Specifications Amendments. Except to the extent specifically required by relevant Health Authorities, Impax shall not modify the Product Specifications without Schering's prior written approval, such approval not to be unreasonably withheld.
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. 20 3.9 Records........................................................ 21 3.10 Manufacturing Agreement........................................ 21 3.11
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. RIBI may not amend and/or supplement the Product Specifications without the written approval of SP Ltd., which will not be unreasonably withheld or delayed.
Specifications Amendments. The Specifications shall be amended or supplemented to comply with GMPs and to comply with any applicable Agency directive and may also be amended or supplemented (including, without limitation, for the purpose of incorporating improvements) from time to time. In the event CIMA intends to amend the Specifications, WCH shall receive prompt advance notice of any such amendments. No such amendment shall be filed with any applicable Agency or otherwise become effective without the prior written mutual approval of WCH and CIMA. In the event that after the parties have initially agreed upon the Specifications, WCH requests that the Specifications be amended, CIMA 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 Product for WCH hereunder and WCH shall reimburse CIMA for the actual costs incurred by CIMA (provided that such costs are approved in writing by WCH prior to being incurred by CIMA) because such amendment requires changes to be made in the processes, equipment, testing procedures, or components used to manufacture Product for WCH hereunder. Upon WCH's request, CIMA shall use Commercially Reasonable Efforts to eliminate animal derived materials from the Product and WCH shall reimburse CIMA for the actual costs incurred by CIMA (provided that such are approved in writing by WCH prior to being incurred by CIMA) in connection therewith. In each case, such costs may include, without limitation, validation of new processes, equipment and facilities, development of testing methods and start-up costs. To the extent that any costs incurred by CIMA in implementing an amendment of the Specifications under this Section have been reimbursed by WCH such costs shall not be included in CIMA's Direct Manufacturing Cost.
Specifications Amendments. 17 8.2 Ribi Approvals..................................................................... 17 8.3 Records............................................................................ 17 8.4
Specifications Amendments. 32 3.10 Records.......................................... 33 3.11 Third Party Raw Material Supply.................. 33 3.12 Quality Assurance................................ 33
