Transition Assistance. Impax agrees to reasonably cooperate with Durect and its designee(s) to facilitate a smooth, orderly and prompt transition of the Development and Commercialization of Product to Durect and/or its designee(s) during the notice period (if terminated pursuant to the first sentence of Section 10.2) and a [* * *] period after the effective date of termination, which may be extended for up to another [* * *] upon Durect’s written request (collectively, the “Transition Period”), provided that (i) the Parties shall use reasonable efforts to complete such transition prior to the expiration of the initial [* * *] period without such extension, and (ii) if Durect requests for such extension, [* * *]. Upon request by Durect within [* * *] after the effectiveness of termination, Impax shall transfer to Durect some or all quantities of Product in its or its Affiliates’ Control; provided, however, that Durect shall reimburse Impax for its actual costs to manufacture or otherwise acquire the quantities so provided to Durect. If any Product was manufactured by any Third Party for Impax, or Impax had contracts with vendors which contracts are specific to Product and necessary or useful for Durect to take over responsibility for Product in the Territory, then Impax shall to the extent possible and requested in writing by Durect, assign all of the relevant Third-Party contracts to Durect, and in any case, Impax agrees to cooperate with Durect Confidential treatment has been sought for portions of this Agreement. The copy filed herewith omits the information subject to the confidential treatment request. Omissions are designated as * * *. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission. to facilitate uninterrupted supply of Product. If Impax or its Affiliate manufactured any Product at the time of termination, then Impax (or its Affiliate) shall continue to provide for manufacturing of such Product for Durect, at its fully-burdened manufacturing cost therefor, from the effectiveness of such termination until such time as Durect is able, using Commercially Reasonable Efforts, to secure an acceptable alternative commercial manufacturing source from which sufficient quantities of Product may be procured and legally sold in the Territory, but no longer than the Transition Period.
Appears in 2 contracts
Samples: Assignment and Assumption Agreement, Assignment and Assumption Agreement (Durect Corp)
Transition Assistance. Impax agrees Collaborator shall, for a reasonable period of time, provide such assistance, at no cost to reasonably cooperate with Durect and its designee(s) Affymax, to facilitate a smoothtransfer and/or transition to Affymax all other technology or know-how, orderly and prompt transition of the Development and Commercialization of Product to Durect and/or its designee(s) during the notice period (if terminated pursuant to the first sentence of Section 10.2) and a [* * *] period after the effective date of termination, which may be extended for up to another [* * *] upon Durect’s written request (collectively, the “Transition Period”), provided that (i) the Parties shall use reasonable efforts to complete such transition prior to the expiration of the initial [* * *] period without such extension, and (ii) if Durect requests for such extension, [* * *]. Upon request by Durect within [* * *] after the effectiveness of termination, Impax shall transfer to Durect some or all quantities of Product in its or its Affiliates’ Control; provided, howeverthen-existing commercial arrangements, that Durect shall reimburse Impax for its actual costs to manufacture or otherwise acquire the quantities so provided to Durect. If any Product was manufactured by any Third Party for Impaxis, or Impax had contracts with vendors which contracts are specific to Product and are, reasonably necessary or useful for Durect Affymax to take over responsibility for Product commence or continue Developing, conducting Finished Manufacturing of or Commercializing Products in the Licensed Territory, then Impax shall to the extent possible and requested in writing by DurectCollaborator is then performing or having performed such activities, assign all including without limitation transferring, upon request of the relevant Affymax, any agreements or arrangements with Third-Party contracts suppliers or vendors to Durectsupply or sell Products in the Licensed Territory, to the extent practicable. If any such contract between Collaborator and a Third Party for the supply of Bulk Hematide or Finished Product for the Licensed Territory is not assignable to Affymax, then Collaborator shall reasonably cooperate with Affymax to arrange to continue to obtain such supply from such entity, and Collaborator shall supply such Bulk Hematide or Finished Product, as applicable, to Affymax, at a cost [*] (calculated in any casea manner consistent with the definition of [*]) for a reasonable period. In addition, Impax agrees to cooperate with Durect Confidential treatment has been sought for portions of this Agreement. The copy filed herewith omits the information subject to the confidential treatment request. Omissions are designated as * * *. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission. to facilitate uninterrupted supply of Product. If Impax extent that Collaborator or its Affiliate manufactured any Product at is then manufacturing Bulk Hematide and/or Finished Products for the time of terminationLicensed Territory, then Impax (or its Affiliate) Collaborator shall continue to provide manufacture, and shall supply to Affymax, at a cost that equals [*] (calculated in a manner consistent with the definition of [*]), such Bulk Hematide and/or Finished [*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED. 76 Products for Affymax's use in the Licensed Territory for a reasonable period in order to permit Affymax to establish sufficient manufacturing of such capacity for Bulk Hematide and/or Finished Product for Durectthe Licensed Territory, at in addition to that which it had in place for its fully-burdened manufacturing cost therefor, from the effectiveness of such termination until such time as Durect is able, using Commercially Reasonable Efforts, to secure an acceptable alternative commercial manufacturing source from which sufficient quantities of Product may be procured and legally sold use in the Affymax Territory, but . Such period shall be no longer more than twelve (12) months unless otherwise agreed by the Transition PeriodParties.
Appears in 1 contract
Transition Assistance. Impax agrees Licensee shall use Commercially Reasonable Efforts to reasonably cooperate with Durect and its designee(s) to facilitate a smooth, seek an orderly and prompt transition of the Development and Commercialization of Product the Compound and Products to Durect and/or Exelixis or its designee(s) during the notice period (if terminated pursuant to the first sentence of designee. Except for termination by Licensee under Section 10.2) and a [* * *] period after 15.2, Exelixis may, in its sole discretion, postpone the effective date of termination, which may be extended any termination for a period of up to another [[ * * *] upon Durect’s written request (collectively, the “Transition Period”), provided that (i) the Parties shall use reasonable efforts to complete such transition prior to the expiration of the initial [* * *] period without such extension, and (ii) if Durect requests for such extension, [* * *]. Upon request Except in the event of termination by Durect within [Licensee under Section 15.2(a) for material breach by Exelixis, Licensee shall, at no cost to Exelixis, provide reasonable consultation and assistance for a period of no more than [ * * *] after the effectiveness of termination, Impax shall transfer to Durect some or all quantities of Product in its or its Affiliates’ Control; provided, however, that Durect shall reimburse Impax for its actual costs to manufacture or otherwise acquire the quantities so provided to Durect. If any Product was manufactured by any Third Party for Impax, or Impax had contracts with vendors which contracts are specific to Product and necessary or useful for Durect to take over responsibility for Product in the Territory, then Impax shall to the extent possible and requested in writing by Durect, assign all of the relevant Third-Party contracts to Durect, termination (and in any casecase not to exceed a total of [ * ] of working time including the assistance provided under Section 15.4(b)) for the purpose of transferring or transitioning to Exelixis all Licensee Know-How not [ * ] = Certain confidential information contained in this document, Impax agrees to cooperate with Durect Confidential treatment marked by brackets, has been sought for portions of this Agreement. The copy filed herewith omits the information subject to the confidential treatment request. Omissions are designated as * * *. A complete version of this exhibit has been omitted and filed separately with the Securities and Exchange CommissionCommission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. to facilitate uninterrupted supply of Product. If Impax or its Affiliate manufactured any Product at the time of termination, then Impax (or its Affiliate) shall continue to provide for manufacturing of such Product for Durectalready in Exelixis’ possession and, at its fullyExelixis’ request, all then-burdened manufacturing cost therefor, from existing commercial arrangements relating to the effectiveness of such termination until such time as Durect Products that Licensee is able, using Commercially Reasonable Efforts, to secure an acceptable alternative commercial manufacturing source from which sufficient quantities transfer or transition to Exelixis or its designee, in each case, to the extent reasonably necessary or for Exelixis to continue the Development and/or Commercialization of Product may be procured the Compound and legally sold Products in the Licensee Territory. If any such contract between Licensee and a Third Party is not assignable to Exelixis or its designee (whether by such contract’s terms or because such contract does not relate specifically to the Products) but is otherwise reasonably necessary for Exelixis to continue the Development and/or Commercialization of the Compound and Products in the Licensee Territory, but or if Licensee is performing such work for the Compound and Product itself (and thus there is no longer than contract to assign), then Licensee shall reasonably cooperate with Exelixis to negotiate for the Transition Periodcontinuation of such services for Exelixis from such entity, or Licensee shall continue to perform such work for Exelixis, as applicable, for a reasonable period (not to exceed [ * ]) after termination at Exelixis’ cost until Exelixis establishes an alternate, validated source of such services.
