Common use of Changes to Specifications Clause in Contracts

Changes to Specifications. (a) If Connetics desires any material change to the Specifications 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 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 incorporated within the Product Specification pursuant to a written amendment to this Agreement. Connetics shall be responsible for obtaining any required FDA approval prior to implementation of such a change at Connetics' cost. (b) APG will communicate to Connetics in a timely manner any change in the Product Specification, including the manufacturing process, initiated by APG, and will obtain Connetics' written approval by way of written amendment of this Agreement incorporating such change within the Product Specification prior to implementation of the change. No such change may be instituted except in compliance with this Agreement and the Quality Agreement. Connetics shall have the option of obtaining, or having APG obtain any required FDA approval or other regulatory approval prior to implementation of such a change. 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 Connetics' purchase order, and all data and results from such additional services shall be owned by Connetics and protected as confidential under this Agreement.

Changes to Specifications. (a) If Connetics desires any material change Either of the PARTIES hereunder shall have the right to request changes to the Specifications 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 noticeSPECIFICATIONS; provided, however, that no such change shall be implemented unless: (a) the Specifications or process other PARTY gives its prior written consent to any such changes, which consent shall not be supplementedunreasonably withheld, modified conditioned or amended delayed, (b) the PARTIES agree in writing concerning the implementation date of any respect without such change, and (c) in the prior written agreement 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 PartiesMANUFACTURING SERVICES, the PARTIES agree in writing upon an equitable adjustment in the payment therefore. 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 In addition, in the event any change to a Product Specificationin the SPECIFICATIONS is requested or required by any GOVERNMENTAL AGENCY, including the manufacturing processFDA, the PARTIES shall meet and discuss the implications of such change, the costs associated therewith, the capacity required to implement such change, and APG agrees that 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 feasibleimplemented, 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 incorporated within implemented until such change has been so approved. Notwithstanding the Product Specification pursuant to foregoing, the COST shall not be increased as a written amendment to this Agreement. Connetics shall be responsible for obtaining result of any required FDA approval prior to implementation of such a change at Connetics' cost. (b) APG will communicate to Connetics in a timely manner any change change, alteration or modification in the Product Specificationevent such change, including alteration or modification is related generally to the manufacturing process, initiated by APG, and will obtain Connetics' written approval by way of written amendment of this Agreement incorporating such change within the Product Specification prior to implementation of the change. No such change may be instituted except in compliance with this Agreement and the Quality Agreement. Connetics shall have the option of obtaining, or having APG obtain any required FDA approval PLANT or other regulatory approval prior to implementation of such a change. APG may provide additional services products manufactured by BIRI in conjunction the PLANT, with the manufacture exception of Products, such as additional formulation, process development or stability testing, at the request of Connetics and pursuant to Connetics' purchase order, and all data and results from such additional services shall be owned any mandated regulatory changes required by Connetics and protected as confidential under this Agreementa Governmental Agency.

Changes to Specifications. (a) If Connetics desires 8.1 All Specifications and any material changes thereto agreed to by the parties from time to time shall be in writing, dated and signed by the parties. Any change to the Process shall be deemed a Specification change. No change in the Specifications shall be implemented by Catalent, whether requested by Client or manufacturing processrequested or required by any Regulatory Authority, Connetics 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 deliverrespond promptly to any request made by Client for a change in the Specifications, sixty (60) days prior and both parties shall use commercially reasonable efforts to agree to the expected date terms 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 noticea timely manner; provided, however, that in the Specifications case of any change that is requested by Client in response to (i) requirements imposed by a Regulatory Authority or process shall not be supplementedApplicable Laws, modified or amended in any respect without (ii) a safety or toxicity issue, 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 only terms of such notice. If Connetics requests a change that Catalent may object to a Product Specificationare the Change Date, including the manufacturing processChange Costs and any requested change that would reasonably be expected to affect Catalent’s other customers or regulatory status, and APG agrees that Catalent shall use commercially reasonable, good faith efforts to resolve any such change objection in an expedited manner. As soon as possible after a request is feasible, such change shall be incorporated within the Product Specification pursuant to a written amendment to this Agreement. Connetics shall be responsible made for obtaining any required FDA approval prior to implementation of such a change at Connetics' cost. (b) APG will communicate to Connetics in a timely manner any change in Specifications, Catalent shall notify Client of the Product Specification, including the manufacturing process, initiated by APG, and will obtain Connetics' written approval by way of written amendment of this Agreement incorporating costs associated with such change within 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 Product Specification prior to implementation terms of the change. No such change may be instituted except in compliance with this Agreement and the terms of the Specifications, this Agreement shall control. 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, taking into account the total manufacturing environment including technology, industry standards, specifications, Raw Materials, inventory and forecasting. After the Effective Date, Catalent and Client shall establish the 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 potential cost reduction efforts that are identified. In addition, Client may propose to Catalent certain changes to the Specifications or the manufacturing process that it reasonably believes will improve the manufacturing process or lower costs or that Client otherwise wishes to implement in connection with the Product or the Processing thereof. Upon Client’s request, Catalent shall review any such proposed change by Client and the parties will discuss in good faith potential implementation of such change. The parties shall mutually agree on which changes, if any, shall be further developed or implemented in accordance with the change control procedures set forth in the Quality Agreement. Connetics Except as the parties may otherwise agree in writing, Catalent and Client shall have share in any cost savings resulting from the option of obtainingimplementation thereof based on [***]. Notwithstanding anything to the contrary, or having APG obtain any required FDA approval or other regulatory approval prior each party may withhold its consent to implementation of any cost saving changes in its sole discretion. Promptly following such a change. APG may provide additional services in conjunction with implementation, the manufacture of Products, such Unit Pricing for the Product payable by Client as additional formulation, process development or stability testing, at the request of Connetics and pursuant to Connetics' purchase order, and all data and results from such additional services set forth on Attachment C shall be owned by Connetics and protected as confidential under this Agreementreduced to reflect Client’s share of such cost savings.

