Common use of Quality Control; Change in Specifications or Supplier Clause in Contracts

Quality Control; Change in Specifications or Supplier. (a) BMS shall conduct all quality control testing of the Product prior to shipment in accordance with the Product Registration and applicable Laws. BMS shall retain records and samples of the Product relating to such testing as required by applicable Law and shall provide the Company with reasonable access during normal business hours to such records during any Audit in accordance with the procedures set forth in Section 7.04; provided, however, that such access does not unreasonably disrupt the normal operations of BMS. If the Company conducts quality control testing of the Product after delivery thereof to the Company, the Company shall use a laboratory qualified by BMS to ensure consistency of testing with the BMS results. If reasonably required by the Company, BMS shall promptly after the Effective Date (and in no event later than *** days provide all analytical methodology used by BMS for quality control testing of the Product. (b) The Company shall have the right: (i) subject to BMS’ prior written consent not to be unreasonably withheld, to change the Specifications with respect to the Product from time to time; (ii) subject to BMS’ prior written consent not to be unreasonably withheld, to change the tubes used for the Product; (iii) to change the Specifications with respect to the Product without prior written consent, from time to time, as may be required by any Governmental Entity having jurisdiction over the Product; or (iv) to change the Specifications with respect to the Product by mutual agreement of the Parties and in each case, on not less than *** calendar days prior written notice to BMS (or such shorter period as required by any Governmental Entity or mutually agreed by the Parties). In such event, upon the reasonable request of the Company and at the Company’s sole expense, BMS shall assist with all analytical or experimental work to be performed in connection with making such change, but the Company shall be responsible, at the Company’s expense, for filing all changes proposed by the Company to any Product Registration, and for seeking approval of any such change required by each applicable Governmental Entity. The Company shall reimburse BMS or its Affiliates for *** in implementing any changes to the Specifications in accordance with this Section 2.06(b) requested by the Company in BMS’ or its Affiliates’ Facility, and for filing, amending or supplementing any Manufacturing Facility Registration required thereby and shall not hold BMS responsible for any reasonable disruption of supply resulting from any such change in the Specifications. (c) At any time and from time to time, BMS may, (i) in its sole discretion, without the consent of the Company (but with *** prior written notice) change the manufacturer or source of manufacturing used in the manufacturing of the Product to an Affiliate of BMS, or to another BMS owned and operated facility, provided that BMS shall remain responsible for all of its obligations set forth herein, and provided further that any such change which will result in a delay in BMS’ or such other party’s ability to meet the Company’s delivery requirements for Products pursuant to Firm Orders made pursuant to Section 2.03 shall require the prior written consent of the Company (not to be unreasonably withheld or delayed), (ii) with the Company’s prior written consent (not to be *** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission. unreasonably withheld) change the manufacturer or source of manufacturing used in the manufacturing of the Product to a Third Party; provided that BMS shall be responsible for the acts or omissions of such Third Party or (iii) without the consent of the Company (but with *** prior written notice) change the manufacturer or manufacturing source used in the manufacturing of the Product to a successor (whether by merger, consolidation, reorganization or other similar event) or purchaser of the Facility and/or substantially all of its business assets relating to the Product, provided, that, such successor or purchaser has agreed in writing to assume all of BMS’ rights and obligations hereunder and a copy of such assumption is provided to the Company, and provided further that any such change which will result in a delay in BMS’ or such other party’s ability to meet the Company’s delivery requirements for Products pursuant to Firm Orders made pursuant to Section 2.03 shall require the prior written consent of the Company (not to be unreasonably withheld or delayed). The Company shall cooperate with BMS (and such other manufacturer, if applicable) in any reasonable manner to effect such transfer to an Affiliate of BMS, Third Party or successor. BMS shall be responsible for making any required Manufacturing Facility Registration with respect to such change in manufacturer and seeking approval from each applicable Governmental Entity. The Company shall be responsible for making any required filing with respect to any Product Registration in connection with such change in manufacturer or source of manufacturing. BMS shall bear all costs incurred by either Party with respect to such change in manufacturer or source of manufacturing including without limitation any Product Registration filings, and shall compensate the Company for *** incurred pursuant to any such change. (d) At any time and from time to time, BMS in its sole discretion may change, without the consent of but with *** prior written notice to and consultation with