Manufacturing. Bellicum shall have the right to manufacture or have manufactured such quantities of any Dimerizer as it may require in order to develop and commercialize any Licensed Product pursuant to the terms of this Agreement. Bellicum will notify ARIAD in writing of its intent to manufacture (or have manufactured by a Third Party) any Dimerizer at least […***…] prior to commencement of manufacture by itself or through a Third Party. Upon ARIAD’s request at any time, the Parties will negotiate in good faith a supply agreement under which ARIAD will provide […***…] rolling […***…] forecasts of its anticipated need for such Dimerizer (of which an agreed number of months will be binding) provided that, under such supply agreement, either (a) Bellicum will use commercially reasonable efforts to supply all quantities of Dimerizer ordered by ARIAD and will supply such Dimerizer to ARIAD and ARIAD’s licensees on at a price equal to fully burdened manufacturing costs plus […***…] percent ([…***…]%); or (b) if a Third Party manufactures such Dimerizer for Bellicum, then Bellicum shall (i) procure for ARIAD and its Affiliates and licensees the right to purchase such Dimerizers from the Third Party on terms no less favorable than those granted to Bellicum, giving ARIAD and its Affiliates and licensees equal priority with respect to quantity or lead time for delivery of such Dimerizers as given to Bellicum, its Affiliates and its Sublicensees, and (ii) grant to such Third Party all licenses to Patent Rights and Technology Controlled by Bellicum (without Bellicum incurring additional expense or obligations to Third Party licensors of Bellicum) as may be required in order for the Third Party to supply ARIAD and ARIAD’s licensees with such Dimerizers. In addition, the supply agreement will provide that, if Bellicum or its Third Party manufacturer fails to supply Dimerizer as required thereby, Bellicum or its Third Party manufacturer will transfer to ARIAD or its designee all technology necessary to manufacture such Dimerizer and will grant all necessary licenses to ARIAD or its designee on a royalty fee basis.
Appears in 3 contracts
Samples: License Agreement (Bellicum Pharmaceuticals, Inc), License Agreement (Bellicum Pharmaceuticals, Inc), License Agreement (Bellicum Pharmaceuticals, Inc)
Manufacturing. Bellicum (a) Subject to this Section 3.7(a), during the Term, CDI (and its Affiliates) shall have the exclusive right to manufacture and supply human iPSC (including TiPSC) and the Licensed Products to Century, its Affiliates and Sublicensees for [***] beginning on the Effective Date. If at any time following [***] of the Effective Date, Century wishes to have a Third Party manufacture human iPSC (including TiPSC), Century shall discuss with CDI in good faith the possibility of using such Third Party to manufacture human iPSC (including TiPSC), provided that Century shall have the sole discretion to determine whether to use CDI or have manufactured such quantities Third Party for such manufacture of any Dimerizer as it may require in order iPSC (including TiPSC). In the event that Century elects to develop and commercialize any Licensed Product pursuant use a Third Party manufacturer, CDI hereby agrees to amend the terms of this Agreement for no additional consideration under this Agreement and without delay to provide Century, its Affiliates and Sublicensees with the necessary licenses under the Licensed Technology for the Exploitation of such products, including amending the definition of “Licensed Product” to remove the limitation that iPSC be exclusive manufactured by CDI. The Parties shall negotiate in good faith as soon as reasonably practical the terms of a manufacturing and supply agreement under which CDI or its Affiliate would itself manufacture and supply human iPSC (including TiPSC) and CDI and/or its Affiliates or contractors would manufacture and supply the Licensed Products to Century, its Affiliates and Sublicensees (a “Supply Agreement. Bellicum will notify ARIAD ”) and the terms of a quality agreement which would provide the responsibilities of Century and CDI or its Affiliates for quality assurance of human iPSC (including TiPSC) and the Licensed Products referenced in writing the Supply Agreement (a “Quality Agreement”).
(b) The Supply Agreement and Quality Agreement shall each contain terms and conditions that are commercially reasonable given the terms of the Parties’ collaboration under this Agreement, including manufacturing capacity, quantity, forecasting, timeliness of delivery, quality, cost, and failure of supply that are consistent with prevailing industry standards for Third Party contract manufacturing agreements for comparable products.
