No Harmful Actions. If a Party believes that the other Party is taking or intends to take any action with respect to a Product that could reasonably be expected to have a material adverse impact upon the regulatory status of such Product in the first Party’s territory, then such Party may bring the matter to the attention of the JDC and the Parties shall discuss in good faith to resolve such concern.
No Harmful Actions. If either Party believes that the other Party is taking or intends to take any action with respect to a Licensed Product that could have a material adverse impact upon the Regulatory Approval of any Licensed Product in or for the Territory (if such Party is Licensee) or outside the Territory (if such Party is Licensor), then such Party shall have the right to bring the matter to the attention of the other Party and the Parties shall discuss in good faith to resolve such concern. Without limiting the foregoing, unless the Parties otherwise agree: (i) Licensee shall not communicate with any Regulatory Authority having jurisdiction only outside the Territory with respect to a Licensed Product, unless so ordered by such Regulatory Authority, in which case Licensee shall immediately notify Licensor of such order; (ii) Licensee shall not submit any regulatory filings or seek Regulatory Approvals for any Licensed Product outside the Territory (unless such regulatory filings or Regulatory Approvals are also for the Territory); (iii) Licensor shall not communicate with any Regulatory Authority having jurisdiction only in or for the Territory with respect to a Licensed Product, unless so ordered by such Regulatory Authority, in which case Licensor shall immediately notify Licensee of such order, and (iv) Licensor shall not submit any regulatory filings or seek Regulatory Approvals for any Licensed Products in or for the Territory. Licensor shall provide Licensee with any information that reasonably could have an adverse effect on the Development or Commercialization of the Licensed Products in or for the Territory, prior to making such information public.
No Harmful Actions. If Paratek believes that Zai is taking or intends to take any action with respect to the Licensed Product that could have a material adverse impact upon the regulatory status of the Licensed Product outside the Territory, Paratek will have the right to bring the matter to the attention of the JSC and the Parties will discuss in good faith to resolve such concern. Without limiting the foregoing, unless the Parties otherwise agree: (a) Zai will not communicate with any Regulatory Authority having jurisdiction outside the Territory, unless so ordered by such Regulatory Authority, in which case Zai will immediately notify Paratek of such order; and (b) Zai will not submit any Regulatory Submissions or seek regulatory approvals for the Licensed Product outside the Territory. To the extent practicable, Paratek will provide Zai with any information that reasonably could affect the Development or Commercialization of the Licensed Product in the Territory, prior to making such information public.
No Harmful Actions. If either Party believes that the other Party is taking or intends to take any action with respect to a Licensed Product in such other Party’s territory that could have a material adverse impact upon the regulatory status of any Licensed Product in its respective territory, then such Party shall have the right to bring the matter to the attention of the JSC and the Parties shall discuss in good faith a resolution to such concern. Without limiting the foregoing, unless the Parties otherwise agree (or unless otherwise set forth in the Global Development Plan): (a) neither Party shall communicate with any Regulatory Authority having jurisdiction outside of its respective territory with respect to any Licensed Product, unless so ordered by such Regulatory Authority, in which case such Party shall immediately notify the other Party of such order; and (b) neither Party shall submit any Regulatory Submissions or seek regulatory approvals for any Licensed Product in the other Party’s respective territory.
No Harmful Actions. If TPTX believes that Zai is taking or intends to take any action with respect to a Product that could have a material adverse impact upon the regulatory status of the Product outside the Territory, TPTX shall have the right to bring the matter to the attention of the JDC and the Parties shall discuss in good faith to resolve such concern. Without limiting the foregoing, unless the Parties otherwise agree: (a) Zai shall not communicate with any Regulatory Authority having jurisdiction outside the Territory, unless so ordered by such Regulatory Authority, in which case Zai shall immediately notify TPTX of such order; and (b) Zai shall not submit any Regulatory Submissions or seek Regulatory Approvals for the Product outside the Territory.
