Common use of Manufacturing Technology Transfer Clause in Contracts

Manufacturing Technology Transfer. In addition to the Zymeworks Know-How provided to Jazz pursuant to the Initial Technology Transfer, upon Jazz’s written request, Zymeworks will promptly work with Jazz to prepare and submit to the JSC, for its review, a plan (“Manufacturing Technology Transfer Plan”) for the transfer to Jazz or its designee of all Zymeworks Know-How and certain biological materials Controlled by Zymeworks with respect to the manufacture of Licensed Antibody or Licensed Product (“Zymeworks Manufacturing IP”), including, without limitation, [***] and the conduct by Zymeworks of such consultation activities, as are necessary or useful to enable Jazz or any Third Party contract manufacturing organization (a “CMO”) designated by Jazz to manufacture for the Territory Licensed Antibody and Licensed Product (such actions, “Manufacturing Technology Transfer”). Jazz shall have the right to request a single Manufacturing Technology Transfer for both Licensed Antibody and Licensed Product or a single Manufacturing Technology Transfer for Licensed Product and a single, separate Manufacturing Technology Transfer for Licensed Antibody. Following the review and approval by the JSC of the applicable Manufacturing Technology Transfer Plan, Zymeworks will perform (or cause one or more applicable Third Parties (including, as applicable, any CMO engaged by Zymeworks to manufacture Licensed Antibody or Licensed Product) to perform) the requested Manufacturing Technology Transfer in accordance with such Manufacturing Technology Transfer Plan to Jazz or to a CMO designated by Jazz[***]. Zymeworks will complete the Manufacturing Technology Transfer promptly (and in any event within [***] after the Parties’ agreement on the Manufacturing Technology Transfer Plan) in accordance with the timeline agreed by the Parties, following Jazz’s request and in accordance with the applicable Manufacturing Technology Transfer Plan. Thereafter during the Term, Zymeworks will provide Jazz with additional Zymeworks Manufacturing IP as part of the Continuing Technology Transfer in accordance with Section 4.1, and Jazz shall disclose Jazz Manufacturing IP in accordance with Section 7.4(c). All Licensed Antibody and Licensed Product manufactured by or on behalf of Jazz or its CMO shall be manufactured in compliance with all Applicable Laws and applicable specifications for the Licensed Antibody and Licensed Product.

Manufacturing Technology Transfer. In addition to the Zymeworks Know-How provided to Jazz BeiGene pursuant to the Initial Technology Transfer, upon JazzBeiGene’s written requestrequest approximately […***…] in advance of the date on which BeiGene intends to commence manufacture of Licensed Product, Zymeworks will promptly work with Jazz to prepare and submit to the JSC, for its review, a plan (( “Manufacturing Technology Transfer Plan”) for the transfer to Jazz or its designee BeiGene of all Zymeworks Know-How and certain biological materials Controlled by Zymeworks with respect to the manufacture Manufacture of Licensed Antibody or Licensed Product (“Zymeworks Manufacturing IP”), including, without limitation, [***] and the conduct by Zymeworks of such consultation activities, as are necessary or useful to enable Jazz BeiGene or any Third Party contract manufacturing organization (a the “CMO”) designated by Jazz BeiGene and agreed by the Parties in writing to manufacture for the Territory (a) the Licensed Antibody and as the Active Ingredient of the applicable Licensed Product and/or (b) the applicable Licensed Product (such actions, “Manufacturing Technology Transfer”). Jazz shall have the right to request a single Manufacturing Technology Transfer for both Licensed Antibody and Licensed Product or a single Manufacturing Technology Transfer for Licensed Product and a single, separate Manufacturing Technology Transfer for Licensed Antibody. Following the review and approval by the JSC of the applicable Manufacturing Technology Transfer Plan, Zymeworks will perform (or cause one or more applicable Third Parties (including, as applicable, any CMO engaged by Zymeworks to manufacture Licensed Antibody or the Licensed Product) to perform) the requested Manufacturing Technology Transfer […***…] in accordance with such Manufacturing Technology