Other Effects of Termination. Except for termination of this Agreement by Verve under Section 15.3, (a) Where permitted by Applicable Law, upon written request, Verve shall assign to Beam all of its right, title and interest in and to, and transfer possession to Beam of, all Regulatory Documentation (including, for clarity, regulatory approvals) then in its name applicable to any Terminated Product other than (i) an Independent Product that is not a Collaboration Product or (ii) a former Collaboration Product for which Beam exercised the Beam Opt-Out Option if Verve has terminated this Agreement within [**] following Beam’s exercise of such Beam Opt-Out Option (such Terminated Product, other than as described in the foregoing clauses (i) and (ii), a “Terminated Reversion Product”), in the same form in which Verve maintains such Regulatory Documentation, and upon request execute and deliver such additional documents or instruments reasonably necessary to effect such transfer, in each case at Beam’s cost and expense; (b) Upon written request, Verve shall grant and hereby grants, and shall cause its Affiliates to grant, to Beam an exclusive (even as to Verve and its Affiliates), perpetual, irrevocable, royalty-bearing (as set forth in and subject to this Section 15.5.2(b)) license under the Patent Rights and Know-How Controlled by Verve or its Affiliates as of the effective date of termination that either (i) claim or cover the composition, use or manufacture of the applicable Terminated Reversion Product(s) or (ii) were otherwise used or practiced in the Development, Manufacture, Commercialization or exploitation of the Terminated Reversion Product(s) on or prior to the effective date of termination (collectively, “Post-Termination Licensed Technology”), solely to Develop, Manufacture, Commercialize or otherwise exploit such Terminated Reversion Product(s) in the Field in the Territory, provided, however, that in the case of any such Patent Right or Know-How that requires payment to a Third Party pursuant to an applicable license or other agreement, such Patent Right or Know-How shall be [**] to such Third Party as a result of Beam’s exercise of such license. Unless Beam terminates this Agreement for Verve’s material breach of this Agreement under Section 15.3.1 (in which case no royalties are owed), Beam will pay Verve royalties equal to [**] percent ([**]%) of the annual aggregate Net Sales resulting from the sale of each such Terminated Reversion Product in the Field in the Territory and such royalties will be due to Verve, on a Product-by-Product and country-by-country basis for the duration of the Royalty Term for the applicable Terminated Reversion Product in the applicable country as if this Agreement had stayed in effect. [**]. (c) Unless expressly prohibited by any Regulatory Authority, upon written request of Beam, Verve shall transfer control to Beam conduct of any Clinical Trials of such Terminated Reversion Product(s) being conducted as of the effective date of termination and continue to conduct such Clinical Trial(s) in accordance with a budget and plan agreed upon by the Parties, at Beam’s cost and expense, for up to [**] to enable such transfer to be completed without interruption of such Clinical Trial(s); provided that Beam shall not have any obligation to continue any Clinical Trial unless required by Applicable Law; (d) To the extent that, as of the effective date of termination of this Agreement, Verve has existing and ongoing contracts with Third Parties related to the Development, Manufacture or Commercialization of the Terminated Reversion Product(s), at the written request of Beam, Verve will use good faith commercially reasonable efforts to transfer such contracts and arrangements to Beam, including using good faith commercially reasonable efforts to assign contracts and arrangements to Beam in part or facilitate separate arrangements with Beam if such contracts and arrangements relate to more than solely the Terminated Reversion Product(s); (e) At Beam’s written request, Verve shall deliver such quantities of the applicable Terminated Reversion Product(s) that Verve or its Affiliates has in its respective inventory or control (including inventory in its control on the premises of a Third Party subcontractor) as of the date of Beam’s request; provided that Beam shall reimburse Verve for the Cost of Goods Manufactured and the costs of shipping and handling with respect to such quantities; provided further that, with respect to a Collaboration Product, Beam shall only be obligated to reimburse Verve for any portion of the costs thereof not previously reimbursed pursuant to this Agreement. (f) If Beam does not manufacture the applicable Terminated Reversion Product(s) either itself or on its behalf, Verve shall supply to Beam such reasonable quantities of such Terminated Reversion Product(s) as Beam indicates in written forecasts and orders from time to time, until the earlier of (i) such time as Beam has established an alternative, validated source of supply for such Terminated Reversion Product(s) and (ii) the [**] of the effective date of termination of this Agreement. The costs to Beam for supply of such Terminated Reversion Product(s) from Verve shall be equal to Verve’s Cost of Goods Manufactured for such Terminated Reversion Product(s) [**]. Notwithstanding