Common use of Manufacturing Transfer Clause in Contracts

Manufacturing Transfer. Vir shall have the right at any time during the Term and on [***] written notice to WuXi, to request that WuXi transition the Manufacture of Vir Antibodies and Products to Vir (or a mutually agreed upon designee of Vir, including a CMO reasonably acceptable to WuXi) so as to obtain Clinical Supply and/or Commercial Supply of Vir Antibodies and Products from a Third Party, including where (i) [***]. If Vir makes such a request to transition the Manufacturing Process and Manufacturing of Vir Antibodies or Products for Vir (the “Transitioned Manufacturing”) to an alternate source of preclinical or Clinical Supply or Commercial Supply, the Parties shall cooperate to transition the Transitioned Manufacturing to Vir (or to Vir’s selected contract manufacturing organization the “Approved CMO”). If WuXi or any Affiliate has an existing relationship with such Approved CMO, WuXi shall facilitate discussions between Vir and such Approved CMO with respect to Vir’s negotiation and entry into a contract for the continued supply of Vir Antibodies or Product for Vir’s further supply needs for Products. In any event, WuXi shall cooperate to provide to Vir (or to such Approved CMO under obligations of confidentiality) all existing manufacturing data, information or other Know-How (including the then-current Manufacturing Process) then in WuXi’s or its Affiliates’ possession and Control and reasonably required for Vir (or such Approved CMO) to perform such Transitioned Manufacturing of Vir Antibodies or Products (the “WuXi Manufacturing Know-How”) at Vir’s reasonable cost and expense. WuXi shall also, in connection therewith, grant and hereby grants to Vir or to such Approved CMO a non-exclusive, royalty-free (except for any royalties payable under the Cell Line License Agreement) license under any WuXi Manufacturing Know-How, to use such manufacturing technology solely for the purposes of Manufacturing or having Manufactured Vir Antibodies or Products for Vir for the Vir Territory under a manufacturing transfer and licensing agreement. Subject to Article 13, Vir shall be responsible for all reasonable costs associated with the transition to Vir (or to such Approved CMO) (including payment at a commercially reasonable full time equivalent personnel rate for hours of consulting support provided by WuXi). Vir shall be responsible for all costs associated with the Manufacture, technology transfer and supply of Products by any such Approved CMO. The Parties shall use their Commercially Reasonable Efforts to complete the transition of the Transitioned Manufacturing as soon as practicable, as applicable, and in any event within four (4) months following the date of Vir’s initial request. Where WuXi transfers a Licensed Cell Line to a Third Party CMO, Vir shall be responsible for the payment of a royalty to WuXi on Net Sales in the Vir Territory for Product manufactured by CMOs other than WuXi, in accordance with the terms of the Cell Line License Agreement. Where WuXi performs Transitioned Manufacturing, it shall provide Vir with an estimate of reasonable, documented costs associated with such transition to Vir (or to such Approved CMO) within [***] following the end of the applicable Calendar Quarter, and provide an invoice therefor within [***] following the end of such Calendar Quarter. Vir shall pay any undisputed invoice within [***] following receipt of the invoice from WuXi.

Manufacturing Transfer. Vir (a) The Assigned Agreements relating to the manufacture and supply of the 500mg Product and the API (each, an “Assigned Manufacturing Agreement”) shall have the right at any time during the Term be assigned by Depomed in their entirety to Santarus, and on [***] written notice to WuXi, to request that WuXi transition shall be assumed in their entirety by Santarus promptly following (but in no event later than five (5) business days following) the Manufacture Transfer Date for the 500mg Product, pursuant to an Assignment and Assumption Agreement to be negotiated in good faith by the parties. From and after such assignment and assumption, Santarus shall be solely responsible for Manufacturing, or having Manufactured, the 500mg Product and the API for the 500mg Product. (b) Promptly after the Manufacture Transfer Date for the 500mg Product, Depomed shall notify each counterparty to any Assigned Manufacturing Agreement that such Assigned Manufacturing Agreement has been assigned to, and assumed by, Santarus, and shall authorize and instruct such counterparty to grant Santarus access to all technical, regulatory and other information and materials relating to the 500mg Product that are then in the possession of Vir Antibodies and Products such counterparty in accordance with the applicable Assigned