Common use of Manufacturing Changes Clause in Contracts

Manufacturing Changes. (a) Licensee may unilaterally and in its sole discretion make one or more Required Manufacturing Changes by giving written notice thereof to Quoin, whereupon the Parties shall cooperate in implementing such Required Manufacturing Changes as promptly as reasonably practicable. Licensee may request one or more Discretionary Manufacturing Changes by giving at least ninety (90) days written notice thereof to Quoin, whereupon if Quoin accepts the requested Discretionary Manufacturing Changes (such acceptance not to be unreasonably withheld or delayed), the Parties shall cooperate in implementing such Discretionary Manufacturing Changes as promptly as reasonably practicable. Quoin shall promptly provide to Licensee Quoin’s good faith and detailed estimate of the actual and reasonable costs that will be incurred by Quoin resulting directly from any such Required or Discretionary Manufacturing Changes, including the cost of any obsolete inventory resulting from the changes. All such reasonable and documented costs shall be borne by Licensee. (b) Quoin shall not in any respect amend, modify or supplement the Specifications or the manufacturing process or any materials or sources of materials used in connection with manufacturing the Product without the prior written consent of Licensee. Quoin may request or recommend one or more Discretionary Manufacturing Changes by giving at least ninety (90) days written notice thereof to Licensee and shall provide Licensee with appropriate documentation relating to any such changes to the Specifications or manufacturing process. If Licensee approves any such Discretionary Manufacturing Change, Quoin may implement such change in accordance with the specifications provided by Quoin to Licensee. All costs arising out of any Discretionary Manufacturing Changes requested by Quoin shall be borne by Quoin.

Manufacturing Changes. (a) Licensee may unilaterally and in its sole discretion 5.3.1 IMPAX shall not make one or more Required any changes to the Manufacturing Changes by giving written notice thereof to Quoin, whereupon the Parties shall cooperate in implementing such Required Manufacturing Changes as promptly as reasonably practicable. Licensee may request one or more Discretionary Manufacturing Changes by giving at least ninety (90) days written notice thereof to Quoin, whereupon if Quoin accepts the requested Discretionary Manufacturing Changes (such acceptance not to be unreasonably withheld or delayed)process, the Parties shall cooperate in implementing such Discretionary Manufacturing Changes as promptly as reasonably practicable. Quoin shall promptly provide to Licensee Quoin’s good faith and detailed estimate equipment, the Specifications, the Materials, the sources of the actual and reasonable costs that will be incurred by Quoin resulting directly from any such Required or Discretionary Manufacturing Changes, including the cost of any obsolete inventory resulting from the changes. All such reasonable and documented costs shall be borne by Licensee. (b) Quoin shall not in any respect amend, modify or supplement the Specifications Materials or the manufacturing process or any materials or sources Methods of materials used in connection with manufacturing the Product Analysis without the prior written consent of LicenseeWCH, which consent shall not be unreasonably withheld. Quoin If either Party requests in writing a change in the Manufacturing process, the Manufacturing equipment, the Specifications, the Materials, the source of Materials or Methods of Analysis with respect to any Product that is not the result of a requirement of FDA or any other Regulatory Authority, the other Party shall use Commercially Reasonable Efforts to make or accept such change, as the case may request or recommend one or more Discretionary Manufacturing Changes by giving at least ninety (90) days written notice thereof to Licensee and be. The requesting Party shall provide Licensee the other Party with appropriate documentation relating to any such a detailed written report of all proposed changes to the Specifications Manufacturing process, the Manufacturing equipment, the Specifications, the Materials, the sources of Materials or manufacturing the Methods of Analysis. 