anything to the contrary in this Agreement, if any such Terminated Reversion Product is manufactured for Verve by a Third Party contract manufacturer pursuant to a written contract, then Verve may satisfy its obligations pursuant to this Section 15.5.2(f) with respect to such Terminated Reversion Product by assigning its rights and obligations under such contract (or the portion of such contract pertaining to such Terminated Reversion Product) to Beam. (g) Verve shall, at the written request and expense of Beam, provide Beam with such assistance as is reasonably necessary to effectuate a smooth and orderly transition to Beam or its designee of any Development, Manufacture and Commercialization activities relating to the applicable Terminated Reversion Product(s) so as to minimize the disruption of such activities, provided, however, that Verve shall not be obligated to initiate any new substantive activity, distinct from any previously ongoing substantive activity, that would itself create any new obligations on the part of Verve that would continue following such termination. Further, upon Beam’s written request, Verve shall make its personnel reasonably available to provide such technical assistance, at no cost to Beam (except for reimbursement of Verve’s direct out of pocket costs therefor), as may reasonably be requested to transfer all Manufacturing technology Controlled by Verve or its Affiliates that is or had been used by or on behalf of Verve and its Affiliates in connection with the Manufacture of any Terminated Reversion Product.
Appears in 2 contracts
Samples: Collaboration and License Agreement (Verve Therapeutics, Inc.), Collaboration and License Agreement (Verve Therapeutics, Inc.)
Other Effects of Termination. Except for Upon any early termination of this Agreement by Verve before the end of the Term in any such case in its entirety or with respect to any countries in the Territory, and subject only to the limited sell-off rights granted to Catalyst under Section 15.3,9.10(d) and to the continuing rights under any licenses under Section 9.2 (License Following Expiration of Royalty Term):
(a) Where permitted all licenses granted under this Agreement by Applicable Law, upon written request, Verve shall assign either Party to Beam all of its right, title and interest in and tothe other Party, and transfer possession any sublicenses granted by either Party under any such license (subject to Beam of, all Regulatory Documentation (including, for clarity, regulatory approvals) then in its name applicable to any Terminated Product other than (i) an Independent Product that is not a Collaboration Product or (ii) a former Collaboration Product for which Beam exercised the Beam Opt-Out Option if Verve has terminated this Agreement within [**] following Beam’s exercise of such Beam Opt-Out Option (such Terminated Product, other than as described in the foregoing clauses (i) and (iiSection 9.10(b)), a “Terminated Reversion Product”), in the same form in which Verve maintains such Regulatory Documentationshall automatically terminate, and upon request execute Catalyst, its Affiliates and deliver such additional documents or instruments reasonably necessary to effect such transferterminated Sublicensees shall refrain from using the Licensed Intellectual Property and Xxxxxxxx’s trademarks with immediate effect, in each case at Beamand shall not hold themselves out as being Santhera’s cost and expenselicensees;
(b) Upon written requestif a Sublicensee is then in good standing under its sublicense agreement with Catalyst, Verve then Santhera shall grant consider whether or not it wants to agree (unless Xxxxxxxx has agreed in writing in advance) that the sublicense held by such Sublicensee shall become a direct license under the Licensed Intellectual Property granted by Santhera that is the same scope as the sublicense granted by Catalyst on the same terms and hereby grants, and shall cause its Affiliates to grant, to Beam an exclusive (even as to Verve and its Affiliates), perpetual, irrevocable, royalty-bearing (as conditions set forth in and subject to this Section 15.5.2(b)Agreement;
(c) license under the Patent Rights and Know-How Controlled by Verve Party that has Confidential Information of the other Party shall destroy or return (at the discretion of the Disclosing Party) all such Confidential Information in its Affiliates possession as of the effective date of termination (with the exception of one copy of such Confidential Information, which may be retained by the Party that either (i) claim or cover the composition, use or manufacture of the applicable Terminated Reversion Product(s) or (ii) were otherwise used or practiced in the Development, Manufacture, Commercialization or exploitation of the Terminated Reversion Product(s) on or prior to the effective date of termination (collectively, “Post-Termination Licensed Technology”), solely to Develop, Manufacture, Commercialize or otherwise exploit received such Terminated Reversion Product(s) in the Field in the Territory, provided, however, that in the case of any such Patent Right or Know-How that requires payment Confidential Information subject to a Third Party pursuant continuing obligation of non-use and non-disclosure to an applicable license or other agreement, such Patent Right or Knowconfirm compliance with the non-How shall be [**] to such Third Party as a result of Beam’s exercise of such license. Unless Beam terminates this Agreement for Verve’s material breach use and non-disclosure provisions of this Agreement and/or to comply with document retention obligations under Section 15.3.1 (in which case no royalties are owedApplicable Laws), Beam will pay Verve royalties equal to [**] percent ([**]%) of the annual aggregate Net Sales resulting from the sale of provided that each such Terminated Reversion Product in the Field in the Territory and such royalties will be due to Verve, on a Product-by-Product and country-by-country basis for the duration of the Royalty Term for the applicable Terminated Reversion Product in the applicable country as if this Agreement had stayed in effect. [**].
