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.
Specifications for Products. All products supplied by Seller here under shall be furnished in accordance with all terms and conditions of this agreement, as well as all specifications set forth in Exhibit A attached hereto or any subsequent engineering change orders relating thereto and approved by Buyer consistent with the terms and conditions of the Agreement.
Specifications for Products. The Parties shall designate one of the Parties to be responsible for establishing, subject to approval by the JDC and the MC, the specifications for bulk and finished Product, and providing and maintaining any necessary documentation, certificates of analysis and test results, for each Product. 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 each Party. The Cost of Goods (including [*] for Products actually used (and not sold) for all Pre-Clinical Development and Development studies shall be included in Development Costs. [*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Act of 1934, as amended.
