Commercialization. (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 may attend and participate in international congresses or symposia outside the Territory with respect to the Products; and (ii) GW, its Affiliates and licensees may attend and participate in international congresses or symposia in the Territory with respect to the Products.
Appears in 3 contracts
Samples: Distribution and License Agreement (Gw Pharmaceuticals PLC), Distribution and License Agreement (Gw Pharmaceuticals PLC), Distribution and License Agreement (Gw Pharmaceuticals PLC)
Commercialization. (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 determine whether it is willing to Manufacture Regional Antibody Candidates and Regional Licensed Products for use in Commercialization of such countryRegional Antibody Candidates and Regional Licensed Products in 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 in accordance with the foregoing, then, Surface may elect, by written notice to Novartis no later than [***] after 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, howeverhowever that Surface may not require of Novartis more than [***] such transfers for any Regional Licensed Product. Further, that within sixty (60) days after each Calendar Quarter in which GW has made any Named Patient Sales 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 the technology transfer is completed or (y) [***] If Novartis is willing to Manufacture Regional Antibody Candidates and Regional Licensed Products for use in Commercialization in the Surface Territory and Surface elects to utilize Novartis for such Commercial Manufacturing in the Surface Territory, GW will provide to Novartis a written report showing the Net Sales terms of each Product supply of such Regional Antibody Candidates and Regional Licensed Products for use in each country Commercialization of such Regional Antibody Candidates and Regional Licensed Products in the Surface Territory during the reporting period by GW, which report shall will 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 set forth in the Territory under this RLP Supply Agreement, the Parties agree that:
(i) Novartis, its Affiliates and Sublicensees may attend and participate in international congresses or symposia outside the Territory with respect to the Products; and
(ii) GW, its Affiliates and licensees may attend and participate in international congresses or symposia in the Territory with respect to the Products.
Appears in 3 contracts
Samples: Collaboration Agreement (Surface Oncology, Inc.), Collaboration Agreement (Surface Oncology, Inc.), Collaboration Agreement (Surface Oncology, Inc.)
Commercialization. (a) Novartis will Each Party shall be solely responsible for [***] of all aspects of Commercialization of the Product Manufacturing Costs relating to Regional Licensed Products for use by such Party or its Related Parties 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 Regional Licensed Products in the such Party’s Territory. Notwithstanding the foregoing, subject With respect to Section 6.4, Novartis’ application Regional Licensed Products (including any Component of Commercially Reasonable Efforts shall not require a Regional Licensed Product that is a Combination) purchased by Surface from 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 use in the Surface Territory, Surface shall pay 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 Commercial Manufacturing Cost for 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 AgreementRegional Licensed Products. For purposes hereof, the Parties agree that“Commercial Manufacturing Cost” shall be calculated as follows:
(i) Novartis, its Affiliates and Sublicensees may attend and participate in international congresses or symposia outside the Territory with With respect to any Regional Licensed Product which is not a Combination, an amount equal to Manufacturing Cost plus a Xxxx-Up. The Xxxx-Up shall be set forth in the ProductsRLP Supply Agreement to be entered into between the Parties; andin the event the Parties are unable to agree upon such Xxxx-Up, the dispute shall be submitted to Expedited Arbitration for resolution. 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.
(ii) GWWith respect to any Regional Licensed Product which is a Combination, its Affiliates and licensees may attend and participate an amount specified on Exhibit A-2. Any Xxxx-Up set forth in international congresses or symposia such Exhibit shall be set forth in the Territory with respect RLP Supply Agreement to be entered into between the ProductsParties; in the event the Parties are unable to agree upon such Xxxx-Up, the dispute shall be submitted to Expedited Arbitration for resolution.
Appears in 3 contracts
Samples: Collaboration Agreement (Surface Oncology, Inc.), Collaboration Agreement (Surface Oncology, Inc.), Collaboration Agreement (Surface Oncology, Inc.)
Commercialization. (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) NovartisBMS, its Affiliates and Sublicensees may attend and participate shall be entitled to continue to sell (but not to actively promote after the effective date of termination) any existing inventory of Products in international congresses or symposia outside 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 Products; and
(ii) GWCommercialization Wind-Down Period, BMS, its Affiliates and licensees may attend 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 participate Regulatory Approvals needed to sell and import the terminated Product in international congresses 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 symposia (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 Territory with respect to the Productscase of termination by BMS under Section 12.2(b) based on Safety Reasons.
Appears in 3 contracts
Samples: Option and License Agreement (Bavarian Nordic a/S / ADR), Option and License Agreement (Bavarian Nordic a/S / ADR), Option and License Agreement (Bavarian Nordic a/S / ADR)
Commercialization. (a) Novartis will be solely responsible for all aspects of Commercialization of the Product To avoid disruption in the Territoryavailability of Terminated Products to patients, including planning if this Agreement is terminated after the First Commercial Sale of a Terminated Product, AbbVie, its Affiliates and implementationits Sublicensees shall continue to distribute such Terminated Product, 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’ thenthe terms and conditions of this Agreement, in each country for which Regulatory Approval therefor has been obtained, until [***] 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 any expiration or termination of this Agreement (the “Commercialization Wind-current Commercialization Plan.
(c) Novartis down Period”); provided that AbbVie, its Affiliates and its Sublicensees shall itselfcease such activities, or through its Affiliates or Sublicenseesany portion thereof, 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 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 TerritorySecurities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request. Agreement, GW 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 make Named Patient Sales engage one or more other distributor(s) and/or licensee(s) of the Product in such country; provided, however, that within sixty (60) days after each Calendar Quarter in which GW has made any Named Patient Sales in all or part of the Territory. Any Product sold or disposed of by AbbVie, GW will provide to Novartis a written report showing the Net Sales of each Product in each country its Affiliates or its Sublicensees in the Territory during the reporting period by GW, which report Commercialization Wind-down Period shall be accompanied by subject to applicable payment obligations under ARTICLE 6 above. Within [***] of expiration of the Commercialization Wind-down Period, AbbVie shall notify Licensor of any quantity of the Product remaining in AbbVie’s inventory and Licensor shall have the option, upon notice to Novartis AbbVie, to repurchase any such quantities of an amount the Product from AbbVie at a price equal to fifty percent (50%) AbbVie’s Manufacturing Cost of such Net Salesquantities.
(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 may attend and participate in international congresses or symposia outside the Territory with respect to the Products; and
(ii) GW, its Affiliates and licensees may attend and participate in international congresses or symposia in the Territory with respect to the Products.
