Common use of Manufacture and Supply Clause in Contracts

Manufacture and Supply. 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, for the Combined Therapy Clinical Trial, and shall supply such BMS Study Drug as either commercially labeled or unlabeled vials to the Recipient or its 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 the Combined Therapy Clinical Trial to the extent necessary. The cost of Manufacture and supply (including shipping, taxes and duty, if applicable) of the BMS Study Drug for the Combined Therapy Clinical Trial shall be 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 the Combined Therapy Clinical Trial. The BMS Study Drug shall be 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 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 allow 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 regulatory compliance of the 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, the Parties shall cooperate in accordance with Applicable Law to minimize indirect taxes (such as value added tax, sales tax, consumption tax and other similar taxes) relating to the BMS Study Drug in connection with this Agreement.

Manufacture and Supply. BMS shall Manufacture or have Manufactured the BMS Study Drug in reasonable quantities needed, and at the points in time as agreed to by As between the Parties, for the Combined Therapy Clinical TrialOtsuka 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 such BMS Study Drug as either commercially labeled or unlabeled vials Licensed Product to the Recipient Acucela or its designee for use solely in the Combined Therapy Clinical Trial. The Recipient will at its sole expense, package and label the BMS Study Drug 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 Combined Therapy Clinical Trial 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 extent necessaryJCC. The cost of Manufacture 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 shippingOther Indication Product(s), taxes and duty, if as applicable) of and from time to time shall update Acucela on any foreseeable delays and/or other material issues relating to Manufacturing the BMS Study Drug for Licensed Product (including Other Indication Product(s), as applicable). Through the Combined Therapy Clinical Trial JDC or applicable Operating Team, Otsuka and Acucela shall be borne solely by BMSconfer and discuss CMC matters, and BMS shall bear the risk Otsuka agrees to consider suggestions 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 the Combined Therapy Clinical Trial. The BMS Study Drug shall be 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 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 allow 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 regulatory compliance of the 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, the Parties shall cooperate in accordance with Applicable Law to minimize indirect taxes (such as value added tax, sales tax, consumption tax and other similar taxes) relating to the BMS Study Drug in connection with this AgreementAcucela regarding CMC matters.

Manufacture and Supply. BMS shall Manufacture Zai will be responsible for, and use Commercially Reasonable Efforts to Manufacture, or have Manufactured (pursuant to Section 2.4), Licensed Products, sufficient and solely to meet the BMS Study Drug in reasonable quantities needed, Development and at the points in time as agreed to by the Parties, for the Combined Therapy Clinical Trial, and shall supply such BMS Study Drug as either commercially labeled or unlabeled vials to the Recipient or its designee for use solely Commercialization requirements of a Licensed Product in the Combined Therapy Clinical Trial. The Recipient will Territory, at its sole cost and expense. Zai will undertake such Manufacturing activities of the Licensed Products in accordance with the Product Specifications. [*] = Certain confidential information contained in this document, package marked by brackets, has been omitted and label filed separately with the BMS Study Drug Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended. If [*], Paratek will permit Paratek’s suppliers to provide such supply to Zai and shall reasonably assist Zai to obtain a supply of Licensed Products for use the Development and Commercialization activities contemplated hereunder by introducing Zai to suppliers that Paratek utilizes at that time. Zai will ensure that any arrangement between Zai and such suppliers (a) will not alter or affect Paratek’s supply related to the Licensed Product, and (b) Paratek will not have any liability or obligation related to such arrangements. If Zai is required by the CFDA 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 involvement in the Combined Therapy Clinical Trial Development, Manufacture or Commercialization of the Licensed Product as an imported product, and Zai will maintain appropriate minimum liability insurance (to be determined in the extent necessaryImported Product Agreement) levels. The cost For the avoidance of Manufacture doubt, (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 any obligation to (i) accommodate the supply (including shipping, taxes and duty, if applicabledirectly or indirectly) of the BMS Study Drug for the Combined Therapy Clinical Trial shall Compound or Licensed Product to Zai, or (ii) be borne solely by BMS, and BMS shall bear the risk an applicant on a regulatory application or holder of loss for such quantities of BMS Study Drug until delivery of such quantities of BMS Study Drug a regulatory approval related 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 Zai’s Exploitation of the BMS Study Drug used in the Combined Therapy Clinical Trial. The BMS Study Drug shall be 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 BMS Study Drug. BMS shall deliver certificates of analysis, and any other documents specified in the Supply and Quality Documentation, including such documentation Licensed Product as is necessary to allow 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 regulatory compliance of the 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, the Parties shall cooperate in accordance with Applicable Law to minimize indirect taxes (such as value added tax, sales tax, consumption tax and other similar taxes) relating to the BMS Study Drug in connection with this Agreementan imported product.

