Common use of Development Supply for the Development Program Clause in Contracts

Development Supply for the Development Program. Company shall have the right to Manufacture Collaboration Compounds and/or finished Products in the Company Territory or the Reserved Territory as necessary for the conduct of the Development Program in the Company Territory other than Initial Phase I Clinical Trials. In an effort to establish efficient Manufacturing for Collaboration Compounds and/or finished Products, the Parties agree to use Commercially Reasonable Efforts to coordinate the Manufacturing activities in their respective territories, provided that each Party shall retain the right to Manufacture Collaboration Compounds and/or finished Products in quantities necessary for the Development Program in their respective territories. In the event that one Party agrees to supply the other Party with its requirements of Collaboration Compounds and/or finished Products in quantities necessary for the Development Program in their respective territories, then the transfer price for such Collaboration Compounds and/or Products for the conduct of the Development Program will be (i) [...***...] if the Collaboration Compounds and/or Products are Manufactured by a Party or its *Confidential Information, indicated by [...***...], has been omitted from this filing and filed separately with the Securities Exchange Commission. Affiliates in its or their own facility, or (ii) [...***...] if the Collaboration Compounds and/or Products are Manufactured by a contract manufacturer. Notwithstanding the foregoing, Licensor has the right to Manufacture Collaboration Compounds and/or finished Products as necessary for the Development Program or for the Commercialization of Products in the Reserved Territory and for the Initial Phase I Clinical Trials. In the event that, before expiry of the Option Date, Company has not exercised the option to continue the Agreement under Section 4.1(b) above, and Licensor in good faith concludes that Phase II Clinical Trial supplies of Collaboration Compound and/or finished Product and/or supplies of Collaboration Compound and/or finished Product for use in a 3-month tox study to enable a Phase III Clinical Trial need to be Manufactured to be able to meet the timelines set forth in the Development Plan, then Licensor shall notify Company and bring such need to Manufacture to the JAC for discussion and review, and the Parties shall negotiate in good faith whether or not, within which timeframe and under which terms and conditions such Manufacture is required to be assured (the “Phase II Clinical Trial Manufacturing”). Should the Parties be unable, after due consideration by the JAC, to reach agreement on the Phase II Clinical Trial Manufacturing, then Licensor shall have the right to procure Phase II Clinical Trial Manufacturing in the Reserved Territory at Licensor’s sole expense, as Licensor considers necessary. In the event that Licensor has so decided to procure Phase II Clinical Trial Manufacturing in the Reserved Territory at Licensor’s sole expense, and should thereafter, following exercise by Company of the option to continue the Agreement under section 4.1(b) above, process changes implemented by Company in the Manufacture of Collaboration Compound and/or Product require Licensor to implement any such Manufacturing process changes into the Manufacturing processes established by Licensor in the Reserved Territory to conform the Collaboration Compound and/or Product to be used in Phase II Clinical Trials in the Reserved Territory with the Collaboration Compound and/or Product to be used in Phase II Clinical Trials in the Company Territory, such that portions of the Collaboration Compound and/or finished Product produced by Licensor at Licensor’s expense in the Phase II Clinical Trial Manufacturing can no longer be utilized for Phase II Clinical Trials, then Company agrees to reimbursed Licensor for the Out of Pocket Expenses incurred by Licensor in the Manufacture of such portion(s) of the Phase II Clinical Trial Manufacturing against appropriate documentation provided by Licensor.

Appears in 1 contract

Samples: License Agreement (BeiGene, Ltd.)

