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

Sources: 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)

Commercialization. BMS(a) Novartis will be solely responsible for all aspects of Commercialization of the Product in the Territory, including planning and implementation, distribution, booking of sales, pricing, reimbursement, regulatory, manufacturing (limited to packaging and trade dress), phase IV studies, marketing and sales activities. (b) All such Commercialization activities will be conducted in accordance with Novartis’ then-current Commercialization Plan. (c) Novartis shall itself, or through its Affiliates or Sublicensees, use Commercially Reasonable Efforts in pursuing the Commercialization of the Products in the Territory. Notwithstanding the foregoing, subject to Section 6.4, Novartis’ application of Commercially Reasonable Efforts shall not require Novartis to Commercialize a Product in any country in which Novartis (acting reasonably) determines it is not commercially reasonable to do so for such Product. Should Novartis determine that it is not commercially reasonable to Commercialize the Product in a particular country in the Territory, Novartis shall promptly notify GW of such determination and the basis on which Novartis has made that determination. (d) Novartis shall not Commercialize a Product in the Territory in conjunction or otherwise together with, any other product(s) as a loss leader without GW’s prior written approval, which approval may be withheld by GW for any reason. Novartis shall not offer for sale or sell in any country in the Territory a Product at a greater discount to list price than the usual or customary discounts it applies to other pharmaceutical products it offers for sale or sells in that country. Novartis shall not sell a Product as one of a number of items without a separate price i.e. Novartis will not sell a Product as part of a bundled transaction. (e) Subject to compliance with Sections 6.2(b), (c) and (d), the Commercialization of the Products in the Territory shall be in Novartis’ sole discretion. (f) Notwithstanding the exclusive licenses granted to Novartis under Section 2.1, or the remaining provisions of this Section 6.2, prior to the receipt of the first Marketing Approval for a given Product in a given country in the Territory, GW shall have the right to make Named Patient Sales in such country; provided, however, that within sixty (60) days after each Calendar Quarter in which GW has made any Named Patient Sales in the Territory, GW will provide to Novartis a written report showing the Net Sales of each Product in each country in the Territory during the reporting period by GW, which report shall be accompanied by payment to Novartis of an amount equal to fifty percent (50%) of such Net Sales. (g) Notwithstanding: (I) the territorial restrictions on the licenses granted to Novartis under Section 2.1; or (II) the exclusive rights granted to Novartis in the Territory under this Agreement, the Parties agree that: (i) Novartis, 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 may attend and participate in each terminated Region of international congresses or symposia outside 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(sthe Products; and (ii) and terminated Region(s). After the Commercialization Wind-Down Period, BMSGW, its Affiliates and Sublicensees shall not sell such terminated Products licensees may attend and participate in such terminated Region(s) international congresses or make any representation regarding BMS’s status as a licensee of such Product symposia in such Region(s). Either (i) at the request of BN at the end of the Commercialization Wind-Down Period or (ii) prior Territory with respect 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 ReasonsProducts.

Appears in 3 contracts

Sources: Distribution and License Agreement (Gw Pharmaceuticals PLC), Distribution and License Agreement (Gw Pharmaceuticals PLC), Distribution and License Agreement (Gw Pharmaceuticals PLC)

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

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

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

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

Commercialization. BMS3.7.1 Prometheus shall solely control and assume all responsibility, at its own cost, for conducting all commercialization activities within the Prometheus Territory relating to the Product, including marketing, promotion, sales detailing and any other activities relating to the Exploitation of the Product or Sublicense of rights to the Product. 3.7.2 Prometheus may, in its sole discretion, package, label, market, promote and sell the Product in the Prometheus Territory under either or both of the Alizyme Trademark or another trademark owned or Controlled by Prometheus and may register upon notice to Alizyme one or more domain names in the Prometheus Territory utilizing the Alizyme Trademark alone (to the extent not registered to Alizyme in which case, if requested by Prometheus, Alizyme shall place a link from such Alizyme registered domain name to a web page or website maintained in accordance with applicable Laws by Prometheus, its Affiliates and and/or its Sublicensees in connection with the Exploitation of the Product in the Prometheus Territory) or in combination with another trademark owned or Controlled by Prometheus ("Prometheus Product Trademark") provided that Prometheus shall use Commercially Reasonable Efforts to ensure that its use of the Alizyme Trademark shall in no way reduce or diminish the reputation, image or prestige of the Alizyme Trademark. For the avoidance of doubt, Prometheus shall not be obligated to use any Alizyme Trademark in connection with the packaging, labeling, marketing, promotion or selling of the Product. Prometheus shall be entitled to continue to sell (but not to actively promote after responsible for the effective date of termination) any existing inventory of Products in each terminated Region selection, registration, and maintenance of the Territory for which Regulatory Approval and Prometheus Product Trademarks throughout the Prometheus Territory, as well as all pricing and reimbursement approvals therefor have been obtained (provided expenses associated therewith; provided, however, that such Products Prometheus 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 provide advanced written notice to BMS that it wishes to assume sale Alizyme of the terminated Product in a terminated countryname under which it intends to market the Product. With respect to the foregoing, thenPrometheus shall use good faith efforts to provide six (6) months advanced notice of any such use of such name. 3.7.3 Each Party may, in either case (i) or (ii)its sole discretion, at BN’s election, BMS shall sell share marketing plans and transfer materials with the other Party with the object of coordinating a world-wide marketing effort to BN such portion maximize the commercial potential 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 2 contracts