Appears in 1 contract
Samples: Collaboration and License Agreement (Exelixis, Inc.)
Transition Assistance. Impax agrees The Transition Agreement shall require Gilead, […***…], to disclose and provide to Galapagos (1) […***…] and that is necessary for Galapagos to Develop, Manufacture or Commercialize the applicable Reversion Product(s) with respect to the applicable Terminated Region(s) and (2) at Galapagos’ request, all then-existing commercial arrangements of Gilead or any of its Affiliates to the extent relating solely and specifically to the applicable Reversion Product(s) and the applicable Terminated Region(s) (which may be redacted to the extent necessary to comply with Gilead’ or its Affiliate’s obligation to the Third Party to any such commercial arrangement), and to provide reasonable consultation and assistance with respect thereto for a period of no more than […***…] days following the completion of such disclosure and provision. The foregoing obligation Option, License and Collaboration Agreement described in clause (2) shall include assigning to Galapagos, upon request of Galapagos, any agreements between Gilead or any of its Affiliates and Third Party suppliers or vendors to the extent such agreements solely and specifically relate to the supply or sale of the applicable Reversion Product(s) with respect to the applicable Terminated Region(s). If any such agreement is not assignable to Galapagos (whether by such agreement’s terms or because such agreement does not solely and specifically relate to the supply or sale of the applicable Reversion Product(s) with respect to the applicable Terminated Region(s)) but is otherwise reasonably necessary or useful for Galapagos to Develop, Manufacture or Commercialize any such Reversion Product(s) with respect to the applicable Terminated Region(s), then Gilead shall reasonably cooperate with Durect Galapagos in Galapagos’ efforts to obtain from such Third Party the assignment of such agreement or of that portion of such agreement that solely and its designee(sspecifically relates to the supply or sale of such Reversion Product(s) with respect to facilitate a smooththe applicable Terminated Region(s). With respect to any applicable Reversion Product(s) and the applicable Terminated Region(s), orderly unless and prompt transition of the Development and Commercialization of Product until any such agreements are assigned to Durect and/or its designee(s) during the notice period (if terminated Galapagos pursuant to the first sentence preceding sentences, or if Gilead Manufactures such Reversion Product(s) itself (and thus there is no agreement to assign), the Transition Agreement shall require Gilead to supply bulk finished quantities of Section 10.2such Reversion Product(s) and to Galapagos with respect to the applicable Terminated Region(s) for a [* * *] reasonable period after following the effective date of terminationtermination (not to exceed […***…] months) to enable Galapagos to establish an alternate, which may be extended for up to another [* * *] upon Durect’s written request (collectively, the “Transition Period”), provided that (i) the Parties shall use reasonable efforts to complete such transition prior to the expiration validated source of the initial [* * *] period without such extension, and (ii) if Durect requests supply for such extension, [* * *]. Upon request by Durect within [* * *] after the effectiveness of termination, Impax shall transfer to Durect some or all quantities of Product in its or its Affiliates’ Control; provided, however, that Durect shall reimburse Impax for its actual costs to manufacture or otherwise acquire the quantities so provided to Durect. If any Product was manufactured by any Third Party for Impax, or Impax had contracts with vendors which contracts are specific to Product and necessary or useful for Durect to take over responsibility for Product in the Territory, then Impax shall to the extent possible and requested in writing by Durect, assign all of the relevant Third-Party contracts to Durect, and in any case, Impax agrees to cooperate with Durect Confidential treatment has been sought for portions of this AgreementReversion Product(s). The copy filed herewith omits the information subject cost to the confidential treatment request. Omissions are designated as * * *. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission. to facilitate uninterrupted Galapagos for supply of Product. If Impax or its Affiliate manufactured any such Reversion Product at the time of termination, then Impax (or its Affiliate) shall continue to provide for manufacturing of such Product for Durect, at its fully-burdened manufacturing cost therefor, from the effectiveness of such termination until such time as Durect is able, using Commercially Reasonable Efforts, to secure an acceptable alternative commercial manufacturing source from which sufficient quantities of Product may be procured and legally sold in the Territory, but no longer than the Transition Period[…***…].
