Common use of Manufacture and Supply Clause in Contracts

Manufacture and Supply. As between the Parties, Otsuka shall be responsible for, shall bear all costs associated with, and shall have all decision-making authority over, all Manufacturing Activities (subject to discussion of CMC matters with Acucela through the JDC or applicable Operating Team as discussed below); provided, that Otsuka shall supply Licensed Product to Acucela or its permitted subcontractors for use in clinical trials conducted in accordance with each Development Plan and, if applicable, Commercialization Plan (i.e., Phase 3b Clinical Trials or Post-Approval Studies, if any), free of charge and in such quantities as are agreed by the JDC or the JCC (as applicable) or are otherwise required to seek or obtain Regulatory Approval. In addition, if and after Acucela exercises an Opt-In Right under Section 3.1, Otsuka shall supply promotional samples of Licensed Product to Acucela for use in its performance of Co-Promotion, in such quantities and on such terms as are determined by the JCC. The cost of promotional samples of Licensed Product, which shall be included in Commercialization Costs, shall be established by the JCC based on Otsuka’s per-unit cost to manufacture such promotional samples (but, for the avoidance of doubt, Otsuka shall have no obligation to disclose any information relating to its manufacturing costs), but in no event shall such promotional sample cost exceed * per promotional sample unless mutually agreed otherwise by the Parties. Acucela’s and its permitted subcontractors’ obligations to conduct Development activities, and upon Acucela’s exercise of its Opt-in Right pursuant to Section 3.1, to conduct Development and Commercialization activities, shall be expressly conditioned upon Otsuka fulfilling its Licensed Product supply obligations as set forth in the Development Plan or the Commercialization Plan, as applicable. To the extent that Otsuka reasonably believes is necessary for performance of Development or Commercialization, Otsuka agrees to keep Acucela reasonably informed from time to time, through the JDC, JCC or applicable Operating Team, regarding the general status of Manufacturing Activities related to the Licensed Product * Confidential Treatment Requested. (including Other Indication Product(s), as applicable) and from time to time shall update Acucela on any foreseeable delays and/or other material issues relating to Manufacturing the Licensed Product (including Other Indication Product(s), as applicable). Through the JDC or applicable Operating Team, Otsuka and Acucela shall confer and discuss CMC matters, and Otsuka agrees to consider suggestions of Acucela regarding CMC matters.

Manufacture and Supply. As between BMS shall Manufacture or have Manufactured the BMS Study Drug in reasonable quantities needed, and at the points in time as agreed to by the Parties, Otsuka shall be responsible for, shall bear all costs associated withfor the Combined Therapy Clinical Trial, and shall have all decision-making authority over, all Manufacturing Activities (subject supply such BMS Study Drug as either commercially labeled or unlabeled vials to discussion of CMC matters with Acucela through the JDC or applicable Operating Team as discussed below); provided, that Otsuka shall supply Licensed Product to Acucela Recipient or its permitted subcontractors designee for use solely in the Combined Therapy Clinical Trial. The Recipient will at its sole expense, package and label the BMS Study Drug for use in clinical trials conducted in accordance with each Development Plan and, if applicable, Commercialization Plan (i.e., Phase 3b the Combined Therapy Clinical Trials or Post-Approval Studies, if any), free of charge and in such quantities as are agreed by Trial to the JDC or the JCC (as applicable) or are otherwise required to seek or obtain Regulatory Approval. In addition, if and after Acucela exercises an Opt-In Right under Section 3.1, Otsuka shall supply promotional samples of Licensed Product to Acucela for use in its performance of Co-Promotion, in such quantities and on such terms as are determined by the JCCextent necessary. The cost of promotional samples Manufacture and supply (including shipping, taxes and duty, if applicable) of Licensed Product, which the BMS Study Drug for the Combined Therapy Clinical Trial shall be included borne solely by BMS, and BMS shall bear the risk of loss for such quantities of BMS Study Drug until delivery of such quantities of BMS Study Drug to the Recipient or its designee. BMS shall also be responsible for the payment of any Third Party License Payments that may be due based on the manufacture, *CONFIDENTIAL TREATMENT REQUESTED. supply and use of the BMS Study Drug used in