Sources: License Agreement (Prometheus Laboratories Inc), License Agreement (Prometheus Laboratories Inc)

Commercialization. BMS, (a) Teva and its Affiliates and Sublicensees shall be entitled solely responsible for and shall possess the sole and exclusive right and authority to continue to sell (but not to actively promote after the effective date of termination) any existing inventory of Commercialize all Collaboration 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)Territory, in accordance with the terms Marketing Plans, but except as otherwise provided in Section 3.5(c)(iv). Teva and conditions its Affiliates shall use commercially reasonable efforts to Commercialize all Collaboration Products in the Territory, including taking, processing and fulfilling all orders for Collaboration Products in the Territory on a timely basis and in accordance with applicable industry standards. Teva shall also be solely responsible for, and shall assess and address, all Collaboration Product quality control issues. If Acorda receives any Collaboration Product Certain portions of this AgreementExhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [ ] and an asterisk*, have been separately filed with the Commission. orders, it shall use reasonable efforts to forward such orders to Teva within one (1) Business Day after Acorda’s receipt thereof. Teva shall provide to the CSC written reports, in a format and on a schedule established by the CSC, summarizing the Commercialization activities undertaken by Teva (or its Affiliate) and the results thereof and any significant developments or results of such Commercialization. Teva shall consult with Acorda regarding its Commercialization efforts and methods and shall answer and seek to accommodate all reasonable questions and comments of Acorda. (b) All sales of Collaboration Products shall be recorded, invoiced and collected by Teva. All terms regarding Collaboration Product sales, including, without limitation, terms respecting credit, pricing, cash discounts, rebates, chargebacks, bad debt write-offs, and other fees, charges, returns and allowances shall be set by Teva in accordance with applicable guidelines established by the Marketing Committee. (c) Teva and its Affiliates shall use commercially reasonable efforts, consistent with good pharmaceutical industry practices, to ensure that clinical trial supplies and Collaboration Products are manufactured in accordance with the then-current Good Manufacturing Practices, as specified by the applicable laws and regulations in the Territory, and the relevant specifications as determined in writing by the Parties. Teva and its Affiliates shall use commercially reasonable efforts, consistent with good pharmaceutical industry practices, to conduct all manufacturing of Collaboration Products so that Teva can supply Collaboration Products in sufficient quantities to meet all accepted firm purchase orders for a period Collaboration Products in the Territory in accordance with the then-current Marketing Plans, as determined by the Marketing Committee, and which purchase orders do not to exceed [***] from of the effective date quantity of such termination Collaboration Product that is in the relevant Forecast (the “Commercialization Wind-Down Period”as defined below). Any Products sold Not less than six (6) months prior to any Launch Date, and thereafter on or disposed before the first day of September of each year, the Marketing Committee shall provide to Teva a three (3) year forecast, with an annual breakdown, of the anticipated Collaboration Product requirements (by BMSquantity, NDC number and SKU) for the next succeeding three (3) calendar years. Furthermore, within ten (10) Business Days of the beginning of each calendar quarter, the Marketing Committee shall provide to Teva a forecast of the anticipated Collaboration Product requirements (by quantity, NDC number and SKU) for the next four (4) calendar quarters on a quarterly basis, which quarterly forecasts will be the basis for firm orders to Teva. (Each three (3) year forecast and quarterly forecast, including allowances for Product Samples and Free Products, a “Forecast.”) The Parties shall use their diligent efforts to adjust to changes in any Forecast. Each Forecast shall also specify Collaboration Product quantities required for use as Product Samples. (d) If Teva 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 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 fail to manufacture and supply Collaboration Products in accordance with the request provisions of BN at the end of the Commercialization Wind-Down Period Section 6.2(c), or (ii) prior are otherwise unwilling or unable to manufacture Collaboration Products or experiencing difficulties with manufacturing Collaboration Products such that it may be unable to meet Collaboration Product requirements as provided under Section 6.2(c) (in either case, a “Supply Disruption”), Teva shall provide prompt written notice of such situation to Acorda. Teva shall, in any event, use its reasonable commercial efforts to resolve any Supply Disruption and avoid any inability to supply the end of market demands for the Commercialization Wind-Down Period, if BN has assumed responsibilities for regulatory activities under Collaboration Products in the Regulatory Approval, has received all clearances and Regulatory Approvals needed to sell and import the terminated Product in a given terminated countryTerritory, and provides written notice to BMS that it wishes to assume sale shall keep Acorda fully informed 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 all 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 Reasonsefforts.