(c) The Supply Agreement shall provide:
(i) CDI’s (and its intent Affiliates) exclusive right to manufacture and supply human iPSC (including TiPSC) and the Licensed Products to Century, its Affiliates and Sublicensees;
(ii) obligations of CDI (or have manufactured by its Affiliates or contractors) to perform manufacturing activities in a Third Partygood scientific manner and in compliance in all material respects with all applicable Law; and
(iii) any Dimerizer at least […***…] prior Century’s ability to commencement of manufacture by itself or through a Third Party. Upon ARIAD’s request at any timeits Affiliate, the Parties will negotiate in good faith a supply agreement under which ARIAD will provide […***…] rolling […***…] forecasts of its anticipated need for such Dimerizer (of which an agreed number of months will be binding) provided that, under such supply agreement, either (a) Bellicum will use commercially reasonable efforts or to supply all quantities of Dimerizer ordered by ARIAD and will supply such Dimerizer grant to ARIAD and ARIAD’s licensees on at a price equal to fully burdened manufacturing costs plus […***…] percent ([…***…]%); or (b) if a Third Party manufactures such Dimerizer for Bellicummanufacturer, then Bellicum shall excluding any manufacturer set forth on Schedule 3.7(a), (ia “Century CMO”) procure for ARIAD and its Affiliates and licensees the right to purchase manufacture, the Licensed Products in minimal quantities necessary to prevent a supply interruption in the event of a Non-Supply Event and for such Dimerizers from purposes CDI’s transfer of the Third Party on terms no less favorable than those granted Licensed Technology to Bellicum, giving ARIAD and Century or its Affiliates and licensees equal priority with respect to quantity Affiliate or lead time for delivery of such Dimerizers as given to Bellicum, its Affiliates and its Sublicensees, and (ii) grant to such Third Party all licenses to Patent Rights and Technology Controlled manufacturer, upon Century’s request. Details of the technology transfer provided by Bellicum (without Bellicum incurring additional expense or obligations to Third Party licensors of Bellicum) as may CDI will be required set forth in order for the Third Party to supply ARIAD and ARIAD’s licensees with such Dimerizers. In addition, the supply agreement will provide that, if Bellicum or its Third Party manufacturer fails to supply Dimerizer as required thereby, Bellicum or its Third Party manufacturer will transfer to ARIAD or its designee all technology necessary to manufacture such Dimerizer and will grant all necessary licenses to ARIAD or its designee on a royalty fee basisSupply Agreement.
Appears in 2 contracts
Samples: License Agreement (Century Therapeutics, Inc.), License Agreement (Century Therapeutics, Inc.)
Manufacturing. Bellicum Except as otherwise agreed by the Parties or set forth herein, Neurocrine shall be responsible for all manufacture and supply of Compounds and Licensed Products for use in the Territory, including all pre-clinical requirements of Licensed Products necessary to carry out the [***] Research and Development Program and the M1 Lead Candidate Research and Development Program. As between the Parties, and subject to the oversight of the JSC, Heptares shall be responsible for transferring to Neurocrine or its designee the cGMP batches of Licensed Product incorporating [***] and [***] manufactured on behalf of Heptares prior to the Execution Date. Heptares shall also be responsible for manufacturing an additional CMC batch of [***]. Promptly following the Effective Date, Heptares will transfer to Neurocrine or its designee the cGMP batches of Licensed Product incorporating [***] and [***] which have been manufactured for Heptares by a Third Party CMO prior to the right Execution Date. The costs of any manufacturing activities that Heptares carries out in accordance with this clause will be included in the Development Costs and will be reimbursed by Neurocrine. Within [***] days of the Effective Date the Parties will agree a plan for the technology transfer of the manufacturing process for each Licensed Product to Neurocrine. The timing of such transfer will differ for each Licensed Product depending on when it is intended that Neurocrine will take over the responsibility to manufacture or have manufactured the Licensed Product. Once such quantities plan is agreed the Parties will carry out the transfer of the manufacturing process for each Licensed Product in accordance with such plan. Such transfer shall include, if requested by Neurocrine, Heptares using commercially reasonable efforts to effect assignments of any Dimerizer as it may require in order agreements with any Third Party CMO or other service provider entered into by Heptares to develop the extent that such agreements exclusively relate to such Licensed Product. Neurocrine shall be responsible for all other manufacturing activities relating to Licensed Products. Heptares has used prior to the Execution Date and commercialize any shall be free to use after the Execution Date a Third Party CMO to manufacture Licensed Product pursuant Products. Heptares’ obligations under this Agreement to