Commercialization Costs, the Combined Therapy Clinical Trial. The BMS Study Drug shall be established manufactured in accordance with Applicable Law (including GMP) and shall be of similar quality to the BMS Study Drug used by BMS for its other clinical trials of the JCC based on Otsuka’s per-unit cost BMS Study Drug. BMS shall deliver certificates of analysis, and any other documents specified in the Supply and Quality Documentation, including such documentation as is necessary to manufacture such promotional samples (butallow the Recipient to compare the BMS Study Drug certificate of analysis to the BMS Study Drug specifications. Pursuant to the Supply and Quality Documentation, BMS shall be responsible for the avoidance regulatory compliance of doubtthe quality of the BMS Study Drug at the time the BMS Study Drug is delivered to the Recipient with the regulatory filings in the countries in the Territory where the Combined Therapy Clinical Trial will be performed. Subject to Section 4.4, Otsuka the Parties shall have no obligation cooperate in accordance with Applicable Law to disclose any information minimize indirect taxes (such as value added tax, sales tax, consumption tax and other similar taxes) relating to its manufacturing costs), but the BMS Study Drug in no event shall such promotional sample cost exceed * per promotional sample unless mutually agreed otherwise by the Parties. Acucela’s and its permitted subcontractors’ obligations to conduct Development activities, and upon Acucela’s exercise of its Opt-in Right pursuant to Section 3.1, to conduct Development and Commercialization activities, shall be expressly conditioned upon Otsuka fulfilling its Licensed Product supply obligations as set forth in the Development Plan or the Commercialization Plan, as applicable. To the extent that Otsuka reasonably believes is necessary for performance of Development or Commercialization, Otsuka agrees to keep Acucela reasonably informed from time to time, through the JDC, JCC or applicable Operating Team, regarding the general status of Manufacturing Activities related to the Licensed Product * Confidential Treatment Requested. (including Other Indication Product(s), as applicable) and from time to time shall update Acucela on any foreseeable delays and/or other material issues relating to Manufacturing the Licensed Product (including Other Indication Product(s), as applicable). Through the JDC or applicable Operating Team, Otsuka and Acucela shall confer and discuss CMC matters, and Otsuka agrees to consider suggestions of Acucela regarding CMC mattersconnection with this Agreement.

Manufacture and Supply. As between the Parties, Otsuka shall Zai will be responsible for, shall bear all costs associated withand use Commercially Reasonable Efforts to Manufacture, or have Manufactured (pursuant to Section 2.4), Licensed Products, sufficient and shall have all decision-making authority over, all Manufacturing Activities (subject solely to discussion meet the Development and Commercialization requirements of CMC matters with Acucela through the JDC or applicable Operating Team as discussed below); provided, that Otsuka shall supply a Licensed Product to Acucela or in the Territory, at its permitted subcontractors for use in clinical trials conducted sole cost and expense. Zai will undertake such Manufacturing activities of the Licensed Products in accordance with each Development Plan andthe Product Specifications. [*] = Certain confidential information contained in this document, if applicablemarked by brackets, Commercialization Plan (i.e.has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, Phase 3b Clinical Trials or Post-Approval Studiesas amended. If [*], if any), free of charge Paratek will permit Paratek’s suppliers to provide such supply to Zai and in such quantities as are agreed by the JDC or the JCC (as applicable) or are otherwise required shall reasonably assist Zai to seek or obtain Regulatory Approval. In addition, if and after Acucela exercises an Opt-In Right under Section 3.1, Otsuka shall a supply promotional samples of Licensed Product Products for the Development and Commercialization activities contemplated hereunder by introducing Zai to Acucela for use in its performance of Co-Promotion, in suppliers that Paratek utilizes at that time. Zai will ensure that any arrangement between Zai and such quantities and on such terms as are determined by suppliers (a) will not alter or affect Paratek’s supply related to the JCC. The cost of promotional samples of Licensed Product, which shall be included in Commercialization Costs, shall be established and (b) Paratek will not have any liability or obligation related to such arrangements. If Zai is required by the JCC based on OtsukaCFDA to Commercialize the