Common use of Transition Assistance Clause in Contracts

Transition Assistance. (i) Subject to Sections 10.6(d)-(h) above, to the extent reasonably permissible under the circumstances at the time, and to the extent requested by Xencor in writing within […***…] following termination as provided in the first sentence of this Section 10.6, MorphoSys shall also provide such assistance as may be reasonably necessary to transfer and/or transition over a reasonable period of time to Xencor any MorphoSys Know-How, trademarks, regulatory filings, licenses and other contracts specific to Licensed Antibody(ies) and Licensed Products including clinical trial and manufacturing agreements with respect thereto, and provided that Xencor agrees to assume financial responsibility and all other obligations under each such license or contract (other than the case where MorphoSys has failed to obtain royalty-free rights under the the Post-Sublicensing Patents). Xencor shall be responsible for the reasonable costs and expenses of MorphoSys in providing such assistance, other than FTE-based compensation, but including the expenses and costs of travel food and lodging. (ii) In addition, to the extent that MorphoSys or a MorphoSys Affiliate is then manufacturing itself (respectively) Licensed Products in the MorphoSys Territory and upon Xencor’s request, MorphoSys shall use Commercially Reasonable Efforts to (or cause its Affiliate to) continue to manufacture Licensed Products for Xencor’s use in the MorphoSys Territory until the earlier of (i) two (2) years and if reasonably required by Xencor to fully accomplish the technology and transfer without supply interruption then an additional year (for a total in that case of three (3) years) after the effective date of termination, and (ii) such time as Xencor has validated an alternative manufacturer, and quantities of Licensed Product supplied by such manufacturer may legally be sold in the MorphoSys Territory. Any such Licensed Product shall be supplied to Xencor and Xencor shall reimburse MorphoSys at MorphoSys’ (or its Affiliate’s) fully burdened manufacturing cost, determined in accordance with GAAP.

Appears in 5 contracts

Samples: Collaboration and License Agreement (MorphoSys AG), Collaboration and License Agreement (MorphoSys AG), Collaboration and License Agreement (Xencor Inc)

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Transition Assistance. Subject to the Collaboration Agreement, if and as applicable, in the event of a termination (including expiration) of this Agreement in its entirety for any reason except where the Parties enter into the Exclusive License Agreement, Receptos shall: (i) Subject where permitted by Applicable Law, transfer to Sections 10.6(d)-(h) aboveAbbVie all of its right, to the extent reasonably permissible under the circumstances at the timetitle, and interest in all Regulatory Documentation assigned to the extent requested by Xencor in writing within […***…] following termination as provided in the first sentence of this AbbVie pursuant to Section 10.6, MorphoSys shall also provide such assistance as may be reasonably necessary to transfer and/or transition over a reasonable period of time to Xencor any MorphoSys Know-How, trademarks, regulatory filings, licenses and other contracts specific to Licensed Antibody(ies) and Licensed Products including clinical trial and manufacturing agreements with respect thereto, and provided that Xencor agrees to assume financial responsibility and all other obligations under each such license or contract (other than the case where MorphoSys has failed to obtain royalty-free rights under the the Post-Sublicensing Patents10.6(ii). Xencor shall be responsible for the reasonable costs and expenses of MorphoSys in providing such assistance, other than FTE-based compensation, but including the expenses and costs of travel food and lodging.; (ii) In additionnotify the applicable Regulatory Authorities and take any other action reasonably necessary to effect the transfer set forth in clause (i) above; (iii) unless expressly prohibited by any Regulatory Authority, to the extent that MorphoSys or a MorphoSys Affiliate is then manufacturing itself (respectively) Licensed Products in the MorphoSys Territory and upon Xencorat AbbVie’s written request, MorphoSys transfer control to AbbVie of all clinical studies being conducted by Receptos as of the effective date of termination and continue to conduct such clinical studies for up to *** months to enable such transfer to be completed without interruption of any such clinical study; provided that (A) AbbVie shall use Commercially Reasonable Efforts not have any obligation to continue any clinical study unless required by Applicable Law, and (B) with respect to each clinical study for which such transfer is expressly prohibited by the applicable Regulatory Authority, if any, Receptos shall continue to conduct such clinical study to completion; (iv) at AbbVie’s written request, assign (or cause its Affiliate toAffiliates to assign) continue to manufacture AbbVie any or all agreements with any Third Party with respect to the conduct of pre-clinical development activities or clinical studies for any Licensed Products for Xencor’s use in the MorphoSys Territory until the earlier of (i) two (2) years and if reasonably required by Xencor to fully accomplish the technology and transfer without supply interruption then an additional year (for a total in that case of three (3) years) after the effective date of terminationCompound, including agreements with contract research organizations, clinical sites, and investigators, unless, with respect to any such agreement, such agreement expressly prohibits such assignment, in which case Receptos shall cooperate with AbbVie in reasonable respects to secure the consent of the applicable Third Party to such assignment; and (iiv) Receptos shall duly execute and deliver, or cause to be duly executed and delivered, such time as Xencor has validated an alternative manufacturerinstruments and shall do and cause to be done such acts and things, including the filing of such assignments, agreements, documents, and quantities of Licensed Product supplied by such manufacturer instruments, as may legally be sold necessary under, or as AbbVie may reasonably request in connection with, or to carry out more effectively the MorphoSys Territory. Any such Licensed Product shall be supplied purpose of, or to Xencor better assure and Xencor shall reimburse MorphoSys at MorphoSys’ (or confirm unto AbbVie its Affiliate’s) fully burdened manufacturing costrights under, determined in accordance with GAAPthis Section 10.7 and Section 10.6.

Appears in 3 contracts

Samples: Development License and Option Agreement (Receptos, Inc.), Development License and Option Agreement (Receptos, Inc.), Development License and Option Agreement (Receptos, Inc.)

Transition Assistance. (i) Subject to Sections 10.6(d)-(h) aboveFor any licensed subject matter described in this Section 10.5 for which Xxxxxxx has exercised its Option and a definitive license agreement has CONFIDENTIAL - Xxxxxxx Biotech Inc. & Poseida Therapeutics Inc. License Agreement – August 3, to 2015 been executed between the extent reasonably permissible under Parties, Poseida shall provide the circumstances at the timefollowing transitional assistance, and to the extent requested by Xencor in writing within […***…] following termination as provided in the first sentence of this Section 10.6unless specifically set forth below: i. […***…], MorphoSys Poseida shall also provide such assistance as may be reasonably necessary promptly return to transfer and/or transition over a reasonable period of time to Xencor any MorphoSys Xxxxxxx all Know-How, trademarksdata, regulatory filings, licenses materials and other contracts Confidential Information made available to Poseida by Xxxxxxx under this Agreement. ii. […***…], Poseida shall promptly provide Xxxxxxx with a copy of each Poseida In-License, and other license agreements, collaboration agreement and/or vendor agreement then effective between Poseida (or its Affiliates) and a Third Party uniquely specific to Licensed Antibody(iesany Centyrin CAR Molecule(s) and/or Centyrin Therapeutic Molecule(s) covered by the Poseida CAR Molecule Technology and/or Poseida Therapeutic Molecule Technology that is the subject of such license, and the Development and Commercialization thereof. Upon Xxxxxxx’x request, Poseida shall assign or sublicense, and shall ensure that its Affiliates assign or sublicense, to Xxxxxxx, or terminate, any such agreement(s) (as determined by Xxxxxxx in its sole discretion) and Licensed Products including clinical trial and manufacturing agreements shall permit Xxxxxxx access through any communication portal so established with respect thereto, and provided that Xencor agrees such Third Party under any agreement so assigned or sublicensed to assume financial responsibility and all other obligations under each such license or contract (other than the case where MorphoSys has failed to obtain royalty-free rights under the the Post-Sublicensing Patents). Xencor shall be responsible for the reasonable costs and expenses of MorphoSys in providing such assistance, other than FTE-based compensation, but including the expenses and costs of travel food and lodgingXxxxxxx. iii. Poseida shall, at Xxxxxxx’x request […***…], transfer to Xxxxxxx (iiincluding when available, in electronic format) In additionall Poseida Know-How that is included within the Poseida CAR Molecule Technology and/or Poseida Therapeutic Molecule Technology that is the subject of such license, including without limitation: study protocols, study results, analytical methodologies, CMC information (including bulk and final product manufacturing processes, batch records, vendor information and validation documentation), expert opinions, analyses, in each case to the extent such materials are uniquely specific to any such Centyrin CAR Molecule(s) and/or Centyrin Therapeutic Molecule(s) covered by the Poseida CAR Molecule Technology and/or Poseida Therapeutic Molecule Technology that MorphoSys or a MorphoSys Affiliate is the subject of such license, and shall provide Xxxxxxx reasonable technical assistance in connection therewith. iv. At Xxxxxxx’x request […***…], Poseida shall transfer to Xxxxxxx any and all existing inventory of Centyrin CAR Molecule(s) and/or Centyrin Therapeutic Molecule(s) covered by the Poseida CAR Molecule Technology and/or Poseida Therapeutic Molecule Technology that is the subject of such license (including all research materials, final product, bulk drug substance, intermediates, work-in-process, formulation materials, reference standards, drug product clinical reserve samples, packaged retention samples, cell lines, and the like) then manufacturing itself (respectively) Licensed Products in the MorphoSys Territory and upon Xencor’s requestpossession of Poseida, MorphoSys shall use Commercially Reasonable Efforts to (its Affiliates or cause its Affiliate to) continue to manufacture Licensed Products for Xencor’s use in the MorphoSys Territory until the earlier of (i) two (2) years and if reasonably required by Xencor to fully accomplish the technology and transfer without supply interruption then an additional year (for a total in that case of three (3) years) after the effective date of terminationSublicensees, and (ii) such time as Xencor has validated an alternative manufacturer, and quantities of Licensed Product supplied by such manufacturer may legally be sold in the MorphoSys Territory. Any such Licensed Product shall be supplied continue or have continued any ongoing stability studies pertaining to Xencor and Xencor shall reimburse MorphoSys at MorphoSys’ (or its Affiliate’s) fully burdened manufacturing cost, determined in accordance with GAAPany materials so transferred.

Appears in 3 contracts

Samples: License Agreement (Poseida Therapeutics, Inc.), License Agreement (Poseida Therapeutics, Inc.), License Agreement (Poseida Therapeutics, Inc.)

Transition Assistance. (i) Subject to Sections 10.6(d)-(h) above, to the extent reasonably permissible under the circumstances at the time, and to the extent requested by Xencor in writing within […***…] following termination as provided in the first sentence of this Section 10.6, MorphoSys shall also provide such assistance as may be reasonably necessary to transfer and/or transition over a reasonable period of time to Xencor any MorphoSys Know-How, trademarks, regulatory filings, licenses and other contracts specific to Licensed Antibody(ies) and Licensed Products including clinical trial and manufacturing agreements with respect thereto, and provided that Xencor agrees to assume financial responsibility and all other obligations under each such license or contract (other than the case where MorphoSys has failed to obtain royalty-free rights under the the Post-Sublicensing Patents). Xencor shall be responsible for the reasonable costs and expenses of MorphoSys in providing such assistance, other than FTE-based compensation, but including the expenses and costs of travel food and lodging. (ii) In addition, to the extent that MorphoSys or a MorphoSys Affiliate is then manufacturing itself (respectively) Licensed Products in the MorphoSys Territory and upon Xencor’s request, MorphoSys Collaborator shall use Commercially Reasonable Efforts to seek an orderly transition of the Development and Commercialization of the Compound and Products to Exelixis or its 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 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 Products that Collaborator is able, using Commercially Reasonable Efforts, to 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 the Compound and 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 cause its Affiliate tobecause 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, or if Collaborator is performing such work for the Compound and Product itself (and thus there is no contract to assign), then Collaborator shall reasonably cooperate with Exelixis to negotiate for the continuation of such services for Exelixis from such entity, or Collaborator shall continue to manufacture Licensed Products perform such work for Xencor’s use in the MorphoSys Territory until the earlier of (i) two (2) years and if reasonably required by Xencor to fully accomplish the technology and transfer without supply interruption then an additional year (Exelixis, as applicable, for a total in that case of three reasonable period (3) yearsnot to exceed [ * ]) after the effective date termination at Exelixis’ cost until Exelixis establishes an alternate, validated source of termination, and (ii) such time as Xencor has validated an alternative manufacturer, and quantities of Licensed Product supplied by such manufacturer may legally be sold in the MorphoSys Territory. Any such Licensed Product shall be supplied to Xencor and Xencor shall reimburse MorphoSys at MorphoSys’ (or its Affiliate’s) fully burdened manufacturing cost, determined in accordance with GAAPservices.

Appears in 3 contracts

Samples: Collaboration and License Agreement (Exelixis, Inc.), Collaboration and License Agreement (Exelixis, Inc.), Collaboration and License Agreement (Exelixis, Inc.)

Transition Assistance. Oncothyreon agrees to fully cooperate with Array and its designee(s) to facilitate a smooth, orderly and prompt transition of the development and commercialization of Products to Array and/or its designee(s) during the Commercialization Wind-Down Period. Without limiting the foregoing Oncothyreon shall promptly provide Array manufacturing information (iincluding protocols for the production, packaging, testing and other manufacturing activities) Subject relating to Sections 10.6(d)-(hthe Product in Oncothyreon’s Control, which in each case Array shall have the right to use and disclose for any purpose during this Commercialization Wind-Down Period and thereafter solely as reasonably necessary or useful to manufacture, or have manufactured, the Product. Upon request by Array, Oncothyreon shall transfer to Array some or all quantities of the Product in its or its Affiliates’ Control (as requested by Array), within thirty (30) abovedays after the end of this Commercialization Wind-Down Period, and Array shall buy such quantities at the Purchase Price. If any Product was manufactured by any Third Party for Oncothyreon, or Oncothyreon had contracts with vendors which contracts are necessary or useful for Array to take over responsibility for the Product in the Territory, then Oncothyreon shall to the extent reasonably permissible under possible and requested in writing by Array, assign all of the circumstances relevant Third-Party contracts to Array, and in any case, Oncothyreon agrees to cooperate with Array to ensure uninterrupted supply of the Products. If Oncothyreon or its Affiliate manufactured any Product at the time, and to the extent requested by Xencor in writing within […***…] following termination as provided in the first sentence of this Section 10.6, MorphoSys shall also provide such assistance as may be reasonably necessary to transfer and/or transition over a reasonable period of time to Xencor any MorphoSys Know-How, trademarks, regulatory filings, licenses and other contracts specific to Licensed Antibody(ies) and Licensed Products including clinical trial and manufacturing agreements with respect thereto, and provided that Xencor agrees to assume financial responsibility and all other obligations under each such license or contract (other than the case where MorphoSys has failed to obtain royalty-free rights under the the Post-Sublicensing Patents). Xencor shall be responsible for the reasonable costs and expenses of MorphoSys in providing such assistance, other than FTE-based compensation, but including the expenses and costs of travel food and lodging. (ii) In addition, to the extent that MorphoSys or a MorphoSys Affiliate is then manufacturing itself (respectively) Licensed Products in the MorphoSys Territory and upon Xencor’s request, MorphoSys shall use Commercially Reasonable Efforts to (or cause its Affiliate to) continue to manufacture Licensed Products for Xencor’s use in the MorphoSys Territory until the earlier of (i) two (2) years and if reasonably required by Xencor to fully accomplish the technology and transfer without supply interruption then an additional year (for a total in that case of three (3) years) after the effective date of termination, and (ii) such time as Xencor has validated an alternative manufacturer, and quantities of Licensed Product supplied by such manufacturer may legally be sold in the MorphoSys Territory. Any such Licensed Product shall be supplied to Xencor and Xencor shall reimburse MorphoSys at MorphoSys’ then Oncothyreon (or its Affiliate’s) fully shall continue to provide for manufacturing of such Product for Array, at its fully-burdened manufacturing costcost therefor, determined plus ten percent (10%), from the date of notice of such termination until such time as Array is able, using diligent 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 accordance with GAAPthe Territory.