manufacture Licensed Products shall be qualified by and shall be subject to the terms of this Agreementeach such agreement with the applicable Third Party CMO, and unless resulting from Heptares’ acts or omissions, Heptares shall not be responsible for any failure by a Third Party to supply Licensed Product or for any other liability arising from the use of any Licensed Product manufactured by such a Third Party. Bellicum will notify ARIAD If requested by Heptares, Neurocrine will, where Neurocrine is Developing the same Compound or Licensed Product, negotiate in writing good faith and agree the terms of a supply agreement to govern the supply of such Compounds and Licensed Products to Heptares by Neurocrine for the purposes of the exercise by Heptares of the Heptares Retained Rights, at a supply price equal to Neurocrine's fully-burdened cost plus (i) [***] percent ([***]%) for clinical supply or (ii) [***] percent ([***]%) for commercial supply. Heptares shall also be entitled at its intent option and cost to manufacture (or have manufactured by a Third Party) Party CMO any Dimerizer at least […***…] prior to commencement of manufacture by itself or through a Third Party. Upon ARIAD’s request at any time, M1 Target Agonists anywhere in the Parties will negotiate in good faith a supply agreement under which ARIAD will provide […***…] rolling […***…] forecasts of its anticipated need for such Dimerizer (of which an agreed number of months will be binding) provided that, under such supply agreement, either (a) Bellicum will use commercially reasonable efforts to supply all quantities of Dimerizer ordered by ARIAD and will supply such Dimerizer to ARIAD and ARIAD’s licensees on at a price equal to fully burdened manufacturing costs plus […***…] percent ([…***…]%); or (b) if a Third Party manufactures such Dimerizer for Bellicum, then Bellicum shall (i) procure for ARIAD and its Affiliates and licensees the right to purchase such Dimerizers from the Third Party on terms no less favorable than those granted to Bellicum, giving ARIAD and its Affiliates and licensees equal priority with respect to quantity or lead time for delivery of such Dimerizers as given to Bellicum, its Affiliates and its Sublicensees, and (ii) grant to such Third Party all licenses to Patent Rights and Technology Controlled by Bellicum (without Bellicum incurring additional expense or obligations to Third Party licensors of Bellicum) as may be required in order for the Third Party to supply ARIAD and ARIAD’s licensees with such Dimerizers. In addition, the supply agreement will provide that, if Bellicum or its Third Party manufacturer fails to supply Dimerizer Territory as required thereby, Bellicum or its Third Party manufacturer will transfer by Heptares to ARIAD or its designee all technology necessary to manufacture such Dimerizer and will grant all necessary licenses to ARIAD or its designee on a royalty fee basisexercise the Heptares Retained Rights.
Appears in 1 contract
Samples: Collaboration and License Agreement (Neurocrine Biosciences Inc)
Manufacturing. Bellicum shall have the right to manufacture or have manufactured such quantities of any Dimerizer as it may require in order to develop and commercialize any Licensed Product pursuant to the terms of this Agreement. Bellicum will notify ARIAD in writing of its intent to manufacture (or have manufactured by a Third Party) any Dimerizer at least […***…] prior to commencement of manufacture by itself or through a Third Party. Upon ARIAD’s request at any time, the Parties will negotiate in good faith a supply agreement under which ARIAD will provide […***…] rolling […***…] forecasts of its anticipated need ***Confidential Treatment Requested for such Dimerizer (of which an agreed number of months will be binding) provided that, under such supply agreement, either (a) Bellicum will use commercially reasonable efforts to supply all quantities of Dimerizer ordered by ARIAD and will supply such Dimerizer to ARIAD and ARIAD’s licensees on at a price equal to fully burdened manufacturing costs plus […***…] percent ([…***…]%); or (b) if a Third Party manufactures such Dimerizer for Bellicum, then Bellicum shall (i) procure for ARIAD and its Affiliates and licensees the right to purchase such Dimerizers from the Third Party on terms no less favorable than those granted to Bellicum, giving ARIAD and its Affiliates and licensees equal priority with respect to quantity or lead time for delivery of such Dimerizers as given to Bellicum, its Affiliates and its Sublicensees, and (ii) grant to such Third Party all licenses to Patent Rights and Technology Controlled by Bellicum (without Bellicum incurring additional expense or obligations to Third Party licensors of Bellicum) as may be required in order for the Third Party to supply ARIAD and ARIAD’s licensees with such Dimerizers. In addition, the supply agreement will provide that, if Bellicum or its Third Party manufacturer fails to supply Dimerizer as required thereby, Bellicum or its Third Party manufacturer will transfer to ARIAD or its designee all technology necessary to manufacture such Dimerizer and will grant all necessary licenses to ARIAD or its designee on a royalty fee basis.