Licensed Product as an imported product, the Parties will negotiate in good faith the terms of an agreement to address this event (an “Imported Product Agreement”), and such agreement will include, but not be limited to, provisions whereby Zai will indemnify Paratek for any liability (including product liability) related to Paratek’s per-unit cost involvement in the Development, Manufacture or Commercialization of the Licensed Product as an imported product, and Zai will maintain appropriate minimum liability insurance (to manufacture such promotional samples (but, for be determined in the Imported Product Agreement) levels. For the avoidance of doubt, Otsuka shall (y) Paratek will be adequately protected from any liability based on Zai’s activities in the Territory including Zai’s sourcing of the Compound or Licensed Product, and (z) absent the Parties agreement to terms pursuant to an Imported Product Agreement, Paratek will not have no any obligation to disclose any information relating to its manufacturing costs), but in no event shall such promotional sample cost exceed * per promotional sample unless mutually agreed otherwise by (i) accommodate the Parties. Acucela’s and its permitted subcontractors’ obligations to conduct Development activities, and upon Acucela’s exercise supply (directly or indirectly) of its Opt-in Right pursuant to Section 3.1, to conduct Development and Commercialization activities, shall be expressly conditioned upon Otsuka fulfilling its the Compound or Licensed Product supply obligations as set forth in the Development Plan to Zai, or the Commercialization Plan, as applicable. To the extent that Otsuka reasonably believes is necessary for performance (ii) be an applicant on a regulatory application or holder of Development or Commercialization, Otsuka agrees to keep Acucela reasonably informed from time to time, through the JDC, JCC or applicable Operating Team, regarding the general status of Manufacturing Activities a regulatory approval related to Zai’s Exploitation of the Licensed Product * Confidential Treatment Requested. (including Other Indication Product(s), as applicable) and from time to time shall update Acucela on any foreseeable delays and/or other material issues relating to Manufacturing the Licensed Product (including Other Indication Product(s), as applicable). Through the JDC or applicable Operating Team, Otsuka and Acucela shall confer and discuss CMC matters, and Otsuka agrees to consider suggestions of Acucela regarding CMC mattersan imported product.

Manufacture and Supply. As between During the PartiesTerm and subject to the terms and conditions set forth herein, Otsuka VTM shall procure Inventory and manufacture and assemble DSAs in compliance with the Specifications, Quality Agreement, applicable Laws and the other terms of this Agreement and deliver them to OptiNose or its designee. Delivery of the DSAs shall be responsible forEXW (“Ex-Works”) VTM’s manufacturing facility 00 Xxxxxx Xxxx, shall bear all costs associated withXxxxxxxxxx, and shall have all decision-making authority over, all Manufacturing Activities XX 00000 (subject to discussion of CMC matters with Acucela through the JDC or applicable Operating Team as discussed belowINCOTERMS 2000); provided, that Otsuka [***] shall supply Licensed Product arrange for the DSAs to Acucela be picked up by a carrier identified and paid by [***] or its permitted subcontractors designee. During the Term, VTM shall use [***] to ensure that it has the Capacity to meet all of OptiNose’s requirements for DSAs in a timely manner based on the applicable Forecast under this Agreement; provided that if new or additional OptiNose Equipment is required, VTM will inform OptiNose with sufficient lead time for such OptiNose Equipment to be acquired by OptiNose [***] and qualified for use under this Agreement taking into account normal equipment malfunctions and breakdowns not preventable through normal maintenance; Capacity metrics will be agreed upon and equipment will be initiated if projected utilization for the following year exceeds [***], or if OptiNose deems to initiate a project for business continuity. Section 2.02 Inputs for Supply of DSA’s. (a) OptiNose is responsible for negotiation of agreements and payment to third parties for the items listed on Exhibit B (the “Third Party Components”) and was responsible for the agreements and payment for the Pre-Existing Inventory (as defined in Exhibit A) listed on Exhibit B (collectively with the Third Party Components, the “OptiNose Components”), in each instance for use in clinical trials conducted the manufacture of DSAs. (b) OptiNose will manage the relationship with suppliers of the OptiNose Components identified in Exhibit B, placing orders for Third Party Components, arranging delivery to VTM of the OptiNose Components at OptiNose’s cost, and ensuring that such suppliers perform in accordance with requirements of OptiNose. VTM shall manage suppliers of the OptiNose Components within VTM’s quality systems as appropriate to ensure compliance with the quality agreements referenced in this Section 2.02(b). OptiNose may initiate the addition or replacement of suppliers for each Development Plan andOptiNose Component upon [***] written notice to VTM and will work with VTM to execute such addition or replacement according to relevant OptiNose and VTM procedures at OptiNose’s expense. 