unable to reliably and consistently manufacture Compound or Licensed Product in accordance with such quality requirements; (c) Licensee fails to comply with the obligations contained in Section 3.7 of this Agreement; (d) Licensee fails to comply with the obligations contained in Section 3.12 of this Agreement; (e) a Temporary Waiver is approved by MPP and Shionogi and WHO or an SRA denies WHO Prequalification or SRA approval or any provisional or emergency use authorizations available through WHO or an SRA; (f) Licensee repeatedly fails to comply with, or to timely provide MPP with the reports contemplated under this Agreement, including, but not limited to, the reports required under Sections 3.4, 3.8, 3.9, 3.10. 4.5 and 11.2 of this Agreement; (fg) Licensee fails to file for WHO Prequalification of the Licensed Product within six (6) months of a WHO Expression of Interest for the Licensed Product or such other time as may be mutually agreed between the Parties; (gh) any material safety issue that Pfizer Shionogi or MPP reasonably believes makes it inadvisable to proceed or continue with the Commercialization of Licensed Product in the Territory; (hi) the legal or beneficial ownership of Licensee or any of its Affiliates changes, directly or indirectly, without the prior written consent of Pfizer Shionogi and MPP in accordance with Section 14.814.9; (ij) any serious or intentional violation of any Applicable Law or misappropriation of a Third Party’s 's intellectual property rights by Licensee anywhere in the world, which in Pfizer’s Shionogi's and MPP’s 's judgement, may reflect unfavorably on PfizerShionogi, MPP, their reputation or Licensed Product; or (jk) Licensee is in breach of Section 8.3, Section 8.4 or Section 8.5 of this Agreement.

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 5 of this Agreement4; (b) MPP becomes aware of any action (including any official notifications or communications) taken by any Agency regulatory authority involving a determination of Licensee’s 's failure to comply with cGMP good manufacturing practices as prescribed in the applicable legal or regulatory standards in connection with for the manufacture and handling of the Licensed 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 9.13.2, Licensee is unable to reliably and consistently manufacture Compound Substance or Licensed Product in accordance with such quality requirements; (c) Licensee fails to comply with the obligations contained in Section 3.7 3.3 of this Agreement; (d) Licensee repeatedly fails to comply with the obligations contained in Section 3.12 of this Agreement; (e) Licensee repeatedly fails to comply with, or to timely provide MPP with the reports contemplated under this Agreement, including, but not limited to, the reports required under Sections 3.4, 3.8, 3.9, 4.5 3.4 and 11.2 9.2 of this Agreement;; or (fe) Licensee fails to file for WHO Prequalification Pre-Qualification of the Licensed Product within six (6) months of a WHO Expression of Interest for the Licensed Product or such other time as may be mutually agreed between the Parties;. (gf) any material safety issue that Pfizer or MPP reasonably believes makes it inadvisable to proceed or continue with the Commercialization of Licensed Product in the Territory; (h) the The legal or beneficial ownership of Licensee or any of its Affiliates changes, directly or indirectly, without changes in such a manner as MPP after consulting with Licensee reasonably determines to be significant and adversely impacts the prior written consent ability of Pfizer and MPP in accordance with Section 14.8; (i) any serious or intentional violation of any Applicable Law or misappropriation of a Third Party’s intellectual property rights by Licensee anywhere in the world, which in Pfizer’s and MPP’s judgement, may reflect unfavorably on Pfizer, MPP, their reputation or Licensed Product; or (j) Licensee is in breach of Section 8.3, Section 8.4 or Section 8.5 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 DocuSign Envelope ID: C36B61B8-31EC-4A9C-AE01-0FC0E44D78D5 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.

