Modification of Product. The Parties acknowledge and agree that any modification to the Equipment or Software other than by Vendor or its authorized service agents shall void the warranties provided by Vendor in Sections 11.1 through 11.4.
Modification of Product. At its sole discretion, and providing SUNWAY gives DISTRIBUTOR a minimum of 60 day written notice, SUNWAY may also discontinue the production or sale or modify the design or material specifications of the Product or its parts without any liability or obligation to DISTRIBUTOR or its sub-Distributors, agents, representatives or customers, including, without limitation, any obligation to modify any Product previously ordered by DISTRIBUTOR.
Modification of Product. 7.1 SWISSRAY may modify the PRODUCT in its sole, absolute discretion prior to delivery of PRODUCT. If such modifications materially affect specifications or FDA submissions, SWISSRAY shall use its best efforts to notify HMSA of such modifications in writing at least ninety (90) days prior to first delivery of the modified PRODUCT. In no event will SWISSRAY be obligated to make any such modification to Products previously supplied to HMSA or to continue to supply Products as made prior to such modification.
Modification of Product. Supplier reserves the right to make Improvements during the Term and shall give prior notice to the Purchaser of any Improvement, which could require approval by Regulatory Authorities under applicable Laws. For greater certainty, prior notice to the Purchaser is required for Improvements that are considered a “Level 1 Change” (i.e. change requiring a Supplement to a New Drug Submission), a “Level 2 Change” (i.e. Notifiable Change) or a “Level 3 Change” (i.e. Notice of Change) under HC’s Changes to Marketed New Drug Products Policy. For a “Level 4 Change” as described in HC’s Changes to Marketed New Drug Policy, Supplier will provide to Purchaser a copy of revised batch documents for Canadian GMP Product release purposes as and when they are revised. For a “Level 1 Change” and a “Level 2 Change”, Supplier and Purchaser shall agree upon the procedure and a reasonable period of time for the implementation of the Improvements, including, without limitation, for obtaining any necessary Regulatory Approvals with regard to any such Improvement pursuant to Section 7 hereof and the launch thereof. In the event that material changes are made to HC’s Changes to Marketed New Drug Products Policy, then the following applies: For any Improvement that requires prior notice to HC or approval from HC prior to implementation, the Parties shall agree in advance upon the procedure and a reasonable period of time for the implementation of the Improvements. For all other Improvements, Oscient shall provide Abbott Canada with regular updates and documentation of any Improvements made, including whenever requested by Xxxxxx Canada due to an upcoming or actual inspection by HC or a request by HC.
Modification of Product. RESOLUX shall forward information concerning any product modification to the Supplier via the agreed share site (appendix 5). In case of modifications the supplier shall immediately report about existing stock or items in process in order for RESOLUX to decide whether to use these products or to scrap them. Based on the information and the character of the modification the Supplier shall work out a new quotation which shall be forwarded to RESOLUX for approval. The quotation must include specification of changes in the prices and needs of raw materials (if any) and non-recurring expenses for tools etc. (if any).
Modification of Product. Thomson shall not modify the Product in any function without the express written permission of DPI. Such permission will not be unreasonably withheld and all such modifications will be done jointly.
Modification of Product. Distributor may not modify or have modified any Product unless it obtains the prior written consent of Manufacturer, which consent may be withheld in the sole discretion of Manufacturer. Any unauthorized modification of any Product by Distributor or any third party shall relieve Manufacturer from any obligation it would otherwise have had with respect to such Product under the limited warranty described in Section 10.
Modification of Product. Oscient reserves the right to modify, change, develop or improve the Active Pharmaceutical Ingredient, including changes in the manufacturing process or the site at which such manufacture is to occur, (an “Alteration”) during the Term and shall give prior notice to MIOL of any Alteration which could give rise to notification requirements to Regulatory Authorities or the need for any Regulatory Approval under Applicable Law; provided that any material change to the Specifications shall require MIOL’s consent, not to be unreasonably withheld. Any reasonable and verifiable costs associated with any such Alteration shall be borne by Oscient. It is however understood that if an Alteration requires a Regulatory Approval no Active Pharmaceutical Ingredient manufactured after implementation of such Alteration shall be supplied pursuant to this Agreement before the Regulatory Approval is granted. The Parties agree to pursue diligently any such Regulatory Approvals following notice of any proposed Alteration from Oscient. Oscient agrees that it shall not cause an Alteration to be made after MIOL submits an application for Marketing Authorization and prior to receipt of such Market Authorization.