Changes to Specifications. (a) If Connetics desires 11.1 Without the prior written consent of FOAMIX, ASM shall not modify or waive the Specifications, raw materials, production documents or any material change aspect of the Manufacturing Process for the Product nor alter the batch size of Products. ASM shall not manufacture the Product at any manufacturing facility other than the Facility. 11.2 FOAMIX may request changes to the Specifications or manufacturing processin its discretion, Connetics shall deliver, sixty (60) days prior provided that any amendment that proposes to change the expected date Manufacturing Process 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 the Specifications or process a Product shall not be supplemented, modified or amended in any respect without the prior written agreement of effective until agreed upon by the Parties. APG will use Commercially Reasonable Efforts 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 changes within one hundred such modification. The final decision on modifications of the Specifications remains solely at FOAMIX’s discretion. To the extent that such modifications result in an increase or decrease in the cost of Manufacturing and/or packaging the Products, the Parties shall jointly examine and twenty (120) days after APG's acknowledgement mutually agree upon the consequences thereof and shall make appropriate adjustments to the Product Price. ASM shall promptly notify FOAMIX of such notice. If Connetics requests 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 a Product Specificationto, including the manufacturing processSpecifications and/or Manufacturing Process. After written approval by FOAMIX, and APG agrees that ASM shall promptly implement any such change is feasible, 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 incorporated within borne by FOAMIX. ASM shall provide FOAMIX with the documentation required to evidence such changes and to support their approval by Governmental Authorities. 11.4 The cost of Product Specification pursuant Material which becomes obsolete due to a written amendment to this Agreement. Connetics change of Specifications induced by FOAMIX or a Governmental Authority shall be responsible borne by FOAMIX, but only to the extent that such material cannot be used by ASM for obtaining any required FDA approval prior to implementation of such a change at Connetics' costother operations. (b) APG will communicate to Connetics in a timely manner any change in the Product Specification, including the manufacturing process, initiated by APG, and will obtain Connetics' written approval by way of written amendment of this Agreement incorporating such change within the Product Specification prior to implementation of the change. No such change may be instituted except in compliance with this Agreement and the Quality Agreement. Connetics shall have the option of obtaining, or having APG obtain any required FDA approval or other regulatory approval prior to implementation of such a change. 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 Connetics' purchase order, and all data and results from such additional services shall be owned by Connetics and protected as confidential under this Agreement.