Appears in 2 contracts

Sources: Collaboration Agreement (Acorda Therapeutics Inc), Collaboration Agreement (Acorda 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

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

Commercialization. BMS(a) Except as otherwise set forth in this Agreement, its Affiliates and Sublicensees Inspire shall be entitled to continue to sell (but not to actively promote after the effective date solely responsible for commercialization of termination) any existing inventory of Inspire Licensed Products in the Field in the Territory, including without limitation with respect to: (i) sales and marketing; (ii) advertising, marketing and promotional materials; (iii) sales representatives and sales force matters; (iv) distribution; (v) regulatory compliance and communications and regulatory fees (e.g., adverse event reporting programs, establishment and product fees under the Prescription Drug User Fee Act), in each terminated Region case to the extent such responsibilities or fees arise following Regulatory Approval of the Current Product and transfer of the Regulatory Dossier for the Current Product in the applicable country of the Territory for which Regulatory Approval as provided above in Section 3.3(a); and (vi) product inquiries and all pricing and reimbursement approvals therefor have been obtained complaints. (provided that such Products b) Inspire 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 use Commercially Reasonable Efforts 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 commercialize an Inspire Licensed Product in such Region(s). Either the Field in the Territory, promptly after (i) at Regulatory Approval for such Inspire Licensed Product in the request of BN at the end of the Commercialization Wind-Down Period or Territory has been obtained, (ii) prior to such other approvals (including without limitation reimbursement approvals) as are necessary for the end marketing of such Inspire Licensed Product in the Territory have been obtained, and (iii) the transitions as provided under Sections 2.9 (provided Inspire has made the election set forth therein) and 3.3(a) (as applicable) have been given effect (collectively, “Launch Approval”). (c) Without limiting the foregoing, Inspire agrees that it shall effect a First Commercial Sale 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 Current 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 United States no less later than [***] shelf-life remaining) as had been allocated to calendar days after Launch Approval for the terminated Region(s) Current Product is obtained in the United States; provided, however, that such obligation shall be suspended during any period in which [***]. This Section 12.7(b. (d) Inspire shall not apply include in promotional kits any Subject Products intended for sale without InSite’s consent, such consent not to be unreasonably withheld; provided, however, that the case foregoing limitation shall not affect or restrict any sampling practices of termination by BMS under Section 12.2(b) based on Safety ReasonsInspire.

Appears in 2 contracts

Sources: License Agreement (Inspire Pharmaceuticals Inc), License Agreement (Insite Vision 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

Sources: Co Development and Option Agreement (Alector, Inc.), Co 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