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 5 of this Agreement; (b) MPP becomes aware of any action (including any official notifications or communications) taken by any Agency involving a determination of Licensee’s failure to comply with cGMP in connection with for the manufacture and handling of the Licensed 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 9.1, Licensee is unable to reliably and consistently manufacture Compound or Licensed Product in accordance with such quality requirements; (c) Licensee fails to comply with the obligations contained in Section 3.7 of this Agreement; (d) Licensee fails to comply with the obligations contained in Section 3.12 of this Agreement; (e) Licensee repeatedly fails to comply with, or to timely provide MPP with the reports contemplated under this Agreement, including, but not limited to, the reports required under Sections 3.4, 3.8, 3.9, 4.5 and 11.2 of this Agreement; (f) Licensee fails to file for WHO Prequalification of the Licensed Product within six (6) months of a WHO Expression of Interest for the Licensed Product or such other time as may be mutually agreed between the Parties; (g) any material safety issue that Pfizer or MPP reasonably believes makes it inadvisable to proceed or continue with the Commercialization of Licensed Product in the Territory;; DocuSign Envelope ID: 174398E9-7BC6-4D69-97DC-01A43A37BFC6 (h) the legal or beneficial ownership of Licensee or any of its Affiliates changes, directly or indirectly, without the prior written consent of Pfizer and MPP in accordance with Section 14.8; (i) any serious or intentional violation of any Applicable Law or misappropriation of a Third Party’s intellectual property rights by Licensee anywhere in the world, which in Pfizer’s and MPP’s judgement, may reflect unfavorably on Pfizer, MPP, their reputation or Licensed Product; or (j) Licensee is in breach of Section 8.3, Section 8.4 or Section 8.5 of this Agreement.

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 5 of this Agreement; (b) MPP becomes aware of any action (including any official notifications or communications) taken by any Agency involving a determination of Licensee’s failure to comply with cGMP in connection with for the manufacture and handling of the Licensed 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 9.1, Licensee is unable to reliably and consistently manufacture Compound or Licensed Product in accordance with such quality requirements; (c) Licensee fails to comply with the obligations contained in Section 3.7 of this Agreement; (d) Licensee fails to comply with the obligations contained in Section 3.12 of this Agreement; (e) Licensee repeatedly fails to comply with, or to timely provide MPP with the reports contemplated under this Agreement, including, but not limited to, the reports required under Sections 3.4, 3.8, 3.9, 4.5 and 11.2 of this Agreement; (f) Licensee fails to file for WHO Prequalification of the Licensed Product within six (6) months of a WHO Expression of Interest for the Licensed Product or such other time as may be mutually agreed between the Parties; (g) any material safety issue that Pfizer or MPP reasonably believes makes it inadvisable to proceed or continue with the Commercialization of Licensed Product in the Territory;; DocuSign Envelope ID: 20ED8EAA-71E5-4C18-B49D-62DBEC763D25 (h) the legal or beneficial ownership of Licensee or any of its Affiliates changes, directly or indirectly, without the prior written consent of Pfizer and MPP in accordance with Section 14.8; (i) any serious or intentional violation of any Applicable Law or misappropriation of a Third Party’s intellectual property rights by Licensee anywhere in the world, which in Pfizer’s and MPP’s judgement, may reflect unfavorably on Pfizer, MPP, their reputation or Licensed Product; or (j) Licensee is in breach of Section 8.3, Section 8.4 or Section 8.5 of this Agreement.

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 5 of this Agreement; (b) MPP becomes aware of any action (including any official notifications or communications) taken by any Agency involving a determination of Licensee’s failure to comply with cGMP in connection with for the manufacture and handling of the Licensed 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 9.1, Licensee is unable to reliably and consistently manufacture Compound or Licensed Product in accordance with such quality requirements; (c) Licensee fails to comply with the obligations contained in Section 3.7 of this Agreement; (d) Licensee fails to comply with the obligations contained in Section 3.12 of this Agreement; (e) Licensee repeatedly fails to comply with, or to timely provide MPP with the reports contemplated under this Agreement, including, but not limited to, the reports required under Sections 3.4, 3.8, 3.9, 4.5 and 11.2 of this Agreement; (f) Licensee fails to file for WHO Prequalification of the Licensed Product within six (6) months of a WHO Expression of Interest for the Licensed Product or such other time as may be mutually agreed between the Parties; (g) any material safety issue that Pfizer or MPP reasonably believes makes it inadvisable to proceed or continue with the Commercialization of Licensed Product in the Territory;; DocuSign Envelope ID: D912197B-D81E-47C3-A57B-57CF17C9819B (h) the legal or beneficial ownership of Licensee or any of its Affiliates changes, directly or indirectly, without the prior written consent of Pfizer and MPP in accordance with Section 14.8; (i) any serious or intentional violation of any Applicable Law or misappropriation of a Third Party’s intellectual property rights by Licensee anywhere in the world, which in Pfizer’s and MPP’s judgement, may reflect unfavorably on Pfizer, MPP, their reputation or Licensed Product; or (j) Licensee is in breach of Section 8.3, Section 8.4 or Section 8.5 of this Agreement.

