Manufacturing Specifications. The Manufacture of all ▇▇▇▇▇▇ Products during the term of this Agreement shall be the responsibility of DURA. DURA shall manufacture, or cause its subcontractor to manufacture, the ▇▇▇▇▇▇ Products under this Agreement in compliance in all material respects with all requirements of applicable laws and regulations and all applicable good manufacturing practices, as prescribed from time to time by the FDA and other applicable worldwide regulatory authorities, using the specifications, manufacturing methods and formulae as agreed upon by DURA and ▇▇▇▇▇▇ Corp. II in writing.
Appears in 3 contracts
Sources: Manufacturing and Marketing Agreement (Spiros Development Corp Ii Inc), Manufacturing and Marketing Agreement (Dura Pharmaceuticals Inc/Ca), Manufacturing and Marketing Agreement (Dura Pharmaceuticals Inc/Ca)