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Development Supply for the Development Program. Company shall have the right to Manufacture Collaboration Compounds and/or finished Products in or outside the Company Territory or the Reserved Territory as necessary for the conduct of the Development Program in the Company Territory other than Initial Phase I Clinical Trials. In an effort to establish efficient Manufacturing for Collaboration Compounds and/or finished Products, the Parties agree to use Commercially Reasonable Efforts to coordinate the Manufacturing activities in their respective territories, provided that each Party shall retain the right to Manufacture Collaboration Compounds and/or finished Products in quantities necessary for the Development Program in their respective territories. In the event that one Party agrees to supply the other Party with its requirements of Collaboration Compounds and/or finished Products in quantities necessary for the Development Program in their respective territories, then the transfer price for such Collaboration Compounds and/or Products for the conduct of the Development Program will be (i) [...***...] if the Collaboration Compounds and/or Products are Manufactured manufactured by a Party or its Affiliates in its or their own facility, or (ii) [...***...] if the Collaboration Compounds and/or Products are manufactured by a contract manufacturer. Notwithstanding the foregoing, Licensor has the right to Manufacture Collaboration Compounds and/or finished Products necessary for the Development Program or for the Commercialization of Products outside the Territory and for Initial Phase I Clinical Trials conducted by Licensor. In the event that, before expiry of the Option Date, Company has not exercised the option to continue the Agreement under Section 4.1(b) above, Licensor in good faith concludes that Phase II Clinical Trial supplies of Collaboration Compound and/or finished Product need to be Manufactured to be able to meet the timelines set forth in the Development Plan, then Licensor shall notify Company *Confidential Information, indicated by [...***...], has been omitted from this filing and filed separately with the Securities Exchange Commission. Affiliates in its or their own facility, or (ii) [...***...] if the Collaboration Compounds and/or Products are Manufactured by a contract manufacturer. Notwithstanding the foregoing, Licensor has the right to Manufacture Collaboration Compounds and/or finished Products as necessary for the Development Program or for the Commercialization of Products in the Reserved Territory and for the Initial Phase I Clinical Trials. In the event that, before expiry of the Option Date, Company has not exercised the option to continue the Agreement under Section 4.1(b) above, and Licensor in good faith concludes that Phase II Clinical Trial supplies of Collaboration Compound and/or finished Product and/or supplies of Collaboration Compound and/or finished Product for use in a 3-month tox study to enable a Phase III Clinical Trial need to be Manufactured to be able to meet the timelines set forth in the Development Plan, then Licensor shall notify Company and bring such need to Manufacture to the JAC for discussion and review, and the Parties shall negotiate in good faith whether or not, within which timeframe and under which terms and conditions such Manufacture is required to be assured (the “Phase II Clinical Trial Manufacturing”). Should the Parties be unable, after due consideration by the JAC, to reach agreement on the Phase II Clinical Trial Manufacturing, then Licensor shall have the right to procure Phase II Clinical Trial Manufacturing in outside the Reserved Territory at Licensor’s sole expense, as Licensor considers necessary. In the event that Licensor has so decided to procure Phase II Clinical Trial Manufacturing in outside the Reserved Territory at Licensor’s sole expense, and should thereafter, following exercise by Company of the option to continue the Agreement under section Section 4.1(b) above, process changes implemented by Company in the Manufacture of Collaboration Compound and/or Product require Licensor to implement any such Manufacturing process changes into the Manufacturing processes established by Licensor in outside the Reserved Territory to conform the Collaboration Compound and/or Product to be used in Phase II Clinical Trials in outside the Reserved Territory with the Collaboration Compound and/or Product to be used in Phase II Clinical Trials in the Company Territory, such that portions of the Collaboration Compound and/or finished Product produced by Licensor at Licensor’s expense in the Phase II Clinical Trial Manufacturing can no longer be utilized by Licensor for Phase II Clinical Trials, then Company agrees to reimbursed reimburse Licensor for the Out of Out-of-Pocket Expenses incurred by Licensor in the Manufacture of such portion(s) of the Phase II Clinical Trial Manufacturing against appropriate documentation provided by Licensor.

Appears in 1 contract

Samples: License Agreement (BeiGene, Ltd.)

Development Supply for the Development Program. Company shall have the right to Manufacture Collaboration Compounds and/or finished Products in the Company Territory or the Reserved Territory as necessary for the conduct of the Development Program in the Company Territory other than Initial Phase I Clinical Trials. In an effort to establish efficient Manufacturing for Collaboration Compounds and/or finished Products, the Parties agree to use Commercially Reasonable Efforts to coordinate the Manufacturing activities in their respective territories, provided that each Party shall retain the right to Manufacture Collaboration Compounds and/or finished Products in quantities necessary for the Development Program in their respective territories. In the event that one Party agrees to supply the other Party with its requirements of Collaboration Compounds and/or finished Products in quantities necessary for the Development Program in their respective territories, then the transfer price for such Collaboration Compounds and/or Products for the conduct of the Development Program will be (i) [...***...] if the Collaboration Compounds and/or Products are Manufactured by a Party or its *Confidential Information, indicated by [...***...], has been omitted from this filing and filed separately with the Securities and Exchange Commission. Affiliates in its or their own facility, or (ii) [...***...] if the Collaboration Compounds and/or Products are Manufactured by a contract manufacturer. Notwithstanding the foregoing, Licensor has the right to Manufacture Collaboration Compounds and/or finished Products as necessary for the Development Program or for the Commercialization of Products in the Reserved Territory and for the Initial Phase I Clinical Trials. In the event that, before expiry of the Option Date, Company has not exercised the option to continue the Agreement under Section 4.1(b) above, and Licensor in good faith concludes that Phase II Clinical Trial supplies of Collaboration Compound and/or finished Product and/or supplies of Collaboration Compound and/or finished Product for use in a 3-month tox study to enable a Phase III Clinical Trial need to be Manufactured to be able to meet the timelines set forth in the Development Plan, then Licensor shall notify Company and bring such need to Manufacture to the JAC for discussion and review, and the Parties shall negotiate in good faith whether or not, within which timeframe and under which terms and conditions such Manufacture is required to be assured (the “Phase II Clinical Trial Manufacturing”). Should the Parties be unable, after due consideration by the JAC, to reach agreement on the Phase II Clinical Trial Manufacturing, then Licensor shall have the right to procure Phase II Clinical Trial Manufacturing in the Reserved Territory at Licensor’s sole expense, as Licensor considers necessary. In the event that Licensor has so decided to procure Phase II Clinical Trial Manufacturing in the Reserved Territory at Licensor’s sole expense, and should thereafter, following exercise by Company of the option to continue the Agreement under section 4.1(b) above, process changes implemented by Company in the Manufacture of Collaboration Compound and/or Product require Licensor to implement any such Manufacturing process changes into the Manufacturing processes established by Licensor in the Reserved Territory to conform the Collaboration Compound and/or Product to be used in Phase II Clinical Trials in the Reserved Territory with the Collaboration Compound and/or Product to be used in Phase II Clinical Trials in the Company Territory, such that portions of the Collaboration Compound and/or finished Product produced by Licensor at Licensor’s expense in the Phase II Clinical Trial Manufacturing can no longer be utilized for Phase II Clinical Trials, then Company agrees to reimbursed Licensor for the Out of Pocket Expenses incurred by Licensor in the Manufacture of such portion(s) of the Phase II Clinical Trial Manufacturing against appropriate documentation provided by Licensor.