Appears in 1 contract
Samples: License Agreement
Manufacturing. Bellicum shall have the right to manufacture or have manufactured such quantities of any Dimerizer as it may require in order to develop and commercialize any Licensed Product pursuant to the terms of this Agreement. Bellicum will notify ARIAD in writing of its intent to manufacture (or have manufactured by a Third Party) any Dimerizer at least […***…] prior to commencement of manufacture by itself or through a Third Party. Upon ARIAD’s request at any time, the Parties will negotiate in good faith a supply agreement under which ARIAD will provide […***…] rolling […***…] forecasts of its anticipated need for such Dimerizer (of which an agreed number of months will be binding) provided that, under such supply agreement, either (a) Bellicum will use commercially reasonable efforts to supply all quantities of Dimerizer ordered by ARIAD and will supply such Dimerizer to ARIAD and ARIAD’s licensees on at a price equal to fully burdened manufacturing costs plus […***…] percent ([…***…]%); or (b) if a Third Party manufactures such Dimerizer for Bellicum, then Bellicum shall (i) procure for ARIAD and its Affiliates and licensees the right to purchase such Dimerizers from the Third Party on terms no less favorable than those granted to Bellicum, giving ARIAD and its Affiliates and licensees equal priority with Portions of this Exhibit, indicated by the xxxx “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. respect to quantity or lead time for delivery of such Dimerizers as given to Bellicum, its Affiliates and its Sublicensees, and (ii) grant to such Third Party all licenses to Patent Rights and Technology Controlled by Bellicum (without Bellicum incurring additional expense or obligations to Third Party licensors of Bellicum) as may be required in order for the Third Party to supply ARIAD and ARIAD’s licensees with such Dimerizers. In addition, the supply agreement will provide that, if Bellicum or its Third Party manufacturer fails to supply Dimerizer as required thereby, Bellicum or its Third Party manufacturer will transfer to ARIAD or its designee all technology necessary to manufacture such Dimerizer and will grant all necessary licenses to ARIAD or its designee on a royalty fee basis.
Appears in 1 contract
Manufacturing. Bellicum shall have 3.3.1. Isis will Manufacture and supply API for each Collaboration Program through [***]. Such API will be Manufactured with systems, processes and procedures consistent with cGMP practices. The Parties may discuss, without obligation, the right to manufacture or have manufactured such quantities continued Manufacture and supply of API for Development Candidates after [***].
