Transitional Support. (a) On a Product-by-Product basis, Customer may elect, upon written notice to Manufacturer, for Manufacturer to provide Customer with reasonable technical support, as more fully set forth in this Section 2.10, to transfer production of a given Product or Products to a Customer facility or a facility of an alternative source of supply as designated by Customer (such support, “Technical Support” and such facility, the “Receiving Site”). Customer may make such election for Technical Support at any time during the Term (including in the event of a Triggering Event under Section 2.5(a) or in advance of any expiration of this Agreement) or promptly after the termination or expiration of this Agreement but in no event more than ninety (90) days following the effective date of such termination or expiration. Such reasonable Technical Support shall consist of: (i) supply of a technical package to facilitate the transfer of all relevant manufacturing information for such Product(s) to the Receiving Site, including formulation descriptions, manufacturing instructions, Specifications, methods, data required for applicable regulatory submissions and facility qualification, and material supplier information, as applicable, except for any information that is subject to confidentiality obligations owing to a Third Party; provided that the technical package will not include any manufacturing information, including formulation descriptions, manufacturing instructions, Specifications, methods and material supplier information, that is generally available to or known by the public, can be obtained on reasonable terms from Third Parties or is already available or being utilized by Customer or its Affiliate at one of Customer’s or its Affiliate’s facilities; (ii) host site visits to the Manufacturer’s Facility by Customer to observe production of the applicable Product or Products, in each case, at a mutually agreed date and subject to confidentiality procedures or requirements as may be requested or implemented by Manufacturer; provided that the request for each such visit shall be made so as to allow for sufficient advance preparation time and can be accommodated in the requested timeframe without interruption to Manufacturer’s routine production or operations; (iii) performance of high-level consultation and answering reasonable queries for Customer through the transfer process; and (iv) provision of reasonable Product samples required under applicable Law for transfer activities. (b) Customer shall be responsible for identifying and requesting any and all Technical Support that is required from Manufacturer to assure such technology transfer is successful. (c) The Parties shall reasonably cooperate and mutually agree to facilitate the provision of any additional reasonable Technical Support with respect to the applicable Product or Products to Customer, including assistance through the transfer process, Manufacturer Personnel visits to the Receiving Site and training and troubleshooting during the Receiving Site’s first production run of the applicable Product or Products, in each case, as and to the extent reasonably agreed by Manufacturer in each instance (and subject to Sections 2.10(d), 2.10(e) and 2.10(f)). (d) The Parties will work together in good faith to plan for upcoming and ongoing Technical Support needs and to accommodate such plans in order to maintain ongoing business continuity. In addition, Manufacturer shall have no obligation to hire or retain any individuals or make any capital expenditures in connection with Technical Support, and Manufacturer’s obligation to provide Technical Support is contingent upon the continued employment by Manufacturer of those individuals capable of providing such Technical Support. Manufacturer may terminate its obligation to provide any Technical Support with respect to the applicable Product under this Agreement if Customer or any of its Affiliates hires any Manufacturer Personnel involved in providing Technical Support to Customer hereunder (without limiting any applicable non-solicitation obligations of Customer pursuant to the Business Combination Agreement). (e) Customer shall be solely responsible for any and all regulatory or other Governmental Authority requirements, activities and related costs and expenses that arise in conjunction with any Technical Support, technology transfer of production or production of each Product to or at the Receiving Site. These activities may also include, but are not limited to, creation of additional data or technical information, analytical method modifications or other work of a technical nature required to support regulatory queries or contemporary standards and guidelines driven by the manufacturing transfer (subject to Section 8.2). (f) Subject to Section 2.5(e), Customer is responsible for, and shall promptly reimburse Manufacturer for, any and all reasonable out-of-pocket costs and expenses incurred by or on behalf of Manufacturer in connection with any Technical Support provided to Customer under this Agreement, including employee costs to be charged at a rate that reasonably approximates the cost of providing the Technical Support, without any intent to cause Manufacturer to make profit or incur loss. (g) With respect to each Product for which Manufacturer provides Technical Support under this Agreement, Manufacturer shall provide to Customer any analytical materials and methods in Manufacturer’s possession or control that are required in connection with disclosures to any applicable Governmental Authority to qualify the applicable Product Materials, Buy-Sell Materials, or Customer-Supplied Materials for such Product or such Product itself for release testing to meet the then-current applicable marketing authorization, in each case, subject to Section 13. (h) Nothing in this Agreement shall require Manufacturer to provide more than 75 hours per calendar year per Product in connection with any Technical Support. Notwithstanding anything to the contrary herein, except as expressly provided in Section 2.10(g), Manufacturer shall have no obligation to disclose, license or otherwise provide confidential or proprietary information of Manufacturer, its Affiliates or any Third Party in connection with this Agreement or any Technical Support or technology transfer therein.