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 5 of this Agreement; (b) MPP becomes aware of any action (including any official notifications or communications) taken by any Agency involving a determination of Licensee’s failure to comply with cGMP in connection with for the manufacture and handling of the Licensed 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 9.1, Licensee is unable to reliably and consistently manufacture Compound or Licensed Product in accordance with such quality requirements; (c) Licensee fails to comply with the obligations contained in Section 3.7 of this Agreement; (d) Licensee fails to comply with the obligations contained in Section 3.12 of this Agreement; (e) Licensee repeatedly fails to comply with, or to timely provide MPP with the reports contemplated under this Agreement, including, but not limited to, the reports required under Sections 3.4, 3.8, 3.9, 4.5 and 11.2 of this Agreement; (f) Licensee fails to file for WHO Prequalification of the Licensed Product within six (6) months of a WHO Expression of Interest for the Licensed Product or such other time as may be mutually agreed between the Parties; (g) any material safety issue that Pfizer or MPP reasonably believes makes it inadvisable to proceed or continue with the Commercialization of Licensed Product in the Territory;; DocuSign Envelope ID: 91216EB2-F486-414B-B694-F90CEB5F065E (h) the legal or beneficial ownership of Licensee or any of its Affiliates changes, directly or indirectly, without the prior written consent of Pfizer and MPP in accordance with Section 14.8; (i) any serious or intentional violation of any Applicable Law or misappropriation of a Third Party’s intellectual property rights by Licensee anywhere in the world, which in Pfizer’s and MPP’s judgement, may reflect unfavorably on Pfizer, MPP, their reputation or Licensed Product; or (j) Licensee is in breach of Section 8.3, Section 8.4 or Section 8.5 of this Agreement.

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 5 of this Agreement; (b) MPP becomes aware of any action (including any official notifications or communications) taken by any Agency involving a determination of Licensee’s failure to comply with cGMP in connection with for the manufacture and handling of the Licensed 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 9.1, Licensee is unable to reliably and consistently manufacture Compound or Licensed Product in accordance with such quality requirements; (c) Licensee fails to comply with the obligations contained in Section 3.7 of this Agreement; (d) Licensee fails to comply with the obligations contained in Section 3.12 of this Agreement; (e) Licensee repeatedly fails to comply with, or to timely provide MPP with the reports contemplated under this Agreement, including, but not limited to, the reports required under Sections 3.4, 3.8, 3.9, 4.5 and 11.2 of this Agreement; (f) Licensee fails to file for WHO Prequalification of the Licensed Product within six (6) months of a WHO Expression of Interest for the Licensed Product or such other time as may be mutually agreed between the Parties; (g) any material safety issue that Pfizer or MPP reasonably believes makes it inadvisable to proceed or continue with the Commercialization of Licensed Product in the Territory;; DocuSign Envelope ID: F0C62F1B-BD77-4D06-9219-67924AA8E188 (h) the legal or beneficial ownership of Licensee or any of its Affiliates changes, directly or indirectly, without the prior written consent of Pfizer and MPP in accordance with Section 14.8; (i) any serious or intentional violation of any Applicable Law or misappropriation of a Third Party’s intellectual property rights by Licensee anywhere in the world, which in Pfizer’s and MPP’s judgement, may reflect unfavorably on Pfizer, MPP, their reputation or Licensed Product; or (j) Licensee is in breach of Section 8.3, Section 8.4 or Section 8.5 of this Agreement.