Appears in 2 contracts
Samples: Co Development and Option Agreement (Alector, Inc.), Co Development and Option Agreement (Alector, Inc.)
Commercialization. (a) Novartis will Teva and its Affiliates shall be solely responsible for and shall possess the sole and exclusive right and authority to Commercialize all aspects of Commercialization of Collaboration Products in the Product Territory, in accordance with the Marketing Plans, but except as otherwise provided in Section 3.5(c)(iv). Teva and its Affiliates shall use commercially reasonable efforts to Commercialize all Collaboration Products in the Territory, including planning taking, processing and implementationfulfilling 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, distributionand shall assess and address, booking all Collaboration Product quality control issues. If Acorda receives any Collaboration Product Certain portions of salesthis Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, pricingwhich are marked with brackets [ ] and an asterisk*, reimbursementhave been separately filed with the Commission. orders, regulatoryit 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, manufacturing in a format and on a schedule established by the CSC, summarizing the Commercialization activities undertaken by Teva (limited 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 packaging accommodate all reasonable questions and trade dress), phase IV studies, marketing and sales activitiescomments of Acorda.
(b) All such Commercialization activities will sales of Collaboration Products shall be conducted 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 Novartis’ then-current Commercialization Planapplicable guidelines established by the Marketing Committee.
(c) Novartis shall itself, or through Teva and its Affiliates or Sublicensees, shall 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 efforts, consistent with good pharmaceutical industry practices, to do so for such Product. Should Novartis determine ensure that it is not commercially reasonable to Commercialize clinical trial supplies and Collaboration Products are manufactured in accordance with the Product in a particular country then-current Good Manufacturing Practices, as specified by the applicable laws and regulations in the Territory, Novartis shall promptly notify GW of such determination 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 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 exceed [***] of the quantity of Collaboration Product that is in the relevant Forecast (as defined below). Not less than six (6) months prior to any Launch Date, and thereafter on or 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 quantity, 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 on which Novartis has made that determinationfor 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) Novartis shall not Commercialize a Product If Teva and its Affiliates (i) fail to manufacture and supply Collaboration Products in accordance with the Territory in conjunction provisions of Section 6.2(c), or (ii) are otherwise together with, any other product(s) as a loss leader without GW’s prior written approval, which approval unwilling or unable to manufacture Collaboration Products or experiencing difficulties with manufacturing Collaboration Products such that it may be withheld by GW for any reasonunable 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. Novartis shall not offer for sale or sell Teva shall, in any country in event, use its reasonable commercial efforts to resolve any Supply Disruption and avoid any inability to supply the Territory a Product at a greater discount to list price than market demands for 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 Collaboration 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 and shall have the right to make Named Patient Sales in keep Acorda fully informed of all 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 Salesefforts.
(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 may attend and participate in international congresses or symposia outside the Territory with respect to the Products; and
(ii) GW, its Affiliates and licensees may attend and participate in international congresses or symposia in the Territory with respect to the Products.
Appears in 2 contracts
Samples: Collaboration Agreement (Acorda Therapeutics Inc), Collaboration Agreement (Acorda Therapeutics Inc)
Commercialization. (a) Novartis will be solely responsible for all aspects Provided that the termination of Commercialization this Agreement is not a termination by Galderma pursuant to Section 12.2.4, if requested by NovaBay, Galderma and its Affiliates and Marketing Partners shall continue to distribute and sell Collaboration Products in the Field in each country of the Product in the TerritoryGalderma Territory for which Marketing Approval therefor has been obtained, 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.
the terms and conditions of this Agreement, for a period requested by NovaBay not to exceed two (c2) Novartis shall itself, or through its Affiliates or Sublicensees, use Commercially Reasonable Efforts in pursuing years from 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 effective date of such determination and the basis on which Novartis has made that determination.
expiration or termination (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 purposes of this Section 6.212.6.3, prior the 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 receipt of Agreement Wind-Down Period, Galderma’s, its Affiliates’ and its Marketing Partners’ rights with respect to Collaboration Products (including the first Marketing Approval for a given Product in a given country in the Territory, GW licenses granted under Section 7.1.1) shall be non-exclusive and NovaBay shall have the right to make Named Patient Sales in such country; provided, however, that within sixty (60engage one or more other partner(s) days after each Calendar Quarter in which GW has made any Named Patient Sales or distributor(s) of Collaboration Products in the Field in all or part of the Galderma Territory, GW will provide to Novartis a written report showing the Net Sales of each Product in each country in the Territory . Any Collaboration Products sold or disposed by Galderma or its Affiliates or Marketing Partners during the reporting period by GW, which report Agreement Wind-Down Period shall be accompanied by payment subject 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 applicable royalties under Section 2.1; or (II) 8.5. After the exclusive rights granted to Novartis in the Territory under this AgreementAgreement Wind-Down Period, the Parties agree that:
(i) Novartis, Galderma and its Affiliates and Sublicensees may attend Marketing Partners shall not make any representation regarding 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 participate other customer information relating to Collaboration Products reasonably necessary in international congresses or symposia outside Galderma’s reasonable opinion for NovaBay to continue to Commercialize such Collaboration Products, which NovaBay shall have the Territory right to use and disclose for any purpose during the Agreement Wind-Down Period and thereafter. ***Confidential treatment requested pursuant to a request for confidential treatment filed with respect to the Products; and
(ii) GW, its Affiliates Securities and licensees may attend and participate in international congresses or symposia in Exchange Commission. Omitted portions have been filed separately with the Territory with respect to the ProductsCommission.
Appears in 2 contracts
Samples: Collaboration and License Agreement (NovaBay Pharmaceuticals, Inc.), Collaboration and License Agreement (NovaBay Pharmaceuticals, Inc.)
Commercialization. (a) Novartis will Except as otherwise set forth in this Agreement, Inspire shall be solely responsible for all aspects commercialization of Commercialization of Inspire Licensed Products in the Product Field in the Territory, including planning without limitation with respect to:
(i) sales and implementation, distribution, booking of sales, pricing, reimbursement, regulatory, manufacturing marketing;
(limited to packaging and trade dress), phase IV studiesii) advertising, marketing and promotional materials;
(iii) sales activitiesrepresentatives 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 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 as provided above in Section 3.3(a); and
(vi) product inquiries and complaints.