5.3.2 If FDA or any other Regulatory Authority requests or requires any change in the Manufacturing process. If Licensee approves , the Manufacturing equipment, the Specifications, the Materials, the source of Materials or Methods of Analysis with respect to any such Discretionary Manufacturing Change, Quoin may implement Product the Parties shall meet and discuss an implementation plan for such change and use all Commercially Reasonable Efforts to accommodate such change to meet the FDA’s or such other Regulatory Authority’s requirements. Each Party will bear its respective costs associated with, or incurred as a result of, such change. Each Party agrees to promptly forward to the other copies of any written communication received by such Party from the FDA or any other Regulatory Authority that may affect the Manufacture or supply of any Product as contemplated herein. Notwithstanding the foregoing, if after Launch of the D-12 Product IMPAX determines, in accordance the exercise of its reasonable judgment, that a change required by the FDA or other Regulatory Authority creates an unreasonable burden on IMPAX or results in the continuing compliance by IMPAX with this Agreement uneconomical and if, upon IMPAX’s request, WCH does not agree (i) to pay the incremental cost of complying with the specifications provided changes required by Quoin FDA or such other Regulatory Authority (which costs shall not be included in Direct Manufacturing Costs hereunder to Licensee. All costs arising out of any Discretionary Manufacturing Changes requested the extent paid by Quoin shall be borne WCH), or (ii) to exercise its right to Manufacture pursuant to Section 2.2, then IMPAX may by Quoinnotice in writing to WCH, given no later than thirty (30) days after such refusal by WCH, terminate this Agreement.

Manufacturing Changes. Once Product Qualification is successfully completed with respect to a Sipex Product, Silan shall not make any changes to the manufacturing process that do or could reasonably be expect to affect product quality, price, performance or yield for that Sipex Product (asuch change, a "Major Process Change") Licensee may unilaterally and without Sipex's prior written consent. If Silan wishes to make a Major Process Change it shall inform Sipex in its sole discretion make one or more Required Manufacturing Changes by giving written notice thereof to Quoin, whereupon the Parties shall cooperate in implementing such Required Manufacturing Changes as promptly as reasonably practicable. Licensee may request one or more Discretionary Manufacturing Changes by giving writing at least ninety (90) days written in advance of the proposed change setting forth the nature of the change and Silan's reasons for wanting to make such change and any anticipated changes to the manufacturing costs or price of a Sipex Product resulting from such Major Process Change. Sipex shall respond it writing to Silan within five (5) Business Days of receiving such notice thereof whether (i) Sipex approves such change, (ii) Sipex will not consent to Quoinsuch change being made, whereupon if Quoin accepts or (iii) Sipex requires additional information from Silan in order to approve or disapprove such change. If Sipex does not respond in five (5) Business Days in accordance with the requested Discretionary Manufacturing Changes foregoing, the Major Process Change as described in the Silan notice shall be deemed approved. If Sipex does respond within five (5) Business Days in accordance with the foregoing, Silan shall not make any Major Process Change unless it is approved by Sipex in writing. To the extent any manufacturing changes are made or allowed happen and Sipex approves any such acceptance not to be unreasonably withheld or delayed)changes, the Parties shall cooperate discuss in implementing such Discretionary Manufacturing Changes as promptly as reasonably practicable. Quoin shall promptly provide to Licensee Quoin’s good faith and detailed estimate an equitable solution to remedy any adverse effects that result from or arise out of the actual and reasonable costs that will be incurred by Quoin resulting directly from any such Required or Discretionary Manufacturing Changeschange, including adverse effects to the Sipex Product, its yield, reliability or conformance to the Specification and the Parties also discuss in good faith an equitable sharing of all costs, including for re-qualifying the relevant Sipex Product where necessary, associated therewith. Notwithstanding the foregoing, Sipex shall not be responsible for any manufacturing cost increase or increase to the prices of any obsolete inventory the Sipex Products resulting from the changes. All such reasonable and documented costs shall be borne by Licensee. (b) Quoin shall not in any respect amend, modify or supplement the Specifications or the manufacturing process or any materials or sources of materials used in connection with manufacturing the Product without the prior written consent of Licensee. Quoin may request or recommend one or more Discretionary Manufacturing Changes by giving at least ninety (90) days written notice thereof to Licensee and shall provide Licensee with appropriate documentation relating to any such changes to the Specifications or