(c) Unless expressly prohibited by any Regulatory Authority, upon written request of Beam, Verve shall transfer control to Beam conduct of any Clinical Trials of such Terminated Reversion Product(s) being conducted as of the effective date of termination Party may retain and continue to conduct use such Clinical Trial(s) in accordance with a budget and plan agreed upon by Confidential Information of the Parties, at Beam’s cost and expense, for up other Party to [**] the extent necessary to enable such transfer to be completed without interruption of such Clinical Trial(s); provided that Beam shall not have exercise any obligation to continue any Clinical Trial unless required by Applicable Lawsurviving rights or obligations under this Agreement;
(d) Catalyst shall not, and shall cause its Affiliates and permitted Sublicensees, not to, use or register any trademark, name, sign, logo, domain name, or social media presence consisting of or containing signs identical or confusingly similar, to the word “AGAMREE”, or to Xxxxxxxx’s other Trademarks previously used in relation to the Product in any region of the Territory. To the extent thatthat Catalyst or its Affiliates own upon termination any trademark used in connection with the sale of the Product in any region of the Territory, Catalyst agrees to transfer, and to cause its Affiliates, and permitted Sublicensees, to transfer, such trademark to Santhera upon Xxxxxxxx’s request and without any compensation, and to execute all documents and perform all acts necessary or useful to give effect to such transfer and to register Santhera as the new trademark owner in all relevant registers in the Territory.
(e) Catalyst and its Affiliates and Sublicensees shall have the non-exclusive right, for a period of nine (9) months following termination by Santhera (other than termination by Santhera pursuant to Section 9.4 (Termination for Cause), Section 9.6 (Termination on Insolvency of a Party), or Section 9.8 (Termination by Santhera for Patent Challenge) in which event no such right shall exist) or by Catalyst (other than termination by Catalyst pursuant to Section 9.5 (Termination by Catalyst Without Cause)), to sell-off all inventory of the Products within the Territory then included in the license for such Product, subject to the duty to report Net Sales and pay Royalties related to such sell-off activities. For clarity, no right to sell-off inventory shall exist in case of a termination by Catalyst pursuant to Section 9.5 (Termination by Catalyst Without Cause). Subject to the foregoing, Xxxxxxxx has the right, but not the obligation, to re-purchase all or part of Catalyst’s and its Affiliates’ and its permitted Sublicensees’ inventory of the Products, provided that such Products have a minimum remaining shelf life of twelve (12) months, at a price equal to the Supply Price paid by Catalyst to Santhera therefor. For this purpose, Catalyst shall provide to Santhera a list of the relevant Product(s) in the inventory of Catalyst, its Affiliates and permitted Sublicensees, including information on the remaining quantities and the remaining shelf life of the relevant Products in the inventory at the effective date of termination of this Agreementthe termination, Verve has existing and ongoing contracts with Third Parties related to the Development, Manufacture or Commercialization of the Terminated Reversion Product(s), at the written request of Beam, Verve will use good faith commercially reasonable efforts to transfer such contracts and arrangements to Beam, including using good faith commercially reasonable efforts to assign contracts and arrangements to Beam in part or facilitate separate arrangements with Beam if such contracts and arrangements relate to more than solely the Terminated Reversion Product(s);
(e) At Beam’s written request, Verve shall deliver such quantities of as well as on the applicable Terminated Reversion Product(s) that Verve or its Affiliates has in its respective inventory or control (including inventory in its control on the premises of a Third Party subcontractor) as of the date of Beam’s request; provided that Beam shall reimburse Verve for the Cost of Goods Manufactured re-purchase prices and the costs of shipping and handling with respect documents allowing to verify such quantities; provided further thatrepurchase prices. In case Santhera did not exercise its re-purchase option, with respect to a Collaboration Product, Beam shall only be obligated to reimburse Verve for any portion of the costs thereof not previously reimbursed pursuant to this Agreement.