Appears in 4 contracts
Samples: Manufacturing and Supply Agreement (Viatris Inc), Manufacturing and Supply Agreement (Viatris Inc), Manufacturing and Supply Agreement (Upjohn Inc)
Transitional Support. (a) On Upon or within a Product-by-Product basismutually agreed time period prior to the expiration or termination of the Term of any Joinder Agreement (or such earlier time as may be requested by Purchaser), Customer may electwith respect to each family of Purchaser Products provided pursuant to such Joinder Agreement, upon written notice to Manufacturer, for Manufacturer to Producer shall provide Customer with reasonable technical supportsupport to Purchaser, as more fully set forth in this Section 2.1010.3, to assist Purchaser in the technology transfer of production of a given Product or such Purchaser Products to a Customer either one (1) facility of Purchaser or a one (1) facility of an alternative source of supply (which shall not in any case be a Prohibited Person) as designated by Customer Purchaser (such support, “Technical Support,” and such facility, the “Receiving Site”). Customer may make such election for ; provided that this Section 10.3 shall not be deemed to require Producer to transfer any rights with respect to Patents, Trademarks or Other Intellectual Property (other than information related solely to Purchaser and its businesses); provided further that, to the extent any written agreement between Producer and Purchaser with respect to any Joinder Agreement sets forth a number of hours of Producer’s time or other requirements (or limitations) with respect to the Technical Support at obligations described herein, such requirements or limitations shall supersede any time during more general requirements described in this Section 10.3 with respect to the Term (including in the event of a Triggering Event under Section 2.5(a) or in advance of any expiration of this Agreement) or promptly after the termination or expiration of this Agreement but in no event more than ninety (90) days following the effective date of such termination or expirationsame subject matter. Such reasonable Technical Support shall consist of:
(i) supply of Supplying a technical package to facilitate the transfer of all relevant manufacturing information for such Product(s) to the Receiving Site, including formulation descriptions, manufacturing instructions, Specificationsspecifications, methods, data required for applicable regulatory submissions and facility qualification, methods and material supplier information, as applicable, except for any information that is (A) Sensitive Producer Technology or (B) subject to confidentiality obligations owing to a Third Party; provided that the technical package will not include any manufacturing information, including formulation descriptions, manufacturing instructions, Specifications, methods and material supplier information, that is generally available to or known by the public, can be obtained on reasonable terms from Third Parties or is already available or being utilized by Customer Party other than Purchaser or its Affiliate at one of Customer’s or its Affiliate’s facilitiesAffiliates;
(ii) host Hosting one (1) site visits visit to the ManufacturerProducer’s Facility by Customer the Purchaser or such designated alternative source supplier to observe production of the applicable Product or Purchaser Products (such that, for clarity, no more than one (1) such site visit shall occur for such family of Purchaser Products), in each case, case at a mutually agreed date and time during Producer’s normal operating hours and subject to such confidentiality procedures or requirements as may be requested or implemented by Manufacturer; Producer, provided that (A) the request for each such visit shall be made so as to allow for sufficient advance preparation time and can be accommodated in the requested timeframe without interruption to ManufacturerProducer’s routine production or operationsproduction, (B) such visit shall not include access to Sensitive Producer Technology and (C) additional visits shall be permitted upon reasonable request of Purchaser, so long as such visits do not disrupt the ordinary course operations of Producer’s other businesses;
(iii) performance of Performing high-level consultation and answering reasonable queries for Customer Purchaser through the transfer process; and
(iv) provision of reasonable Providing Purchaser Product samples required under applicable Law for transfer activities, in each case of clauses (i)-(iv) at the expense of Purchaser.
(b) Customer Purchaser or such designated alternative source supplier shall be responsible for providing leadership of any technology transfer from Producer. For the avoidance of doubt, Purchaser or such designated alternative source supplier shall be solely responsible (subject in any case to the limitations described herein, including in Section 10.3(a), with respect to the scope of the Technical Support) for identifying and requesting any and all Technical Support that is required from Manufacturer Producer to assure such technology transfer is successful.