Changes to Specifications. (a) If Connetics desires The Parties may revise the Specifications for any material change Product upon mutual written consent (such consent not to 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. Any changes to the Specifications that are agreed upon or manufacturing processrequired pursuant to this Section 6.5 shall be effective as of the date mutually agreed upon in writing by the Parties, Connetics shall deliver, sixty (60) days prior and all references to the expected date relevant Specifications shall thereafter be deemed to refer to the Specifications as so modified. (b) If either Party (the "Proposing Party") desires to change any Specifications it shall notify the other Party (the "Recipient") in writing of implementation, written notice to APG specifying such the proposed change desired by Connetics(a "Proposed Specification Change"), and APG the Development Team shall acknowledge in writing review and discuss such Proposed Specification Change. As soon as reasonably practicable after receiving any such notice notification, but in any event within thirty (30) days after APG receives such receipt, the notice; provided, however, 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 jurisdiction in which OSI is developing and/or marketing the Specifications or process Product affected by the Proposed Specification Change shall not be supplemented, modified or amended in any respect without the prior written agreement of the Partiesreferred to herein as a "Required" change. 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 The Parties shall make each Proposed Specification Change to a Product Specificationset of Specifications that is Required. (c) For each Proposed Specification Change, including Gilead shall indicate for informational purposes whether the manufacturing process, and APG agrees that implementation of such change is feasible, such change shall be incorporated within 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 pursuant Changes that are not Required, promptly after Gilead's notice of any Additional Costs, OSI shall indicate in writing whether it continues to a written amendment wish to this Agreementimplement such Proposed Specification Change. Connetics Neither Party shall be responsible for obtaining have any required FDA approval prior obligation to implementation of implement any Proposed Specification Changes unless such a change at Connetics' costProposed Specification Changes are Required or the Parties (via their participation in the Development Teams) have agreed in writing nonetheless to implement such Proposed Specification Changes (each, an "Implemented Change"). (bd) APG will communicate For Additional Costs associated with Implemented Changes, the Parties shall adjust the Transfer Price to Connetics in a timely manner any change in reflect such Additional Costs as part of Gilead's Fully Burdened Costs to manufacture the affected Product Specification, including the manufacturing process, initiated by APG, and will obtain Connetics' written approval by way of written amendment of this Agreement incorporating such change within the Product Specification prior to implementation as of the change. No such change may be instituted except date the Implemented Change goes into effect, as set forth in compliance with this Agreement and the Quality Agreement. Connetics shall have the option of obtaining, or having APG obtain any required FDA approval or other regulatory approval prior to implementation of such a change. 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 Connetics' purchase order, and all data and results from such additional services shall be owned by Connetics and protected as confidential under this AgreementSection 9.2(f).