(b) All Inspire shall use Commercially Reasonable Efforts to commercialize an Inspire Licensed Product in the Field in the Territory, promptly after (i) Regulatory Approval for such Commercialization activities will be conducted Inspire Licensed Product in accordance with Novartis’ then-current Commercialization Planthe Territory has been obtained, (ii) such other approvals (including without limitation reimbursement approvals) as are necessary for the 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) Novartis shall itself, or through its Affiliates or Sublicensees, use Commercially Reasonable Efforts in pursuing the Commercialization of the Products in the Territory. Notwithstanding Without limiting 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 Inspire agrees that it is not commercially reasonable to Commercialize shall effect a First Commercial Sale of 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 Current 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 United States no later than [***] calendar days after Launch Approval for any reason. Novartis shall not offer for sale or sell in any country the Current Product is obtained 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 countryUnited States; provided, however, that within sixty (60) days after each Calendar Quarter such obligation shall be suspended during any period 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[***].
(gd) Notwithstanding: (I) Inspire shall not 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 territorial restrictions on the licenses granted to Novartis under Section 2.1; foregoing limitation shall not affect or (II) the exclusive rights granted to Novartis in the Territory under this Agreement, the Parties agree that:
(i) Novartis, its Affiliates and Sublicensees may attend and participate in international congresses or symposia outside the Territory with respect to the Products; and
(ii) GW, its Affiliates and licensees may attend and participate in international congresses or symposia in the Territory with respect to the Productsrestrict any sampling practices of Inspire.
Appears in 2 contracts
Samples: License Agreement (Insite Vision Inc), License Agreement (Inspire Pharmaceuticals Inc)
Commercialization. (a) Novartis will be solely responsible for all aspects of Commercialization of Except to the Product in extent 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 applicable termination was made in accordance with Novartis’ thenSection 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 continue to distribute such Terminated Product, in accordance with the terms and conditions of this Agreement, in each country for which Regulatory Approval therefor has been obtained, until [***] after the effective date of termination (the “Commercialization Wind-current Commercialization Plan.
(c) Novartis down Period”); provided that Takeda, its Affiliates and its Sublicensees shall itselfcease such activities, or through its Affiliates or Sublicenseesany portion thereof, 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 upon [***] days’ notice by Denali requesting that such activities (or portion thereof) be ceased. Notwithstanding any other provision of this Agreement, during the TerritoryCommercialization Wind-down Period, GW 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 make Named Patient Sales engage one or more other distributor(s) and/or licensee(s) of the Terminated Product in such country; provided, however, that within sixty (60) days after each Calendar Quarter in which GW has made any Named Patient Sales in all or part of the Territory. Any Terminated Product sold or disposed of by Takeda, GW will provide to Novartis a written report showing the Net Sales of each Product in each country its Affiliates or its Sublicensees in the Territory during the reporting Commercialization Wind-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 GWTakeda, which report shall be accompanied by payment to Novartis of an amount equal to fifty percent (50%its Affiliates, or Sublicensees) 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 during the Commercialization Wind-down Period shall be subject to applicable payment obligations to Takeda under this AgreementSection 14.7.1. Within [***] days of expiration of the Commercialization Wind-down Period, Takeda shall notify Denali of any quantity of Terminated Product remaining in Takeda’s inventory and Denali shall have the Parties agree that:
option, upon notice to Takeda, to repurchase any such quantities of the Terminated Product from Takeda at a price equal to [***] of such quantities (i) Novartis, its Affiliates and Sublicensees may attend and participate in international congresses or symposia outside the Territory with respect to the Products; and
(ii) GW, its Affiliates and licensees may attend and participate in international congresses or symposia in the Territory with respect to the Productsextent [***]).
Appears in 2 contracts
Samples: Option and Collaboration Agreement (Denali Therapeutics Inc.), Option and Collaboration Agreement (Denali Therapeutics Inc.)
Commercialization. 3.7.1 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 (a) Novartis will be solely responsible for all aspects of Commercialization 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/or its Sublicensees in connection with the Exploitation of the Product in the Prometheus Territory, including planning and implementation, distribution, booking of sales, pricing, reimbursement, regulatory, manufacturing ) or in combination with another trademark owned or Controlled by Prometheus (limited to packaging and trade dress), phase IV studies, marketing and sales activities.
(b"Prometheus Product Trademark") All such Commercialization activities will be conducted in accordance with Novartis’ then-current Commercialization Plan.
(c) Novartis provided that Prometheus shall itself, or through its Affiliates or Sublicensees, use Commercially Reasonable Efforts in pursuing the Commercialization to ensure that its use of the Products Alizyme Trademark shall in no way reduce or diminish the Territoryreputation, image or prestige of the Alizyme Trademark. Notwithstanding For the foregoingavoidance of doubt, subject to Section 6.4, Novartis’ application of Commercially Reasonable Efforts Prometheus shall not require Novartis be obligated to Commercialize a Product use any Alizyme Trademark in any country in which Novartis (acting reasonably) determines it is not commercially reasonable to do so for such connection with the packaging, labeling, marketing, promotion or selling of the Product. Should Novartis determine that it is not commercially reasonable to Commercialize Prometheus shall be responsible for the selection, registration, and maintenance of the Prometheus Product in a particular country in Trademarks throughout the Prometheus 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 well 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 countryall expenses associated therewith; provided, however, that within sixty (60) days after each Calendar Quarter in Prometheus shall provide advanced written notice to Alizyme of the name under which GW has made any Named Patient Sales in it intends to market 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 may attend and participate in international congresses or symposia outside the Territory with Product. With respect to the Products; andforegoing, Prometheus shall use good faith efforts to provide six (6) months advanced notice of any such use of such name.
(ii) GW3.7.3 Each Party may, in its Affiliates sole discretion, share marketing plans and licensees may attend and participate in international congresses or symposia in materials with the Territory other Party with respect the object of coordinating a world-wide marketing effort to maximize the Productscommercial potential of the Product.
Appears in 2 contracts
Samples: License Agreement (Prometheus Laboratories Inc), License Agreement (Prometheus Laboratories Inc)
Commercialization. (a) Novartis will be solely responsible for all aspects To avoid disruption in the availability of Commercialization Licensed Product to patients, if this Agreement is terminated after the First Commercial Sale of the Licensed Product in the Territory, including planning then to the extent requested by Licensor, Licensee and implementationRelated Parties shall continue to distribute the Licensed Product, 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’ thenthe 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-current Commercialization Plan.