the Company, any manufacturing processes used in manufacturing the Product, any active pharmaceutical ingredient, intermediates, excipients, reagents or other compounds used in the manufacture of the Product, and any suppliers of any components used in making the Product; provided that, any such change requiring approval of an amendment or supplement to any Product Registration will not be effected or implemented without the prior written consent of the Company (not to be unreasonably withheld or delayed); and provided further that except where such change results from a manufacturing Improvement made in response to a pronouncement of a Governmental Entity (other than as a result of non-compliance by BMS), a Force Majeure Event, or a change in applicable Law, no such change shall be effected in a manner that would result in or cause an interruption of supply of the Product to the Company. Each Party will fully cooperate with the other in any reasonable manner to effect such change in a timely manner. The Company shall be responsible for all Product Registration filings needed to effect such change, and will use its commercially reasonable efforts to make all such regulatory filings (subject to receipt of necessary information from BMS) and take such actions as may be required to implement and seek regulatory approval for such change on a timely basis. BMS shall be responsible for making any required filing to any Manufacturing Facility Registration with respect to such change and seeking approval from each applicable Governmental Entity, BMS shall reimburse the Company for *** in seeking and obtaining or assisting BMS in seeking and obtaining any qualification or regulatory approval of such change. However, if such change is required by a change in Law or by a Governmental Entity (other than as a result of non-compliance by BMS), or is requested by the Company, in which event the Company shall reimburse BMS for *** to seek and obtain any regulatory approval for such change and to implement such change. (e) With respect to any regulatory filings and approvals made or sought by either Party under this Section 2.06, each Party shall provide reasonable cooperation to the other Party in connection therewith. If a change proposed to be made under this Section 2.06 requires prior approval by any applicable Governmental Entity before implementation, such change will not be implemented until such change has been so approved. *** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

Quality Control; Change in Specifications or Supplier. (a) BMS shall conduct all quality control testing of the Product prior to shipment in accordance with the Product Registration and applicable Laws. BMS shall retain records and samples of the Product relating to such testing as required by applicable Law and shall provide the Company with reasonable access during normal business hours to such records during any Audit in accordance with the procedures set forth in Section 7.04; provided, however, that such access does not unreasonably disrupt the normal operations of BMS. If the Company conducts quality control testing of the Product after delivery thereof to the Company, the Company shall use a laboratory qualified by BMS to ensure consistency of testing with the BMS results. If reasonably required by the Company, BMS shall promptly after the Effective Date (and in no event later than *** days thirty (30) days) provide all analytical methodology used by BMS for quality control testing of the Product. (b) The Company shall have the right: (i) subject to BMS’ ' prior written consent not to be unreasonably withheld, to change the Specifications with respect to the Product from time to time; (ii) subject to BMS’ prior written consent not to be unreasonably withheld, to change the tubes used for the Product; (iii) to change the Specifications with respect to the Product without prior written consent, from time to time, as may be required by any Governmental Entity having jurisdiction over the Product; or (iviii) to change the Specifications with respect to the Product by mutual agreement of the Parties and in each case, on not less than *** one hundred twenty (120) calendar days prior written notice to BMS (or such shorter period as required by any Governmental Entity or mutually agreed by the Parties). In such event, upon the reasonable request of the Company and at the Company’s 's sole expense, BMS shall assist with all analytical or experimental work to be performed in connection with making such change, but the Company shall be responsible, at the Company’s 's expense, for filing all changes proposed by the Company to any Product Registration, and for seeking approval of any such change required by each applicable Governmental Entity. The Company shall reimburse BMS or its Affiliates for *** its Fully-Burdened Costs incurred plus 15% in implementing any changes to the Specifications in accordance with this Section 2.06(b) requested by the Company in BMS’ ' or its Affiliates’ ' Facility, and for filing, amending or supplementing any Manufacturing Facility Registration required thereby and shall not hold BMS responsible for any reasonable disruption of supply resulting from any such change in the Specifications. (c) At any time and from time to time, BMS may, (i) in its sole discretion, without the consent of the Company (but with *** sixty (60) days' prior written notice) change the manufacturer or source of manufacturing used in the manufacturing of the Product to an Affiliate of BMS, or to another BMS owned and operated facility, provided that BMS shall remain responsible