Transfer Plan to Jazz (a) […***…] and (b) either BeiGene or to a CMO designated by Jazz(other than […***…]) designated by BeiGene, […***…]. Zymeworks will complete the Manufacturing Technology Transfer for each Licensed Product promptly (and in any event within […***…] after agreement by the Parties’ agreement on Parties with respect to the Manufacturing Technology Transfer PlanPlan and the CMO to receive such transfer, as applicable) in accordance with the timeline agreed by the Parties, following JazzBeiGene’s request and in accordance with the applicable Manufacturing Technology Transfer Plan. Thereafter during the Term, Zymeworks will provide Jazz BeiGene with additional Zymeworks Manufacturing IP as part of the Continuing Technology Transfer in accordance with Section 4.1. After completion of the Manufacturing Technology Transfer to a facility, and Jazz use of such facility to manufacture the Licensed Product shall disclose Jazz be subject to successful completion of any necessary inspections required by applicable Regulatory Authorities, as well as a qualifying audit by or on behalf of Zymeworks (collectively, the “Qualifying Audits”); provided, that, Zymeworks hereby agrees to complete each such Qualifying Audit for each facility within […***…] of the completion of the Manufacturing IP Technology Transfer to such facility. BeiGene may use Licensed Product manufactured at its qualified facilities or those of the CMO to which the Manufacturing Technology Transfer is made, for clinical or commercial purposes in accordance with Section 7.4(c)the Territory. All Licensed Antibody and Licensed Product manufactured by or on behalf of Jazz BeiGene or its CMO shall be manufactured in compliance with all Applicable Laws and applicable specifications for the Licensed Antibody and Licensed Product.Product.62

Manufacturing Technology Transfer. In addition to the Zymeworks Licensed Know-How provided to Jazz BeiGene pursuant to the Initial Technology Know-How Transfer, upon JazzBeiGene’s written requestrequest and approximately [***] in advance of the date on which BeiGene intends to commence manufacture of Licensed Product, Zymeworks Leap will promptly work with Jazz to prepare and submit to the JSCJDC, for its review, a plan (“Manufacturing Technology Transfer Plan”) for the transfer to Jazz or its designee BeiGene of all Zymeworks Know-How and certain biological materials Controlled by Zymeworks Leap with respect to the manufacture Manufacture of Licensed Antibody or Licensed Product (“Zymeworks Leap Manufacturing IP”), including, without limitationand the conduct by Leap of such consultation activities, [***] and the conduct by Zymeworks of such consultation activities(as provided in this Section 7.2), as are necessary or useful to enable Jazz BeiGene or any Third Party contract manufacturing organization (a the “CMO”) designated by Jazz BeiGene and reasonably acceptable to Leap, such acceptance not to be unreasonably withheld, to manufacture for the Territory (a) the Licensed Antibody and as the Active Ingredient of the applicable Licensed Product and/or (b) the applicable Licensed Product (such actions, “Manufacturing Technology Transfer”). Jazz shall have the right to request a single Manufacturing Technology Transfer for both Licensed Antibody and Licensed Product or a single Manufacturing Technology Transfer for Licensed Product and a single, separate Manufacturing Technology Transfer for Licensed Antibody. Following the review and approval by the JSC JDC of the applicable Manufacturing Technology Transfer Plan, Zymeworks Leap will perform (or cause one or more applicable Third Parties (including, as applicable, any CMO engaged by Zymeworks Leap to manufacture Licensed Antibody or the Licensed Product) to perform) the requested Manufacturing Technology Transfer [***] in accordance with such Manufacturing Technology Transfer Plan to Jazz either BeiGene or to a CMO designated by JazzBeiGene, [***]. Zymeworks Leap will complete the Manufacturing Technology Transfer for each Licensed Product promptly (and in any event within [***] after agreement by the Parties’ agreement on Parties with respect to the Manufacturing Technology Transfer PlanPlan and the CMO to receive such transfer, as applicable) in accordance with the timeline agreed by the Parties, following JazzBeiGene’s request