6 [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. (c) If the suppliers of the OptiNose Components cause the assembly line at VTM to halt production due to lack of OptiNose Components, and if applicableVTM has provided OptiNose at least [***] advance written notice of VTM’s projected or actual shortage of such OptiNose Components, Commercialization Plan then subject to the following sentence, VTM may invoice OptiNose for the reasonable costs incurred by VTM for such idle VTM operator time, which shall not exceed $[***]per week for [***] shift, or $[***] per week if running [***] shifts, in the aggregate, for which VTM shall provide OptiNose with a detailed breakdown of such costs and which shall solely include the compensation of the operators (i.e.and not any other overhead, Phase 3b Clinical Trials facility costs, or Post-Approval Studies, if anyprofit of VTM), free such amount to be the sole amount payable by OptiNose with respect to such idle time. If OptiNose provides VTM with at [***] prior written notice of charge any such lack of OptiNose Components then VTM shall use its [***] efforts to reassign its staff and in such quantities as are agreed by the JDC or the JCC (as applicable) or are otherwise required to seek or obtain Regulatory Approval. In addition, if and after Acucela exercises an Opt-In Right under Section 3.1, Otsuka shall supply promotional samples of Licensed Product to Acucela for use in mitigate its performance of Co-Promotion, in such quantities and on such terms as are determined by the JCC. The cost of promotional samples of Licensed Productcosts, which shall be included deducted from any amounts due by OptiNose to VTM for such lack of OptiNose Components. (d) If any time after [***] VTM’s production of DSA requires less operators than anticipated or no operators at all, and then an increase in Commercialization Costsdemand requires operators to be retrained to manufacture and assemble the DSAs, (1) OptiNose shall pay for such retraining at a rate [***], and (2) OptiNose must provide at least [***] prior written notice before VTM shall be established by required to effectuate such an increase. (e) At OptiNose’s request, VTM shall warehouse up to [***] pallets of the JCC based OptiNose Components listed on OtsukaExhibit B. The parties will mutually agree to any additional warehousing and associated cost. Notwithstanding the foregoing, VTM shall at OptiNose’s per-unit cost request warehouse [***] any and all OptiNose Components that VTM previously manufactured for OptiNose pursuant to manufacture such promotional samples the Molded Parts Agreement. (but, f) [***] is responsible for the avoidance negotiation, payment, purchase, and delivery to VTM of doubt, Otsuka shall have no obligation to disclose any information relating to its manufacturing costs)all Inventory, but in no event shall such promotional sample cost exceed * per promotional sample unless mutually agreed otherwise by not the PartiesOptiNose Components. Acucela’s Appropriate agreements and its permitted subcontractors’ obligations to conduct Development activities, and upon Acucela’s exercise documentation of its Opt-in Right pursuant to quality related requirements will also be the responsibility of [***]. Section 3.1, to conduct Development and Commercialization activities, shall be expressly conditioned upon Otsuka fulfilling its Licensed Product supply obligations as set forth in the Development Plan or the Commercialization Plan, as applicable. To the extent that Otsuka reasonably believes is necessary for performance of Development or Commercialization, Otsuka agrees to keep Acucela reasonably informed from time to time, through the JDC, JCC or applicable Operating Team, regarding the general status of Manufacturing Activities related to the Licensed Product * Confidential Treatment Requested. (including Other Indication Product(s), as applicable) and from time to time shall update Acucela on any foreseeable delays and/or other material issues relating to Manufacturing the Licensed Product (including Other Indication Product(s), as applicable). Through the JDC or applicable Operating Team, Otsuka and Acucela shall confer and discuss CMC matters, and Otsuka agrees to consider suggestions of Acucela regarding CMC matters.2.03