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 5 of this Agreement; (b) MPP becomes aware of any action (including any official notifications or communications) taken by any Agency involving a determination of Licensee’s failure to comply with cGMP in connection with for the manufacture and handling of the Licensed 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 9.1, Licensee is unable to reliably and consistently manufacture Compound or Licensed Product in accordance with such quality requirements; (c) Licensee fails to comply with the obligations contained in Section 3.7 of this Agreement; (d) Licensee fails to comply with the obligations contained in Section 3.12 of this Agreement; (e) Licensee repeatedly fails to comply with, or to timely provide MPP with the reports contemplated under this Agreement, including, but not limited to, the reports required under Sections 3.4, 3.8, 3.9, 4.5 and 11.2 of this Agreement; (f) Licensee fails to file for WHO Prequalification of the Licensed Product within six (6) months of a WHO Expression of Interest for the Licensed Product or such other time as may be mutually agreed between the Parties; (g) any material safety issue that Pfizer or MPP reasonably believes makes it inadvisable to proceed or continue with the Commercialization of Licensed Product in the Territory;; DocuSign Envelope ID: E389DDA3-3EA0-4C1B-801D-93CD35BC54C2 (h) the legal or beneficial ownership of Licensee or any of its Affiliates changes, directly or indirectly, without the prior written consent of Pfizer and MPP in accordance with Section 14.8; (i) any serious or intentional violation of any Applicable Law or misappropriation of a Third Party’s intellectual property rights by Licensee anywhere in the world, which in Pfizer’s and MPP’s judgement, may reflect unfavorably on Pfizer, MPP, their reputation or Licensed Product; or (j) Licensee is in breach of Section 8.3, Section 8.4 or Section 8.5 of this Agreement.

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 5 of this Agreement4; (b) MPP becomes aware of any action (including any official notifications or communications) taken by any Agency regulatory authority involving a determination of Licensee’s 's failure to comply with cGMP good manufacturing practices as prescribed in the applicable legal or regulatory standards in connection with for the manufacture and handling of the Licensed 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 9.13.2, Licensee is unable to reliably and consistently manufacture Compound Substance or Licensed Product in accordance with such quality requirements; (c) Licensee fails to comply with the obligations contained in Section 3.7 3.3 of this Agreement; (d) Licensee repeatedly fails to comply with the obligations contained in Section 3.12 of this Agreement; (e) Licensee repeatedly fails to comply with, or to timely provide MPP with the reports contemplated under this Agreement, including, but not limited to, the reports required under Sections 3.4, 3.8, 3.9, 4.5 3.4 and 11.2 9.2 of this Agreement;; or (fe) Licensee fails to file for WHO Prequalification Pre-Qualification of the Licensed Product within six (6) months of a WHO Expression of Interest for the Licensed Product or such other time as may be mutually agreed between the Parties;. (gf) any material safety issue that Pfizer or MPP reasonably believes makes it inadvisable to proceed or continue with the Commercialization of Licensed Product in the Territory; (h) the The legal or beneficial ownership of Licensee or any of its Affiliates changes, directly or indirectly, without changes in such a manner as MPP after consulting with Licensee reasonably determines to be significant and adversely impacts the prior written consent ability of Pfizer and MPP in accordance with Section 14.8; (i) any serious or intentional violation of any Applicable Law or misappropriation of a Third Party’s intellectual property rights by Licensee anywhere in the world, which in Pfizer’s and MPP’s judgement, may reflect unfavorably on Pfizer, MPP, their reputation or Licensed Product; or (j) Licensee is in breach of Section 8.3, Section 8.4 or Section 8.5 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 agencyof competent jurisdiction, including in a re-examination or oppositionproceeding, or as a defense to enforcement of this Agreement or the terms of thisAgreement, including applicable payment obligations. The Parties understand that this right of termination is required pursuant to MSD's upstream contractual DocuSign Envelope ID: 4CE20236-04CA-4B30-8D1A-9D3D06558FC4 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.