3.3.2. Following the exercise of any Dimerizer as it may require in order to develop and commercialize any Licensed Product pursuant to the terms of this Agreement. Bellicum Option hereunder, GSK will notify ARIAD Isis in writing of its intent GSK’s good faith intention to manufacture (or have manufactured by use a Third PartyParty to Manufacture clinical supplies of API for any Licensed Compound(s) any Dimerizer at least […***…] prior or Licensed Products. Isis will have thirty (30) days from the receipt of such notice to commencement notify GSK in writing whether Isis desires to negotiate with GSK regarding the Manufacture of manufacture by itself the API for such Licensed Compound(s). If Isis fails to respond to GSK’s notice within such thirty (30) day period, or through if Isis declines in writing to exercise its right of first negotiation, then GSK will be free to use a Third PartyParty to Manufacture and supply the API for such Licensed Compound(s) and Isis shall promptly transfer its Licensed Know-How to such Third Party pursuant to Section 4.2.1 solely for use by such Third Party to Manufacture API for such Licensed Compound(s) for GSK. Upon ARIAD’s request at any timeIf Isis wishes to Manufacture the API for such Licensed Compound(s), the Parties will negotiate in good faith the terms of a supply manufacturing agreement under which ARIAD will provide […***…] rolling […***…] forecasts regarding clinical supplies of such API. If, despite good-faith negotiations, GSK and Isis do not reach an agreement within ninety (90) days from Isis’ exercise of its anticipated need for such Dimerizer (right of which an agreed number of months first negotiation, then GSK will be binding) provided that, under such supply agreement, either (a) Bellicum will free to use commercially reasonable efforts to supply all quantities of Dimerizer ordered by ARIAD and will supply such Dimerizer to ARIAD and ARIAD’s licensees on at a price equal to fully burdened manufacturing costs plus […***…] percent ([…***…]%); or (b) if a Third Party manufactures to Manufacture and supply the API for such Dimerizer for BellicumLicensed Compound(s) on terms, then Bellicum shall (i) procure for ARIAD and its Affiliates and licensees the right to purchase such Dimerizers from the Third Party on terms no less which, when taken as a whole, are not more favorable than those granted the terms last offered to Bellicum, giving ARIAD and its Affiliates and licensees equal priority with respect to quantity or lead time for delivery of such Dimerizers as given to Bellicum, its Affiliates and its Sublicensees, and (ii) grant to such Third Party all licenses to Patent Rights and Technology Controlled Isis by Bellicum (without Bellicum incurring additional expense or obligations to Third Party licensors of Bellicum) as may be required in order for the Third Party to supply ARIAD and ARIAD’s licensees with such Dimerizers. In addition, the supply agreement will provide that, if Bellicum or its Third Party manufacturer fails to supply Dimerizer as required thereby, Bellicum or its Third Party manufacturer will transfer to ARIAD or its designee all technology necessary to manufacture such Dimerizer and will grant all necessary licenses to ARIAD or its designee on a royalty fee basisGSK.
Appears in 1 contract
Samples: Research, Development and License Agreement (Isis Pharmaceuticals Inc)
Manufacturing. Bellicum shall have the right to manufacture or have manufactured such quantities of any Dimerizer as it may require in order to develop and commercialize any Licensed Product pursuant to the terms of this Agreement. Bellicum will notify ARIAD in writing of its intent to manufacture (or have manufactured by a Third Party) any Dimerizer at least […***…] prior to commencement of manufacture by itself or through a Third Party. Upon ARIAD’s request at any time, the Parties will negotiate in good faith a supply agreement under which ARIAD will provide […***…] rolling […***…] forecasts of its anticipated need for such Dimerizer (of which an agreed number of months will be binding) provided that, under such supply agreement, either need
(a) Bellicum will use commercially reasonable efforts to supply all quantities of Dimerizer ordered by ARIAD and will supply such Dimerizer to ARIAD and ARIAD’s licensees on at a price equal to fully burdened manufacturing costs plus […***…] percent ([…***…]%); or (b) if a Third Party manufactures such Dimerizer for Bellicum, then Bellicum shall (i) procure for ARIAD and its Affiliates and licensees the right to purchase such Dimerizers from the Third Party on terms no less favorable than those granted to Bellicum, giving ARIAD and its Affiliates and licensees equal priority with respect to quantity or lead time for delivery of such Dimerizers as given to Bellicum, its Affiliates and its Sublicensees, and (ii) grant to such Third Party all licenses to Patent Rights and Technology Controlled by Bellicum (without Bellicum incurring additional expense or obligations to Third Party licensors of Bellicum) as may be required in order for the Third Party to supply ARIAD and ARIAD’s licensees with such Dimerizers. In addition, the supply agreement will provide that, if Bellicum or its Third Party manufacturer fails to supply Dimerizer as required thereby, Bellicum or its Third Party manufacturer will transfer to ARIAD or its designee all technology necessary to manufacture such Dimerizer and will grant all necessary licenses to ARIAD or its designee on a royalty fee basis.
Appears in 1 contract
Samples: License Agreement