(c) The Parties shall reasonably cooperate and mutually agree to facilitate the provision of any additional reasonable Technical Support with respect to the applicable Purchaser Product to Purchaser or Products to Customersuch designated alternative source supplier, including assistance through the transfer process, Manufacturer Personnel Producer personnel visits to the Receiving Site Site, and training and troubleshooting during the Receiving Site’s first production run of the applicable Product or ProductsPurchaser Product, in each case, case as and to the extent reasonably agreed by Manufacturer Producer in each instance (and subject to Sections 2.10(d), 2.10(e) and 2.10(fSection 10.3(f)).
(d) The Parties will work together in good faith Producer shall have the right to plan for upcoming prioritize its own projects and ongoing activities over any Technical Support needs hereunder with respect to staffing, production activities and to accommodate such plans in order to maintain ongoing business continuityother resources or obligations. In addition, Manufacturer Producer shall have no obligation to hire or retain any individuals or make any capital expenditures in connection with the Technical Support, and ManufacturerProducer’s obligation to provide Technical Support is contingent upon the continued employment by Manufacturer Producer of those individuals capable of providing such Technical Support. Manufacturer may terminate If any Producer personnel involved in providing the Technical Support to Purchaser hereunder is hired by Purchaser or any of its Affiliates, Producer’s obligation to provide any portion of the Technical Support with respect to the applicable Product under this Agreement if Customer that was previously provided by such Producer personnel shall terminate and be of no further force or any of its Affiliates hires any Manufacturer Personnel involved in providing Technical Support to Customer hereunder effect (without limiting any applicable non-solicitation obligations of Customer Purchaser pursuant to the Business Combination Separation Agreement or any other Ancillary Agreement).
(e) Customer Purchaser shall be solely responsible for any and all regulatory or other Governmental Authority requirements, activities and related costs and expenses that arise in conjunction with any Technical Support, technology transfer of production or production of each Purchaser Product to or at the Receiving Site. These activities may also include, but are not limited to, creation of additional data or technical information, analytical method modifications or other work of a technical nature required to support regulatory queries or contemporary standards and guidelines driven by the manufacturing transfer (subject to Section 8.2)transfer.
(f) Subject Except in the event of termination of this Agreement by Purchaser or its Affiliates pursuant to Section 2.5(eSections 10.2(a) or 10.2(b), Customer is Purchaser shall be responsible for, and shall promptly reimburse Manufacturer Producer upon Producer’s written request for, any and all reasonable out-of-pocket costs and expenses incurred by or on behalf of Manufacturer Producer in connection with any Technical Support provided to Customer under this Agreement, including employee costs to be as well as Producer’s time (charged at a rate that reasonably approximates the cost of providing the Technical Support, without any intent to cause Manufacturer to make profit or incur lossthen-current staff rates).
(g) With respect to each Product for which Manufacturer provides Technical Support under this AgreementPurchaser Product, Manufacturer Producer shall provide to Customer any Purchaser, in connection with the Technical Support or reasonably promptly following Purchaser’s written request therefor following termination of the applicable Joinder Agreement, such analytical materials books and methods records (including with respect to methods) in ManufacturerProducer’s possession or control that are required in connection with disclosures to any applicable Governmental Authority to qualify the applicable Producer Product Materials, Buy-Sell Materials, or Customer-Supplied Materials for such Product or such Product itself for release testing to meet the then-current applicable marketing authorizationMarketing Authorization, in each case, subject to case in accordance with Section 1315.1.
(h) Nothing in this Agreement shall require Manufacturer to provide more than 75 hours per calendar year per Product in connection with any Technical Support. Notwithstanding anything to the contrary herein, except as expressly provided in Section 2.10(g10.3(g), Manufacturer Producer shall have no obligation to disclose, license or otherwise provide confidential or proprietary information of Manufacturer, its Affiliates Producer or any Third Party Party, including any Sensitive Producer Technology, in connection with this Agreement or any Technical Support or technology transfer therein.