Appears in 3 contracts

Samples: License Agreement (Seattle Genetics Inc /Wa), License Agreement (Oncothyreon Inc.), License Agreement (Array Biopharma Inc)

Transition Assistance. With regard to Products in countries for which the licenses to Sanofi are terminating, Sanofi shall provide the following transitional assistance, with costs allocated as set forth below: (i) Subject Each Party shall comply with Section 11.6 with regard to Sections 10.6(d)-(heach Party’s Confidential Information. (ii) aboveTo the extent Sanofi has the right to do so, Sanofi shall promptly provide MyoKardia with a redacted copy of each license agreement, collaboration agreement and/or vendor agreement then effective between Sanofi (or its Affiliates) and a Third Party that specifically relates to any Product, or the Development, Manufacture and Commercialization thereof, and, upon MyoKardia’s request, to the extent reasonably permissible under Sanofi has the circumstances at the timeright to do so, Sanofi shall assign or sublicense, and shall ensure that its Affiliates assign or sublicense, to MyoKardia any such agreement(s). (iii) Sanofi shall, at MyoKardia’s request, provide reasonable technical assistance and transfer copies of (including when available, in electronic format) all Sanofi Licensed Know-How relating to any Products to MyoKardia or its designee, including without limitation: study protocols, study results, analytical methodologies, bulk and final product manufacturing processes, batch records, vendor information, validation documentation, regulatory documentation, patent information, transfer of sponsorship and ownership of compound identifiers and/or generic names used, or designated for use, by Sanofi with respect to any Products, expert opinions, analyses, manufacturing data, right to publications (including data to be published, manuscript in preparation and pending publications), in each case to the extent requested by Xencor such materials are within the scope of the licenses to MyoKardia set forth in writing within […***…] following termination as provided Section 12.3(b). From and after such time, all such Know-How so licensed and solely relating to the Products shall be deemed Confidential Information of both MyoKardia and Sanofi. (iv) At the end of the sell-off period set forth in Section 12.3(c), Sanofi shall transfer to MyoKardia any and all inventory of Products (including all research materials, final product, bulk drug substance, intermediates, work-in-process, formulation materials, reference standards, drug product clinical reserve samples, packaged retention samples, and the like) then in the first sentence possession of this Section 10.6Sanofi, MorphoSys shall also provide such assistance as may be reasonably necessary its Affiliates or Sublicensees, and continue or have continued any ongoing stability studies pertaining to transfer and/or transition over any materials so transferred to MyoKardia for a reasonable period of time until MyoKardia can assume responsibility for such activities. Notwithstanding the allocation of costs described below, all such inventory shall be purchased by MyoKardia at a price equal to Xencor the Manufacturing Costs therefor. * Confidential Information, indicated by [***], has been omitted from this filing and filed separately with the Securities and Exchange Commission (v) If at the time of such termination, MyoKardia or its Affiliates are not Manufacturing a particular Product, then, at MyoKardia’s request, Sanofi shall: (A) continue to Manufacture and supply MyoKardia with such Product at the Manufacturing Costs for such Product plus [***] percent ([***]%) for a period of [***] after such termination; and (B) if it has the right to do so, assign or transfer to MyoKardia any MorphoSys Know-How, trademarks, regulatory filings, licenses Manufacturing agreement between Sanofi and other contracts specific to Licensed Antibody(ies) and Licensed Products including clinical trial and manufacturing agreements a Third Party contract manufacturer with respect thereto, and provided to such Product; and/or (C) conduct a technology transfer analogous to that Xencor agrees to assume financial responsibility and all other obligations under each such license or contract (other than the case where MorphoSys has failed to obtain royalty-free rights under the the Post-Sublicensing Patents). Xencor shall be responsible for the reasonable costs and expenses of MorphoSys described in providing such assistance, other than FTE-based compensation, but including the expenses and costs of travel food and lodgingSection 7.3. (iivi) In additionIf at the time of such termination, Sanofi or its Affiliates are conducting any clinical trials of a Product, then, at MyoKardia’s election on a trial-by-trial basis: (A) Sanofi shall fully cooperate, and shall ensure that its Affiliates fully cooperate, with MyoKardia to transfer the extent that MorphoSys or a MorphoSys Affiliate is then manufacturing itself (respectively) Licensed Products in the MorphoSys Territory conduct of all such clinical trials to MyoKardia and upon Xencor’s request, MorphoSys MyoKardia shall use Commercially Reasonable Efforts to (or cause its Affiliate to) continue to manufacture Licensed Products assume any and all liability for Xencor’s use in the MorphoSys Territory until the earlier of (i) two (2) years and if reasonably required by Xencor to fully accomplish the technology and transfer without supply interruption then an additional year (for a total in that case of three (3) years) such clinical trials after the effective date of such termination (except to the extent Sanofi has an obligation of indemnification under Article 14), provided that each Party shall continue to bear its share of Registration Program Costs to the extent specified Section 12.3(f). (vii) If at the time of such termination, Sanofi or its Affiliates are Commercializing a particular Product, then, at MyoKardia’s request, the Parties shall negotiate in good faith a transition services agreement to cover detailing and promotion of such Product (in the same manner and no more extensive than the then-current detailing and promotional efforts of Sanofi) by Sanofi or its Affiliate or contract sales force pursuant to a transition plan agreed by the Parties for a period not to exceed (A) six (6) months, in the case of a termination by Sanofi under Section 12.2(a) and (iiB) such time as Xencor has validated three (3) months, for all other terminations, in each case ((A) and (B)) until MyoKardia establishes its own sales force or a relationship with a contract sales organization or other applicable vendor (whether its own or through assignment of an alternative manufacturer, and quantities of Licensed Product supplied by such manufacturer may legally be sold in the MorphoSys Territory. Any such Licensed Product shall be supplied to Xencor and Xencor shall reimburse MorphoSys at MorphoSys’ (or its Affiliate’s) fully burdened manufacturing cost, determined agreement with Sanofi in accordance with GAAPSection 12.3(g)(ii)), and MyoKardia shall pay Sanofi a commercially reasonable amount to conduct such activities (which amount would include a commercially reasonable per-detail rate). (viii) Sanofi shall conduct a technology transfer to MyoKardia in accordance with Section 7.3(c) (as applied to any terminated Products). (ix) In addition to the foregoing, Sanofi shall use reasonable efforts with respect to those activities for which it is responsible hereunder to cooperate with MyoKardia to achieve an orderly transition of the Development, Manufacturing and Commercialization of Products from Sanofi or its applicable Affiliate to MyoKardia. (x) Except as provided in Section 12.3(g)(iv), Sanofi’s activities under this Section 12.3(g) shall be conducted [***] to MyoKardia, except in the case Sanofi terminates this agreement under Section 12.2(b). * Confidential Information, indicated by [***], has been omitted from this filing and filed separately with the Securities and Exchange Commission

Appears in 2 contracts

Samples: License and Collaboration Agreement (MyoKardia Inc), License and Collaboration Agreement (MyoKardia Inc)

Transition Assistance. (i1) Subject if this Agreement is terminated with respect to Sections 10.6(d)-(h) above, to the extent reasonably permissible under the circumstances at the time, and to the extent requested by Xencor all Targets in writing within […***…] following termination as provided all countries in the first sentence of this Section 10.6Territory, MorphoSys Servier shall also provide such assistance as may be reasonably necessary promptly return to transfer and/or transition over a reasonable period of time to Xencor any MorphoSys Miragen, all Know-How, trademarksdata, regulatory filings, licenses materials and other contracts specific Confidential Information transferred by Miragen to Servier under this Agreement. (2) if at the time of such termination, Servier is supplying the Licensed Antibody(ies) Oligos or Licensed Products for the terminated Target to Miragen or for Servier’s own use in the terminated countries, Servier shall assist Miragen in establishing an alternative supplier for such Licensed Oligos and Licensed Products including clinical trial and manufacturing agreements shall supply such Licensed Oligos and Licensed Products to Miragen, at the same financial conditions under which Servier was supplying Miragen prior to termination or at Servier’s cost [*] if Servier was supplying itself prior to termination, until Miragen has established an alternative supplier, provided such obligation shall under no circumstances lead to Servier having to supply Miragen with respect theretoLicensed Products or Licensed Oligos (i) for use in human in the US or (ii) if termination was for reasons of safety. [*] = Certain confidential information contained in this document, marked by brackets, is filed with the Securities and provided that Xencor agrees Exchange Commission pursuant to assume financial responsibility and all other obligations under each such license or contract (other than Rule 406 of the case where MorphoSys has failed to obtain royalty-free rights under the the Post-Sublicensing Patents). Xencor shall be responsible for the reasonable costs and expenses Securities Act of MorphoSys in providing such assistance1933, other than FTE-based compensation, but including the expenses and costs of travel food and lodgingas amended. (ii3) In additionupon Miragen’s request, Servier shall, at Servier’s choice, assign or sublicense to Miragen any license agreements (where Servier or its Affiliates is the licensor or where Servier or its Affiliates is granted a license to intellectual property that is not Servier Therapeutic IP) with respect to the extent that MorphoSys or a MorphoSys Affiliate is then manufacturing itself (respectively) Licensed Products in the MorphoSys Field in the Territory and upon Xencorany agreements or arrangement with Third Party vendors that are specific or necessary to the development, manufacture and commercialization of the Licensed Products in the Field in the Territory, provided that (i) such provision shall only apply in respect of terminated countries and terminated Targets, (ii) Miragen shall reimburse to Servier all reasonable costs borne by Servier to satisfy such obligation, which costs shall be subject to Miragen’s prior review and approval (not to be unreasonably withheld) and (iii) Servier is entitled to do so without breaching any obligation it may have with a Third Party. (4) Servier shall, at Miragen’s request, MorphoSys shall use Commercially Reasonable Efforts provide reasonable technical assistance and transfer all Servier Know-How relating to (the Licensed Oligos or cause its Affiliate to) continue to manufacture Licensed Products for Xencor’s use the terminated Target to Miragen or its designee; (5) if at the time of such termination, Servier is conducting any clinical trials for the Licensed Product for the terminated Target in the MorphoSys Territory until terminated countries, then, at Miragen’s election on a trial-by-trial basis: (A) Servier shall fully cooperate with Miragen to transfer the earlier conduct of (i) two (2) years all such clinical trials to Miragen and if reasonably required by Xencor to fully accomplish the technology Miragen shall assume any and transfer without supply interruption then an additional year (all liability and costs for a total in that case of three (3) years) such clinical trials after the effective date of such termination, and (ii) such time as Xencor has validated an alternative manufacturer, and quantities of Licensed Product supplied by such manufacturer may legally be sold provided that in the MorphoSys Territoryevent this Agreement is terminated by Miragen under Section 12.2(c)(ii) or 12.2(d), Servier shall continue to bear all costs and expenses incurred in connection with such clinical trial until the earlier of the completion of such trial or [*] after the effective date of such termination; or (B) Servier shall, at its expense, orderly wind down the conduct of any such clinical trial which is not assumed by Miragen under clause (A). Any In each case, if Servier is the contracting party for any Third Party agreement relating to such Licensed Product clinical trials, Servier shall reimburse Miragen for any non-cancellable and non-refundable out-of-pocket costs Miragen may incur under such Third Party agreement in connection with the conduct or wind down of all such clinical trials if such costs were incurred prior to the effective date of such termination; and (6) if this Agreement is terminated by Servier under Section 12.2(b) or by Miragen under Section 12.2(c)(ii), Servier shall be supplied responsible for any non-cancelable and non-refundable out-of-pocket costs already committed by Miragen pursuant to Xencor the Research Plan or the Development Plan. Miragen shall do its reasonable efforts to limit as much as possible its commitments in terms of non-cancelable and Xencor shall reimburse MorphoSys at MorphoSys’ (or its Affiliate’s) fully burdened manufacturing cost, determined in accordance non-refundable out-of-pocket costs while entering into agreements with GAAPThird Parties.

Appears in 2 contracts

Samples: License and Collaboration Agreement (Signal Genetics, Inc.), License and Collaboration Agreement (Signal Genetics, Inc.)

Transition Assistance. In the event of a termination of this Agreement for any reason, Licensee shall, at AbbVie’s written request, perform any or all of the following and agree upon a transition plan with AbbVie that shall address the timing and logistics of the following: 10.6.1. Licensee shall, where permitted by Applicable Law, transfer to AbbVie all of its right, title, and interest in all Regulatory Documentation assigned to AbbVie pursuant to Section 10.5.2; 10.6.2. Licensee shall notify the applicable Regulatory Authorities and take any other action reasonably necessary to effect the transfer set forth in Section 10.6.1 above; 10.6.3. Licensee shall, unless expressly prohibited by any Regulatory Authority, transfer control to AbbVie of all clinical studies being conducted by Licensee as of the effective date of termination and continue to conduct such clinical studies, at Licensee’s cost, for up to [***] to enable such transfer to be completed without interruption of any such clinical study; provided that (ia) Subject AbbVie shall not have any obligation to Sections 10.6(d)-(hcontinue any clinical study unless required by Applicable Law, and (b) abovewith respect to each clinical study for which such transfer is expressly prohibited by the applicable Regulatory Authority, if any, Licensee shall continue to conduct such clinical study to completion, at Licensee’s cost; 10.6.4. Licensee shall assign (or cause its Affiliates to assign) to AbbVie any or all agreements with any Third Party with respect to the conduct of pre-clinical development activities or clinical studies for the Reversion Products, including agreements with contract research organizations, clinical sites, and investigators, unless, with respect to any such agreement, such agreement expressly prohibits such assignment, in which case Licensee shall cooperate with AbbVie in reasonable respects to secure the consent of the applicable Third Party to such assignment; 10.6.5. Licensee shall supply to AbbVie all of AbbVie’s requirements of the Reversion Products until the later of (a) such time as AbbVie has established an alternate, validated source of supply for the Reversion Products, and AbbVie is receiving supply from such alternative source and (b) the date that is [***] following the effective date of the termination of this Agreement. The cost to AbbVie for such supply shall be at Licensee’s actual cost to Manufacture such Reversion Products plus [***]; 10.6.6. at Licensee’s expense, to the extent reasonably permissible under the circumstances at the timeapplicable, and to the extent requested by Xencor in writing Licensee shall within [***] following termination as provided of AbbVie’s written request, (a) diligently conduct a Know-How transfer to AbbVie, including all relevant Know-How and data, included in the first sentence license set forth in Section 10.5.2, and (b) provide other reasonable assistance necessary to permit AbbVie to Develop, Manufacture or Commercialize such Licensed Products; 10.6.7. Licensee shall duly execute and deliver, or cause to be duly executed and delivered, such instruments and shall do and cause to be done such acts and things, including the filing of such assignments, agreements, documents, and instruments, as may be necessary under, or as AbbVie may reasonably request in connection with, or to carry out more effectively the purpose of, or to better assure and confirm unto AbbVie its rights under, Section 10.5 and this Section 10.6, MorphoSys shall also provide such assistance as may be reasonably necessary to transfer and/or transition over a reasonable period of time to Xencor any MorphoSys Know-How, trademarks, regulatory filings, licenses and other contracts specific to Licensed Antibody(ies) and Licensed Products including clinical trial and manufacturing agreements with respect thereto, and provided that Xencor agrees to assume financial responsibility and all other obligations under each such license or contract (other than the case where MorphoSys has failed to obtain royalty-free rights under the the Post-Sublicensing Patents). Xencor shall be responsible for the reasonable costs and expenses of MorphoSys in providing such assistance, other than FTE-based compensation, but including the expenses and costs of travel food and lodging. (ii) In addition, to the extent that MorphoSys or a MorphoSys Affiliate is then manufacturing itself (respectively) Licensed Products in the MorphoSys Territory and upon Xencor’s request, MorphoSys shall use Commercially Reasonable Efforts to (or cause its Affiliate to) continue to manufacture Licensed Products for Xencor’s use in the MorphoSys Territory until the earlier of (i) two (2) years and if reasonably required by Xencor to fully accomplish the technology and transfer without supply interruption then an additional year (for a total in that case of three (3) years) after the effective date of termination, and (ii) such time as Xencor has validated an alternative manufacturer, and quantities of Licensed Product supplied by such manufacturer may legally be sold in the MorphoSys Territory. Any such Licensed Product shall be supplied to Xencor and Xencor shall reimburse MorphoSys at MorphoSys’ (or its Affiliate’s) fully burdened manufacturing cost, determined in accordance with GAAP.

