Manufacture definition
Examples of Manufacture in a sentence
At Biodexa’s expense, Biodexa shall use Commercially Reasonable Efforts to Develop and obtain Regulatory Approval for Licensed Products for one or more indications in the Field in the United States, Europe and China in accordance with the Development Plan and to Manufacture and Commercialize Licensed Products in the Field in the Territory in accordance with the Commercialization Plan.
During the Term, Biodexa (either itself or through its Affiliates or Sublicensees) is solely responsible for carrying out at its expense all activities necessary to obtain or maintain Regulatory Approval of the Licensed Product in the Field in the Territory, including preparing Regulatory Materials and conducting communications with the relevant Regulatory Authorities related to or needed for the Development, Manufacture or Commercialization of Licensed Products in the Field in the Territory.
In addition, Licensor will disclose and make available to Licensee any improvements, modifications or enhancement to the Licensed Know-How Controlled by Licensor during the Term that are necessary or reasonably useful to the Development, Manufacture or Commercialization of Compounds or Products in the Field in the Territory.
Upon Licensee’s request, and without prejudice to Licensee’s right to Manufacture or have Manufactured Compounds and Products itself or by a Third Party, the Parties will negotiate in good faith the terms and conditions, including minimum volumes, of a commercial supply agreement together with a corresponding quality agreement pursuant to which Licensor would Manufacture and supply, itself or through an Affiliate or Third Party manufacturer, the Compounds and Products to Licensee.
Upon reasonable advance notice, and no more than [***], except for cause, each Party or its representatives shall have the right to audit the regulatory, safety, quality and compliance systems of the other Party, its Affiliates, Sublicensees or Subcontractors (including Clinical Trial sites) relating to the Development, Manufacture and Commercialization of the Products.