and in accordance with the applicable Manufacturing Technology Transfer Plan. Thereafter during the Term, Zymeworks Leap will provide Jazz BeiGene with additional Zymeworks Leap Manufacturing IP as part of the Continuing Technology Know-How Transfer in accordance with Section 4.1. After completion of the Manufacturing Technology Transfer to a facility, and Jazz the use of such facility to manufacture the Licensed Product shall disclose Jazz be subject to the successful completion of any necessary inspections required by applicable Regulatory Authorities. BeiGene may use Licensed Product manufactured at its facilities or those of the CMO to which the Manufacturing IP Technology Transfer is made, for clinical or commercial purposes in accordance with Section 7.4(c)the Territory. All Licensed Antibody and Licensed Product manufactured by or on behalf of Jazz BeiGene or its CMO shall be manufactured in compliance with all Applicable Laws and applicable specifications for the Licensed Antibody and Licensed Product. Leap will invoice BeiGene for any expenses for technology transfer activities under this Section 7.2 [***], for up to [***] for a period of up to [***], at a rate of [***], prorated to $[***], assuming [***]. BeiGene’s liability for technology transfer activities under this Section 7.2 will in no event exceed [***] in total.55 53 Competitive Information – Commercially Sensitive Terms. 54 Competitive Information – Commercially Sensitive Terms.

Manufacturing Technology Transfer. In addition to the Zymeworks Know-How provided to Jazz pursuant to the Initial Technology Transfer, upon Jazz’s written requestrequest at any time during the Term, Zymeworks will promptly work with Jazz to prepare and submit to the JSC, for its review, a plan (“Manufacturing Technology Transfer Plan”) for the transfer to Jazz or its designee of all Zymeworks Know-How and certain biological materials Controlled by Zymeworks with respect to the manufacture of Licensed Antibody or Licensed Product (“Zymeworks Manufacturing IP”), including, without limitation, [***] and the conduct by Zymeworks of such consultation activities, as are necessary or useful to enable Jazz or any Third Party contract manufacturing organization (a “CMO”) designated by Jazz to manufacture for the Territory Licensed Antibody and Licensed Product (such actions, “Manufacturing Technology Transfer”). Jazz shall have the right to request a single Manufacturing Technology Transfer for both Licensed Antibody and Licensed Product or a single Manufacturing Technology Transfer for Licensed Product and a single, separate Manufacturing Technology Transfer for Licensed Antibody. Following the review and approval by the JSC of the applicable Manufacturing Technology Transfer Plan, Zymeworks will perform (perform, or cause one or more applicable Third Parties (including, as applicable, any CMO engaged by Zymeworks to manufacture Licensed Antibody or Licensed Product) to perform) , the requested Manufacturing Technology Transfer in accordance with such Manufacturing Technology Transfer Plan to Jazz or to a CMO designated by JazzJazz [***]. For the avoidance of doubt, Jazz contracting directly with a CMO of Zymeworks for clinical or commercial supply, or a CMO of Zymeworks conducting an internal technology transfer to another location or affiliate of such CMO, in each case, using a Manufacturing process and scale that are materially similar to those used by such CMO, shall not count towards the limit of Manufacturing Technology Transfers. Zymeworks will complete the Manufacturing Technology Transfer promptly (and in any event within [***] after the Parties’ agreement on the Manufacturing Technology Transfer Plan) in accordance with the timeline agreed by the Parties, following Jazz’s request and in accordance with the applicable Manufacturing Technology Transfer Plan. Thereafter during the Term, Zymeworks will provide Jazz with additional Zymeworks Manufacturing IP as part of the Continuing Technology Transfer in accordance with Section 4.1, and Jazz shall disclose Jazz Manufacturing IP in accordance with Section 7.4(c7.4(d). All Licensed Antibody and Licensed Product manufactured by or on behalf of Jazz or its CMO shall be manufactured in compliance with all Applicable Laws and applicable specifications for the Licensed Antibody and Licensed Product.