Changes to Specifications. (a) If Connetics desires MEDIMMUNE shall promptly advise ▇▇▇▇▇▇ of any material change proposed or required changes to the Specifications 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 noticeSPECIFICATIONS; provided, however, that ▇▇▇▇▇▇’▇ consent (not to be unreasonably withheld) shall be required to make any Discretionary Changes (as defined below) that will adversely affect a REGULATORY FILING submitted by ▇▇▇▇▇▇ to the Specifications or process REGULATORY AUTHORITIES in the TERRITORY. Changes to the SPECIFICATIONS that are required to comply with the requirements of applicable REGULATORY AUTHORITIES in the MAJOR MARKETS shall not be supplemented, modified or amended in any respect without the prior written agreement of the Parties. APG will use Commercially Reasonable Efforts deemed “Required Changes.” Other changes 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 including those required in connection with the change in THIRD PARTY MANUFACTURER (but not an initial selection of a THIRD PARTY MANUFACTURER) or changes that such change is feasible, such change are intended to promote quality control/quality assurance and/or achieve greater efficiency or cost savings in the manufacturing process shall be incorporated within deemed “Discretionary Changes.” For the Product Specification pursuant avoidance of doubt, a change from one formulation of a PRODUCT to another is a written amendment Discretionary Change; provided, however, that notwithstanding anything in this Section 7.7 to the 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 AgreementSection 7.7, (ii) ▇▇▇▇▇▇ acknowledges that it has received the SPECIFICATIONS 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. Connetics Notwithstanding anything in this AGREEMENT to the contrary, ▇▇▇▇▇▇ hereby agrees to conduct any clinical studies required by any REGULATORY AUTHORITIES in the MAJOR MARKETS to obtain REGULATORY APPROVAL for the liquid formulation of SYNAGIS; provided, however, that, ▇▇▇▇▇▇ shall not be responsible 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 Manufacturing Steering Committee, then MEDIMMUNE may, but is not obligated to, commence such trial and its own cost before January 1, 2006. (a) MEDIMMUNE shall, at its cost, use COMMERCIALLY REASONABLE EFFORTS to implement Required Changes to the manufacturing process as soon as practicable, and ▇▇▇▇▇▇ shall, at its cost, use COMMERCIALLY REASONABLE EFFORTS to promptly (i) make any changes, filings or refilings of PRODUCT REGISTRATIONS, (ii) obtain approval for obtaining any required FDA approval prior to the implementation of such a change at Connetics' costRequired Changes in the TERRITORY and (iii) conduct any clinical studies required by the applicable REGULATORY AUTHORITIES to implement such Required Changes. (b) APG 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 have the authority to approve any proposed Discretionary Change if its implementation will communicate to Connetics adversely impact any pending application for REGULATORY APPROVAL in a timely manner any change country in the Product Specification, including the manufacturing process, initiated by APGTERRITORY, and will obtain Connetics' written (ii) any such approval of a Discretionary Change by way of written amendment of this Agreement incorporating such change within the Product Specification prior to 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 changeDiscretionary Change shall cause ▇▇▇▇▇▇ to incur substantial unbudgeted costs to obtain REGULATORY APPROVAL for such Discretionary Change. No such change may For the purposes of clause (ii) of the preceding sentence, a “substantial unbudgeted” cost shall be instituted except in compliance with this Agreement deemed to be a cost which was not discussed and reviewed by the Quality Agreement. Connetics shall have the option of obtaining, or having APG obtain any required FDA approval or other regulatory approval 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 changes, filings or refilings of PRODUCT REGISTRATIONS, (ii) obtain approval for the implementation of such a changeDiscretionary 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. APG may provide additional services MEDIMMUNE shall, in conjunction with writing, notify ▇▇▇▇▇▇ of any Discretionary Changes to the manufacture SPECIFICATION of Productsany PRODUCT which, if implemented, would require notification to REGULATORY AUTHORITIES in the TERRITORY. Upon receipt of such as additional formulationnotification, process development or stability testing, at the request of Connetics and pursuant to Connetics' purchase order, and all data and results from such additional services ▇▇▇▇▇▇ shall be owned 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 cooperate with ▇▇▇▇▇▇ in making such Discretionary Changes. To the extent such changes 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 Connetics and protected among MEDIMMUNE, ▇▇▇▇▇▇ and any THIRD PARTY MANUFACTURER in the quality/technical agreement described above, subject to review and approval of the Manufacturing Steering Committee. (d) Any PRODUCT that becomes unsalable following a change in PRODUCT REGISTRATION as confidential a result of a Discretionary Change to the SPECIFICATIONS 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 in PRODUCT REGISTRATION as a result of a Discretionary Change to the SPECIFICATIONS initiated by ▇▇▇▇▇▇, MEDIMMUNE shall be excused from meeting its obligations to supply the affected PRODUCT(S).

Changes to Specifications. In each case subject to clause 3.11: (a) If Connetics desires any material change Amendments, modifications and additions to the Specifications (“Specification Changes”), the Manufacturing Process of a Batch (“Process Changes”), or manufacturing process, Connetics shall deliver, sixty the quality of Components (60“Component Changes”) 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 the Specifications or process shall not may only be supplemented, modified or amended in any respect without the prior made upon mutual written agreement between the Parties in each case, in accordance with the applicable provisions 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 noticeapplicable Quality Agreement. If Connetics requests a change Specification Changes, Process Changes or Component Changes are so agreed to a Product Specificationby the Parties, including OXB shall promptly implement the manufacturing processsame. The cost allocation between the Parties for any other Specification Changes, Process Changes and APG agrees that such change is feasible, such change shall Component Changes will be incorporated within as agreed to by the Product Specification pursuant to a written amendment to this Agreement. Connetics shall be responsible for obtaining any required FDA approval prior to implementation of such a change at Connetics' costParties in writing. (b) APG will communicate Notwithstanding clause 3.4(a), OXB shall use commercially reasonable efforts to Connetics 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 a timely manner any change writing to cover such costs), or require Client to perform Services materially different from those described in the Product Specificationapplicable Scope of Work, including 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 manufacturing process, initiated by APG, and will obtain Connetics' written approval by way of written amendment of this Agreement incorporating such change within the Product Specification prior to potential implementation of the change. No 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 change may be instituted except agreement, the Parties shall execute a Change Order in compliance accordance with this 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 Quality AgreementParties. Connetics shall have Without limiting the option foregoing, for clarity, no Specification Changes, Process Changes or Component Changes will be implemented by OXB without the prior written consent of obtaining, or having APG obtain any required FDA approval or other regulatory approval prior to implementation of such a change. APG may provide additional services Client in conjunction with the manufacture of Products, such as additional formulation, process development or stability testing, at the request of Connetics and pursuant to Connetics' purchase order, and all data and results from such additional services shall be owned by Connetics and protected as confidential under this Agreementeach instance.

