Common use of Manufacture and Supply Clause in Contracts

Manufacture and Supply. 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 Development and Commercialization requirements of a Licensed Product in the 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, 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 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 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 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 Imported Product Agreement) levels. For the avoidance of 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 (directly or indirectly) of the Compound or Licensed Product to Zai, or (ii) be an applicant on a regulatory application or holder of a regulatory approval related to Zai’s Exploitation of the Licensed Product as an imported product.

Manufacture and Supply. Zai will be responsible for2.1 On and subject to the provisions of this Agreement, the Supplier shall Manufacture and use Commercially Reasonable Efforts to Manufacturesupply, or have Manufactured (pursuant and supplied, to Section 2.4)the Purchaser, Licensed Productsand the Purchaser shall purchase, sufficient and solely to meet or procure the Development and Commercialization requirements of a Licensed Product in the Territory, at its sole cost and expense. Zai will undertake such Manufacturing activities purchase by an Affiliate of the Licensed Purchaser of, the Products for which a Firm Order is placed until the end of the applicable Product Term and: (A) in accordance with clause 3 (Forecasts and Orders — Push/Pull) in respect of Pull Products; and (B) in accordance with (Forecasts and Orders — Push/Pull) and Exhibit 17 (Push Products) in respect of Push Products. 2.2 The Purchaser may commence purchasing each Product under this Agreement from the applicable Commencement Date, unless otherwise agreed in writing by the Parties. 2.3 The Supplier shall (or, subject to clause 2.6, shall procure that a Permitted Subcontractor or Nominated Supplier will) Manufacture the Products at the Manufacturing Sites in accordance with: (A) the applicable Specifications on the Effective Date (unless changed in accordance with clause 20 (Product Specifications)); (B) current Good Manufacturing Practice and responsible procurement guidelines; (C) the applicable Manufacturing Licences; (D) the applicable Marketing Authorisations (in the case of Shared Chemical/API Products, to the extent relevant); (E) the Quality Agreement and the applicable Quality Standards; (F) Pull Firm Orders and Push Firm Orders; (G) Applicable Law in the country of Manufacture relevant to the Manufacture of the Product; and (H) Applicable Law in the Territory where the Product Specifications(or in the case of Shared Chemical/API Products or Shared Packaging Materials, any product incorporating such Products or Materials) is to be sold in relation to the Manufacture of such Product. 2.4 During the Term, the Supplier shall (or, subject to clause 2.6 shall procure that a Permitted Subcontractor or Nominated Supplier will) obtain (where not held already) and maintain all necessary Manufacturing Licences from the relevant Governmental Entity as are required for the Manufacture of the Products at the Manufacturing Sites. 2.5 The Parties hereby acknowledge that the Supplier may, on prior written notice to the Purchaser, nominate any of its Affiliates to act as its Nominated Supplier under this Agreement to Manufacture and supply Products to, and receive payment from, the Purchaser (or its Affiliate), provided that: (A) the Supplier shall remain primarily liable to the Purchaser as principal obligor for the performance of its obligations under this Agreement in respect of such supply; and (B) such entity shall cease to be a Nominated Supplier if it ceases to be an Affiliate of the Supplier and the Supplier shall be required to either perform the obligations of such former Affiliate or procure its replacement by another Affiliate prior to it ceasing to be an Affiliate. [*] = Certain confidential information contained The Supplier may change the Nominated Supplier from time to time by notice in writing to the Purchaser (provided always that such Nominated Supplier is an Affiliate of the Supplier) subject to the terms set forth in clause 40 (Technical Transfer). References in this documentAgreement to the Supplier shall be deemed to include any appointed Nominated Suppliers. 2.6 The Supplier may not sub-contract the Manufacture of Products (or any part thereof) to a Third Party without the prior written consent of the Purchaser (such consent not to be unreasonably withheld, marked conditioned or delayed), provided that each Third Party arrangement set out in Annex E of the Quality Agreement shall be deemed to have been given the prior written consent of the Purchaser and the Third Party listed shall be a Permitted Subcontractor. Any Third Party sub-contractor engaged by brackets, has been omitted and filed separately the Supplier with the Securities and Exchange Commission pursuant to Rule 406 prior written consent of the Securities Act of 1933, as amendedPurchaser in accordance with this clause 2.6 shall be deemed to be a Permitted Subcontractor. 