Manufacturing Agreement. Santarus shall be entitled to Vir consult with such counterparty’s technical personnel with respect to Manufacturing activities as set forth in such Assigned Manufacturing Agreement. (or a mutually agreed upon designee of Virc) Promptly after the Effective Date, including a CMO reasonably acceptable to WuXi) so as to obtain Clinical Supply and/or Commercial Supply of Vir Antibodies and Products from a Third Party, including where (i) Depomed [***]. Santarus will manage any transfer and validation of Manufacturing the 500mg Product at Patheon’s Manati facility, [***]. (d) In the event the parties mutually agree for the BLS Supply Agreement or successor Third Party supplier agreement for the 1000mg Product to be assigned to Santarus, the parties will work together to obtain any necessary consent to assign the BLS Supply Agreement, and upon receipt of such consent, Depomed will assign the BLS Supply Agreement or successor agreement to Santarus. If Vir Depomed makes such a request to transition assignment, Santarus will assume the Manufacturing Process and Manufacturing of Vir Antibodies BLS Supply Agreement or Products for Vir (the “Transitioned Manufacturing”) successor agreement, pursuant to an alternate source of preclinical or Clinical Assignment and Assumption Agreement to be negotiated in good faith by the parties. (e) If the BLS Supply or Commercial SupplyAgreement is assigned to Santarus pursuant to Section 3.5(d), then promptly after the Parties shall cooperate to transition the Transitioned Manufacturing to Vir (or to Vir’s selected contract manufacturing organization the “Approved CMO”). If WuXi or any Affiliate has an existing relationship with such Approved CMO, WuXi shall facilitate discussions between Vir and such Approved CMO with respect to Vir’s negotiation and entry into a contract Manufacture Transfer Date for the continued supply 1000mg Product, Depomed shall deliver a copy of Vir Antibodies the fully-executed Assignment and Assumption Agreement to BLS or such Third Party, and shall authorize and instruct BLS or such Third Party to grant Santarus access to all technical, regulatory and other information and materials relating to the 1000mg Product for Vir’s further supply needs for Products. In any event, WuXi shall cooperate to provide to Vir (or to such Approved CMO under obligations of confidentiality) all existing manufacturing data, information or other Know-How (including the then-current Manufacturing Process) that are then in WuXi’s or its Affiliates’ the possession and Control and reasonably required for Vir (of BLS or such Approved CMO) to perform such Transitioned Manufacturing of Vir Antibodies or Products (the “WuXi Manufacturing Know-How”) at Vir’s reasonable cost and expense. WuXi shall also, in connection therewith, grant and hereby grants to Vir or to such Approved CMO a non-exclusive, royalty-free (except for any royalties payable under the Cell Line License Agreement) license under any WuXi Manufacturing Know-How, to use such manufacturing technology solely for the purposes of Manufacturing or having Manufactured Vir Antibodies or Products for Vir for the Vir Territory under a manufacturing transfer and licensing agreement. Subject to Article 13, Vir shall be responsible for all reasonable costs associated with the transition to Vir (or to such Approved CMO) (including payment at a commercially reasonable full time equivalent personnel rate for hours of consulting support provided by WuXi). Vir shall be responsible for all costs associated with the Manufacture, technology transfer and supply of Products by any such Approved CMO. The Parties shall use their Commercially Reasonable Efforts to complete the transition of the Transitioned Manufacturing as soon as practicable, as applicable, and in any event within four (4) months following the date of Vir’s initial request. Where WuXi transfers a Licensed Cell Line to a Third Party CMO, Vir shall be responsible for the payment of a royalty to WuXi on Net Sales in the Vir Territory for Product manufactured by CMOs other than WuXi, in accordance with the terms of BLS Supply Agreement or successor agreement. Santarus shall be entitled to consult with BLS’s or such Third Party’s technical personnel with respect to Manufacturing activities as set forth in the Cell Line License Agreement. Where WuXi performs Transitioned Manufacturing, it shall provide Vir with an estimate of reasonable, documented costs associated with such transition to Vir (BLS Supply Agreement or to such Approved CMO) within [***] following the end of the applicable Calendar Quarter, and provide an invoice therefor within [***] following the end of such Calendar Quarter. Vir shall pay any undisputed invoice within [***] following receipt of the invoice from WuXisuccessor agreement.