Appears in 2 contracts

Samples: License Agreement (Gemini Therapeutics, Inc. /DE), License Agreement (Gemini Therapeutics, Inc. /DE)

Transition Assistance. (ia) Subject Seller shall, and shall cause its Subsidiaries to, use commercially reasonable efforts to Sections 10.6(d)-(hassist in the transition of the Business, records, customers and operations (including IT) aboveat Closing to Buyer as reasonably requested by Buyer between the date hereof and the Closing in furtherance of the consummation of the transactions contemplated by this Agreement (such assistance, the “Transition Assistance”). Prior to Closing, Buyer and Seller shall each bear their own expenses incurred in respect of such Transition Assistance; provided that Buyer shall promptly reimburse Seller for the costs of third party consultants, contractors and advisors in connection with the Transition Assistance provided during such period. (b) From and after Closing, Seller shall use commercially reasonable efforts to assist the Buyer in connection with the Buyer’s preparation and audit of any financial statements of the Business or the Buyer that the Buyer determines, in its reasonable discretion, are required or advisable under applicable laws (including applicable securities laws and regulations) in connection with the Buyer’s acquisition of the Business (the “Financial Statement Assistance”). As part of the Financial Statement Assistance (and without limiting the generality of the foregoing), the Seller shall use commercially reasonable efforts to (a) cause its accountants to be available to the Buyer (upon reasonable prior notice and at mutually agreeable times and at no cost to the Buyer) to respond to questions and information requests, and participate in interview sessions, to the extent reasonably permissible under necessary in connection with the circumstances at the timeBuyer’s preparation and audit of any such financial statements and (b) cause its manager, officers and other agents to the extent execute and deliver any and all management representation letters and other certificates as may reasonably be requested by Xencor the Buyer or its accountants in writing within […***…] connection with the preparation and/or audit of any such financial statements. Buyer will pay or, if paid, promptly reimburse the Seller, following termination as provided invoice from the Seller, for any reasonable out-of-pocket and overhead costs incurred by such Seller in complying with the first sentence provisions of this Section 10.6, MorphoSys shall also provide such assistance 5.14(b). (c) As soon as may be reasonably necessary to transfer and/or transition over a reasonable period of practicable and regularly from time to Xencor any MorphoSys Know-Howtime during the ninety (90) day period following the date hereof, trademarksBuyer and Seller shall confer and negotiate in good faith to reach agreement on a definitive form of the Services Schedule (as defined in the Transition Services Agreement), regulatory filings, licenses and other contracts specific to Licensed Antibody(ieswhich shall provide additional detail in the description of the Services (as defined in the Transition Services Agreement) and Licensed Products including clinical trial and manufacturing agreements with respect the calculation of the fees relating thereto, and provided in accordance with the Transition Services Agreement attached to Exhibit E to this Agreement; provided, however, that Xencor agrees any in the event Seller is required to assume financial responsibility and all other obligations under each such license or contract (other than the case where MorphoSys has failed pay any licensing fees in connection with Seller providing any IT related services to obtain royalty-free rights Buyer under the the Post-Sublicensing Patents). Xencor Transition Services Agreement, Buyer agrees that Buyer shall be responsible for reimbursing Seller for all such amounts. The definitive Transition Services Agreement entered into at the reasonable costs Closing shall incorporate the Services Schedule as mutually agreed by Buyer and expenses of MorphoSys in providing such assistance, other than FTE-based compensation, but including the expenses and costs of travel food and lodging. (ii) In addition, to the extent that MorphoSys or a MorphoSys Affiliate is then manufacturing itself (respectively) Licensed Products in the MorphoSys Territory and upon Xencor’s request, MorphoSys shall use Commercially Reasonable Efforts to (or cause its Affiliate to) continue to manufacture Licensed Products for Xencor’s use in the MorphoSys Territory until the earlier of (i) two (2) years and if reasonably required by Xencor to fully accomplish the technology and transfer without supply interruption then an additional year (for a total in that case of three (3) years) after the effective date of termination, and (ii) such time as Xencor has validated an alternative manufacturer, and quantities of Licensed Product supplied by such manufacturer may legally be sold in the MorphoSys Territory. Any such Licensed Product shall be supplied to Xencor and Xencor shall reimburse MorphoSys at MorphoSys’ (or its Affiliate’s) fully burdened manufacturing cost, determined Seller in accordance with GAAPthis Section 5.15(c).

Appears in 1 contract

Samples: Stock and Asset Purchase Agreement (Terex Corp)

Transition Assistance. (ia) Subject Seller shall, and shall cause its Subsidiaries to, use commercially reasonable efforts to Sections 10.6(d)-(hassist in the transition of the Business, records, customers and operations (including IT) aboveat Closing to Buyer as reasonably requested by Buyer between the date hereof and the Closing in furtherance of the consummation of the transactions contemplated by this Agreement (such assistance, the “Transition Assistance”). Prior to Closing, Buyer and Seller shall each bear their own expenses incurred in respect of such Transition Assistance; provided that Buyer shall promptly reimburse Seller for the costs of third party consultants, contractors and advisors in connection with the Transition Assistance provided during such period. (b) From and after Closing, Seller shall use commercially reasonable efforts to assist the Buyer in connection with the Buyer’s preparation and audit of any financial statements of the Business or the Buyer that the Buyer determines, in its reasonable discretion, are required or advisable under applicable laws (including applicable securities laws and regulations) in connection with the Buyer’s acquisition of the Business (the “Financial Statement Assistance”). As part of the Financial Statement Assistance (and without limiting the generality of the foregoing), the Seller shall use commercially reasonable efforts to (a) cause its accountants to be available to the Buyer (upon reasonable prior notice and at mutually agreeable times and at no cost to the Buyer) to respond to questions and information requests, and participate in interview sessions, to the extent reasonably permissible under necessary in connection with the circumstances at the timeBuyer’s preparation and audit of any such financial statements and (b) cause its manager, officers and other agents to the extent execute and deliver any and all management representation letters and other certificates as may reasonably be requested by Xencor the Buyer or its accountants in writing within […***…] connection with the preparation and/or audit of any such financial statements. Buyer will pay or, if paid, promptly reimburse the Seller, following termination as provided invoice from the Seller, for any reasonable out- of-pocket and overhead costs incurred by such Seller in complying with the first sentence provisions of this Section 10.6, MorphoSys shall also provide such assistance 5.15(b). (c) As soon as may be reasonably necessary to transfer and/or transition over a reasonable period of practicable and regularly from time to Xencor any MorphoSys Know-Howtime during the ninety (90) day period following the date hereof, trademarksBuyer and Seller shall confer and negotiate in good faith to reach agreement on a definitive form of the Services Schedule (as defined in the Transition Services Agreement), regulatory filings, licenses and other contracts specific to Licensed Antibody(ieswhich shall provide additional detail in the description of the Services (as defined in the Transition Services Agreement) and Licensed Products including clinical trial and manufacturing agreements with respect the calculation of the fees relating thereto, and provided in accordance with the Transition Services Agreement attached to Exhibit E to this Agreement; provided, however, that Xencor agrees any in the event Seller is required to assume financial responsibility and all other obligations under each such license or contract (other than the case where MorphoSys has failed pay any licensing fees in connection with Seller providing any IT related services to obtain royalty-free rights Buyer under the the Post-Sublicensing Patents). Xencor Transition Services Agreement, Xxxxx agrees that Buyer shall be responsible for reimbursing Seller for all such amounts. The definitive Transition Services Agreement entered into at the reasonable costs Closing shall incorporate the Services Schedule as mutually agreed by Xxxxx and expenses of MorphoSys in providing such assistance, other than FTE-based compensation, but including the expenses and costs of travel food and lodging. (ii) In addition, to the extent that MorphoSys or a MorphoSys Affiliate is then manufacturing itself (respectively) Licensed Products in the MorphoSys Territory and upon Xencor’s request, MorphoSys shall use Commercially Reasonable Efforts to (or cause its Affiliate to) continue to manufacture Licensed Products for Xencor’s use in the MorphoSys Territory until the earlier of (i) two (2) years and if reasonably required by Xencor to fully accomplish the technology and transfer without supply interruption then an additional year (for a total in that case of three (3) years) after the effective date of termination, and (ii) such time as Xencor has validated an alternative manufacturer, and quantities of Licensed Product supplied by such manufacturer may legally be sold in the MorphoSys Territory. Any such Licensed Product shall be supplied to Xencor and Xencor shall reimburse MorphoSys at MorphoSys’ (or its Affiliate’s) fully burdened manufacturing cost, determined Seller in accordance with GAAPthis Section 5.15(c).

Appears in 1 contract

Samples: Stock and Asset Purchase Agreement

Transition Assistance. G&W shall provide reasonable consultation and assistance (i“Transition Assistance”) Subject for a period of no more than one hundred eighty (180) days after the effective date of termination for the purpose of transferring or transitioning to Sections 10.6(d)-(hLiquidia the Licensed Products for which such termination is effective, including necessary intellectual Confidential treatment has been requested with respect to portions of this agreement as indicated by “[***]” and such confidential portions have been deleted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. property, documents and materials thereof. In addition, G&W will provide Liquidia with, at Liquidia’s request, all then-existing Third Party agreements relating solely to such Terminated Compound(s) aboveand Terminated Product(s) in the Terminated Territory that G&W is able, using commercially reasonable efforts to, assign to Liquidia, in each case, to the extent reasonably permissible under necessary for Liquidia to continue researching, developing, manufacturing, or commercializing such Terminated Compound(s) and Terminated Product(s) in the circumstances at the timeTerminated Territory, and provided, however, that G&W shall be required to assign any such agreement solely to the extent requested assignment is permitted by Xencor such agreement, and G&W is not required to pay any consideration or commence dispute resolution in writing within […***…] following termination as provided in the first sentence order to effect an assignment of this Section 10.6, MorphoSys shall also provide any such assistance as may be agreement to Liquidia. If any such agreement between G&W and a Third Party is not assignable to Liquidia (whether by such agreement’s terms or because such agreement does not relate solely to such Terminated Compound(s) or Terminated Product(s)) but is otherwise reasonably necessary for Liquidia to transfer and/or transition over continue researching, developing, manufacturing, or commercializing such Terminated Compound(s) and Terminated Product(s), then G&W shall reasonably cooperate with Liquidia to negotiate for the continuation of services from such entity; provided, however, that G&W shall not be required to pay any consideration or commence dispute resolution in connection therewith. If G&W manufactures the Terminated Product(s) itself (and thus there is no agreement to assign), then G&W shall supply such bulk Terminated Compound or finished Terminated Product, as applicable, to Liquidia, at cost of goods (to be defined consistently with the corresponding Supply Agreement) plus 30% for a reasonable period of time (not to Xencor any MorphoSys Know-How, trademarks, regulatory filings, licenses and other contracts specific to Licensed Antibody(iesexceed six (6) and Licensed Products including clinical trial and manufacturing agreements with respect thereto, and provided that Xencor agrees to assume financial responsibility and all other obligations under each such license or contract (other than the case where MorphoSys has failed to obtain royalty-free rights under the the Post-Sublicensing Patents). Xencor shall be responsible for the reasonable costs and expenses of MorphoSys in providing such assistance, other than FTE-based compensation, but including the expenses and costs of travel food and lodging. (ii) In addition, to the extent that MorphoSys or a MorphoSys Affiliate is then manufacturing itself (respectively) Licensed Products in the MorphoSys Territory and upon Xencor’s request, MorphoSys shall use Commercially Reasonable Efforts to (or cause its Affiliate to) continue to manufacture Licensed Products for Xencor’s use in the MorphoSys Territory until the earlier of (i) two (2) years and if reasonably required by Xencor to fully accomplish the technology and transfer without supply interruption then an additional year (for a total in that case of three (3) years) months after the effective date of termination), and (ii) such time as Xencor has validated an alternative manufacturer, and quantities of Licensed Product supplied pursuant to a supply agreement to be negotiated in good faith by such manufacturer may legally be sold in the MorphoSys TerritoryParties. Any such Licensed Product shall be supplied to Xencor and Xencor Liquidia shall reimburse MorphoSys at MorphoSys’ G&W or any of G&W’s Third Party manufacturers for all reasonable, documented internal and out-of-pocket costs incurred pursuant to this subsection (or its Affiliate’s) fully burdened manufacturing cost, determined in accordance with GAAPf).

Appears in 1 contract

Samples: Development and License Agreement (Liquidia Technologies Inc)

Transition Assistance. Astellas shall provide the following transitional assistance, at its own cost unless specifically set forth below. (i) Subject If this Agreement is terminated in its entirety, Astellas shall promptly return to Sections 10.6(d)-(h) above, to the extent reasonably permissible under the circumstances at the time, and to the extent requested by Xencor in writing within […***…] following termination as provided in the first sentence of this Section 10.6, MorphoSys shall also provide such assistance as may be reasonably necessary to transfer and/or transition over a reasonable period of time to Xencor any MorphoSys Cytokinetics all Know-How, trademarksdata, regulatory filings, licenses materials and other contracts specific Confidential Information made available to Licensed Antibody(ies) and Licensed Products including clinical trial and manufacturing agreements with respect thereto, and provided that Xencor agrees to assume financial responsibility and all other obligations Astellas by Cytokinetics under each such license or contract (other than the case where MorphoSys has failed to obtain royalty-free rights under the the Post-Sublicensing Patents). Xencor shall be responsible for the reasonable costs and expenses of MorphoSys in providing such assistance, other than FTE-based compensation, but including the expenses and costs of travel food and lodgingthis Agreement. (ii) In additionUpon request by Cytokinetics after termination of this Agreement, Astellas shall promptly provide Cytokinetics with a copy of each license agreement, collaboration agreement and/or vendor agreement then effective between Astellas (or its Affiliates) and a Third Party with respect to the Product, or the Development, Manufacture and Commercialization thereof, [*]. Upon Cytokinetics’ request, Astellas shall use its Diligent Efforts to assign or sublicense, and shall ensure that its Affiliates assign or sublicense, to Cytokinetics any such agreement(s) and shall permit Cytokinetics access through any communication portal so established with such Third Party under any agreement so assigned to Cytokinetics. (iii) Astellas shall, at Cytokinetics’ request after termination of this Agreement, transfer (including when available, in electronic format) all Astellas Know-How and Collaboration Know-How relating to the Product to Cytokinetics or its designee, including without limitation: study protocols, study results, analytical methodologies, CMC Information (including bulk and final product manufacturing processes, batch records, vendor information and validation documentation), expert opinions, analyses, in each case to the extent that MorphoSys such materials pertain to [*], and shall provide Cytokinetics reasonable technical assistance in connection therewith. From and after such time, all such Know-How shall be deemed Confidential Information of Cytokinetics. (iv) Astellas shall transfer to Cytokinetics or a MorphoSys Affiliate is its designee any and all inventory of Tirasemtiv and Product [*] (including all final product, bulk drug substance, work-in-process, formulation materials, reference standards, drug product clinical reserve samples, packaged retention samples, and the like) then manufacturing itself (respectively) Licensed Products in the MorphoSys Territory and upon Xencor’s possession of Astellas, its Affiliates or sublicensees at Astellas’ Manufacturing Costs. Astellas shall continue or have continued any ongoing stability studies pertaining to any materials so transferred if such studies will take less than [*] to complete. The Parties shall agree on the procedures by which to transfer any longer stability studies to Cytokinetics or its designee in a manner that minimizes the disruption of such studies. (v) If at the time of such termination, Cytokinetics or its Affiliates are not Manufacturing the Product [*], then, at Cytokinetics’ request, MorphoSys shall use Commercially Reasonable Efforts to Astellas shall: (or cause its Affiliate toA) continue to manufacture Licensed Products for Xencor’s use in Manufacture and supply Cytokinetics with the MorphoSys Territory until the earlier of (i) two (2) years and if reasonably required by Xencor to fully accomplish the technology and transfer without supply interruption then an additional year (Product [*] for a total period of [*] year after such termination; (B) assign or transfer to Cytokinetics any Manufacturing agreement between Astellas and a Third Party contract manufacturer with respect to the Product [*]; and/or (C) transfer to Cytokinetics (or its designee) all Know-How and materials to enable Cytokinetics or such designee to assume the Manufacture and supply of such the Product [*] and shall provide reasonable technical assistance in connection therewith; [*] = 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. (vi) If at the time of such termination, Astellas or its Affiliates are conducting any clinical trials for the Product [*], then, at Cytokinetics’ election on a trial-by-trial basis: (A) Astellas shall fully cooperate, and shall ensure that case its Affiliates fully cooperate, with Cytokinetics to transfer the conduct of three (3) years) all such clinical trials to Cytokinetics. [*] the conduct of such clinical trials after the effective date of such termination (except to the extent [*]); or (B) Astellas shall, [*], orderly wind-down the conduct of any such clinical trial which is not assumed by Cytokinetics under clause (A). In each case [*] in connection with the conduct or wind-down of all such clinical trials as of the effective date of such termination. (vii) In addition to the foregoing, Astellas shall use its Diligent Efforts with respect to those activities for which it is responsible to ensure orderly transition and uninterrupted Development, Manufacturing, Commercialization and Medical Affairs Activities of the Product [*] by Cytokinetics and to enable Cytokinetics to enter into an agreement with a Third Party to continue these activities with minimal disruption and delay. (iiviii) such time as Xencor has validated an alternative manufacturerAstellas shall transfer to Cytokinetics all rights to publications relating to the Product [*] (including data to be published, manuscript in preparation and quantities of Licensed Product supplied by such manufacturer may legally be sold in the MorphoSys Territory. Any such Licensed Product shall be supplied to Xencor and Xencor shall reimburse MorphoSys at MorphoSys’ (or its Affiliate’s) fully burdened manufacturing cost, determined in accordance with GAAPpending publications).

