Common use of Commercialization Clause in Contracts

Commercialization. BMS, its Affiliates and Sublicensees shall be entitled to continue to sell (but not to actively promote after the effective date of termination) any existing inventory of Products in each terminated Region of the Territory for which Regulatory Approval and all pricing and reimbursement approvals therefor have been obtained (provided that such Products shall have launched in each such terminated country as of the applicable effective date of termination), in accordance with the terms and conditions of this Agreement, for a period not to exceed [***] from the effective date of such termination (the “Commercialization Wind-Down Period”). Any Products sold or disposed of by BMS, its Affiliates or Sublicensees during the Commercialization Wind-Down Period shall be subject to the same Total Compensation under Section 8.5 as would have applied had this Agreement otherwise remained in force and effect with respect to such terminated Product(s) and terminated Region(s). After the Commercialization Wind-Down Period, BMS, its Affiliates and Sublicensees shall not sell such terminated Products in such terminated Region(s) or make any representation regarding BMS’s status as a licensee of such Product in such Region(s). Either (i) at the request of BN at the end of the Commercialization Wind-Down Period or (ii) prior to the end of the Commercialization Wind-Down Period, if BN has assumed responsibilities for regulatory activities under the Regulatory Approval, has received all clearances and Regulatory Approvals needed to sell and import the terminated Product in a given terminated country, and provides written notice to BMS that it wishes to assume sale of the terminated Product in a terminated country, then, in either case (i) or (ii), at BN’s election, BMS shall sell and transfer to BN such portion of the terminated Product inventory then held by BMS or its Affiliates which is in a saleable condition (including that it is undamaged, has been stored in proper conditions and has no less than [***] shelf-life remaining) as had been allocated to the terminated Region(s) [***]. This Section 12.7(b) shall not apply in the case of termination by BMS under Section 12.2(b) based on Safety Reasons.

Appears in 3 contracts

Samples: Option and License Agreement (Bavarian Nordic a/S / ADR), Option and License Agreement (Bavarian Nordic a/S / ADR), Option and License Agreement (Bavarian Nordic a/S / ADR)

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Commercialization. BMS, its Affiliates Novartis shall have the right to determine whether it is willing to Manufacture Regional Antibody Candidates and Sublicensees shall be entitled to continue to sell (but not to actively promote after the effective date Regional Licensed Products for use in Commercialization of termination) any existing inventory of such Regional Antibody Candidates and Regional Licensed Products in each terminated Region the Surface Territory and shall communicate such determination by written notice to Surface no later than Initiation of the first Phase 3 Study. If Novartis CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED. notifies Surface that it is willing to Manufacture Regional Antibody Candidates and Regional Licensed Products for use in Commercialization in the Surface Territory for which Regulatory Approval and all pricing and reimbursement approvals therefor have been obtained (provided that such Products shall have launched in each such terminated country as of the applicable effective date of termination), in accordance with the terms and conditions of this Agreementforegoing, for a period not to exceed [***] from the effective date of such termination (the “Commercialization Wind-Down Period”). Any Products sold or disposed of then, Surface may elect, by BMS, its Affiliates or Sublicensees during the Commercialization Wind-Down Period shall be subject to the same Total Compensation under Section 8.5 as would have applied had this Agreement otherwise remained in force and effect with respect to such terminated Product(s) and terminated Region(s). After the Commercialization Wind-Down Period, BMS, its Affiliates and Sublicensees shall not sell such terminated Products in such terminated Region(s) or make any representation regarding BMS’s status as a licensee of such Product in such Region(s). Either (i) at the request of BN at the end of the Commercialization Wind-Down Period or (ii) prior to the end of the Commercialization Wind-Down Period, if BN has assumed responsibilities for regulatory activities under the Regulatory Approval, has received all clearances and Regulatory Approvals needed to sell and import the terminated Product in a given terminated country, and provides written notice to BMS that it wishes to assume sale of the terminated Product in a terminated country, then, in either case (i) or (ii), at BN’s election, BMS shall sell and transfer to BN such portion of the terminated Product inventory then held by BMS or its Affiliates which is in a saleable condition (including that it is undamaged, has been stored in proper conditions and has Novartis no less later than [***] shelf-life remainingafter its receipt of such notice from Novartis whether to utilize Novartis for such Commercial Manufacturing in the Surface Territory or to retain a Third Party contract manufacturer(s) for such purpose. If either Novartis is not willing to provide such Commercial supply (a “Novartis Election”) or Surface elects not to utilize Novartis for such Commercial supply (a “Surface Election”), then Novartis shall effect a technology transfer to a Third Party contract manufacturer(s) to enable such Third Party to provide Commercial supply of Regional Antibody Candidates and Regional Licensed Products for use in the Surface Territory, provided that such Third Party contract manufacturer(s) is approved by Novartis, such approval not to be unreasonably withheld, conditioned or delayed. The cost of such technology transfer shall be borne by (a) Novartis in the case of a Novartis Election; and (b) Surface in the case of either (i) a Surface Election or (ii) any request for a second technology transfer, whether in the case of a Novartis Election or Surface Election; provided, however that Surface may not require of Novartis more than [***] such transfers for any Regional Licensed Product. Further, in the case of a Novartis Election, Novartis shall remain responsible for Manufacturing Commercial supply for use in the Surface Territory until the earlier of (x) such time as had been allocated to the terminated Region(stechnology transfer is completed or (y) [***]. This Section 12.7(b) shall not apply ] If Novartis is willing to Manufacture Regional Antibody Candidates and Regional Licensed Products for use in Commercialization in the case Surface Territory and Surface elects to utilize Novartis for such Commercial Manufacturing in the Surface Territory, the terms of termination by BMS under Section 12.2(b) based on Safety Reasonssupply of such Regional Antibody Candidates and Regional Licensed Products for use in Commercialization of such Regional Antibody Candidates and Regional Licensed Products in the Surface Territory will be set forth in the RLP Supply Agreement.

Appears in 3 contracts

Samples: Collaboration Agreement (Surface Oncology, Inc.), Collaboration Agreement (Surface Oncology, Inc.), Collaboration Agreement (Surface Oncology, Inc.)

Commercialization. BMSTo avoid disruption in the availability of Terminated Products to patients, if this Agreement is terminated after the First Commercial Sale of a Terminated Product, AbbVie, its Affiliates and its Sublicensees shall be entitled to continue to sell (but not to actively promote after the effective date of termination) any existing inventory of Products in each terminated Region of the Territory for which Regulatory Approval and all pricing and reimbursement approvals therefor have been obtained (provided that distribute such Products shall have launched in each such terminated country as of the applicable effective date of termination)Terminated Product, in accordance with the terms and conditions of this Agreement, in each country for a period not to exceed which Regulatory Approval therefor has been obtained, until [***] from after the date on which Licensor notifies AbbVie in writing that Licensor has secured an alternative distributor or licensee for the Terminated Product in such country, but in no event more for than [***] after the effective date of such any expiration or termination of this Agreement (the “Commercialization Wind-Down down Period”); provided that AbbVie, its Affiliates and its Sublicensees shall cease such activities, or any portion thereof, in a given country upon [***] notice by Licensor requesting that such activities (or portion thereof) be ceased. Notwithstanding any other provision of this *** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request. Agreement, during the Commercialization Wind-down Period, AbbVie’s and its Affiliates’ and Sublicensees’ rights with respect to Terminated Products shall be non-exclusive and, without limiting the foregoing, Licensor shall have the right to engage one or more other distributor(s) and/or licensee(s) of the Product in all or part of the Territory. Any Products Product sold or disposed of by BMSAbbVie, its Affiliates or its Sublicensees in the Territory during the Commercialization Wind-Down down Period shall be subject to the same Total Compensation applicable payment obligations under Section 8.5 as would have applied had this Agreement otherwise remained in force and effect with respect to such terminated Product(s) and terminated Region(s)ARTICLE 6 above. After the Commercialization Wind-Down Period, BMS, its Affiliates and Sublicensees shall not sell such terminated Products in such terminated Region(s) or make any representation regarding BMS’s status as a licensee Within [***] of such Product in such Region(s). Either (i) at the request of BN at the end expiration of the Commercialization Wind-Down Period or (ii) prior to the end down Period, AbbVie shall notify Licensor of any quantity of the Commercialization Wind-Down PeriodProduct remaining in AbbVie’s inventory and Licensor shall have the option, if BN has assumed responsibilities for regulatory activities under the Regulatory Approval, has received all clearances and Regulatory Approvals needed to sell and import the terminated Product in a given terminated country, and provides written upon notice to BMS that it wishes AbbVie, to assume sale repurchase any such quantities of the terminated Product in from AbbVie at a terminated country, then, in either case (i) or (ii), at BNprice equal to AbbVie’s election, BMS shall sell and transfer to BN Manufacturing Cost of such portion of the terminated Product inventory then held by BMS or its Affiliates which is in a saleable condition (including that it is undamaged, has been stored in proper conditions and has no less than [***] shelf-life remaining) as had been allocated to the terminated Region(s) [***]. This Section 12.7(b) shall not apply in the case of termination by BMS under Section 12.2(b) based on Safety Reasonsquantities.

Appears in 2 contracts

Samples: Development and Option Agreement (Alector, Inc.), Development and Option Agreement (Alector, Inc.)

Commercialization. BMSExcept to the extent the applicable termination was made in accordance with Section 14.6, if this Agreement is terminated after the First Commercial Sale of a Terminated Product and Takeda is the Commercial Lead with respect to the applicable Terminated Product, Takeda, its Affiliates and its Sublicensees shall be entitled to continue to sell (but not to actively promote after the effective date of termination) any existing inventory of Products in each terminated Region of the Territory for which Regulatory Approval and all pricing and reimbursement approvals therefor have been obtained (provided that distribute such Products shall have launched in each such terminated country as of the applicable effective date of termination)Terminated Product, in accordance with the terms and conditions of this Agreement, in each country for a period not to exceed which Regulatory Approval therefor has been obtained, until [***] from after the effective date of such termination (the “Commercialization Wind-Down down Period”); provided that Takeda, its Affiliates and its Sublicensees shall cease such activities, or any portion thereof, in a given country upon [***] days’ notice by Denali requesting that such activities (or portion thereof) be ceased. Notwithstanding any other provision of this Agreement, during the Commercialization Wind-down Period, Takeda’s and its Affiliates’ and Sublicensees’ rights with respect to Terminated Products shall be non-exclusive and, without limiting the foregoing, Denali shall have the right to engage one or more other distributor(s) and/or licensee(s) of the Terminated Product in all or part of the Territory. Any Products Terminated Product sold or disposed of by BMSTakeda, its Affiliates or its Sublicensees in the Territory during the Commercialization Wind-Down down Period shall be subject to applicable payment obligations under Article 8. Unless [***], any Terminated Product sold or disposed of by Denali, its Affiliates or its Sublicensees (but not, for clarity any sales during such period by Takeda, its Affiliates, or Sublicensees) in the same Total Compensation under Section 8.5 as would have applied had this Agreement otherwise remained in force and effect with respect to such terminated Product(s) and terminated Region(s). After Territory during the Commercialization Wind-Down Period, BMS, its Affiliates and Sublicensees down Period shall not sell such terminated Products in such terminated Region(s) or make any representation regarding BMS’s status as a licensee be subject to applicable payment obligations to Takeda under Section 14.7.1. Within [***] days of such Product in such Region(s). Either (i) at the request of BN at the end expiration of the Commercialization Wind-Down Period or (ii) prior down Period, Takeda shall notify Denali of any quantity of Terminated Product remaining in Takeda’s inventory and Denali shall have the option, upon notice to the end Takeda, to repurchase any such quantities of the Commercialization Wind-Down Period, if BN has assumed responsibilities for regulatory activities under the Regulatory Approval, has received all clearances and Regulatory Approvals needed Terminated Product from Takeda at a price equal to sell and import the terminated Product in a given terminated country, and provides written notice to BMS that it wishes to assume sale of the terminated Product in a terminated country, then, in either case (i) or (ii), at BN’s election, BMS shall sell and transfer to BN such portion of the terminated Product inventory then held by BMS or its Affiliates which is in a saleable condition (including that it is undamaged, has been stored in proper conditions and has no less than [***] shelf-life remaining) as had been allocated of such quantities (to the terminated Region(s) extent [***]. This Section 12.7(b) shall not apply in the case of termination by BMS under Section 12.2(b) based on Safety Reasons).