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 5 of this Agreement; (b) MPP becomes aware of any action (including any official notifications or communications) taken by any Agency involving a determination of Licensee’s failure to comply with cGMP in connection with for the manufacture and handling of the Licensed 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 9.1, Licensee is unable to reliably and consistently manufacture Compound or Licensed Product in accordance with such quality requirements; (c) Licensee fails to comply with the obligations contained in Section 3.7 of this Agreement; (d) Licensee fails to comply with the obligations contained in Section 3.12 of this Agreement; (e) Licensee repeatedly fails to comply with, or to timely provide MPP with the reports contemplated under this Agreement, including, but not limited to, the reports required under Sections 3.4, 3.8, 3.9, 4.5 and 11.2 of this Agreement; (f) Licensee fails to file for WHO Prequalification of the Licensed Product within six (6) months of a WHO Expression of Interest for the Licensed Product or such other time as may be mutually agreed between the Parties; (g) any material safety issue that Pfizer or MPP reasonably believes makes it inadvisable to proceed or continue with the Commercialization of Licensed Product in the Territory;; DocuSign Envelope ID: E68F63E3-D274-4CA3-9C96-ECE5CBD30F63 (h) the legal or beneficial ownership of Licensee or any of its Affiliates changes, directly or indirectly, without the prior written consent of Pfizer and MPP in accordance with Section 14.8; (i) any serious or intentional violation of any Applicable Law or misappropriation of a Third Party’s intellectual property rights by Licensee anywhere in the world, which in Pfizer’s and MPP’s judgement, may reflect unfavorably on Pfizer, MPP, their reputation or Licensed Product; or (j) Licensee is in breach of Section 8.3, Section 8.4 or Section 8.5 of this Agreement.

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 5 of this Agreement; (b) MPP becomes aware of any action (including any official notifications or communications) taken by any Agency involving a determination of Licensee’s failure to comply with cGMP in connection with for the manufacture and handling of the Licensed 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 9.1, Licensee is unable to reliably and consistently manufacture Compound or Licensed Product in accordance with such quality requirements; (c) Licensee fails to comply with the obligations contained in Section 3.7 of this Agreement; (d) Licensee fails to comply with the obligations contained in Section 3.12 of this Agreement; (e) Licensee repeatedly fails to comply with, or to timely provide MPP with the reports contemplated under this Agreement, including, but not limited to, the reports required under Sections 3.4, 3.8, 3.9, 4.5 and 11.2 of this Agreement; (f) Licensee fails to file for WHO Prequalification of the Licensed Product within six (6) months of a WHO Expression of Interest for the Licensed Product or such other time as may be mutually agreed between the Parties; (g) any material safety issue that Pfizer or MPP reasonably believes makes it inadvisable to proceed or continue with the Commercialization of Licensed Product in the Territory;; DocuSign Envelope ID: 76B8C7A6-66D1-43C9-84E7-0D151DB61944 (h) the legal or beneficial ownership of Licensee or any of its Affiliates changes, directly or indirectly, without the prior written consent of Pfizer and MPP in accordance with Section 14.8; (i) any serious or intentional violation of any Applicable Law or misappropriation of a Third Party’s intellectual property rights by Licensee anywhere in the world, which in Pfizer’s and MPP’s judgement, may reflect unfavorably on Pfizer, MPP, their reputation or Licensed Product; or (j) Licensee is in breach of Section 8.3, Section 8.4 or Section 8.5 of this Agreement.

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 5 of this Agreement; (b) MPP becomes aware of any action (including any official notifications or communications) taken by any Agency involving a determination of Licensee’s 's failure to comply with cGMP in connection with for the manufacture and handling of the Licensed Products, or otherwise reasonably determines that, due to material deficiencies in Licensee’s 's compliance, or repeated failure to comply, with the quality requirements of Section 9.1, Licensee is unable to reliably and consistently manufacture Compound or Licensed Product in accordance with such quality requirements; (c) Licensee fails to comply with the obligations contained in Section 3.7 of this Agreement; (d) Licensee fails to comply with the obligations contained in Section 3.12 of this Agreement; (e) Licensee repeatedly fails to comply with, or to timely provide MPP with the reports contemplated under this Agreement, including, but not limited to, the reports required under Sections 3.4, 3.8, 3.9, 4.5 and 11.2 of this Agreement; (f) Licensee fails to file for WHO Prequalification of the Licensed Product within six (6) months of a WHO Expression of Interest for the Licensed Product or such other time as may be mutually agreed between the Parties; (g) any material safety issue that Pfizer or MPP reasonably believes makes it inadvisable to proceed or continue with the Commercialization of Licensed Product in the Territory; (h) the legal or beneficial ownership of Licensee or any of its Affiliates changes, directly or indirectly, without the prior written consent of Pfizer and MPP in accordance with Section 14.8; (i) any serious or intentional violation of any Applicable Law or misappropriation of a Third Party’s 's intellectual property rights by Licensee anywhere in the world, which in Pfizer’s 's and MPP’s 's judgement, may reflect unfavorably on Pfizer, MPP, their reputation or Licensed Product; or (j) Licensee is in breach of Section 8.3, Section 8.4 or Section 8.5 of this Agreement.

