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.

Changes to Specifications. Either MEDIMMUNE shall promptly advise ▇▇▇▇▇▇ of the PARTIES hereunder shall have the right to request any proposed or required changes to the SPECIFICATIONS; provided, however, that no such change shall be implemented unless: ▇▇▇▇▇▇’▇ consent (a) the other PARTY gives its prior written consent not to any such changes, which consent shall not be unreasonably withheld, conditioned or delayed, ) shall be required to make any Discretionary Changes (bas defined below) that will adversely affect a REGULATORY FILING submitted by ▇▇▇▇▇▇ to the PARTIES agree in writing concerning the implementation date of any such change, and (c) REGULATORY AUTHORITIES in the event any such change increases or decreases or is reasonably likely TERRITORY. Changes to increase or decrease BIRI'S COSTS the SPECIFICATIONS that are required to comply with the requirements of applicable REGULATORY AUTHORITIES in the MAJOR MARKETS shall be deemed “Required Changes.” Other changes to the manufacturing process, including those required in connection with the performance change in THIRD PARTY MANUFACTURER (but not an initial selection of the MANUFACTURING SERVICES, the PARTIES agree in writing upon an equitable adjustment a THIRD PARTY MANUFACTURER) or changes that are intended to promote quality control/quality assurance and/or achieve greater efficiency or cost savings in the payment therefore. In additionmanufacturing process shall be deemed “Discretionary Changes.” For the avoidance of doubt, a change from one formulation of a PRODUCT to another is a Discretionary Change; provided, however, that notwithstanding anything in this Section 7.7 to the event any contrary, (i) ▇▇▇▇▇▇ is hereby deemed to have consented to the change from the lyophilized formulation of SYNAGIS to the liquid formulation of SYNAGIS without the need to undergo the consent/approval procedures set forth in this Section 7.7, (ii) ▇▇▇▇▇▇ acknowledges that it has received the SPECIFICATIONS is requested or for the liquid formulation of SYNAGIS (attached as Exhibit A-2) and waives its ability to comment on such SPECIFICATIONS as permitted by this Section 7.7. Notwithstanding anything in this AGREEMENT to the contrary, ▇▇▇▇▇▇ hereby agrees to conduct any clinical studies required by any GOVERNMENTAL AGENCYREGULATORY AUTHORITIES in the MAJOR MARKETS to obtain REGULATORY APPROVAL for the liquid formulation of SYNAGIS; provided, including however, that, ▇▇▇▇▇▇ shall not be obligated to commence any such clinical study required earlier than January 1, 2006; provided, further, that if ▇▇▇▇▇▇ does not commence any such clinical study before January 1, 2006 and such study has otherwise been discussed and reviewed by the FDAManufacturing Steering Committee, the PARTIES shall meet then MEDIMMUNE may, but is not obligated to, commence such trial and discuss the implications of such changeits own cost before January 1, the costs associated therewith2006. (a) MEDIMMUNE shall, the capacity required at its cost, use COMMERCIALLY REASONABLE EFFORTS to implement such changeRequired Changes to the manufacturing process as soon as practicable, and the timeframe in which such change could be implemented. If XANODYNE desires ▇▇▇▇▇▇ shall, at its cost, use COMMERCIALLY REASONABLE EFFORTS to have BIRI implement such change and so notifies BIRI in writingpromptly (i) make any changes, BIRI shall promptly either implement such change orfilings or refilings of PRODUCT REGISTRATIONS, in the event BIRI believes (ii) obtain approval for the implementation of such change would be commercially impractical, notify XANODYNE of its decision not Required Changes in the TERRITORY and (iii) conduct any clinical studies required by the applicable REGULATORY AUTHORITIES to implement such change. BIRI Required Changes. (b) All proposed Discretionary Changes requested by MEDIMMUNE shall be submitted to ▇▇▇▇▇▇ for review and within ten (10) days of such submission, ▇▇▇▇▇▇ shall either approve such Discretionary Changes or request that the Manufacturing Steering Committee meet to review and consider approval and all proposed Discretionary Changes requested by ▇▇▇▇▇▇ shall be submitted to the Manufacturing Steering Committee