for all of its obligations set forth herein, and provided further that any such change which will result in a delay in BMS’ ' or such other party’s 's ability to meet the Company’s 's delivery requirements for Products pursuant to Firm Orders made pursuant to Section 2.03 shall require the prior written consent of the Company (not to be unreasonably withheld or delayed), (ii) with the Company’s 's prior written consent (not to be *** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission. unreasonably withheld) change the manufacturer or source of manufacturing used in the manufacturing of the Product to a Third Party; provided that BMS shall be responsible for the acts or omissions of such Third Party or (iii) without the consent of the Company (but with *** sixty (60) days' prior written notice) change the manufacturer or manufacturing source used in the manufacturing of the Product to a successor (whether by merger, consolidation, reorganization or other similar event) or purchaser of the Facility and/or substantially all of its business assets relating to the Product, provided, that, such successor or purchaser has agreed in writing to assume all of BMS’ ' rights and obligations hereunder and a copy of such assumption is provided to the Company, and provided further that any such change which will result in a delay in BMS’ ' or such other party’s 's ability to meet the Company’s 's delivery requirements for Products pursuant to Firm Orders made pursuant to Section 2.03 shall require the prior written consent of the Company (not to be unreasonably withheld or delayed). The Company shall cooperate with BMS (and such other manufacturer, if applicable) in any reasonable manner to effect such transfer to an Affiliate of BMS, Third Party or successor. BMS shall be responsible for making any required Manufacturing Facility Registration with respect to such change in manufacturer and seeking approval from each applicable Governmental Entity. The Company shall be responsible for making any required filing with respect to any Product Registration in connection with such change in manufacturer or source of manufacturing. BMS shall bear all costs incurred by either Party with respect to such change in manufacturer or source of manufacturing including without limitation any Product Registration filings, and shall compensate the Company for *** its Fully-Burdened Costs incurred pursuant to any such change. (d) At any time and from time to time, BMS in its sole discretion may change, without the consent of but with *** sixty (60) days prior written notice to and consultation with the Company, any manufacturing processes used in manufacturing the Product, any active pharmaceutical ingredient, intermediates, excipients, reagents or other compounds used in the manufacture of the Product, and any suppliers of any components used in making the Product; provided that, any such change requiring approval of an amendment or supplement to any Product Registration will not be effected or implemented without the prior written consent of the Company (not to be unreasonably withheld or delayed); and provided further that except where such change results from a manufacturing Improvement made in response to a pronouncement of a Governmental Entity (other than as a result of non-compliance by BMS), a Force Majeure Event, or a change in applicable Law, no such change shall be effected in a manner that would result in or cause an interruption of supply of the Product to the Company. Each Party will fully cooperate with the other in any reasonable manner to effect such change in a timely manner. The Company shall be responsible for all Product Registration filings needed to effect such change, and will use its commercially reasonable efforts to make all such regulatory filings (subject to receipt of necessary information from BMS) and take such actions as may be required to implement and seek regulatory approval for such change on a timely basis. BMS shall be responsible for making any required filing to any Manufacturing Facility Registration with respect to such change and seeking approval from each applicable Governmental Entity, BMS shall reimburse the Company for *** its Fully-Burdened Costs in seeking and obtaining or assisting BMS in seeking and obtaining any qualification or regulatory approval of such change. However, if such change is required by a change in Law or by a Governmental Entity (other than as a result of non-compliance by BMS), or is requested by the Company, in which event the Company shall reimburse BMS for *** its Fully-Burdened Costs plus 15% to seek and obtain any regulatory approval for such change and to implement such change. (e) With respect to any regulatory filings and approvals made or sought by either Party under this Section 2.06, each Party shall provide reasonable cooperation to the other Party in connection therewith. If a change proposed to be made under this Section 2.06 requires prior approval by any applicable Governmental Entity before implementation, such change will not be implemented until such change has been so approved. *** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