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 5 of this Agreement4; (b) MPP becomes aware of any action (including any official notifications or communications) taken by any Agency regulatory authority involving a determination of Licensee’s 's failure to comply with cGMP good manufacturing practices as prescribed in the applicable legal or regulatory standards in connection with for the manufacture and handling of the Licensed 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 9.13.2, Licensee is unable to reliably and consistently manufacture Compound Substance or Licensed Product in accordance with such quality requirements; (c) Licensee fails to comply with the obligations contained in Section 3.7 3.3 of this Agreement; (d) Licensee repeatedly fails to comply with the obligations contained in Section 3.12 of this Agreement; (e) Licensee repeatedly fails to comply with, or to timely provide MPP with the reports contemplated under this Agreement, including, but not limited to, the reports required under Sections 3.4, 3.8, 3.9, 4.5 3.4 and 11.2 9.2 of this Agreement;; or (fe) Licensee fails to file for WHO Prequalification Pre-Qualification of the Licensed Product within six (6) months of a WHO Expression of Interest for the Licensed Product or such other time as may be mutually agreed between the Parties;. (gf) any material safety issue that Pfizer or MPP reasonably believes makes it inadvisable to proceed or continue with the Commercialization of Licensed Product in the Territory; (h) the The legal or beneficial ownership of Licensee or any of its Affiliates changes, directly or indirectly, without changes in such a manner as MPP after consulting with Licensee reasonably determines to be significant and adversely impacts the prior written consent ability of Pfizer and MPP in accordance with Section 14.8; (i) any serious or intentional violation of any Applicable Law or misappropriation of a Third Party’s intellectual property rights by Licensee anywhere in the world, which in Pfizer’s and MPP’s judgement, may reflect unfavorably on Pfizer, MPP, their reputation or Licensed Product; or (j) Licensee is in breach of Section 8.3, Section 8.4 or Section 8.5 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 DocuSign Envelope ID: 2EDB93D3-290C-4578-91F8-9E7C2C9AB42E 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.

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 5 of this Agreement4; (b) MPP becomes aware of any action (including any official notifications or communications) taken by any Agency regulatory authority involving a determination of Licensee’s 's failure to comply with cGMP good manufacturing practices as prescribed in the applicable legal or regulatory standards in connection with for the manufacture and handling of the Licensed 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 9.13.2, Licensee is unable to reliably and consistently manufacture Compound Substance or Licensed Product in accordance with such quality requirements; (c) Licensee fails to comply with the obligations contained in Section 3.7 3.3 of this Agreement; (d) Licensee repeatedly fails to comply with the obligations contained in Section 3.12 of this Agreement; (e) Licensee repeatedly fails to comply with, or to timely provide MPP with the reports contemplated under this Agreement, including, but not limited to, the reports required under Sections 3.4, 3.8, 3.9, 4.5 3.4 and 11.2 9.2 of this Agreement;; or (fe) Licensee fails to file for WHO Prequalification Pre-Qualification of the Licensed Product within six (6) months of a WHO Expression of Interest for the Licensed Product or such other time as may be mutually agreed between the Parties;. (gf) any material safety issue that Pfizer or MPP reasonably believes makes it inadvisable to proceed or continue with the Commercialization of Licensed Product in the Territory; (h) the The legal or beneficial ownership of Licensee or any of its Affiliates changes, directly or indirectly, without changes in such a manner as MPP after consulting with Licensee reasonably determines to be significant and adversely impacts the prior written consent ability of Pfizer and MPP in accordance with Section 14.8; (i) any serious or intentional violation of any Applicable Law or misappropriation of a Third Party’s intellectual property rights by Licensee anywhere in the world, which in Pfizer’s and MPP’s judgement, may reflect unfavorably on Pfizer, MPP, their reputation or Licensed Product; or (j) Licensee is in breach of Section 8.3, Section 8.4 or Section 8.5 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 DocuSign Envelope ID: AA5A3FE2-ED27-4E48-BA92-55B70228604C 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.