Appears in 2 contracts

Samples: Option and Collaboration Agreement (Denali Therapeutics Inc.), Option and Collaboration Agreement (Denali Therapeutics Inc.)

Commercialization. BMSTo avoid disruption in the availability of Licensed Product to patients, its Affiliates if this Agreement is terminated after the First Commercial Sale of the Licensed Product in the Territory, then to the extent requested by Licensor, Licensee and Sublicensees Related Parties shall be entitled to continue to sell (but not to actively promote after distribute the effective date of termination) any existing inventory of Products in each terminated Region of the Territory for which Regulatory Approval and all pricing and reimbursement approvals therefor have been obtained (provided that such Products shall have launched in each such terminated country as of the applicable effective date of termination)Licensed Product, in accordance with the terms and conditions of this Agreement, in each country of the Territory for which Regulatory Approval therefor has been obtained, [***] following the effective date of termination (the “Wind-down Period”); provided that Licensee and Related Parties shall cease such activities, or any portion thereof, in a given country upon [***] notice by Licensor requesting that such activities be ceased. In the event that the Licensor will not have secured an alternative distributor or licensee for the Licensed Product in a country within the Wind-down Period, the Parties shall cooperate reasonably to execute and deliver such commercially reasonable agreements as may be necessary to preserve for Licensor the benefit of distribution of the Licensed Product in such country for a period not to exceed of up [***] additional months, provided that such period shall, upon Licensor’s request, be extended for an additional [***] (for a total of [***] from the effective date of termination) in the event that Licensor will not have secured an alternative distributor or licensee for the Licensed Product in such country [***] from the effective date of termination (despite having used Commercially Reasonable Efforts to do so. Such agreement shall provide that Licensee will fulfill orders for Licensed Product in the “Commercialization Territory on a contract basis, with Licensor booking all sales and retaining the revenue from such sales while indemnifying and holding the Licensee Indemnities harmless from all costs and expenses of such distribution and any Liabilities from a Third Party Claim arising from, out of or in connection with such distribution. Notwithstanding any other provision of this Agreement, during the Wind-Down down Period”), Licensee’s and its Affiliates’ and, subject to Section 2.3(b) above, Non-Affiliate Sublicensees’ rights with respect to the Licensed Product in the Territory shall be non-exclusive and, without limiting the foregoing, Licensor shall have the right to engage one or more other distributor(s) and/or licensee(s) of the Licensed Product in all or part of the Territory. Any Products Licensed Product sold or disposed of by BMSLicensee, its Affiliates or and, subject to Section 2.3(b) above, its Non-Affiliate Sublicensees in the Territory during the Commercialization Wind-Down down Period shall be subject to the same Total Compensation applicable payment obligations under Article 6 above. The obligations set forth in this Section 8.5 as would have applied had this Agreement otherwise remained in force and effect with respect to such terminated Product(s) and terminated Region(s). After the Commercialization Wind-Down Period, BMS, its Affiliates and Sublicensees shall not sell such terminated Products in such terminated Region(s) or make any representation regarding BMS’s status as a licensee of such Product in such Region(s). Either (i) at the request of BN at the end of the Commercialization Wind-Down Period or (ii) prior to the end of the Commercialization Wind-Down Period, if BN has assumed responsibilities for regulatory activities under the Regulatory Approval, has received all clearances and Regulatory Approvals needed to sell and import the terminated Product in a given terminated country, and provides written notice to BMS that it wishes to assume sale of the terminated Product in a terminated country, then, in either case (i) or (ii), at BN’s election, BMS shall sell and transfer to BN such portion of the terminated Product inventory then held by BMS or its Affiliates which is in a saleable condition (including that it is undamaged, has been stored in proper conditions and has no less than [***] shelf-life remaining) as had been allocated to the terminated Region(s) [***]. This Section 12.7(b11.5(d)(i)(B) shall not apply in any country or jurisdiction in which, as of the case effective date of termination by BMS under Section 12.2(b) based on Safety Reasonsof this Agreement, the Royalty Term with respect to the applicable Licensed Product has expired or Generic Competition with respect to such License Product exists.

Appears in 2 contracts

Samples: License and Collaboration Agreement (Cullinan Oncology, LLC), License and Collaboration Agreement (Cullinan Oncology, LLC)

Commercialization. BMSProvided that the termination of this Agreement is not a termination by Galderma pursuant to Section 12.2.4, if requested by NovaBay, Galderma and its Affiliates and Sublicensees Marketing Partners shall be entitled to continue to distribute and sell (but not to actively promote after the effective date of termination) any existing inventory of Collaboration Products in the Field in each terminated Region country of the Galderma Territory for which Regulatory Marketing Approval and all pricing and reimbursement approvals therefor have has been obtained (provided that such Products shall have launched in each such terminated country as of the applicable effective date of termination)obtained, in accordance with the terms and conditions of this Agreement, for a period requested by NovaBay not to exceed [***] two (2) years from the effective date of such expiration or termination (for purposes of this Section 12.6.3, the “Commercialization Agreement Wind-Down Period); provided that NovaBay may terminate the Agreement Wind-Down Period upon sixty (60) days’ notice to Galderma. Notwithstanding any other provision of this Agreement, during the Agreement Wind-Down Period, Galderma’s, its Affiliates’ and its Marketing Partners’ rights with respect to Collaboration Products (including the licenses granted under Section 7.1.1) shall be non-exclusive and NovaBay shall have the right to engage one or more other partner(s) or distributor(s) of Collaboration Products in the Field in all or part of the Galderma Territory. Any Collaboration Products sold or disposed of by BMS, Galderma or its Affiliates or Sublicensees Marketing Partners during the Commercialization Agreement Wind-Down Period shall be subject to the same Total Compensation applicable royalties under Section 8.5 as would have applied had this Agreement otherwise remained in force and effect with respect to such terminated Product(s) and terminated Region(s)8.5. After the Commercialization Agreement Wind-Down Period, BMS, Galderma and its Affiliates and Sublicensees Marketing Partners shall not sell such terminated Products in such terminated Region(s) or make any representation regarding BMS’s their status as a licensee of or distributor for NovaBay for any Collaboration Product. In addition, Galderma shall promptly provide NovaBay copies of customer lists and other customer information relating to Collaboration Products reasonably necessary in Galderma’s reasonable opinion for NovaBay to continue to Commercialize such Product in such Region(s). Either (i) at Collaboration Products, which NovaBay shall have the request of BN at right to use and disclose for any purpose during the end of the Commercialization Agreement Wind-Down Period or (ii) prior to the end of the Commercialization Wind-Down Period, if BN has assumed responsibilities for regulatory activities under the Regulatory Approval, has received all clearances and Regulatory Approvals needed to sell and import the terminated Product in a given terminated country, and provides written notice to BMS that it wishes to assume sale of the terminated Product in a terminated country, then, in either case (i) or (ii), at BN’s election, BMS shall sell and transfer to BN such portion of the terminated Product inventory then held by BMS or its Affiliates which is in a saleable condition (including that it is undamaged, has been stored in proper conditions and has no less than [thereafter. ***] shelf-life remaining) as had Confidential treatment requested pursuant to a request for confidential treatment filed with the Securities and Exchange Commission. Omitted portions have been allocated to filed separately with the terminated Region(s) [***]. This Section 12.7(b) shall not apply in the case of termination by BMS under Section 12.2(b) based on Safety ReasonsCommission.

Appears in 2 contracts

Samples: Collaboration and License Agreement (NovaBay Pharmaceuticals, Inc.), Collaboration and License Agreement (NovaBay Pharmaceuticals, Inc.)

Commercialization. BMSTo avoid a disruption in the supply of Products to patients, if the Agreement is terminated after the first commercial sale of any Product in the Excluded Region, Cephalon, its Affiliates and Sublicensees its Marketing Partners shall be entitled to continue to sell (but not to actively promote after distribute the effective date of termination) any existing inventory of Products in each terminated Region country of the Territory Excluded Region for which Regulatory Marketing Approval and all pricing and reimbursement approvals therefor have has been obtained (provided that such Products shall have launched in each such terminated country as of the applicable effective date of termination)obtained, in accordance with the terms and conditions of this Agreement, until the date on which Angioblast notifies Cephalon in writing that Angioblast has secured an alternative distributor or licensee for the Products in such country, during the Wind-down Period; provided that Cephalon, its Affiliates and its Marketing Partners shall cease such activities, or any portion thereof, in a period not given country of the Excluded Region upon sixty (60) days’ notice by Angioblast requesting that such activities (or portion thereof) be ceased. Notwithstanding any other provision of this Agreement, during the Wind-down Period, Cephalon’s and its Affiliates’ and Marketing Partners’ rights with respect to exceed the Products in the Excluded Region shall be non-exclusive and, without limiting the foregoing, Angioblast shall have the right to engage one or more other distributor(s) and/or THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED WITH [*** * *] from AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. licensee(s) of any Products in all or part of the effective date of such termination (the “Commercialization Wind-Down Period”)Excluded Region. Any Products sold or disposed of by BMS, its Affiliates or Sublicensees Cephalon in the Excluded Region during the Commercialization Wind-Down down Period shall be subject to the same Total Compensation applicable payment obligations under Section 8.5 as would have applied had this Agreement otherwise remained in force and effect with respect to such terminated Product(s) and terminated Region(s). After the Commercialization Wind-Down Period, BMS, its Affiliates and Sublicensees shall not sell such terminated Products in such terminated Region(s) or make any representation regarding BMS’s status as a licensee of such Product in such Region(s). Either (i) at the request of BN at the end of the Commercialization Wind-Down Period or (ii) prior to the end of the Commercialization Wind-Down Period, if BN has assumed responsibilities for regulatory activities under the Regulatory Approval, has received all clearances and Regulatory Approvals needed to sell and import the terminated Product in a given terminated country, and provides written notice to BMS that it wishes to assume sale of the terminated Product in a terminated country, then, in either case (i) or (ii), at BN’s election, BMS shall sell and transfer to BN such portion of the terminated Product inventory then held by BMS or its Affiliates which is in a saleable condition (including that it is undamaged, has been stored in proper conditions and has no less than [***] shelf-life remaining) as had been allocated to the terminated Region(s) [***]. This Section 12.7(b) shall not apply in the case of termination by BMS under Section 12.2(b) based on Safety ReasonsARTICLE VI above.

Appears in 2 contracts

Samples: Development and Commercialization Agreement (Mesoblast LTD), Development and Commercialization Agreement (Mesoblast LTD)

Commercialization. BMS, Exactus BioSolutions and its Affiliates and Sublicensees shall be entitled to continue to sell (but not to actively promote after the effective date of termination) any existing inventory of Products in each terminated Region country of the Territory for which Regulatory Approval and all pricing and reimbursement approvals therefor have has been obtained (provided that such Products shall have launched in each such terminated country as of the applicable effective date of termination), in accordance with the terms and conditions of this Agreement, for a period not to exceed [***] twelve (12) months from the effective date of such termination (the “Commercialization Wind-Down Period”). Any Products sold or disposed of by BMS, Exactus BioSolutions or its Affiliates or Sublicensees during the Commercialization Wind-Down Period shall be subject to the same Total Compensation royalties under Section 8.5 8.4 as would have applied had this Agreement otherwise remained in force and effect with respect to such terminated Product(s) Product and terminated Region(scountry(ies). After the Commercialization Wind-Down Period, BMS, Exactus BioSolutions and its Affiliates and Sublicensees shall not sell such terminated Products in such terminated Region(scountry(ies) or make any representation regarding BMS’s Exactus BioSolutions’ status as a licensee Exactus BioSolutions of such Product in such Region(scountry(ies). Either (i) at the request of BN Digital Diagnostics at the end of the Commercialization Wind-Down Period or (ii) prior to the end of the Commercialization Wind-Down Period, if BN Digital Diagnostics has assumed responsibilities for regulatory activities under the Regulatory Approval, has received all clearances and Regulatory Approvals needed to sell and import the terminated Product in a given terminated country, and provides written notice to BMS Exactus BioSolutions that it is wishes to assume sale of the terminated Product in a terminated country, then, in either case (i) or (ii), at BN’s election, BMS Exactus BioSolutions shall sell and transfer to BN Digital Diagnostics such portion of the terminated Product inventory then held by BMS Exactus BioSolutions or its Affiliates which is in a saleable condition (including that it is undamaged, has been stored in proper conditions and has no less than [***] shelf-life remaining) Affiliates’ as had been allocated to the terminated Region(scountry(ies) [***]at a price equal to the lowest price at which such Product was sold to a non-Related Party in such terminated country during the preceding twelve (12) month period. This Section 12.7(b13.7(b) shall not apply in the case of termination by BMS Exactus BioSolutions under Section 12.2(b13.2(b) based on Safety Reasons.