Appears in 1 contract
Samples: Option, License and Collaboration Agreement (Galapagos Nv)
Transition Assistance. Impax agrees The Transition Agreement shall require Gilead, […***…], to disclose and provide to Galapagos (1) […***…] and that is necessary for Galapagos to Develop, Manufacture or Commercialize the applicable Reversion Product(s) with respect to the applicable Terminated Region(s) and (2) at Galapagos’ request, all then-existing commercial arrangements of Gilead or any of its Affiliates to the extent relating solely and specifically to the applicable Reversion Product(s) and the applicable Terminated Region(s) (which may be redacted to the extent necessary to comply with Option, License and Collaboration Agreement Gilead’ or its Affiliate’s obligation to the Third Party to any such commercial arrangement), and to provide reasonable consultation and assistance with respect thereto for a period of no more than […***…] days following the completion of such disclosure and provision. The foregoing obligation described in clause (2) shall include assigning to Galapagos, upon request of Galapagos, any agreements between Gilead or any of its Affiliates and Third Party suppliers or vendors to the extent such agreements solely and specifically relate to the supply or sale of the applicable Reversion Product(s) with respect to the applicable Terminated Region(s). If any such agreement is not assignable to Galapagos (whether by such agreement’s terms or because such agreement does not solely and specifically relate to the supply or sale of the applicable Reversion Product(s) with respect to the applicable Terminated Region(s)) but is otherwise reasonably necessary or useful for Galapagos to Develop, Manufacture or Commercialize any such Reversion Product(s) with respect to the applicable Terminated Region(s), then Gilead shall reasonably cooperate with Durect Galapagos in Galapagos’ efforts to obtain from such Third Party the assignment of such agreement or of that portion of such agreement that solely and its designee(sspecifically relates to the supply or sale of such Reversion Product(s) with respect to facilitate a smooththe applicable Terminated Region(s). With respect to any applicable Reversion Product(s) and the applicable Terminated Region(s), orderly unless and prompt transition of the Development and Commercialization of Product until any such agreements are assigned to Durect and/or its designee(s) during the notice period (if terminated Galapagos pursuant to the first sentence preceding sentences, or if Gilead Manufactures such Reversion Product(s) itself (and thus there is no agreement to assign), the Transition Agreement shall require Gilead to supply bulk finished quantities of Section 10.2such Reversion Product(s) and to Galapagos with respect to the applicable Terminated Region(s) for a [* * *] reasonable period after following the effective date of terminationtermination (not to exceed […***…] months) to enable Galapagos to establish an alternate, which may be extended for up to another [* * *] upon Durect’s written request (collectively, the “Transition Period”), provided that (i) the Parties shall use reasonable efforts to complete such transition prior to the expiration validated source of the initial [* * *] period without such extension, and (ii) if Durect requests supply for such extension, [* * *]. Upon request by Durect within [* * *] after the effectiveness of termination, Impax shall transfer to Durect some or all quantities of Product in its or its Affiliates’ Control; provided, however, that Durect shall reimburse Impax for its actual costs to manufacture or otherwise acquire the quantities so provided to Durect. If any Product was manufactured by any Third Party for Impax, or Impax had contracts with vendors which contracts are specific to Product and necessary or useful for Durect to take over responsibility for Product in the Territory, then Impax shall to the extent possible and requested in writing by Durect, assign all of the relevant Third-Party contracts to Durect, and in any case, Impax agrees to cooperate with Durect Confidential treatment has been sought for portions of this AgreementReversion Product(s). The copy filed herewith omits the information subject cost to the confidential treatment request. Omissions are designated as * * *. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission. to facilitate uninterrupted Galapagos for supply of Product. If Impax or its Affiliate manufactured any such Reversion Product at the time of termination, then Impax (or its Affiliate) shall continue to provide for manufacturing of such Product for Durect, at its fully-burdened manufacturing cost therefor, from the effectiveness of such termination until such time as Durect is able, using Commercially Reasonable Efforts, to secure an acceptable alternative commercial manufacturing source from which sufficient quantities of Product may be procured and legally sold in the Territory, but no longer than the Transition Period[…***…].
Appears in 1 contract
Samples: Option, License and Collaboration Agreement (Gilead Sciences Inc)
Transition Assistance. Impax Oncothyreon agrees to reasonably fully cooperate with Durect Array and its designee(s) to facilitate a smooth, orderly and prompt transition of the Development development and Commercialization commercialization of Product Products to Durect Array and/or its designee(s) during the notice period Commercialization Wind-Down Period. Without limiting the foregoing Oncothyreon shall promptly provide Array manufacturing information (if terminated pursuant including protocols for the production, packaging, testing and other manufacturing activities) relating to the first sentence of Section 10.2) and a [* * *] period after the effective date of terminationProduct in Oncothyreon’s Control, which may be extended in each case Array shall have the right to use and disclose for up any purpose during this Commercialization Wind-Down Period and thereafter solely as reasonably necessary or useful to another [* * *] upon Durect’s written request (collectivelymanufacture, or have manufactured, the “Transition Period”), provided that (i) the Parties shall use reasonable efforts to complete such transition prior to the expiration of the initial [* * *] period without such extension, and (ii) if Durect requests for such extension, [* * *]Product. Upon request by Durect within [* * *] after the effectiveness of terminationArray, Impax Oncothyreon shall transfer to Durect Array some or all quantities of the Product in its or its Affiliates’ Control; providedControl (as requested by Array), howeverwithin thirty (30) days after the end of this Commercialization Wind-Down Period, that Durect and Array shall reimburse Impax for its actual costs to manufacture or otherwise acquire buy such quantities at the quantities so provided to DurectPurchase Price. If any Product was manufactured by any Third Party for ImpaxOncothyreon, or Impax Oncothyreon had contracts with vendors which contracts are specific to Product and necessary or useful for Durect Array to take over responsibility for the Product in the Territory, then Impax Oncothyreon shall to the extent possible and requested in writing by DurectArray, assign all of the relevant Third-Party contracts to DurectArray, and in any case, Impax Oncothyreon agrees to cooperate with Durect Confidential treatment has been sought for portions of this Agreement. The copy filed herewith omits the information subject Array to the confidential treatment request. Omissions are designated as * * *. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission. to facilitate ensure uninterrupted supply of Productthe Products. If Impax Oncothyreon or its Affiliate manufactured any Product at the time of termination, then Impax Oncothyreon (or its Affiliate) shall continue to provide for manufacturing of such Product for DurectArray, at its fully-burdened manufacturing cost therefor, plus ten percent (10%), from the effectiveness date of notice of such termination until such time as Durect Array is able, using Commercially Reasonable Effortsdiligent efforts to do so but no longer than the expiration of the Commercialization Wind-Down Period, to secure an acceptable alternative commercial manufacturing source from which sufficient quantities of the Product may be procured and legally sold in the Territory, but no longer than the Transition Period.
Appears in 1 contract
Transition Assistance. Impax agrees Partner shall, at no cost to Medivation, provide reasonable consultation and assistance (“Transition Assistance”) for a period of no more than [*] after the effective date of termination for the purpose of transferring or transitioning to Medivation, (i) in the form and format in which such Partner Know-How is maintained by Partner in the ordinary course of business, all Partner Know-How not already in Medivation’s possession, and (ii) at Medivation’s request, all then-existing Third Party agreements relating solely to Collaboration Molecules and Products hereunder and that Partner is able, using reasonable commercial efforts to, assign to Medivation, in each case, to the extent reasonably [ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. necessary for Medivation to continue researching, Developing, manufacturing, or Commercializing Products, provided, however, that Partner shall be required to assign any such agreement solely to the extent assignment is permitted by such agreement, and Partner is not required to pay any consideration or commence litigation in order to effect an assignment of any such agreement to Medivation. If any such agreement between Partner and a Third Party is not assignable to Medivation (whether by such agreement’s terms or because such agreement does not relate solely to Collaboration Molecules or Products) but is otherwise reasonably necessary for Medivation to continue researching, Developing, manufacturing, or Commercializing Products, then Partner shall reasonably cooperate with Durect Medivation to [*]. If Partner manufactures the Product itself (and its designee(s) thus there is no agreement to facilitate assign), then Partner shall supply such bulk Collaboration Molecule or finished Product, as applicable, to Medivation, for a smooth, orderly and prompt transition of the Development and Commercialization of Product to Durect and/or its designee(s) during the notice reasonable period (if terminated pursuant not to the first sentence of Section 10.2) and a exceed [* * *] period after the effective date of termination, which may be extended for up to another [* * *] upon Durect’s written request (collectively, the “Transition Period”), provided that (i) pursuant to a supply agreement to be negotiated in good faith by the Parties shall use reasonable efforts to complete such transition prior to the expiration of the initial [* * *] period without such extension, and (ii) if Durect requests for such extension, [* * *]Parties. Upon request by Durect within [* * *] after the effectiveness of termination, Impax shall transfer to Durect some or all quantities of Product in its or its Affiliates’ Control; provided, however, that Durect Medivation shall reimburse Impax for its actual costs to manufacture Partner or otherwise acquire the quantities so provided to Durect. If any Product was manufactured by any of Partner’s Third Party manufacturers for Impax, or Impax had contracts with vendors which contracts are specific all reasonable out-of-pocket costs incurred pursuant to Product and necessary or useful for Durect to take over responsibility for Product in the Territory, then Impax shall to the extent possible and requested in writing by Durect, assign all of the relevant Third-Party contracts to Durect, and in any case, Impax agrees to cooperate with Durect Confidential treatment has been sought for portions of this Agreement. The copy filed herewith omits the information subject to the confidential treatment request. Omissions are designated as * * *. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission. to facilitate uninterrupted supply of Product. If Impax or its Affiliate manufactured any Product at the time of termination, then Impax (or its Affiliate) shall continue to provide for manufacturing of such Product for Durect, at its fully-burdened manufacturing cost therefor, from the effectiveness of such termination until such time as Durect is able, using Commercially Reasonable Efforts, to secure an acceptable alternative commercial manufacturing source from which sufficient quantities of Product may be procured and legally sold in the Territory, but no longer than the Transition PeriodSection 13.5(d).