No Harmful Actions. If either Party reasonably believes that the other Party is taking or intends to take any action with respect to a Licensed Product in such other Party’s territory (i.e., the Territory with respect to Jazz, and outside the Territory with respect to Zymeworks) that would reasonably be expected to have a material adverse impact upon the regulatory status or Commercialization of any Licensed Product in the Field in its respective territory, then such Party shall have the right to bring the matter to the attention of the JSC, and the Parties shall discuss in good faith a resolution to such concern. Without limiting the foregoing, unless the Parties otherwise agree (or unless otherwise set forth herein or in the Zymeworks Development Plan or Territory Development Plan): (a) neither Party shall communicate with any Regulatory Authority having jurisdiction outside of its respective territory with respect to any Licensed Product, unless required by such Regulatory Authority, in which case such Party shall notify the other Party of such order within [***] of such communication; and (b) neither Party shall submit any Regulatory Submissions or seek Regulatory Approvals for any Licensed Product in the other Party’s respective territory; provided that Zymeworks may communicate with Regulatory Authorities in the Territory as is reasonably necessary in connection with its manufacture of the Licensed Products.
No Harmful Actions. Each Party will promptly notify the other Party of all material communications or correspondence with Regulatory Authorities with respect to any Licensed Product in such Party’s territory that are (a) received by such Party or its Affiliates, Sublicensees, or other licensees (to the extent that such Party has the right to disclose such material communications or correspondence of other licensees and provided that such Party uses commercially reasonable efforts to obtain such right from such other licensees) from any Regulatory Authority or submitted by such Party, its Affiliates or other licensees to any Regulatory Authority and (b) would reasonably be expected to impact the other Party’s Development, Manufacture, or Commercialization of the Licensed Products in the Field in the other Party’s territory. If either Party believes that the other Party is taking or intends to take any action with respect to a Licensed Product in such other Party’s territory that could have a material adverse impact upon the regulatory status of any Licensed Product in such Party’s territory, then such Party will have the right to bring the matter to the attention of the JSC and the JSC will discuss in good faith a resolution to such concern.
No Harmful Actions. (a) If Licensor reasonably believes that Licensee is taking or intends to take any action with respect to a Product that is likely to have a Material Impact in the Licensor Territory, Licensor may bring the matter to the attention of the JSC. Licensee shall not proceed with any such action or alternative course of action until it is approved by the JSC in accordance with Section 3.1(d).
No Harmful Actions. Collaborator shall not take any action with respect to Products in the Licensed Territory that could reasonably be expected to have a material adverse impact upon the regulatory status or potential sales of Products outside the Licensed Territory, provided that the foregoing shall not restrict Collaborator from taking actions reasonably required to avoid or address any safety or human health problems as required by Regulatory Authorities in the Licensed Territory or the relevant independent data safety monitoring board. If Affymax believes that Collaborator is taking or intends to take any action that could reasonably have such an impact, Affymax shall bring the matter to the attention of the Joint Committee. The Joint Committee shall discuss whether any such action reasonably would be expected to have such an impact, and potential alternative courses of action that Collaborator could take to avoid such an impact. If the Joint Committee cannot reach agreement as to such matters, then either Party may refer such matters for resolution pursuant to Sections 14.1 and 14.2. Furthermore, Collaborator shall use Diligent Efforts to preserve the existence and breadth of any Regulatory Approvals for Products obtained in the Licensed Territory in the course of reexamination, reevaluation and other post marketing surveillance review procedures required by Regulatory Authorities in the Licensed Territory or the relevant independent data safety monitoring board.
No Harmful Actions. Each Party shall not, and shall use commercially reasonable efforts to cause its Affiliates, Sublicensees (with respect to Alexion), Third Party Licensees (with respect to Eidos) and Subcontractors not to, take any action with respect to the Licensed Compound or a Licensed Product that could reasonably be expected to have an adverse impact upon the other Party’s Regulatory Approval status of the Licensed Compound or any Licensed Product in the other Party’s Applicable Territory. If a Party believes that the other Party is (or any of its Affiliates, Sublicensees (with respect to Alexion), Third Party Licensees (with respect to Eidos) or Subcontractors are) taking or intends to take any action with respect to the Licensed Compound or a Licensed Product that could have an adverse impact upon other Party’s Regulatory Approval status of the Licensed Compound or any Licensed Product in such Party’s Applicable Territory, then the Parties shall discuss in good faith a resolution of such concern.