Appears in 1 contract

Samples: License and Collaboration Agreement (Cytokinetics Inc)

Transition Assistance. (iAstellas agrees to reasonably cooperate with Maxygen and its designee(s) Subject to Sections 10.6(d)-(h) abovefacilitate a smooth, orderly and prompt transition of the Alliance including any ongoing Preclinical Development, Development, Manufacturing and Commercialization of Compounds and Products to Maxygen or its designee(s), during this Agreement Wind-Down Period. Without limiting the extent reasonably permissible 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 purpose of commercializing Products being Commercialized under the circumstances at the time, and to the extent requested by Xencor in writing within […***…] following termination Alliance as provided in the first sentence of this Section 10.6, MorphoSys shall also provide such assistance as may be reasonably necessary to transfer and/or transition over a reasonable period of time to Xencor any MorphoSys Know-How, trademarks, regulatory filings, licenses and other contracts specific to Licensed Antibody(ies) and Licensed Products including clinical trial and manufacturing agreements with respect thereto, and provided that Xencor agrees to assume financial responsibility and all other obligations under each such license or contract (other than the case where MorphoSys has failed to obtain royalty-free rights under the the Post-Sublicensing Patents). Xencor shall be responsible for the reasonable costs and expenses of MorphoSys in providing such assistance, other than FTE-based compensation, but including the expenses and costs of travel food and lodging. (ii) In addition, to the extent that MorphoSys or a MorphoSys Affiliate is then manufacturing itself (respectively) Licensed Products in the MorphoSys Territory and upon Xencor’s request, MorphoSys shall use Commercially Reasonable Efforts to (or cause its Affiliate to) continue to manufacture Licensed Products for Xencor’s use in the MorphoSys Territory until the earlier of (i) two (2) years and if reasonably required by Xencor to fully accomplish the technology and transfer without supply interruption then an additional year (for a total in that case of three (3) years) after the effective date of termination during this Agreement Wind-Down Period and thereafter. Upon request by Maxygen, Astellas shall transfer to Maxygen some or all quantities of Products in its or its Affiliates’ possession (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 Maxygen shall reimburse Astellas for [****] percent ([****]%) of the [****] costs that Astellas actually incurred to manufacture or otherwise acquire the quantities so provided to Maxygen. If any Product was manufactured by any Third Party for Astellas, or 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 necessary or useful for Maxygen to take over responsibility for the Products in the Territory, then Astellas shall to the extent possible and requested in writing by Maxygen, assign all of such Third-Party contracts to Maxygen, and in any case, Astellas agrees to reasonably cooperate with Maxygen to facilitate uninterrupted supply of Products. If Astellas or its Affiliate manufactured any Product at the time of termination, and (ii) such time as Xencor has validated an alternative manufacturer, and quantities of Licensed Product supplied by such manufacturer may legally be sold in the MorphoSys Territory. Any such Licensed Product shall be supplied to Xencor and Xencor shall reimburse MorphoSys at MorphoSys’ then Astellas (or its Affiliate’s) fully burdened shall continue to provide for manufacturing costof such Product for Maxygen, determined at [****] percent ([****]%) of the [****] cost therefor, from the date of notice of such termination until such time as Maxygen is able, using diligent efforts to do so but in accordance with GAAP.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

Appears in 1 contract

Samples: Co Development and Commercialization Agreement (Maxygen Inc)

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 (i) Subject if terminated pursuant to Sections 10.6(d)-(h) above, to the extent reasonably permissible under the circumstances at the time, and to the extent requested by Xencor in writing within […***…] following termination as provided in the first sentence of this Section 10.6, MorphoSys shall also provide such assistance as may be reasonably necessary to transfer and/or transition over a reasonable period of time to Xencor any MorphoSys Know-How, trademarks, regulatory filings, licenses and other contracts specific to Licensed Antibody(ies10.2) and Licensed Products including clinical trial and manufacturing agreements with respect thereto, and provided that Xencor agrees to assume financial responsibility and all other obligations under each such license or contract (other than the case where MorphoSys has failed to obtain royalty-free rights under the the Post-Sublicensing Patents). Xencor shall be responsible for the reasonable costs and expenses of MorphoSys in providing such assistance, other than FTE-based compensation, but including the expenses and costs of travel food and lodging. (ii) In addition, to the extent that MorphoSys or a MorphoSys Affiliate is then manufacturing itself (respectively) Licensed Products in the MorphoSys Territory and upon Xencor’s request, MorphoSys shall use Commercially Reasonable Efforts to (or cause its Affiliate to) continue to manufacture Licensed Products for Xencor’s use in the MorphoSys Territory until the earlier of (i) two (2) years and if reasonably required by Xencor to fully accomplish the technology and transfer without supply interruption then an additional year (for a total in that case of three (3) years) [* * *] 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 time as Xencor has validated an alternative manufacturerextension, [* * *]. 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 quantities in any case, Impax agrees to cooperate with Durect Confidential treatment has been sought for portions of Licensed 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 supplied by such manufacturer may legally be sold in at the MorphoSys Territory. Any such Licensed Product shall be supplied to Xencor and Xencor shall reimburse MorphoSys at MorphoSys’ time of termination, then Impax (or its Affiliate’s) fully shall continue to provide for manufacturing of such Product for Durect, at its fully-burdened manufacturing costcost therefor, determined 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 accordance with GAAPthe Territory, but no longer than the Transition Period.

Appears in 1 contract

Samples: Asset Transfer and License Agreement

Transition Assistance. Astellas shall provide the following transitional assistance, at its own cost unless specifically set forth below. (i) Subject If this Agreement is terminated in its entirety, Astellas shall promptly return to Sections 10.6(d)-(h) above, to the extent reasonably permissible under the circumstances at the time, and to the extent requested by Xencor in writing within […***…] following termination as provided in the first sentence of this Section 10.6, MorphoSys shall also provide such assistance as may be reasonably necessary to transfer and/or transition over a reasonable period of time to Xencor any MorphoSys Cytokinetics all Know-How, trademarksdata, regulatory filings, licenses materials and other contracts specific Confidential Information made available to Licensed Antibody(ies) and Licensed Products including clinical trial and manufacturing agreements with respect thereto, and provided that Xencor agrees to assume financial responsibility and all other obligations Astellas by Cytokinetics under each such license or contract (other than the case where MorphoSys has failed to obtain royalty-free rights under the the Post-Sublicensing Patents). Xencor shall be responsible for the reasonable costs and expenses of MorphoSys in providing such assistance, other than FTE-based compensation, but including the expenses and costs of travel food and lodgingthis Agreement. (ii) In additionUpon request by Cytokinetics after termination of this Agreement, Astellas shall promptly provide Cytokinetics with a copy of each license agreement, collaboration agreement and/or vendor agreement then effective between Astellas (or its Affiliates) and a Third Party with respect to any [ * ] Product, or the Development, Manufacture and Commercialization thereof. Upon Cytokinetics’ request, Astellas shall use its Diligent Efforts to assign or sublicense, and shall ensure that its Affiliates assign or sublicense, to Cytokinetics any such agreement(s) and shall permit Cytokinetics access through any communication portal so established with such Third Party under any agreement so assigned to Cytokinetics. (iii) Astellas shall, at Cytokinetics’ request after termination of this Agreement, transfer (including when available, in electronic format) all Astellas Know-How and Collaboration Know-How relating to any [ * ] Products to Cytokinetics or its designee, including without limitation: study protocols, study results, analytical methodologies, CMC Information (including bulk and final product manufacturing processes, batch records, vendor information and validation documentation), expert opinions, analyses, in each case to the extent that MorphoSys or a MorphoSys Affiliate such materials pertain to any [ * ] Products, and shall provide Cytokinetics reasonable technical assistance in connection therewith. From and after such time, all such Know-How shall be deemed Confidential Information of Cytokinetics. [ * ] = Certain confidential information contained in this document, marked by brackets, has been omitted because it is then manufacturing itself (respectively) Licensed Products in the MorphoSys Territory and upon Xencor’s request, MorphoSys shall use Commercially Reasonable Efforts to (or cause its Affiliate to) continue to manufacture Licensed Products for Xencor’s use in the MorphoSys Territory until the earlier of both (i) two not material and (2ii) years would likely cause competitive harm if publicly disclosed. (iv) Astellas shall transfer to Cytokinetics or its designee any and all inventory of [ * ] Products (including all research materials, final product, bulk drug substance, intermediates, work-in-process, formulation materials, reference standards, drug product clinical reserve samples, packaged retention samples, and the like) then in the possession of Astellas, its Affiliates or sublicensees at Astellas’ Manufacturing Costs. Astellas shall continue or have continued any ongoing stability studies pertaining to any materials so transferred if reasonably required such studies will take less than [ * ] to complete. The Parties will agree on the procedures by Xencor which to fully accomplish transfer any longer stability studies to Cytokinetics or its designee in a manner that minimizes the technology disruption of such studies. (v) If at the time of such termination, Cytokinetics or its Affiliates are not Manufacturing a [ * ] Product, then, at Cytokinetics’ request, Astellas shall: (A) [ * ] assign or transfer to Cytokinetics any Manufacturing agreement between Astellas and a Third Party contract manufacturer with respect to such [ * ] Product, and/or (B) transfer without to Cytokinetics (or its designee) all Know-How and materials to enable Cytokinetics or such designee to assume the Manufacture and supply interruption then an additional year of such [ * ] Product and shall provide reasonable technical assistance in connection therewith; (vi) If at the time of such termination, Astellas or its Affiliates are conducting any clinical trials for a total in [ * ] Product, then, at Cytokinetics’ election on a trial-by-trial basis: (A) Astellas shall fully cooperate, and shall ensure that case its Affiliates fully cooperate, with Cytokinetics to transfer the conduct of three (3) years) all such clinical trials to Cytokinetics. [ * ] the conduct of such clinical trials after the effective date of such termination (except to the extent [ * ]); or (B) Astellas shall, [ * ], orderly wind-down the conduct of any such clinical trial which is not assumed by Cytokinetics under clause (A). In each case [ * ] in connection with the conduct or wind-down of all such clinical trials as of the effective date of such termination. (vii) In addition to the foregoing, Astellas shall use its Diligent Efforts with respect to those activities for which it is responsible to ensure orderly transition and uninterrupted Development, Manufacturing, Commercialization and Medical Affairs Activities of [ * ] Products by Cytokinetics and to enable Cytokinetics to enter into an agreement with a Third Party to continue these activities with minimal disruption and delay. (iiviii) such time as Xencor has validated an alternative manufacturerAstellas shall transfer to Cytokinetics all rights to publications relating to any [ * ] Products (including data to be published, manuscript in preparation and quantities of Licensed Product supplied by such manufacturer may legally be sold in the MorphoSys Territory. Any such Licensed Product shall be supplied to Xencor and Xencor shall reimburse MorphoSys at MorphoSys’ (or its Affiliate’s) fully burdened manufacturing cost, determined in accordance with GAAPpending publications).

Appears in 1 contract

Samples: License and Collaboration Agreement (Cytokinetics Inc)

Transition Assistance. (iA) Subject Tautomer shall, upon Xxxx’s request, supply the Licensed Product in its then-current form to Sections 10.6(d)-(hSkye at cost (without markup) above, to the extent reasonably permissible under the circumstances at the time, and to the extent requested by Xencor in writing within […***…] following termination as provided in the first sentence of this Section 10.6, MorphoSys shall also provide such assistance as may be reasonably necessary to transfer and/or transition over for a reasonable period of time until Skye establishes an alternative supplier, and in any event for at least twelve (12) months, and reasonably assist Skye in establishing an alternative supplier for such Licensed Products. (B) Upon Skye’s request, Tautomer shall assign or sublicense to Xencor Skye any MorphoSys Know-How, trademarks, regulatory filings, licenses and other contracts specific to Licensed Antibody(ies) and Licensed Products including clinical trial and manufacturing license agreements with respect thereto, and provided that Xencor agrees to assume financial responsibility and all other obligations under each such license or contract (other than the case where MorphoSys has failed to obtain royalty-free rights under the the Post-Sublicensing Patents). Xencor shall be responsible for the reasonable costs and expenses of MorphoSys in providing such assistance, other than FTE-based compensation, but including the expenses and costs of travel food and lodging. (ii) In addition, to the extent that MorphoSys or a MorphoSys Affiliate is then manufacturing itself (respectively) Licensed Products in the MorphoSys Territory and upon Xencorany agreements or arrangement with Third Party vendors pertaining to the Development, Manufacture or Commercialization of Licensed Products in the Territory. (C) Tautomer shall, at Skye’s request, MorphoSys shall use Commercially Reasonable Efforts provide reasonable technical assistance, including assistance with any inquiries and correspondence with Regulatory Authorities relating to (or cause its Affiliate to) continue to manufacture any Licensed Products for Xencor’s use in the MorphoSys Territory until the earlier of (i) two (2) years and if reasonably required by Xencor to fully accomplish the technology and transfer without supply interruption then an additional year (Product, for a total in that case period of three twelve (312) years) months after the effective date of termination, and transfer all Know-How within the Tautomer IP relating to the Licensed Products. (iiD) If at the time of the notice of termination, Tautomer is conducting any clinical trials for a Licensed Product, then, at Skye’s election on a trial-by-trial basis: (A) Tautomer shall fully cooperate with Skye to transfer the conduct of all such time as Xencor has validated an alternative manufacturerclinical trials to Skye, according to a transition plan to be developed by the Parties, and quantities Xxxx shall assume any and all liability for such clinical trials after the effective date of such transition (except to the extent arising from any act or omission by Tautomer, its Affiliates or their respective employees, agents and contractors), provided that Tautomer shall continue to bear all costs and expenses incurred in connection with the conduct of such clinical trials until the completion of such transition; or (B) Tautomer shall, at its expense, orderly wind down the conduct of any such clinical trial that is not assumed by Skye under clause (A). (E) In addition to the foregoing, Tautomer shall use reasonable efforts with respect to those activities for which it is responsible to ensure orderly transition and uninterrupted Development, Manufacturing and Commercialization of Licensed Product supplied Products by such manufacturer may legally be sold in the MorphoSys Territory. Any such Licensed Product shall be supplied Skye and to Xencor enable Xxxx to enter into an agreement with a Third Party to continue these activities with minimal disruption and Xencor shall reimburse MorphoSys at MorphoSys’ (or its Affiliate’s) fully burdened manufacturing cost, determined in accordance with GAAPdelay.

Appears in 1 contract

Samples: Exclusive License Agreement (Skye Bioscience, Inc.)

Transition Assistance. (i) Subject to Sections 10.6(d)-(h) above, to To the extent reasonably permissible under the circumstances at the time, and to the extent requested by Xencor MorphoSys in writing within [***] calendar days following the applicable termination as provided in the first sentence of this Section 10.6notice, MorphoSys COMPANY shall also (and ensure that its Affiliates and Sublicensees) provide such assistance as may be reasonably necessary to transfer and/or transition over a reasonable period of time to MorphoSys, or if so requested by MorphoSys, to Xencor any MorphoSys rights, items and contracts specified under 17.8(b), (d), (e), (f) and (g), including COMPANY Know-How, trademarksProduct Marks, regulatory filingsGlobal Product Marks, licenses Development Data, Regulatory Data, Regulatory Materials, and other Regulatory Approvals, (including contracts with contract research organisations, contract Manufacturing organisations and distributors) specific to Licensed Antibody(ies) and Licensed Antibody or the Products including clinical trial and manufacturing agreements with respect thereto, and provided that Xencor MorphoSys agrees to assume financial responsibility and all other obligations towards Third Parties under each such license any licenses or contract contracts (other than the case where MorphoSys COMPANY has failed to obtain royalty-free rights under the the Post-Sublicensing Patentsthose certain Xencor Patents licensed to MorphoSys under Section 2.4(b). Xencor shall be responsible for the reasonable costs and expenses of MorphoSys in providing such assistance, other than FTE-based compensation, but including the expenses and costs of travel food and lodging). (ii) In addition, to the extent that MorphoSys COMPANY or a MorphoSys COMPANY Affiliate is then manufacturing itself (respectively) Licensed Products in the MorphoSys Territory and upon Xencor’s requestMorphoSys' request in writing within [***] calendar days after the applicable termination notice, MorphoSys COMPANY shall use Commercially Reasonable Efforts to (or cause ensure that its Affiliate toAffiliate) continue to manufacture Licensed Products for MorphoSys' or Xencor’s use in the MorphoSys Territory until the earlier of (i) two (2) [***] years and if reasonably required by Xencor MorphoSys to fully accomplish the technology and transfer without supply interruption then an additional year [***] (for a total in that case of three (3) years[***]) after the effective date of termination, and (ii) such time as Xencor MorphoSys has validated an alternative manufacturermanufacturer (including [***]), and quantities of Licensed Product supplied by such manufacturer may legally be sold in the MorphoSys Territorysold. Any such Licensed Product shall be supplied to Xencor MorphoSys and Xencor MorphoSys shall reimburse MorphoSys [***] COMPANY at MorphoSys’ COMPANY’s (or its Affiliate’s) fully burdened manufacturing cost[***], determined in accordance with GAAP.