Appears in 1 contract
Transition Assistance. Impax agrees Collaborator shall use Commercially Reasonable Efforts to reasonably cooperate with Durect and its designee(s) to facilitate a smooth, seek an orderly and prompt transition of the Development and Commercialization of Product the Compound and Products to Durect and/or Exelixis or its designee(s) during designee for so long as is necessary to ensure patient safety, including ensuring continuity of supply to any patients. Collaborator shall, at no cost to Exelixis, provide reasonable consultation and assistance for a period of no more than [ * ] after termination for the notice period (if terminated pursuant purpose of transferring or transitioning to Exelixis all Collaborator Know-How not already in Exelixis’ possession and, at Exelixis’ request, all then-existing commercial arrangements relating to the first sentence of Section 10.2) and a [* * *] period after the effective date of termination, which may be extended for up to another [* * *] upon Durect’s written request (collectively, the “Transition Period”), provided Products that (i) the Parties shall use reasonable efforts to complete such transition prior to the expiration of the initial [* * *] period without such extension, and (ii) if Durect requests for such extension, [* * *]. Upon request by Durect within [* * *] after the effectiveness of termination, Impax shall transfer to Durect some or all quantities of Product in its or its Affiliates’ Control; provided, however, that Durect shall reimburse Impax for its actual costs to manufacture or otherwise acquire the quantities so provided to Durect. If any Product was manufactured by any Third Party for Impax, or Impax had contracts with vendors which contracts are specific to Product and necessary or useful for Durect to take over responsibility for Product in the Territory, then Impax shall to the extent possible and requested in writing by Durect, assign all of the relevant Third-Party contracts to Durect, and in any case, Impax agrees to cooperate with Durect Confidential treatment has been sought for portions of this Agreement. The copy filed herewith omits the information subject to the confidential treatment request. Omissions are designated as * * *. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission. to facilitate uninterrupted supply of Product. If Impax or its Affiliate manufactured any Product at the time of termination, then Impax (or its Affiliate) shall continue to provide for manufacturing of such Product for Durect, at its fully-burdened manufacturing cost therefor, from the effectiveness of such termination until such time as Durect Collaborator is able, using Commercially Reasonable Efforts, to secure an acceptable alternative commercial manufacturing source from which sufficient quantities transfer or transition to Exelixis or its designee, in each case, to the extent reasonably necessary or useful for Exelixis to continue the Development and/or Commercialization of Product may be procured the Compound and legally sold Products in the Collaborator Territory. If any such contract between Collaborator and a Third Party is not assignable to Exelixis or its designee (whether by such contract’s terms or because such contract does not relate specifically to the Products) but is otherwise reasonably necessary or useful for Exelixis to continue the Development and/or Commercialization of the Compound and Products in the Collaborator Territory, but or if Collaborator is performing such work for the Compound and Product itself (and thus there is no longer than contract to assign), then Collaborator shall reasonably cooperate with Exelixis to negotiate for [ * ] = Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed. the Transition Periodcontinuation of such services for Exelixis from such entity, or Collaborator shall continue to perform such work for Exelixis, as applicable, for a reasonable period (not to exceed [ * ]) after termination at Exelixis’ cost until Exelixis establishes an alternate, validated source of such services.
Appears in 1 contract
Samples: Collaboration and License Agreement (Exelixis, Inc.)
Transition Assistance. Impax agrees Licensee shall use Commercially Reasonable Efforts to reasonably cooperate with Durect and its designee(s) to facilitate a smooth, seek an orderly and prompt transition of the Development and Commercialization of Product the Compound and Products to Durect and/or Exelixis or its designee(s) during the notice period (if terminated pursuant to the first sentence of designee. Except for termination by Licensee under Section 10.2) and a [* * *] period after 15.2, Exelixis may, in its sole discretion, postpone the effective date of termination, which may be extended any termination for a period of up to another [[ * * *] upon Durect’s written request (collectively, the “Transition Period”), provided that (i) the Parties shall use reasonable efforts to complete such transition prior to the expiration of the initial [* * *] period without such extension, and (ii) if Durect requests for such extension, [* * *]. Upon request Except in the event of termination by Durect within [Licensee under Section 15.2(a) for material breach by Exelixis, Licensee shall, at no cost to Exelixis, provide reasonable consultation and assistance for a period of no more than [ * * *] after the effectiveness of termination, Impax shall transfer to Durect some or all quantities of Product in its or its Affiliates’ Control; provided, however, that Durect shall reimburse Impax for its actual costs to manufacture or otherwise acquire the quantities so provided to Durect. If any Product was manufactured by any Third Party for Impax, or Impax had contracts with vendors which contracts are specific to Product and necessary or useful for Durect to take over responsibility for Product in the Territory, then Impax shall to the extent possible and requested in writing by Durect, assign all of the relevant Third-Party contracts to Durect, termination (and in any casecase not to exceed a total of [ * ] of working time including the assistance provided under Section 15.4(b)) for the purpose of transferring or transitioning to Exelixis all Licensee Know-How not already in Exelixis’ possession and, Impax agrees to cooperate with Durect Confidential treatment has been sought for portions of this Agreement. The copy filed herewith omits the information subject at Exelixis’ request, all then-existing commercial arrangements relating to the confidential treatment request. Omissions are designated as * * *. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission. to facilitate uninterrupted supply of Product. If Impax or its Affiliate manufactured any Product at the time of termination, then Impax (or its Affiliate) shall continue to provide for manufacturing of such Product for Durect, at its fully-burdened manufacturing cost therefor, from the effectiveness of such termination until such time as Durect Products that Licensee is able, using Commercially Reasonable Efforts, to secure an acceptable alternative commercial manufacturing source from which sufficient quantities transfer or transition to Exelixis or its designee, in each case, to the extent reasonably necessary or for Exelixis to continue the Development and/or Commercialization of Product may be procured the Compound and legally sold Products in the Licensee Territory. If any such contract between Licensee and a Third Party is not assignable to Exelixis or its designee (whether by such contract’s terms or because such contract does not relate specifically to the Products) but is otherwise reasonably necessary for Exelixis to continue the Development and/or Commercialization of the Compound and Products in the Licensee Territory, but or if Licensee is performing such work for the Compound and Product itself (and thus there is no longer than contract to assign), then Licensee shall reasonably cooperate with Exelixis to negotiate for the Transition Periodcontinuation of such services for Exelixis from such entity, or Licensee shall continue to perform such work for Exelixis, as applicable, for a reasonable period (not to exceed [ * ]) after termination at Exelixis’ cost until Exelixis establishes an alternate, validated source of such services.
