Product Specifications. “Product Specifications” shall mean the specifications for the Product to be manufactured hereunder, as referenced in ANNEX 1 and made a part hereof, as determined in accordance with the analytical methodology agreed upon by the Parties, as such specifications may be amended from time to time by mutual agreement of the Parties, including without limitation such amendments as may be required to obtain Product Approval.
Appears in 2 contracts
Samples: Supply Agreement (Discovery Laboratories Inc /De/), Quality Agreement (Amag Pharmaceuticals Inc.)
Product Specifications. “Product Specifications” shall mean the specifications for the Product to which will be manufactured hereunder, attached hereto as referenced in ANNEX 1 Exhibit 5 and made a part hereof, as determined in accordance with the analytical methodology agreed upon by the Parties, as such specifications may be amended from time to time by mutual agreement of the Parties, including without limitation such amendments as may be required to obtain Product Approval.
Appears in 2 contracts
Samples: Supply Agreement, Quality Agreement (Barrier Therapeutics Inc)
Product Specifications. “Product Specifications” shall mean the specifications for the Product to be manufactured hereunder, as referenced set forth in ANNEX 1 and made a part hereof1, as determined in accordance with the analytical methodology agreed upon by the Parties, and as such specifications may be amended from time to time by mutual agreement of the Parties, including without limitation such amendments as may be required to obtain Product Approval.
Appears in 1 contract
Samples: Supply Agreement (Omeros Corp)
Product Specifications. “Product Specifications” shall mean the specifications for the Product to be manufactured hereunder, as referenced in ANNEX 1 and made a part hereof, as determined in accordance with the analytical methodology agreed upon by the Parties, as such specifications may be amended from time to time by mutual agreement of the Parties, including without limitation any and all such amendments as may be required mutually agreed upon to obtain Product Approval.
Appears in 1 contract
Samples: Contract Manufacturing and Supply Agreement (Onyx Pharmaceuticals Inc)