Appears in 1 contract

Samples: Collaboration and License Agreement (Incyte Corp)

Transition Assistance. Astellas shall provide the following transitional assistance, at its own cost unless specifically set forth below. (i) Subject If this Agreement is terminated in its entirety, Astellas shall promptly return to Sections 10.6(d)-(h) above, to the extent reasonably permissible under the circumstances at the time, and to the extent requested by Xencor in writing within […***…] following termination as provided in the first sentence of this Section 10.6, MorphoSys shall also provide such assistance as may be reasonably necessary to transfer and/or transition over a reasonable period of time to Xencor any MorphoSys Cytokinetics all Know-How, trademarksdata, regulatory filings, licenses materials and other contracts specific Confidential Information made available to Licensed Antibody(ies) and Licensed Products including clinical trial and manufacturing agreements with respect thereto, and provided that Xencor agrees to assume financial responsibility and all other obligations Astellas by Cytokinetics under each such license or contract (other than the case where MorphoSys has failed to obtain royalty-free rights under the the Post-Sublicensing Patents). Xencor shall be responsible for the reasonable costs and expenses of MorphoSys in providing such assistance, other than FTE-based compensation, but including the expenses and costs of travel food and lodgingthis Agreement. (ii) In additionUpon request by Cytokinetics after termination of this Agreement, Astellas shall promptly provide Cytokinetics with a copy of each license agreement, collaboration agreement and/or vendor agreement then effective between Astellas (or its Affiliates) and a Third Party with respect to any [*] Product, or the Development, Manufacture and Commercialization thereof. Upon Cytokinetics’ request, Astellas shall use its Diligent Efforts to assign or sublicense, and shall ensure that its Affiliates assign or sublicense, to Cytokinetics any such agreement(s) and shall permit Cytokinetics access through any communication portal so established with such Third Party under any agreement so assigned to Cytokinetics. (iii) Astellas shall, at Cytokinetics’ request after termination of this Agreement, transfer (including when available, in electronic format) all Astellas Know-How and Collaboration Know-How relating to any [*] Products to Cytokinetics or its designee, including without limitation: study protocols, study results, analytical methodologies, CMC Information (including bulk and final product manufacturing processes, batch records, vendor information and validation documentation), expert opinions, analyses, in each case to the extent that MorphoSys such materials pertain to any [*] Products, and shall provide Cytokinetics reasonable technical assistance in connection therewith. From and after such time, all such Know-How shall be deemed Confidential Information of Cytokinetics. (iv) Astellas shall transfer to Cytokinetics or a MorphoSys Affiliate is its designee any and all inventory of [*] Products (including all research materials, final product, bulk drug substance, intermediates, work-in-process, formulation materials, reference standards, drug product clinical reserve samples, packaged retention samples, and the like) then manufacturing itself (respectively) Licensed Products in the MorphoSys Territory and upon Xencor’s possession of Astellas, its Affiliates or sublicensees at Astellas’ Manufacturing Costs. Astellas shall continue or have continued any ongoing stability studies pertaining to any materials so transferred if such studies will take less than [*] to complete. The Parties will agree on the procedures by which to transfer any longer stability studies to Cytokinetics or its designee in a manner that minimizes the disruption of such studies. (v) If at the time of such termination, Cytokinetics or its Affiliates are not Manufacturing a particular [*] Product, then, at Cytokinetics’ request, MorphoSys shall use Commercially Reasonable Efforts to Astellas shall: (or cause its Affiliate toA) continue to manufacture Licensed Products for Xencor’s use in the MorphoSys Territory until the earlier of (i) two (2) years Manufacture and if reasonably required by Xencor to fully accomplish the technology and transfer without supply interruption then an additional year (Cytokinetics with such [*] Product at [*] for a total period of [*] after such termination; (B) assign or transfer to Cytokinetics any Manufacturing agreement between Astellas and a Third Party contract manufacturer with respect to such [*] Product; and/or (C) transfer to Cytokinetics (or its designee) all Know-How and materials to enable Cytokinetics or such designee to assume the Manufacture and supply of such [*] Product and shall provide reasonable technical assistance in connection therewith; [ * ] = 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. (vi) If at the time of such termination, Astellas or its Affiliates are conducting any clinical trials for a [*] Product, then, at Cytokinetics’ election on a trial-by-trial basis: (A) Astellas shall fully cooperate, and shall ensure that case its Affiliates fully cooperate, with Cytokinetics to transfer the conduct of three (3) years) all such clinical trials to Cytokinetics. [*] the conduct of such clinical trials after the effective date of such termination (except to the extent [*]); or (B) Astellas shall, [*], orderly wind-down the conduct of any such clinical trial which is not assumed by Cytokinetics under clause (A). In each case [*] in connection with the conduct or wind-down of all such clinical trials as of the effective date of such termination. (vii) In addition to the foregoing, Astellas shall use its Diligent Efforts with respect to those activities for which it is responsible to ensure orderly transition and uninterrupted Development, Manufacturing, Commercialization and Medical Affairs Activities of [*] Products by Cytokinetics and to enable Cytokinetics to enter into an agreement with a Third Party to continue these activities with minimal disruption and delay. (iiviii) such time as Xencor has validated an alternative manufacturerAstellas shall transfer to Cytokinetics all rights to publications relating to any [*] Products (including data to be published, manuscript in preparation and quantities of Licensed Product supplied by such manufacturer may legally be sold in the MorphoSys Territory. Any such Licensed Product shall be supplied to Xencor and Xencor shall reimburse MorphoSys at MorphoSys’ (or its Affiliate’s) fully burdened manufacturing cost, determined in accordance with GAAPpending publications).

Appears in 1 contract

Samples: License and Collaboration Agreement (Cytokinetics Inc)

Transition Assistance. In the event Xxxxxxx exercises its Development Option, DexCom shall cooperate with all reasonable requests of Xxxxxxx for the orderly transfer of DexCom’s development responsibilities to Xxxxxxx. In this regard, DexCom shall deliver to Xxxxxxx all Manufacturing Documentation (inot already in Xxxxxxx’ possession) Subject to Sections 10.6(d)-(h) above, to the extent reasonably permissible under the circumstances at the time, and to the extent requested by Xencor in writing within […***…] following termination as provided in the first sentence of this Section 10.6, MorphoSys shall also provide such assistance as may be reasonably necessary to transfer and/or transition over a reasonable period of time to Xencor any MorphoSys other DexCom Know-How, trademarks, regulatory filings, licenses documents or information then used by DexCom and other contracts specific to Licensed Antibody(ies) necessary for Xxxxxxx’ continued development of the Gen 1 Product and Licensed Products including clinical trial and manufacturing agreements with respect thereto, and provided that Xencor agrees to assume financial responsibility and all other obligations under each such license or contract the Gen 2 Product (other than as the case where MorphoSys has failed may be), including but not limited to obtain royalty-free rights under the the Post-Sublicensing Patents)any documents related to Gen 1 Product and Gen 2 Product designs or specifications. Xencor shall be responsible for the reasonable costs and expenses of MorphoSys in providing such assistance, other than FTE-based compensation, but including the expenses and costs of travel food and lodging. (ii) In addition, to the extent that MorphoSys or a MorphoSys Affiliate is then manufacturing itself (respectively) Licensed Products in the MorphoSys Territory and upon Xencor’s request, MorphoSys shall use DexCom will exert Commercially Reasonable Efforts following the Effective Date to obtain the right (contingent upon Xxxxxxx’ agreement to assume and perform DexCom’s obligations accruing thereafter) to assign and delegate to Xxxxxxx DexCom’s relevant rights and obligations under any agreements (including but not limited to any agreements with contract research organizations and clinical investigators), where such assignment and delegation is in support of such orderly transfer of development responsibilities to Xxxxxxx. DexCom shall promptly inform Xxxxxxx of such agreements and the material terms thereof after the Effective Date (or cause its Affiliate to) continue to manufacture Licensed Products for Xencor’s use in the MorphoSys Territory until the earlier of (i) two (2) years and upon their respective execution if reasonably required by Xencor to fully accomplish the technology and transfer without supply interruption then an additional year (for a total in that case of three (3) years) such execution occurs after the effective date Effective Date) and shall inform Xxxxxxx of terminationany relevant agreement with respect to which DexCom concludes that it cannot, and (ii) despite such time as Xencor has validated an alternative manufacturerCommercially Reasonable Efforts, and quantities of Licensed Product supplied by such manufacturer may legally be sold in the MorphoSys Territory. Any such Licensed Product shall be supplied obtain rights for its assignment to Xencor and Xencor shall reimburse MorphoSys at MorphoSys’ (or its Affiliate’s) fully burdened manufacturing cost, determined Xxxxxxx in accordance with GAAPthis Section 3.5.2. If Xxxxxxx exercises the Development Option pursuant to clause (a) of Section 3.5.1, Xxxxxxx shall bear one-half of DexCom’s reasonable out-of-pocket expense incurred due to DexCom’s activities under this Section 3.5.2, and Xxxxxxx will pay or reimburse DexCom for its half of such expenses within thirty (30) days of receiving DexCom’s invoices therefore (including reasonable supporting documentation) from time to time. If Xxxxxxx exercises the Development Option pursuant to clause (b) of Section 3.5.1, DexCom shall bear all of its costs incurred due to DexCom’s activities under this Section 3.5.2.

Appears in 1 contract

Samples: Collaboration Agreement (Dexcom Inc)

Transition Assistance. (i) Subject to Sections 10.6(d)-(h) aboveDuring the Transition Term, to the extent reasonably permissible under the circumstances at the time, and to the extent requested by Xencor in writing within […***…] following termination as provided in the first sentence of this Section 10.6, MorphoSys shall also provide such assistance as may be reasonably necessary to transfer and/or transition over a reasonable period of time to Xencor any MorphoSys Know-How, trademarks, regulatory filings, licenses and other contracts specific to Licensed Antibody(ies) and Licensed Products including clinical trial and manufacturing agreements with respect thereto, and provided that Xencor agrees to assume financial responsibility and all other obligations under each such license or contract (other than the case where MorphoSys has failed to obtain royalty-free rights under the the Post-Sublicensing Patents). Xencor shall be responsible for the reasonable costs and expenses of MorphoSys in providing such assistance, other than FTE-based compensation, but including the expenses and costs of travel food and lodging. (ii) In addition, to the extent that MorphoSys or a MorphoSys Affiliate is then manufacturing itself (respectively) Licensed Products in the MorphoSys Territory and upon Xencor’s request, MorphoSys Forendo shall use its Commercially Reasonable Efforts to provide assistance to Licensee, at no out-of-pocket cost to Licensee (or cause its Affiliate toexcept as set forth below), to effect the orderly transfer of the Licensed Product and related documentation to Licensee (the “Transition Assistance”). Without limiting the foregoing, such Transition Assistance shall include: (a) continue the transfer by Forendo to manufacture Licensee of the existing IND for the Licensed Product; (b) the transfer to Licensee of mutually agreed quantities of API already available to Forendo at Forendo’s actual cost; (c) all Forendo Know-How related to the Development and Manufacture of the Licensed Products; (d) the identification of all sublicensees, consultants, physicians, and other Third Parties who materially participated in the development of the Licensed Products for Xencor’s use by Forendo; and (e) the translation to English of any documents pertaining to any Forendo Know-How and any documents necessary or useful in connection with the submission for, or maintenance of, any Regulatory Approval in the MorphoSys Territory, including without limitation: • transfer of copies of the results of and data from the pre-clinical and clinical studies conducted prior to and as of the Effective Date relating to any Licensed Product (including all regulatory information, clinical data, pre-clinical data, hard-copy case report forms and reports to the extent they exist); • transfer of copies of any written communications with the FDA and other Regulatory Authorities in the Territory until the earlier of (i) two (2) years and if reasonably required by Xencor to fully accomplish the technology and transfer without supply interruption then an additional year (for a total in that case of three (3) years) after the effective date of terminationany relevant written communications with other Regulatory Authorities, and the minutes of any meetings with the FDA and any such other Regulatory Authority, in each case relating to any Licensed Product; and [***]Confidential Information, indicated by [***], has been omitted by this filing and filed separately with the Securities and Exchange Commission. • transfer of copies of the data and results of any relevant manufacturing activities (ii) including CMC activities incident to the Licensed Product. To the extent any documentation to be transferred as part of the Transition Assistance exists in an electronic format, including scanned versions of a hardcopy, Forendo shall provide to Licensee an electronic copy of such time documentation. For Documentation which exists only as Xencor has validated an alternative manufacturerhardcopy, and quantities Forendo shall provide to Licensee a physical copy of Licensed Product supplied by such manufacturer may legally be sold in the MorphoSys Territory. Any such Licensed Product shall be supplied to Xencor and Xencor shall reimburse MorphoSys at MorphoSys’ (or its Affiliate’s) fully burdened manufacturing cost, determined in accordance with GAAPdocumentation.

Appears in 1 contract

Samples: License Agreement (Apricus Biosciences, Inc.)

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Transition Assistance. In the event of a termination of this Agreement in its entirety for any reason (iexcept Licensor’s material breach in which case the provisions below shall be subject to execution of the Negotiated Exclusive License), Licensee shall: a) Subject where permitted by Applicable Law transfer to Sections 10.6(d)-(hLicensor all of its right, title, and interest in all Regulatory Documentation assigned to Licensor pursuant to Section 10.5.b); b) notify the applicable Regulatory Authorities and take any other action reasonably necessary to effect the transfer set forth in clause (a) above; c) unless expressly prohibited by any Regulatory Authority, at Licensor’s written request, transfer control to Licensor of all clinical studies being conducted by Licensee as of the extent reasonably permissible under the circumstances effective date of termination and continue to conduct such clinical studies, at the timeLicensee’s cost, and for up to the extent requested by Xencor in writing within [***…] following termination as provided in the first sentence of this Section 10.6]months, MorphoSys shall also provide or such assistance as may be reasonably necessary to transfer and/or transition over a reasonable shorter period of time which the parties may reasonably agree is sufficient for purposes of patient safety, to Xencor enable such transfer to be completed without interruption of any MorphoSys Know-Howsuch clinical study; provided that (A) Licensor shall not have any obligation to continue any clinical study unless required by Applicable Law, trademarks, regulatory filings, licenses and other contracts specific to Licensed Antibody(ies(B) and Licensed Products including clinical trial and manufacturing agreements with respect theretoto each clinical study for which such transfer is expressly prohibited by the applicable Regulatory Authority, and provided that Xencor agrees if any, Licensee shall continue to assume financial responsibility and all other obligations under each conduct such license or contract (other than the case where MorphoSys has failed clinical study to obtain royalty-free rights under the the Post-Sublicensing Patents). Xencor shall be responsible for the reasonable costs and expenses of MorphoSys in providing such assistancecompletion, other than FTE-based compensation, but including the expenses and costs of travel food and lodging.at Licensee’s cost; (iid) In addition, to the extent that MorphoSys or a MorphoSys Affiliate is then manufacturing itself (respectively) Licensed Products in the MorphoSys Territory and upon Xencorat Licensor’s written request, MorphoSys shall use Commercially Reasonable Efforts to assign (or cause its Affiliate toAffiliates to assign) continue to manufacture Licensor any or all agreements with any Third Party with respect to the conduct of pre-clinical development activities or clinical studies for the Licensed Products, including agreements with contract research organizations, clinical sites, and investigators, unless, with respect to any such agreement, such agreement expressly prohibits such assignment, in which case Licensee shall cooperate with Licensor in reasonable respects to secure the consent of the applicable Third Party to such assignment; e) at Licensor’s written request, Licensee shall supply to Licensor all of Licensor’s reasonable requirements of the Licensed Compound and Licensed Products for Xencor’s use in the MorphoSys Territory until the earlier of (iA) two such time as Licensor has established an alternate, validated source of supply for the Licensed Compound and Licensed Products, and Licensor is receiving supply from such alternative source and (2B) years and if reasonably required by Xencor to fully accomplish the technology and transfer without supply interruption then an additional year (for a total in date that case of three (3) years) after is [***] months following the effective date of terminationthe termination of this Agreement. The cost to Licensor for such supply shall be at Licensee’s actual cost to Manufacture such Licensed Compound and Licensed Products; f) at Licensee’s expense, to the extent applicable, Licensee will within [***] days of Licensor’s written request, (i) diligently conduct a Know-How transfer to Licensor, including all relevant Know-How and data, included in the license set forth in Section 10.5.b), and (ii) provide other reasonable assistance necessary to permit Licensor to Develop, Manufacture or Commercialize such time as Xencor has validated an alternative manufacturerLicensed Products; and g) Licensee shall duly execute and deliver, or cause to be duly executed and delivered, such instruments and shall do and cause to be done such acts and things, including the filing of such assignments, agreements, documents, and quantities of Licensed Product supplied by such manufacturer instruments, as may legally be sold necessary under, or as Licensor may reasonably request in connection with, or to carry out more effectively the MorphoSys Territory. Any such Licensed Product shall be supplied purpose of, or to Xencor better assure and Xencor shall reimburse MorphoSys at MorphoSys’ (or confirm unto Licensor its Affiliate’s) fully burdened manufacturing costrights under, determined in accordance with GAAPthis Section 10.6 and Section 10.5.