Appears in 1 contract
Samples: Collaboration and License Agreement (Exelixis, Inc.)
Transition Assistance. Impax agrees Collaborator shall, for a reasonable period of time, provide such assistance, at no cost to reasonably cooperate with Durect and its designee(s) Affymax, to facilitate a smoothtransfer and/or transition to Affymax all other technology or know-how, orderly and prompt transition of the Development and Commercialization of Product to Durect and/or its designee(s) during the notice period (if terminated pursuant to the first sentence of Section 10.2) and a [* * *] period after the effective date of termination, which may be extended for up to another [* * *] upon Durect’s written request (collectively, the “Transition Period”), provided that (i) the Parties shall use reasonable efforts to complete such transition prior to the expiration of the initial [* * *] period without such extension, and (ii) if Durect requests for such extension, [* * *]. Upon request by Durect within [* * *] after the effectiveness of termination, Impax shall transfer to Durect some or all quantities of Product in its or its Affiliates’ Control; provided, howeverthen-existing commercial arrangements, that Durect shall reimburse Impax for its actual costs to manufacture or otherwise acquire the quantities so provided to Durect. If any Product was manufactured by any Third Party for Impaxis, or Impax had contracts with vendors which contracts are specific to Product and are, reasonably necessary or useful for Durect Affymax to take over responsibility for Product commence or continue Developing, conducting Finished Manufacturing of or Commercializing Products in the Licensed Territory, then Impax shall to the extent possible and requested in writing by DurectCollaborator is then performing or having performed such activities, assign all including without limitation transferring, upon request of the relevant Affymax, any agreements or arrangements with Third-Party contracts suppliers or vendors to Durectsupply or sell Products in the Licensed Territory, to the extent practicable. If any such contract between Collaborator and a Third Party for the supply of Bulk Hematide or Finished Product for the Licensed Territory is not assignable to Affymax, then Collaborator shall reasonably cooperate with Affymax to arrange to continue to obtain such supply from such entity, and Collaborator shall supply such Bulk Hematide or Finished Product, as applicable, to Affymax, at a cost that equals [*] of Collaborator's cost (calculated in any casea manner consistent with the definition of Affymax's Manufacturing Cost) for a reasonable period. In addition, Impax agrees to cooperate with Durect Confidential treatment has been sought for portions of this Agreement. The copy filed herewith omits the information subject to the confidential treatment request. Omissions are designated as * * *. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission. to facilitate uninterrupted supply of Product. If Impax extent that Collaborator or its Affiliate manufactured any Product at is then manufacturing Bulk Hematide and/or Finished Products for the time of terminationLicensed Territory, then Impax (or its Affiliate) Collaborator shall continue to provide manufacture, and shall supply to Affymax, at a cost that equals [*] of Collaborator's cost (calculated in a manner consistent with the definition of Affymax's Manufacturing Cost), such Bulk Hematide and/or Finished [*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED. 76 Products for Affymax's use in the Licensed Territory for a reasonable period in order to permit Affymax to establish sufficient manufacturing of such capacity for Bulk Hematide and/or Finished Product for Durectthe Licensed Territory, at in addition to that which it had in place for its fully-burdened manufacturing cost therefor, from the effectiveness of such termination until such time as Durect is able, using Commercially Reasonable Efforts, to secure an acceptable alternative commercial manufacturing source from which sufficient quantities of Product may be procured and legally sold use in the Affymax Territory, but . Such period shall be no longer more than twelve (12) months unless otherwise agreed by the Transition PeriodParties.
Appears in 1 contract
Transition Assistance. Impax agrees Licensee shall use Commercially Reasonable Efforts to reasonably cooperate with Durect and its designee(s) to facilitate a smooth, seek an orderly and prompt transition of the Development and Commercialization of Product the Compound and Products to Durect and/or Exelixis or its designee(s) during the notice period (if terminated pursuant to the first sentence of designee. Except for termination by Licensee under Section 10.2) and a [* * *] period after 15.2, Exelixis may, in its sole discretion, postpone the effective date of termination, which may be extended any termination for a period of up to another [[ * * *] upon Durect’s written request (collectively, the “Transition Period”), provided that (i) the Parties shall use reasonable efforts to complete such transition prior to the expiration of the initial [* * *] period without such extension, and (ii) if Durect requests for such extension, [* * *]. Upon request Except in the event of termination by Durect within [Licensee under Section 15.2(a) for material breach by Exelixis, Licensee shall, at no cost to Exelixis, provide reasonable consultation and assistance for a period of no more than [ * * *] after the effectiveness of termination, Impax shall transfer to Durect some or all quantities of Product in its or its Affiliates’ Control; provided, however, that Durect shall reimburse Impax for its actual costs to manufacture or otherwise acquire the quantities so provided to Durect. If any Product was manufactured by any Third Party for Impax, or Impax had contracts with vendors which contracts are specific to Product and necessary or useful for Durect to take over responsibility for Product in the Territory, then Impax shall to the extent possible and requested in writing by Durect, assign all of the relevant Third-Party contracts to Durect, termination (and in any casecase not to exceed a total of [ * ] of working time including the assistance provided under Section 15.4(b)) for the purpose of transferring or transitioning to Exelixis all Licensee Know-How not [ * ] = Certain confidential information contained in this document, Impax agrees to cooperate with Durect Confidential treatment marked by brackets, has been sought for portions of this Agreement. The copy filed herewith omits the information subject to the confidential treatment request. Omissions are designated as * * *. A complete version of this exhibit has been omitted and filed separately with the Securities and Exchange CommissionCommission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. to facilitate uninterrupted supply of Product. If Impax or its Affiliate manufactured any Product at the time of termination, then Impax (or its Affiliate) shall continue to provide for manufacturing of such Product for Durectalready in Exelixis’ possession and, at its fullyExelixis’ request, all then-burdened manufacturing cost therefor, from existing commercial arrangements relating to the effectiveness of such termination until such time as Durect Products that Licensee is able, using Commercially Reasonable Efforts, to secure an acceptable alternative commercial manufacturing source from which sufficient quantities transfer or transition to Exelixis or its designee, in each case, to the extent reasonably necessary or for Exelixis to continue the Development and/or Commercialization of Product may be procured the Compound and legally sold Products in the Licensee Territory. If any such contract between Licensee and a Third Party is not assignable to Exelixis or its designee (whether by such contract’s terms or because such contract does not relate specifically to the Products) but is otherwise reasonably necessary for Exelixis to continue the Development and/or Commercialization of the Compound and Products in the Licensee Territory, but or if Licensee is performing such work for the Compound and Product itself (and thus there is no longer than contract to assign), then Licensee shall reasonably cooperate with Exelixis to negotiate for the Transition Period.continuation of such services for Exelixis from such entity, or Licensee shall continue to perform such work for Exelixis, as applicable, for a reasonable period (not to exceed [ * ]) after termination at Exelixis’ cost until Exelixis establishes an alternate, validated source of such services. (g)