Appears in 1 contract

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

Commercialization. BMS, MEI and its Affiliates and Sublicensees shall be entitled to continue to sell distribute (but shall not be obligated to actively promote after the effective date of terminationmarket or promote) any existing inventory of Products such Product(s) in each terminated Region of the Territory for which if Regulatory Approval and all pricing and reimbursement approvals therefor have has been obtained (provided that such Products shall have launched in each such terminated country as of the applicable effective date of termination)obtained, in accordance with the terms and conditions of this Agreement, for a period not up to exceed [***] from twelve (12) months following the effective date of any such termination (the “Commercialization Wind-Down Wind down Period”); provided, that, the Parties shall enter into a transition services agreement pursuant to which MEI will continue to distribute such Product(s) in such country(ies) [*CONFIDENTIAL*]. At Presage’s request, such transition services agreement shall be negotiated in good faith during the applicable notice period preceding termination of this Agreement. In any event, MEI shall, and shall cause its Affiliates and Sublicensees to, cease distribution of the Product, or any portion thereof, upon [*CONFIDENTIAL*] notice by Presage requesting that such activities (or portion thereof) be ceased at any time following the expiration of Wind down Period). Notwithstanding any other provision of this Agreement, during the Wind down Period, MEI’s rights with respect to Compound and Product in the Territory shall be non-exclusive and Presage shall have the right to engage one or more other distributor(s) and/or licensee(s) of the Compound and Product in the Territory. Any Products sold or disposed of by BMSMEI, its Affiliates or Sublicensees and/or Sublicensees, in the Territory during the Commercialization Wind-Down Wind down Period shall be subject to payments under and in accordance with Section 5 above. Within [*CONFIDENTIAL*] of expiration of the same Total Compensation under Section 8.5 as would have applied had this Agreement otherwise remained in force and effect Wind down Period, MEI shall notify Presage of any quantity of Compound and/or A request for confidential treatment has been made with respect to such terminated Product(s) and terminated Region(s). After the Commercialization Wind-Down Period, BMS, its Affiliates and Sublicensees shall not sell such terminated Products in such terminated Region(s) or make any representation regarding BMS’s status as a licensee of such Product in such Region(s). Either (i) at the request of BN at the end portions of the Commercialization Wind-Down Period or (ii) prior to the end of the Commercialization Wind-Down Period, if BN has assumed responsibilities for regulatory activities under the Regulatory Approval, has received all clearances and Regulatory Approvals needed to sell and import the terminated Product in a given terminated country, and provides written notice to BMS following document that it wishes to assume sale of the terminated Product in a terminated country, then, in either case (i) or (ii), at BN’s election, BMS shall sell and transfer to BN such portion of the terminated Product inventory then held by BMS or its Affiliates which is in a saleable condition (including that it is undamaged, has been stored in proper conditions and has no less than are marked with [***] shelf-life remaining) as had been allocated to the terminated Region(s) [**CONFIDENTIAL*]. This The redacted portions have been filed separately with the SEC. Product remaining in MEI’s inventory and Presage shall repurchase any such quantities of Compound and/or Product, as applicable, from MEI at a price equal to the supply price paid by MEI for such Compound and/or Product plus [*CONFIDENTIAL*]; except with respect to any such quantities of such Compound and/or Product manufactured by MEI (or its contract manufacturer), in respect of which the price shall be equal to MEI’s actual costs for such quantities of Compound and/or Product, as applicable, plus [*CONFIDENTIAL*]. In addition, MEI shall use Commercially Reasonable Efforts to cooperate, at Presage’s sole cost and expense, to transition to Presage upon Presage’s request any arrangement with any contractor from which MEI was obtaining supply of any Compound and/or Product to the extent such arrangement solely pertains to the Compound and/or Product and no other products of MEI. Notwithstanding anything to the contrary in this Section 12.7(b) 10.4(c)(iii), in the event of a safety or ethical concern regarding the continued Commercialization or use of the Product, MEI shall not apply in be obligated to continue Commercializing the case of termination by BMS under Section 12.2(b) based on Safety ReasonsProduct.

Appears in 1 contract

Samples: License Agreement (MEI Pharma, Inc.)

Commercialization. BMS, its Affiliates and Sublicensees shall be entitled to continue to sell (but not to actively promote after the effective date of termination) any existing inventory of Products in each terminated Region Upon successful completion of the Territory for which Regulatory Approval Development and all pricing Manufacturing Phase and reimbursement approvals therefor have been obtained (provided that such Products shall have launched in each such terminated country as upon receipt of the applicable effective date of termination)Regulatory Approval in a given country in the Territory required in order to sell the Assay in such country, Microgenics shall use Commercially Reasonable Efforts to exclusively commercialize and market the Assay, under the Thermo Scientific tradename and packaging and utilizing Microgenics’ and its Affiliate’s commercial infrastructure, in accordance with each country within the terms Territory in which Achaogen is commercializing Plazomicin for so long as Achaogen is commercializing Plazomicin in such country. Solely to the extent Achaogen elects to promote an assay which may be capable of measuring Plazomicin in a given Primary Country ([***]) in the Territory, and subject to receipt and conditions of this Agreementany applicable Regulatory Approvals, for a period not Achaogen shall prioritize the promotion of the Assay relative to exceed any other assay which may be capable of measuring Plazomicin, in its marketing and sales efforts in such Primary Country; provided, however, that in the event (a) Microgenics [***] from is unable to supply the effective date of such termination (the “Commercialization Wind-Down Period”). Any Products sold or disposed of by BMSAssay in quantities sufficient to meet each applicable Binding Forecast, its Affiliates or Sublicensees during the Commercialization Wind-Down Period shall be subject to the same Total Compensation under Section 8.5 as would have applied had this Agreement otherwise remained in force and effect with respect to such terminated Product(s) and terminated Region(s). After the Commercialization Wind-Down Period, BMS, its Affiliates and Sublicensees shall not sell such terminated Products in such terminated Region(s) or make any representation regarding BMS’s status as a licensee of such Product in such Region(s). Either (i) at the request of BN at the end of the Commercialization Wind-Down Period or (ii) prior to the end of the Commercialization Wind-Down Period, if BN has assumed responsibilities for regulatory activities under the Regulatory Approval, has received all clearances and Regulatory Approvals needed to sell and import the terminated Product in a given terminated country, and provides written notice to BMS that it wishes to assume sale of the terminated Product in a terminated country, then, in either case (i) or (ii), at BN’s election, BMS shall sell and transfer to BN such portion of the terminated Product inventory then held by BMS or its Affiliates which is in a saleable condition (including that it is undamaged, has been stored in proper conditions and has no less than [***] shelf-life remaining) as had been allocated to the terminated Region(s], or (b) [***]. This Section 12.7(b) shall not apply , Achaogen may prioritize the promotion of assays capable of measuring Plazomicin in the case affected country(ies). For clarity, and notwithstanding anything to the contrary in this Agreement, including this Section 4.2, Achaogen expressly reserves and retains the right to, directly or indirectly (including through contractors or collaborators), research, develop, manufacture, use or commercialize assays capable of termination measuring Plazomicin other than the Assay; provided, that, Achaogen may not, directly or indirectly (including through contractors or collaborators) commercialize any immunoassay [***], other than the Assay in accordance herewith, [***]; provided, further, that the restriction on Achaogen’s right to commercialize immunoassays [***], other than the Assay, shall be of no force or effect if Microgenics is unable to supply the Assay for [***] ([***]) days at any time [***] or if the Parties mutually determine that Microgenics will not be able to supply the Assay. Additional commercialization and supply terms may be added to this Agreement in the form of an amendment. Without limiting the foregoing: [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential Treatment has been requested with respect to the omitted portions. Confidential Treatment Requested by BMS under Section 12.2(b) based on Safety Reasons.Achaogen, Inc.

Appears in 1 contract

Samples: Collaborative Development and Commercialization Agreement (Achaogen Inc)

Commercialization. BMSTo avoid a disruption in the supply of XenoPort Products to patients, if this Agreement is terminated after the first commercial sale of any XenoPort Product in the Territory, Xanodyne and its Affiliates and Sublicensees shall be entitled to continue to sell market, promote, distribute and otherwise commercialize (but not including with the assistance of any Co-Promotion Partner, to actively promote after the effective date of terminationextent permitted by any agreement with such Co-Promotion Partner) any existing inventory of the XenoPort Products in each terminated Region of the Territory for which Regulatory Marketing Approval and all pricing and reimbursement approvals therefor have by the FDA has been obtained (provided unless the FDA or a court of competent jurisdiction in the Territory issues a directive or order that such Products shall have launched a particular XenoPort Product be recalled or withdrawn in each such terminated country as of the applicable effective date of termination)Territory, or the Parties mutually agree that a particular XenoPort Product should be recalled or withdrawn in the Territory) and in accordance with the terms * Certain confidential information contained in this document, marked by brackets, is filed with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. and conditions of this Agreement, for a period not to exceed until [***... * ...], but in no event [... * ...] from after the effective date of any such termination of this Agreement (the “Commercialization Wind-Down down Period”); provided that Xanodyne and its Affiliates shall cease such activities, or any portion thereof, upon [... * ...] notice by XenoPort requesting that such activities (or portion thereof) be ceased. Notwithstanding any other provision of this Agreement, during the Wind-down Period, Xanodyne’s rights with respect to the Compound and XenoPort Products in the Territory shall be non-exclusive and, without limiting the foregoing, XenoPort shall have the right to engage one or more other distributor(s) and/or licensee(s) of the Compound and/or any XenoPort Product in the Territory. Any Products sold or disposed of by BMS, its Affiliates or Sublicensees Xanodyne in the Territory during the Commercialization Wind-Down down Period shall be subject to the same Total Compensation applicable payment obligations under Section 8.5 as would have applied had Article 6 above and all relevant deductions or credits due to Xanodyne in accordance with this Agreement otherwise remained in force and effect with respect to such terminated Product(s) and terminated Region(s)Agreement. After Within [... * ...] of expiration of the Commercialization Wind-Down down Period, BMS, its Affiliates and Sublicensees Xanodyne shall not sell such terminated Products in such terminated Region(s) or make notify XenoPort of any representation regarding BMS’s status as a licensee of such Product in such Region(s). Either (i) at the request of BN at the end quantity of the Commercialization Wind-Down Period or (ii) prior Intermediate, Compound and/or XenoPort Products remaining in Xanodyne’s inventory and XenoPort shall have the option, upon notice to the end Xanodyne, to repurchase any such quantities of the Commercialization WindIntermediate, Compound and/or XenoPort Products, as applicable, from Xanodyne at a price equal to [... * ...] calculated in accordance with GAAP and Xanodyne’s then-Down Periodprevailing standard procedures for calculating costs of good sold. For the sake of clarity, if BN has assumed responsibilities for regulatory activities under the Regulatory Approval, has received all clearances and Regulatory Approvals needed to sell and import the terminated Product in a given terminated country, and provides written notice to BMS that it wishes to assume sale of the terminated Product in a terminated country, then, in either case (i) or (ii), at BN’s election, BMS shall sell and transfer to BN such portion of the terminated Product inventory then held by BMS or its Affiliates which is in a saleable condition (including that it is undamaged, has been stored in proper conditions and has no less than [***] shelf-life remaining) as had been allocated to the terminated Region(s) [***... * ...]. This Section 12.7(b) shall not apply in the case of termination by BMS under Section 12.2(b) based on Safety Reasons.