Manufacturing Technology Transfer. In addition to the Zymeworks Know-How provided to Jazz BeiGene pursuant to the Initial Technology Transfer, upon JazzBeiGene’s written requestrequest after the receipt of the Trial Completion Notice and approximately […***…] in advance of the date on which BeiGene intends to commence manufacture of Licensed Product, Zymeworks will promptly work with Jazz to prepare and submit to the JSC, for its review, a plan (“Manufacturing Technology Transfer Plan”) for the transfer to Jazz or its designee BeiGene of all Zymeworks Know-How and certain biological materials Controlled by Zymeworks with respect to the manufacture Manufacture of Licensed Antibody or Licensed Product (“Zymeworks Manufacturing IP”), including, without limitation, [***] and the conduct by Zymeworks of such consultation activities, as are necessary or useful to enable Jazz BeiGene or any Third Party contract manufacturing organization (a the “CMO”) designated by Jazz BeiGene and agreed by the Parties in writing to manufacture for the Territory (a) the Licensed Antibody and Antibody-Drug Conjugate as the Active Ingredient of the applicable Licensed Product and/or (b) the applicable Licensed Product (such actions, “Manufacturing Technology Transfer”). Jazz shall have the right to request a single Manufacturing Technology Transfer for both Licensed Antibody and Licensed Product or a single Manufacturing Technology Transfer for Licensed Product and a single, separate Manufacturing Technology Transfer for Licensed Antibody. Following the review and approval by the JSC of the applicable Manufacturing Technology Transfer Plan, Zymeworks will perform (or cause one or more applicable Third Parties (including, as applicable, any CMO engaged by Zymeworks to manufacture Licensed Antibody or the Licensed Product) to perform) the requested Manufacturing Technology Transfer […***…] in accordance with such Manufacturing Technology Transfer Plan to Jazz (a) […***…] and (b) either BeiGene or to a CMO designated by Jazz(other than […***…]) designated by BeiGene, […***…]. Zymeworks will complete the Manufacturing Technology Transfer for each Licensed Product promptly (and in any event within […***…] after agreement by the Parties’ agreement on Parties with respect to the Manufacturing Technology Transfer PlanPlan and the CMO to receive 61 Competitive Information – Commercially Sensitive Terms. such transfer, as applicable) in accordance with the timeline agreed by the Parties, following JazzBeiGene’s request and in accordance with the applicable Manufacturing Technology Transfer Plan. Thereafter during the Term, Zymeworks will provide Jazz BeiGene with additional Zymeworks Manufacturing IP as part of the Continuing Technology Transfer in accordance with Section 4.1. After completion of the Manufacturing Technology Transfer to a facility, and Jazz use of such facility to manufacture the Licensed Product shall disclose Jazz be subject to successful completion of any necessary inspections required by applicable Regulatory Authorities, as well as a qualifying audit by or on behalf of Zymeworks (collectively, the “Qualifying Audits”); provided, that, Zymeworks hereby agrees to complete each such Qualifying Audit for each facility within […***…] of the completion of the Manufacturing IP Technology Transfer to such facility. BeiGene may use Licensed Product manufactured at its qualified facilities or those of the CMO to which the Manufacturing Technology Transfer is made, for clinical or commercial purposes in accordance with Section 7.4(c)the Territory. All Licensed Antibody and Licensed Product manufactured by or on behalf of Jazz BeiGene or its CMO shall be manufactured in compliance with all Applicable Laws and applicable specifications for the Licensed Antibody and Licensed Product.Product.62