Appears in 1 contract
Samples: Collaboration and License Agreement
Transition Assistance. Impax agrees Collaborator shall, for a reasonable period of time, provide such assistance, at no cost to reasonably cooperate with Durect and its designee(s) Affymax, to facilitate a smoothtransfer and/or transition to Affymax all other technology or know-how, orderly and prompt transition of the Development and Commercialization of Product to Durect and/or its designee(s) during the notice period (if terminated pursuant to the first sentence of Section 10.2) and a [* * *] period after the effective date of termination, which may be extended for up to another [* * *] upon Durect’s written request (collectively, the “Transition Period”), provided that (i) the Parties shall use reasonable efforts to complete such transition prior to the expiration of the initial [* * *] period without such extension, and (ii) if Durect requests for such extension, [* * *]. Upon request by Durect within [* * *] after the effectiveness of termination, Impax shall transfer to Durect some or all quantities of Product in its or its Affiliates’ Control; provided, howeverthen-existing commercial arrangements, that Durect shall reimburse Impax for its actual costs to manufacture or otherwise acquire the quantities so provided to Durect. If any Product was manufactured by any Third Party for Impaxis, or Impax had contracts with vendors which contracts are specific to Product and are, reasonably necessary or useful for Durect Affymax to take over responsibility for Product commence or continue Developing, conducting Finished Manufacturing of or Commercializing Products in the Licensed Territory, then Impax shall to the extent possible and requested in writing by DurectCollaborator is then performing or having performed such activities, assign all including without limitation transferring, upon request of the relevant Affymax, any agreements or arrangements with Third-Party contracts suppliers or vendors to Durectsupply or sell Products in the Licensed Territory, to the extent practicable. If any such contract between Collaborator and a Third Party for the supply of Bulk Hematide or Finished Product for the Licensed Territory is not assignable to Affymax, then Collaborator shall reasonably cooperate with Affymax to arrange to continue to obtain such supply from such entity, and Collaborator shall supply such Bulk Hematide or Finished Product, as applicable, to Affymax, at a cost that equals [ * ] of Collaborator’s cost (calculated in any casea manner consistent with the definition of Affymax’s Manufacturing Cost) for a reasonable period. [ * ] = Certain confidential information contained in this document, Impax agrees to cooperate with Durect Confidential treatment marked by brackets, has been sought for portions of this Agreement. The copy filed herewith omits the information subject to the confidential treatment request. Omissions are designated as * * *. A complete version of this exhibit has been omitted and filed separately with the Securities and Exchange CommissionCommission pursuant to Rule 406 of the Securities Act of 1933, as amended. In addition, to facilitate uninterrupted supply of Product. If Impax the extent that Collaborator or its Affiliate manufactured any Product at is then manufacturing Bulk Hematide and/or Finished Products for the time of terminationLicensed Territory, then Impax (or its Affiliate) Collaborator shall continue to provide manufacture, and shall supply to Affymax, at a cost that equals [ * ] of Collaborator’s costs (calculated in a manner consistent with the definition of Affymax’s Manufacturing Cost), such Bulk Hematide and/or Finished Products for Affymax’s use in the Licensed Territory for a reasonable period in order to permit Affymax to establish sufficient manufacturing of such capacity for Bulk Hematide and/or Finished Product for Durectthe Licensed Territory, at in addition to that which it had in place for its fully-burdened manufacturing cost therefor, from the effectiveness of such termination until such time as Durect is able, using Commercially Reasonable Efforts, to secure an acceptable alternative commercial manufacturing source from which sufficient quantities of Product may be procured and legally sold use in the Affymax Territory, but . Such period shall be no longer more than twelve (12) months unless otherwise agreed by the Transition PeriodParties.
Appears in 1 contract
Transition Assistance. Impax Astellas agrees to reasonably cooperate with Durect Maxygen and its designee(s) to facilitate a smooth, orderly and prompt transition of the Development Alliance including any ongoing Preclinical Development, Development, Manufacturing and Commercialization of Product Compounds and Products to Durect and/or Maxygen or its designee(s) ), during this Agreement Wind-Down Period. Without limiting the notice period (if terminated pursuant foregoing, Astellas shall promptly provide Maxygen copies of customer lists, customer data and other customer information for the Products, which Maxygen shall have the right to use and disclose solely for the first sentence purpose of Section 10.2) and a [* * *] period after commercializing Products being Commercialized under the Alliance as of the effective date of termination, which may be extended for up to another [* * *] upon Durect’s written request (collectively, the “Transition Period”), provided that (i) the Parties shall use reasonable efforts to complete such transition prior to the expiration of the initial [* * *] period without such extension, termination during this Agreement Wind-Down Period and (ii) if Durect requests for such extension, [* * *]thereafter. Upon request by Durect within [* * *] after the effectiveness of terminationMaxygen, Impax Astellas shall transfer to Durect Maxygen some or all quantities of Product Products in its or its Affiliates’ Controlpossession (as requested by Maxygen) to the extent not committed to Third Parties, within [****] days after the end of this Agreement Wind-Down Period; provided, however, that Durect Maxygen shall reimburse Impax Astellas for its actual [****] percent ([****]%) of the [****] costs that Astellas actually incurred to manufacture or otherwise acquire the quantities so provided to DurectMaxygen. If any Product was manufactured by any Third Party for ImpaxAstellas, or Impax Astellas had * Certain information on this page has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. contracts with vendors which contracts relate solely to Products and are specific to Product and necessary or useful for Durect Maxygen to take over responsibility for Product the Products in the Territory, then Impax Astellas shall to the extent possible and requested in writing by DurectMaxygen, assign all of the relevant such Third-Party contracts to DurectMaxygen, and in any case, Impax Astellas agrees to reasonably cooperate with Durect Confidential treatment has been sought for portions of this Agreement. The copy filed herewith omits the information subject to the confidential treatment request. Omissions are designated as * * *. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission. Maxygen to facilitate uninterrupted supply of ProductProducts. If Impax Astellas or its Affiliate manufactured any Product at the time of termination, then Impax Astellas (or its Affiliate) shall continue to provide for manufacturing of such Product for DurectMaxygen, at its fully-burdened manufacturing [****] percent ([****]%) of the [****] cost therefor, from the effectiveness date of notice of such termination until such time as Durect Maxygen is able, using Commercially Reasonable Effortsdiligent efforts to do so but in any event no longer than the expiration of the Agreement Wind-Down Period, to secure an acceptable alternative commercial manufacturing source from which sufficient quantities of Product may be procured and legally sold in the Territory, but no longer than the Transition Period.