Quality Control; Change in Specifications or Supplier. (a) 2.7.1 Except as provided in the Xxxxxx Supply Agreement or as specifically provided otherwise in Section 2.11 hereof or in any Related Agreement, BMS shall conduct all quality control testing of the Product prior to shipment in accordance with the applicable NDAs and BMS' customary practices therefor (for Product Registration and applicable Lawsshipped by Xxxxxx, BMS' quality control testing shall be conducted solely on the bulk Product supplied by BMS prior to shipment to Xxxxxx). BMS shall retain records and samples of the Product relating pertaining to such testing as required by applicable Law and shall provide the Company with reasonable access during normal business hours to such records during any Audit in accordance with the procedures set forth in Section 7.04; provided, however, that such access does not unreasonably disrupt the normal operations of BMS. If the Company conducts quality control testing of the Product after delivery thereof to the Company, the Company shall use a laboratory qualified by BMS to ensure consistency of testing with the BMS results. If reasonably required by the Company, BMS shall promptly after the Effective Date (and in no event later than *** days provide all analytical methodology used by BMS for quality control testing of the Productlaw. (b) The Company 2.7.2 BMS shall have the right: (i) subject to BMS’ prior written consent not to be unreasonably withheld, at its expense and in consultation with DURA, to change the Specifications with respect to the Product from time to time; (ii) subject time at any time during the term of this Agreement or if BMS is required to BMS’ prior written consent not to be unreasonably withheld, to change the tubes used for the Product; (iii) to change the Specifications with respect to the Product without prior written consent, from time to time, as may be required do so by any Governmental Entity regulatory agency having jurisdiction over the Product; or (iv) to change the Specifications with respect to the Product by mutual agreement of the Parties and in each case, on not less than *** calendar days 120 days' prior written notice to BMS (or such shorter period as required by any Governmental Entity or mutually agreed by the Parties)DURA. In such event, upon the reasonable request of the Company and at the Company’s sole expense, BMS shall assist with all analytical or experimental work to be performed in connection with making such change, but the Company shall be responsible, responsible at the Company’s expense, its expense for filing all changes proposed by the Company to any Product Registration, and for seeking approval of any such change required by each applicable Governmental Entity. The Company shall reimburse BMS or its Affiliates for *** in implementing any changes to the Specifications in accordance with this Section 2.06(b) requested by the Company in BMS’ or its Affiliates’ Facility, and for filing, amending or supplementing any Manufacturing Facility Registration required thereby and shall not hold BMS responsible for any reasonable disruption of supply resulting from any such change in the Specifications. (c) At any time and from time to time, BMS may, (i) in its sole discretion, without the consent of the Company (but with *** prior written notice) change the manufacturer or source of manufacturing used in the manufacturing of the Product to an Affiliate of BMS, or to another BMS owned and operated facility, provided that BMS shall remain responsible for all of its obligations set forth herein, and provided further ensuring that any such change which is approved by each applicable regulatory authority in the Territory, and DURA shall provide reasonable cooperation to BMS in connection therewith. If a change requires prior approval by FDA, such change will result not be implemented in a delay in BMS’ or respect of such other party’s ability Product until such change has been so approved. BMS agrees to meet the Company’s delivery requirements for Products pursuant to Firm Orders made pursuant to Section 2.03 shall require the prior written consent of the Company (not to be unreasonably withheld or delayed), (ii) with the Company’s seek DURA's prior written consent (not to be *** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission. unreasonably withheld) for changes to the Specifications that BMS may elect to make that would impose a material adverse cost upon DURA or that would involve a change in form or potency of any Product set forth on Exhibit 1.1A. 2.7.3 BMS shall determine in its sole discretion, and may from time to time change, the manufacturer or source of manufacturing used in the manufacturing supply of the Product without the consent of DURA, provided that BMS shall give DURA prior written notice of its intention to a Third Party; provided do so, and that BMS shall be responsible for the acts or omissions of such Third Party or (iii) without the consent of the Company (but with *** prior written notice) change the manufacturer or manufacturing source used in the manufacturing of the Product to a successor (whether by merger, consolidation, reorganization or other similar event) or purchaser of the Facility and/or substantially securing all of its business assets relating to the Product, provided, that, such successor or purchaser has agreed in writing to assume all of regulatory approvals at BMS’ rights and obligations hereunder and a copy of such assumption is provided to the Company, and provided further ' expense that any such change which will result in a delay in BMS’ or such other party’s ability to meet the Company’s delivery requirements for Products pursuant to Firm Orders made pursuant to Section 2.03 shall require the prior written consent of the Company (not to may be unreasonably withheld or delayed). The Company shall cooperate with BMS (and such other manufacturer, if applicable) in any reasonable manner required to effect such transfer change. DURA understands and accepts that BMS is planning to an