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 the Development and Commercialization activities contemplated hereunder by introducing Zai to suppliers that Paratek utilizes at that time. Zai The Supplier will ensure that any arrangement between Zai all Permitted Subcontractors and such suppliers all Nominated Suppliers act in compliance with the terms and conditions of this Agreement, including but not limited to, complying with all Applicable Laws, and shall ensure that the Permitted Subcontractors and Nominated Suppliers are subject to confidentiality obligations that are no less restrictive than those found at clause 31 (aConfidentiality) will not alter or affect Paratek’s supply related and, to the Licensed extent practicable, grant the Purchaser audit and inspection rights substantially equivalent to those set out in clause 33 (Audit and Inspection Rights). The engagement of Permitted Subcontractors and Nominated Suppliers shall not relieve the Supplier from any of its liabilities or obligations under this Agreement and the Supplier shall remain liable as primary obligor to the Purchaser for the acts or omissions of all Permitted Subcontractors and Nominated Suppliers as if they were the acts or omissions of the Supplier. 2.7 The Supplier may not: (A) change a Permitted Subcontractor; (B) make any material amendments to contracts with Permitted Subcontractors relating to the Manufacture or supply of Products (including any amendment that would adversely affect the Purchaser or require an amendment to a Marketing Authorisation or permit held by the Purchaser) except where such changes are required by a Governmental Entity (and in such case, only upon reasonable advance notice to the Purchaser); or (C) in respect of a Product, change (or permit a Nominated Supplier or Permitted Subcontractor to change) the API Supplier or the supplier of any registered Materials, in each case without the prior written consent of the Purchaser (such consent not to be unreasonably withheld or delayed) and in accordance with any applicable change control provisions set out in the Quality Agreement. 2.8 The Supplier may not change or permit the change of any Manufacturing Site other than as provided for in the Long Term Transfer Plan without the prior written consent of the Purchaser (bsuch consent not to be unreasonably withheld, conditioned or delayed), provided that any change of any Manufacturing Site (other than any provided for in the Long Term Transfer Plan) Paratek will not have shall: (A) be subject to any liability applicable change control provisions set out in the Quality Agreement; and (B) comply with Applicable Law. 2.9 In the event that Applicable Law or obligation related a Governmental Entity or local customs office requires that the Parties (or their Affiliates) enter into a local agreement in relation to such arrangements. If Zai is required the Manufacture or supply of a particular Product by the CFDA Supplier (or its Nominated Supplier) to Commercialize the Licensed Product as an imported productPurchaser (or its designated Affiliate), the Parties will shall negotiate in good faith and enter into such local agreements on a Product-by-Product and country-by-country basis to give effect to the transactions contemplated by this Agreement in relation to such Product in such country, provided that: (A) the Parties shall only enter into such local agreements where required by Applicable Law or a Governmental Entity or local customs office to do so; (B) each such local agreement shall be limited in scope to those matters for which it is necessary for the Parties (or their Affiliates) to contract locally; (C) subject to clause 2.9(B), each local agreement shall be consistent with the terms of this Agreement and not have an disproportionate adverse effect on either Party; (D) the Parties shall procure that, in respect of any Product, such local agreement is terminated in the event that this Agreement expires or is terminated in relation to such Product; and (E) subject to clause 2.9(A) and any requirements of Applicable Law, in the event of any conflict or inconsistency between the provisions of this Agreement and the provisions of such a local agreement, the provisions of this Agreement shall prevail. Without prejudice to the rights and obligations of the Parties under clause 10 (Price and Price Adjustments), to the extent there is an inconsistency between the provisions of this Agreement and the provisions of any local agreement, either Party may refer the matter to the Manufacturing and Supply Team which may agree a mechanism to address this event (an “Imported Product Agreement”)any such inconsistency. 2.10 The Supplier shall not be obliged to Manufacture and/or supply, and the Purchaser shall not be obliged to purchase, any Product if such agreement will includeManufacture, supply or purchase would cause that Party to be in breach of Sanctions and Export Controls (including but not limited to debarred individuals and ITAR). U.S. export control and economic sanctions laws and the export control and economic sanctions laws of other countries, including but not limited to EU Member States, Singapore, and Switzerland, may govern the export, sale, and/or use of Products. The Purchaser shall be limited toresponsible for obtaining any required government authorisations under the relevant Sanctions and Export Controls. Each Party to this Agreement agrees to comply fully with all relevant Sanctions and Export Controls to assure that no Product or any portion thereof is exported, provisions whereby Zai will indemnify Paratek for any liability (including product liability) related to Paratek’s involvement sold, or otherwise transferred directly or indirectly, in violation of Applicable Law. 2.11 Until the Development, Manufacture or Commercialization transfer of the Licensed Brazil Delayed Business to the Supplier’s Group: (A) the Supplier shall not commence Manufacture and supply under this Agreement of any Product as an imported product, and Zai will maintain appropriate minimum liability insurance for