Appears in 2 contracts
Samples: Manufacturing and Supply Agreement (Baxalta Inc), Manufacturing Agreement (Baxalta Inc)
Transitional Support. (a) On Upon or within a Product-by-Product basismutually agreed time period prior to the expiration or termination of the Term (or such earlier time as may be requested by Purchaser), Customer may electwith respect to each family of Purchaser Products provided pursuant to this Agreement, upon written notice to Manufacturer, for Manufacturer Producer shall use commercially reasonable efforts to provide Customer with reasonable technical supportsupport to Purchaser, as more fully set forth in this Section 2.109.3, to assist Purchaser in the technology transfer of production of a given Product or such Purchaser Products to a Customer either one facility of Purchaser or a one facility of an alternative source of supply as designated by Customer Purchaser (such support, “Technical Support,” and such facility, the “Receiving Site”). Customer may make such election for Technical Support at any time during the Term (including in the event of a Triggering Event under Section 2.5(a) or in advance of any expiration of this Agreement) or promptly after the termination or expiration of this Agreement but in no event more than ninety (90) days following the effective date of such termination or expiration. Such reasonable Technical Support shall consist of:
(i) supply of a technical package to facilitate the transfer of all relevant manufacturing information for such Product(s) to the Receiving Site, including formulation descriptions, manufacturing instructions, Specifications, methods, data required for applicable regulatory submissions and facility qualification, and material supplier information, as applicable, except for any information that is subject to confidentiality obligations owing to a Third Party; provided that the technical package will this Section 9.3 shall not include be deemed to require Producer to transfer any manufacturing informationrights with respect to Intellectual Property; provided further that, including formulation descriptions, manufacturing instructions, Specifications, methods and material supplier information, that is generally available to or known by the public, can be obtained on reasonable terms from Third Parties or is already available or being utilized by Customer or its Affiliate at one of Customer’s or its Affiliate’s facilities;
(ii) host site visits to the Manufacturerextent any written agreement between Producer and Purchaser with respect to this Agreement sets forth a number of hours of Producer’s Facility by Customer time or other requirements (or limitations) with respect to observe production of the applicable Product Technical Support obligations described herein, such requirements or Products, limitations shall supersede any more general requirements described in each case, at a mutually agreed date and this Section 9.3 with respect to the same subject to confidentiality procedures or requirements as may be requested or implemented by Manufacturer; provided that the request for each such visit shall be made so as to allow for sufficient advance preparation time and can be accommodated in the requested timeframe without interruption to Manufacturer’s routine production or operations;
(iii) performance of high-level consultation and answering reasonable queries for Customer through the transfer process; and
(iv) provision of reasonable Product samples required under applicable Law for transfer activitiesmatter.
(b) Customer Purchaser or such designated alternative source supplier shall be responsible for providing leadership of any technology transfer from Producer. For the avoidance of doubt, Purchaser or such designated alternative source supplier shall be solely responsible (subject in any case to the limitations described herein, including in Section 9.3(a), with respect to the scope of the Technical Support) for identifying and requesting any and all Technical Support that is required from Manufacturer Producer to assure such technology transfer is successful.
(c) The Parties shall reasonably cooperate and mutually agree to facilitate the provision of any additional reasonable Technical Support with respect to the applicable Purchaser Product to Purchaser or Products to Customersuch designated alternative source supplier, including assistance through the transfer process, Manufacturer Personnel Producer personnel visits to the Receiving Site Site, and training and troubleshooting during the Receiving Site’s first production run of the applicable Product or ProductsPurchaser Product, in each case, case as and to the extent reasonably agreed by Manufacturer Producer in each instance (and subject to Sections 2.10(d), 2.10(e) and 2.10(fSection 9.3(f)).
(d) The Parties will work together in good faith Producer shall have the right to plan for upcoming prioritize its own projects and ongoing activities over any Technical Support needs hereunder with respect to staffing, production activities and to accommodate such plans in order to maintain ongoing business continuityother resources or obligations. In addition, Manufacturer Producer shall have no obligation to hire or retain any individuals or make any capital expenditures in connection with the Technical Support, and ManufacturerProducer’s obligation to provide Technical Support is contingent upon the continued employment by Manufacturer Producer of those individuals capable of providing such Technical Support. Manufacturer may terminate If any Producer personnel involved in providing the Technical Support to Purchaser hereunder is hired by Purchaser or any of its Affiliates, Producer’s obligation to provide any portion of the Technical Support with respect to the applicable Product under this Agreement if Customer that was previously provided by such Producer personnel shall terminate and be of no further force or any of its Affiliates hires any Manufacturer Personnel involved in providing Technical Support to Customer hereunder (without limiting any applicable non-solicitation obligations of Customer pursuant to the Business Combination Agreement)effect.