Affiliate of change its manufacturing facility for the Azactam-Registered Trademark- Product from BMS' New Brunswick, Third Party or successor. New Jersey facility to a BMS shall be responsible for making any required Manufacturing Facility Registration with respect to such change Affiliate's manufacturing facility in manufacturer and seeking approval from each applicable Governmental Entity. The Company shall be responsible for making any required filing with respect to any Product Registration in connection with such change in manufacturer or source of manufacturing. BMS shall bear all costs incurred by either Party with respect to such change in manufacturer or source of manufacturing including without limitation any Product Registration filingsAnagni, and shall compensate the Company for *** incurred pursuant to any such changeItaly. (d) At any time and from time to time, 2.7.4 BMS in its sole discretion shall determine, and may change, from time to time change without the consent of but with *** prior written or notice to DURA, the Affiliate that shall invoice DURA for any Product supplied hereunder, and, subject to Section 2.7.2 hereof and consultation with to Section 4.4.3, 4.4.4 and 4.12 of the CompanyDistribution Agreement, any manufacturing processes used in manufacturing the a given Product, any active pharmaceutical ingredient, intermediates, excipients, reagents or other compounds used in the manufacture of the any Product, and any suppliers of any components used in making the a Product; provided that, any such change requiring approval of an amendment or supplement to any Product Registration will not be effected or implemented without the prior written consent of the Company (not to be unreasonably withheld or delayed); and provided further that except where such change results from a manufacturing Improvement made in response to a pronouncement of a Governmental Entity (other than as a result of non-compliance by BMS), a Force Majeure Event, or a change in applicable Law, no such change shall be effected in a manner that would result in or cause an interruption of supply of the Product to the Company. Each Party will fully cooperate with the other in any reasonable manner to effect such change in a timely manner. The Company shall be responsible for all Product Registration filings needed to effect such change, and will use its commercially reasonable efforts to make all such regulatory filings (subject to receipt of necessary information from BMS) and take such actions as may be required to implement and seek regulatory approval for such change on a timely basis. BMS shall be responsible for making any required filing to any Manufacturing Facility Registration with respect to such change and seeking approval from each applicable Governmental Entity, BMS shall reimburse the Company for *** in seeking and obtaining or assisting BMS in seeking and obtaining any qualification or regulatory approval of such change. However, if such change is required by a change in Law or by a Governmental Entity (other than as a result of non-compliance by BMS), or is requested by the Company, in which event the Company shall reimburse BMS for *** to seek and obtain any regulatory approval for such change and to implement such change. (e) With respect to any regulatory filings and approvals made or sought by either Party under this Section 2.06, each Party shall provide reasonable cooperation to the other Party in connection therewith. If a change proposed to be made under this Section 2.06 requires prior approval by any applicable Governmental Entity before implementation, such change will not be implemented until such change has been so approved. *** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

Quality Control; Change in Specifications or Supplier. (a) BMS 2.7.1 WSP shall conduct all quality control testing of the Product Products prior to shipment in accordance with the Product Registration applicable NDAs and applicable Laws. BMS WSP shall retain records and samples of the Product relating pertaining to such testing as required by applicable Law and and, from time to time upon the prior notice shall provide the Company WC with reasonable access during normal business hours to such records during any Audit in accordance with the procedures set forth in Section 7.04records; provided, however, that such access does not unreasonably disrupt the normal operations of BMS. If the Company conducts quality control testing of the Product after delivery thereof to the Company, the Company shall use a laboratory qualified by BMS to ensure consistency of testing with the BMS results. If reasonably required by the Company, BMS shall promptly after the Effective Date (and in no event later than *** days provide all analytical methodology used by BMS for quality control testing of the ProductWSP. (b) The Company 2.7.2 WC shall have the right: (i) subject to BMS’ prior written consent not to be unreasonably withheld, at its expense and in consultation with WSP, to change the Specifications with respect to the Product from time to time; (ii) subject to BMS’ prior written consent not to be unreasonably withheld, to change the tubes used for the Product; (iii) to change the Specifications with respect to the Product without prior written consent, from time to time, including as may be required by any Governmental Entity regulatory agency having jurisdiction over the Product; or (iv) to change the Specifications with respect to the Product by mutual agreement of the Parties and in each case, on not less than *** calendar days one hundred and [REDACTED] prior