Costs of Changes. 4.1 The provisions of Schedule 16 (Review Procedure) shall apply PROVIDED THAT the Operator's costs in responding to RFCs and in preparing Change Responses etc. shall be borne by the Operator and shall not constitute Eligible Expenditure for the purposes of Schedule 16 (Review Procedure).
Costs of Changes. Any and all costs associated with (i) Required Changes initiated by either Party, or (ii) Discretionary Changes initiated by the Buyer shall be borne by the Buyer. Any Discretionary Changes initiated by Seller shall be agreed to by the Parties including which Party or Parties shall be responsible for the funding of such Discretionary Change.
Costs of Changes. All modifications to a Product will be implemented at the sole expense of Vivint, unless the modification is (i) requested by Vivint Solar, or (ii) the defect or nonconformity necessitating the modification is the fault of Vivint Solar in providing defective functional specifications for Products, in which events Vivint Solar shall be responsible for the reasonable expenses of such modification, including a reasonable allocation of labor and overhead.
Costs of Changes. Except as may otherwise be agreed in the Statement of Work, [*] any and all costs with respect to Required Changes that are required to bring its manufacturing operations into compliance with Applicable Laws, and [*] any and all other costs related to Required Changes affecting the Product, which are unrelated to bringing Pfizer’s manufacturing operations into compliance with Applicable Laws. Any Discretionary Changes to the Product Specifications or the Manufacturing Process initiated by either Party will be agreed to by the Parties, including which Party or Parties will be responsible for the funding of such Discretionary Changes. All Discretionary or Required Changes will be implemented in accordance with the change control provisions of the Quality & Technical Agreement.
Costs of Changes. Unless otherwise agreed by the parties, any and all direct costs associated with changes requested by AAI DS and changes required by Applicable Law that apply generally to AAI DS' facility where the applicable Manufacturing occurs shall be borne by AAI DS. Unless otherwise agreed by the parties, any and all direct costs associated with all other changes, including, without limitation, changes requested by Purchaser, changes required by Applicable Laws that apply specifically to a Product, and changes required by a change to a Marketing Authorization, shall be borne by Purchaser (collectively, the "Other Changes"). If the change is an Other Change, (i) the Purchase Prices shall be adjusted by the change in AAI DS' cost of Manufacture of the Product caused by such Other Change, plus an amount necessary to maintain AAI DS' profit margin on such Product (with such profit margin calculated as the percentage markup of the Purchase Price over COGS for such Product), and (ii) Purchaser shall reimburse AAI DS for costs, expenses or losses associated with write-offs, obsolescence and/or destruction of any work in process or finished inventory resulting from any such Other Change.
Costs of Changes. Subject to Section 1.4, any and all costs associated with Mandatory Changes that primarily relate to the manufacturing, packaging, testing and supply of Products for distribution in the United States (including Regulatory Authority filings, write off and other costs due to such changes associated with obsolete Raw Materials, work-in-process and Products inventories) shall be borne by Purchaser and the costs of all other Mandatory Changes shall be borne by Manufacturer. Any and all costs associated with Discretionary Changes shall be paid by the Party requesting such changes. Each Party shall reasonably document such costs and provide such documentation upon request to the Party bearing or paying for such costs.
Costs of Changes. Unless otherwise agreed by the Parties, any and all direct costs associated with changes requested by AAIPharma and changes required by Applicable Law that apply generally to AAIPharma’s facility where the applicable Manufacturing occurs shall be [***] Certain information on this page has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. borne by AAIPharma. Unless otherwise agreed by the Parties, any and all direct costs associated with all other changes, including, without limitation, changes requested by Company, changes required by Applicable Laws that apply specifically to a Product, and changes required by a change to a Marketing Authorization, shall be borne by Company (collectively, the “Other Changes”). If the change is an Other Change, (i) the Purchase Prices shall be adjusted by the change in AAIPharma’s cost of Manufacture of the Product caused by such Other Change, plus an amount necessary to maintain AAIPharma’s profit margin on such, and (ii) Company shall reimburse AAIPharma for costs, expenses or losses associated with write-offs, obsolescence and/or destruction of any work in process or finished inventory resulting from any such Other Change.
Costs of Changes. Any and all costs associated with Required Changes shall be borne by Hospira. Any Discretionary Changes initiated by either party shall be agreed to by the Parties including which Party or Parties shall be responsible for the funding of such Discretionary Change. Notwithstanding the foregoing, any Required Changes during the first three (3) months after the Effective Date that are required in order to comply with laws and other Regulatory Requirements in effect as of the Effective Date shall be at Xxxxxx'x sole cost and expense.
Costs of Changes. Unless otherwise agreed by the Parties, any and all direct costs associated with changes requested by Company and/or changes required by Applicable Law(s) that apply generally to Company’s Facility where the applicable Manufacturing occurs shall be borne by Company; provided, however, in the event Applicable Law(s) imposes a registration fee (such as GDUFA or PDUFA) or similar user fee, and the fee relates to Company's Services hereunder, the Parties shall determine in good faith an equitable portion of such fee to be paid by Client. The Parties understand and agree that Company shall Manufacture the Drug Product in accordance with Applicable Law(s) and regulations, as the same may be amended from time to time. Each Party shall keep the other promptly and fully advised of any new instructions or specifications required by regulatory authority or Applicable Law(s) and shall discuss the cost of implementing such requirements, including by way of example, implementation of serialization. Unless otherwise agreed by the Parties, or otherwise necessitated by Company’s gross negligence and/or intentional acts or omissions, any and all direct costs associated with other changes, including, without limitation, changes requested by Client, changes required by Applicable Law(s) that apply specifically to API or Drug Product, and changes required by a change to a Marketing Authorization, shall be borne by Client (collectively, the “Other Changes”). If the change is an Other Change, (i) the Purchase Prices shall be adjusted by the change in Company’s cost of Manufacture of the API or Drug Product caused by such Other Change, and (ii) Client shall reimburse Company for costs, expenses or losses associated with write-offs, obsolescence and/or destruction of any work in process or finished inventory resulting from any such Other Change. If permitted by Applicable Law(s) and cGMP, any work in process and/or finished inventory resulting from any Other Change may be made available for delivery or pickup by Client, at Client’s sole cost and expense. The Parties agree to use good faith efforts to discuss changes to the Purchase Prices due to any Other Change, or otherwise, prior to any Purchase Price increase taking effect. Client may be required to make changes to the proposed API or Drug Product presentations based on clinical data and/or FDA feedback. In such instances, both Parties will work in good faith to identify and implement these changes expeditiously and agree on a...
Costs of Changes. If Required Changes are solely related to the Product or Nycomed's Capital Equipment installed at Patheon, all cost and expenses of these Changes should be paid for by Nycomed. Costs and expenses related to all other Required Changes should be paid for by Patheon. All costs and expenses associated with Discretionary Changes shall be borne by the Party requesting such Change, unless such Changes is suggested by Patheon in order to optimize the Manufacturing process of the Product, in which case the Parties shall meet and in good faith negotiate the costs and expenses and the settlement of said cost and expenses.