(c) Novartis down Period”); provided that Licensee and Related Parties shall itselfcease such activities, or through its Affiliates 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 Sublicenseeslicensee for the Licensed Product in a country within the Wind-down Period, use 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 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 in pursuing the Commercialization of the Products to do so. Such agreement shall provide that Licensee will fulfill orders for Licensed Product in the TerritoryTerritory 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 foregoingWind-down Period, Licensee’s and its Affiliates’ and, subject to Section 6.42.3(b) above, NovartisNon-Affiliate Sublicensees’ application of Commercially Reasonable Efforts shall not require Novartis rights with respect to Commercialize a the Licensed 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 non-exclusive and, without limiting the exclusive licenses granted to Novartis under Section 2.1foregoing, 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 Licensor shall have the right to make Named Patient Sales engage one or more other distributor(s) and/or licensee(s) of the Licensed Product in such country; provided, however, that within sixty (60) days after each Calendar Quarter in which GW has made any Named Patient Sales in all or part of the Territory. Any Licensed Product sold or disposed by Licensee, GW will provide its Affiliates and, subject to Novartis a written report showing the Net Sales of each Product in each country Section 2.3(b) above, its Non-Affiliate Sublicensees in the Territory during the reporting period by GW, which report Wind-down Period shall be accompanied by subject to applicable payment to Novartis obligations under Article 6 above. The obligations set forth in this Section 11.5(d)(i)(B) shall not apply in any country or jurisdiction in which, as of an amount equal to fifty percent (50%) the effective date 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 termination of this Agreement, the Parties agree that:
(i) Novartis, its Affiliates and Sublicensees may attend and participate in international congresses or symposia outside the Territory Royalty Term with respect to the Products; and
(ii) GW, its Affiliates and licensees may attend and participate in international congresses applicable Licensed Product has expired or symposia in the Territory Generic Competition with respect to the Productssuch License Product exists.
Appears in 2 contracts
Samples: License and Collaboration Agreement (Cullinan Oncology, LLC), License and Collaboration Agreement (Cullinan Oncology, LLC)
Commercialization. (a) Novartis will Subject to anything stated to the contrary herein, LICENSEE shall be solely responsible responsible, at its own cost and expense, for all aspects of the Commercialization of the Product Licensed Products in the Field in the Licensed Territory, including planning including, without limitation, (i) commercial launch and implementationpre-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, distributionad boards, booking of etc., subject to Article 8.5; (v) sales, pricinglogistics and distribution of Licensed Products; (vi) pre-sale and post-sale customer handling and support; (vii) order processing, reimbursement, regulatory, manufacturing invoicing and debt collection; and (limited to packaging viii) accounting for inventory and trade dress), phase IV studies, marketing and sales activitiesreceivables.
(b) All 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 Commercialization activities will 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 conducted obligated to launch Licensed Products in accordance with Novartis’ then-current Commercialization Planany particular country if the JSC, upon LICENSEE’s request, determines that it would not be commercially reasonable to launch in such country.
(c) Novartis shall itself, or through its Affiliates or Sublicensees, LICENSOR will use Commercially Reasonable Efforts in pursuing the to fully support LICENSEE's 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 activities at LICENSEE’s 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 determinationrequest.
(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) Any 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 may attend and participate in international congresses or symposia outside the Territory all transactions with respect to the Products; and
(ii) GW, Commercialization of Licensed Products be-tween LICENSEE and its Affiliates and licensees may attend sub-licensees, on the one hand, and participate in international congresses Fresenius Medical Care AG & Co. KGaA or symposia in any member of the Territory with respect to Fresenius Medical Care group of companies, on the Productsother hand, shall be on arm’s-length terms.
Appears in 1 contract
Samples: License and Collaboration Agreement (Travere Therapeutics, Inc.)
Commercialization. (a) Novartis will be solely responsible for all aspects To avoid a disruption in the supply of Commercialization XenoPort Products to patients, if this Agreement is terminated after the first commercial sale of the any XenoPort Product in the Territory, including planning Xanodyne 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 Sublicenseesshall continue to market, use Commercially Reasonable Efforts in pursuing promote, distribute and otherwise commercialize (including with the Commercialization assistance of any Co-Promotion Partner, to the extent permitted by any agreement with such Co-Promotion Partner) the XenoPort Products in the Territory. Notwithstanding Territory for which Marketing Approval by the foregoing, subject to Section 6.4, Novartis’ application FDA has been obtained (unless the FDA or a court of Commercially Reasonable Efforts shall not require Novartis to Commercialize competent jurisdiction in the Territory issues 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 directive or order that it is not commercially reasonable to Commercialize the Product in a particular country XenoPort Product be recalled or withdrawn in the Territory, Novartis shall promptly notify GW of such determination and or the basis on which Novartis has made Parties mutually agree that determination.
(d) Novartis shall not Commercialize a particular XenoPort Product should be recalled or withdrawn in the Territory Territory) and in conjunction accordance with the terms * Certain confidential information contained in this document, marked by brackets, is filed with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. and conditions of this Agreement, until [... * ...], but in no event [... * ...] after the effective date of any such termination of this Agreement (the “Wind-down Period”); provided that Xanodyne and its Affiliates shall cease such activities, or otherwise together withany portion thereof, upon [... * ...] notice by XenoPort requesting that such activities (or portion thereof) be ceased. Notwithstanding any other product(s) as a loss leader without GWprovision of this Agreement, during the Wind-down Period, Xanodyne’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 rights with respect to 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) Compound and (d), the Commercialization of the XenoPort Products in the Territory shall be in Novartis’ sole discretion.
(f) Notwithstanding non-exclusive and, without limiting the exclusive licenses granted to Novartis under Section 2.1foregoing, 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 XenoPort shall have the right to make Named Patient Sales in such country; provided, however, that within sixty (60engage one or more other distributor(s) days after each Calendar Quarter in which GW has made and/or licensee(s) of the Compound and/or any Named Patient Sales XenoPort Product in the Territory, GW will provide to Novartis a written report showing the Net Sales of each Product in each country . Any Products sold or disposed by Xanodyne in the Territory during the reporting period by GW, which report Wind-down Period shall be accompanied by subject to the applicable payment obligations under Article 6 above and all relevant deductions or credits due to Novartis Xanodyne in accordance with this Agreement. Within [... * ...] of an amount expiration of the Wind-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 applicable, from Xanodyne at a price equal to fifty percent (50%) [... * ...] calculated in accordance with GAAP and Xanodyne’s then-prevailing standard procedures for calculating costs of good sold. For the sake of clarity, 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 may attend and participate in international congresses or symposia outside the Territory with respect to the Products; and
(ii) GW, its Affiliates and licensees may attend and participate in international congresses or symposia in the Territory with respect to the Products.
Appears in 1 contract
Samples: Licensing Agreement (Xenoport Inc)
Commercialization. (a) Novartis 5.1. TTY, at its own expense, will be solely responsible for all aspects sales and marketing activities related to the Licensed Product in the Territory.