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

Commercialization. BMS, its Affiliates and Sublicensees shall be entitled to continue to sell (but not to actively promote after the effective date 6.1 Commercialization of termination) any existing inventory of VEGF Products in each terminated Region Co-Marketing Countries In the event (and for so long as) the Parties are not permitted under local Law to Co-Promote a VEGF Product in a country in the Territory, but are permitted to Co-Market such VEGF Product in such country, then Regeneron may elect, prior to First Commercial Sale in such country of such VEGF Product, to Co-Market the Territory for which Regulatory Approval VEGF Product in such country in accordance with this Section 6.1 and, to the extent not inconsistent therewith and all pricing and reimbursement approvals therefor have been obtained (provided that not prohibited by applicable Law in such Products shall have launched in each such terminated country as of the applicable effective date of termination)country, in accordance with the terms obligations set forth in this Article 6 and conditions the other provisions of this Agreement. Aventis shall supply Regeneron at Aventis’ Manufacturing Cost with its Commercial Supply Requirements of VEGF Products in the Co-Marketing Countries to the extent reasonably available giving higher priority to the Commercial Supply Requirements of countries consistent with their relative contribution to the overall commercial potential of the VEGF Products, and giving equal priority to Aventis’ Commercial Supply Requirements in such Co-Marketing Countries. In the event any such provisions of this Agreement are prohibited by applicable Law in a Co-Marketing Country, then such provision shall be considered a Severed Clause under Section 20.7 solely with respect to such Co-Marketing Country. 6.2 Co-Commercialization of VEGF Products in Co-Commercialization Countries (a) Exercise of Option by Regeneron. In the event that Regeneron desires to Co-Promote a VEGF Product in a particular Co-Commercialization Country for use in a period Therapeutic Area, Regeneron shall notify Aventis of [****************] If Regeneron does not timely notify Aventis of its preliminary indication or of its final decision within the periods set forth in clause (i) or (ii) above, as applicable, Regeneron shall not be entitled to exceed exercise its option to Co-Promote such VEGF Product in such Co-Commercialization Country for use in such Therapeutic Area until on or after the [************************]. (b) Co-Commercialization. Aventis and Regeneron (through their respective Affiliates where appropriate) shall Co-Commercialize VEGF Products under the applicable Product Trademarks in each Co-Commercialization Country in accordance with the then-current and applicable Country Co-Commercialization Plan and Country Co-Commercialization Budget. Each Party shall use, or shall cause its local Affiliates to use, Commercially Reasonable Efforts to Co-Commercialize the VEGF Products in the Co-Commercialization Countries, carry out the activities assigned to it in the applicable Country Co-Commercialization Plan and conduct all such activities in compliance with applicable Laws. Each Party shall ensure that its Commercialization activities conform with the parameters in the approved Country Co-Commercialization Plan and the Global Co-Commercialization Plan. No Party may initiate or sponsor any Non-Approval Trial in a Co-Commercialization Country without prior approval from the applicable Joint Country Commercialization Sub-Committee. (c) Decision to Discontinue Co-Commercialization. In the event that Regeneron decides it no longer wishes to Co-Commercialize a VEGF Product in a particular Co-Commercialization Country for use in a Therapeutic Area or does not wish to maintain its minimum sales force FTE requirement for use in such Therapeutic Area, Regeneron must give Aventis [***] from the effective date prior written notice of such termination (decision. At the end of such [***] period, Regeneron shall cease all Co-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 activities 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 VEGF Product in such Region(s)Co-Commercialization Country for use in such Therapeutic Area. Either (iOnce Regeneron exercises its rights to cease Co-Commercializing in a Co-Commercialization Country for use in a Therapeutic Area, Regeneron will not again be able to exercise its rights pursuant to Section 6.2(a) at to Co-Commercialize such VEGF Product in such Co-Commercialization Country, except with the request of BN at the end prior written consent of the Joint Country Commercialization WindSub-Down Period Committee with respect to such Co-Commercialization Country, such consent not to be unreasonably withheld or (iidelayed, it being understood that it shall not be unreasonable for such consent to be withheld if Aventis’ representatives on such Joint Country Commercialization Sub-Committee reasonably determine that such Co-Promotion would be inconsistent with the Collaboration Purpose or would require Aventis to unreasonably restructure its sales force. Regeneron shall have the right to recommence Co-Commercialization of a VEGF Product in a Co-Commercialization Country for use in a Therapeutic Area terminated pursuant to this Section 6.2(c) only once. Any such recommencement will occur no earlier than [**********] after Regeneron’s request therefor. 6.3 Co-Commercialization Plans. The initial Country Co-Commercialization Plan and Country Co-Commercialization Budget for each VEGF Product in each Co-Commercialization Country will be prepared by the applicable Joint Country Commercialization Sub-Committee at least [**********] before the Anticipated First Commercial Sale of such VEGF Product in such Co-Commercialization Country. Each Country Co-Commercialization Plan and Country Co-Commercialization Budget for each subsequent Contract Year shall be prepared by the applicable Joint Country Commercialization Sub-Committee at least [**********] prior to the end of the then current Contract Year. For the avoidance of doubt any disputes regarding a Country Co-Commercialization WindPlan or Country Co-Down PeriodCommercialization Budget shall be determined in accordance with Section 3.12. Each Country Co-Commercialization Plan and Country Co-Commercialization Budget shall include, if BN has assumed as applicable: (a) strategies for Co-Promoting the VEGF Products, including recommended target Professionals for such activities, Strengths, Weaknesses, Opportunities and Threats analysis and competitive analysis; (b) the allocation between the Parties of responsibilities for regulatory marketing, sales and promotional activities under and, with respect to sales representatives, the Regulatory Approvalpercentage of such representatives’ time dedicated to the sale of VEGF Products, has received all clearances which shall be commensurate with the percentage of total annual incentive payments which will be payable to such representatives in respect of their sales of VEGF Products; (c) anticipated marketing, sales and Regulatory Approvals needed to sell promotion efforts by each Party (or its Affiliates); (d) market and import the terminated Product sales forecasts in a given terminated countryform to be agreed between the Parties via the applicable Joint Country Commercialization Sub-Committee; (e) advertising, public relations and other promotional programs and sampling, to be used in the Co-Promotion; (f) patient advocacy programs, medical affairs programs, including professional symposia and other educational activities, and provides written notice to BMS that it wishes to assume sale of the terminated Product in a terminated countrymedical affairs studies based upon Joint Country Commercialization Sub-Committee-approved protocols; (g) reimbursement and patient assistance, 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; (h) shall not apply Non-Approval Trials in the case applicable Co-Commercialization Country relating to the VEGF Products, which trials shall be based upon Joint Country Commercialization Sub-Committee-approved protocols; and (i) as appropriate, a training plan for the Parties’ sales representatives. In addition to the detailed plan and budget for the next upcoming calendar year, each Country Co-Commercialization Plan and Country Co-Commercialization Budget will include an outline of termination by BMS under Section 12.2(b) based on Safety Reasonsthe projected plan and estimated budget for the following calendar year.