(e) Customer Purchaser shall be solely responsible for any and all regulatory or other Governmental Authority requirements, activities and related costs and expenses that arise in conjunction with any Technical Support, technology transfer of production or production of each Purchaser Product to or at the Receiving Site. These activities may also include, but are not limited to, include creation of additional data or technical information, analytical method modifications or other work of a technical nature required to support regulatory queries or contemporary standards and guidelines driven by the manufacturing transfer (subject to Section 8.2)transfer.
(f) Subject to Section 2.5(e), Customer is Purchaser shall be responsible for, for and shall promptly reimburse Manufacturer Producer upon Producer’s written request for, any and all reasonable out-of-pocket costs and expenses incurred by or on behalf of Manufacturer Producer in connection with any Technical Support provided to Customer under this Agreement, including employee costs to be as well as Producer’s time (charged at a rate that reasonably approximates the cost of providing the Technical Support, without any intent to cause Manufacturer to make profit or incur lossthen-current staff rates).
(g) With respect to each Product for which Manufacturer provides Technical Support under this Agreement, Manufacturer shall provide to Customer any analytical materials and methods in Manufacturer’s possession or control that are required in connection with disclosures to any applicable Governmental Authority to qualify the applicable Product Materials, Buy-Sell Materials, or Customer-Supplied Materials for such Product or such Product itself for release testing to meet the then-current applicable marketing authorization, in each case, subject to Section 13.
(h) Nothing in this Agreement shall require Manufacturer to provide more than 75 hours per calendar year per Product in connection with any Technical Support. Notwithstanding anything to the contrary herein, except as expressly provided in Producer’s obligations pursuant to this Section 2.10(g)9.3 shall only apply if (i) Producer has terminated this Agreement pursuant to Section 9.2(c)(ii) and (ii) both at the time of Producer providing notice of termination pursuant to Section 9.2(c) (ii) and at any time between the date of such notice and the termination date, Manufacturer Producer has no other termination right. For the avoidance of doubt, Purchaser shall have no rights to any continuing supply of the Supplied Products or any technology or processes related to the production of such Supplied Products if this Agreement expires or terminates other than pursuant to Section 9.2(c) (ii). If Producer is required to provide the transitional support described in this Section 9.3, in no case shall such obligation required Producer to disclose, license or otherwise provide confidential or proprietary information of Manufacturer, its Affiliates Producer for any purpose other than continued production of the Supplied Products with respect to the Business or any Third Party Party, in connection with this Agreement or any Technical Support or technology transfer therein.
(h) Any and all Intellectual Property (including Specifications, know-how or other information related to the manufacture of the Supplied Products) owned by the Producer as of the Effective Date shall remain owned, as between the Parties, solely by Producer or its applicable Affiliates. If Producer has terminated this Agreement solely pursuant to Section 9.2(c) (ii) (and for clarity, Producer had no other termination right as of the termination notice date or any other time between such notice date and termination), Producer hereby grants to Purchaser (effective only as of the time of such termination) a non-exclusive, perpetual, irrevocable, non-transferable, royalty-free (except for any pass-through royalties or other payments owed to a Third Party therefor), non-sublicensable license to use or practice any Producer Intellectual Property that was used by Producer in manufacturing the Purchaser Products hereunder, in each case, solely to the extent necessary for Purchaser or an alternative source of supply designated by Purchaser to continue manufacturing such Purchaser Products or line extensions of such Purchaser Products or combinations of such Purchaser Products other Products of Purchaser, in each case, for use solely in the Business.
Appears in 2 contracts
Samples: Manufacturing Agreements (Zimmer Biomet Holdings, Inc.), Manufacturing Agreements (ZimVie Inc.)