Manufacturing Transfer. Vir shall have (a) Subject to the right at remainder of this Section 3.2.2, as promptly as possible and in any time during event in accordance with the Term timing set forth in the Technology Transfer Plan, Relay will initiate and on [***] written notice complete (and if applicable, use Commercially Reasonable Efforts to WuXicause its CMO to initiate and complete) a technology transfer to Licensee, or to request its CMO of the Phase Ia Product, such CMO to be selected by Licensee and reasonably acceptable to Relay, of Relay Know-How, documentation and other Materials that WuXi transition relate to the Manufacture of Vir Antibodies the Lead Candidate or Lead Product (such Know-How, documentation and Products to Vir Materials, the “Manufacturing Know-How and Materials”) and that are listed on the Technology Transfer Plan (such transfer, the “Manufacturing Transfer”). To the extent any copies of documents or a mutually agreed upon designee materials within the Manufacturing Know-How and Materials are in possession of Vir, including a CMO reasonably acceptable to WuXi) so as to obtain Clinical Supply and/or Commercial Supply of Vir Antibodies and Products from a Third Party, including Relay is solely responsible, at its own cost and expense, to procure and provide to Licensee all such Manufacturing Know-How and Materials, together with all rights to access and use any such Development Know-How and Materials in accordance with this Agreement (which may be procured or provided by letters of authorization or comparable instruments where (i) [***]. If Vir makes such a request to transition the Manufacturing Process and Manufacturing of Vir Antibodies or Products for Vir (the “Transitioned Manufacturing”) to an alternate source of preclinical or Clinical Supply or Commercial Supply, the Parties shall cooperate to transition the Transitioned Manufacturing to Vir (or to Vir’s selected contract manufacturing organization the “Approved CMO”approved by Licensee). If WuXi Relay will make available its personnel and use Commercially Reasonable Efforts to cause its CMO and other Third Party Subcontractors with relevant subject matter expertise to be available on a reasonable basis to consult with Licensee or any Affiliate has an existing relationship with such Approved CMO, WuXi shall facilitate discussions between Vir and such Approved Licensee’s CMO with respect to Vir’s negotiation and entry into a contract for the continued supply of Vir Antibodies or Product for Vir’s further supply needs for Products. In any event, WuXi shall cooperate to provide to Vir (or to such Approved CMO under obligations of confidentiality) all existing manufacturing data, information or other Manufacturing Know-How (including and Materials and the then-current Manufacturing Process) then in WuXi’s or its Affiliates’ possession and Control and reasonably Transfer. Relay will not be required for Vir (or such Approved CMO) to perform a Manufacturing Transfer to more than one CMO of Licensee. Subject to the completion of the Manufacturing Transfer, Licensee will be solely responsible for contracting with its CMO for the supply of the Licensed Candidates or Licensed Products, and Relay will have no obligations under such Transitioned Manufacturing of Vir Antibodies or Products agreement between Licensee and such CMO. (the “WuXi b) It is understood and agreed that there may be additional Manufacturing Know-How”) How and Materials that are not identified at Vir’s reasonable cost the time of the Manufacturing Transfer and expenseare thereafter identified. WuXi If after the Manufacturing Transfer, either Party identifies any such additional Know-How and Materials such Party shall alsonotify the other Party, in connection therewith, grant and hereby grants to Vir or to if such Approved CMO a non-exclusive, royalty-free (except for any royalties payable under the Cell Line License Agreement) license under any WuXi Manufacturing Know-HowHow and Materials are in Relay’s Control, Relay shall transfer such additional Know-How and Materials to use Licensee promptly after such manufacturing technology solely for identification and notification. (c) To the purposes of extent any additional Manufacturing or having Manufactured Vir Antibodies or Products for Vir for Know-How and Materials are generated by Relay after the Vir Territory under a manufacturing Effective Date, Relay shall identify such Know-How and Materials and shall thereafter transfer such additional Know-How and licensing agreement. Subject to Article 13, Vir shall be responsible for all Materials in reasonable costs associated with batches as discussed by the transition to Vir (or to such Approved CMO) (including payment at a commercially reasonable full time equivalent personnel rate for hours of consulting support provided by WuXi). Vir shall be responsible for all costs associated with the Manufacture, technology transfer and supply of Products by any such Approved CMO. The Parties shall use their Commercially Reasonable Efforts to complete the transition of the Transitioned Manufacturing as soon as practicable, as applicable, and in any event within four (4) months following the date of Vir’s initial request. Where WuXi transfers a Licensed Cell Line to a Third Party CMO, Vir shall be responsible for the payment of a royalty to WuXi on Net Sales in the Vir Territory for Product manufactured by CMOs other than WuXi, in accordance with the terms of the Cell Line License Agreement. Where WuXi performs Transitioned Manufacturing, it shall provide Vir with an estimate of reasonable, documented costs associated with such transition to Vir (or to such Approved CMO) within [***] following the end of the applicable Calendar Quarter, and provide an invoice therefor within [***] following the end of such Calendar Quarter. Vir shall pay any undisputed invoice within [***] following receipt of the invoice from WuXiParties.