Changes to Specifications. 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 other Party. The following provisions shall apply to changes in the API Specifications or the Product Specifications: (a) If Connetics desires The Party seeking the change(s) shall promptly advise the other Party in writing of any material change such change(s) to the Product Specifications 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 ConneticsAPI Specifications, and APG ▇▇▇▇▇▇▇ shall acknowledge in writing promptly advise NitroMed as to any scheduling, price or other adjustments that may result from such notice within thirty (30) days after APG receives the notice; providedchange(s), however, that 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 incorporated within the Product Specification pursuant to a written amendment to this Agreement. Connetics shall be responsible for obtaining any required FDA approval prior to implementation of such a change at Connetics' costif any. (b) APG will communicate to Connetics In the event of a change of the nature described in a timely manner any CLAUSE (i) above, the Party seeking the change shall notify the other Party in writing promptly upon being informed of or identifying the Product Specificationpotential need for such change and shall consult with the other Party on an ongoing basis regarding such change, including the manufacturing processneed 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 Product Specifications or the API Specifications, initiated 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; PROVIDED, HOWEVER, that in no event shall any change be implemented until such time as such change has been approved by APGthe FDA. (d) NitroMed shall be responsible for, and will obtain Connetics' written approval shall promptly reimburse ▇▇▇▇▇▇▇ for, all reasonable costs and expenses incurred by way or on behalf of written amendment ▇▇▇▇▇▇▇ or its supply contractors in connection with the implementation of this Agreement incorporating such change within changes to the Product Specification prior Specifications or the API Specifications that are mandatory or are requested by NitroMed. Additionally, if any changes to implementation of the change. No such change may Product Specifications or the API Specifications result in an increase in ▇▇▇▇▇▇▇'▇ manufacturing costs with respect to the Product, the supply prices set forth on SCHEDULE 4.1 shall be instituted except in compliance with this Agreement and adjusted to fully account for the Quality Agreement. Connetics shall have the option of obtaining, or having APG obtain any required FDA approval or other regulatory approval prior to implementation amount of such a change. 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 Connetics' purchase order, and all data and results from such additional services shall be owned by Connetics and protected as confidential under this Agreementincrease.

Changes to Specifications. 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 other Party. The following provisions shall apply to changes to the Product Specifications: (a) If Connetics desires The Party seeking the change(s) shall promptly advise the other Party in writing of any material change such change(s) to the Specifications Product Specifications, and APP shall promptly advise MDCO as to any scheduling, price or manufacturing processother adjustments that may result from such change(s), Connetics if any. (b) In the event of a change of the nature described in clause (i) above, the Party seeking the change shall delivernotify 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, sixty including the need for such potential change and the appropriate way to address the issue giving rise to such potential change. (60c) days prior Each Party shall use Commercially Reasonable Efforts to implement any required or agreed-upon changes to the expected date Product Specifications as soon as practicable after the nature of implementationthe change is determined and, written notice if applicable, the applicable Party has consented 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 noticechange; provided, however, that in no event shall any change be implemented until such time as such change has been approved by the Specifications or process FDA, if such approval is required. (d) MDCO 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 processresponsible for, and APG agrees that such change is feasibleshall promptly reimburse APP for, such change shall be incorporated within all reasonable costs and expenses incurred by or on behalf of APP or its supply contractors in connection with the implementation of changes to the Product Specification pursuant Specifications that are requested by MDCO or are necessary to a written amendment to this Agreementcomply with MDCO's requests. Connetics APP shall be responsible for obtaining changes required by FDA. Additionally, if any required FDA approval prior changes to implementation the Product Specifications result in a change in Cost of Goods with respect to the Product, the Purchase Prices shall be adjusted to fully account for the amount of such a change at Connetics' costchange. (b) APG will communicate to Connetics in a timely manner any change in the Product Specification, including the manufacturing process, initiated by APG, and will obtain Connetics' written approval by way of written amendment of this Agreement incorporating such change within the Product Specification prior to implementation of the change. No such change may be instituted except in compliance with this Agreement and the Quality Agreement. Connetics shall have the option of obtaining, or having APG obtain any required FDA approval or other regulatory approval prior to implementation of such a change. 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 Connetics' purchase order, and all data and results from such additional services shall be owned by Connetics and protected as confidential under this Agreement.