Transitional Support. (a) On Upon or within a mutually agreed time period prior to the expiration or termination of the Term of each Product Addendum, with respect to each Customer-Exclusive Product-by-Product basis, Customer may elect, upon written notice to Manufacturer, for Manufacturer to shall provide Customer with reasonable technical supportsupport to Customer, as more fully set forth in this Section 2.1011.7, to assist Customer in the technology transfer of production of a given each such Product to either one (1) facility of Customer or Products to a Customer facility or a one (1) facility of an alternative source of supply as designated by Customer (such support, “Technical Support” ”, and such facility, the “Receiving Site”). Customer may make such election for Technical Support at any time during the Term (including in the event of a Triggering Event under Section 2.5(a) or in advance of any expiration of this Agreement) or promptly after the termination or expiration of this Agreement but in no event more than ninety (90) days following the effective date of such termination or expiration. Such reasonable Technical Support shall consist of:
(i) supply Supply of a technical package to facilitate the transfer of all relevant manufacturing information for such Product(s) to the Receiving Site, including formulation descriptions, manufacturing instructions, Specificationsspecifications, methods, data required for applicable regulatory submissions and facility qualification, methods and material supplier information, as applicable, except for any information that is (i) Sensitive Manufacturer Technology or (ii) subject to confidentiality obligations owing to a Third Party; provided that the technical package will not include any manufacturing information, including formulation descriptions, manufacturing instructions, Specifications, methods and material supplier information, that is generally available to or known by the public, can be obtained on reasonable terms from Third Parties or is already available or being utilized by third party other than Customer or its Affiliate at one of Customer’s or its Affiliate’s facilitiesAffiliates;
(ii) host Host one (1) site visits visit to the Manufacturer’s Facility by the Customer and/or such designated alternative source supplier to observe production of the applicable Product or Products(such that, for clarity, no more than one (1) such site visit shall occur for each Product), in each case, case at a mutually agreed date and time during Manufacturer’s normal operating hours and subject to such confidentiality procedures or requirements as may be requested or implemented by Manufacturer; , provided that (i) the request for each such visit shall be made so as to allow for sufficient advance preparation time and can be accommodated in the requested timeframe without interruption to Manufacturer’s routine production or operationsproduction, and (ii) such visit shall not include access to Sensitive Manufacturer Technology;
(iii) performance Performance of high-level consultation and answering reasonable queries for Customer through the transfer process; and
(iv) provision Provision of reasonable Product samples required under applicable Law for transfer activities, in each case at the expense of Customer.
(b) Customer and/or such designated alternative source supplier shall be responsible for providing leadership of any technology transfer from Manufacturer. For the avoidance of doubt, the Customer and/or such designated alternative source supplier shall be solely responsible for identifying and requesting any and all Technical Support that is required from Manufacturer to assure such technology transfer is successful.
(c) The Parties shall reasonably cooperate and mutually agree to facilitate the provision of any additional reasonable Technical Support with respect to the applicable Product to Customer or Products to Customersuch designated alternative source supplier, including assistance through the transfer process, Manufacturer Personnel personnel visits to the Receiving Site Site, and training and troubleshooting during the Receiving Site’s first production run of the applicable Product or ProductsProduct, in each case, case as and to the extent reasonably agreed by Manufacturer in each instance (and subject to Sections 2.10(d), 2.10(e) and 2.10(fSection 11.7(f)).
(d) The Parties will work together in good faith Manufacturer shall have the right to plan for upcoming prioritize its own projects and ongoing activities over any Technical Support needs hereunder with respect to staffing, production activities and to accommodate such plans in order to maintain ongoing business continuityother resources or obligations. In addition, Manufacturer shall have no obligation to hire or retain any individuals or make any capital expenditures in connection with the Technical Support, and Manufacturer’s obligation to provide Technical Support is contingent upon the continued employment by Manufacturer of those individuals capable of providing such Technical Support. Manufacturer may terminate its Manufacturer’s obligation to provide any Technical Support with respect to the applicable Product under this Agreement shall terminate and be of no further force or effect if Customer or any of its Affiliates hires hire any Manufacturer Personnel personnel involved in providing the Technical Support to Customer hereunder (without limiting any applicable non-solicitation obligations of Customer pursuant to the Business Combination Separation Agreement or any other Ancillary Agreement).
(e) Customer shall be solely responsible for any and all regulatory or other Governmental Authority requirements, activities and related costs and expenses that arise in conjunction with any Technical Support, technology transfer of production or production of each Product to or at the Receiving Site. These activities may also include, but are not limited to, creation of additional data or technical information, analytical method modifications or other work of a technical nature required to support regulatory queries or contemporary standards and guidelines driven by the manufacturing transfer (subject to Section 8.26.2).
(f) Subject to Section 2.5(e), Customer is shall be responsible for, and shall promptly reimburse Manufacturer upon Manufacturer’s written request for, any and all reasonable out-of-pocket costs and expenses incurred by or on behalf of Manufacturer in connection with any Technical Support provided to Customer under this Agreement, including employee costs to be charged at a rate that reasonably approximates the cost of providing the Technical Support, without any intent to cause Manufacturer to make profit or incur loss.