to review and consider approval; provided, however, that (i) the Manufacturing Steering Committee shall not unreasonably refuse have the authority to approve any proposed Discretionary Change if its implementation will adversely impact any pending application for REGULATORY APPROVAL in any country in the TERRITORY, and (ii) any such approval of a Discretionary Change by the Manufacturing Steering Committee may be delayed until the next calendar year in the event that ▇▇▇▇▇▇ reasonably notifies the Manufacturing Steering Committee, in writing, that the implementation of the Discretionary Change shall cause ▇▇▇▇▇▇ to incur substantial unbudgeted costs to obtain REGULATORY APPROVAL for such Discretionary Change. For the purposes of clause (ii) of the preceding sentence, a “substantial unbudgeted” cost shall be deemed to be a cost which was not discussed and reviewed by the Manufacturing Steering Committee prior to September 30 of the calendar year in which a Discretionary Change is requested by MEDIMMUNE and which would have a material adverse financial impact on ▇▇▇▇▇▇’▇ overall budget related to the PRODUCTS for the calendar year in which the Discretionary Change was requested. If approved by the Manufacturing Steering Committee, MEDIMMUNE shall, at its cost, use its COMMERCIALLY REASONABLE EFFORTS to implement all such Discretionary Changes to the manufacturing process as soon as practicable, and ▇▇▇▇▇▇ shall, at its cost, use COMMERCIALLY REASONABLE EFFORTS to promptly (i) make any change changes, filings or refilings of PRODUCT REGISTRATIONS, (ii) obtain approval for the implementation of such Discretionary Changes in the TERRITORY, (iii) conduct any clinical studies required by the applicable REGULATORY AUTHORITIES to implement such Discretionary Changes and (iv) obtain the approval of the applicable REGULATORY AUTHORITIES in the TERRITORY for implementation of such Discretionary Changes (if necessary) as soon as practicable. MEDIMMUNE shall, in writing, notify ▇▇▇▇▇▇ of any Discretionary Changes to the SPECIFICATION of any PRODUCT which, if implemented, would require notification to REGULATORY AUTHORITIES in the TERRITORY. Upon receipt of such notification, ▇▇▇▇▇▇ shall be entitled to provide recommendations to MEDIMMUNE regarding the manner and timing of the adoption of such Discretionary Changes. MEDIMMUNE shall, to the extent commercially reasonable under the circumstances, reasonably take into consideration ▇▇▇▇▇▇’▇ recommendations and shall implement all cooperate with ▇▇▇▇▇▇ in making such Discretionary Changes. To the extent such changes that are not commercially impractical require a new or amended PRODUCT REGISTRATION, MEDIMMUNE and ▇▇▇▇▇▇ shall cooperate and coordinate the adoption of such changes to the SPECIFICATIONS so as to minimize any disruption of the marketing, promotion and sale of PRODUCT in any country within the TERRITORY. (c) MEDIMMUNE and ▇▇▇▇▇▇ shall define appropriate change control procedures by and among MEDIMMUNE, ▇▇▇▇▇▇ and any THIRD PARTY MANUFACTURER in the quality/technical agreement described above, subject to [**]. Prior to implementing any review and approval of the Manufacturing Steering Committee. (d) Any PRODUCT that becomes unsalable following a 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 PRODUCT REGISTRATION 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 a Discretionary Change to the SPECIFICATIONS requires FDA or other GOVERNMENTAL AGENCY approval, such initiated by MEDIMMUNE shall be deemed to be a defective PRODUCT and shall entitle ▇▇▇▇▇▇ to the remedies provided under Section 7.3 of this Agreement. To the extent any PRODUCT becomes unsalable following a change shall not be implemented until such change has been so approved. Notwithstanding the foregoing, the COST shall not be increased in PRODUCT REGISTRATION as a result of any change, alteration or modification in the event such change, alteration or modification is related generally a Discretionary Change to the PLANT or other products manufactured SPECIFICATIONS initiated by BIRI in ▇▇▇▇▇▇, MEDIMMUNE shall be excused from meeting its obligations to supply the PLANT, with the exception of any mandated regulatory changes required by a Governmental Agencyaffected PRODUCT(S).

