Common use of Specifications for Products Clause in Contracts

Specifications for Products. The Parties shall designate one of the Parties to be responsible for establishing, subject to approval by the MC, the specifications for bulk and finished Product, and providing any necessary documentation, certificates of analysis and test results, for the relevant Product to be manufactured under this Section 8. Copies of all such specifications and other information and documentation will be provided promptly to the Parties. In addition, notice of, and results and data from, all FDA (or its foreign equivalent) audits relating to the manufacture of Product will be provided to the Parties. The Cost of Goods (including qualification batches for FDA (or its foreign equivalent) approval) for Products actually used (and not sold) for all Pre-Clinical Development and Development studies shall be included in Development Costs.