Appears in 1 contract

Samples: Licensing Agreement (Xenoport Inc)

Commercialization. BMSTo avoid a disruption in the supply of XenoPort Products to patients, if this Agreement is terminated after the first commercial sale of any XenoPort Product in the Territory, Xanodyne and its Affiliates and Sublicensees shall be entitled to continue to sell market, promote, distribute and otherwise commercialize (but not including with the assistance of any Co-Promotion Partner, to actively promote after the effective date of terminationextent permitted by any agreement with such Co-Promotion Partner) any existing inventory of the XenoPort Products in each terminated Region of the Territory for which Regulatory Marketing Approval and all pricing and reimbursement approvals therefor have by the FDA has been obtained (provided unless the FDA or a court of competent jurisdiction in the Territory issues a directive or order that such Products shall have launched a particular XenoPort Product be recalled or withdrawn in each such terminated country as of the applicable effective date of termination)Territory, or the Parties mutually agree that a particular XenoPort Product should be recalled or withdrawn in the Territory) and in accordance with the terms and conditions of this Agreement, until the date on which XenoPort notifies Xanodyne in writing that XenoPort has secured an alternative distributor or licensee for a period not to exceed [***] from the Compound and XenoPort Products in the Territory, but in no event for more than six(6) months after the effective date of any such termination of this Agreement (the “Commercialization "Wind-Down down Period"); provided that Xanodyne and its Affiliates shall cease such activities, or any portion thereof, upon sixty (60) days' notice by XenoPort requesting that such activities (or portion thereof) be ceased. Notwithstanding any other provision of this Agreement, during the Wind-down Period, Xanodyne's rights with respect to the Compound and XenoPort Products in the Territory shall be non-exclusive and, without limiting the foregoing, XenoPort shall have the right to engage one or more other distributor(s) and/or licensee(s) of the Compound and/or any XenoPort Product in the Territory. Any Products sold or disposed of by BMS, its Affiliates or Sublicensees Xanodyne in the Territory during the Commercialization Wind-Down down Period shall be subject to the same Total Compensation applicable payment obligations under Section 8.5 as would have applied had Article 6 above and all relevant deductions or credits due to Xanodyne in accordance with this Agreement otherwise remained in force and effect with respect to such terminated Product(sAgreement. Within thirty (30) and terminated Region(s). After days of expiration of the Commercialization Wind-Down down Period, BMSXanodyne shall notify XenoPort of any quantity of the Intermediate, its Affiliates Compound and/or XenoPort Products remaining in Xanodyne's inventory and Sublicensees XenoPort shall have the option, upon notice to Xanodyne, to repurchase any such quantities of the Intermediate, Compound and/or XenoPort Products, as applicable, from Xanodyne at a price equal to the fully burdened costs (excluding overhead) incurred by Xanodyne to manufacture or have manufactured such Intermediate, Compound and/or XenoPort Products, as applicable, calculated in accordance with GAAP and Xanodyne's then-prevailing standard procedures for calculating costs of good sold. For the sake of clarity, such fully burdened costs shall not sell such terminated Products in such terminated Region(s) include any margins or make any representation regarding BMS’s status as a licensee of such Product in such Region(s). Either (i) at the request of BN at the end of the Commercialization Wind-Down Period or (ii) prior to the end of the Commercialization Wind-Down Period, if BN has assumed responsibilities for regulatory activities under the Regulatory Approval, has received all clearances and Regulatory Approvals needed to sell and import the terminated Product in a given terminated country, and provides written notice to BMS that it wishes to assume sale of the terminated Product in a terminated country, then, in either case (i) or (ii), at BN’s election, BMS shall sell and transfer to BN such portion of the terminated Product inventory then held by BMS or its Affiliates which is in a saleable condition (including that it is undamaged, has been stored in proper conditions and has no less than [***] shelf-life remaining) as had been allocated to the terminated Region(s) [***]. This Section 12.7(b) shall not apply in the case of termination by BMS under Section 12.2(b) based on Safety Reasonsother markup.

Appears in 1 contract

Samples: Licensing Agreement (Xanodyne Pharmaceuticals Inc)

Commercialization. BMS, its Affiliates and Sublicensees shall be entitled (a) Subject to continue to sell (but not to actively promote after the effective date of termination) any existing inventory of Products in each terminated Region of the Territory for which Regulatory Approval and all pricing and reimbursement approvals therefor have been obtained (provided that such Products shall have launched in each such terminated country as of the applicable effective date of termination), in accordance with the terms and conditions of this Agreement, GSK shall have the exclusive right, and sole responsibility and decision-making authority (either itself or through one or more Affiliates, Sublicensees or other Third Parties selected by GSK), in all matters relating to the Commercialization of any Compound and any Product for the GSK Territory as of and following the Effective Date (except for the Scynexis Transitional Commercialization Rights). Without limiting the generality of the foregoing and except for the Scynexis Transitional Commercialization Rights, GSK, at its sole expense, is solely responsible for and has full control over, all sales, marketing and other Commercialization activities for any Product for the GSK Territory as of and following the Effective Date, including sole responsibility for (i) any decisions and negotiations with relevant Regulatory Authorities regarding price and reimbursement status of any Product for the GSK Territory, and (ii) the creation, preparation, production, reproduction, and filing with the applicable Regulatory Authorities of relevant written sales, promotion and advertising materials relating to any Product for use in the GSK Territory. GSK shall, except for the Scynexis Transitional Commercialization Rights, sell, distribute, and book all sales of all Products in the GSK Territory. Subject to its diligence obligations set forth in Section ‎4.6, GSK has the sole right, in its discretion, to decide whether to launch or continue to sell any Product in any market in the GSK Territory. During the Commercialization Transition Period, the Parties shall complete their respective activities under the Commercialization Transition Plan to enable GSK to efficiently initiate Commercialization in the United States of the Product marketed by Scynexis as of the Execution Date under the Trademark BREXAFEMME® (including, the assignment by Scynexis or its Affiliates to GSK and the assumption by GSK of all of Scynexis’s post-Effective Date obligations thereunder, (x) of all distribution, commercialization, payor and similar agreements, to the extent relating to any Product in the GSK Territory (the “Scynexis 39 Commercial Contracts”) to the extent such agreements are assignable and (y) all Scynexis Websites and Copyrights) and Scynexis shall consult with GSK on the activities allocated to Scynexis under the Commercialization Transition Plan and consider in good faith any and all feedback and reasonable instructions provided by GSK with respect thereto; provided that either Party may propose amendments to the Commercialization Transition Plan at any time during the Commercialization Transition Period by delivering a period not written notice to exceed the other Party for review and discussion; provided, further, that the Commercialization Transition Plan may only be amended by mutual written agreement of the Parties. Scynexis shall make Scynexis Personnel reasonably available to accomplish the activities set forth in such Commercialization Transition Plan, provided Scynexis shall have no obligation to retain or employ any Scynexis Personnel to fulfill this obligation. Any and all reasonable and documented FTE Costs and Out-of-Pocket Costs incurred by Scynexis or its Representatives under this Section ‎4.4 (except to the extent that such FTE Costs or Out-of-Pocket Costs are incurred by Scynexis or its Representatives in connection with CMC activities required to be conducted to remedy any identified errors in existence as of the Effective Date that are necessary to be remedied in order to obtain or maintain the applicable Regulatory Approval) shall be reimbursed by GSK, and shall be due and payable within [***] ([***]) from the effective date on which GSK receives a Valid Invoice; provided further that (A) a good faith estimate of such termination (the “Commercialization WindFTE Costs and Out-Down Period”). Any Products sold or disposed of-Pocket Costs and any good faith material updates of by BMS, its Affiliates or Sublicensees during the Commercialization Windthese good faith estimates of such FTE Costs and Out-Down Period of-Pocket Costs shall be subject approved by GSK prior to such FTE Costs and Out-of-Pocket Costs being incurred and if GSK does not provide such approval within [***] ([***]) of receipt from Scynexis of the estimate or updated estimate of the relevant FTE Costs and Out-of-Pocket Costs, then Scynexis shall not be obligated to perform the applicable activity, and (B) to the same Total Compensation under Section 8.5 as would have applied had this Agreement otherwise remained in force extent GSK approves such estimate or updated estimate, GSK shall be obligated to pay the amount of such FTE Costs and effect with respect to such terminated Product(s) and terminated Region(s). After the Commercialization WindOut-Down Period, BMS, its Affiliates and Sublicensees shall not sell such terminated Products of-Pocket Costs set forth in such terminated Region(s) Valid Invoice so long as such amount does not exceed such approved estimate or make any representation regarding BMS’s status as a licensee of such Product in such Region(s). Either (i) at the request of BN at the end of the Commercialization Wind-Down Period or (ii) prior to the end of the Commercialization Wind-Down Period, if BN has assumed responsibilities for regulatory activities under the Regulatory Approval, has received all clearances and Regulatory Approvals needed to sell and import the terminated Product in a given terminated country, and provides written notice to BMS that it wishes to assume sale of the terminated Product in a terminated country, then, in either case (i) or (ii), at BN’s election, BMS shall sell and transfer to BN such portion of the terminated Product inventory then held updated estimate by BMS or its Affiliates which is in a saleable condition (including that it is undamaged, has been stored in proper conditions and has no less more than [***] shelf-life remaining) as had been allocated to the terminated Region(s) percent ([***]. This Section 12.7(b) shall not apply in the case of termination by BMS under Section 12.2(b) based on Safety Reasons%).

Appears in 1 contract

Samples: Exclusive License Agreement (Scynexis Inc)

Commercialization. BMSDermelix will have the exclusive right to Commercialize Licensed Products itself or through one or more Affiliates or Sublicensees selected by Dermelix, in its sole discretion. Subject to Section 9.7, Dermelix (itself or through one or more Affiliates and or Sublicensees selected by Dermelix, in its sole discretion) shall be entitled required to continue use Commercially Reasonable Efforts to sell Commercialize at least one (but not to actively promote after 1) Licensed Product for the effective date of terminationPrimary Indication and at least one (1) any existing inventory of Products Licensed Product for each Additional Indication selected by Dermelix under Section 2.4 or Section 2.5, in each terminated Region of the Territory in the Field. If Exicure reasonably believes that Dermelix (or its Affiliate or Sublicensee, as applicable) has failed to use Commercially Reasonable Efforts to Commercialize Licensed Products as described in this paragraph, then such failure, if not cured, shall be grounds for which Regulatory Approval a material breach of this Agreement, subject to and all pricing and reimbursement approvals therefor have been obtained (provided that such Products shall have launched in each such terminated country as of the applicable effective date of termination), in accordance with the terms termination provisions of Section 9.4 and conditions the dispute resolution provisions of Article 10. Upon any final determination of an uncured material breach under the provisions of Section 9.4 and Article 10, Exicure shall have the right to terminate this AgreementAgreement immediately on written notice to Dermelix, for a period with respect to the license rights granted to Dermelix under Article 2 with respect to the Indication(s) to which the breach applies. Dermelix will bear all costs and expenses associated with Commercialization of Licensed Products in the Field. Notwithstanding the foregoing, Dermelix will inform and consult with Exicure on important strategic matters, and in particular matters related to pricing of Licensed Products, as set out in the Guiding Principles. Notwithstanding the foregoing, this Agreement and the license rights granted under Article 2 shall continue in full force in effect with respect to all Indications that are not subject to exceed such termination. [***] from the effective date of such termination = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE EXICURE, INC. HAS DETERMINED THAT SUCH INFORMATION (the “Commercialization Wind-Down Period”). Any Products sold or disposed of by BMS, its Affiliates or Sublicensees during the Commercialization Wind-Down Period shall be subject to the same Total Compensation under Section 8.5 as would have applied had this Agreement otherwise remained in force and effect with respect to such terminated Product(sI) and terminated Region(s). After the Commercialization Wind-Down Period, BMS, its Affiliates and Sublicensees shall not sell such terminated Products in such terminated Region(sIS NOT MATERIAL AND (II) or make any representation regarding BMS’s status as a licensee of such Product in such Region(s). Either (i) at the request of BN at the end of the Commercialization Wind-Down Period or (ii) prior to the end of the Commercialization Wind-Down Period, if BN has assumed responsibilities for regulatory activities under the Regulatory Approval, has received all clearances and Regulatory Approvals needed to sell and import the terminated Product in a given terminated country, and provides written notice to BMS that it wishes to assume sale of the terminated Product in a terminated country, then, in either case (i) or (ii), at BN’s election, BMS shall sell and transfer to BN such portion of the terminated Product inventory then held by BMS or its Affiliates which is in a saleable condition (including that it is undamaged, has been stored in proper conditions and has no less than [***] shelf-life remaining) as had been allocated to the terminated Region(s) [***]. This Section 12.7(b) shall not apply in the case of termination by BMS under Section 12.2(b) based on Safety ReasonsWOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

Appears in 1 contract

Samples: License and Development Agreement (Exicure, Inc.)