manufacturing process. If Licensee approves any such Discretionary Manufacturing Change, Quoin may implement such change unless Sipex has approved such increases. Except as set forth in accordance with Section 4.2(c) of the specifications provided by Quoin PTTLA, in no event shall Silan be required to Licensee. All costs indemnify and hold Sipex harmless under Article 6 of the Master Agreement for any Action or Liability for infringement of a third party's Intellectual Property Rights arising out of Sipex's sale or offer for sale of any Discretionary Manufacturing Changes requested Sipex Products not manufactured by Quoin Silan to the extent such Action or Liability is based on any Silan Process Technology Improvements and Sipex shall be borne by Quoin.solely liable for any such Action and Liability. Forecasts, Purchase Orders and Production Holds

Manufacturing Changes. 10.4.1 Procedures governing changes to the Specifications and/or changes in the Manufacturing process, Manufacturing facilities and/or materials (aor sources of materials) Licensee may unilaterally used by AstraZeneca to Manufacture any Licensed Product (each a “Manufacturing Change”) will be set out in the QA. Any Manufacturing Change shall be implemented in accordance with the provisions of this Section 10.4 and the QA. 10.4.2 During the SOTC Period, AstraZeneca shall have final decision-making authority with respect to any Manufacturing Changes required by a Health Authority (“Required Manufacturing Changes”), including whether and how to implement any such Manufacturing Changes; provided that AstraZeneca shall consult in its sole discretion good faith with Buyer prior to making any decision with respect to any Required Manufacturing Changes, and shall consider in good faith any other Manufacturing Changes proposed by ▇▇▇▇▇. After the SOTC Period, Buyer shall have final decision-making authority with respect to any Required Manufacturing Changes, including whether and how to implement any such Manufacturing Changes; provided that Buyer shall consider in good faith any Manufacturing Changes proposed by AstraZeneca. During the Term, neither Party shall make one or more any Manufacturing Changes that are not Required Manufacturing Changes by giving without the other Party’s written notice thereof agreement. AstraZeneca shall use [***] to Quoin, whereupon the Parties shall cooperate in implementing such carry out any Required Manufacturing Changes as promptly as reasonably practicable. Licensee may request one or more Discretionary Manufacturing Changes by giving at least ninety (90) days written notice thereof practicable in order to Quoin, whereupon if Quoin accepts the requested Discretionary Manufacturing Changes (such acceptance not prevent any disruption in supply and in a manner to be unreasonably withheld or delayed), the Parties shall cooperate in implementing such Discretionary Manufacturing Changes as promptly as reasonably practicable. Quoin shall promptly provide to Licensee Quoin’s good faith and detailed estimate ensure continued compliance of the actual Licensed Product with the Specifications and reasonable costs the applicable Regulatory Approvals and Buyer shall, where required, reasonably assist in carrying out such changes. 10.4.3 The Parties agree that will be incurred by Quoin resulting directly from any such Required or Discretionary Manufacturing Changes, including the cost of any obsolete inventory resulting from the changes. All such reasonable and documented incremental internal costs and out-of-pocket costs and expenses of the Parties directly incurred in relation to any Manufacturing Change shall be borne by Licenseethe Party initiating such Manufacturing Change. For these purposes [***]. (b) Quoin shall not 10.4.4 Where a Manufacturing Change is required by Buyer and such change results in rendering obsolete any respect amend, modify inventory of Licensed Products or supplement the Specifications or the manufacturing process or any materials or sources of materials used in connection with manufacturing the Product without Manufacture of the prior written consent Licensed Products, [***] shall bear the cost of Licensee. Quoin may request or recommend one or more Discretionary Manufacturing Changes by giving at least ninety such write-off (90including waste disposal costs) days written notice thereof to Licensee and shall provide Licensee with appropriate documentation relating to any such changes to the Specifications or manufacturing process. If Licensee approves any such Discretionary Manufacturing Change, Quoin may implement such change in accordance with the specifications provided by Quoin to Licensee. All costs arising out of any Discretionary Manufacturing Changes requested by Quoin shall be borne by Quoinfor Licensed Products.