Manufacturing Transfer. Vir As soon as practicable after the Effective Date, Denali shall have the right at any time during the Term and on [***] written notice to WuXi, to request that WuXi transition the Manufacture of Vir Antibodies and Products to Vir (or a mutually agreed upon designee of Vir, including a CMO reasonably acceptable to WuXi) so as to obtain Clinical Supply and/or Commercial Supply of Vir Antibodies and Products from a Third Party, including where (i) [***]. If Vir makes such a request transfer to transition Sanofi, at no cost to Sanofi, all inventories of raw materials, starting materials, Licensed Compounds, reference standards (Licensed Compounds and impurities) and Licensed Products; and (ii) transfer to Sanofi the Manufacturing Process of Licensed Compounds and Licensed Product as further described in the Technology Transfer Plan (“Manufacturing of Vir Antibodies Transfer”), in each case (i) and (ii) except for those quantities as are necessary for Denali to perform the activities allocated to Denali under the Technology Transfer Plan or Products for Vir the CNS Development Plan, and to perform its Manufacturing obligations under Section 4.2 (Manufacturing Responsibility). Notwithstanding anything to the “Transitioned Manufacturing”) to an alternate source of preclinical or Clinical Supply or Commercial Supplycontrary in this Agreement, the Parties Manufacturing Transfer shall cooperate be subject to transition the Transitioned Manufacturing to Vir (or to Vir’s selected contract terms and conditions of the agreements between Denali and its applicable Third Party Providers of manufacturing organization the “Approved CMO”). If WuXi or any Affiliate has an existing relationship with such Approved CMO, WuXi shall facilitate discussions between Vir services and such Approved CMO technology with respect to Vir’s negotiation Licensed Compounds and entry into a contract for the continued supply of Vir Antibodies or Product for Vir’s further supply needs for Products. In any event, WuXi shall cooperate to provide to Vir (or to such Approved CMO under obligations of confidentiality) all existing manufacturing data, information or other Know-How (including the then-current Manufacturing Process) then in WuXi’s or its Affiliates’ possession and Control and reasonably required for Vir (or such Approved CMO) to perform such Transitioned Manufacturing of Vir Antibodies or Licensed Products (the each agreement, a “WuXi Manufacturing Know-HowCMO Supply Agreement”) at Vir’s reasonable cost listed on Schedule 4.1. Each Party will be responsible for its own FTE Costs incurred in performing the Manufacturing Transfer with respect to the Licensed Compounds and expense. WuXi shall alsoLicensed Products, in connection therewith, grant and hereby grants to Vir or to such Approved CMO a non-exclusive, royalty-free (except for any royalties payable under the Cell Line License Agreement) license under any WuXi Manufacturing Know-How, to use such manufacturing technology solely for the purposes of Manufacturing or having Manufactured Vir Antibodies or Products for Vir for the Vir Territory under a manufacturing transfer and licensing agreement. Subject to Article 13, Vir Sanofi shall be responsible for all reasonable costs associated with Out-of-Pocket Costs incurred in performing such Manufacturing Transfer, and shall reimburse Denali for any such Out-of-Pocket Costs incurred by Denali in performing such Manufacturing Transfer. Promptly after the transition Effective Date, Denali shall provide access to Vir (or Sanofi to such Approved CMO) all necessary documentation (including payment at a commercially reasonable full time equivalent personnel rate for hours copies of consulting support provided by WuXi). Vir shall be responsible for all costs associated with the Manufacture, technology transfer quality agreements in place between Denali and supply of Products by any such Approved CMO. The Parties shall use their Commercially Reasonable Efforts to complete the transition of the Transitioned Manufacturing as soon as practicable, as applicable, and in any event within four (4) months following the date of Vir’s initial request. Where WuXi transfers a Licensed Cell Line to a its Third Party CMO, Vir shall be responsible Providers for the payment Manufacture of a royalty such Licensed Compounds or Licensed Products) and access to WuXi on Net Sales in the Vir Territory for Product manufactured by CMOs other than WuXi, in accordance with the terms of the Cell Line License Agreement. Where WuXi performs Transitioned Manufacturing, it shall provide Vir with an estimate of reasonable, documented costs associated relevant Third Party Providers to allow Sanofi to coordinate its anticipated activities with such transition Third Party Providers, including the release by Sanofi, for use in Clinical Studies, of inventories of Licensed Compounds or Licensed Products transferred by Denali to Vir Sanofi pursuant to (or to such Approved CMOi) within [***] following the end of the applicable Calendar Quarter, and provide an invoice therefor within [***] following the end of such Calendar Quarter. Vir shall pay any undisputed invoice within [***] following receipt of the invoice from WuXihereof.