Appears in 1 contract

Sources: Collaboration Agreement (Regeneron Pharmaceuticals Inc)

Commercialization. BMS5.1.1 Subject to oversight by the JSC, its Affiliates and Sublicensees Astellas shall be entitled responsible for: (a) launching and commercializing, and shall use Diligent Efforts to continue to sell (but not to actively promote after launch and commercialize, the effective date of termination) any existing inventory of Products Product in each terminated Region country in the Territory in accordance with a commercialization plan submitted by Astellas to the JSC (“Commercialization Plan”); and (b) manufacturing, and shall use Diligent Efforts to manufacture, the Compound and Product necessary to support the launching and commercialization of the Territory for which Regulatory Approval and all pricing and reimbursement approvals therefor have been obtained (provided that such Products shall have launched Product in each such terminated country as of in the applicable effective date of termination), Territory in accordance with the terms Commercialization Plan. Without limiting the foregoing, Astellas agrees to use Diligent Efforts to launch the Product as soon as practicable in the Territory, and conditions thereafter to manufacture, market, promote and sell such Product and to maximize the Net Sales of the Product in the Territory. Astellas agrees to provide to the JSC updated versions of the Commercialization Plan at least annually, and any material modification or addition to the Commercialization Plan within a reasonable period of time prior to adoption and implementation thereof. Astellas shall keep XenoPort reasonably informed as to the progress of its launch, manufacturing and commercialization activities relating to the Product in the Territory, by way of updates to the JSC at its meetings and as otherwise reasonably requested by XenoPort. It is understood and agreed that, subject to oversight by the JSC, and consistent with the other provisions of this Agreement, all commercialization and manufacturing efforts for a period not to exceed [***] from the effective date Product in the Territory shall be at the sole discretion and expense of such termination (the “Commercialization Wind-Down Period”). Any Products sold or disposed of by BMSAstellas, its Affiliates or Sublicensees during the Commercialization Wind-Down Period Subdistributors. 5.1.2 XenoPort or its licensee(s) shall be subject responsible for launching, manufacturing and commercializing the Product outside the Territory. XenoPort shall keep Astellas reasonably informed as to the same Total Compensation under Section 8.5 progress of its and/or [… * …] its other licensees’ launch, manufacturing and commercialization activities relating to Product outside the Territory, by way of updates to the JSC at its meetings and as would have applied had this Agreement otherwise remained in force reasonably requested by Astellas but no more often than once annually other than at the JSC meeting. It is understood and effect with respect to such terminated Product(s) agreed that all manufacturing and terminated Region(s). After commercialization efforts for the Commercialization Wind-Down Period, BMSProduct outside the Territory shall be at the sole discretion and expense of XenoPort, 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 undamagedother licensees. * CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, 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 ReasonsMARKED BY BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

Appears in 1 contract

Sources: Distribution and License 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

Sources: Licensing Agreement (Xanodyne Pharmaceuticals Inc)