5.2. TTY agrees to use Commercially Reasonable Efforts to promote the sale, marketing, and distribution of, and otherwise commercialize and sell, the Licensed Product in the Territory for all indications that have received Governmental Approval. TTY shall provide BDSI with quarterly written reports of Commercialization TTY’s commercialization efforts and activities for such quarter and a description of its plans for future commercialization efforts and activities. In addition, TTY shall provide such other information, financial or otherwise, BDSI may reasonably request relating to the marketing, sale or distribution of the Product.
5.3. Beginning on the date of First Commercial Sale, TTY shall use Commercially Reasonable Efforts to deploy its sales representatives to sell the Licensed Product in the Territory, including planning and implementationwho 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, distributionBREAKYL, booking of salesor any other trademarks, 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 Sublicenseeslogos used with respect to the Licensed Product outside the Territory are granted to TTY under this Agreement, use Commercially Reasonable Efforts in pursuing and, notwithstanding anything to the Commercialization of the Products in the Territory. Notwithstanding the foregoingcontrary, subject to Section 6.4, Novartis’ application of Commercially Reasonable Efforts BDSI shall not require Novartis be required to Commercialize a CONFIDENTIAL TREATMENT REQUESTED WITH RESPECT TO CERTAIN PORTIONS HEREOF DENOTED WITH “***” include any such trademark, trade dress or logo on any packaging or related materials concerning any Licensed Product in any country in which Novartis (acting reasonably) determines it is not commercially reasonable supplied to do so TTY. Any trademark, logo, design and/or trade dress for such Product. Should Novartis determine that it is not commercially reasonable to Commercialize the Product in a particular country in the TerritoryLicensed Products used by TTY, 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 its Affiliates, or Sublicensees in the Territory in conjunction or otherwise together with, any other product(s) as a loss leader without GWshall be subject to BDSI’s prior written approval, which such approval may not to be withheld unreasonably withheld, comply with Applicable Laws, and not infringe or misappropriate the intellectual property rights of any Third Party. Any trademark filing or registered 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)TTY and/or logo, (c) and (d), the Commercialization of the Products trade dress designed by TTY in the Territory shall be in Novartis’ sole discretion.
(f) Notwithstanding the exclusive licenses granted solely belong to Novartis under Section 2.1TTY, excluding any trademarks owned or used by BDSI any affiliate thereof, or the remaining provisions licensee of this Section 6.2, either of the foregoing prior to the receipt Effective Date 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 may attend and participate in international congresses or symposia outside the Territory with respect to the Products; and
(ii) GW, its Affiliates and licensees may attend and participate in international congresses or symposia in the Territory with respect to the Products.
Appears in 1 contract
Samples: License and Supply Agreement
Commercialization. (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 GSK shall have the right to make Named Patient Sales grant sublicenses to Sublicensees under the license granted to it under Section 8.1.1 with respect to Royalty-Bearing Products for sale in such countrythe Royalty-Bearing Territory; provided, howeverthat, (a) to the extent any such sublicense is with respect to [***] except that GSK may utilize a contract sales organization in the Royalty-Bearing Territory and in the Co-Commercialization Territory if both GSK and SYNTA are unable to provide their respective requirements of Representatives necessary to conduct the GSK Co-Commercialization Activities or SYNTA Co-Commercialization Activities, as the case may be, in its discretion upon prior notice to SYNTA; (b) it shall be a condition of any such sublicense that such Sublicensee agrees to be bound by all terms of this Agreement Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934. applicable to the Commercialization of Royalty-Bearing Products in the Royalty-Bearing Territory (including, without limitation, Article 7); (c) GSK shall provide written notice to SYNTA of any such proposed sublicense at least [***] days prior to such execution and provide material terms or redacted copies, at GSK’s option, to SYNTA of each such sublicense within sixty [***] days of its execution; (60d) days after each Calendar Quarter in which GW has made any Named Patient Sales if GSK grants a sublicense to a Sublicensee, GSK shall be deemed to have guaranteed that such Sublicensee will fulfill all of GSK’s obligations under this Agreement applicable to the subject matter of such sublicense; (e) GSK shall not be relieved of its obligations pursuant to this Agreement as a result of such sublicense. For the avoidance of doubt, GSK shall not be required to obtain approval of SYNTA with respect to sublicenses granted to its Affiliates, or sub-contracting out its Manufacturing activities in the 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 may attend and participate in international congresses or symposia outside the Territory with respect to the Products; and
(ii) GW, its Affiliates and licensees may attend and participate in international congresses or symposia in the Territory with respect to the Products.
Appears in 1 contract
Samples: Collaborative Development, Commercialization and License Agreement (Synta Pharmaceuticals Corp)
Commercialization. (a) Novartis 5.1. TTY, at its own expense, will be solely responsible for all aspects sales and marketing activities related to the Licensed Product in the Territory.
5.2. TTY agrees to use Commercially Reasonable Efforts to promote the sale, marketing, and distribution of, and otherwise commercialize and sell, the Licensed Product in the Territory for all indications that have received Governmental Approval. TTY shall provide BDSI with quarterly written reports of Commercialization TTY’s commercialization efforts and activities for such quarter and a description of its plans for future commercialization efforts and activities. In addition, TTY shall provide such other information, financial or otherwise, BDSI may reasonably request relating to the marketing, sale or distribution of the Product.
5.3. Beginning on the date of First Commercial Sale, TTY shall use Commercially Reasonable Efforts to deploy its sales representatives to sell the Licensed Product in the Territory, including planning and implementationwho 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, distributionBREAKYL, booking of salesor any other trademarks, 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 Sublicenseeslogos used with respect to the Licensed Product outside the Territory are granted to TTY under this Agreement, use Commercially Reasonable Efforts in pursuing and, notwithstanding anything to the Commercialization of the Products in the Territory. Notwithstanding the foregoingcontrary, subject to Section 6.4, Novartis’ application of Commercially Reasonable Efforts BDSI shall not require Novartis be required to Commercialize a include any such trademark, trade dress or logo on any packaging or related materials concerning any Licensed Product in any country in which Novartis (acting reasonably) determines it is not commercially reasonable supplied to do so TTY. Any trademark, logo, design and/or trade dress for such Product. Should Novartis determine that it is not commercially reasonable to Commercialize the Product in a particular country in the TerritoryLicensed Products used by TTY, 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 its Affiliates, or Sublicensees in the Territory in conjunction or otherwise together with, any other product(s) as a loss leader without GWshall be subject to BDSI’s prior written approval, which such approval may not to be withheld unreasonably withheld, comply with Applicable Laws, and not infringe or misappropriate the intellectual property rights of any Third Party. Any trademark filing or registered 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)TTY and/or logo, (c) and (d), the Commercialization of the Products trade dress designed by TTY in the Territory shall be in Novartis’ sole discretion.
