Manufacture of Licensed Product for the Territory Clause Samples
The 'Manufacture of Licensed Product for the Territory' clause defines the rights and obligations regarding the production of a licensed product specifically for distribution or sale within a designated geographic area. Typically, this clause outlines who is authorized to manufacture the product, any quality standards or regulatory requirements that must be met, and whether manufacturing must occur within the territory or can be outsourced. Its core practical function is to ensure that the licensed product is produced in compliance with agreed standards and legal requirements for the territory, thereby protecting both parties' interests and ensuring a reliable supply chain.
Manufacture of Licensed Product for the Territory. Subject to the terms and conditions of this Article 7, Jazz shall have the right to (a) purchase Development supply of Licensed Antibody and Licensed Product from Zymeworks or Zymeworks’ CMO pursuant to the Clinical Supply Agreement, (b) exercise its license under Section 2.1(a) to (i) manufacture or have manufactured by a CMO clinical and/or commercial supply of Licensed Antibody and Licensed Product for the Territory itself or to have Licensed Antibody and Licensed Product manufactured by a CMO, in each case after successful completion of the Manufacturing Technology Transfer in accordance with Section 7.2 and (ii) package and label Licensed Product supplied by Zymeworks or manufactured by or on behalf of Jazz, and (c) purchase commercial supply of Licensed Antibody and Licensed Product from Zymeworks or Zymeworks’ CMO pursuant to the Commercial Supply Agreement. As between the Parties, Jazz shall have the right and obligation to package and label all Licensed Product for Development conducted by or on behalf of Jazz, its Affiliate or sublicensee and Commercialization in the Field in the Territory, subject to Zymeworks’ right to make or have made the Licensed Antibody and Licensed Product for supply to Jazz in bright stock form for use in the Field in the Territory pursuant to the Clinical Supply Agreement and Commercial Supply Agreement.
Manufacture of Licensed Product for the Territory. Subject to the terms and conditions of this Article 7, BeiGene shall have the right to (a) purchase Development supply from AssemblyBio or AssemblyBio’s CMO pursuant to the Clinical Supply Agreement, and (b) purchase commercial supply of Licensed Product from AssemblyBio or AssemblyBio’s CMO pursuant to the Commercial Supply Agreement.
Manufacture of Licensed Product for the Territory. Subject to the terms and conditions of this Article 7, BeiGene shall have the right to (a) purchase Development supply from Zymeworks or Zymeworks’ CMO pursuant to the Clinical Supply Agreement, (b) exercise its license under Section 2.1(b)(ii) to manufacture clinical and/or commercial supply of Licensed Product for the Territory itself or have such Licensed Product manufactured by a Third Party CMO agreed upon by the Parties, in each case after successful completion of the Manufacturing Technology Transfer and Qualifying Audits in accordance with Section 7.2, or (c) purchase 59 Competitive Information – Commercially Sensitive Terms. 60 Competitive Information – Commercially Sensitive Terms. 61 Competitive Information – Commercially Sensitive Terms. commercial supply of Licensed Product from Zymeworks or Zymeworks’ CMO pursuant to the Commercial Supply Agreement.
Manufacture of Licensed Product for the Territory. Subject to the terms and conditions of this Article 7 and only after BeiGene’s exercise of the Option and payment of the Option Exercise Fee, BeiGene shall have the right to (a) purchase Development supply of Licensed Product from Leap or its Affiliates or Leap’s CMO pursuant to the Clinical Supply Agreement, or (b) exercise its license under Section 2.2 to manufacture commercial supply of Licensed Product for the Territory itself or have such Licensed Product manufactured by a Third Party CMO in the Territory agreed upon by the Parties, in each case after successful completion of the Manufacturing Technology Transfer.
Manufacture of Licensed Product for the Territory. Subject to the terms and conditions of this Article 7, BeiGene shall have the right to (a) purchase Development supply from Zymeworks or Zymeworks’ CMO pursuant to the Clinical Supply Agreement, (b) exercise its license under Section 2.1(b)(ii) to manufacture clinical and/or commercial supply of Licensed Product for the Territory itself or have such Licensed Product manufactured by a Third Party CMO agreed upon by the Parties, in each case after successful completion of the Manufacturing Technology Transfer and Qualifying Audits in accordance with Section 7.2, or (c) purchase commercial supply of Licensed Product from Zymeworks or Zymeworks’ CMO pursuant to the Commercial Supply Agreement.