written notice to BMS WSP (or such shorter period as required by any Governmental Entity regulatory agency or mutually agreed by the Parties). In such event, upon the reasonable WSP shall, at WC's request of the Company and at the Company’s sole expense, BMS shall assist with all analytical or experimental work to be performed in connection with making such change, but the Company and WC shall be responsible, at the Company’s its expense, for filing all changes proposed by the Company to any Product Registration, WC and for seeking approval of any such change required by each applicable Governmental Entityregulatory authority. The Company shall reimburse BMS or its Affiliates for *** in implementing any changes to Parties may also amend the Specifications in accordance with this Section 2.06(b) requested by the Company in BMS’ or its Affiliates’ Facility, and for filing, amending or supplementing any Manufacturing Facility Registration required thereby and shall not hold BMS responsible for any reasonable disruption of supply resulting from any such change in the Specificationsmutual agreement. (c) 2.7.3 At any time and from time to time, BMS may, (i) WSP in its sole discretiondiscretion may change, without the consent of the Company (but with *** prior written notice) change notice to and consultation with, WC, the manufacturer or source of manufacturing used in the manufacturing of the Product Products to an BMS or another Affiliate of BMS, or to another BMS owned and operated facility, provided that (a) WSP shall bear all costs of transferring production to BMS or such Affiliate and (b) the Purchase Price for the Products shall remain responsible for all of its obligations set forth herein, and provided further that any such change which will result in a delay in BMS’ or such other party’s ability to meet substantially the Company’s delivery requirements for Products pursuant to Firm Orders made pursuant to Section 2.03 shall require the prior written consent of the Company (not to be unreasonably withheld or delayed), (ii) with the Company’s prior written consent (not to be *** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commissionsame. unreasonably withheld) change the manufacturer or source of manufacturing used in the manufacturing of the Product to a Third Party; provided that BMS shall be responsible for the acts or omissions of such Third Party or (iii) without the consent of the Company (but with *** prior written notice) change the manufacturer or manufacturing source used in the manufacturing of the Product to a successor (whether by merger, consolidation, reorganization or other similar event) or purchaser of the Facility and/or substantially all of its business assets relating to the Product, provided, that, such successor or purchaser has agreed in writing to assume all of BMS’ rights and obligations hereunder and a copy of such assumption is provided to the Company, and provided further that any such change which will result in a delay in BMS’ or such other party’s ability to meet the Company’s delivery requirements for Products pursuant to Firm Orders made pursuant to Section 2.03 shall require the prior written consent of the Company (not to be unreasonably withheld or delayed). The Company WC shall cooperate with BMS (and such other manufacturer, if applicable) WSP in any reasonable manner to effect such transfer to an Affiliate of BMS, Third Party or successor. BMS and shall be responsible for making any required Manufacturing Facility Registration filing with respect to such change in manufacturer and seeking approval from each applicable Governmental Entityregulatory authority. The Company WSP shall be responsible reimburse WC for making any required filing with respect to any Product Registration all reasonable out-of-pocket expenses incurred by WC or its Affiliates or agents in connection with such change in manufacturer or source of manufacturing. BMS shall bear all costs incurred by either Party with respect to such change in manufacturer or source of manufacturing including without limitation any Product Registration filings, filings and shall compensate the Company for *** incurred pursuant to any such changepreparation thereof. (d) At 2.7.4 Subject to Section 2.7.2, at any time and from time to time, BMS WSP in its sole discretion may change, without the consent of but with *** prior written notice to and consultation with the Companywith, WC, any manufacturing processes and/or locations used in manufacturing the any Product, any active pharmaceutical ingredient, intermediates, excipients, reagents or other compounds used in the manufacture of the any Product, and any suppliers of any components used in making a Product, provided that (a) WSP shall bear all costs associated with changing any manufacturing processes and/or locations used in manufacturing any Product and (b) the Product; provided that, Purchase Price for any such change requiring approval of an amendment or supplement to any Product Registration will not be effected or implemented without Products shall remain substantially the prior written consent of the Company (not to be unreasonably withheld or delayed); and provided further that except where such change results from a manufacturing Improvement made in response to a pronouncement of a Governmental Entity (other than as a result of non-compliance by BMS), a Force Majeure Event, or a change in applicable Law, no such change same. WC shall be effected in a manner that would result in or cause an interruption of supply of the Product to the Company. Each Party will fully cooperate