Examples of Manufacturing Party in a sentence
The Manufacturing Party shall advise the other Parties immediately if an authorized agent of the FDA or other regulatory authority visits any of the Manufacturing Party's manufacturing facilities, or the facilities where the Collaboration Products are being manufactured, for an inspection with respect to the Collaboration Products.
The Manufacturing Party shall furnish to the other Parties the report by such agency of such visit, to the extent that such report relates to Collaboration Products, within ten (10) business days of the Manufacturing Party's receipt of such report, and the other Parties shall have the right to comment on any response by the Manufacturing Party to such inspecting agency.
The Manufacturing Party selected pursuant to Section 7.3 above shall perform, or cause its contract manufacturer(s) to perform, quality assurance and control tests on each lot of Collaboration Products before delivery and shall prepare, or cause its contract manufacturer(s) to prepare and deliver, a written report of the results of such tests (for purposes of Sections 7.4, 7.5 and 7.6, such contract manufacturer(s) shall be included in the definition of the term "Manufacturing Party").
The Distributing Party shall cooperate with the Manufacturing Party in connection with the Manufacturing Party's obligations under this Section 7.3. The Distributing Party shall provide to the Manufacturing Party, the necessary reports relating to complaints and product performance issues relating to the Products on a timely basis to permit the reporting party to fulfill its regulatory obligations.
The Manufacturing Party may subcontract with Genzyme, Dyax or Third Parties for the manufacture or packaging of Collaboration Products, as determined by the Steering Committee.