Appears in 1 contract

Samples: License Agreement (Aduro Biotech, Inc.)

Transition Assistance. Astellas shall provide the following transitional assistance, at its own cost. (a) During the period of [ * ] days after the Effective Date, Cytokinetics may request Astellas to assign the rights and have Cytokinetics assume the obligations under any agreement(s) listed in Exhibit I. Upon such request from Cytokinetics, Astellas shall (i) Subject subject to Sections 10.6(d)-(h) above, to the extent reasonably permissible under the circumstances at the time[ * ] assign, and to ensure that its Affiliates assign all of its rights under such agreement(s), in whole or in part to Cytokinetics, subject to Cytokinetics assuming the extent requested by Xencor in writing within […***…] following termination as provided in the first sentence of this Section 10.6, MorphoSys shall also provide then remaining unaccrued obligations under such assistance as may be reasonably necessary to transfer and/or transition over a reasonable period of time to Xencor any MorphoSys Know-How, trademarks, regulatory filings, licenses and other contracts specific to Licensed Antibody(ies) and Licensed Products including clinical trial and manufacturing agreements with respect theretoagreement(s), and provided (iii) subject to [ * ], permit Cytokinetics access to any communication portal (if any) so established with such counterparty of such agreement. In any case, Astellas shall [ * ] of such agreement before assignment to Cytokinetics. For clarity, Astellas [ * ]of any such agreement [ * ] to assign such agreement to Cytokinetics. For any agreement(s) listed in Exhibit I that Xencor agrees is not assigned by Astellas to assume financial responsibility Cytokinetics, at Cytokinetics’ request and all other obligations under each such license or contract expense (other than the case where MorphoSys has failed to obtain royalty-free rights under the the Post-Sublicensing Patents). Xencor shall be responsible for the reasonable costs and expenses of MorphoSys in providing such assistance, other than FTE-based compensation, but including the expenses and costs specified to be borne by Astellas under this Agreement), Astellas shall complete any ongoing projects and obtain any deliverables for the sole benefit of travel food Cytokinetics. Subject to [ * ], Astellas shall provide Cytokinetics with the right and lodging. access to the work product generated thereunder. In addition, Astellas shall (i) continue to monitor, and at Cytokinetics’ request and at Cytokinetics’ sole cost and expense, use Diligent Efforts to enforce [ * ] = Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) In additionwould likely cause competitive harm if publicly disclosed. any confidentiality, non-use, exclusivity, covenant and indemnification provisions thereunder for the sole benefit of Cytokinetics (provided that Astellas shall not [ * ] without Cytokinetics’ request and agreement [ * ]), and (ii) in the event any intellectual property is generated under any such agreement that would otherwise be owned by, or licensed or assigned to Astellas under the terms of such agreement, subject to [ * ], notify Cytokinetics and, promptly assign or sublicense, as applicable, to the extent that MorphoSys or a MorphoSys Affiliate is then manufacturing itself (respectively) Licensed Products Cytokinetics all of its rights, title and interest in the MorphoSys Territory and upon Xencor’s request, MorphoSys shall use Commercially Reasonable Efforts such intellectual property to (or cause its Affiliate to) continue Cytokinetics. If at any time prior to manufacture Licensed Products for Xencor’s use in the MorphoSys Territory until the earlier of (i) two such date falling [ * ] months from the Effective Date and (2ii) years the date of [ * ], either Party discovers that there was any Third Party agreement that Astellas entered into in connection with the exploitation of any FSRA Product under the Collaboration Agreement that was omitted in Exhibit I, then such Party shall promptly notify the other Party in writing and such agreement shall be subject to this Section 2.6(a). (b) Within [ * ] days after the Effective Date, Astellas shall transfer and deliver (including when available, in electronic format), at no cost to Cytokinetics, the Astellas FSRA Know-How and Collaboration Know-How assigned to Cytokinetics under Section 2.2(a) or licensed under Section 2.2(b) that are in Astellas’ possession as of the Effective Date, all as set forth on Exhibit G to Cytokinetics or its designee, through the delivery of documents to a data room or other means to be agreed between the Parties. If at any time prior to the earlier of (i) such date falling [ * ] months from the Effective Date and (ii) the date of [ * ], either Party discovers, after such transfer, that Astellas is still in possession of any other Astellas FSRA Know-How or Collaboration Know-How, including without limitation: study protocols, study results, analytical methodologies, statistical analysis plans, CMC Information (including bulk and final product manufacturing processes, batch records, vendor information and validation documentation, and any other Know-How and materials required for Cytokinetics or its designee to assume the manufacture of FSRAs and/or FSRA Products), expert opinions, and analyses, in each case to the extent such materials pertain to FSRAs and FSRA Products, then such Party shall promptly notify the other Party in writing and Astellas shall to the extent within the possession or Control of Astellas or its Affiliates promptly transfer and deliver such other Astellas FSRA Know-How or Collaboration Know-How to Cytokinetics through a data room or other means to be agreed between the Parties at no cost to Cytokinetics. The ownership of such Astellas FSRA Know-How and Collaboration Know-How shall be deemed to be assigned to Cytokinetics as of the Effective Date. In addition, at Cytokinetics’ reasonable request, and subject to Astellas’ consent to provide such assistance which consent shall not be unreasonably withheld, Astellas shall provide Cytokinetics reasonable technical assistance in connection with such Astellas FSRA Know-How and Collaboration Know-How related to Manufacturing the FSRAs and/or FSRA Products through [ * ], or any successor of them appointed by Astellas at Astellas’ sole discretion who has sufficient knowledge to provide such assistance, subject to Section 2.6(e) (the “CMC Assistance”). From and after the Effective Date, all such Astellas FSRA Know-How or Collaboration Know-How transferred and delivered to Cytokinetics under this Section 2.6(b) shall be deemed as Confidential Information of Cytokinetics and shall be retained by Astellas solely for the purpose of providing the assistance to Cytokinetics as described herein. On the [ * ] anniversary of the date when they are transferred to Cytokinetics or sooner if reasonably requested by Cytokinetics in writing, Astellas shall delete any electronic copies and destroy any tangible copies of such Know-How, provided that Astellas shall not be required to delete any electronic copy on its archival server as a result of its routine archival practice or as otherwise required by Xencor Law, provided that all such copies shall remain subject to fully accomplish the technology confidentiality and non-use obligation of Astellas under this Agreement. [ * ] = Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) would likely cause competitive harm if publicly disclosed. (c) Astellas shall transfer without supply interruption then an additional year to Cytokinetics all rights to publications relating to FSRAs and FSRA Products (including data to be published, manuscript in preparation and pending publications as set forth on Exhibit J). (d) In addition to the foregoing, Astellas shall use its Diligent Efforts to conduct those activities for which it was responsible for under the Collaboration Agreement to ensure orderly transition and uninterrupted Development, Manufacturing, Commercialization and Medical Affairs Activities of FSRAs and FSRA Products by Cytokinetics, subject to Section 2.6(e). (e) In respect of this Section 2.6, Astellas shall provide (i) up to [ * ] hours per month for CMC Assistance for a total in period of [ * ] months after Cytokinetics receives all the materials and information set forth on Exhibit G (provided that case such materials and information are all provided within [ * ] days of three (3) years) after the effective date Effective Date, otherwise the period will be extended by the period of terminationdelay), and (ii) up to [ * ] hours per month for Regulatory Assistance for a period of [ * ] months after Cytokinetics receives all the materials and information set forth on Exhibit G (provided that such time as Xencor has validated an alternative manufacturermaterials and information are all provided within [ * ] days of the Effective Date, and quantities otherwise the period will be extended by the period of Licensed Product supplied by such manufacturer may legally be sold in the MorphoSys Territorydelay). Any such Licensed Product CMC Assistance or Regulatory Assistance in excess of the foregoing hourly amounts shall be supplied subject to Xencor and Xencor reimbursement by Cytokinetics at the rate of [ * ] Japanese Yen pro-rated per person per day, payable in Dollars. All transitional services shall be conducted on site at Astellas or by teleconference, unless the Parties otherwise agree. Astellas shall not be required to [ * ]. Astellas shall reimburse MorphoSys Cytokinetics for any costs incurred in translating (as certified translations) from Japanese into English those documents [ * ]. For the avoidance of doubt, any transfer or delivery of Astellas FSRA Know-How, Collaboration Know-How, Regulatory Materials, data or other materials pursuant to Sections 2.4 or 2.6 shall be at MorphoSys’ (or its Affiliate’s) fully burdened manufacturing cost, determined in accordance with GAAPno cost to Cytokinetics.

Appears in 1 contract

Samples: Fast Skeletal Regulatory Activator Agreement (Cytokinetics Inc)

Transition Assistance. (a) Following the Closing and for a period of six (6) months thereafter, the Shareholder shall make available to the Purchaser, at the Purchaser's reasonable request at times that are reasonably agreed upon, and at no cost to the Purchaser, up to twenty (20) hours of services of appropriate members of the Shareholder's staff to assist Purchaser with matters arising from the transitioning of the Company business and technology to Purchaser. After twenty (20) hours of free assistance, Shareholder shall make further assistance available to the Purchaser, at the Purchaser's reasonable request at times that are reasonably agreed upon, for a fee of $75 per hour. (b) Without limiting the generality of any other provision of this Agreement, following the Closing and for a period of sixty (60) days thereafter, the Shareholder shall make available to the Purchaser, at the Purchaser's reasonable request at times that are reasonably agreed upon, and at no cost to the Purchaser, all reasonable assistance that the Purchaser may require to (i) Subject secure new agreements with suppliers of the Company where current arrangements with such suppliers are either with the Shareholder (not the Company) or not in writing, (ii) secure the assignment and/or consent of counterparties to Sections 10.6(d)-(h) above, agreements with the Shareholder and/or the Company which require Shareholder Consents and/or Approvals and Shareholder Notices which have not been obtained on or prior to the extent reasonably permissible Closing. Any assistance provided by the Shareholder under this sub-section 10.6(b) shall not derogate from the circumstances at the time, and to the extent requested by Xencor in writing within […***…] following termination as provided in the first sentence Shareholder's obligations under sub-section 10.6(a) hereof or any other provision of this Section 10.6Agreement. (c) After the date hereof, MorphoSys the Shareholder shall also provide such assistance as use its best efforts to aid the Purchaser and the third party service provider contracted by the parties hereto or any of them in documenting the installation and set up configuration instruction procedures for the Company's online systems, which efforts shall include, without limitation, providing all back-up documentation and other information that may be reasonably necessary to transfer and/or transition over assist with documenting the installation and set up configuration instruction procedures for the Company's online systems. In furtherance of the foregoing, the Shareholder agrees to pay fifty percent (50%) of the fees payable to such third party service provider to document such installation and set up configuration instruction procedures, up to a reasonable period maximum of time US$2,500 provided, however, that for greater certainty, the Shareholder shall not be required to Xencor create any MorphoSys Knownew documentation under this sub-How, trademarks, regulatory filings, licenses and other contracts specific to Licensed Antibody(iessection 10.6(c) and Licensed Products including clinical trial and manufacturing agreements where such documentation has not been previously existed with respect theretoto the Company's online systems. Notwithstanding the foregoing, if, for reasons substantially beyond the control of the Purchaser, such documentation has not been completed and provided delivered to the Purchaser by the date that Xencor agrees to assume financial responsibility and all other obligations under each such license or contract is forty-five (other than 45) days after the case where MorphoSys has failed to obtain royalty-free rights under Closing Date, then the the Post-Sublicensing Patents). Xencor Shareholder shall be responsible to pay for all fees for hosting the Company's online system until such time as such documentation is provided to the Purchaser and the Purchaser shall be entitled to claim against the Escrow Shares for any such amount which is not otherwise paid by the Shareholder forthwith upon demand therefor. (d) The Purchaser shall prepare or cause to be prepared and file or cause to be filed all tax returns for the reasonable costs and expenses of MorphoSys in providing such assistanceCompany that are filed after the Closing Date, other than FTE-based compensationtax returns with respect to periods for which a consolidated, but including unitary or combined tax return of the expenses and costs Shareholder will or should include the operations of travel food and lodgingthe Company. (ii) In addition, to the extent that MorphoSys or a MorphoSys Affiliate is then manufacturing itself (respectively) Licensed Products in the MorphoSys Territory and upon Xencor’s request, MorphoSys shall use Commercially Reasonable Efforts to (or cause its Affiliate to) continue to manufacture Licensed Products for Xencor’s use in the MorphoSys Territory until the earlier of (i) two (2) years and if reasonably required by Xencor to fully accomplish the technology and transfer without supply interruption then an additional year (for a total in that case of three (3) years) after the effective date of termination, and (ii) such time as Xencor has validated an alternative manufacturer, and quantities of Licensed Product supplied by such manufacturer may legally be sold in the MorphoSys Territory. Any such Licensed Product shall be supplied to Xencor and Xencor shall reimburse MorphoSys at MorphoSys’ (or its Affiliate’s) fully burdened manufacturing cost, determined in accordance with GAAP.

Appears in 1 contract

Samples: Stock Purchase Agreement (Zim Corp)

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 (i) Subject if terminated pursuant to Sections 10.6(d)-(h) above, to the extent reasonably permissible under the circumstances at the time, and to the extent requested by Xencor in writing within […***…] following termination as provided in the first sentence of this Section 10.6, MorphoSys shall also provide such assistance as may be reasonably necessary to transfer and/or transition over a reasonable period of time to Xencor any MorphoSys Know-How, trademarks, regulatory filings, licenses and other contracts specific to Licensed Antibody(ies10.2) and Licensed Products including clinical trial and manufacturing agreements with respect thereto, and provided that Xencor agrees to assume financial responsibility and all other obligations under each such license or contract (other than the case where MorphoSys has failed to obtain royalty-free rights under the the Post-Sublicensing Patents). Xencor shall be responsible for the reasonable costs and expenses of MorphoSys in providing such assistance, other than FTE-based compensation, but including the expenses and costs of travel food and lodging. (ii) In addition, to the extent that MorphoSys or a MorphoSys Affiliate is then manufacturing itself (respectively) Licensed Products in the MorphoSys Territory and upon Xencor’s request, MorphoSys shall use Commercially Reasonable Efforts to (or cause its Affiliate to) continue to manufacture Licensed Products for Xencor’s use in the MorphoSys Territory until the earlier of (i) two (2) years and if reasonably required by Xencor to fully accomplish the technology and transfer without supply interruption then an additional year (for a total in that case of three (3) years) [* * *] 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 time as Xencor has validated an alternative manufacturerextension, [* * *]. 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 quantities in any case, Impax agrees to cooperate with Durect to facilitate uninterrupted supply of Licensed Product. If Impax or its Affiliate manufactured any Product supplied by such manufacturer may legally be sold in at the MorphoSys Territory. Any such Licensed Product shall be supplied to Xencor and Xencor shall reimburse MorphoSys at MorphoSys’ time of termination, then Impax (or its Affiliate’s) fully shall continue to provide for manufacturing of such Product for Durect, at its fully-burdened manufacturing costcost therefor, determined 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 accordance with GAAPthe Territory, but no longer than the Transition Period.