Manufacturing Changes. The Product Specifications shall be amended as (a) Licensee may unilaterally and in its sole discretion make one reasonably requested by Purchaser or more Required Manufacturing Changes by giving written notice thereof to Quoin, whereupon the Parties shall cooperate in implementing such Required Manufacturing Changes as promptly as reasonably practicable. Licensee may request one or more Discretionary Manufacturing Changes by giving at least ninety (90) days written notice thereof to Quoin, whereupon if Quoin accepts the requested Discretionary Manufacturing Changes (such acceptance not to be unreasonably withheld or delayed), the Parties shall cooperate in implementing such Discretionary Manufacturing Changes as promptly as reasonably practicable. Quoin shall promptly provide to Licensee Quoin’s good faith and detailed estimate of the actual and reasonable costs that will be incurred by Quoin resulting directly from any such Required or Discretionary Manufacturing Changes, including the cost of any obsolete inventory resulting from the changes. All such reasonable and documented costs shall be borne by Licensee. (b) Quoin shall not necessary to conform such Product Specifications to the regulatory requirements necessary to obtain and maintain Regulatory Approvals with respect to the Product in the reasonable discretion of Purchaser. If any respect amendchange in the Product Specifications, modify or supplement if any change in the Specifications Regulatory Approvals, applicable laws, rules, or the manufacturing process or any materials regulations or sources of materials used [*CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT. EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK [***], HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.] Materials requires either (a) a change in the Product manufacturing process, or (b) Supplier to conduct development, testing, or other activities (e.g., process development stability testing, validation of new specifications) (collectively, “Activities”) in addition to those activities Supplier conducted or is required to conduct in its manufacture of the Product prior to such change being requested or required, Purchaser shall reimburse Supplier for all commercially reasonable documented costs incurred by Supplier in connection with manufacturing the Product without the prior written consent of Licenseesuch change. Quoin may request If Supplier requires regulatory changes to support improved process or recommend one or more Discretionary Manufacturing Changes by giving at least ninety (90) days written notice thereof yield improvements, then Purchaser, in consultation with Supplier, agrees to Licensee and shall provide Licensee with appropriate documentation relating to any submit such changes to the Specifications FDA, as required, and Supplier shall pay for such changes. Changes implemented to support improved process or manufacturing process. If Licensee approves any such Discretionary Manufacturing Change, Quoin may implement such change yield improvements shall not result in accordance with interruption in the specifications provided by Quoin to Licensee. All costs arising out supply or quality of any Discretionary Manufacturing Changes requested by Quoin shall be borne by Quointhe Product.