Manufacture and Supply. BMS During the Term and subject to the terms and conditions set forth herein, VTM shall Manufacture 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 have Manufactured its designee. Delivery of the BMS Study Drug in reasonable quantities neededDSAs shall be EXW (“Ex-Works”) VTM’s manufacturing facility 00 Xxxxxx Xxxx, and at the points in time as agreed to by the PartiesXxxxxxxxxx, XX 00000 (INCOTERMS 2000); [***] shall arrange for the Combined Therapy Clinical Trial, DSAs to be picked up by a carrier identified and shall supply such BMS Study Drug as either commercially labeled or unlabeled vials to the Recipient paid by [***] or its designee 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 solely 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 Combined Therapy Clinical Trial. The Recipient will at its sole expenseThird Party Components, package and label the BMS Study Drug “OptiNose Components”), in each instance for use in the Combined Therapy Clinical Trial 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 OptiNose 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 extent necessaryomitted portions. The cost of Manufacture and supply (including shipping, taxes and duty, if applicablec) If the suppliers of the BMS Study Drug OptiNose Components cause the assembly line at VTM to halt production due to lack of OptiNose Components, and if VTM has provided OptiNose at least [***] advance written notice of VTM’s projected or actual shortage of such OptiNose Components, then subject to the following sentence, VTM may invoice OptiNose for the Combined Therapy Clinical Trial 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 (and not any other overhead, facility costs, or profit of VTM), 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 any such lack of OptiNose Components then VTM shall use its [***] efforts to reassign its staff and otherwise mitigate its costs, which shall be borne solely deducted from any amounts due by BMSOptiNose 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 BMS then an increase in demand requires operators to be retrained to manufacture and assemble the DSAs, (1) OptiNose shall bear the risk of loss pay for such quantities retraining at a rate [***], and (2) OptiNose must provide at least [***] prior written notice before VTM shall be required to effectuate such an increase. (e) At OptiNose’s request, VTM shall warehouse up to [***] pallets of BMS Study Drug until delivery of such quantities of BMS Study Drug the OptiNose Components listed on Exhibit B. The parties will mutually agree to any additional warehousing and associated cost. Notwithstanding the foregoing, VTM shall at OptiNose’s request warehouse [***] any and all OptiNose Components that VTM previously manufactured for OptiNose pursuant to the Recipient or its designeeMolded Parts Agreement. BMS shall also be (f) [***] is responsible for the payment of any Third Party License Payments that may be due based on the manufacturenegotiation, *CONFIDENTIAL TREATMENT REQUESTED. supply and use of the BMS Study Drug used in the Combined Therapy Clinical Trial. The BMS Study Drug shall be 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 BMS Study Drug. BMS shall deliver certificates of analysispayment, purchase, and any other documents specified in delivery to VTM of all Inventory, but not the Supply OptiNose Components. Appropriate agreements and Quality Documentation, including such documentation as is necessary to allow of quality related requirements will also be the Recipient to compare the BMS Study Drug certificate responsibility of analysis to the BMS Study Drug specifications[***]. Pursuant to the Supply and Quality Documentation, BMS shall be responsible for the regulatory compliance of the 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, the Parties shall cooperate in accordance with Applicable Law to minimize indirect taxes (such as value added tax, sales tax, consumption tax and other similar taxes) relating to the BMS Study Drug in connection with this Agreement.2.03

Manufacture and Supply. BMS shall Manufacture Zai will be responsible for, and use Commercially Reasonable Efforts to Manufacture, or have Manufactured (pursuant to Section 2.4), Licensed Products, sufficient and solely to meet the BMS Study Drug in reasonable quantities needed, Development and at the points in time as agreed to by the Parties, for the Combined Therapy Clinical Trial, and shall supply such BMS Study Drug as either commercially labeled or unlabeled vials to the Recipient or its designee for use solely Commercialization requirements of a Licensed Product in the Combined Therapy Clinical Trial. The Recipient will Territory, at its sole cost and expense. Zai will undertake such Manufacturing activities of the Licensed Products in accordance with the Product Specifications. If [*], package Paratek will permit Paratek’s suppliers to provide such supply to Zai and label shall reasonably assist Zai to obtain a supply of Licensed Products for the BMS Study Drug Development and Commercialization activities contemplated hereunder by introducing Zai to suppliers that Paratek utilizes at that time. Zai will ensure that any arrangement between Zai and such suppliers (a) will not alter or affect Paratek’s supply related to the Licensed Product, and (b) Paratek will not have any liability or obligation related to such arrangements. If Zai is required by the CFDA 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 use any liability (including product liability) related to Paratek’s involvement in the Combined Therapy Clinical Trial Development, Manufacture or Commercialization of the Licensed Product as an imported product, and Zai will maintain appropriate minimum liability insurance (to be determined in the extent necessaryImported Product Agreement) levels. The cost For the avoidance of Manufacture doubt, (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 any obligation to (i) accommodate the supply (including shipping, taxes and duty, if applicabledirectly or indirectly) of the BMS Study Drug for the Combined Therapy Clinical Trial shall Compound or Licensed Product to Zai, or (ii) be borne solely by BMS, and BMS shall bear the risk an applicant on a regulatory application or holder of loss for such quantities of BMS Study Drug until delivery of such quantities of BMS Study Drug a regulatory approval related 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 Zai’s Exploitation of the BMS Study Drug used Licensed Product as an imported product. [*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Combined Therapy Clinical Trial. The BMS Study Drug shall be manufactured in accordance with Applicable Law (including GMP) Securities and shall be of similar quality Exchange Commission pursuant to the BMS Study Drug used by BMS for its other clinical trials Rule 406 of the BMS Study Drug. BMS shall deliver certificates Securities Act of analysis1933, and any other documents specified in the Supply and Quality Documentation, including such documentation as is necessary to allow 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 regulatory compliance of the 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, the Parties shall cooperate in accordance with Applicable Law to minimize indirect taxes (such as value added tax, sales tax, consumption tax and other similar taxes) relating to the BMS Study Drug in connection with this Agreementamended.