with the other WSP in any reasonable manner to effect such change in a timely manner. The Company shall be responsible for all Product Registration filings needed to effect such change, transfer and will use its commercially reasonable efforts to make all such regulatory filings (subject to receipt of necessary information from BMS) and take such actions as may be required to implement and seek regulatory approval for such change on a timely basis. BMS shall be responsible for making any required filing to any Manufacturing Facility Registration with respect to such change and seeking approval from each applicable Governmental Entity, BMS regulatory authority. WSP shall reimburse WC for all reasonable out-of-pocket expenses incurred by WC or its Affiliates or agents in connection with such filings and the Company for *** in seeking and obtaining or assisting BMS in seeking and obtaining any qualification or regulatory approval of such change. However, if such change is required by a change in Law or by a Governmental Entity (other than as a result of non-compliance by BMS), or is requested by the Company, in which event the Company shall reimburse BMS for *** to seek and obtain any regulatory approval for such change and to implement such changepreparation thereof. (e) 2.7.5 With respect to any regulatory filings and approvals made or sought by either Party under this Section 2.062.7, each Party shall provide reasonable cooperation to the other Party in connection therewith. If a change proposed to be made to the 10 16 Specifications or the manufacture of the Products under this Section 2.06 2.7 requires prior approval by any applicable Governmental Entity regulatory authority before implementation, such change will not be implemented in respect of a Product until such change has been so approved. *** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

Quality Control; Change in Specifications or Supplier. (a) BMS 2.7.1 WSP shall conduct all quality control testing of the Product Products prior to shipment in accordance with the Product Registration applicable NDAs and applicable Laws. BMS WSP shall retain records and samples of the Product relating pertaining to such testing as required by applicable Law and and, from time to time upon the prior notice shall provide the Company WC with reasonable access during normal business hours to such records during any Audit in accordance with the procedures set forth in Section 7.04records; provided, however, that such access does not unreasonably disrupt the normal operations of BMS. If the Company conducts quality control testing of the Product after delivery thereof to the Company, the Company shall use a laboratory qualified by BMS to ensure consistency of testing with the BMS results. If reasonably required by the Company, BMS shall promptly after the Effective Date (and in no event later than *** days provide all analytical methodology used by BMS for quality control testing of the ProductWSP. (b) The Company 2.7.2 WC shall have the right: (i) subject to BMS’ prior written consent not to be unreasonably withheld, at its expense and in consultation with WSP, to change the Specifications with respect to the Product from time to time; (ii) subject to BMS’ prior written consent not to be unreasonably withheld, to change the tubes used for the Product; (iii) to change the Specifications with respect to the Product without prior written consent, from time to time, including as may be required by any Governmental Entity regulatory agency having jurisdiction over the Product; or (iv) to change the Specifications with respect to the Product by mutual agreement of the Parties and in each case, on not less than *** calendar one hundred and twenty (120) days prior written notice to BMS WSP (or such shorter period as required by any Governmental Entity regulatory agency or mutually agreed by the Parties). In such event, upon the reasonable WSP shall, at WC's request of the Company and at the Company’s sole expense, BMS shall assist with all analytical or experimental work to be performed in connection with making such change, but the Company and WC shall be responsible, at the Company’s its expense, for filing all changes proposed by the Company to any Product Registration, WC and for seeking approval of any such change required by each applicable Governmental Entityregulatory authority. The Company shall reimburse BMS or its Affiliates for *** in implementing any changes to Parties may also amend the Specifications in accordance with this Section 2.06(b) requested by the Company in BMS’ or its Affiliates’ Facility, and for filing, amending or supplementing any Manufacturing Facility Registration required thereby and shall not hold BMS responsible for any reasonable disruption of supply resulting from any such change in the Specificationsmutual agreement. (c) 2.7.3 At any time and from time to time, BMS may, (i) WSP in its sole discretiondiscretion may change, without the consent of the Company (but with *** prior written notice) change notice to and consultation with, WC, the manufacturer or source of manufacturing used in the manufacturing of the Product Products to an BMS or another Affiliate of BMS, or to another BMS owned and operated facility, provided that (a) WSP shall bear all costs of transferring production to BMS or such Affiliate and (b) the Purchase Price for the Products shall remain responsible for all of its obligations set forth herein, and provided further that any such change which will result in a delay in BMS’ or such other party’s ability to meet substantially the Company’s delivery