Company Requested Changes. Company shall have the right at any time to make changes in drawings, designs, Specifications, Materials, packaging, quantities of Product under Order (except as restricted by the Table in Section 7), time and place of delivery and method of transportation. Company will request changes by submitting an Engineering Change Notice using the Company’s Change Procedure, a revised production schedule, revised shipping information or similar document. Submission must be in writing and can be transmitted using electronic means such as Facsimile or electronic mail. Contractor has five (5) working days to review and reject Company requested changes. If Contractor does not provide timely notice of rejection of any changes, it shall be deemed to have accepted all changes not so rejected, subject to reasonable price adjustments attributable solely to such change. There will be no change in manufacturing and production service until accepted, in writing, or by failure to provide timely notice of rejection, by the Contractor. If any such changes cause an increase or decrease in the cost or the time required for performance of the order, Contractor shall notify Company in writing (stating the amount of the increase or decrease), within five (5) working days, after receipt of such notice. If such notice concerning an adjustment to cost or time required for performance is timely given, an equitable adjustment shall be made. Contractor agrees to proceed with the performance of this Agreement and in accordance with the accepted production schedule with regard to Product not affected by the request for change.
Company Requested Changes. Company shall have the right at any time to make changes in drawings, designs, Specifications, Materials, packaging, quantities of Die and/or Product ordered (except as restricted by the Table in Section 7), time and place of delivery and method of transportation. Company will request changes by submitting an Engineering Change Notice using the Company’s Change Procedure, a request for change(s) in Delivery Date(s), revised shipping information or similar document. Submission must be in writing and can be transmitted using electronic means such as facsimile or electronic mail. Contractor has five (5) working days to review and reject Company requested changes. If Contractor does not provide timely notice of rejection of any changes, it shall be deemed to have accepted all changes not so rejected, subject to reasonable price adjustments attributable solely to such change. There will be no change in manufacturing or production service until accepted, in writing, or by failure to provide timely notice of rejection, by Contractor. If any such changes cause an increase or decrease in the cost or the time required for performance of Company’s Purchase Order, Contractor shall notify Company in writing (stating the amount of the increase or decrease) within five (5) working days, after receipt of such notice. If such notice concerning an adjustment to cost or time required for performance is timely given, an equitable adjustment shall be made. Contractor agrees to proceed with the performance of this Agreement in accordance with Company Purchase Order(s) with regard to Die and Product not affected by the request for change.
Company Requested Changes. Company shall inform AAIPharma in writing of any proposed modifications to the Specifications or the Manufacturing process. Any proposed change shall require AAIPharma’s prior written consent, which consent shall not be unreasonably withheld or delayed. AAIPharma shall make changes it agrees to as promptly as practicable; provided, however, that such changes comply with Applicable Law, cGMP and the Marketing Authorizations.
Company Requested Changes. In the event Company desires Supplier to make any changes to the Raw Materials, Manufacturing Process, or Specifications for any Product, Company shall promptly advise Supplier in writing of such request. For the avoidance of doubt, Supplier is under no obligation to make any changes to the Raw API Supply Agreement – EXECUTION VERSION 5 Materials, Manufacturing Process, or Specifications for any Product, and Supplier shall determine, in its sole discretion, whether to make any Company requested changes. In the event Supplier agrees to assess the possibility of a change to its Raw Materials, Manufacturing Process or Specifications for a Product, it shall conduct a technical review to determine any scheduling, out-of-pocket expenses, capital expenditure costs, and/or other price adjustments caused by any such change. Prior to implementation of any such change, the Parties shall negotiate in good faith in an attempt to reach agreement on (1) the new price for any Product affected by such change, and (2) any other amendments to this Agreement which may be necessitated by such change (e.g., an adjustment to the lead time for Purchase Orders).
Company Requested Changes. Manufacturer shall make changes as promptly as practicable to the Specifications or Manufacturing process if requested in writing by the Company, including, but not limited to, changes to the existing Products, Active Pharmaceutical Ingredients or Raw Materials related to the Products; provided, however, that such changes comply with applicable Law.
Company Requested Changes. In the event the Company, based upon market conditions, requests Fxxxxx to change the specifications or quality aspects of the Products, the Company shall promptly advise Fxxxxx in writing of such request. Such amendments may only be implemented following a technical review by Fxxxxx and in the event that such changes directly impact Fxxxxx’x scheduling or costs, Fxxxxx shall promptly advise the Company as to any scheduling, out-of-pocket expenses, capital expenditure costs, and/or price adjustments caused by such changes. Prior to implementation of such changes, the Parties agree to negotiate in good faith and attempt to reach agreement through the JSC, on (i) the new price for any Products which embody such changes, provided that the price shall not change more than the direct effect of such changes on Fxxxxx’x costs for the Products, and (ii) any other amendments to this Agreement which may be necessitated by such changes (e.g., an adjustment to the lead time for purchase orders). For the avoidance of doubt, Fxxxxx is under no obligation to make any changes to the specifications absent mutual agreement on the foregoing. All costs arising from the destruction of any remaining stock of packaging material shall be borne by the Company if the requirement for a change in packaging materials comes from the Company.
Company Requested Changes. The Com pany shall have the right to request changes to the ICI Des ign and Construction Requirements, which shall be handled in the same man ner as provided in Article XI with respect to Capital Modifications. The parties shall agree on a form for describing an y change to or clarification of the ICI Design and Construction Requirements so approved by the Borough. The completed form pertaining to each such change shall be appended to the Contract Administration Memorandum containing the Borough's Change Order authorizing the change.