(g) With respect to each Product for which Manufacturer provides Technical Support under this AgreementProduct, Manufacturer shall provide to Customer any Customer, in connection with the Technical Support or reasonably promptly following Customer’s written request therefor following termination of the applicable Product Addendum, such analytical materials and methods in Manufacturer’s possession or control that are required in connection with disclosures to any applicable Governmental Authority to qualify the applicable Product Materials, Buy-Sell Materials, or Customer-Supplied Materials for such Product or such Product itself for release testing to meet the then-current applicable marketing authorizationMarketing Authorization, in each case, subject to case in accordance with Section 1310.1.
(h) Nothing in this Agreement shall require Manufacturer to provide more than 75 hours per calendar year per Product in connection with any Technical Support. Notwithstanding anything to the contrary herein, except as expressly provided in Section 2.10(g11.7(g), Manufacturer shall have no obligation to disclose, license or otherwise provide confidential or proprietary information of Manufacturer, its Affiliates Manufacturer or any Third Party third party, including any Sensitive Manufacturer Technology, in connection with this Agreement or any Technical Support or technology transfer therein.
Appears in 2 contracts
Samples: Master Manufacturing and Supply Agreement, Master Manufacturing and Supply Agreement (Zoetis Inc.)
Transitional Support. (a) On Upon or within a Product-by-Product basismutually agreed time period prior to the expiration or termination of the Term (or such earlier time as may be requested by Purchaser), Customer may electwith respect to each family of Purchaser Products provided pursuant to this Agreement, upon written notice to Manufacturer, for Manufacturer Producer shall use commercially reasonable efforts to provide Customer with reasonable technical supportsupport to Purchaser, as more fully set forth in this Section 2.109.3, to assist Purchaser in the technology transfer of production of a given Product or such Purchaser Products to a Customer either one facility of Purchaser or a one facility of an alternative source of supply as designated by Customer Purchaser (such support, “Technical Support,” and such facility, the “Receiving Site”). Customer may make such election for Technical Support at any time during the Term (including in the event of a Triggering Event under Section 2.5(a) or in advance of any expiration of this Agreement) or promptly after the termination or expiration of this Agreement but in no event more than ninety (90) days following the effective date of such termination or expiration. Such reasonable Technical Support shall consist of:
(i) supply of a technical package to facilitate the transfer of all relevant manufacturing information for such Product(s) to the Receiving Site, including formulation descriptions, manufacturing instructions, Specifications, methods, data required for applicable regulatory submissions and facility qualification, and material supplier information, as applicable, except for any information that is subject to confidentiality obligations owing to a Third Party; provided that the technical package will this Section 9.3 shall not include be deemed to require Producer to transfer any manufacturing informationrights with respect to Intellectual Property; provided further that, including formulation descriptions, manufacturing instructions, Specifications, methods and material supplier information, that is generally available to or known by the public, can be obtained on reasonable terms from Third Parties or is already available or being utilized by Customer or its Affiliate at one of Customer’s or its Affiliate’s facilities;
(ii) host site visits to the Manufacturerextent any written agreement between Producer and Purchaser with respect to this Agreement sets forth a number of hours of Producer’s Facility by Customer time or other requirements (or limitations) with respect to observe production of the applicable Product Technical Support obligations described herein, such requirements or Products, limitations shall supersede any more general requirements described in each case, at a mutually agreed date and this Section 9.3 with respect to the same subject to confidentiality procedures or requirements as may be requested or implemented by Manufacturer; provided that the request for each such visit shall be made so as to allow for sufficient advance preparation time and can be accommodated in the requested timeframe without interruption to Manufacturer’s routine production or operations;
(iii) performance of high-level consultation and answering reasonable queries for Customer through the transfer process; and
(iv) provision of reasonable Product samples required under applicable Law for transfer activitiesmatter.
(b) Customer Purchaser or such designated alternative source supplier shall be responsible for providing leadership of any technology transfer from Producer. For the avoidance of doubt, Purchaser or such designated alternative source supplier shall be solely responsible (subject in any case to the limitations described herein, including in Section 9.3(a), with respect to the scope of the Technical Support) for identifying and requesting any and all Technical Support that is required from Manufacturer Producer to assure such technology transfer is successful.