Appears in 1 contract

Samples: Asset Transfer and License Agreement (Durect Corp)

Transition Assistance. (i) Subject Collaborator shall, for a reasonable period of time, provide such assistance, at no cost to Sections 10.6(d)-(h) aboveAffymax, to transfer and/or transition to Affymax all other technology or know-how, or then-existing commercial arrangements, that is, or are, reasonably necessary or useful for Affymax to commence or continue Developing, conducting Finished Manufacturing of or Commercializing Products in the Licensed Territory, to the extent reasonably permissible under Collaborator is then performing or having performed such activities, including without limitation transferring, upon request of Affymax, any agreements or arrangements with Third-Party suppliers or vendors to supply or sell Products in the circumstances at the timeLicensed Territory, and to the extent requested by Xencor 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 writing within […***…] following termination as provided in a manner consistent with the first sentence definition of this Section 10.6, MorphoSys shall also provide such assistance as may be reasonably necessary to transfer and/or transition over Affymax's Manufacturing Cost) for a reasonable period of time to Xencor any MorphoSys Know-How, trademarks, regulatory filings, licenses and other contracts specific to Licensed Antibody(ies) and Licensed Products including clinical trial and manufacturing agreements with respect thereto, and provided that Xencor agrees to assume financial responsibility and all other obligations under each such license or contract (other than the case where MorphoSys has failed to obtain royalty-free rights under the the Post-Sublicensing Patents)period. Xencor shall be responsible for the reasonable costs and expenses of MorphoSys in providing such assistance, other than FTE-based compensation, but including the expenses and costs of travel food and lodging. (ii) In addition, to the extent that MorphoSys Collaborator or a MorphoSys its Affiliate is then manufacturing itself (respectively) Bulk Hematide and/or Finished Products for the Licensed Products in the MorphoSys Territory and upon Xencor’s requestTerritory, MorphoSys Collaborator shall use Commercially Reasonable Efforts to (or cause its Affiliate to) continue to manufacture Licensed 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 Products for Xencor’s Affymax's use in the MorphoSys Licensed Territory until the earlier of (i) two (2) years and if reasonably required by Xencor to fully accomplish the technology and transfer without supply interruption then an additional year (for a total reasonable period in order to permit Affymax to establish sufficient manufacturing capacity for Bulk Hematide and/or Finished Product for the Licensed Territory, in addition to that case of three (3) years) after the effective date of termination, and (ii) such time as Xencor has validated an alternative manufacturer, and quantities of Licensed Product supplied by such manufacturer may legally be sold which it had in place for its use in the MorphoSys Affymax Territory. Any such Licensed Product Such period shall be supplied to Xencor and Xencor shall reimburse MorphoSys at MorphoSys’ no more than twelve (or its Affiliate’s12) fully burdened manufacturing cost, determined in accordance with GAAPmonths unless otherwise agreed by the Parties.

Appears in 1 contract

Samples: Collaboration and License Agreement (Affymax Inc)

Transition Assistance. Novo Nordisk shall provide the following transitional assistance, at its own cost (iexcept with respect to subsection (4) Subject below). (1) Upon request by XOMA, Novo Nordisk shall provide XOMA with the name and contact information of each Third Party that Novo Nordisk has a license agreement, collaboration agreement and/or vendor agreement with that specifically and solely relates to Sections 10.6(d)-(hany Licensed Antibody or Licensed Product, or the Development, manufacture [*] = 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. and commercialization thereof, provided that Novo Nordisk has the right to disclose such information (or, if Novo Nordisk does not have such right, Novo Nordisk shall use commercially reasonable efforts to promptly obtain the other party’s consent to so disclose such information). Novo Nordisk shall provide a written authorization to such Third Party, which authorization XOMA shall have the right to review and comment upon (and Novo Nordisk shall reasonably consider such comments), to allow such Third Party to share confidentially with XOMA all information and materials that specifically relate to any Licensed Antibody or Licensed Product, [*]. (2) aboveNovo Nordisk shall, at XOMA’s request, transfer (including when available, in electronic format) all relevant and necessary Know-How conceived under this Agreement relating to any Licensed Antibodies or Licensed Products, including the Development, use or manufacture thereof, to XOMA or its designee, including without limitation: study protocols, study results, analytical methodologies, CMC Information (including bulk and final product manufacturing processes, batch records, vendor information and validation documentation), analyses, in each case to the extent reasonably permissible under the circumstances at the timesuch materials pertain to any Licensed Antibodies or Licensed Products, and to the extent requested by Xencor shall provide XOMA reasonable technical assistance in writing within […***…] following termination as provided in the first sentence of this Section 10.6, MorphoSys shall also provide connection therewith. All such assistance as may be reasonably necessary to transfer and/or transition over a reasonable period of time to Xencor any MorphoSys Know-How, trademarks, regulatory filings, licenses How that relates specifically and other contracts specific solely to any Licensed Antibody(ies) and Antibodies or Licensed Products including clinical trial and manufacturing agreements with respect thereto, and provided that Xencor agrees to assume financial responsibility and all other obligations under each such license or contract (other than the case where MorphoSys has failed to obtain royalty-free rights under the the Post-Sublicensing Patents). Xencor shall be responsible for the reasonable costs and expenses deemed to be XOMA’s Confidential Information as of MorphoSys in providing such assistance, other than FTE-based compensation, but including the expenses and costs of travel food and lodging. (ii) In addition, to the extent that MorphoSys or a MorphoSys Affiliate is then manufacturing itself (respectively) Licensed Products in the MorphoSys Territory and upon Xencor’s request, MorphoSys shall use Commercially Reasonable Efforts to (or cause its Affiliate to) continue to manufacture Licensed Products for Xencor’s use in the MorphoSys Territory until the earlier of (i) two (2) years and if reasonably required by Xencor to fully accomplish the technology and transfer without supply interruption then an additional year (for a total in that case of three (3) years) after the effective date of terminationsuch termination and the exceptions in Sections 9.1(a) and (e) shall not apply to Novo Nordisk with respect to such Know-How. Notwithstanding the above, [*]. (3) Novo Nordisk shall at the request of XOMA transfer to XOMA or its designee inventory of Licensed Antibodies and Licensed Products (including research materials, final product, bulk drug substance, intermediates, work-in-process, formulation materials, reference standards, drug product clinical reserve samples, packaged retention samples, and (iithe like) such time as Xencor has validated an alternative manufacturer, and quantities of Licensed Product supplied by such manufacturer may legally be sold then in the MorphoSys Territorypossession of Novo Nordisk or its Affiliates or sublicensees, provided however, that [*]. Any Unless the Agreement is terminated for material breach by Novo Nordisk under Section 10.3, [*]. The Parties will agree on the procedures by which to transfer [*] any stability studies to XOMA or its designee in a manner that minimizes the disruption of such studies. Novo Nordisk shall be permitted for a period of [*] following the effective date of termination to sell its existing stocks of finished and in-process Licensed Products, provided that Novo Nordisk pays to XOMA all royalty payments due on the sales of such Licensed Product shall be supplied to Xencor and Xencor shall reimburse MorphoSys at MorphoSys’ (or its Affiliate’s) fully burdened manufacturing cost, determined Products in accordance with GAAPSections 5.3 through 5.6 with respect thereto.

Appears in 1 contract

Samples: Exclusive License Agreement (XOMA Corp)

Transition Assistance. 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) Subject 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 Sections 10.6(d)-(h) aboveCollaboration Molecules and Products hereunder and that Partner is able, using reasonable commercial efforts to, assign to Medivation, in each case, to the extent reasonably permissible under the circumstances at the time[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, and 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 requested assignment is permitted by Xencor such agreement, and Partner is not required to pay any consideration or commence litigation in writing within […***…] following termination as provided in the first sentence order to effect an assignment of this Section 10.6, MorphoSys shall also provide any such assistance as may be 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 transfer and/or transition over continue researching, Developing, manufacturing, or Commercializing Products, then Partner shall reasonably cooperate with Medivation to [*]. If Partner manufactures the Product itself (and thus there is no agreement to assign), then Partner shall supply such bulk Collaboration Molecule or finished Product, as applicable, to Medivation, for a reasonable period of time (not to Xencor any MorphoSys Know-How, trademarks, regulatory filings, licenses and other contracts specific to Licensed Antibody(ies) and Licensed Products including clinical trial and manufacturing agreements with respect thereto, and provided that Xencor agrees to assume financial responsibility and all other obligations under each such license or contract (other than the case where MorphoSys has failed to obtain royalty-free rights under the the Post-Sublicensing Patents). Xencor shall be responsible for the reasonable costs and expenses of MorphoSys in providing such assistance, other than FTE-based compensation, but including the expenses and costs of travel food and lodging. (ii) In addition, to the extent that MorphoSys or a MorphoSys Affiliate is then manufacturing itself (respectively) Licensed Products in the MorphoSys Territory and upon Xencor’s request, MorphoSys shall use Commercially Reasonable Efforts to (or cause its Affiliate to) continue to manufacture Licensed Products for Xencor’s use in the MorphoSys Territory until the earlier of (i) two (2) years and if reasonably required by Xencor to fully accomplish the technology and transfer without supply interruption then an additional year (for a total in that case of three (3) years) exceed [*] after the effective date of termination), and (ii) such time as Xencor has validated an alternative manufacturer, and quantities of Licensed Product supplied pursuant to a supply agreement to be negotiated in good faith by such manufacturer may legally be sold in the MorphoSys TerritoryParties. Any such Licensed Product shall be supplied to Xencor and Xencor Medivation shall reimburse MorphoSys at MorphoSys’ (Partner or its Affiliate’s) fully burdened manufacturing cost, determined in accordance with GAAPany of Partner’s Third Party manufacturers for all reasonable out-of-pocket costs incurred pursuant to this Section 13.5(d).

Appears in 1 contract

Samples: Collaboration Agreement (Medivation, Inc.)

Transition Assistance. (i) Subject to Sections 10.6(d)-(h) above, to To the extent reasonably permissible under the circumstances at the time, and to the extent requested by Xencor MorphoSys in writing within [***] calendar days following the applicable termination as provided in the first sentence of this Section 10.6notice, MorphoSys COMPANY shall also (and ensure that its Affiliates and Sublicensees) provide such assistance as may be reasonably necessary to transfer and/or transition over a reasonable period of time to MorphoSys, or if so requested by MorphoSys, to Xencor any MorphoSys rights, items and contracts specified under 17.8(b), (d), (e), (f) and (g), including COMPANY Know-How, trademarksProduct Marks, regulatory filingsGlobal Product Marks, licenses Development Data, Regulatory Data, Regulatory Materials, and other Regulatory Approvals, (including contracts with contract research organisations, contract Manufacturing organisations and distributors) specific to Licensed Antibody(ies) and Licensed Antibody or the Products including clinical trial and manufacturing agreements with respect thereto, and provided that Xencor MorphoSys agrees to assume financial responsibility and all other obligations towards Third Parties under each such license any licenses or contract contracts (other than the case where MorphoSys COMPANY has failed to obtain royalty-free rights under the the Post-Sublicensing Patentsthose certain Xencor Patents licensed to MorphoSys under Section 2.4(b). Xencor shall be responsible for the reasonable costs and expenses of MorphoSys in providing such assistance, other than FTE-based compensation, but including the expenses and costs of travel food and lodging). (ii) In addition, to the extent that MorphoSys COMPANY or a MorphoSys COMPANY Affiliate is then manufacturing itself (respectively) Licensed Products in the MorphoSys Territory and upon Xencor’s requestMorphoSys’ request in writing within [***] calendar days after the applicable termination notice, MorphoSys COMPANY shall use Commercially Reasonable Efforts to (or cause ensure that its Affiliate toAffiliate) continue to manufacture Licensed Products for MorphoSys’ or Xencor’s use in the MorphoSys Territory until the earlier of (i) two (2) [***] years and if reasonably required by Xencor MorphoSys to fully accomplish the technology and transfer without supply interruption then an additional year [***] (for a total in that case of three (3) years[***]) after the effective date of termination, and (ii) such time as Xencor MorphoSys has validated an alternative manufacturermanufacturer (including [***]), and quantities of Licensed Product supplied by such manufacturer may legally be sold in the MorphoSys Territorysold. Any such Licensed Product shall be supplied to Xencor MorphoSys and Xencor MorphoSys shall reimburse MorphoSys [***] COMPANY at MorphoSys’ COMPANY’s (or its Affiliate’s) fully burdened manufacturing cost[***], determined in accordance with GAAP.

Appears in 1 contract

Samples: Collaboration and License Agreement (MorphoSys AG)

Transition Assistance. (i) Subject Unless this Agreement is terminated by VIT under Section 14.3(a), VIT shall provide reasonable consultation and assistance for the purpose of transferring or transitioning to Sections 10.6(d)-(h) aboveChemoCentryx all VIT Know-How not already in ChemoCentryx’s possession and, at ChemoCentryx’s request, all then-existing commercial arrangements relating specifically to any Compound or Product that VIT is able, using Commercially Reasonable Efforts, to transfer or transition to ChemoCentryx, in each case, to the extent reasonably permissible under necessary or useful for ChemoCentryx to continue Developing, manufacturing, or Commercializing the circumstances at the time, and to the extent requested by Xencor in writing within […***…] following termination as provided Product in the first sentence Territory. The foregoing shall include transferring, upon request of this Section 10.6ChemoCentryx, MorphoSys any agreements with Third Party suppliers or vendors that specifically cover the supply or sale of any Compound or Product in the Territory; provided that if any such contract between VIT and a Third Party is not assignable to ChemoCentryx (whether by such contract’s terms or because such contract does not relate specifically to any Compound or Product) but is otherwise reasonably necessary or useful for ChemoCentryx to commence Developing, manufacturing, or Commercializing the Product in the Territory, or if VIT manufactures the Product itself (and thus there is no contract to assign), then VIT shall also reasonably cooperate with ChemoCentryx to negotiate for the continuation of services or supply from such entity, or VIT shall supply such Compound or Product, as applicable, to ChemoCentryx for a reasonable period (not to exceed twelve (12) months) until ChemoCentryx establishes an alternate, validated source of such services or supply of finished, packaged, labeled Product for the Territory. ChemoCentryx shall pay VIT for such supply from VIT at a price equal to VIT’s cost. VIT shall provide such assistance as may be reasonably necessary at no cost to transfer and/or transition over ChemoCentryx for a reasonable period of time to Xencor any MorphoSys Know-Howtwelve (12) months after termination, trademarks, regulatory filings, licenses and other contracts specific to Licensed Antibody(ies) and Licensed Products including clinical trial and manufacturing agreements with respect theretoif such termination occurred after First Commercial Sale in the Territory, and provided that Xencor agrees to assume financial responsibility and all other obligations under each such license or contract (other than the case where MorphoSys has failed to obtain royalty-free rights under the the Post-Sublicensing Patents). Xencor shall be responsible for the reasonable costs and expenses of MorphoSys in providing such assistance, other than FTE-based compensation, but including the expenses and costs of travel food and lodging. (ii) In addition, to the extent that MorphoSys or a MorphoSys Affiliate is then manufacturing itself (respectively) Licensed Products in the MorphoSys Territory and upon Xencor’s request, MorphoSys shall use Commercially Reasonable Efforts to (or cause its Affiliate to) continue to manufacture Licensed Products for Xencor’s use in the MorphoSys Territory until the earlier of (i) two (2) years and if reasonably required by Xencor to fully accomplish the technology and transfer without supply interruption then an additional year (otherwise for a total in that case period of three six (36) years) months after termination, and thereafter ChemoCentryx shall reimburse VIT’s reasonable internal and Third Party costs to conduct such transition from and after the effective date of termination, and (ii) such time as Xencor has validated an alternative manufacturer, and quantities of Licensed Product supplied by such manufacturer may legally be sold in the MorphoSys Territory. Any such Licensed Product shall be supplied to Xencor and Xencor shall reimburse MorphoSys at MorphoSys’ (or its Affiliate’s) fully burdened manufacturing cost, determined in accordance with GAAP.

Appears in 1 contract

Samples: Collaboration and License Agreement (ChemoCentryx, Inc.)