Appears in 1 contract

Samples: License Agreement (BeiGene, Ltd.)

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Development Supply for the Development Program. Company shall have the right to Manufacture Collaboration Compounds and/or finished Products in or outside the Company Territory or the Reserved Territory as necessary for the conduct of the Development Program in the Company Territory other than Initial Phase I Clinical Trials. In an effort to establish efficient Manufacturing for Collaboration Compounds and/or finished Products, the Parties agree to use Commercially Reasonable Efforts to coordinate the Manufacturing activities in their respective territories, provided that each Party shall retain the right to Manufacture Collaboration Compounds and/or finished Products in quantities necessary for the Development Program in their respective territories. In the event that one Party agrees to supply the other Party with its requirements of Collaboration Compounds and/or finished Products in quantities necessary for the Development Program in their respective territories, then the transfer price for such Collaboration Compounds and/or Products for the conduct of the Development Program will be (i) [...***...] if the Collaboration Compounds and/or Products are Manufactured manufactured by a Party or its *Confidential Information, indicated by [...***...], has been omitted from this filing and filed separately with the Securities Exchange Commission. Affiliates in its or their own facility, or (ii) [...***...] if the Collaboration Compounds and/or Products are Manufactured manufactured by a contract manufacturer. Notwithstanding the foregoing, Licensor has the right to Manufacture Collaboration Compounds and/or finished Products as necessary for the Development Program or for the Commercialization of Products in outside the Reserved Territory and for the Initial Phase I Clinical TrialsTrials conducted by Licensor. In the event that, before expiry of the Option Date, Company has not exercised the option to continue the Agreement under Section 4.1(b) above, and Licensor in good faith concludes that Phase II Clinical Trial supplies of Collaboration Compound and/or finished Product and/or supplies of Collaboration Compound and/or finished Product for use in a 3-month tox study to enable a Phase III Clinical Trial need to be Manufactured to be able to meet the timelines set forth in the Development Plan, then Licensor shall notify Company *Confidential Information, indicated by [...***...], has been omitted from this filing and filed separately with the Securities and Exchange Commission. and bring such need to Manufacture to the JAC for discussion and review, and the Parties shall negotiate in good faith whether or not, within which timeframe and under which terms and conditions such Manufacture is required to be assured (the “Phase II Clinical Trial Manufacturing”). Should the Parties be unable, after due consideration by the JAC, to reach agreement on the Phase II Clinical Trial Manufacturing, then Licensor shall have the right to procure Phase II Clinical Trial Manufacturing in outside the Reserved Territory at Licensor’s sole expense, as Licensor considers necessary. In the event that Licensor has so decided to procure Phase II Clinical Trial Manufacturing in outside the Reserved Territory at Licensor’s sole expense, and should thereafter, following exercise by Company of the option to continue the Agreement under section Section 4.1(b) above, process changes implemented by Company in the Manufacture of Collaboration Compound and/or Product require Licensor to implement any such Manufacturing process changes into the Manufacturing processes established by Licensor in outside the Reserved Territory to conform the Collaboration Compound and/or Product to be used in Phase II Clinical Trials in outside the Reserved Territory with the Collaboration Compound and/or Product to be used in Phase II Clinical Trials in the Company Territory, such that portions of the Collaboration Compound and/or finished Product produced by Licensor at Licensor’s expense in the Phase II Clinical Trial Manufacturing can no longer be utilized by Licensor for Phase II Clinical Trials, then Company agrees to reimbursed reimburse Licensor for the Out of Out-of-Pocket Expenses incurred by Licensor in the Manufacture of such portion(s) of the Phase II Clinical Trial Manufacturing against appropriate documentation provided by Licensor.

Appears in 1 contract

Samples: License Agreement (BeiGene, Ltd.)

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