(c) The Parties shall reasonably cooperate and mutually agree to facilitate the provision of any additional reasonable Technical Support with respect to the applicable Purchaser Product to Purchaser or Products to Customersuch designated alternative source supplier, including assistance through the transfer process, Manufacturer Personnel Producer personnel visits to the Receiving Site Site, and training and troubleshooting during the Receiving Site’s first production run of the applicable Product or ProductsPurchaser Product, in each case, case as and to the extent reasonably agreed by Manufacturer Producer in each instance (and subject to Sections 2.10(d), 2.10(e) and 2.10(fSection 9.3(f)).
(d) The Parties will work together in good faith Producer shall have the right to plan for upcoming prioritize its own projects and ongoing activities over any Technical Support needs hereunder with respect to staffing, production activities and to accommodate such plans in order to maintain ongoing business continuityother resources or obligations. In addition, Manufacturer Producer shall have no obligation to hire or retain any individuals or make any capital expenditures in connection with the Technical Support, and ManufacturerProducer’s obligation to provide Technical Support is contingent upon the continued employment by Manufacturer Producer of those individuals capable of providing such Technical Support. Manufacturer may terminate If any Producer personnel involved in providing the Technical Support to Purchaser hereunder is hired by Purchaser or any of its Affiliates, Producer’s obligation to provide any portion of the Technical Support with respect to the applicable Product under this Agreement if Customer that was previously provided by such Producer personnel shall terminate and be of no further force or any of its Affiliates hires any Manufacturer Personnel involved in providing Technical Support to Customer hereunder (without limiting any applicable non-solicitation obligations of Customer pursuant to the Business Combination Agreement)effect.
(e) Customer Purchaser shall be solely responsible for any and all regulatory or other Governmental Authority requirements, activities and related costs and expenses that arise in conjunction with any Technical Support, technology transfer of production or production of each Purchaser Product to or at the Receiving Site. These activities may also include, but are not limited to, include creation of additional data or technical information, analytical method modifications or other work of a technical nature required to support regulatory queries or contemporary standards and guidelines driven by the manufacturing transfer (subject to Section 8.2)transfer.
(f) Subject to Section 2.5(e), Customer is Purchaser shall be responsible for, for and shall promptly reimburse Manufacturer Producer upon Producer’s written request for, any and all reasonable out-of-pocket costs and expenses incurred by or on behalf of Manufacturer Producer in connection with any Technical Support provided to Customer under this Agreement, including employee costs to be as well as Producer’s time (charged at a rate that reasonably approximates the cost of providing the Technical Support, without any intent to cause Manufacturer to make profit or incur lossthen-current staff rates).
(g) With respect to each Product for which Manufacturer provides Technical Support under this Agreement, Manufacturer shall provide to Customer any analytical materials and methods in Manufacturer’s possession or control that are required in connection with disclosures to any applicable Governmental Authority to qualify the applicable Product Materials, Buy-Sell Materials, or Customer-Supplied Materials for such Product or such Product itself for release testing to meet the then-current applicable marketing authorization, in each case, subject to Section 13.
(h) Nothing in this Agreement shall require Manufacturer to provide more than 75 hours per calendar year per Product in connection with any Technical Support. Notwithstanding anything to the contrary herein, except as expressly provided in Producer’s obligations pursuant to this Section 2.10(g)9.3 shall only apply if (i) Producer has terminated this Agreement pursuant to Section 9.2(c)(ii) and (ii) both at the time of Producer providing notice of termination pursuant to Section 9.2(c) (ii) and at any time between the date of such notice and the termination date, Manufacturer Producer has no other termination right. For the avoidance of doubt, Purchaser shall have no rights to any continuing supply of the Supplied Products or any technology or processes related to the production of such Supplied Products if this Agreement expires or terminates other than pursuant to Section 9.2(c) (ii). If Producer is required to provide the transitional support described in this Section 9.3, in no case shall such obligation required Producer to disclose, license or otherwise provide confidential or proprietary information of Manufacturer, its Affiliates Producer for any purpose other than continued production of the Supplied Products with respect to the Business or any Third Party Party, in connection with this Agreement or any Technical Support or technology transfer therein.
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Samples: Manufacturing Agreement (ZimVie Inc.), Manufacturing Agreement (Zimmer Biomet Holdings, Inc.)