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 5 of this Agreement4; (b) MPP becomes aware of any action (including any official notifications or communications) taken by any Agency regulatory authority involving a determination of Licensee’s 's failure to comply with cGMP good manufacturing practices as prescribed in the applicable legal or regulatory standards in connection with for the manufacture and handling of the Licensed 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 9.13.2, Licensee is unable to reliably and consistently manufacture Compound Substance or Licensed Product in accordance with such quality requirements; (c) Licensee fails to comply with the obligations contained in Section 3.7 3.3 of this Agreement; (d) Licensee repeatedly fails to comply with the obligations contained in Section 3.12 of this Agreement; (e) Licensee repeatedly fails to comply with, or to timely provide MPP with the reports contemplated under this Agreement, including, but not limited to, the reports required under Sections 3.4, 3.8, 3.9, 4.5 3.4 and 11.2 9.2 of this Agreement;; or (fe) Licensee fails to file for WHO Prequalification Pre-Qualification of the Licensed Product within six (6) months of a WHO Expression of Interest for the Licensed Product or such other time as may be mutually agreed between the Parties;. (gf) any material safety issue that Pfizer or MPP reasonably believes makes it inadvisable to proceed or continue with the Commercialization of Licensed Product in the Territory; (h) the The legal or beneficial ownership of Licensee or any of its Affiliates changes, directly or indirectly, without changes in such a manner as MPP after consulting with Licensee reasonably determines to be significant and adversely impacts the prior written consent ability of Pfizer and MPP in accordance with Section 14.8; (i) any serious or intentional violation of any Applicable Law or misappropriation of a Third Party’s intellectual property rights by Licensee anywhere in the world, which in Pfizer’s and MPP’s judgement, may reflect unfavorably on Pfizer, MPP, their reputation or Licensed Product; or (j) Licensee is in breach of Section 8.3, Section 8.4 or Section 8.5 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 DocuSign Envelope ID: B7A8C789-433F-4E3D-B51B-6D189345BC26 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.

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 5 of this Agreement4; (b) MPP becomes aware of any action (including any official notifications or communications) taken by any Agency regulatory authority involving a determination of Licensee’s 's failure to comply with cGMP good manufacturing practices as prescribed in the applicable legal or regulatory standards in connection with for the manufacture and handling of the Licensed 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 9.13.2, Licensee is unable to reliably and consistently manufacture Compound Substance or Licensed Product in accordance with such quality requirements; (c) Licensee fails to comply with the obligations contained in Section 3.7 3.3 of this Agreement; (d) Licensee repeatedly fails to comply with the obligations contained in Section 3.12 of this Agreement; (e) Licensee repeatedly fails to comply with, or to timely provide MPP with the reports contemplated under this Agreement, including, but not limited to, the reports required under Sections 3.4, 3.8, 3.9, 4.5 3.4 and 11.2 9.2 of this Agreement;; or (fe) Licensee fails to file for WHO Prequalification Pre-Qualification of the Licensed Product within six (6) months of a WHO Expression of Interest for the Licensed Product or such other time as may be mutually agreed between the Parties;. (gf) any material safety issue that Pfizer or MPP reasonably believes makes it inadvisable to proceed or continue with the Commercialization of Licensed Product in the Territory; (h) the The legal or beneficial ownership of Licensee or any of its Affiliates changes, directly or indirectly, without changes in such a manner as MPP after consulting with Licensee reasonably determines to be significant and adversely impacts the prior written consent ability of Pfizer and MPP in accordance with Section 14.8; (i) any serious or intentional violation of any Applicable Law or misappropriation of a Third Party’s intellectual property rights by Licensee anywhere in the world, which in Pfizer’s and MPP’s judgement, may reflect unfavorably on Pfizer, MPP, their reputation or Licensed Product; or (j) Licensee is in breach of Section 8.3, Section 8.4 or Section 8.5 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 DocuSign Envelope ID: 9929F3E7-EF06-4771-9E50-BF10C4486BCA 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.