(f) If Beam does not manufacture the applicable Terminated Reversion Product(s) either itself or on its behalf, Verve shall supply to Beam such reasonable quantities of such Terminated Reversion Product(s) as Beam indicates in written forecasts and orders from time to time, until the earlier of (i) such time at the end of the sell-off period as Beam has established an alternativeper this Section 9.10(e), validated source of supply for such Terminated Reversion Product(s) and or (ii) the [**] of upon the effective date of the termination in case no sell-off right is granted as per this Section 9.10(e), Catalyst shall, and shall instruct its Affiliates and permitted Sublicensees to destroy, any remaining Products in the Territory, and shall send Santhera written confirmation of such destruction. (f) Nothing in this Section 9 (Term and Termination) shall limit any other remedy either Party may have for the other Party’s breach of this Agreement. The costs to Beam for supply of such Terminated Reversion Product(s) from Verve shall be equal to Verve’s Cost of Goods Manufactured for such Terminated Reversion Product(s) [**]. Notwithstanding anything to the contrary in this Agreement, if any such Terminated Reversion Product is manufactured for Verve by a Third Party contract manufacturer pursuant to a written contract, then Verve may satisfy its obligations pursuant to this Section 15.5.2(f) with respect to such Terminated Reversion Product by assigning its rights and obligations under such contract (or the portion of such contract pertaining to such Terminated Reversion Product) to Beam.
(g) Verve shall, at the written request and expense of Beam, provide Beam with such assistance as is reasonably necessary to effectuate a smooth and orderly transition to Beam or its designee of any Development, Manufacture and Commercialization activities relating to the applicable Terminated Reversion Product(s) so as to minimize the disruption of such activities, provided, however, that Verve shall not be obligated to initiate any new substantive activity, distinct from any previously ongoing substantive activity, that would itself create any new obligations on the part of Verve that would continue following such termination. Further, upon Beam’s written request, Verve shall make its personnel reasonably available to provide such technical assistance, at no cost to Beam (except for reimbursement of Verve’s direct out of pocket costs therefor), as may reasonably be requested to transfer all Manufacturing technology Controlled by Verve or its Affiliates that is or had been used by or on behalf of Verve and its Affiliates in connection with the Manufacture of any Terminated Reversion Product.
Appears in 1 contract
Samples: License and Collaboration Agreement (Catalyst Pharmaceuticals, Inc.)