Commercialization. BMSUnless this Agreement expires by its terms or pursuant to Section 13.4, Galderma, its Affiliates and its Sublicensees shall be entitled to continue to sell (but not to actively promote after the effective date of termination) any existing inventory of market, promote, distribute and otherwise commercialize Products in each terminated Region of country in the Galderma Territory for which Regulatory Marketing Approval and all pricing and reimbursement approvals therefor have has been obtained (provided that such Products shall have launched in each such terminated country as of the applicable effective date of termination)obtained, in accordance with the terms and conditions of this Agreement, until three (3) months after the date on which ZARS notifies Galderma in writing that ZARS has secured an alternative distributor or licensee for a period not to exceed [***] from such Product(s) in such country, but in no event for more than nine (9) months after the effective date of such any termination of this Agreement (the “Commercialization Wind-Down down Period”); provided that Galderma, its Affiliates and its Sublicensees shall cease such activities, or any portion thereof, in a given country upon sixty (60) days notice by ZARS requesting that such activities (or portion thereof) be ceased. Notwithstanding any other provision of this Agreement, during the Wind-down Period, (A) Galderma’s and its Affiliates’ and Sublicensees’ rights with respect to a Product in the Galderma Territory shall be non-exclusive and, without limiting the foregoing, ZARS shall have the right to engage one or more other distributor(s) and/or licensee(s) of a Product in all or part of the Galderma Territory and (B) Galderma shall be relieved of its obligations under Section 6.4. Any Products Product sold or disposed of by BMS, its Affiliates or Sublicensees in the Galderma Territory during the Commercialization Wind-Down down Period shall be subject to the same Total Compensation other applicable payment obligations under Section 8.5 as would have applied had this Agreement otherwise remained in force Article 5 and effect with respect to such terminated Product(sArticle 6 above. Within thirty (30) and terminated Region(s). After days of expiration of the Commercialization Wind-Down down Period, BMSGalderma shall notify ZARS of any quantity of Product remaining in Galderma’s inventory and ZARS shall purchase from Galderma any such quantities of Product having at least twelve (12) additional months of shelf life, its Affiliates and Sublicensees at a price equal to the Galderma COGS for such Products, up to maximum amount of such quantities equal to the number of Products sold in the preceding six (6) months. ZARS shall have the right, but not sell the obligation, to purchase any additional quantities of Product remaining in Galderma’s inventory that do not meet the foregoing requirements, at a price equal to the Galderma COGS for such terminated Products. If any Product was manufactured by any Third Party for Galderma, or Galderma had contracts with vendors which contracts are necessary or useful for ZARS to take over responsibility for the Products in such terminated Region(sthe Galderma Territory, then Galderma shall to the extent possible and as requested in writing by ZARS, assign all of the relevant Third-Party contracts to ZARS. If Galderma or its Affiliate manufactured any Product at the time of termination, then Galderma (or its Affiliate) or make any representation regarding BMS’s status as a licensee shall, to the extent practicable, continue to provide for manufacturing of such Product for ZARS, from the date of notice of such termination until such time as ZARS is able, using reasonable efforts to do so, to secure an acceptable alternative commercial manufacturing source from which sufficient quantities of Product may be procured and legally sold in such Region(sthe Galderma Territory (but in no event for longer than fifteen (15) months after notice of termination is delivered). Either (i) at the request of BN at the end of the Commercialization Wind-Down Period or (ii) prior to the end of the Commercialization Wind-Down Period, if BN has assumed responsibilities for regulatory activities under the Regulatory Approval, has received all clearances and Regulatory Approvals needed to sell and import the terminated Product in a given terminated country, and provides written notice ZARS shall compensate Galderma for such quantities at a transfer price equal to BMS that it wishes to assume sale [ * ] of the terminated Product in a terminated country, then, in either case (i) or (ii), at BN’s election, BMS shall sell and transfer to BN such portion of the terminated Product inventory then held by BMS or its Affiliates which is in a saleable condition (including that it is undamaged, has been stored in proper conditions and has no less than [***] shelf-life remaining) as had been allocated to the terminated Region(s) [***]. This Section 12.7(b) shall not apply in the case of termination by BMS under Section 12.2(b) based on Safety ReasonsGalderma COGS.

Appears in 1 contract

Samples: Development and Commercialization Agreement (Zars Inc/Ut)

Commercialization. BMSTo avoid disruption of supply of any Terminated Products to patients if this Agreement is terminated after the Launch of a Terminated Product in the Affected Area, GSK, its Affiliates and Sublicensees shall be entitled to continue to sell (but not to actively promote after the effective date of termination) any existing inventory of Terminated Products in each terminated Region country of the Territory Affected Area for which Regulatory Marketing Approval and all pricing and reimbursement approvals therefor have of such Terminated Product has been obtained (provided that such Products shall have launched in each such terminated country as of the applicable effective date of termination)obtained, in accordance with the terms and conditions of this Agreement, until the date on which Amicus notifies GSK that Amicus has secured an alternative distributor or licensee for a period not to exceed [such Terminated Product in such country of the Affected Area, but in no event more than ***] from *** after the effective date of any such termination of this Agreement (the Commercialization Wind-Down Period”); provided that Amicus may terminate the Wind-Down Period in any country(ies) of the Affected Area upon ****** written notice to GSK; provided further that GSK shall not be obligated to promote the sale of Terminated Products in the Affected Area during the Wind-Down Period. Notwithstanding any other provision of this Agreement, during the Wind-down Period, GSK’s and its Affiliates’ and Sublicensees’ rights with respect to the Terminated Products in the Affected Area shall be non-exclusive and, without limiting the foregoing, Amicus shall have the right to engage one or more other distributor(s) and/or licensee(s) of any Terminated Product in all or part of the Affected Area; provided, however, that in the event that Amicus does so engage one or more other distributor(s) and/or licensee(s) of any Terminated Product in all or part of the Affected Area, GSK shall have no further obligation to continue to sell the Terminated Products in the Affected Area or such part thereof, as applicable. Any Products Terminated Product sold or disposed of by BMS, its Affiliates or Sublicensees GSK in the Affected Area during the Commercialization Wind-Down down Period shall be subject to the same Total Compensation applicable royalty payment obligations under Section 8.5 as would have applied had this Agreement otherwise remained in force 3.4 above, and effect with respect to for such terminated Product(s) purposes, Sections 3.4, 3.5, 3.7, 3.8, 3.9 and terminated Region(s)3.11 shall survive. After Within ****** following the Commercialization expiration of the Wind-Down Period, BMSGSK shall notify Amicus of any quantities of Compound or Terminated Product(s) remaining in GSK’s or its Affiliate’s inventory, as well as any components necessary for the Manufacture of the Compound and Terminated Product(s) in GSK’s or its Affiliates Affiliate’s inventory, and Sublicensees Amicus shall not sell have the option, upon notice to GSK, to repurchase any such terminated quantities of the Compound and/or Terminated Product(s) and/or components from GSK at a price to be mutually agreed by the Parties. If Amicus so elects to purchase any remaining quantities of Compound or Terminated Products in or components from GSK as set forth herein, GSK will transfer to Amicus such terminated Region(squantities of inventory of Compound or Terminated Product(s) or make any representation regarding BMS’s status as a licensee of such Product in such Region(s)components. Either (i) at the request of BN at the end of the Commercialization Wind-Down Period or (ii) prior to the end of the Commercialization Wind-Down Period, if BN has assumed responsibilities for regulatory activities under the Regulatory Approval, has received all clearances and Regulatory Approvals needed to sell and import the terminated Product in a given terminated country, and provides written notice to BMS that it wishes to assume sale of the terminated Product in a terminated country, then, in either case (i) or (ii), at BN’s election, BMS shall sell and transfer to BN such portion of the terminated Product inventory then held by BMS or its Affiliates which is in a saleable condition (including that it is undamaged, has been stored in proper conditions and has no less than [***] shelf-life remaining) as had been allocated to the terminated Region(s) [***]. This Section 12.7(b) shall not apply in * - Material has been omitted and filed separately with the case of termination by BMS under Section 12.2(b) based on Safety ReasonsCommission.

Appears in 1 contract

Samples: Trademark License Agreement (Amicus Therapeutics Inc)

Commercialization. BMS, its Affiliates Novartis shall have the right to determine whether it is willing to Manufacture Regional Antibody Candidates and Sublicensees shall be entitled to continue to sell (but not to actively promote after the effective date Regional Licensed Products for use in Commercialization of termination) any existing inventory of such Regional Antibody Candidates and Regional Licensed Products in each terminated Region the Surface Territory and shall communicate such determination by written notice to Surface no later than Initiation of the first Phase 3 Study. If Novartis notifies Surface that it is willing to Manufacture Regional Antibody Candidates and Regional Licensed Products for use in Commercialization in the Surface Territory for which Regulatory Approval and all pricing and reimbursement approvals therefor have been obtained (provided that such Products shall have launched in each such terminated country as of the applicable effective date of termination), in accordance with the terms and conditions of this Agreementforegoing, for a period not to exceed [***] from the effective date of such termination (the “Commercialization Wind-Down Period”). Any Products sold or disposed of then, Surface may elect, by BMS, its Affiliates or Sublicensees during the Commercialization Wind-Down Period shall be subject to the same Total Compensation under Section 8.5 as would have applied had this Agreement otherwise remained in force and effect with respect to such terminated Product(s) and terminated Region(s). After the Commercialization Wind-Down Period, BMS, its Affiliates and Sublicensees shall not sell such terminated Products in such terminated Region(s) or make any representation regarding BMS’s status as a licensee of such Product in such Region(s). Either (i) at the request of BN at the end of the Commercialization Wind-Down Period or (ii) prior to the end of the Commercialization Wind-Down Period, if BN has assumed responsibilities for regulatory activities under the Regulatory Approval, has received all clearances and Regulatory Approvals needed to sell and import the terminated Product in a given terminated country, and provides written notice to BMS that it wishes to assume sale of the terminated Product in a terminated country, then, in either case (i) or (ii), at BN’s election, BMS shall sell and transfer to BN such portion of the terminated Product inventory then held by BMS or its Affiliates which is in a saleable condition (including that it is undamaged, has been stored in proper conditions and has Novartis no less later than [***] shelf-life remainingafter its receipt of such notice from Novartis whether to utilize Novartis for such Commercial Manufacturing in the Surface Territory or to retain a Third Party contract manufacturer(s) for such purpose. If either Novartis is not willing to provide such Commercial supply (a “Novartis Election”) or Surface elects not to utilize Novartis for such Commercial supply (a “Surface Election”), then Novartis shall effect a technology transfer to a Third Party contract manufacturer(s) to enable such Third Party to provide Commercial supply of Regional Antibody Candidates and Regional Licensed Products for use in the Surface Territory, provided that such Third Party contract manufacturer(s) is approved by Novartis, such approval not to be unreasonably withheld, conditioned or delayed. The cost of such technology transfer shall be borne by (a) Novartis in the case of a Novartis Election; and (b) Surface in the case of either (i) a Surface Election or (ii) any request for a second technology transfer, whether in the case of a Novartis Election or Surface Election; provided, however that Surface may not require of Novartis more than [***] such transfers for any Regional Licensed Product. Further, in the case of a Novartis Election, Novartis shall remain responsible for Manufacturing Commercial supply for use in the Surface Territory until the earlier of (x) such time as had been allocated to the terminated Region(stechnology transfer is completed or (y) [***]. This Section 12.7(b) shall not apply ] If Novartis is willing to Manufacture Regional Antibody Candidates and Regional Licensed Products for use in Commercialization in the case Surface Territory and Surface elects to utilize Novartis for such Commercial Manufacturing in the Surface Territory, the terms of termination by BMS under Section 12.2(b) based on Safety Reasonssupply of such Regional Antibody Candidates and Regional Licensed Products for use in Commercialization of such Regional Antibody Candidates and Regional Licensed Products in the Surface Territory will be set forth in the RLP Supply Agreement.

Appears in 1 contract

Samples: Collaboration Agreement (Coherus BioSciences, Inc.)