(f) Notwithstanding the exclusive licenses granted solely belong to Novartis under Section 2.1TTY, excluding any trademarks owned or used by BDSI any affiliate thereof, or the remaining provisions licensee of this Section 6.2, either of the foregoing prior to the receipt Effective Date 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 may attend and participate in international congresses or symposia outside the Territory with respect to the Products; and
(ii) GW, its Affiliates and licensees may attend and participate in international congresses or symposia in the Territory with respect to the Products.
Appears in 1 contract
Samples: License and Supply Agreement (Biodelivery Sciences International Inc)
Commercialization. Exactus BioSolutions and its Affiliates shall be entitled to continue to sell (abut not to actively promote after the effective date of termination) Novartis will be solely responsible for all aspects any existing inventory of Commercialization Products in each terminated country of the Product Territory for which Regulatory Approval therefor has been obtained (provided that such Products shall have launched in each such terminated country as of the Territory, including planning and implementation, distribution, booking applicable effective date of sales, pricing, reimbursement, regulatory, manufacturing (limited to packaging and trade dresstermination), phase IV studies, marketing and sales activities.
(b) All such Commercialization activities will be conducted in accordance with Novartis’ thenthe terms and conditions of this Agreement, for a period not to exceed twelve (12) months from the effective date of such termination (the “Commercialization Wind-current Commercialization Plan.
(c) Novartis shall itself, Down Period”). Any Products sold or through disposed of by Exactus BioSolutions or its Affiliates or Sublicensees, use Commercially Reasonable Efforts in pursuing during the Commercialization of the Products in the Territory. Notwithstanding the foregoing, Wind-Down Period shall be subject to the same royalties under Section 6.48.4 as would have applied had this Agreement otherwise remained in force and effect with respect to such terminated Product and terminated country(ies). After the Commercialization Wind-Down Period, 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 Exactus BioSolutions 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 its Affiliates shall not sell such terminated Products in such terminated country(ies) or make any representation regarding Exactus BioSolutions’ status as a Exactus BioSolutions of such Product as one in such country(ies). Either (i) at the request of a number Digital Diagnostics at the end 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.
Wind-Down Period or (fii) Notwithstanding the exclusive licenses granted to Novartis under Section 2.1, or the remaining provisions of this Section 6.2, prior to the receipt end of the first Marketing Approval Commercialization Wind-Down Period, if Digital Diagnostics has assumed responsibilities for a given regulatory activities under the Regulatory Approval, has received all clearances and Regulatory Approvals needed to sell and import the terminated Product in a given country in terminated country, and provides written notice to Exactus BioSolutions that it is wishes to assume sale of 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 terminated Product in each country a terminated country, then, 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:
either case (i) Novartisor (ii), Exactus BioSolutions shall sell and transfer to Digital Diagnostics such portion of the terminated Product inventory then held by Exactus BioSolutions or its Affiliates and Sublicensees may attend and participate in international congresses or symposia outside the Territory with respect Affiliates’ as had been allocated to the Products; and
terminated country(ies) at a price equal to the lowest price at which such Product was sold to a non-Related Party in such terminated country during the preceding twelve (ii12) GW, its Affiliates and licensees may attend and participate in international congresses or symposia month period. This Section 13.7(b) shall not apply in the Territory with respect to the Productscase of termination by Exactus BioSolutions under Section 13.2(b) based on Safety Reasons.
Appears in 1 contract
Samples: Collaboration and License Agreement (Exactus, Inc.)
Commercialization. (a) Novartis will be solely responsible for all aspects To avoid a disruption in the supply of Commercialization XenoPort Products to patients, if this Agreement is terminated after the first commercial sale of the any XenoPort Product in the Territory, including planning Xanodyne 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 Sublicenseesshall continue to market, use Commercially Reasonable Efforts in pursuing promote, distribute and otherwise commercialize (including with the Commercialization assistance of any Co-Promotion Partner, to the extent permitted by any agreement with such Co-Promotion Partner) the XenoPort Products in the Territory. Notwithstanding Territory for which Marketing Approval by the foregoing, subject to Section 6.4, Novartis’ application FDA has been obtained (unless the FDA or a court of Commercially Reasonable Efforts shall not require Novartis to Commercialize competent jurisdiction in the Territory issues 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 directive or order that it is not commercially reasonable to Commercialize the Product in a particular country XenoPort Product be recalled or withdrawn in the Territory, Novartis shall promptly notify GW of such determination and or the basis on which Novartis has made Parties mutually agree that determination.
(d) Novartis shall not Commercialize a particular XenoPort Product should be recalled or withdrawn in the Territory Territory) and in conjunction accordance with the terms and conditions of this Agreement, until [**], but in no event [**] after the effective date of any such termination of this Agreement (the "Wind-down Period"); provided that Xanodyne and its Affiliates shall cease such activities, or otherwise together withany portion thereof, upon [**] notice by XenoPort requesting that such activities (or portion thereof) be ceased. Notwithstanding any other product(s) as a loss leader without GW’s prior written approvalprovision of this Agreement, which approval may be withheld by GW for any reason. Novartis shall not offer for sale or sell in any country in during the Territory a Product at a greater discount Wind-down Period, Xanodyne's rights with respect 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) Compound and (d), the Commercialization of the XenoPort Products in the Territory shall be in Novartis’ sole discretion.
(f) Notwithstanding non-exclusive and, without limiting the exclusive licenses granted to Novartis under Section 2.1foregoing, 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 XenoPort shall have the right to make Named Patient Sales in such country; provided, however, that within sixty (60engage one or more other distributor(s) days after each Calendar Quarter in which GW has made and/or licensee(s) of the Compound and/or any Named Patient Sales XenoPort Product in the Territory, GW will provide to Novartis a written report showing the Net Sales of each Product in each country . Any Products sold or disposed by Xanodyne in the Territory during the reporting period by GW, which report Wind-down Period shall be accompanied by subject to the applicable payment obligations under Article 6 above and all relevant deductions or credits due to Novartis Xanodyne in accordance with this Agreement. Within [**] of an amount expiration of the Wind-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 applicable, from Xanodyne at a price equal to fifty percent (50%) [**] calculated in accordance with GAAP and Xanodyne's then-prevailing standard procedures for calculating costs of good sold. For the sake of clarity, 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 may attend and participate in international congresses or symposia outside the Territory with respect to the Products; and
(ii) GW, its Affiliates and licensees may attend and participate in international congresses or symposia in the Territory with respect to the Products.