Other Effects of Termination. Except for Upon termination of this Agreement by Verve under Section 15.3,Agreement:
(a) Where permitted by Applicable Law, upon written request, Verve shall assign to Beam all of its right, title and interest in and to, and transfer possession to Beam of, all Regulatory Documentation (including, for clarity, regulatory approvals) then in its name applicable to any Terminated Product other than (i) an Independent Product that is all licenses granted under this Agreement by either Party to the other Party, and any sublicenses granted by either Party under any such license, shall automatically terminate, and KYE, its Affiliates and terminated sublicensees shall refrain from using the Licensed Intellectual Property and Catalyst’s trademarks with immediate effect, and shall not a Collaboration Product or hold themselves out as being Catalyst’s licensees;
(ii) a former Collaboration Product for which Beam exercised the Beam Opt-Out Option if Verve Party that has terminated this Agreement within [**] following Beam’s exercise of such Beam Opt-Out Option (such Terminated Product, other than as described in the foregoing clauses (i) and (ii), a “Terminated Reversion Product”), in the same form in which Verve maintains such Regulatory Documentation, and upon request execute and deliver such additional documents or instruments reasonably necessary to effect such transfer, in each case at Beam’s cost and expense;
(b) Upon written request, Verve shall grant and hereby grants, and shall cause its Affiliates to grant, to Beam an exclusive (even as to Verve and its Affiliates), perpetual, irrevocable, royalty-bearing Confidential Information (as set forth defined in and subject to this Section 15.5.2(b15.1 (Confidential Information)) license under of the Patent Rights other Party shall destroy or return (at the discretion of the Disclosing Party (as defined in Section 15.2 (Obligations of Confidentiality and KnowNon-How Controlled by Verve or Use)) all such Confidential Information in its Affiliates possession as of the effective date of termination (with the exception of one copy of such Confidential Information, which may be retained by the Party that either received such Confidential Information subject to a continuing obligation of non-use and non-disclosure to confirm compliance with the non-use and non-disclosure provisions of this Agreement and/or to comply with document retention obligations under Applicable Laws), provided that each Party may retain and continue to use such Confidential Information of the other Party to the extent necessary to exercise any surviving rights or obligations under this Agreement;
(iiii) claim or cover the compositionKYE shall not, and shall cause its Affiliates and permitted sublicensees, not to, use or manufacture register any trademark, name, sign, logo, domain name, or social media presence consisting of or containing signs identical or confusingly similar, to the word “AGAMREE” or to other trademarked used in respect of the applicable Terminated Reversion Product in the Territory with the approval of Catalyst per Section 11.6, or to Catalyst or its licensor’s other Trademarks previously used in relation to the Product or Compound. To the extent that KYE or its Affiliates own upon termination any trademark used in connection with the sale of the Product in the Territory, KYE agrees to transfer, and to cause its Affiliates, and permitted sublicensees, to transfer, such trademark to Catalyst upon Catalyst’s request and without any compensation, and to execute all documents and perform all acts necessary or useful to give effect to such transfer and to register Catalyst as the new trademark owner in the Territory.
(iv) Should Catalyst terminate this Agreement, Catalyst shall re-purchase all of KYE’s and its Affiliates’ and its permitted sublicensees’ inventory of the Products, provided that such Products have a minimum remaining shelf life of twelve (12) months, at a price equal to the Supply Price paid by KYE to Catalyst therefor. For all other terminations of this Agreement, Catalyst has the right, but not the obligation, to re-purchase all or part of KYE’s and its Affiliates’ and its permitted sublicensees’ inventory of the Products, provided that such Products have a minimum remaining shelf life of twelve (12) months, at a price equal to the Supply Price paid by KYE to Catalyst therefor. For these purposes, KYE shall provide to Catalyst a list of the relevant Product(s) or (ii) were otherwise used or practiced in the Developmentinventory of KYE, Manufactureits Affiliates and permitted sublicensees, Commercialization or exploitation including information on the remaining quantities and the remaining shelf life of the Terminated Reversion Product(s) on or prior to relevant Products in the inventory at the effective date of termination (collectivelythe termination, “Postas well as on the applicable re-Termination Licensed Technology”)purchase prices and the documents allowing to verify such repurchase prices. In case Catalyst did not exercise its re-purchase option, solely at the request of Catalyst, KYE shall, and shall instruct its Affiliates and permitted sublicensees to Developdestroy, Manufacture, Commercialize or otherwise exploit such Terminated Reversion Product(s) in the Field any remaining Products in the Territory, provided, however, that in the case of any such Patent Right or Know-How that requires payment to a Third Party pursuant to an applicable license or other agreement, such Patent Right or Know-How and shall be [**] to such Third Party as a result of Beam’s exercise send Catalyst written confirmation of such license. Unless Beam terminates this Agreement for Verve’s material breach of this Agreement under Section 15.3.1 (in which case no royalties are owed), Beam will pay Verve royalties equal to [**] percent ([**]%) of the annual aggregate Net Sales resulting from the sale of each such Terminated Reversion Product in the Field in the Territory and such royalties will be due to Verve, on a Product-by-Product and country-by-country basis for the duration of the Royalty Term for the applicable Terminated Reversion Product in the applicable country as if this Agreement had stayed in effect. [**]destruction.