Appears in 1 contract
Samples: Development and Commercialization Agreement (Maxygen Inc)
Transition Assistance. Impax agrees Licensee shall use Commercially Reasonable Efforts to reasonably cooperate with Durect and its designee(s) to facilitate a smooth, seek an orderly and prompt transition of the Development and Commercialization of Product the Compound and Products to Durect and/or Exelixis or its designee(s) during the notice period (if terminated pursuant to the first sentence of designee. Except for termination by Licensee under Section 10.2) and a [* * *] period after 15.2, Exelixis may, in its sole discretion, postpone the effective date of termination, which may be extended any termination for a period of up to another [[ * * *] upon Durect’s written request (collectively, the “Transition Period”), provided that (i) the Parties shall use reasonable efforts to complete such transition prior to the expiration of the initial [* * *] period without such extension, and (ii) if Durect requests for such extension, [* * *]. Upon request Except in the event of termination by Durect within [Licensee under Section 15.2(a) for material breach by Exelixis, Licensee shall, at no cost to Exelixis, provide reasonable consultation and assistance for a period of no more than [ * * *] after the effectiveness of termination, Impax shall transfer to Durect some or all quantities of Product in its or its Affiliates’ Control; provided, however, that Durect shall reimburse Impax for its actual costs to manufacture or otherwise acquire the quantities so provided to Durect. If any Product was manufactured by any Third Party for Impax, or Impax had contracts with vendors which contracts are specific to Product and necessary or useful for Durect to take over responsibility for Product in the Territory, then Impax shall to the extent possible and requested in writing by Durect, assign all of the relevant Third-Party contracts to Durect, termination (and in any casecase not to exceed a total of [ * ] of working time including the assistance provided under Section 15.4(b)) for the purpose of transferring or transitioning to Exelixis all Licensee Know-How not already in Exelixis’ possession and, Impax agrees to cooperate with Durect Confidential treatment has been sought for portions of this Agreement. The copy filed herewith omits the information subject at Exelixis’ request, all then-existing commercial arrangements relating to the confidential treatment request. Omissions are designated as * * *. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission. to facilitate uninterrupted supply of Product. If Impax or its Affiliate manufactured any Product at the time of termination, then Impax (or its Affiliate) shall continue to provide for manufacturing of such Product for Durect, at its fully-burdened manufacturing cost therefor, from the effectiveness of such termination until such time as Durect Products that Licensee is able, using Commercially Reasonable Efforts, to secure an acceptable alternative commercial manufacturing source from which sufficient quantities transfer or transition to Exelixis or its designee, in each case, to the extent reasonably necessary or for Exelixis to continue the Development and/or Commercialization of Product may be procured the Compound and legally sold Products in the Licensee Territory. If any such contract between Licensee and a Third Party is not assignable to Exelixis or its designee (whether by such contract’s terms or because such contract does not relate specifically to the Products) but is otherwise reasonably necessary for Exelixis to continue the Development and/or Commercialization of the Compound and Products in the Licensee Territory, but or if Licensee is performing such work for the Compound and Product itself (and thus there is no longer than contract to assign), then Licensee shall reasonably cooperate with Exelixis to negotiate for the Transition Periodcontinuation of such services for Exelixis from such entity, or Licensee shall continue to perform such work for Exelixis, as applicable, for a reasonable period (not to exceed [ * ]) after termination at Exelixis’ cost until Exelixis establishes an alternate, validated source of such services. [ * ] = Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed.
Appears in 1 contract
Samples: Collaboration and License Agreement (Exelixis, Inc.)
Transition Assistance. Impax Oncothyreon agrees to reasonably fully cooperate with Durect Array and its designee(s) to facilitate a smooth, orderly and prompt transition of the Development development and Commercialization commercialization of Product Products to Durect Array and/or its designee(s) during the notice period Commercialization Wind-Down Period. Without limiting the foregoing Oncothyreon shall promptly provide Array manufacturing information (if terminated pursuant including protocols for the production, packaging, testing and other manufacturing activities) relating to the first sentence of Section 10.2) and a [* * *] period after the effective date of terminationProduct in Oncothyreon’s Control, which may be extended in each case Array shall have the right to use and disclose for up any purpose during this Commercialization Wind-Down Period and thereafter solely as reasonably necessary or useful to another [* * *] upon Durect’s written request (collectivelymanufacture, or have manufactured, the “Transition Period”), provided that (i) the Parties shall use reasonable efforts to complete such transition prior to the expiration of the initial [* * *] period without such extension, and (ii) if Durect requests for such extension, [* * *]Product. Upon request by Durect within [* * *] after the effectiveness of terminationArray, Impax Oncothyreon shall transfer to Durect Array some or all quantities of the Product in its or its Affiliates’ Control; providedControl (as requested by Array), howeverwithin thirty (30) days after the end of this Commercialization Wind-Down Period, that Durect and Array shall reimburse Impax for its actual costs to manufacture or otherwise acquire buy such quantities at the quantities so provided to DurectPurchase Price. If any Product was manufactured by any Third Party for ImpaxOncothyreon, or Impax Oncothyreon had contracts with vendors which contracts are specific to Product and necessary or useful for Durect Array to take over responsibility for the Product in the Territory, then Impax Oncothyreon *Confidential Treatment Requested. shall to the extent possible and requested in writing by DurectArray, assign all of the relevant Third-Party contracts to DurectArray, and in any case, Impax Oncothyreon agrees to cooperate with Durect Confidential treatment has been sought for portions of this Agreement. The copy filed herewith omits the information subject Array to the confidential treatment request. Omissions are designated as * * *. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission. to facilitate ensure uninterrupted supply of Productthe Products. If Impax Oncothyreon or its Affiliate manufactured any Product at the time of termination, then Impax Oncothyreon (or its Affiliate) shall continue to provide for manufacturing of such Product for DurectArray, at its fully-burdened manufacturing cost therefor, plus ten percent (10%), from the effectiveness date of notice of such termination until such time as Durect Array is able, using Commercially Reasonable Effortsdiligent efforts to do so but no longer than the expiration of the Commercialization Wind-Down Period, to secure an acceptable alternative commercial manufacturing source from which sufficient quantities of the Product may be procured and legally sold in the Territory, but no longer than the Transition Period.
Appears in 1 contract
Samples: License Agreement (Oncothyreon Inc.)
Transition Assistance. Impax Penwest agrees to reasonably cooperate with Durect Edison and its designee(s) ), at Edison’s cost, to facilitate a smooth, orderly and prompt transition of the Development development and Commercialization commercialization of Product Terminated Compound(s) (or corresponding Product(s)) to Durect Edison and/or its designee(s) during the notice for a period (if terminated pursuant requested by Edison not to the first sentence of Section 10.2) and a exceed [* * **] period after following the effective date of termination, which may be extended for up to another [* * *] upon Durect’s written request such termination of this Agreement (collectively, the “Transition Agreement Wind-Down Period”). Without limiting the foregoing, provided that Penwest shall promptly provide Edison copies of customer lists, customer data and other customer information relating to such Terminated Compound(s) (i) or corresponding Product(s)), which Edison shall have the Parties shall right to use reasonable efforts to complete such transition prior to the expiration of the initial [* * *] period without such extension, and (ii) if Durect requests disclose for such extension, [* * *]any purpose during this Agreement Wind-Down Period and thereafter. Upon request by Durect within [* * *] after the effectiveness of terminationEdison, Impax Penwest shall transfer to Durect Edison some or all quantities of Product Terminated Compound(s) (or corresponding Product(s)) in its or its Affiliates’ Controlpossession (as requested by Edison), within thirty (30) days after the end of this Agreement Wind-Down Period; provided, however, that Durect Edison shall reimburse Impax Penwest for its actual the out-of-pocket costs that Penwest actually incurred to manufacture or otherwise acquire the quantities so provided to DurectEdison. If any Product Terminated Compound (or corresponding Product) was manufactured by any Third Party for ImpaxPenwest, or Impax Penwest had contracts with vendors which contracts are specific to Product and necessary or useful for Durect Edison to take over responsibility for Product the Terminated Compound(s) (or corresponding Product(s)) in the Territory, then Impax Penwest shall to the extent possible and requested in writing by DurectEdison, assign all of the relevant Third-Third Party contracts to DurectEdison, and in any case, Impax Penwest agrees to cooperate with Durect Confidential treatment has been sought for portions of this Agreement. The copy filed herewith omits the information subject Edison to the confidential treatment request. Omissions are designated as * * *. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission. to facilitate ensure uninterrupted supply of Productsuch Terminated Compound(s) (or corresponding Product(s)). If Impax Penwest or its Affiliate manufactured any Product Terminated Compound (or corresponding Product) at the time of termination, then Impax Penwest (or its Affiliate) shall continue to provide for manufacturing of such Product Terminated Compound (or corresponding Product) for DurectEdison, at its fully-burdened manufacturing cost [**] therefor, from the effectiveness date of notice of such termination until such time as Durect Edison is able, using Commercially Reasonable EffortsEfforts to do so but no longer than the expiration of the Agreement Wind-Down Period, to secure an a reasonably acceptable alternative commercial manufacturing source from which sufficient quantities of Product such Terminated Compound (or corresponding Product) may be procured and legally sold in the Territory, but no longer than the Transition Period.