Appears in 1 contract
Commercialization. (a) Novartis will 5.1.1 Subject to oversight by the JSC, Astellas shall be solely responsible for all aspects of Commercialization of the Product in the Territorylaunching and commercializing, including planning and implementation, distribution, booking of sales, pricing, reimbursement, regulatory, manufacturing (limited shall use Diligent Efforts to packaging launch 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)commercialize, 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 in accordance with a commercialization plan submitted by Astellas to the reporting 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 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 GWway of updates to the JSC at its meetings and as otherwise reasonably requested by XenoPort. It is understood and agreed that, which report shall be accompanied subject to oversight by payment to Novartis the JSC, and consistent with the other provisions of an amount equal to fifty percent (50%) of such Net Sales.
(g) Notwithstanding: (I) this Agreement, all commercialization efforts for the territorial restrictions on the licenses granted to Novartis under Section 2.1; or (II) the exclusive rights granted to Novartis Product in the Territory under this Agreement, shall be at the Parties agree that:
(i) Novartissole discretion and expense of Astellas, its Affiliates or Subdistributors.
5.1.2 XenoPort or its licensee(s) shall be responsible for launching and Sublicensees may attend and participate in international congresses or symposia commercializing the Product outside the Territory with respect Territory. XenoPort shall keep Astellas reasonably informed as to the Products; and
(ii) GWprogress 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 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 document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. the Territory shall be at the sole discretion and expense of XenoPort, its Affiliates and licensees may attend and participate in international congresses or symposia in the Territory with respect to the Productsits other licensees.
Appears in 1 contract
Commercialization. (a) Novartis will be solely responsible for all aspects of 6.1 Commercialization of VEGF Products in 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, including planning 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 VEGF Product in such country in accordance with this Section 6.1 and, to the extent not inconsistent therewith and implementationnot prohibited by applicable Law in such country, distributionin accordance with the obligations set forth in this Article 6 and 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, booking and giving equal priority to Aventis’ Commercial Supply Requirements in such Co-Marketing Countries. In the event any such provisions of salesthis Agreement are prohibited by applicable Law in a Co-Marketing Country, pricingthen 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 Therapeutic Area, reimbursementRegeneron 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, regulatoryas applicable, manufacturing (limited Regeneron shall not be entitled to packaging and trade dress), phase IV studies, marketing and sales activitiesexercise 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) All such 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 activities will be conducted Country in accordance with Novartis’ 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) Novartis shall itself, or through its Affiliates or Sublicensees, use Commercially Reasonable Efforts in pursuing Decision to Discontinue Co-Commercialization. In the Commercialization of the Products in the Territory. Notwithstanding the foregoing, subject event that Regeneron decides it no longer wishes to Section 6.4, Novartis’ application of Commercially Reasonable Efforts shall not require Novartis to Co-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 VEGF Product in a particular country Co-Commercialization Country for use in the Territorya Therapeutic Area or does not wish to maintain its minimum sales force FTE requirement for use in such Therapeutic Area, Novartis shall promptly notify GW Regeneron must give Aventis [***] prior written notice of such determination and decision. At the basis on which Novartis has made end of such [***] period, Regeneron shall cease all Co-Commercialization activities with respect to such VEGF Product in such Co-Commercialization Country for use in such Therapeutic Area. Once 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) to Co-Commercialize such VEGF Product in such Co-Commercialization Country, except with the prior written consent of the Joint Country Commercialization Sub-Committee with respect to such Co-Commercialization Country, such consent not to be unreasonably withheld or delayed, it being understood that determination.
(d) Novartis it 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 unreasonable for such consent to be withheld by GW for any reasonif 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. 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 Regeneron shall have the right to make Named Patient Sales 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 country; provided, however, that within sixty (60) days 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 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 VEGF Product in each country 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 Plan or Country Co-Commercialization Budget shall be determined in accordance with Section 3.12. Each Country Co-Commercialization Plan and Country Co-Commercialization Budget shall include, 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 marketing, sales and promotional activities and, with respect to sales representatives, the percentage of such representatives’ time dedicated to the sale of VEGF Products, 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 promotion efforts by each Party (or its Affiliates);
(d) market and sales forecasts in a form 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 Territory during the reporting period by GWCo-Promotion;
(f) patient advocacy programs, which report shall be accompanied by payment to Novartis of an amount equal to fifty percent (50%) of such Net Sales.medical affairs programs, including professional symposia and other educational activities, and medical affairs studies based upon Joint Country Commercialization Sub-Committee-approved protocols;
(g) Notwithstanding: reimbursement and patient assistance, [*********************];
(Ih) the territorial restrictions on the licenses granted to Novartis under Section 2.1; or (II) the exclusive rights granted to Novartis Non-Approval Trials in the Territory under this Agreementapplicable Co-Commercialization Country relating to the VEGF Products, the Parties agree that:which trials shall be based upon Joint Country Commercialization Sub-Committee-approved protocols; and
(i) Novartisas appropriate, its Affiliates and Sublicensees may attend and participate in international congresses or symposia outside a training plan for the Territory with respect Parties’ sales representatives. In addition to the Products; and
(ii) GWdetailed plan and budget for the next upcoming calendar year, its Affiliates each Country Co-Commercialization Plan and licensees may attend Country Co-Commercialization Budget will include an outline of the projected plan and participate in international congresses or symposia in estimated budget for the Territory with respect to the Productsfollowing calendar year.
Appears in 1 contract
Samples: Collaboration Agreement (Regeneron Pharmaceuticals Inc)
Commercialization. (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 determine whether it is willing to Manufacture Regional Antibody Candidates and Regional Licensed Products for use in Commercialization of such countryRegional Antibody Candidates and Regional Licensed Products in 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 in accordance with the foregoing, then, Surface may elect, by written notice to Novartis no later than [***] after 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, howeverhowever that Surface may not require of Novartis more than [***] such transfers for any Regional Licensed Product. Further, that within sixty (60) days after each Calendar Quarter in which GW has made any Named Patient Sales 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 the technology transfer is completed or (y) [***] If Novartis is willing to Manufacture Regional Antibody Candidates and Regional Licensed Products for use in Commercialization in the Surface Territory and Surface elects to utilize Novartis for such Commercial Manufacturing in the Surface Territory, GW will provide to Novartis a written report showing the Net Sales terms of each Product supply of such Regional Antibody Candidates and Regional Licensed Products for use in each country Commercialization of such Regional Antibody Candidates and Regional Licensed Products in the Surface Territory during the reporting period by GW, which report shall will 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 set forth in the Territory under this RLP Supply Agreement, the Parties agree that:
(i) Novartis, its Affiliates and Sublicensees may attend and participate in international congresses or symposia outside the Territory with respect to the Products; and
(ii) GW, its Affiliates and licensees may attend and participate in international congresses or symposia in the Territory with respect to the Products.