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Commercialization. BMS, its Affiliates and Sublicensees shall be entitled to continue to sell (but not to actively promote after the effective date of termination) any existing inventory of Products in each terminated Region of the Territory for which Regulatory Approval and all pricing and reimbursement approvals therefor have been obtained (provided that such Products GSK shall have launched the right to grant sublicenses to Sublicensees under the license granted to it under Section 8.1.1 with respect to Royalty-Bearing Products for sale in each the Royalty-Bearing Territory; provided, that, (a) to the extent any such terminated country as of the applicable effective date of termination), in accordance sublicense is with the terms and conditions of this Agreement, for a period not respect to exceed [***] from except that GSK may utilize a contract sales organization in the effective date Royalty-Bearing Territory and in the Co-Commercialization Territory if both GSK and SYNTA are unable to provide their respective requirements of Representatives necessary to conduct the GSK Co-Commercialization Activities or SYNTA Co-Commercialization Activities, as the case may be, in its discretion upon prior notice to SYNTA; (b) it shall be a condition of any such termination (sublicense that such Sublicensee agrees to be bound by all terms of this Agreement Portions of this Exhibit were omitted and have been filed separately with the “Commercialization Wind-Down Period”)Secretary of the Commission pursuant to the Company’s application requesting confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934. Any Products sold or disposed of by BMS, its Affiliates or Sublicensees during applicable to the Commercialization Windof Royalty-Down Period shall be subject to the same Total Compensation under Section 8.5 as would have applied had this Agreement otherwise remained in force and effect with respect to such terminated Product(s) and terminated Region(s). After the Commercialization Wind-Down Period, BMS, its Affiliates and Sublicensees shall not sell such terminated Bearing Products in such terminated Region(sthe Royalty-Bearing Territory (including, without limitation, Article 7); (c) or make any representation regarding BMS’s status as a licensee of such Product in such Region(s). Either (i) at the request of BN at the end of the Commercialization Wind-Down Period or (ii) prior to the end of the Commercialization Wind-Down Period, if BN has assumed responsibilities for regulatory activities under the Regulatory Approval, has received all clearances and Regulatory Approvals needed to sell and import the terminated Product in a given terminated country, and provides GSK shall provide written notice to BMS that it wishes to assume sale SYNTA of the terminated Product in a terminated country, then, in either case (i) or (ii), any such proposed sublicense at BN’s election, BMS shall sell and transfer to BN such portion of the terminated Product inventory then held by BMS or its Affiliates which is in a saleable condition (including that it is undamaged, has been stored in proper conditions and has no less than least [***] shelf-life remaining) as had been allocated days prior to the terminated Region(s) such execution and provide material terms or redacted copies, at GSK’s option, to SYNTA of each such sublicense within [***]. This Section 12.7(b] days of its execution; (d) if GSK grants a sublicense to a Sublicensee, GSK shall be deemed to have guaranteed that such Sublicensee will fulfill all of GSK’s obligations under this Agreement applicable to the subject matter of such sublicense; (e) GSK shall not apply be relieved of its obligations pursuant to this Agreement as a result of such sublicense. For the avoidance of doubt, GSK shall not be required to obtain approval of SYNTA with respect to sublicenses granted to its Affiliates, or sub-contracting out its Manufacturing activities in the case of termination by BMS under Section 12.2(b) based on Safety ReasonsTerritory.

Appears in 1 contract

Samples: Stock Purchase Agreement (Synta Pharmaceuticals Corp)

Commercialization. BMSAt MGI’s request, if Marketing Authorization has been or is obtained for the Licensed Products, then Licensee and its Affiliates and Sublicensees shall be entitled to continue to sell (but not to actively promote after Commercialize the effective date of termination) any existing inventory of Licensed Products in the same manner in each terminated Region of country in the Territory for which Regulatory Approval and all pricing and reimbursement approvals therefor have Marketing Authorization therefore has been obtained (provided that such Products shall have launched in each such terminated country as of the applicable effective date of termination)obtained, in accordance with the terms and conditions of this Agreement, for a period not to exceed [***] from the effective date of two hundred forty (240) days following such termination (it being understood that MGI and Licensee will work diligently to transition such activities as soon as reasonably practicable. Notwithstanding any other provision of this Agreement, during the “Commercialization Wind-Down down Period”). Any Products sold or disposed of by BMS, Licensee’s and its Affiliates or Sublicensees during the Commercialization Wind-Down Period shall be subject to the same Total Compensation under Section 8.5 as would have applied had this Agreement otherwise remained in force and effect Affiliates’ rights with respect to such terminated Product(sthe Licensed Products shall be non-exclusive, and MGI shall have the right to engage one or more other distributor(s) and/or licensee(s) to Develop and terminated Region(s)Commercialize the Licensed Products in all portions of the Territory that have been terminated. After Article 3 shall continue to apply with respect to all the Commercialization Licensed Products sold, used or disposed by Licensee and its Affiliates during the Wind-Down Period, BMS, down Period or otherwise as set forth below. All rights of Licensee and its Affiliates and Sublicensees with respect to the Licensed Products shall not sell such be terminated Products in such terminated Region(s) or make any representation regarding BMS’s status as a licensee of such Product in such Region(s). Either (i) at the request of BN at the end of the Commercialization Wind-Down Period or (ii) prior to the end of the Commercialization Wind-Down down Period, if BN has assumed responsibilities for regulatory activities under the Regulatory Approval, has received all clearances and Regulatory Approvals needed unless otherwise mutually agreed or unless rights have been terminated only with respect to sell and import the terminated Product in a given terminated specified country, and provides written notice Licensee retains rights to BMS Develop and Commercialize the Licensed Products for other countries, all the Licensed Products in the possession of Licensee and its Affiliates that it wishes to assume sale are not sold during such Wind-down Period shall be destroyed, provided, however, that Licensee shall have a minimum of one hundred-eighty (180) days following termination of the terminated Product in a terminated countryWind-down Period to sell its remaining inventory, then, in either case (i) or (ii), at BN’s election, BMS shall sell and transfer without regard to BN such portion the actual length of the terminated Product Wind-down Period. Any remaining unsold inventory then held by BMS or its Affiliates which is in a saleable condition (including that it is undamaged, has been stored in proper conditions and has no less than [***] shelf-life remaining) as had been allocated shall be transferred to the terminated Region(s) [***]. This Section 12.7(b) shall not apply in the case of termination by BMS under Section 12.2(b) based on Safety ReasonsMGI at cost.

Appears in 1 contract

Samples: License Agreement (Mgi Pharma Inc)

Commercialization. BMSTo avoid a disruption in the supply of Product to patients, if the Agreement is terminated after the First Commercial Sale, Apollo, its Affiliates and its Sublicensees shall be entitled to continue to sell (but not to actively promote after distribute the effective date of termination) any existing inventory of Products Product in each terminated Region of the Territory for which Regulatory Approval and all pricing and reimbursement approvals therefor have been obtained (provided that such Products shall have launched Field in each such terminated country as of the applicable effective date of termination)Territory, in accordance with the terms and conditions of this Agreement, until the date on which Inovio notifies Apollo in writing that Inovio has secured an alternative distributor or licensee for a period not to exceed [***] from the Product in the Field in the Territory, but in no event more for than six (6) months after the effective date of such any termination of this Agreement (the “Commercialization Wind-Down down Period”). Any Products sold or disposed of by BMS, its Affiliates or Sublicensees during the Commercialization Wind-Down Period shall be subject to the same Total Compensation under Section 8.5 as would have applied had this Agreement otherwise remained in force and effect with respect to such terminated Product(s) and terminated Region(s). After the Commercialization Wind-Down Period, BMS; provided that Apollo, its Affiliates and its Sublicensees shall not sell cease such terminated Products in such terminated Region(s) activities, or make any representation regarding BMS’s status as a licensee of such Product in such Region(s). Either (i) at the request of BN at the end of the Commercialization Wind-Down Period or (ii) prior to the end of the Commercialization Wind-Down Periodportion thereof, if BN has assumed responsibilities for regulatory activities under the Regulatory Approval, has received all clearances and Regulatory Approvals needed to sell and import the terminated Product in a given terminated countrycountry upon sixty (60) days’ notice by Inovio requesting that such activities (or portion thereof) be ceased. Notwithstanding any other provision of this Agreement, during the Wind-down Period, Apollo’s and provides written notice its Affiliates’ and Sublicensees’ rights with respect to BMS that it wishes to assume sale of the terminated Product in a terminated country, then, in either case (i) or (ii), at BN’s election, BMS shall sell and transfer to BN such portion of the terminated Product inventory then held by BMS or its Affiliates which is in a saleable condition (including that it is undamaged, has been stored in proper conditions and has no less than [***] shelf-life remaining) as had been allocated to the terminated Region(s) VGX-3100 CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS EXHIBIT. THE COPY FILED HEREWITH OMITS THE INFORMATION SUBJECT TO A CONFIDENTIALITY REQUEST. OMISSIONS ARE DESIGNATED [***]. This Section 12.7(b) shall not apply A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. and the Products in the case Field in the Territory shall be non-exclusive and, without limiting the foregoing, Inovio shall have the right to engage one or more other distributor(s) and/or licensee(s) of termination any Product in all or part of the Territory. Any Product sold or disposed by BMS Apollo in the Field in the Territory during the Wind-down Period shall be subject to applicable payment obligations under Section 12.2(bArticle 6 above. Within thirty (30) based on Safety Reasonsdays of expiration of the Wind-down Period, Apollo shall notify Inovio of any quantity of the Products remaining in Apollo’s inventory and Inovio shall have the option, upon notice to Apollo, to repurchase any such quantities of the Products from [***] to cover indirect costs.

Appears in 1 contract

Samples: License and Collaboration Agreement (Inovio Pharmaceuticals, Inc.)

Commercialization. BMSIf this Agreement is terminated after the First Commercial Sale of a Terminated Denali Product in the Terminated Area, Sanofi, its Affiliates and its Sublicensees shall be entitled to continue to sell (but not to actively promote after fulfill orders for the effective date Terminated Area through their respective then-existing distribution network of termination) any existing inventory internal and external distributors of Products in each terminated Region of the Territory for which Regulatory Approval and all pricing and reimbursement approvals therefor have been obtained (provided that such Products shall have launched in each such terminated country as of the applicable effective date of termination)Terminated Denali Product, in accordance with the terms and conditions of this Agreement, in each country for which Regulatory Approval therefor has been obtained, for [***] after the effective date of termination (“Commercialization Wind-down Period”); [***]; provided, further, that Sanofi, its Affiliates and its Sublicensees shall cease any such activities being conducted pursuant to this Section (f)(ii), or any portion thereof, in a given country within the Terminated Area upon [***] notice by Denali requesting that such activities (or portion thereof) be ceased. Notwithstanding any other provision of this Agreement, during the Commercialization Wind-down Period, Sanofi’s and its Affiliates’ and Sublicensees’ rights with respect to applicable Terminated Denali Product(s) in the Terminated Area shall be non-exclusive and, without limiting the foregoing, Denali shall have the right to engage one or more other distributor(s) or licensee(s) of such Terminated Denali Product(s) in any country within the Terminated Area. Any Terminated Denali Product sold or disposed of by Sanofi, its Affiliates or its Sublicensees in any country within the Terminated Area during the Commercialization Wind-down Period shall be subject to applicable payment obligations under Article 7 (Payments). In addition, if at the effective time of such termination, Sanofi or its Affiliates are undertaking Detailing or MSL Activities with respect to a particular Terminated Denali Product in any country within the Terminated Area, then, at Denali’s request, the Parties will negotiate and agree upon a plan for the orderly wind down of such activities for a period not to exceed [***] from ]. Any FTE Costs or Out-of-Pocket Costs incurred by Sanofi or its Affiliates in accordance with such plan for the wind down of Sanofi’s activities shall be (a) reimbursed by Denali if the relevant Terminated Denali Product is not, immediately prior to the effective date of such termination (the “Commercialization Wind-Down Period”). Any Products sold or disposed of by BMStermination, its Affiliates or Sublicensees during the Commercialization Wind-Down Period shall be subject to the same Total Compensation under Section 8.5 as would have applied had this Agreement otherwise remained in force and effect with respect to such terminated Product(s) and terminated Region(s). After the Commercialization Wind-Down Period, BMS, its Affiliates and Sublicensees shall not sell such terminated Products in such terminated Region(s) or make any representation regarding BMS’s status as a licensee of such Product in such Region(s). Either (i) at the request of BN at the end of the Commercialization Wind-Down Period Cost Profit Sharing Product; or (iib) continue to be allocated towards Allowable Expenses until such wind down is complete, if the relevant Terminated Denali Product is a Cost Profit Sharing Product immediately prior to the end effective date of the Commercialization Wind-Down Period, if BN has assumed responsibilities for regulatory activities under the Regulatory Approval, has received all clearances and Regulatory Approvals needed to sell and import the terminated Product in a given terminated country, and provides written notice to BMS that it wishes to assume sale of the terminated Product in a terminated country, then, in either case (i) or (ii), at BN’s election, BMS shall sell and transfer to BN such portion of the terminated Product inventory then held by BMS or its Affiliates which is in a saleable condition (including that it is undamaged, has been stored in proper conditions and has no less than [***] shelf-life remaining) as had been allocated to the terminated Region(s) [***]. This Section 12.7(b) shall not apply in the case of termination by BMS under Section 12.2(b) based on Safety Reasonstermination.