Appears in 1 contract
Samples: Collaboration and License Agreement (Penwest Pharmaceuticals Co)
Transition Assistance. Impax Upon expiration of the Term, termination of the Agreement by Santarus pursuant to Section 13.2, 13.3 or 13.5, or termination of the Agreement by Norgine pursuant to Section 13.2, 13.4.2 or 13.5, Norgine agrees to reasonably cooperate fully cooperate, at its own expense (in the case of termination by Santarus pursuant to Sections 13.2, 13.3 or 13.5 or termination by Norgine pursuant to 13.4.2) or at Santarus’ expense (in the case of termination by *** Certain information on this page has been omitted and filed separately with Durect the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. Norgine pursuant to Sections 13.2 or 13.5), with Santarus and its designee(s) to facilitate a smooth, orderly and prompt transition of the Development development, manufacture and Commercialization commercialization of Product Licensed Products to Durect and/or Santarus or its designee(s) during in the notice period Territory. Without limiting the foregoing, Norgine shall promptly provide Santarus, at Norgine’s expense and to the extent permitted by Applicable Laws (if terminated a) copies of customer lists, customer data and other customer information to the extent it can, pursuant to its contractual obligations to the first sentence relevant Third Parties, and (b) marketing and promotional materials relating to Licensed Products at Norgine’s expense, and (c) any other Licensed Product related information, licenses or permits reasonably requested by Santarus, all of Section 10.2which Santarus shall have the right to use for any purpose related to Licensed Products. Upon request by Santarus, Norgine shall transfer to Santarus some or all quantities of Licensed Products in Norgine’s or its Affiliates’ possession (as requested by Santarus) and a [* * *] period intended for sale in the Territory, within thirty (30) days after the effective date of such termination, which may be extended for up to another [* * *] upon Durect’s written request (collectively, the “Transition Period”), provided that (i) the Parties shall use reasonable efforts to complete such transition prior to the expiration of the initial [* * *] period without such extension, and (ii) if Durect requests for such extension, [* * *]. Upon request by Durect within [* * *] after the effectiveness of termination, Impax shall transfer to Durect some or all quantities of Product in its or its Affiliates’ Control; provided, however, that Durect Santarus shall reimburse Impax Norgine for its actual the out-of-pocket costs that Norgine actually incurred to manufacture or otherwise acquire the quantities so provided to DurectSantarus. If any Licensed Product was manufactured by any Third Party for ImpaxNorgine, or Impax Norgine had contracts with vendors which contracts are specific to Product and necessary or useful for Durect Santarus to take over responsibility for Product the Licensed Products in the Territory, then Impax Norgine shall to the extent possible and requested in writing by DurectSantarus, assign all of the relevant Third-Party contracts to DurectSantarus, and in any case, Impax Norgine agrees to cooperate with Durect Confidential treatment has been sought for portions of this Agreement. The copy filed herewith omits the information subject Santarus to the confidential treatment request. Omissions are designated as * * *. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission. to facilitate ensure uninterrupted supply of ProductLicensed Products. If Impax Norgine or its Affiliate manufactured any Licensed Product at the time of such termination, then Impax Norgine (or its Affiliate) shall continue to provide for manufacturing of such Licensed Product for DurectSantarus, at its fully-burdened a mutually agreed “cost of goods” that would be comparable to pricing typically established by a Third Party contract manufacturing cost therefororganization, from the effectiveness date of written notice of such termination until such time as Durect Santarus is able, using Commercially Reasonable EffortsEfforts to do so but no longer than twenty-four (24) months after the effective date of such termination, to secure an acceptable alternative commercial manufacturing source from which sufficient quantities of Licensed Product may be procured and legally sold in the Territory, but no longer than the Transition Period.
Appears in 1 contract
Samples: License Agreement (Santarus Inc)
Transition Assistance. Impax Oncothyreon agrees to reasonably fully cooperate with Durect Array and its designee(s) to facilitate a smooth, orderly and prompt transition of the Development development and Commercialization commercialization of Product Products to Durect Array and/or its designee(s) during the notice period Commercialization Wind-Down Period. Without limiting the foregoing Oncothyreon shall promptly provide Array manufacturing information (if terminated pursuant including protocols for the production, packaging, testing and other manufacturing activities) relating to the first sentence of Section 10.2) and a [* * *] period after the effective date of terminationProduct in Oncothyreon’s Control, which may be extended in each case Array shall have the right to use and disclose for up any purpose during this Commercialization Wind-Down Period and thereafter solely as reasonably necessary or useful to another [* * *] upon Durect’s written request (collectivelymanufacture, or have manufactured, the “Transition Period”), provided that (i) the Parties shall use reasonable efforts to complete such transition prior to the expiration of the initial [* * *] period without such extension, and (ii) if Durect requests for such extension, [* * *]Product. Upon request by Durect within [* * *] after the effectiveness of terminationArray, Impax Oncothyreon shall transfer to Durect Array some or all quantities of the Product in its or its Affiliates’ Control; providedControl (as requested by Array), howeverwithin thirty (30) days after the end of this Commercialization Wind-Down Period, that Durect and Array shall reimburse Impax for its actual costs to manufacture or otherwise acquire buy such quantities at the quantities so provided to DurectPurchase Price. If any Product was manufactured by any Third Party for ImpaxOncothyreon, or Impax Oncothyreon had contracts with vendors which contracts are specific to Product and necessary or useful for Durect Array to take over responsibility for the Product in the Territory, then Impax Oncothyreon shall to the extent possible and requested in writing by DurectArray, assign all of the relevant Third-Party contracts to DurectArray, and in any case, Impax Oncothyreon agrees to cooperate with Durect Confidential treatment has been sought for portions of this Agreement. The copy filed herewith omits the information subject Array to the confidential treatment request. Omissions are designated as * * *. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission. to facilitate ensure uninterrupted supply of Productthe Products. If Impax Oncothyreon or its Affiliate manufactured any Product at the time of termination, then Impax Oncothyreon (or its Affiliate) shall continue to provide for manufacturing of such Product for DurectArray, at its fully-burdened manufacturing cost therefor, plus ten percent (10%), from the effectiveness date of notice [***] Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended. Confidential treatment has been requested with respect to this information. of such termination until such time as Durect Array is able, using Commercially Reasonable Effortsdiligent efforts to do so but no longer than the expiration of the Commercialization Wind-Down Period, to secure an acceptable alternative commercial manufacturing source from which sufficient quantities of the Product may be procured and legally sold in the Territory, but no longer than the Transition Period.
Appears in 1 contract