requirements for Products pursuant to Firm Orders made pursuant to Section 2.03 shall require the prior written consent of the Company (not to be unreasonably withheld or delayed), (ii) with the Company’s prior written consent (not to be *** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commissionsame. unreasonably withheld) change the manufacturer or source of manufacturing used in the manufacturing of the Product to a Third Party; provided that BMS shall be responsible for the acts or omissions of such Third Party or (iii) without the consent of the Company (but with *** prior written notice) change the manufacturer or manufacturing source used in the manufacturing of the Product to a successor (whether by merger, consolidation, reorganization or other similar event) or purchaser of the Facility and/or substantially all of its business assets relating to the Product, provided, that, such successor or purchaser has agreed in writing to assume all of BMS’ rights and obligations hereunder and a copy of such assumption is provided to the Company, and provided further that any such change which will result in a delay in BMS’ or such other party’s ability to meet the Company’s delivery requirements for Products pursuant to Firm Orders made pursuant to Section 2.03 shall require the prior written consent of the Company (not to be unreasonably withheld or delayed). The Company WC shall cooperate with BMS (and such other manufacturer, if applicable) WSP in any reasonable manner to effect such transfer to an Affiliate of BMS, Third Party or successor. BMS and shall be responsible for making any required Manufacturing Facility Registration filing with respect to such change in manufacturer and seeking approval from each applicable Governmental Entityregulatory authority. The Company WSP shall be responsible reimburse WC for making any required filing with respect to any Product Registration all reasonable out-of-pocket expenses incurred by WC or its Affiliates or agents in connection with such change in manufacturer or source of manufacturing. BMS shall bear all costs incurred by either Party with respect to such change in manufacturer or source of manufacturing including without limitation any Product Registration filings, filings and shall compensate the Company for *** incurred pursuant to any such changepreparation thereof. (d) At 2.7.4 Subject to Section 2.7.2, at any time and from time to time, BMS WSP in its sole discretion may change, without the consent of but with *** prior written notice to and consultation with the Companywith, WC, any manufacturing processes and/or locations used in manufacturing the any Product, any active pharmaceutical ingredient, intermediates, excipients, reagents or other compounds used in the manufacture of the any Product, and any suppliers of any components used in making a Product, provided that (a) WSP shall bear all costs associated with changing any manufacturing processes and/or locations used in manufacturing any Product and (b) the Product; provided that, Purchase Price for any such change requiring approval of an amendment or supplement to any Product Registration will not be effected or implemented without Products shall remain substantially the prior written consent of the Company (not to be unreasonably withheld or delayed); and provided further that except where such change results from a manufacturing Improvement made in response to a pronouncement of a Governmental Entity (other than as a result of non-compliance by BMS), a Force Majeure Event, or a change in applicable Law, no such change same. WC shall be effected in a manner that would result in or cause an interruption of supply of the Product to the Company. Each Party will fully cooperate with the other WSP in any reasonable manner to effect such change in a timely manner. The Company shall be responsible for all Product Registration filings needed to effect such change, transfer and will use its commercially reasonable efforts to make all such regulatory filings (subject to receipt of necessary information from BMS) and take such actions as may be required to implement and seek regulatory approval for such change on a timely basis. BMS shall be responsible for making any required filing to any Manufacturing Facility Registration with respect to such change and seeking approval from each applicable Governmental Entity, BMS regulatory authority. WSP shall reimburse WC for all reasonable out-of-pocket expenses incurred by WC or its Affiliates or agents in connection with such filings and the Company for *** in seeking and obtaining or assisting BMS in seeking and obtaining any qualification or regulatory approval of such change. However, if such change is required by a change in Law or by a Governmental Entity (other than as a result of non-compliance by BMS), or is requested by the Company, in which event the Company shall reimburse BMS for *** to seek and obtain any regulatory approval for such change and to implement such changepreparation thereof. (e) 2.7.5 With respect to any regulatory filings and approvals made or sought by either Party under this Section 2.062.7, each Party shall provide reasonable cooperation to the other Party in connection therewith. If a change proposed to be made to the 10 16 Specifications or the manufacture of the Products under this Section 2.06 2.7 requires prior approval by any applicable Governmental Entity regulatory authority before implementation, such change will not be implemented in respect of a Product until such change has been so approved. *** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.