Transfer of Manufacturing Technology. (a) Upon request by BMS, Ambrx shall provide to BMS the Ambrx Manufacturing Technology and Manufacturing Technology Documentation to the extent requested for the purposes of preparing and supporting Regulatory Materials for Compound and Product. (b) Upon request by BMS for purposes of establishing manufacturing capability for Compound and/or Product, Ambrx shall transfer to BMS (or to a Third Party manufacturer designated by BMS in accordance with Section 6.4) the Ambrx Manufacturing Technology, in order to enable BMS (or its Third Party manufacturer) to use the Ambrx Manufacturing Technology for purposes of the manufacture of the Compounds and/or Products and to replicate the processes employed by or on behalf of Ambrx (including any Third Party manufacturer of Ambrx), provided that Ambrx shall not be obligated to transfer the ReCODE Components to BMS separately from the strains used to express Compounds. Such transfer shall include a written description of such Ambrx Manufacturing Technology (the “Manufacturing Technology Documentation”). As applicable, if requested by BMS, Ambrx shall (and will use Diligent Efforts to ensure that any Ambrx Third Party manufacturer will) cooperate with and provide technical assistance (including on-site assistance) and consultation as reasonably requested by BMS in connection with the transfer and the implementation of such Ambrx Manufacturing Technology by BMS or its Third Party manufacturer, and to enable BMS or its Third Party manufacturer to use such Ambrx Manufacturing Technology to manufacture Compounds and/or Products and to obtain Regulatory Approval for (including the CMC, DMF or other regulatory filings relating thereto) the process for the manufacture of Compounds and/or Products. All such Manufacturing Technology Documentation shall be in the English language, and in sufficient detail and clarity for BMS or its Third Party manufacturer to understand and use the manufacturing processes disclosed thereunder. If available in electronic form, the Manufacturing Technology Documentation shall be provided in electronic format. (c) For avoidance of doubt, the transfer of Ambrx Manufacturing Technology under Section 6.2(b) shall include the transfer to BMS (or its Third Party manufacturer) of the research cell bank for the production strain for the Compound (and the host/control strain for such production strain). In addition, upon request by BMS, Ambrx shall transfer to BMS available research strains for Compounds (and host/control strains for such research strains) for purposes including the testing and evaluation of the Compound and/or developing the process for the manufacture of such Compound.
Appears in 4 contracts
Samples: Collaboration and License Agreement (Ambrx Biopharma Inc.), Collaboration and License Agreement (Ambrx Biopharma Inc.), Collaboration and License Agreement (Ambrx Inc)
Transfer of Manufacturing Technology. (a) Upon request by BMS, Ambrx shall provide to BMS the Ambrx Manufacturing Technology and Manufacturing Technology Documentation to the extent requested for the purposes of preparing and supporting Regulatory Materials for Compound and Product.
(b) Upon request by BMS for purposes of establishing manufacturing capability for Compound and/or Product, Ambrx shall transfer to BMS (or to a Third Party manufacturer designated by BMS in accordance with Section 6.4) the Ambrx Manufacturing Technology, in order to enable BMS (or its Third Party manufacturer) to use the Ambrx Manufacturing Technology for purposes of the manufacture of the Compounds and/or Products and to replicate the processes employed by or on behalf of Ambrx (including any Third Party manufacturer of Ambrx), provided that Ambrx shall not be obligated to transfer the ReCODE Components to BMS separately from the strains used to express Compounds. Such transfer shall include a written description of such Ambrx Manufacturing Technology (the “Manufacturing Technology Documentation”). As applicable, if requested by BMS, Ambrx shall (and will use Diligent Efforts to ensure that any Ambrx Third Party manufacturer will) cooperate with and provide technical assistance (including on-site assistance) and consultation as reasonably requested by BMS in connection with the transfer and the implementation of such Ambrx Manufacturing Technology by BMS or its Third Party manufacturer, and to enable BMS or its Third Party manufacturer to use such Ambrx Manufacturing Technology to manufacture Compounds and/or Products and to obtain Regulatory Approval for (including the CMC, DMF or other regulatory filings relating thereto) the process for the manufacture of Compounds and/or Products. All such Manufacturing Technology Documentation shall be in the English language, and in sufficient detail and clarity for BMS or its Third Party manufacturer to understand and use the manufacturing processes disclosed thereunder. If available in electronic form, the Manufacturing Technology Documentation shall be provided in electronic format.
(c) For avoidance of doubt, the transfer of Ambrx Manufacturing Technology under Section 6.2(b) shall include the transfer to BMS (or its Third Party manufacturer) of the research master cell bank for the production strain for the Compound (and the host/control strain for such production strain). In addition, upon request by BMS, Ambrx shall transfer to BMS available research strains for Compounds (and host/control strains for such research strains) for purposes including the testing and evaluation of the Compound and/or developing the process for the manufacture of such Compound.