Manufacture and Supply. As between the Parties, Otsuka shall Zai will be responsible for, shall bear all costs associated withand use Commercially Reasonable Efforts to Manufacture, or have Manufactured (pursuant to Section 2.4), Licensed Products, sufficient and shall have all decision-making authority over, all Manufacturing Activities (subject solely to discussion meet the Development and Commercialization requirements of CMC matters with Acucela through the JDC or applicable Operating Team as discussed below); provided, that Otsuka shall supply a Licensed Product to Acucela or in the Territory, at its permitted subcontractors for use in clinical trials conducted sole cost and expense. Zai will undertake such Manufacturing activities of the Licensed Products in accordance with each Development Plan andthe Product Specifications. If [*], if applicable, Commercialization Plan (i.e., Phase 3b Clinical Trials or Post-Approval Studies, if any), free of charge Paratek will permit Paratek’s suppliers to provide such supply to Zai and in such quantities as are agreed by the JDC or the JCC (as applicable) or are otherwise required shall reasonably assist Zai to seek or obtain Regulatory Approval. In addition, if and after Acucela exercises an Opt-In Right under Section 3.1, Otsuka shall a supply promotional samples of Licensed Product Products for the Development and Commercialization activities contemplated hereunder by introducing Zai to Acucela for use in its performance of Co-Promotion, in suppliers that Paratek utilizes at that time. Zai will ensure that any arrangement between Zai and such quantities and on such terms as are determined by suppliers (a) will not alter or affect Paratek’s supply related to the JCC. The cost of promotional samples of Licensed Product, which shall be included in Commercialization Costs, shall be established and (b) Paratek will not have any liability or obligation related to such arrangements. If Zai is required by the JCC based on OtsukaCFDA to Commercialize the Licensed Product as an imported product, the Parties will negotiate in good faith the terms of an agreement to address this event (an “Imported Product Agreement”), and such agreement will include, but not be limited to, provisions whereby Zai will indemnify Paratek for any liability (including product liability) related to Paratek’s per-unit cost involvement in the Development, Manufacture or Commercialization of the Licensed Product as an imported product, and Zai will maintain appropriate minimum liability insurance (to manufacture such promotional samples (but, for be determined in the Imported Product Agreement) levels. For the avoidance of doubt, Otsuka shall (y) Paratek will be adequately protected from any liability based on Zai’s activities in the Territory including Zai’s sourcing of the Compound or Licensed Product, and (z) absent the Parties agreement to terms pursuant to an Imported Product Agreement, Paratek will not have no any obligation to disclose any information relating to its manufacturing costs), but in no event shall such promotional sample cost exceed * per promotional sample unless mutually agreed otherwise by (i) accommodate the Parties. Acucela’s and its permitted subcontractors’ obligations to conduct Development activities, and upon Acucela’s exercise supply (directly or indirectly) of its Opt-in Right pursuant to Section 3.1, to conduct Development and Commercialization activities, shall be expressly conditioned upon Otsuka fulfilling its the Compound or Licensed Product supply obligations as set forth in the Development Plan to Zai, or the Commercialization Plan, as applicable. To the extent that Otsuka reasonably believes is necessary for performance (ii) be an applicant on a regulatory application or holder of Development or Commercialization, Otsuka agrees to keep Acucela reasonably informed from time to time, through the JDC, JCC or applicable Operating Team, regarding the general status of Manufacturing Activities a regulatory approval related to Zai’s Exploitation of the Licensed Product * Confidential Treatment Requestedas an imported product. (including Other Indication Product(s)[*] = 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 406 of the Securities Act of 1933, as applicable) and from time to time shall update Acucela on any foreseeable delays and/or other material issues relating to Manufacturing the Licensed Product (including Other Indication Product(s), as applicable). Through the JDC or applicable Operating Team, Otsuka and Acucela shall confer and discuss CMC matters, and Otsuka agrees to consider suggestions of Acucela regarding CMC mattersamended.