Manufacturing Technology Transfer. In addition Subject to its compliance with Applicable Laws and this Agreement, Betta will commence manufacturing technology transfer as contemplated under this Section 5.2 by written notice to Agenus (the Zymeworks Know-How provided to Jazz pursuant to “Tech Transfer Notice”) no later than [*] from the Initial Technology TransferEffective Date. [*] of the Tech Transfer Notice, upon Jazz’s written request, Zymeworks the Parties will promptly work with Jazz to prepare and submit to enter into a technology transfer agreement (the JSC, for its review, “Tech Transfer Agreement”) detailing a technology transfer plan (the “Manufacturing Technology Tech Transfer Plan”) for the transfer to Jazz or its designee of all Zymeworks Know-How Agenus Manufacturing Technology for both Licensed Antibodies; provided that, notwithstanding the Tech Transfer Agreement and certain biological materials Controlled Tech Transfer Plan, any assistance provided by Zymeworks Agenus in connection with respect the Tech Transfer Plan and Tech Transfer Agreement will be subject to the manufacture provisions contained in Section 4.4. [*] following the execution of the Tech Transfer Agreement, the Parties will begin the transfer of the Agenus Manufacturing Technology for both Licensed Antibody Antibodies from Agenus to Betta, its Affiliate or Licensed Product a permitted Third Party manufacturer engaged by Betta (which will be approved by Agenus, [*] (the “Zymeworks Manufacturing IPThird Party Manufacturer”), includingin accordance with the Tech Transfer Plan at Betta’s sole cost and expense, without limitationsubject to Section 4.4. Among other things, the Tech Transfer Plan will provide that Agenus will [***] (i) provide reasonable assistance to Betta in accordance with Section 4.4 and (ii) make available reasonably sufficient quantities of the conduct by Zymeworks Manufacturing Materials for the Licensed Antibodies to support the ongoing production of such consultation activitiesLicensed Antibodies for commercial manufacturing purposes, together with appropriate documentation regarding the history, validation, stability and propagation of such Manufacturing Materials and such other documentation and information as are necessary Betta, its Affiliate or useful to enable Jazz or any the Third Party contract manufacturing organization (a “CMO”) designated by Jazz to manufacture for the Territory Licensed Antibody and Licensed Product (such actions, “Manufacturing Technology Transfer”). Jazz shall have the right to request a single Manufacturing Technology Transfer for both Licensed Antibody and Licensed Product or a single Manufacturing Technology Transfer for Licensed Product and a single, separate Manufacturing Technology Transfer for Licensed Antibody. Following the review and approval by the JSC of the applicable Manufacturing Technology Transfer Plan, Zymeworks will perform (or cause one or more applicable Third Parties (includingManufacturer, as applicable, may reasonably request. Subject to Section 4.4, Betta will reimburse all out of pocket travel and accommodation costs incurred by Agenus and Affiliates in the course of the performance of the Tech Transfer Plan. Any and all Know-How transferred under the Agenus Manufacturing Technology may only be used by Betta, its Affiliate, or the Third Party Manufacturer, as applicable, to Manufacture the Licensed Antibodies and/or the Licensed Products in the Territory, in the Field, during the Term, and not for any CMO engaged by Zymeworks to manufacture Licensed Antibody or Licensed Productother purpose. Upon [*], the transfer of Agenus Manufacturing Technology contemplated under this Section 5.2(b) to perform) will be deemed completed (the requested “Manufacturing Technology Transfer in accordance Completion”), and Betta will provide Agenus with such Manufacturing Technology Transfer Plan to Jazz or to a CMO designated by Jazz[***]. Zymeworks will complete written confirmation of the Manufacturing Technology Transfer promptly (and in any event within Completion [**] of the occurrence thereof, and pay Agenus the Tech Transfer Fee in accordance with Section 7.2. Notwithstanding anything to the contrary, Betta will [*] after the Parties’ agreement on ensure the Manufacturing Technology Transfer Plan) in accordance with Completion will occur within [*] following the timeline agreed by the Parties, following Jazz’s request and in accordance with the applicable Manufacturing Technology Transfer Plan. Thereafter during the Term, Zymeworks will provide Jazz with additional Zymeworks Manufacturing IP as part effective date of the Continuing Technology Tech Transfer in accordance with Section 4.1, and Jazz shall disclose Jazz Manufacturing IP in accordance with Section 7.4(c). All Licensed Antibody and Licensed Product manufactured by or on behalf of Jazz or its CMO shall be manufactured in compliance with all Applicable Laws and applicable specifications for the Licensed Antibody and Licensed ProductAgreement.