Appears in 4 contracts
Samples: Collaboration and License Agreement (Ambrx Biopharma Inc.), Collaboration and License Agreement (Ambrx Biopharma Inc.), Collaboration and License Agreement (Ambrx Inc)
Transfer of Manufacturing Technology. (a) Upon request by BMS, Ambrx shall provide to BMS the Ambrx Manufacturing Technology and Manufacturing Technology Documentation to the extent requested for the purposes of preparing and supporting Regulatory Materials for Compound and Product.
(b) Upon request by BMS during the Research Term and for a period of [***] thereafter for purposes of establishing manufacturing capability for Compound and/or Product, Ambrx CytomX shall transfer to BMS (or to a Third Party manufacturer designated by BMS in accordance with Section 6.4) 6.3), the Ambrx CytomX Manufacturing Technology, in order to enable BMS (or its Third Party manufacturer) to use the Ambrx CytomX Manufacturing Technology for the sole purposes of the manufacture of the Compounds and/or Products and to replicate the processes employed by or on behalf of Ambrx CytomX (including any Third Party manufacturer of AmbrxCytomX), provided that Ambrx shall not be obligated to transfer the ReCODE Components to BMS separately from the strains used to express Compounds. Such transfer shall include a written description of such Ambrx CytomX Manufacturing Technology (the “Manufacturing Technology Documentation”). As applicable, if requested by BMS, Ambrx CytomX shall (and will use Diligent Efforts to ensure that any Ambrx CytomX Third Party manufacturer will) cooperate with and provide reasonable technical assistance (including on-site assistance) and consultation consultation, at a reasonable consulting rate CytomX, [***] as reasonably requested by BMS in connection with the transfer and the implementation of such Ambrx CytomX Manufacturing Technology by BMS or its Third Party manufacturer, and to enable BMS or its Third Party manufacturer to use such Ambrx CytomX Manufacturing Technology to manufacture Compounds and/or Products and to obtain Regulatory Approval for (including the CMC, DMF or other regulatory filings relating thereto) the process for the manufacture of Compounds and/or Products. All such Manufacturing Technology Documentation shall be in the English language, and in sufficient detail and clarity for BMS or its Third Party manufacturer to understand and use the manufacturing processes disclosed thereunder. If available in electronic form, the Manufacturing Technology Documentation shall be provided in electronic format.
(c) For avoidance of doubt, the transfer of Ambrx Manufacturing Technology under Section 6.2(b) shall include the transfer to BMS (or its Third Party manufacturer) of the research cell bank for the production strain for the Compound (and the host/control strain for such production strain). In addition, upon request by BMS, Ambrx shall transfer to BMS available research strains for Compounds (and host/control strains for such research strains) for purposes including the testing and evaluation of the Compound and/or developing the process for the manufacture of such Compound.
Appears in 3 contracts
Samples: Collaboration and License Agreement (CytomX Therapeutics, Inc.), Collaboration and License Agreement (CytomX Therapeutics, Inc.), Collaboration and License Agreement (CytomX Therapeutics, Inc.)
Transfer of Manufacturing Technology. (a) Upon request by BMS, Ambrx shall provide to BMS the Ambrx Manufacturing Technology and Manufacturing Technology Documentation to the extent requested for the purposes of preparing and supporting Regulatory Materials for Compound and Product.
(b) Upon request by BMS during the Research Term and for a period of five (5) years thereafter for purposes of establishing manufacturing capability for Compound and/or Product, Ambrx CytomX shall transfer to BMS (or to a Third Party manufacturer designated by BMS in accordance with Section 6.4) 6.3), the Ambrx CytomX Manufacturing Technology, in order to enable BMS (or its Third Party manufacturer) to use the Ambrx CytomX Manufacturing Technology for the sole purposes of the manufacture of the Compounds and/or Products and to replicate the processes employed by or on behalf of Ambrx CytomX (including any Third Party manufacturer of AmbrxCytomX), provided that Ambrx shall not be obligated to transfer the ReCODE Components to BMS separately from the strains used to express Compounds. Such transfer shall include a written description of such Ambrx CytomX Manufacturing Technology (the “Manufacturing Technology Documentation”). As applicable, if requested by BMS, Ambrx CytomX shall (and will use Diligent Efforts to ensure that any Ambrx CytomX Third Party manufacturer will) cooperate with and provide reasonable technical assistance (including on-site assistance) and consultation, at a reasonable consulting rate CytomX, provided that the first [***] hours of consultation will be provided by CytomX at no cost to BMS, as reasonably requested by BMS in connection with the transfer and the implementation of such Ambrx CytomX Manufacturing Technology by BMS or its Third Party manufacturer, and to enable BMS or its Third Party manufacturer to use such Ambrx CytomX Manufacturing Technology to manufacture Compounds and/or Products and to obtain Regulatory Approval for (including the CMC, DMF or other regulatory filings relating thereto) the process for the manufacture of Compounds and/or Products. All such Manufacturing Technology Documentation shall be in the English language, and in sufficient detail and clarity for BMS or its Third Party manufacturer to understand and use the manufacturing processes disclosed thereunder. If available in electronic form, the Manufacturing Technology Documentation shall be provided in electronic format.