Commercialization. BMS5.1. TTY, at its Affiliates own expense, will be responsible for all sales and Sublicensees shall be entitled marketing activities related to continue the Licensed Product in the Territory. 5.2. TTY agrees to sell (but not use Commercially Reasonable Efforts to actively promote after the effective date of termination) any existing inventory of Products sale, marketing, and distribution of, and otherwise commercialize and sell, the Licensed Product in each terminated Region of the Territory for which Regulatory Approval all indications that have received Governmental Approval. TTY shall provide BDSI with quarterly written reports of TTY’s commercialization efforts and all pricing activities for such quarter and reimbursement approvals therefor have been obtained (provided that a description of its plans for future commercialization efforts and activities. In addition, TTY shall provide such Products shall have launched in each such terminated country as other information, financial or otherwise, BDSI may reasonably request relating to the marketing, sale or distribution of the applicable effective Product. 5.3. Beginning on the date of termination)First Commercial Sale, TTY shall use Commercially Reasonable Efforts to deploy its sales representatives to sell the Licensed Product in accordance the Territory, who will target physicians reasonably identified by TTY as potentially high volume prescribing physicians for the Licensed Product. 5.4. No rights to the trademark ONSOLIS, BREAKYL, or any other trademarks, trade dress, or logos used with respect to the terms and conditions of Licensed Product outside the Territory are granted to TTY under this Agreement, for a period and, notwithstanding anything to the contrary, BDSI shall not be required to exceed [CONFIDENTIAL TREATMENT REQUESTED WITH RESPECT TO CERTAIN PORTIONS HEREOF DENOTED WITH “***] from the effective date of ” include any such termination (the “Commercialization Wind-Down Period”)trademark, trade dress or logo on any packaging or related materials concerning any Licensed Product supplied to TTY. Any trademark, logo, design and/or trade dress for the Licensed Products sold or disposed of used by BMSTTY, its Affiliates Affiliates, or Sublicensees during in the Commercialization Wind-Down Period Territory shall be subject to BDSI’s prior written approval, such approval not to be unreasonably withheld, comply with Applicable Laws, and not infringe or misappropriate the same Total Compensation under Section 8.5 as would have applied had this Agreement otherwise remained intellectual property rights of any Third Party. Any trademark filing or registered by TTY and/or logo, trade dress designed by TTY in force and effect with respect the Territory shall solely belong to such terminated Product(s) and terminated Region(s). After TTY, excluding any trademarks owned or used by BDSI any affiliate thereof, or 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 either of the Commercialization Wind-Down Period or (ii) foregoing 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 Reasonsthis Agreement.

Appears in 1 contract

Sources: License and Supply Agreement

Commercialization. BMS(a) Subject to anything stated to the contrary herein, LICENSEE shall be solely responsible, at its own cost and expense, for the Commercialization of Licensed Products in the Field in the Licensed Territory, including, without limitation, (i) commercial launch and pre-launch planning; (ii) market access and pricing and reimbursement approval of Licensed Products; (iii) marketing and promotion activities; (iv) medical education and other medical activities for supporting sales such as publications, ad boards, etc., subject to Article 8.5; (v) sales, logistics and distribution of Licensed Products; (vi) pre-sale and post-sale customer handling and support; (vii) order processing, invoicing and debt collection; and (viii) accounting for inventory and receivables. (b) LICENSEE shall use Commercially Reasonable Efforts to launch and Commercialize Licensed Products in the Licensed Territory to the extent it has obtained regulatory approval and, if applicable, pricing and reimbursement approval, within six (6) months after obtaining such approval(s), provided that sufficient quantities of Licensed Products in good quality and complying with the specifications set forth in the regulatory approvals are available. Any decision by LICENSEE not to launch and Commercialize Licensed Products in any country in the Licensed Territory within such six (6) month period is subject to the review of the JSC. LICENSEE shall not be obligated to launch Licensed Products in any particular country if the JSC, upon LICENSEE’s request, determines that it would not be commercially reasonable to launch in such country. (c) LICENSOR will use Commercially Reasonable Efforts to fully support LICENSEE's Commercialization activities at LICENSEE’s reasonable request. (d) Any and all transactions with respect to the Commercialization of Licensed Products be-tween LICENSEE and its Affiliates and Sublicensees sub-licensees, on the one hand, and Fresenius Medical Care AG & Co. KGaA or any member of the Fresenius Medical Care group of companies, on the other hand, 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 Windon arm’s-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 Reasonslength terms.

Appears in 1 contract

Sources: License and Collaboration Agreement (Travere Therapeutics, Inc.)

