Specifications Amendments Clause Samples

Specifications Amendments. Anthra reserves the *** CONFIDENTIAL TREATMENT REQUESTED. 19 right to amend and/or supplement the Product Specifications unilaterally for the purpose of complying with GMPs or applicable Approvals, incorporating improvements, or for any other reasonable business purpose, subject to the grant of any Approvals required by applicable law in the Territory in connection with any such changes; provided, however, that Anthra may not amend the Product Specifications so as to incorporate any Additional Development therein, without the prior written consent of Nycomed, which shall not be unreasonably withheld; provided, however, that withholding such consent because of a disagreement between the parties as to the appropriate rate of royalty to be paid by Nycomed with respect to such Additional Development shall not be deemed unreasonable for purposes of this Section 3.8.

Specifications Amendments. 12 3.10 Records...................................................... 12

Specifications Amendments. Anthra reserves the right to amend and/or supplement the Product Specifications *** CONFIDENTIAL TREATMENT REQUESTED. 15 11 unilaterally for the purpose of complying with GMPs or applicable Registrations, incorporating improvements, or for any other reasonable business purpose, subject to the grant of any Approvals required by applicable law in the Territory in connection with any such changes.

Specifications Amendments. 20 3.9 Records........................................................ 21 3.10 Manufacturing Agreement........................................ 21 3.11

Specifications Amendments. The Specifications and CMC shall be amended or supplemented to comply with Regulatory Guidelines and Requirements and may be amended or supplemented (including, without limitation, for the purpose of incorporating improvements) from time to time by Anthra with the prior written consent of Genchem Pharma, which shall not be unreasonably withheld.

Specifications Amendments. The Specifications shall be amended or supplemented to comply with cGMPs and to comply with any applicable Regulatory Authority directive and may also be amended or supplemented (including, without limitation, for the purpose of incorporating improvements) from time to time. In the event GalaGen intends to amend the Specifications, Wyeth-Ayerst shall receive prompt advance notice of any such amendments. No such amendment shall be filed with any applicable Regulatory Authority or otherwise become effective without the prior written mutual approval of Wyeth-Ayerst and GalaGen. In the event that, after the Parties have initially agreed upon the Specifications, Wyeth-Ayerst requests that the Specifications be amended, GalaGen shall receive prompt advance notice of any such amendment for the purpose of determining what, if any, impact the proposed amendment would have on the Manufacture of Ingredient for Wyeth-Ayerst hereunder and Wyeth-Ayerst shall reimburse GalaGen for the actual costs incurred by GalaGen (provided that such costs are approved in writing by Wyeth-Ayerst prior to being incurred by GalaGen) because such amendment requires changes to be made in the processes, equipment, testing procedures, or components used to Manufacture the Ingredient for Wyeth-Ayerst hereunder. Such costs may include, without limitation, validation of new processes, equipment and facilities, development of testing methods and start-up

Specifications Amendments. RIBI may not amend and/or supplement the Product Specifications without the written approval of Schering, which will not be unreasonably withheld or delayed.

Specifications Amendments. 17 8.2 Ribi Approvals..................................................................... 17 8.3 Records............................................................................ 17 8.4

Specifications Amendments. The NZO Specifications shall be amended or supplemented to comply with GMPs and may be amended or supplemented (including, without limitation, for the purpose of incorporating improvements) from time to time upon the written request of S-P. In the event such amendment requires additional actual cost to NTC for the manufacture of the NZO, S-P and NTC shall agree on the additional compensation therefore.