Common use of No Harmful Actions Clause in Contracts

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. 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 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 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 , except AssemblyBio’s right to seek, obtain and maintain Clinical Trial Applications for the Licensed Products in the Field in the Territory as is reasonably necessary in connection accordance with its manufacture of the Licensed ProductsAssemblyBio’s retained rights under Section 2.3, which shall not be limited.

No Harmful Actions. If either Party reasonably believes that the other Party is taking or intends to take any action with respect to a the Licensed Product in such other Party’s territory (i.e., the Territory with respect to Jazz, and outside the Territory with respect to Zymeworks) Products that would reasonably be expected to could have a material adverse impact affect upon the regulatory status or Commercialization of any the Licensed Product in the Field in its respective territoryProducts, then such Party shall will have the right to bring the matter to the attention of the JSC, other Party and the Parties shall will promptly meet to discuss in good faith a resolution to resolve 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): agree: (a) neither Party shall will communicate with any Regulatory Authority having jurisdiction outside of its respective territory with respect to any Territory regarding the Licensed ProductProducts, unless required so ordered by such Regulatory Authority, in which case such Party shall will promptly notify the other Party of such order within [***] of such communication; and the Parties will work together in good faith on any potential response, provided that nothing in this clause (a) will prohibit a Party from responding solely to the extent required by Applicable Law, (b) neither Party shall will submit any Regulatory Submissions or seek Regulatory Approvals Materials for any the Licensed Product Products in the other Party’s respective territory; provided that Zymeworks may communicate with Territory, and (c) neither Party will seek any Regulatory Authorities Approvals for the Licensed Products in the Territory as is reasonably necessary in connection with its manufacture of the Licensed Productsother Party’s Territory.

No Harmful Actions. If either a Party reasonably believes that the other Party and/or any of its Affiliates and/or any Third Party acting under such other Party’s or its Affiliate’s authority, is taking or intends to take any action with respect to a Licensed Molecule or 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 could have a material adverse impact upon the regulatory status or Commercialization of any Licensed Product in the Field in its respective territorythe Party’s 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 concernconcern [***]. Without limiting the foregoing, unless the Parties otherwise agree (or unless otherwise and except as expressly set forth herein or in the Zymeworks Development Plan or Territory Development Plan): herein: (a) neither Party nor any of its Affiliates and/or any Third Party acting under such Party’s or its Affiliate’s authority shall communicate with any Regulatory Authority having jurisdiction outside of its respective territory in the other Party’s Territory with respect to any Licensed Molecule or Licensed Product, unless required by such Regulatory Authority, in which case such Party shall notify the other Party of such order requirement within [***] of such communication; and (b) neither Party nor any of its Affiliates and/or any Third Party acting under such Party’s or its Affiliate’s authority shall submit any Regulatory Submissions Material, or seek any Regulatory Approvals for Approval for, any Licensed Molecule or 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 ProductsTerritory.

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 Jazz 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 (i) Zymeworks may communicate with Regulatory Authorities in the Territory as is reasonably necessary in connection with its manufacture of the Licensed ProductsProducts and (ii) Jazz may communicate with Regulatory Authorities outside of the Territory as is reasonably necessary with respect to the Zymeworks Ongoing Studies and Zymeworks Korean Studies.