Common use of Changes to Specifications Clause in Contracts

Changes to Specifications. Either of the PARTIES hereunder shall have the right to request changes to the SPECIFICATIONS; provided, however, that no such change shall be implemented unless: (a) the other PARTY gives its prior written consent to any such changes, which consent shall not be unreasonably withheld, conditioned or delayed, (b) the PARTIES agree in writing concerning the implementation date of any such change, and (c) in the event any such change increases or decreases or is reasonably likely to increase or decrease BIRI'S COSTS in connection with the performance of the MANUFACTURING SERVICES, the PARTIES agree in writing upon an equitable adjustment in the payment therefore. In addition, in the event any change in the SPECIFICATIONS is requested or required by any GOVERNMENTAL AGENCY, including the FDA, the PARTIES shall meet and discuss the implications of such change, the costs associated therewith, the capacity required to implement such change, and the timeframe in which such change could be implemented. If XANODYNE desires to have BIRI implement such change and so notifies BIRI in writing, BIRI shall promptly either implement such change or, in the event BIRI believes the implementation of such change would be commercially impractical, notify XANODYNE of its decision not to implement such change. BIRI shall not unreasonably refuse to implement any change and shall implement all changes that are not commercially impractical subject to [**]. Prior to implementing any change in the SPECIFICATIONS, the PARTIES shall agree in writing upon an equitable adjustment in the payments to BIRI to reflect any increased or decreased COSTS incurred by BIRI as a result of the implementation of such change. Commencing on the date any change in the SPECIFICATIONS is implemented, the payments to BIRI shall be adjusted as agreed in writing, and inventories of PRODUCTS, ingredients, packaging and LABELING components, and other in process work maintained by BIRI in accordance with Section 3.1(b) hereof which cannot be used by BIRI as the result of such change in the SPECIFICATIONS shall be identified by BIRI and purchased by XANODYNE from BIRI at BIRI'S COST therefore (including any costs associated with shipping and/or disposing of such materials in accordance with XANODYNE's instructions). If any change to the SPECIFICATIONS requires FDA or other GOVERNMENTAL AGENCY approval, such change shall not be implemented until such change has been so approved. Notwithstanding the foregoing, the COST shall not be increased as a result of any change, alteration or modification in the event such change, alteration or modification is related generally to the PLANT or other products manufactured by BIRI in the PLANT, with the exception of any mandated regulatory changes required by a Governmental Agency.

Changes to Specifications. Either of the PARTIES hereunder shall have the right to request changes (a) If Connetics desires any material change to the SPECIFICATIONSSpecifications or manufacturing process, Connetics shall deliver, sixty (60) days prior to the expected date of implementation, written notice to APG specifying such change desired by Connetics, and APG shall acknowledge in writing any such notice within thirty (30) days after APG receives the notice; provided, however, that no the Specifications or process shall not be supplemented, modified or amended in any respect without the prior written agreement of the Parties. APG will use Commercially Reasonable Efforts to implement changes within one hundred and twenty (120) days after APG's acknowledgement of such notice. If Connetics requests a change to a Product Specification, including the manufacturing process, and APG agrees that such change is feasible, such change shall be implemented unless: (a) incorporated within the other PARTY gives its Product Specification pursuant to a written amendment to this Agreement. Connetics shall be responsible for obtaining any required FDA approval prior written consent to any implementation of such changes, which consent shall not be unreasonably withheld, conditioned or delayed, a change at Connetics' cost. (b) the PARTIES agree APG will communicate to Connetics in writing concerning the implementation date of any such change, and (c) in the event any such change increases or decreases or is reasonably likely to increase or decrease BIRI'S COSTS in connection with the performance of the MANUFACTURING SERVICES, the PARTIES agree in writing upon an equitable adjustment in the payment therefore. In addition, in the event a timely manner any change in the SPECIFICATIONS is requested or required by any GOVERNMENTAL AGENCYProduct Specification, including the FDAmanufacturing process, the PARTIES shall meet and discuss the implications of such change, the costs associated therewith, the capacity required to implement such changeinitiated by APG, and the timeframe in which will obtain Connetics' written approval by way of written amendment of this Agreement incorporating such change could be implementedwithin the Product Specification prior to implementation of the change. If XANODYNE desires to have BIRI implement No such change may be instituted except in compliance with this Agreement and so notifies BIRI in writingthe Quality Agreement. Connetics shall have the option of obtaining, BIRI shall promptly either implement such change or, in the event BIRI believes the or having APG obtain any required FDA approval or other regulatory approval prior to implementation of such change would be commercially impractical, notify XANODYNE of its decision not to implement such a change. BIRI shall not unreasonably refuse APG may provide additional services in conjunction with the manufacture of Products, such as additional formulation, process development or stability testing, at the request of Connetics and pursuant to implement any change Connetics' purchase order, and shall implement all changes that are not commercially impractical subject to [**]. Prior to implementing any change in the SPECIFICATIONS, the PARTIES shall agree in writing upon an equitable adjustment in the payments to BIRI to reflect any increased or decreased COSTS incurred by BIRI as a result of the implementation of data and results from such change. Commencing on the date any change in the SPECIFICATIONS is implemented, the payments to BIRI additional services shall be adjusted owned by Connetics and protected as agreed in writing, and inventories of PRODUCTS, ingredients, packaging and LABELING components, and other in process work maintained by BIRI in accordance with Section 3.1(b) hereof which cannot be used by BIRI as the result of such change in the SPECIFICATIONS shall be identified by BIRI and purchased by XANODYNE from BIRI at BIRI'S COST therefore (including any costs associated with shipping and/or disposing of such materials in accordance with XANODYNE's instructions). If any change to the SPECIFICATIONS requires FDA or other GOVERNMENTAL AGENCY approval, such change shall not be implemented until such change has been so approved. Notwithstanding the foregoing, the COST shall not be increased as a result of any change, alteration or modification in the event such change, alteration or modification is related generally to the PLANT or other products manufactured by BIRI in the PLANT, with the exception of any mandated regulatory changes required by a Governmental Agencyconfidential under this Agreement.