Manufacturing Party definition
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 shall maintain such certificates for a period of not less than five (5) years from the date of manufacture and for so long as required under applicable requirements of the FDA or other applicable regulatory authority.
Upon receipt by the Non-performing Manufacturing Party of written notice from the other Party to the effect that such other Party is exercising its rights under this Section 7.6, the Non-performing Manufacturing Party shall provide reasonable assistance, at its sole cost and expense, to enable such other Party to Manufacture or have Manufactured and supplied such Licensed Product.
Pursuant to the schedule approved by the JSC, or upon request of the JDC, the Lead Manufacturing Party shall conduct an inspection or audit of the facilities of such Third Party contract manufacturers.