which the Delayed Site is the Manufacturing Site; and (B) each Delayed Site Transferring Product for which the Delayed Site is the Manufacturing Site shall be deemed not to be determined included in this Agreement until the Imported Delayed Site Transferring Product AgreementCommencement Date. 2.12 In respect of each Delayed Site Transferring Product: (A) levels. For with effect from the avoidance Delayed Site Transferring Product Commencement Date, the Supplier shall commence Manufacture and supply under this Agreement of doubt, each Delayed Site Transferring Product for which the Delayed Site is the Manufacturing Site; (yB) 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 Delayed Site Transferring Products which: (i) accommodate were ordered by the supply (directly or indirectly) Purchaser’s Group in the ordinary course of business prior to the Compound or Licensed Delayed Site Transferring Product to Zai, or Commencement Date; and (ii) are scheduled to be an applicant delivered on or after the Delayed Site Transferring Product Commencement Date, (as recorded in the Supplier’s Systems in the ordinary course of business on the Delayed Site Transferring Product Commencement Date) shall be deemed to have been ordered by the Purchaser under this Agreement pursuant to Firm Orders and shall be Delivered (and invoiced) in accordance with this Agreement. 2.13 Where not already provided in Exhibit 1 (Products), prior to the Delayed Site Transferring Product Commencement Date, the Parties shall agree, on a regulatory application or holder basis consistent with the terms of a regulatory approval related to Zai’s Exploitation this Agreement, upon the applicable MOQ, Lead Time, Specifications, Firm Zone, Total Product Cost, Supply Price, Manufacturing Site and, if applicable, Permitted Subcontractor(s) in respect of the Licensed Product as an imported productManufacture of the relevant Delayed Site Transferring Product.

Manufacture and Supply. 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 Development and Commercialization requirements of a Licensed Product in the 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, 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 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 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 Pfizer shall be responsible for the manufacture of all preclinical and clinical materials for each Licensed Product and for the commercial supply related to the of each Licensed Product. Quark shall use reasonable efforts to promptly assign to Pfizer or its designated Affiliate the development and supply agreement, and dated [ * ] (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”), between Quark and such agreement will include[ * ]. If the [ * ], but not be limited to, provisions whereby Zai will indemnify Paratek for any liability (including product liability) related to Paratek’s involvement in Pfizer shall use [ * ] until the Development, Manufacture or Commercialization earlier of the Licensed Product as an imported product, and Zai will maintain appropriate minimum liability insurance (to be determined in the Imported Product Agreement) levels. For the avoidance of 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 (directly or indirectly) of the Compound or Licensed Product to Zai, [ * ] or (ii) [ * ]. Nothing herein shall restrict Quark from engaging [ * ] to manufacture any materials other than Biomolecules or Licensed Products. (b) If during the Term Pfizer determines that it desires to produce one or both strands of any Biomolecule for the commercial supply of any Licensed Product at a second site, whether such second site would be an applicant operated by Pfizer or by a Third Party, Pfizer shall give written notice of such determination to Quark (a “Supply Notice”). If within [ * ] following receipt of the Supply Notice, Quark notifies Pfizer that Quark desires to be considered as a supplier of such stand(s) of any Biomolecule set forth in the Supply Notice, then Pfizer shall negotiate exclusively with Quark and in good faith for a period of not less than [ * ] to determine whether Quark can satisfy the requirements of Pfizer. Such [ * ] period shall commence with the first substantive meeting between the parties to discuss the manufacturing requirements of Pfizer. In the course of its negotiations, Pfizer shall not impose on Quark supply conditions of quality, price, capacity or risk allocation that it would not require of Third Party suppliers or impose upon itself. It is the intent of this paragraph for Pfizer to select Quark as the supplier that provides a regulatory application second site for the manufacture of such strand(s) of any Biomolecule selected by Pfizer if Quark desires to fill such role, is capable of doing so on competitive terms and Quark’s manufacturing capabilities in terms of quality, reliability and otherwise is reasonably satisfactory to Pfizer. For purposes of this paragraph only, “site” shall mean a geographical location of manufacturing facilities ([ * ]), and “second site” shall mean any manufacturing site that is not the initial site for the manufacture of Biomolecules for the commercial supply of Licensed Products. The initial site shall include both [ * ]’s site (which may be used solely to manufacture the registration batches and the launch supply of Biomolecule for the country or holder the group of countries for which the first Regulatory Approval is obtained) and Pfizer’s initial site, including the expansion of a regulatory approval related to Zai’s Exploitation of the Licensed Product as an imported productfacility within such site.