Manufacturing Changes. (a) Licensee may unilaterally and in its sole discretion make one or more Required Manufacturing Changes by giving written notice thereof to Quoin, whereupon the Parties shall cooperate in implementing such Required Manufacturing Changes as promptly as reasonably practicable. Licensee may request one or more Discretionary Manufacturing Changes by giving at least ninety (90) days written notice thereof to Quoin, whereupon if Quoin accepts the requested Discretionary Manufacturing Changes (such acceptance not to be unreasonably withheld or delayed), the Parties shall cooperate in implementing such Discretionary Manufacturing Changes as promptly as reasonably practicable. Quoin shall promptly provide to Licensee Quoin’s good faith and detailed estimate of the actual and reasonable costs that will be incurred by Quoin resulting directly from any such Required or Discretionary Manufacturing Changes, including the cost of any obsolete inventory resulting from the changes. All such reasonable and documented costs shall be borne by Licensee. (b) Quoin shall not in any respect amend, modify or supplement the Specifications or the manufacturing process or any materials or sources of materials used in connection with manufacturing the Product without the prior written consent of Licensee. Quoin may request or recommend one or more Discretionary Manufacturing Changes by giving at least ninety (90) days written notice thereof to Licensee and shall provide Licensee with appropriate documentation relating to any such changes to the Specifications or manufacturing process. If Licensee approves any such Discretionary Manufacturing Change, Quoin may implement such change in accordance with the specifications provided by Quoin to Licensee. If such a Change requires regulatory approval, Quoin shall provide all necessary documents, information and materials needed for such an approval. The Licensee shall promptly provide to Quoin Licensee’s good faith and detailed estimate of the actual and reasonable costs that will be incurred by Licensee resulting directly from any such Discretionary Manufacturing Changes, including the cost of any obsolete inventory resulting from the changes. All costs arising out of any Discretionary Manufacturing Changes requested by Quoin Quoin, including Licensee's reasonable and documented costs, shall be borne by Quoin.

Manufacturing Changes. The Product Specifications shall be amended as (a) Licensee may unilaterally and in its sole discretion make one reasonably requested by Purchaser or more Required Manufacturing Changes by giving written notice thereof to Quoin, whereupon the Parties shall cooperate in implementing such Required Manufacturing Changes as promptly as reasonably practicable. Licensee may request one or more Discretionary Manufacturing Changes by giving at least ninety (90) days written notice thereof to Quoin, whereupon if Quoin accepts the requested Discretionary Manufacturing Changes (such acceptance not to be unreasonably withheld or delayed), the Parties shall cooperate in implementing such Discretionary Manufacturing Changes as promptly as reasonably practicable. Quoin shall promptly provide to Licensee Quoin’s good faith and detailed estimate of the actual and reasonable costs that will be incurred by Quoin resulting directly from any such Required or Discretionary Manufacturing Changes, including the cost of any obsolete inventory resulting from the changes. All such reasonable and documented costs shall be borne by Licensee. (b) Quoin shall not necessary to conform such Product Specifications to the regulatory requirements necessary to obtain and maintain Regulatory Approvals with respect to the Product in the reasonable discretion of Purchaser. If any respect amendchange in the Product Specifications, modify or supplement if any change in the Specifications Regulatory Approvals, applicable laws, rules, or the manufacturing process or any materials regulations or sources of materials used Materials requires either (a) a change in the Product manufacturing process, or (b) Supplier to conduct development, testing, or other activities (e.g., process development, stability testing, validation of new specifications) (collectively, “Activities”) in addition to those activities Supplier conducted or is required to [*CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT. EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK [***], HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.] conduct in its manufacture of the Product prior to such change being requested or required, Purchaser shall reimburse Supplier for all commercially reasonable documented costs incurred by Supplier in connection with manufacturing the Product without the prior written consent of Licenseesuch change. Quoin may request If Supplier requires regulatory changes to support improved process or recommend one or more Discretionary Manufacturing Changes by giving at least ninety (90) days written notice thereof yield improvements, then Purchaser, in consultation with Supplier, agrees to Licensee and shall provide Licensee with appropriate documentation relating to any submit such changes to the Specifications EMEA or manufacturing processMHRA, as required, and Supplier shall pay for such changes. If Licensee approves any such Discretionary Manufacturing Change, Quoin may implement such change Changes implemented to support improved process or yield improvements shall not result in accordance with interruption in the specifications provided by Quoin to Licensee. All costs arising out supply or quality of any Discretionary Manufacturing Changes requested by Quoin shall be borne by Quointhe Product.