Changes to Specifications. Either Subject to the remaining provisions of this Section 4.3, the Product Specifications may be changed from time to time (i) if required by the FDA, or (ii) upon the request of either Party and with the consent of the PARTIES hereunder other Party. The following provisions shall have the right apply to request changes to the SPECIFICATIONSProduct Specifications: (a) The Party seeking the change(s) shall promptly advise the other Party in writing of any such change(s) to the Product Specifications, and APP shall promptly advise MDCO as to any scheduling, price or other adjustments that may result from such change(s), if any. (b) In the event of a change of the nature described in clause (i) above, the Party seeking the change shall notify the other Party in writing promptly upon being informed of or identifying the potential need for such change and shall consult with the other Party on an ongoing basis regarding such change, including the need for such potential change and the appropriate way to address the issue giving rise to such potential change. (c) Each Party shall use Commercially Reasonable Efforts to implement any required or agreed-upon changes to the Product Specifications as soon as practicable after the nature of the change is determined and, if applicable, the applicable Party has consented to the change; provided, however, that in no event shall any change be implemented until such time as such change has been approved by the FDA, if such approval is required. (d) MDCO 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 changeresponsible for, and (c) in the event any such change increases shall promptly reimburse APP for, all reasonable costs and expenses incurred by or decreases on behalf of APP or is reasonably likely to increase or decrease BIRI'S COSTS its supply contractors in connection with the performance implementation of changes to the MANUFACTURING SERVICESProduct Specifications that are requested by MDCO or are necessary to comply with MDCO's requests. APP shall be responsible for changes required by FDA. Additionally, if any changes to the Product Specifications result in a change in Cost of Goods with respect to the Product, the PARTIES agree in writing upon an equitable adjustment in Purchase Prices shall be adjusted to fully account for 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 amount 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 11.1 Without the prior written consent of FOAMIX, ASM shall not modify or waive the Specifications, raw materials, production documents or any aspect of the PARTIES hereunder Manufacturing Process for the Product nor alter the batch size of Products. ASM shall have not manufacture the right to Product at any manufacturing facility other than the Facility. 11.2 FOAMIX may request changes to the SPECIFICATIONS; providedSpecifications in its discretion, howeverprovided that any amendment that proposes to change the Manufacturing Process of a Product shall not be effective until agreed upon by the Parties. If ASM proposes changes to the Specifications, it shall notify FOAMIX as early as practicable and the Parties shall agree on whether and when to implement such modification. The final decision on modifications of the Specifications remains solely at FOAMIX’s discretion. To the extent that no such modifications result in an increase or decrease in the cost of Manufacturing and/or packaging the Products, the Parties shall jointly examine and mutually agree upon the consequences thereof and shall make appropriate adjustments to the Product Price. ASM shall promptly notify FOAMIX of the date of implementation of any modification. 11.3 Each Party shall notify the other promptly of any request that it receives from a Governmental Authority to change, or which would have the effect of requiring a change to, the Specifications and/or Manufacturing Process. After written approval by FOAMIX, ASM shall promptly implement any such change in the Specifications and/or Manufacturing Process that may be requested by a Governmental Authority. Any additional costs incurred by ASM due to such change shall be implemented unless: (a) the other PARTY gives its prior written consent to any such changes, which consent borne by FOAMIX. ASM 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 provide FOAMIX 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 documentation required to implement evidence such change, changes and the timeframe in to support their approval by Governmental Authorities. 11.4 The cost of Product Material which such becomes obsolete due to a 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 Specifications induced by FOAMIX 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 Governmental Authority shall be adjusted as agreed in writingborne by FOAMIX, 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 but only to the extent that such material 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 ASM for 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 Agencyoperations.

Changes to Specifications. Either of (a) The Parties may revise the PARTIES hereunder shall have the right Specifications for any Product upon mutual written consent (such consent not to request be unreasonably withheld), except that, as further described below in this Section 6.5, neither Party may withhold its consent to Required (as defined below) changes to the SPECIFICATIONS; provided, however, Specifications. Any changes to the Specifications that no such change are agreed upon or required pursuant to this Section 6.5 shall be implemented unless: (a) effective as of the other PARTY gives its prior written consent date mutually agreed upon in writing by the Parties, and all references to any such changes, which consent the relevant Specifications shall not thereafter be unreasonably withheld, conditioned or delayed, deemed to refer to the Specifications as so modified. (b) If either Party (the PARTIES agree "Proposing Party") desires to change any Specifications it shall notify the other Party (the "Recipient") in writing concerning of the implementation date proposed change (a "Proposed Specification Change"), and the Development Team shall review and discuss such Proposed Specification Change. As soon as reasonably practicable after receiving any such notification, but in any event within thirty (30) days after such receipt, the