Manufacture and Supply. Zai 4.1 Manufacturing and Supply Agreement for DHE. 4.1.1 Promptly following the Effective Date, Xcel will exercise good faith efforts to enter into an agreement with [***]. POZEN will exercise good faith efforts to assist Xcel in its discussions and negotiations with [***] with respect to such agreement. Xcel will keep POZEN informed of the progress of Xcel’s negotiations with [***] and, as applicable, provide POZEN with a near-final draft of such agreement and a copy of such agreement as executed. 4.1.2 Xcel hereby covenants and agrees that, [***]. 4.2 Manufacturing and Supply Agreement for [***]. 4.2.1 Promptly following the Effective Date, Xcel will exercise good faith efforts to enter into an agreement with [***]. POZEN will exercise good faith efforts to assist Xcel in its discussions and negotiations with [***] with respect to such agreement. Xcel will keep POZEN informed of the progress of Xcel’s negotiations with [***] and, as applicable, provide POZEN with a near-final draft of such agreement and a copy of such agreement as executed. 4.2.2 The Parties acknowledge that POZEN and [***] have executed an agreement pursuant to which [***] is scaling up the manufacturing process for bulk packaged Initial Licensed Product to [***]. POZEN will exercise its Commercially Reasonable Efforts so that, as soon as reasonably possible following the Effective Date, [***] produces a demonstration batch of bulk packaged Initial Licensed Product from such [***] process which meets or exceeds all of the release specifications set forth in the POZEN NDA (the “Demonstration Batch”). [***] will be responsible forfor all costs incurred for producing batches of bulk packaged Initial Licensed Product until the Demonstration Batch is determined to meet or exceed all of the release specifications set forth in the POZEN NDA. Thereafter, [***] the costs incurred for producing batches of bulk packaged Initial Licensed Product from such [***] process until [***] batches are produced which each meet or exceed all of the release specifications set forth in the POZEN NDA approved by the FDA (such [***] batches referred to as the “Validation Batches”), and use each of the Parties will exercise its Commercially Reasonable Efforts to Manufacture, or have Manufactured (pursuant cause such production to Section 2.4), Licensed Products, sufficient and solely to meet the Development and Commercialization requirements of a Licensed Product in the Territory, at its sole cost and expense. Zai will undertake such Manufacturing activities of the Licensed Products in accordance with the Product Specifications. occur as soon as reasonably possible [***] = Certain confidential information contained in this documentto manufacture bulk packaged Initial Licensed Product. Notwithstanding the preceding sentence, 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 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 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) either Party will not alter or affect Paratek’s supply related have the right to request the manufacture of bulk packaged Initial Licensed Product [***] to manufacture bulk packaged Initial Licensed Product, provided that [***] will bear all costs reasonably incurred by either Party in connection with such manufacture, and (b) Paratek [***] will not have any liability pay or obligation related to such arrangements. If Zai is required by reimburse [***] the CFDA to Commercialize costs reasonably incurred in connection with 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 Development, Manufacture or Commercialization manufacture of the Licensed Product as an imported product, and Zai will maintain appropriate minimum liability insurance (to be determined in the Imported Product Agreement) levels. For the avoidance of 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 (directly or indirectly) of the Compound or Licensed Product to Zai, or (ii) be an applicant on a regulatory application or holder of a regulatory approval related to Zai’s Exploitation of the Licensed Product as an imported productValidation Batches.