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Samples: Collaboration Agreement (Coherus BioSciences, Inc.)
Commercialization. (a) Novartis will be solely responsible for all aspects To avoid a disruption in the supply of Commercialization XenoPort Products to patients, if this Agreement is terminated after the first commercial sale of the any XenoPort Product in the Territory, Xanodyne and its Affiliates shall continue to market, promote, distribute and otherwise commercialize (including planning with the assistance of any Co-Promotion Partner, to the extent permitted by any agreement with such Co-Promotion Partner) the XenoPort Products in the Territory for which Marketing Approval by the FDA has been obtained (unless the FDA or a court of competent jurisdiction in the Territory issues a directive or order that a particular XenoPort Product be recalled or withdrawn in the Territory, or the Parties mutually agree that a particular XenoPort Product should be recalled or withdrawn in the Territory) 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 itselfthe terms and conditions of this Agreement, until the date on which XenoPort notifies Xanodyne in writing that XenoPort has secured an alternative distributor or through its Affiliates or Sublicensees, use Commercially Reasonable Efforts in pursuing licensee for the Commercialization of 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 "Wind-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 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 approvalprovision of this Agreement, which approval may be withheld by GW for any reason. Novartis shall not offer for sale or sell in any country in during the Territory a Product at a greater discount Wind-down Period, Xanodyne's rights with respect 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) Compound and (d), the Commercialization of the XenoPort Products in the Territory shall be in Novartis’ sole discretion.
(f) Notwithstanding non-exclusive and, without limiting the exclusive licenses granted to Novartis under Section 2.1foregoing, 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 XenoPort shall have the right to make Named Patient Sales in such country; provided, however, that within sixty (60engage one or more other distributor(s) days after each Calendar Quarter in which GW has made and/or licensee(s) of the Compound and/or any Named Patient Sales XenoPort Product in the Territory, GW will provide to Novartis a written report showing the Net Sales of each Product in each country . Any Products sold or disposed by Xanodyne in the Territory during the reporting period by GW, which report Wind-down Period shall be accompanied by subject to the applicable payment obligations under Article 6 above and all relevant deductions or credits due to Novartis Xanodyne in accordance with this Agreement. Within thirty (30) days of an amount expiration of the Wind-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 applicable, from Xanodyne at a price equal to fifty percent the fully burdened costs (50%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 Net Salesfully burdened costs shall not include any margins or other markup.
(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 may attend and participate in international congresses or symposia outside the Territory with respect to the Products; and
(ii) GW, its Affiliates and licensees may attend and participate in international congresses or symposia in the Territory with respect to the Products.
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Commercialization. 5.1.1 Subject to oversight by the JSC, Astellas shall be responsible for: (a) Novartis will be solely responsible for all aspects of Commercialization of the Product in the Territorylaunching and commercializing, including planning and implementation, distribution, booking of sales, pricing, reimbursement, regulatory, manufacturing (limited shall use Diligent Efforts to packaging launch 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)commercialize, 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 in accordance with a commercialization plan submitted by Astellas to the reporting period by GWJSC (“Commercialization Plan”); and (b) manufacturing, which report and shall be accompanied by payment use Diligent Efforts to Novartis manufacture, the Compound and Product necessary to support the launching and commercialization 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 Product in each country in the Territory under in accordance with the Commercialization Plan. Without limiting the foregoing, Astellas agrees to use Diligent Efforts to launch the Product as soon as practicable in the Territory, and 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 the Parties agree that:
(i) NovartisProduct in the Territory shall be at the sole discretion and expense of Astellas, its Affiliates or Subdistributors.
5.1.2 XenoPort or its licensee(s) shall be responsible for launching, manufacturing and Sublicensees may attend commercializing the Product outside the Territory. XenoPort shall keep Astellas reasonably informed as to the progress of its and/or [… * …] its other licensees’ launch, manufacturing and participate in international congresses or symposia commercialization activities relating to Product outside the Territory, by way of updates to the JSC at its meetings and as 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 manufacturing and commercialization efforts for the Product outside the Territory with respect to shall be at the Products; and
(ii) GWsole discretion and expense of XenoPort, its Affiliates and licensees may attend and participate in international congresses or symposia in the Territory with respect to the Productsits other licensees. * CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
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Commercialization. (a) Novartis will Subject to anything stated to the contrary herein, LICENSEE shall be solely responsible responsible, at its own cost and expense, for all aspects of the Commercialization of the Product Licensed Products in the Field in the Licensed Territory, including planning including, without limitation, (i) commercial launch and implementationpre-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, distributionad boards, booking of etc.; (v) sales, pricinglogistics and distribution of Licensed Products; (vi) pre-sale and post-sale customer handling and support; (vii) order processing, reimbursement, regulatory, manufacturing invoicing and debt collection; and (limited to packaging viii) accounting for inventory and trade dress), phase IV studies, marketing and sales activitiesreceivables.
(b) All LICENSEE shall use Commercially Reasonable Efforts to (A) launch Licensed Products in the Field in each country or territory within the Licensed Territory for which it has received regulatory approval and, if applicable, pricing and reimbursement approval within [****] ([****]) 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 activities will be conducted of Licensed Products in accordance with Novartis’ then-current Commercialization Plansuch or any other country in the Licensed Territory.
(c) Novartis shall itselfIn any case, or through its Affiliates or Sublicensees, LICENSOR will use Commercially Reasonable Efforts in pursuing to fully support LICENSEE’s Commercialization activities and the Commercialization commercially successful exploitation 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 License at LICENSEE’s 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 determinationrequest.
(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) Any 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 may attend and participate in international congresses or symposia outside the Territory all transactions with respect to the Products; and
(ii) GW, Commercialization of Licensed Products between LICENSEE and its Affiliates and licensees may attend sublicensees, on the one hand, and participate in international congresses Fresenius Medical Care AG & Co. KGaA or symposia in any member of the Territory with respect to Fresenius Medical Care group of companies, on the Products.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]
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