Recipient shall respond in writing to the Proposing Party whether it agrees to effect the Proposed Specification Change. Any Proposed Specification Change that is required by a Regulatory Authority or law or regulation of any such jurisdiction in which OSI is developing and/or marketing the Product affected by the Proposed Specification Change shall be referred to herein as a "Required" change, and . The Parties shall make each Proposed Specification Change to a set of Specifications that is Required. (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 SERVICESFor each Proposed Specification Change, 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 Gilead 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 indicate for informational purposes whether the implementation of such change would be commercially impracticalis expected to result in material additional capital costs or other expenses of manufacturing the Product governed by such Specifications over those which Gilead is then incurring to manufacture or have such Product or API manufactured ("Additional Costs"). For Proposed Specification Changes that are not Required, notify XANODYNE promptly after Gilead's notice of its decision not any Additional Costs, OSI shall indicate in writing whether it continues to wish to implement such changeProposed Specification Change. BIRI Neither Party shall not unreasonably refuse have any obligation to implement any change and shall implement all changes that Proposed Specification Changes unless such Proposed Specification Changes are not commercially impractical subject to [**]. Prior to implementing any change Required or the Parties (via their participation in the SPECIFICATIONSDevelopment Teams) have agreed in writing nonetheless to implement such Proposed Specification Changes (each, an "Implemented Change"). (d) For Additional Costs associated with Implemented Changes, the PARTIES Parties shall agree in writing upon an equitable adjustment in adjust the payments to BIRI Transfer Price to reflect any increased or decreased COSTS incurred by BIRI such Additional Costs as a result part of Gilead's Fully Burdened Costs to manufacture the affected Product as of the implementation of such change. Commencing on date the date any change Implemented Change goes into effect, as set forth 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 instructions9.2(f). 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 Subject to the remaining provisions of this SECTION 3.5, the API Specifications and the Product Specifications may be changed from time to time (i) if required by applicable U.S. laws or the FDA or (ii) upon the request of either Party and with the consent of the PARTIES hereunder other Party. The following provisions shall have apply to changes in the right API Specifications or the Product Specifications: (a) The Party seeking the change(s) shall promptly advise the other Party in writing of any such change(s) to request the Product Specifications or the API Specifications, and ▇▇▇▇▇▇▇ shall promptly advise NitroMed as to any scheduling, price or other adjustments that may result from such change(s), if any. (b) In the event of a change of the nature described in CLAUSE (i) above, the Party seeking the change shall notify the other Party in writing promptly upon being informed of or identifying the potential need for such change and shall consult with the other Party on an ongoing basis regarding such change, including the need for such potential change and the appropriate way to address the issue giving rise to such potential change. (c) Each Party shall use its commercially reasonable efforts to implement any required or agreed-upon changes to the SPECIFICATIONSProduct Specifications or the API Specifications, as applicable, as soon as practicable after the nature of the change is determined and, if applicable, the applicable Party has consented to the change; providedPROVIDED, howeverHOWEVER, that in no event shall any change be implemented until such time as such change has been approved by the FDA. (d) NitroMed 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 changeresponsible for, and (c) in the event any such change increases shall promptly reimburse ▇▇▇▇▇▇▇ for, all reasonable costs and expenses incurred by or decreases on behalf of ▇▇▇▇▇▇▇ or is reasonably likely to increase or decrease BIRI'S COSTS its supply contractors in connection with the performance implementation of changes to the MANUFACTURING SERVICESProduct Specifications or the API Specifications that are mandatory or are requested by NitroMed. Additionally, if any changes to the Product Specifications or the API Specifications result in an increase in ▇▇▇▇▇▇▇'▇ manufacturing costs with respect to the Product, 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 supply prices set forth on the date any change in the SPECIFICATIONS is implemented, the payments to BIRI SCHEDULE 4.1 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 to fully account for the result amount 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 Agencyincrease.

Changes to Specifications. Either of 8.1 All Specifications and any changes thereto agreed to by the PARTIES hereunder parties from time to time shall have be in writing, dated and signed by the right to request changes parties. Any change to the SPECIFICATIONSProcess shall be deemed a Specification change. No change in the Specifications shall be implemented by Catalent, whether requested by Client or requested or required by any Regulatory Authority, until the parties have agreed in writing to such change, the implementation date of such change (“Change Date”), and any increase or decrease in costs, expenses or fees associated with such change (including any change to Unit Pricing) (“Change Costs”). Catalent shall respond promptly to any request made by Client for a change in the Specifications, and both parties shall use commercially reasonable efforts to agree to the terms of such change in a timely manner; provided, however, that no in the case of any change that is requested by Client in response to (i) requirements imposed by a Regulatory Authority or Applicable Laws, or (ii) a safety or toxicity issue, the only terms of such change that Catalent may object to are the Change Date, the Change Costs and any requested change that would reasonably be expected to affect Catalent’s other customers or regulatory status, and Catalent shall be implemented unless: (a) the other PARTY gives its prior written consent use commercially reasonable, good faith efforts to resolve any such objection in an expedited manner. As soon as possible after a request is made for any change in Specifications, Catalent shall notify Client of the costs associated with such change and shall provide such supporting documentation as Client may reasonably require. Client shall pay all reasonable costs associated with such agreed upon changes. If there is a conflict between the terms of this Agreement and the terms of the Specifications, which consent this Agreement shall not be unreasonably withheldcontrol. Catalent reserves the right to postpone effecting changes to the Specifications until such time as the parties agree to and execute the required written amendment. 