Appears in 1 contract

Samples: Collaboration and License Agreement (Denali Therapeutics Inc.)

Commercialization. BMS, its Affiliates and Sublicensees (a) Xxxxx shall be entitled fully responsible for, and shall have full control and authority over, the research, development and commercialization of the Licensed Products and all costs and expenses related thereto, including (i) all activities related to continue human clinical trials, including the proposed Phase III oral calcitonin clinical trial at all sites, (ii) subject to sell Section 2.3 and Section 2.4, all activities relating to manufacture and supply of all Licensed Products and (but not iii) all activities relating to actively promote after any regulatory filings, registrations, applications and Regulatory Approvals relating to any of the effective date of termination) any existing inventory of Products foregoing, in each terminated Region of case in accordance with the Territory for which Regulatory Approval Development Timeline. Notwithstanding the foregoing, until such time as Unigene assigns to Xxxxx each Calcitonin IND and all pricing and reimbursement approvals therefor have been obtained (provided that such Products shall have launched in each such terminated country as of the applicable effective date of termination), Assigned Contracts in accordance with the terms hereof, Unigene shall take all actions in connection with the development of the Licensed Calcitonin Products, including conducting clinical trials and conditions interactions with Regulatory Authorities (which, in the case of this Agreementcorrespondence, for a period not to exceed [***] from the effective date of such termination (the “Commercialization Wind-Down Period”). Any Products sold or disposed of by BMS, its Affiliates or Sublicensees during the Commercialization Wind-Down Period shall be subject to the same Total Compensation under Section 8.5 as would have applied had this Agreement otherwise remained in force and effect with respect to such terminated Product(s) and terminated Region(s). After the Commercialization Wind-Down PeriodXxxxx’x prior approval or, BMS, its Affiliates and Sublicensees shall not sell such terminated Products in such terminated Region(s) or make any representation regarding BMS’s status as a licensee of such Product in such Region(s). Either (i) at the request of BN at the end of the Commercialization Wind-Down Period or (ii) prior to the end of the Commercialization Wind-Down Period, if BN has assumed responsibilities for regulatory activities under the Regulatory Approval, has received all clearances and Regulatory Approvals needed to sell and import the terminated Product in a given terminated country, and provides written notice to BMS that it wishes to assume sale of the terminated Product in a terminated country, then, in either case (i) or (ii), at BN’s election, BMS shall sell and transfer to BN such portion of the terminated Product inventory then held by BMS or its Affiliates which is in a saleable condition (including that it is undamaged, has been stored in proper conditions and has no less than [***] shelf-life remaining) as had been allocated to the terminated Region(s) [***]. This Section 12.7(b) shall not apply in the case of termination meetings, shall include Xxxxx representatives as attendees), as may be reasonably requested by BMS under Section 12.2(bXxxxx at Xxxxx’x direction and expense (including payment to Unigene at the FTE Rate for work performed by Unigene and reimbursement of Unigene’s reasonable out-of-pocket expenses); provided that, Unigene shall not be required without its consent to take actions pursuant to this sentence for a period longer than *** days from the Effective Date. The “Development Timeline,” which is attached to this Agreement as Schedule 4 and made an integral part hereof and which may be amended as set forth in this Agreement, sets forth the following timelines for development and commercialization of a Licensed Calcitonin Product: (A) based on Safety Reasonscompletion of the proposed ***; (B) filing of ***; (C) obtaining of ***; (D) Xxxxx’x identification of and ***; and (E) if Xxxxx elects not to ***. Xxxxx shall own all applications for Regulatory Approval filed by Xxxxx or its Sublicensees and all Regulatory Approvals issuing therefrom for the Licensed Products and all data associated therewith. Unigene shall have a *** with respect to the following data and information included in all *** and *** for the Licensed Calcitonin Products obtained or submitted by Xxxxx or any Sublicensee and any other *** made by Xxxxx or any Sublicensee with respect to the Licensed Calcitonin Products, solely for the purpose of obtaining *** for *** in the *** data. Xxxxx promptly will provide, and cause its Sublicensees to provide, a signed statement to effect this ***, if requested by Unigene, in accordance with *** or any foreign counterpart to such ***.

Appears in 1 contract

Samples: License Agreement (Unigene Laboratories Inc)

Commercialization. BMSSolely in the case of a termination of this Agreement by GSK pursuant to Section 13.2, to avoid disruption of supply of any Terminated Product(s) to patients if termination occurs after the Launch of a Terminated Product(s) in the Affected Area, Amicus, its Affiliates and Sublicensees shall be entitled to continue to sell (but not to actively promote after the effective date of terminationTerminated Product(s) any existing inventory of Products in each terminated Region of the Territory for which Regulatory Approval and all pricing and reimbursement approvals therefor have been obtained (provided that such Products shall have launched in each such terminated country as of the applicable effective date of termination), Affected Area in accordance with the terms and conditions of this Agreement, for a period not up to exceed [***] from *** or such shorter period of time as requested by GSK as provided below, after the effective date of any such termination of this Agreement with respect to any such Terminated Product(s) (the Commercialization Amicus Wind-Down Period”). Any Products sold or disposed of by BMS, its Affiliates or Sublicensees during ; provided that GSK may terminate the Commercialization Amicus Wind-Down Period in the Affected Area upon ****** written notice to Amicus; provided further that (i) Amicus shall not be subject obligated to promote the same Total Compensation under Section 8.5 as would have applied had this Agreement otherwise remained sale of such Terminated Products in force the Affected Area during the Amicus Wind-Down Period; and effect (ii) if the Terminated Product is a Co-Formulation Product, then GSK shall continue to supply Amicus with respect to its (and its Affiliates’ and sublicensees’) reasonable requirements of such terminated Product(s) and terminated Region(s)Terminated Product for such purposes. After Within ****** following the Commercialization expiration of the Amicus Wind-Down Period, BMS, its Affiliates and Sublicensees Amicus shall not sell such terminated Products in such terminated Region(s) or make notify GSK of any representation regarding BMS’s status as a licensee of such Product in such Region(s). Either (i) at the request of BN at the end quantities of the Commercialization Wind-Down Period Terminated Product(s) remaining in Amicus’ or (ii) prior its Affiliates’ inventory and GSK shall have the option, upon notice to the end Amicus, to repurchase any such quantities of the Commercialization Wind-Down Period, if BN has assumed responsibilities for regulatory activities under the Regulatory Approval, has received all clearances and Regulatory Approvals needed Terminated Product(s) from Amicus at a price equal to sell and import the terminated Product in a given terminated country, and provides written notice Amicus’ Manufacturing Costs. If GSK so elects to BMS that it wishes to assume sale purchase any remaining quantities of the terminated Product in a terminated countryTerminated Product(s) from Amicus as set forth herein, then, in either case (i) or (ii), at BN’s election, BMS shall sell and Amicus will transfer to BN GSK such portion quantities of inventory of the terminated Product inventory then held by BMS or its Affiliates which is in a saleable condition (including that it is undamaged, has been stored in proper conditions and has no less than [***] shelf-life remaining) as had been allocated to the terminated Region(s) [***]. This Section 12.7(b) shall not apply in the case of termination by BMS under Section 12.2(b) based on Safety ReasonsTerminated Product(s).

Appears in 1 contract

Samples: Trademark License Agreement (Amicus Therapeutics Inc)

Commercialization. BMSGSK, its Affiliates and Sublicensees, shall continue, to the extent that GSK, its Affiliates and Sublicensees shall be entitled to continue to sell have stocks of usable Product, to fulfill orders received from customers for the Product in the GSK Territory (or, if the termination is limited to a specific country, within such country) until up to [**] days after the later of (A) the date on which Sepracor notifies GSK in writing that Sepracor has secured an alternative distributor or licensee for the Product in the GSK Territory and (B) GSK has initiated transition of the XXXx and Marketing Approvals for the Product in the GSK Territory (or, if the termination is limited to a specific country, within such country) to such distributor or licensee, but not to actively promote in no event for more for than [**] after the date of notice of termination. For the Products sold by GSK after the effective date of termination) any existing inventory of Products in each terminated Region of a termination (i.e., after the Territory for which Regulatory Approval and all pricing and reimbursement approvals therefor have been obtained (provided that such Products shall have launched in each such terminated country as expiration of the applicable termination notice period), GSK shall continue to pay royalties on the amount of Net Sales from such sales pursuant to Section 7.3. Notwithstanding the foregoing, GSK, its Affiliates and its Sublicensees shall cease such activities in the GSK Territory (or, if termination is limited to a specific country, within such country), as the case may be, upon [**] written notice given by Sepracor at any time after the effective date of termination), in accordance with a termination requesting that such activities (or portion thereof) cease. In the terms and conditions case of a termination of this AgreementAgreement in its entirety, for a period not to exceed within [**] after Sepracor has given notice to GSK requesting the cessation of activities pursuant to the provision of this Section, GSK shall notify Sepracor of an estimate of the quantity of the Product and its shelf life remaining in GSK’s inventory and Sepracor shall have the right to purchase any such quantities of the Product from GSK for [**], being the amount [**]. To the extent Sepracor does not purchase such quantities, GSK may sell such quantities in the GSK Territory during the [**] from after the effective date of such termination (within the “Commercialization Wind-Down Period”). Any Products sold or disposed of by BMS, its Affiliates or Sublicensees during shelf life remaining for the Commercialization Wind-Down Period shall be subject to the same Total Compensation under Section 8.5 as would have applied had this Agreement otherwise remained in force and effect with respect to such terminated Product(s) and terminated Region(s). After the Commercialization Wind-Down Period, BMS, its Affiliates and Sublicensees shall not sell such terminated Products in such terminated Region(s) or make any representation regarding BMS’s status as a licensee of such Product in such Region(s). Either (i) at the request of BN at the end of the Commercialization Wind-Down Period or (ii) prior to the end of the Commercialization Wind-Down Period, if BN has assumed responsibilities for regulatory activities under the Regulatory Approval, has received all clearances and Regulatory Approvals needed to sell and import the terminated Product in a given terminated country, and provides written notice to BMS that it wishes to assume sale of the terminated Product in a terminated country, then, in either case (i) or (ii), at BN’s election, BMS shall sell and transfer to BN such portion of the terminated Product inventory then held by BMS or its Affiliates which is in a saleable condition (including that it is undamaged, has been stored in proper conditions and has no less than [***] shelf-life remaining) as had been allocated to the terminated Region(s) [***]. This Section 12.7(b) shall not apply in the case of termination by BMS under Section 12.2(b) based on Safety ReasonsProduct.

Appears in 1 contract

Samples: Development, License and Commercialization Agreement (Sepracor Inc /De/)