Commercialization. BMS5.1.1 Subject to oversight by the JSC, its Affiliates and Sublicensees Astellas shall be entitled responsible for launching and commercializing, and shall use Diligent Efforts to continue to sell (but not to actively promote after launch and commercialize, the effective date of termination) any existing inventory of Products Product in each terminated Region of country in 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 a commercialization plan submitted by Astellas to the terms JSC (“Commercialization Plan”). Without limiting the foregoing, Astellas agrees to use Diligent Efforts to launch the Product as soon as practicable in the Territory, and conditions thereafter to market, promote and sell such Product and to maximize the Net Sales of the Product in the Territory. Astellas agrees to provide to the JSC updated versions of the Commercialization Plan at least annually, and any material modification or addition to the Commercialization Plan within a reasonable period of time prior to adoption and implementation thereof. Astellas shall keep XenoPort reasonably informed as to the progress of its launch and commercialization activities relating to the Product in the Territory, by way of updates to the JSC at its meetings and as otherwise reasonably requested by XenoPort. It is understood and agreed that, subject to oversight by the JSC, and consistent with the other provisions of this Agreement, all commercialization efforts for a period not to exceed [***] from the effective date Product in the Territory shall be at the sole discretion and expense of such termination (the “Commercialization Wind-Down Period”). Any Products sold or disposed of by BMSAstellas, its Affiliates or Sublicensees during the Commercialization Wind-Down Period Subdistributors. 5.1.2 XenoPort or its licensee(s) shall be subject responsible for launching and commercializing the Product outside the Territory. XenoPort shall keep Astellas reasonably informed as to the same Total Compensation under Section 8.5 progress of its and/or [... * ...] its other licensees’ launch and commercialization activities relating to Product outside the Territory, by way of updates to the JSC at its meetings and as would have applied had otherwise reasonably requested by Astellas but no more often than once annually other than at the JSC meeting. It is understood and agreed that all commercialization efforts for the Product outside * Certain confidential information contained in this Agreement otherwise remained in force document, marked by brackets, has been omitted and effect filed separately with respect the Securities and Exchange Commission pursuant to such terminated Product(s) Rule 24b-2 of the Securities Exchange Act of 1934, as amended. the Territory shall be at the sole discretion and terminated Region(s). After the Commercialization Wind-Down Period, BMSexpense of XenoPort, 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 Reasonsother licensees.

Appears in 1 contract

Sources: Distribution and License 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, 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

Sources: Licensing Agreement (Xanodyne Pharmaceuticals 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

Sources: Collaboration Agreement (Coherus BioSciences, Inc.)

Commercialization. BMS(a) Subject to anything stated to the contrary herein, its Affiliates and Sublicensees LICENSEE shall be entitled to continue to sell (but not to actively promote after solely responsible, at its own cost and expense, for the effective date Commercialization of termination) any existing inventory of Licensed Products in the Field in the Licensed Territory, including, without limitation, (i) commercial launch and pre-launch planning; (ii) market access and pricing; (iii) marketing and promotion activities; (iv) medical education and other medical activities for supporting sales such as publications, ad boards, etc.; (v) sales, logistics and distribution of Licensed Products; (vi) pre-sale and post-sale customer handling and support; (vii) order processing, invoicing and debt collection; and (viii) accounting for inventory and receivables. (b) LICENSEE shall use Commercially Reasonable Efforts to (A) launch Licensed Products in the Field in each terminated Region of country or territory within the Licensed Territory for which Regulatory Approval and all it has received regulatory approval and, if applicable, 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 approval within [****] 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 months after obtaining such approval(s), provided that (i) such launch is consistent with LICENSEE’s exercise of Commercially Reasonable Efforts, and (ii) sufficient quantities of Licensed Products in good quality are available and (B) Commercialize such Licensed Products in such countries or territories thereafter. Such launches of Licensed Products are intended to take place in each Major Market, it being understood and agreed that LICENSEE may elect further countries within the Licensed Territory to launch and Commercialize Licensed Products. Notwithstanding the foregoing, LICENSEE shall not be obligated to launch Licensed Products in a particular country if it determines, in its sole discretion, that based on the pricing and reimbursement approval obtained for such country such launch would negatively affect the profitability of the Commercialization of Licensed Products in such or any other country in the Licensed Territory. (c) In any case, LICENSOR will use Commercially Reasonable Efforts to fully support LICENSEE’s Commercialization activities and the commercially successful exploitation of the License at LICENSEE’s reasonable request. (d) Any and all transactions with respect to the terminated Region(s) Commercialization of Licensed Products between LICENSEE and its Affiliates and sublicensees, on the one hand, and Fresenius Medical Care AG & Co. KGaA or any member of the Fresenius Medical Care group of companies, on the other hand, shall be on arm’s-length terms. [****] = [CONFIDENTIAL PORTION HAS BEEN OMITTED BECAUSE IT (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED]. 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

Sources: License Agreement (Angion Biomedica Corp.)