8.2 Catalent and Client shall use commercially reasonable efforts to continually improve the net cost of Processing and to develop cost reduction initiatives as part of an overall cost improvement program, conditioned or delayedtaking into account the total manufacturing environment including technology, (b) industry standards, specifications, Raw Materials, inventory and forecasting. After the PARTIES agree in writing concerning Effective Date, Catalent and Client shall establish the implementation date of JSC that will meet from time to time to review and share ideas for these improvements. Through the JSC, the parties shall promptly notify one another regarding any such changepotential cost reduction efforts that are identified. In addition, and (c) in Client may propose to Catalent certain changes to the event any such change increases Specifications or decreases the manufacturing process that it reasonably believes will improve the manufacturing process or is reasonably likely lower costs or that Client otherwise wishes to increase or decrease BIRI'S COSTS implement in connection with the performance of Product or the MANUFACTURING SERVICESProcessing thereof. Upon Client’s request, the PARTIES agree in writing upon an equitable adjustment in the payment therefore. In addition, in the event Catalent shall review any such proposed 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, Client and the timeframe parties will discuss 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 good faith potential implementation of such change. Commencing The parties shall mutually agree on which changes, if any, shall be further developed or implemented in accordance with the date any change control procedures set forth in the SPECIFICATIONS is implemented, Quality Agreement. Except as the payments to BIRI shall be adjusted as agreed parties may otherwise agree in writing, Catalent and inventories Client shall share in any cost savings resulting from the implementation thereof based on [***]. Notwithstanding anything to the contrary, each party may withhold its consent to implementation of PRODUCTSany cost saving changes in its sole discretion. Promptly following such implementation, ingredients, packaging and LABELING components, and other in process work maintained the Unit Pricing for the Product payable by BIRI in accordance with Section 3.1(b) hereof which cannot Client as set forth on Attachment C shall be used by BIRI as the result reduced to reflect Client’s share 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 Agencycost savings.

Changes to Specifications. Either of the PARTIES hereunder shall have the right In each case subject to request changes to the SPECIFICATIONS; provided, however, that no such change shall be implemented unless: clause 3.11: (a) Amendments, modifications and additions to the Specifications (“Specification Changes”), the Manufacturing Process of a Batch (“Process Changes”), or the quality of Components (“Component Changes”) may only be made upon mutual written agreement between the Parties in each case, in accordance with the applicable provisions of the applicable Quality Agreement. If Specification Changes, Process Changes or Component Changes are so agreed to by the Parties, OXB shall promptly implement the same. The cost allocation between the Parties for any other PARTY gives its Specification Changes, Process Changes and Component Changes will be as agreed to by the Parties in writing. (b) Notwithstanding clause 3.4(a), OXB shall use commercially reasonable efforts to implement any reasonable Specification Changes, Process Changes or Component Changes which are requested by Client (each, a “Requested Change”), provided that: (i) such Requested Change does not affect the cost to OXB of performing the relevant Services (unless Client agrees in writing to cover such costs), or require Client to perform Services materially different from those described in the applicable Scope of Work, Work Order or Change Order, or require OXB to breach any contractual obligations owed to, or to incur any additional expense in relation to (unless Client agrees in writing to cover such costs) in relation to any other customer; and (ii) if OXB notifies Client of a reasoned technical concern regarding such Requested Change and if Client nevertheless wishes to evaluate the potential implementation of the Requested Change, then: (1) the Parties will enter into a Scope of Work or Work Order for one or more pilot batch(es) implementing the Requested Change; (2) if Client deems the pilot batch(es) successful, the Parties will work together in good faith to align on implementation of the Requested Changes, taking into account the results of the pilot batch(es); and (3) if the Parties are able to come to such agreement, the Parties shall execute a Change Order in accordance with clause 3.1 and OXB will promptly implement the applicable changes, in accordance with the Change Order. (c) To the extent necessary, the Parties shall amend the Quality Agreement and Scope of Work or Work Order to reflect any such Specifications Changes, Process Changes and Component Changes agreed in writing by the Parties. Without limiting the foregoing, for clarity, no Specification Changes, Process Changes or Component Changes will be implemented by OXB without the prior written consent to any such changes, which consent shall not be unreasonably withheld, conditioned or delayed, (b) the PARTIES agree of Client 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 Agencyeach instance.