(cv) Unless expressly prohibited by any Regulatory Authority, upon written request If this Agreement is terminated prior to KYE being issued a notice of Beam, Verve shall transfer control compliance from Health Canada pursuant to Beam conduct of any Clinical Trials of such Terminated Reversion Product(s) being conducted as section C.08.004 of the effective date of termination Food and continue Drug Regulations to conduct such Clinical Trial(s) market the Products in accordance with the Territory, a budget and plan agreed upon by the Parties, at Beam’s cost and expense, for up reasonable transition period will be implemented to [**] to enable such transfer to be completed without interruption of such Clinical Trial(s); provided that Beam shall not have transition any obligation to continue any Clinical Trial unless required by Applicable Law;
Studies (d) To the extent that, as of the effective date of termination defined in section 2.5 of this Agreement, Verve has existing and ongoing contracts with Third Parties related to the Development, Manufacture or Commercialization of the Terminated Reversion Product(s), at the written request of Beam, Verve will use good faith commercially reasonable efforts to transfer such contracts and arrangements to Beam, including using good faith commercially reasonable efforts to assign contracts and arrangements to Beam in part or facilitate separate arrangements with Beam if such contracts and arrangements relate to more than solely the Terminated Reversion Product(s);
(e) At Beam’s written request, Verve shall deliver such quantities of the applicable Terminated Reversion Product(s) that Verve or its Affiliates has in its respective inventory or control (including inventory in its control on the premises of a Third Party subcontractor) as of the date of Beam’s request; provided that Beam shall reimburse Verve for the Cost of Goods Manufactured and the costs of shipping and handling with respect to such quantities; provided further that, with respect to a Collaboration Product, Beam shall only be obligated to reimburse Verve for any portion of the costs thereof not previously reimbursed pursuant to this Agreement.
(f) If Beam does not manufacture the applicable Terminated Reversion Product(s) either itself or on its behalf, Verve shall supply to Beam such reasonable quantities of such Terminated Reversion Product(s) as Beam indicates in written forecasts and orders from time to time, until the earlier of (i) such time as Beam has established an alternative, validated source of supply for such Terminated Reversion Product(s) and (ii) the [**] of the effective date of termination of this Agreement. The costs to Beam for supply of such Terminated Reversion Product(s) from Verve shall be equal KYE back to Verve’s Cost of Goods Manufactured for Catalyst, or such Terminated Reversion Product(s) [**]. Notwithstanding anything to the contrary in this Agreement, if any such Terminated Reversion Product is manufactured for Verve other third party designated by a Third Party contract manufacturer pursuant to a written contract, then Verve may satisfy its obligations pursuant to this Section 15.5.2(f) with respect to such Terminated Reversion Product by assigning its rights and obligations under such contract (or the portion of such contract pertaining to such Terminated Reversion Product) to BeamCatalyst.
(g) Verve shall, at the written request and expense of Beam, provide Beam with such assistance as is reasonably necessary to effectuate a smooth and orderly transition to Beam or its designee of any Development, Manufacture and Commercialization activities relating to the applicable Terminated Reversion Product(s) so as to minimize the disruption of such activities, provided, however, that Verve shall not be obligated to initiate any new substantive activity, distinct from any previously ongoing substantive activity, that would itself create any new obligations on the part of Verve that would continue following such termination. Further, upon Beam’s written request, Verve shall make its personnel reasonably available to provide such technical assistance, at no cost to Beam (except for reimbursement of Verve’s direct out of pocket costs therefor), as may reasonably be requested to transfer all Manufacturing technology Controlled by Verve or its Affiliates that is or had been used by or on behalf of Verve and its Affiliates in connection with the Manufacture of any Terminated Reversion Product.
Appears in 1 contract
Samples: License, Supply and Commercialization Agreement (Catalyst Pharmaceuticals, Inc.)