Commercialization. BMSArticle 6(b) of the Agreement is hereby amended with the addition of the following paragraph: “Notwithstanding the provisions above and elsewhere in the Agreement, its Affiliates any decision to (i) file for regulatory approval of Licensed Products and/or to (ii) launch and Sublicensees Commercialize Licensed Products in any country of the Additional Licensed Territory shall be entitled at the sole discretion of the LICENSEE, which shall consider any input from LICENSOR, including through the JSC. The LICENSEE shall not be obligated to continue (i) file for regulatory approval of Licensed Products and/or to sell (but not to actively promote after the effective date of terminationii) any existing inventory of launch and Commercialize Licensed Products in each terminated Region of any given country in the Additional Licensed Territory if LICENSEE determines it would not be commercially reasonable to do so in such country; provided that, if (i) LICENSEE does not file 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, regulatory approval for a period not to exceed Licensed Product in any given country in the Additional Licensed Territory within [***] from following the effective date of such termination (the “Commercialization Wind-Down Period”). Any Products sold or disposed of by BMSAmendment Effective Date, 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 Periodor, 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 if filing for pricing and reimbursement approval is a requirement in order to the end of the Commercialization Wind-Down PeriodCommercialize, if BN has assumed responsibilities LICENSEE does not file for regulatory activities under the Regulatory Approval, has received all clearances pricing and Regulatory Approvals needed to sell and import the terminated reimbursement approval for a Licensed Product in a any given terminated country, and provides written notice to BMS that it wishes to assume sale of country in 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 Additional Licensed Territory within [***] shelf-life remainingfollowing regulatory approval, or (iii) as had been allocated to LICENSEE does not launch and Commercialize a Licensed Product in any given country in the terminated Region(s) Additional Licensed Territory within [***]. This Section 12.7(b) shall not apply ] following receipt of regulatory approval and, if required to Commercialize, pricing and reimbursement approval, in such country assuming that sufficient quantities of Licensed Products in good quality and complying with the specifications set forth in the regulatory approvals are available for clause (iii) to be applicable, then LICENSOR shall have the right to terminate the License and all rights granted to LICENSEE hereunder related to such country, and the rights related to such country shall revert to LICENSOR and such country shall no longer be included in the Territory. In such a case and following a specific discussion at JSC upon the expiration of termination the applicable [***] period, LICENSOR may exercise such right by BMS under Section 12.2(b) based on Safety Reasons.sending a written notice to LICENSEE to that effect. *** Certain Confidential Information Omitted Amendment No. 2 to License and Collaboration Agreement

Appears in 1 contract

Sources: License and Collaboration Agreement (Travere Therapeutics, Inc.)

Commercialization. BMS5.1. TTY, at its Affiliates own expense, will be responsible for all sales and Sublicensees shall be entitled marketing activities related to continue the Licensed Product in the Territory. 5.2. TTY agrees to sell (but not use Commercially Reasonable Efforts to actively promote after the effective date of termination) any existing inventory of Products sale, marketing, and distribution of, and otherwise commercialize and sell, the Licensed Product in each terminated Region of the Territory for which Regulatory Approval all indications that have received Governmental Approval. TTY shall provide BDSI with quarterly written reports of TTY’s commercialization efforts and all pricing activities for such quarter and reimbursement approvals therefor have been obtained (provided that a description of its plans for future commercialization efforts and activities. In addition, TTY shall provide such Products shall have launched in each such terminated country as other information, financial or otherwise, BDSI may reasonably request relating to the marketing, sale or distribution of the applicable effective Product. 5.3. Beginning on the date of termination)First Commercial Sale, TTY shall use Commercially Reasonable Efforts to deploy its sales representatives to sell the Licensed Product in accordance the Territory, who will target physicians reasonably identified by TTY as potentially high volume prescribing physicians for the Licensed Product. 5.4. No rights to the trademark ONSOLIS, BREAKYL, or any other trademarks, trade dress, or logos used with respect to the terms and conditions of Licensed Product outside the Territory are granted to TTY under this Agreement, for a period and, notwithstanding anything to the contrary, BDSI shall not be required to exceed [***] from the effective date of include any such termination (the “Commercialization Wind-Down Period”)trademark, trade dress or logo on any packaging or related materials concerning any Licensed Product supplied to TTY. Any trademark, logo, design and/or trade dress for the Licensed Products sold or disposed of used by BMSTTY, its Affiliates Affiliates, or Sublicensees during in the Commercialization Wind-Down Period Territory shall be subject to BDSI’s prior written approval, such approval not to be unreasonably withheld, comply with Applicable Laws, and not infringe or misappropriate the same Total Compensation under Section 8.5 as would have applied had this Agreement otherwise remained intellectual property rights of any Third Party. Any trademark filing or registered by TTY and/or logo, trade dress designed by TTY in force and effect with respect the Territory shall solely belong to such terminated Product(s) and terminated Region(s). After TTY, excluding any trademarks owned or used by BDSI any affiliate thereof, or 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 either of the Commercialization Wind-Down Period or (ii) foregoing 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 Reasonsthis Agreement.

Appears in 1 contract

Sources: License and Supply Agreement (Biodelivery Sciences International Inc)