Transition Assistance. Genentech shall provide the following transitional assistance, at its own cost unless specifically set forth below: (i) Subject to Sections 10.6(d)-(hAt NewLink’s request, Genentech shall: (A) above, manufacture and supply NewLink with Advanced Reversion Products at [*] for a period of [*] after such termination; (B) to the extent reasonably permissible under the circumstances at the time[*], assign or transfer to NewLink any manufacturing agreement between Genentech and a Third Party contract manufacturer with respect to the extent requested by Xencor in writing within […***…] following termination as any Advanced Reversion Product, provided in the first sentence of this Section 10.6, MorphoSys shall that such manufacturing agreement does not also provide such assistance as may be reasonably necessary pertain to products that are not Advanced Reversion Products; and/or (C) transfer and/or transition over a reasonable period of time to Xencor any MorphoSys NewLink (or its designee) all Know-How, trademarks, regulatory filings, licenses How and other contracts specific materials to Licensed Antibody(ies) and Licensed Products including clinical trial and manufacturing agreements with respect thereto, and provided that Xencor agrees enable NewLink or such designee to assume financial responsibility the manufacture and all other obligations under each such license or contract (other than the case where MorphoSys has failed to obtain royalty-free rights under the the Post-Sublicensing Patents). Xencor supply of any Advanced Reversion Product and shall be responsible for the provide reasonable costs and expenses of MorphoSys technical assistance in providing such assistance, other than FTE-based compensation, but including the expenses and costs of travel food and lodgingconnection therewith. (ii) In additionIf at the time of such termination, to the extent that MorphoSys Genentech or a MorphoSys Affiliate is then manufacturing itself (respectively) Licensed Products in the MorphoSys Territory and upon Xencor’s request, MorphoSys shall use Commercially Reasonable Efforts to (or cause its Affiliate to) continue to manufacture Licensed Products for Xencor’s use in the MorphoSys Territory until the earlier of (i) two (2) years and if reasonably required by Xencor to fully accomplish the technology and transfer without supply interruption then an additional year (Affiliates are conducting any clinical trials for a total in that case Reversion Product, then Genentech shall pay for the costs of three (3) years) all such clinical trials for up to [*] after the effective date of terminationtermination and, at NewLink’s election with respect to any such trial that does not involve the combination of a Reversion Product with an Active Ingredient that is proprietary to Genentech, Genentech shall cooperate, and shall ensure that its Affiliates cooperate, with NewLink to transfer the conduct of all such clinical trials to NewLink, in which case NewLink shall assume any and all liability for the conduct of such transferred clinical trials after the effective date of such termination (except (A) for Genentech’s obligation to pay costs pursuant to this subsection (ii) such time as Xencor has validated an alternative manufacturerand (B) to the extent arising prior to the transfer date or from any act or omission by Genentech, its Affiliates or their respective employees, agents and quantities of Licensed Product supplied by such manufacturer may legally be sold in the MorphoSys Territorycontractors). Any such Licensed Product shall be supplied With respect to Xencor and Xencor shall reimburse MorphoSys at MorphoSys’ (any clinical trials that Genentech or its Affiliate’s) fully burdened manufacturing costAffiliates is conducting at the time of Confidential Execution Version termination that are not transferred to NewLink pursuant to the preceding sentence, determined in accordance with GAAPGenentech shall, at its expense, orderly wind-down the conduct of any such clinical trial.

Appears in 1 contract

Samples: License and Collaboration Agreement (Newlink Genetics Corp)

Transition Assistance. Astellas shall provide the following transitional assistance, at its own cost unless specifically set forth below. (i) Subject If this Agreement is terminated in its entirety, Astellas shall promptly return to Sections 10.6(d)-(h) above, to the extent reasonably permissible under the circumstances at the time, and to the extent requested by Xencor in writing within […***…] following termination as provided in the first sentence of this Section 10.6, MorphoSys shall also provide such assistance as may be reasonably necessary to transfer and/or transition over a reasonable period of time to Xencor any MorphoSys Cytokinetics all Know-How, trademarksdata, regulatory filings, licenses materials and other contracts specific Confidential Information made available to Licensed Antibody(ies) and Licensed Products including clinical trial and manufacturing agreements with respect thereto, and provided that Xencor agrees to assume financial responsibility and all other obligations Astellas by Cytokinetics under each such license or contract (other than the case where MorphoSys has failed to obtain royalty-free rights under the the Post-Sublicensing Patents). Xencor shall be responsible for the reasonable costs and expenses of MorphoSys in providing such assistance, other than FTE-based compensation, but including the expenses and costs of travel food and lodgingthis Agreement. (ii) In additionUpon request by Cytokinetics after termination of this Agreement, Astellas shall promptly provide Cytokinetics with a copy of each license agreement, collaboration agreement and/or vendor agreement then effective between Astellas (or its Affiliates) and a Third Party with respect to the Product, or the Development, Manufacture and Commercialization thereof, [*]. Upon Cytokinetics’ request, Astellas shall use its Diligent Efforts to assign or sublicense, and shall ensure that its Affiliates assign or sublicense, to Cytokinetics any such agreement(s) and shall permit Cytokinetics access through any communication portal so established with such Third Party under any agreement so assigned to Cytokinetics. (iii) Astellas shall, at Cytokinetics’ request after termination of this Agreement, transfer (including when available, in electronic format) all Astellas Know-How and Collaboration Know-How relating to the Product to Cytokinetics or its designee, including without limitation: study protocols, study results, analytical methodologies, CMC Information (including bulk and final product manufacturing processes, batch records, vendor information and validation documentation), expert opinions, analyses, in each case to the extent that MorphoSys such materials pertain to [*], and shall provide Cytokinetics reasonable technical assistance in connection therewith. From and after such time, all such Know-How shall be deemed Confidential Information of Cytokinetics. [*] = 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. (iv) Astellas shall transfer to Cytokinetics or a MorphoSys Affiliate is its designee any and all inventory of Tirasemtiv and Product [*] (including all final product, bulk drug substance, work-in-process, formulation materials, reference standards, drug product clinical reserve samples, packaged retention samples, and the like) then manufacturing itself (respectively) Licensed Products in the MorphoSys Territory and upon Xencor’s possession of Astellas, its Affiliates or sublicensees at Astellas’ Manufacturing Costs. Astellas shall continue or have continued any ongoing stability studies pertaining to any materials so transferred if such studies will take less than [*] to complete. The Parties shall agree on the procedures by which to transfer any longer stability studies to Cytokinetics or its designee in a manner that minimizes the disruption of such studies. (v) If at the time of such termination, Cytokinetics or its Affiliates are not Manufacturing the Product [*], then, at Cytokinetics’ request, MorphoSys shall use Commercially Reasonable Efforts to Astellas shall: (or cause its Affiliate toA) continue to manufacture Licensed Products for Xencor’s use in Manufacture and supply Cytokinetics with the MorphoSys Territory until the earlier of (i) two (2) years and if reasonably required by Xencor to fully accomplish the technology and transfer without supply interruption then an additional year (Product [*] for a total period of [*] year after such termination; (B) assign or transfer to Cytokinetics any Manufacturing agreement between Astellas and a Third Party contract manufacturer with respect to the Product [*]; and/or (C) transfer to Cytokinetics (or its designee) all Know-How and materials to enable Cytokinetics or such designee to assume the Manufacture and supply of such the Product [*] and shall provide reasonable technical assistance in connection therewith; (vi) If at the time of such termination, Astellas or its Affiliates are conducting any clinical trials for the Product [*], then, at Cytokinetics’ election on a trial-by-trial basis: (A) Astellas shall fully cooperate, and shall ensure that case its Affiliates fully cooperate, with Cytokinetics to transfer the conduct of three (3) years) all such clinical trials to Cytokinetics. [*] the conduct of such clinical trials after the effective date of such termination (except to the extent [*]); or (B) Astellas shall, [*], orderly wind-down the conduct of any such clinical trial which is not assumed by Cytokinetics under clause (A). In each case [*] in connection with the conduct or wind-down of all such clinical trials as of the effective date of such termination. (vii) In addition to the foregoing, Astellas shall use its Diligent Efforts with respect to those activities for which it is responsible to ensure orderly transition and uninterrupted Development, Manufacturing, Commercialization and Medical Affairs Activities of the Product [*] by Cytokinetics and to enable Cytokinetics to enter into an agreement with a Third Party to continue these activities with minimal disruption and delay. (iiviii) such time as Xencor has validated an alternative manufacturerAstellas shall transfer to Cytokinetics all rights to publications relating to the Product [*] (including data to be published, manuscript in preparation and quantities of Licensed Product supplied by such manufacturer may legally be sold in the MorphoSys Territory. Any such Licensed Product shall be supplied to Xencor and Xencor shall reimburse MorphoSys at MorphoSys’ (or its Affiliate’s) fully burdened manufacturing cost, determined in accordance with GAAPpending publications).

Appears in 1 contract

Samples: License and Collaboration Agreement (Cytokinetics Inc)

Transition Assistance. Astellas shall provide the following transitional assistance, at its own cost unless specifically set forth below. (i) Subject If this Agreement is terminated in its entirety, Astellas shall promptly return to Sections 10.6(d)-(h) above, to the extent reasonably permissible under the circumstances at the time, and to the extent requested by Xencor in writing within […***…] following termination as provided in the first sentence of this Section 10.6, MorphoSys shall also provide such assistance as may be reasonably necessary to transfer and/or transition over a reasonable period of time to Xencor any MorphoSys Cytokinetics all Know-How, trademarksdata, regulatory filings, licenses materials and other contracts specific Confidential Information made available to Licensed Antibody(ies) and Licensed Products including clinical trial and manufacturing agreements with respect thereto, and provided that Xencor agrees to assume financial responsibility and all other obligations Astellas by Cytokinetics under each such license or contract (other than the case where MorphoSys has failed to obtain royalty-free rights under the the Post-Sublicensing Patents). Xencor shall be responsible for the reasonable costs and expenses of MorphoSys in providing such assistance, other than FTE-based compensation, but including the expenses and costs of travel food and lodgingthis Agreement. (ii) In additionUpon request by Cytokinetics after termination of this Agreement, Astellas shall promptly provide Cytokinetics with a copy of each license agreement, collaboration agreement and/or vendor agreement then effective between Astellas (or its Affiliates) and a Third Party with respect to any [*] Product, or the Development, Manufacture and Commercialization thereof. Upon Cytokinetics’ request, Astellas shall use its Diligent Efforts to assign or sublicense, and shall ensure that its Affiliates assign or sublicense, to Cytokinetics any such agreement(s) and shall permit Cytokinetics access through any communication portal so established with such Third Party under any agreement so assigned to Cytokinetics. (iii) Astellas shall, at Cytokinetics’ request after termination of this Agreement, transfer (including when available, in electronic format) all Astellas Know-How and Collaboration Know-How relating to any [*] Products to Cytokinetics or its designee, including without limitation: study protocols, study results, analytical methodologies, CMC Information (including bulk and final product manufacturing processes, batch records, vendor information and validation documentation), expert opinions, analyses, in each case to the extent that MorphoSys such materials pertain to any [*] Products, and shall provide Cytokinetics reasonable technical assistance in connection therewith. From and after such time, all such Know-How shall be deemed Confidential Information of Cytokinetics. (iv) Astellas shall transfer to Cytokinetics or a MorphoSys Affiliate is its designee any and all inventory of [*] Products (including all research materials, final product, bulk drug substance, intermediates, work-in-process, formulation materials, reference standards, drug product clinical reserve samples, packaged retention samples, and the like) then manufacturing itself (respectively) Licensed Products in the MorphoSys Territory and upon Xencor’s possession of Astellas, its Affiliates or sublicensees at Astellas’ Manufacturing Costs. Astellas shall continue or have continued any ongoing stability studies pertaining to any materials so transferred if such studies will take less than [*] to complete. The Parties will agree on the procedures by which to transfer any longer stability studies to Cytokinetics or its designee in a manner that minimizes the disruption of such studies. (v) If at the time of such termination, Cytokinetics or its Affiliates are not Manufacturing a particular [*] Product, then, at Cytokinetics’ request, MorphoSys shall use Commercially Reasonable Efforts to Astellas shall: (or cause its Affiliate toA) continue to manufacture Licensed Products for Xencor’s use in the MorphoSys Territory until the earlier of (i) two (2) years Manufacture and if reasonably required by Xencor to fully accomplish the technology and transfer without supply interruption then an additional year (Cytokinetics with such [*] Product at [*] for a total period of [*] year after such termination; (B) assign or transfer to Cytokinetics any Manufacturing agreement between Astellas and a Third Party contract manufacturer with respect to such [*] Product; and/or (C) transfer to Cytokinetics (or its designee) all Know-How and materials to enable Cytokinetics or such designee to assume the Manufacture and supply of such [*] Product and shall provide reasonable technical assistance in connection therewith; (vi) If at the time of such termination, Astellas or its Affiliates are conducting any clinical trials for a [*] Product, then, at Cytokinetics’ election on a trial-by-trial basis: (A) Astellas shall fully cooperate, and shall ensure that case its Affiliates fully cooperate, with Cytokinetics to transfer the conduct of three (3) years) all such clinical trials to Cytokinetics. [*] the conduct of such clinical trials after the effective date of such termination (except to the extent [*]); or (B) Astellas shall, [*], orderly wind-down the conduct of any such clinical trial which is not assumed by Cytokinetics under clause (A). In each case [*] in connection with the conduct or wind-down of all such clinical trials as of the effective date of such termination. (vii) In addition to the foregoing, Astellas shall use its Diligent Efforts with respect to those activities for which it is responsible to ensure orderly transition and uninterrupted Development, Manufacturing, Commercialization and Medical Affairs Activities of [*] Products by Cytokinetics and to enable Cytokinetics to enter into an agreement with a Third Party to continue these activities with minimal disruption and delay. (iiviii) such time as Xencor has validated an alternative manufacturerAstellas shall transfer to Cytokinetics all rights to publications relating to any [*] Products (including data to be published, manuscript in preparation and quantities of Licensed Product supplied by such manufacturer may legally be sold in the MorphoSys Territory. Any such Licensed Product shall be supplied to Xencor and Xencor shall reimburse MorphoSys at MorphoSys’ (or its Affiliate’s) fully burdened manufacturing cost, determined in accordance with GAAPpending publications).

Appears in 1 contract

Samples: License and Collaboration Agreement (Cytokinetics Inc)

Transition Assistance. (a) In the event BGFA terminates this Agreement with respect to the Trust or any Portfolio in accordance with Section 8, or upon the expiration of the Initial Term or any Renewal Term and non-renewal of this Agreement: (i) Subject the Sub-Administrator will immediately upon receipt of notice of termination or non-renewal, commence and prosecute diligently to Sections 10.6(d)-(h) abovecompletion the transfer of all property and the delivery of all assets of BGFA and the Portfolios as to which this Agreement is terminated, duly endorsed, and all records maintained under the terms hereof and of the Service Level Agreement(s), directly to the extent reasonably permissible under successor administrator selected by BGFA or the circumstances at the timeTrust, and to the extent requested by Xencor in writing within […***…] following termination as provided in the first sentence of this Section 10.6, MorphoSys shall also provide such assistance as may be reasonably necessary to transfer and/or transition over a reasonable period of time to Xencor any MorphoSys Know-How, trademarks, regulatory filings, licenses and other contracts specific to Licensed Antibody(ies) and Licensed Products including clinical trial and manufacturing agreements with respect thereto, and provided that Xencor agrees to assume financial responsibility and all other obligations under each such license or contract applicable (other than the case where MorphoSys has failed to obtain royalty-free rights under the the Post-Sublicensing Patents"Transfer"). Xencor shall be responsible for the reasonable costs and expenses of MorphoSys in providing such assistance, other than FTE-based compensation, but including the expenses and costs of travel food and lodging.; (ii) In additionthe Sub-Administrator will provide such reasonably necessary transition assistance, as described below in this Section 9 (the "Transition Assistance"). The Sub-Administrator will fully cooperate with BGFA and will provide such reasonable assistance as directed by BGFA to effectively transition the services provided by the Sub-Administrator to BGFA under this Agreement to a successor entity (or entities) as designated by BGFA in its sole discretion, including but not limited to using its commercially reasonable efforts to provide for an orderly transition of funds from the Sub-Administrator's custody to the extent that MorphoSys or a MorphoSys Affiliate is then manufacturing itself (respectively) Licensed Products successor's custody. During such transition period, BGFA will continue to pay the Sub-Administrator the fees applicable to such services set forth in the MorphoSys Territory then-current Fee Schedule, plus an amount calculated based on additional time and upon Xencor’s requestmaterials outside the usual services provided under this Agreement and required to effect the conversion of the services to a successor service provider. The Sub-Administrator shall provide Transition Assistance for a period of up to twenty-four (24) months as requested by BGFA; (iii) the Sub-Administrator and BGFA shall negotiate in good faith to agree on a plan for the orderly transition of BGFA and the Trust to a successor service provider by no later than sixty (60) days after the date of termination or non-renewal; (iv) BGFA shall, MorphoSys shall use Commercially Reasonable Efforts to (or cause its Affiliate to) continue to manufacture Licensed Products for Xencor’s use in the MorphoSys Territory until event Transition Assistance is required for more than twenty-four (24) months from the earlier of (i) two (2) years and if reasonably required by Xencor to fully accomplish the technology and transfer without supply interruption then an additional year (for a total in that case of three (3) years) after the effective date of termination, pay the Sub-Administrator an annual bonus on a monthly basis in an amount equal to 5% of the aggregate fees being charged as of the date of termination; and (v) BGFA and (ii) such time the Sub-Administrator will take all reasonably necessary steps as Xencor has validated an alternative manufacturermutually agreed by the Parties, and quantities to assure the retention of Licensed Product supplied by such manufacturer may legally be sold key employees of the Sub-Administrator involved in the MorphoSys Territory. Any such Licensed Product shall be supplied to Xencor and Xencor shall reimburse MorphoSys at MorphoSys’ (or its Affiliate’s) fully burdened manufacturing cost, determined in accordance with GAAPprovision of Transition Assistance.

Appears in 1 contract

Samples: Sub Administration Agreement (Barclays Foundry Investment Trust)

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