(c) For avoidance of doubt, the transfer of Ambrx Manufacturing Technology under Section 6.2(b) shall include the transfer to BMS (or its Third Party manufacturer) of the research cell bank for the production strain for the Compound (and the host/control strain for such production strain). In addition, upon request by BMS, Ambrx shall transfer to BMS available research strains for Compounds (and host/control strains for such research strains) for purposes including the testing and evaluation of the Compound and/or developing the process for the manufacture of such Compound.
Appears in 2 contracts
Samples: Collaboration and License Agreement (CytomX Therapeutics, Inc.), Collaboration and License Agreement (CytomX Therapeutics, Inc.)
Transfer of Manufacturing Technology. (a) Upon request by BMS, Ambrx shall provide to BMS the Ambrx Manufacturing Technology and Manufacturing Technology Documentation to the extent requested for the purposes of preparing and supporting Regulatory Materials for Compound and Product.
(b) Upon request by BMS for purposes of establishing manufacturing capability for Compound and/or Product, Ambrx shall transfer to BMS (or to a Third Party manufacturer designated by BMS in accordance with Section 6.4) the Ambrx Manufacturing Technology, in order to enable BMS (or its Third Party manufacturer) to use the Ambrx Manufacturing Technology for purposes of the manufacture of the Compounds and/or Products and to replicate the processes employed by or on behalf of Ambrx (including any Third Party manufacturer of Ambrx), provided that Ambrx shall not be obligated to transfer the ReCODE ReCODE/EuCODE Components to BMS separately from the strains used to express CompoundsHost Cell Lines. Such transfer shall include a written description of such Ambrx Manufacturing Technology (the “Manufacturing Technology Documentation”). As applicable, if requested by BMS, Ambrx shall (and will use Diligent Efforts to ensure that any Ambrx Third Party manufacturer will) cooperate with and provide technical assistance (including on-site assistance) and consultation as reasonably requested by BMS in connection with the transfer and the implementation of such Ambrx Manufacturing Technology by BMS or its Third Party manufacturer, and to enable BMS or its Third Party manufacturer to use such Ambrx Manufacturing Technology to manufacture Compounds and/or Products and to obtain Regulatory Approval for (including the CMC, DMF or other regulatory filings relating thereto) the process for the manufacture of Compounds and/or Products. All such Manufacturing Technology Documentation shall be in the English language, and in sufficient detail and clarity for BMS or its Third Party manufacturer to understand and use the manufacturing processes disclosed thereunder. If available in electronic form, the Manufacturing Technology Documentation shall be provided in electronic format. It is agreed and understood that the extent and detail of Ambrx Manufacturing Technology and/or the Manufacturing Technology Documentation to be transferred or otherwise disclosed to a Third Party manufacturer under this Agreement shall be limited to that which is required or necessary for such Third Party manufacturer to manufacture Compound and/or Product for BMS (or BMS’ Affiliates and Sublicensees).
(c) For avoidance of doubt, the transfer of Ambrx Manufacturing Technology under Section 6.2(b) shall include the transfer to BMS (or its Third Party manufacturer) of the research cell bank for the production strain for the Compound (and the host/control strain for such production strain). In additioninclude, upon request by BMS, Ambrx shall the transfer to BMS available of research strains cell banks for Compounds (Compound expression cell lines prepared by Ambrx and host/control strains for such research strainsHost Cell Lines. The Host Cell Lines, and any parts thereof, shall at all times be used by BMS solely for the purposes expressly permitted under this Section 6.2(c) and for no other purpose. The Host Cell Lines may be used by BMS solely for purposes including the testing and evaluation of the Compound expression of Bare Compounds and/or developing as controls or other purposes solely to the process extent necessary to support the Development and Regulatory Approval and Commercialization of Products. BMS shall not engineer, reverse engineer, extract or modify the ReCODE/EuCODE Components for any Host Cell Line, except to the manufacture extent as may be expressly permitted in advance in writing by Ambrx. The Host Cell Lines (including any parts thereof) shall not be transferred to any Third Party (whether a Third Party manufacturer or otherwise) without the prior written approval of Ambrx, such approval not to be unreasonably withheld or delayed. BMS shall maintain documentation tracking the transfer, location and use of all samples of the Host Cell Lines, and shall provide copies of such Compounddocumentation to Ambrx upon request. All samples of the Host Cell Lines shall be promptly destroyed (or returned to Ambrx, as directed by Ambrx) upon termination of the Agreement.
Appears in 2 contracts
Samples: Collaboration and Exclusive License Agreement (Ambrx Inc), Collaboration and Exclusive License Agreement (Ambrx Inc)