Manufacturing Changes. 5.4.1 The Parties acknowledge that, during the development of a Product (a) Licensee and possibly thereafter), the Specifications for the Material may unilaterally and change on more than one occasion, provided that such changes must be mutually agreed to in its sole discretion make one or more Required Manufacturing Changes writing by giving written notice thereof to Quoin, whereupon the Parties shall cooperate in implementing such Required Manufacturing Changes as promptly as reasonably practicable. Licensee may request one or more Discretionary Manufacturing Changes by giving at least ninety (90) days written notice thereof to Quoin, whereupon if Quoin accepts the requested Discretionary Manufacturing Changes (such acceptance consent not to be unreasonably withheld withheld). 5.4.2 CAMBRIDGE shall report to ONYX any significant proposed changes to its Manufacturing process which would be reflected in the NDA for the Material or delayedany equivalent document filed in any other country or any change that would cause a change to the Specifications as soon as possible, but in no event later than [*] prior to the date scheduled for implementation. ONYX may purchase up to [*] supply of Material prior to the implementation of any such change requiring prior approval by FDA or any applicable Regulatory Authority, which Material shall be supplied in accordance with the then current Manufacturing process and using then current raw materials (with a mutually agreeable Delivery Date), unless otherwise agreed to by the Parties shall cooperate in implementing such Discretionary Manufacturing Changes as promptly as reasonably practicable. Quoin writing. 5.4.3 In addition to any changes that require FDA or any Regulatory Authority approval, CAMBRIDGE shall promptly provide notify ONYX if there have been any significant changes in batch size, raw materials, raw material suppliers, Manufacturing location, Manufacturing equipment or testing procedures for the Material (including without limitation any change which would be reflected in the NDA for the Material or any equivalent document filed in other countries worldwide, changes resulting in a change of impurity profile or total impurities, changes to Licensee Quoin’s good faith particle size distribution, loss on drying changes, scale-up of batch size and detailed estimate any results of changes to the Specifications). 5.4.4 CAMBRIDGE will not make any of the actual and reasonable costs that foregoing changes or any changes in CAMBRIDGE’s Manufacturing process which would require ONYX to file an amendment, supplement or variation to the NDA or any other applicable regulatory filings worldwide for a Product without ONYX’s prior written consent, which will not be unreasonably withheld, unless required to do so by Applicable Laws. 5.4.5 Any major unplanned deviations from CAMBRIDGE’s Manufacturing process for the Material will be incurred by Quoin filed in the NDA in the United States or applicable regulatory document for other countries worldwide, and changes resulting directly from in a change of impurity profile or total impurities, further scale-up of batch size for the Material and any such Required or Discretionary Manufacturing Changes, including the cost results of any obsolete inventory resulting from the changes. All such reasonable and documented costs shall be borne by Licensee. (b) Quoin shall not in any respect amend, modify or supplement the Specifications or the manufacturing process or any materials or sources of materials used in connection with manufacturing the Product without the prior written consent of Licensee. Quoin may request or recommend one or more Discretionary Manufacturing Changes by giving at least ninety (90) days written notice thereof to Licensee and shall provide Licensee with appropriate documentation relating to any such changes to the Specifications or manufacturing processwill be immediately reported in writing to ONYX. If Licensee approves [*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. 5.4.6 Upon ONYX’s request, in the event of any such Discretionary Manufacturing Changechange described in this Section 5.4, Quoin may implement CAMBRIDGE shall within [*] of implementation of such change (but in no event later than CAMBRIDGE’s next shipment of Material to ONYX) provide ONYX, at ONYX’s reasonable expense, with a minimum of [*] samples of Material Manufactured in accordance with the specifications provided by Quoin to Licenseesuch change or process for ONYX’s evaluation. All costs arising out The size of any Discretionary Manufacturing Changes requested by Quoin such samples shall be borne reasonably agreed upon by Quoinboth Parties, but shall be of sufficient size to permit ONYX to conduct a meaningful evaluation. At least [*] samples shall come from each of [*] different Lots. 5.4.7 Notwithstanding the foregoing, CAMBRIDGE shall adhere to batch record review and deviation reporting the Lots as required by the Act and applicable FDA or any Regulatory Authority regulations and guidelines.