Commercialization. BMSTo avoid disruption of supply of any Terminated Products to patients if this Agreement is terminated after the Launch of a Terminated Product in the Affected Area, GSK, its Affiliates and Sublicensees shall be entitled to continue to sell (but not to actively promote after the effective date of termination) any existing inventory of Terminated Products in each terminated Region country of the Territory Affected Area for which Regulatory Marketing Approval and all pricing and reimbursement approvals therefor have of such Terminated Product has been obtained (provided that such Products shall have launched in each such terminated country as of the applicable effective date of termination)obtained, in accordance with the terms and conditions of this Agreement, until the date on which Amicus notifies GSK that Amicus has secured an alternative distributor or licensee for a period not to exceed [such Terminated Product in such country of the Affected Area, but in no event more than ***] from *** after the effective date of any such termination of this Agreement (the Commercialization Wind-Down Period”); provided that Amicus may terminate the Wind-Down Period in any country(ies) of the Affected Area upon ****** written notice to GSK; provided further that GSK shall not be obligated to promote the sale of Terminated Products in the Affected Area during the Wind-Down Period. Notwithstanding any other provision of this Agreement, during the Wind-down Period, GSK’s and its Affiliates’ and Sublicensees’ rights with respect to the Terminated Products in the Affected Area shall be non-exclusive and, without limiting the foregoing, Amicus shall have the right to engage one or more other distributor(s) and/or licensee(s) of any Terminated Product in all or part of the Affected Area; provided, however, that in the event that Amicus does so engage one or more other distributor(s) and/or licensee(s) of any Terminated Product in all or part of the Affected Area, GSK shall have no further obligation to continue to sell the Terminated Products in the Affected Area or such part thereof, as applicable. Any Products Terminated Product sold or disposed of by BMS, its Affiliates or Sublicensees GSK in the Affected Area during the Commercialization Wind-Down down Period shall be subject to the same Total Compensation applicable royalty payment obligations under Section 8.5 as would have applied had this Agreement otherwise remained in force 3.4 above, and effect with respect to for such terminated Product(s) purposes, Sections 3.4, 3.5, 3.7, 3.8, 3.9 and terminated Region(s)3.11 shall survive. After Within ****** following the Commercialization expiration of the Wind-Down Period, BMSGSK shall notify Amicus of any quantities of Compound or Terminated Product(s) remaining in GSK’s or its Affiliate’s inventory, as well as any components necessary for the Manufacture of the Compound and Terminated Product(s) in GSK’s or its Affiliates Affiliate’s inventory, and Sublicensees Amicus shall not sell have the option, upon notice to GSK, to repurchase any such terminated quantities of the Compound and/or Terminated Product(s) and/or components from GSK at a price to be mutually agreed by the Parties. If Amicus so elects to purchase any remaining quantities of Compound or Terminated Products in or components from GSK as set forth herein, GSK will transfer to Amicus such terminated Region(squantities of inventory of Compound or Terminated Product(s) or make any representation regarding BMS’s status as a licensee of such Product in such Region(s)components. Either (i) at the request of BN at the end of the Commercialization Wind-Down Period or (ii) prior to the end of the Commercialization Wind-Down Period, if BN has assumed responsibilities for regulatory activities under the Regulatory Approval, has received all clearances and Regulatory Approvals needed to sell and import the terminated Product in a given terminated country, and provides written notice to BMS that it wishes to assume sale of the terminated Product in a terminated country, then, in either case (i) or (ii), at BN’s election, BMS shall sell and transfer to BN such portion of the terminated Product inventory then held by BMS or its Affiliates which is in a saleable condition (including that it is undamaged, has been stored in proper conditions and has no less than [***] shelf-life remaining) as had been allocated to the terminated Region(s) [***]* - Material has been omitted and filed separately with the Commission. This Section 12.7(b) shall not apply in the case of termination by BMS under Section 12.2(b) based on Safety Reasons.63

Appears in 1 contract

Samples: Trademark License Agreement

Commercialization. BMSTo avoid a disruption in the supply of XenoPort Products to patients, if this Agreement is terminated after the first commercial sale of any XenoPort Product in the Territory, Xanodyne and its Affiliates and Sublicensees shall be entitled to continue to sell market, promote, distribute and otherwise commercialize (but not including with the assistance of any Co-Promotion Partner, to actively promote after the effective date of terminationextent permitted by any agreement with such Co-Promotion Partner) any existing inventory of the XenoPort Products in each terminated Region of the Territory for which Regulatory Marketing Approval and all pricing and reimbursement approvals therefor have by the FDA has been obtained (provided unless the FDA or a court of competent jurisdiction in the Territory issues a directive or order that such Products shall have launched a particular XenoPort Product be recalled or withdrawn in each such terminated country as of the applicable effective date of termination)Territory, or the Parties mutually agree that a particular XenoPort Product should be recalled or withdrawn in the Territory) and in accordance with the terms and conditions of this Agreement, for a period not to exceed until [**], but in no event [**] from after the effective date of any such termination of this Agreement (the “Commercialization "Wind-Down down Period"); provided that Xanodyne and its Affiliates shall cease such activities, or any portion thereof, upon [**] notice by XenoPort requesting that such activities (or portion thereof) be ceased. Notwithstanding any other provision of this Agreement, during the Wind-down Period, Xanodyne's rights with respect to the Compound and XenoPort Products in the Territory shall be non-exclusive and, without limiting the foregoing, XenoPort shall have the right to engage one or more other distributor(s) and/or licensee(s) of the Compound and/or any XenoPort Product in the Territory. Any Products sold or disposed of by BMS, its Affiliates or Sublicensees Xanodyne in the Territory during the Commercialization Wind-Down down Period shall be subject to the same Total Compensation applicable payment obligations under Section 8.5 as would have applied had Article 6 above and all relevant deductions or credits due to Xanodyne in accordance with this Agreement otherwise remained in force and effect with respect to such terminated Product(s) and terminated Region(s)Agreement. After the Commercialization Wind-Down Period, BMS, its Affiliates and Sublicensees shall not sell such terminated Products in such terminated Region(s) or make any representation regarding BMS’s status as a licensee of such Product in such Region(s). Either (i) at the request of BN at the end of the Commercialization Wind-Down Period or (ii) prior to the end of the Commercialization Wind-Down Period, if BN has assumed responsibilities for regulatory activities under the Regulatory Approval, has received all clearances and Regulatory Approvals needed to sell and import the terminated Product in a given terminated country, and provides written notice to BMS that it wishes to assume sale of the terminated Product in a terminated country, then, in either case (i) or (ii), at BN’s election, BMS shall sell and transfer to BN such portion of the terminated Product inventory then held by BMS or its Affiliates which is in a saleable condition (including that it is undamaged, has been stored in proper conditions and has no less than Within [***] shelfof expiration of the Wind-life remaining) down Period, Xanodyne shall notify XenoPort of any quantity of the Intermediate, Compound and/or XenoPort Products remaining in Xanodyne's inventory and XenoPort shall have the option, upon notice to Xanodyne, to repurchase any such quantities of the Intermediate, Compound and/or XenoPort Products, as had been allocated applicable, from Xanodyne at a price equal to the terminated Region(s) [**] calculated in accordance with GAAP and Xanodyne's then-prevailing standard procedures for calculating costs of good sold. For the sake of clarity, such [**]. This Section 12.7(b) shall not apply in the case of termination by BMS under Section 12.2(b) based on Safety Reasons.

Appears in 1 contract

Samples: Licensing Agreement (Xanodyne Pharmaceuticals Inc)

Commercialization. BMSPartner shall have the final say with respect to decisions regarding the following activities for the Shared Territory: the JCC Final Decision Exceptions set forth in [*] but not those set forth in [*], its Affiliates and Sublicensees which shall be entitled referred to continue the Executive Officers for final decision pursuant to sell Section 2.7(c); provided, however, that with respect to decisions regarding the Shared Territory Commercialization Budget under [*], if (x) the amended Shared Territory Commercialization Budget at issue is for a Calendar Year included in the Initial Shared Territory Commercialization Budget and such amended total aggregate Shared Territory Commercialization Budget for such Calendar Year exceeds by more than [*] the total aggregate budget for such Calendar Year set forth in the Initial Shared Territory Commercialization Budget attached hereto (or if such total aggregate budget has been updated and approved by the JSC, the total aggregate budget approved by the JSC), in all cases excluding [*], and (y) the JSC does not reach consensus on such amended total aggregate Budget, then such issue shall not be referred to the Executive Officers, but not rather Partner shall have final say with respect to actively promote after the effective date of terminationsuch proposed Budget and Medivation’s forty percent (40%) any existing inventory of Products in each terminated Region share of the Territory for which Regulatory Approval and all pricing and reimbursement approvals therefor have been obtained (provided that amount in excess of such Products shall have launched in each such terminated country as [*] amount of the applicable effective date total aggregate budget for such Calendar Year (“Excess Initial Shared Territory Commercialization Budget Amount”) in the Initial Shared Territory Commercialization Budget attached hereto (or if such total aggregate budget has been updated and approved by consensus of termination)the JSC, the total aggregate budget approved by the JSC) not approved by Medivation, shall be paid by Partner but deducted from Medivation’s share of Operating Profit or otherwise any sales milestone payable under Sections 8.2 and 8.4, respectively, in accordance with the terms procedure set forth in Section 8.2 and conditions of this Agreement8.4, for a period not to exceed [***] from as appropriate. All other decisions or disputes regarding the effective date of such termination (Shared Territory Commercialization Budget shall be handled by the “Commercialization Wind-Down Period”Executive Officers as set forth in Section 2.7(c)(ii). Any Products sold or disposed For the avoidance of by BMSdoubt, its Affiliates or Sublicensees during the Commercialization Wind-Down Period decisions with respect to Manufacturing Costs shall be subject to the same Total Compensation under Section 8.5 as would have applied had this Agreement otherwise remained in force and effect with respect to such terminated Product(s2.7(b)(iii) and terminated Region(s). After the Commercialization Wind-Down Period, BMS, its Affiliates and Sublicensees shall not sell such terminated Products in such terminated Region(s) or make any representation regarding BMS’s status as a licensee of such Product in such Region(s). Either (i) at the request of BN at the end of the Commercialization Wind-Down Period or (ii) prior to the end of the Commercialization Wind-Down Period, if BN has assumed responsibilities for regulatory activities under the Regulatory Approval, has received all clearances and Regulatory Approvals needed to sell and import the terminated Product in a given terminated country, and provides written notice to BMS that it wishes to assume sale of the terminated Product in a terminated country, then, in either case (i) or (ii), at BN’s election, BMS shall sell and transfer to BN such portion of the terminated Product inventory then held by BMS or its Affiliates which is in a saleable condition (including that it is undamaged, has been stored in proper conditions and has no less than [***] shelf-life remaining) as had been allocated to the terminated Region(s) [***]. This Section 12.7(b) shall not apply in the case of termination by BMS under Section 12.2(b) based on Safety Reasonsabove.

Appears in 1 contract

Samples: Collaboration Agreement (Medivation, Inc.)

Commercialization. BMSTo avoid disruption of supply of any Terminated Product(s) to patients if termination occurs after the Launch of a Terminated Product(s) in the relevant Affected Area, GSK, its Affiliates and Sublicensees shall be entitled to continue to sell (but not to actively promote after the effective date of terminationTerminated Product(s) any existing inventory of Products in each terminated Region of the Territory for which Regulatory Approval and all pricing and reimbursement approvals therefor have been obtained (provided that such Products shall have launched in each such terminated country as of the applicable effective date of termination)relevant Affected Area, in accordance with the terms and conditions of this Agreement, for a period not up to exceed [***] from *** or such shorter period of time as requested by Amicus as provided below, after the effective date of any such termination of any such Terminated Product(s) (the Commercialization GSK Wind-Down Period”). Any Products sold or disposed of by BMS, its Affiliates or Sublicensees during ; provided that Amicus may terminate the Commercialization GSK Wind-Down Period in any country of the relevant Affected Area upon ****** written notice to GSK; provided further that GSK shall not be subject obligated to promote the sale of Terminated Products in the Affected Area during the GSK Wind-Down Period. Subject to the same Total Compensation under Section 8.5 as would have applied had this Agreement otherwise remained in force and effect with respect to such terminated Product(s) and terminated Region(s). After foregoing obligations of GSK, during the Commercialization GSK Wind-Down Period, BMS, its Affiliates and Sublicensees shall GSK may transfer any remaining inventory of Terminated Product(s) from the Affected Area to a country within the GSK Territory for which GSK’s rights with respect to such Product(s) have not sell such terminated Products in such terminated Region(s) or make any representation regarding BMS’s status as a licensee of such Product in such Region(s)been terminated. Either (i) at Within ****** following the request of BN at the end expiration of the Commercialization Wind-Down Period or (ii) prior to the end of the Commercialization GSK Wind-Down Period, if BN has assumed responsibilities GSK shall notify Amicus of any quantities of Terminated Product(s) for regulatory activities under the Regulatory ApprovalAffected Area remaining in GSK’s or its Affiliates’ inventory and Amicus shall have the option, has received all clearances and Regulatory Approvals needed to sell and import the terminated Product in a given terminated country, and provides written upon notice to BMS that it wishes GSK, to assume sale repurchase any such quantities of the terminated Product in Terminated Product(s) from GSK at a terminated countryprice equal to GSK’s Manufacturing Costs. If Amicus so elects to purchase any remaining quantities of Terminated Product(s) from GSK as set forth herein, then, in either case (i) or (ii), at BN’s election, BMS shall sell and GSK will transfer to BN Amicus such portion quantities of inventory of Terminated Products. If Amicus does not elect to purchase any such remaining quantities of inventory of Terminated Products, GSK may transfer any such remaining inventory of Terminated Product(s) to a country within the terminated Product inventory then held by BMS or its Affiliates GSK Territory for which is in a saleable condition (including that it is undamaged, has GSK’s rights with respect to such Product(s) have not been stored in proper conditions and has no less than [***] shelf-life remaining) as had been allocated to the terminated Region(s) [***]. This Section 12.7(b) shall not apply in the case of termination by BMS under Section 12.2(b) based on Safety Reasonsterminated.

Appears in 1 contract

Samples: Trademark License Agreement (Amicus Therapeutics Inc)

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