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
Sources: 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 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
Sources: Option and License Agreement (Bavarian Nordic a/S / ADR), Option and License Agreement (Bavarian Nordic a/S / ADR), Option and License Agreement (Bavarian Nordic a/S / ADR)
Commercialization. (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
Sources: 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 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
Sources: Co Development and Option Agreement (Alector, Inc.), Co Development and Option Agreement (Alector, 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
Sources: License Agreement (Prometheus Laboratories Inc), License Agreement (Prometheus Laboratories 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
Sources: Option and Collaboration Agreement (Denali Therapeutics Inc.), Option and Collaboration Agreement (Denali Therapeutics 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
Sources: License Agreement (Inspire Pharmaceuticals Inc), License Agreement (Insite Vision 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
Sources: Collaboration and License Agreement (NovaBay Pharmaceuticals, Inc.), Collaboration and License Agreement (NovaBay Pharmaceuticals, 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
Sources: 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; (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]
Appears in 1 contract
Commercialization. (a) Novartis will be solely responsible for all aspects To avoid disruption of Commercialization supply of any Terminated Products to patients if this Agreement is terminated after the Launch of a Terminated Product in the TerritoryAffected Area, including planning GSK, its Affiliates and implementationSublicensees shall continue to sell the Terminated Products in each country of the Affected Area for which Marketing Approval of such Terminated Product has been obtained, 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 Amicus notifies GSK that Amicus has secured an alternative distributor or through its Affiliates or Sublicensees, use Commercially Reasonable Efforts licensee for such Terminated Product in pursuing the Commercialization such country of the Affected Area, but in no event more than ****** after the effective date of any such termination of this Agreement (“Wind-Down Period”); provided that Amicus may terminate the Wind-Down Period in any country(ies) of the Affected Area upon ****** written notice to GSK; provided further that GSK shall not be obligated to promote the sale of Terminated Products in the TerritoryAffected Area during the Wind-Down Period. Notwithstanding any other provision of this Agreement, during the Wind-down Period, GSK’s and its Affiliates’ and Sublicensees’ rights with respect to the Terminated Products in the Affected Area shall be non-exclusive and, without limiting the foregoing, 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 Amicus shall have the right to make Named Patient Sales engage one or more other distributor(s) and/or licensee(s) of any Terminated Product in such countryall or part of the Affected Area; 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 event that Amicus does so engage one or more other distributor(s) and/or licensee(s) of each any Terminated Product in each country all or part of the Affected Area, GSK shall have no further obligation to continue to sell the Terminated Products in the Territory Affected Area or such part thereof, as applicable. Any Terminated Product sold or disposed by GSK in the Affected Area during the reporting period by GW, which report Wind-down Period shall be accompanied by subject to applicable royalty 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 obligations under Section 2.1; 3.4 above, and for such purposes, Sections 3.4, 3.5, 3.7, 3.8, 3.9 and 3.11 shall survive. Within ****** following the expiration of the Wind-Down Period, GSK shall notify Amicus of any quantities of Compound or (IITerminated Product(s) remaining in GSK’s or its Affiliate’s inventory, as well as any components necessary for the exclusive rights granted Manufacture of the Compound and Terminated Product(s) in GSK’s or its Affiliate’s inventory, and Amicus shall have the option, upon notice to Novartis in GSK, to repurchase any such quantities of the Territory under this AgreementCompound and/or Terminated Product(s) and/or components from GSK at a price to be mutually agreed by the Parties. If Amicus so elects to purchase any remaining quantities of Compound or Terminated Products or components from GSK as set forth herein, GSK will transfer to Amicus such quantities of inventory of Compound or Terminated Product(s) or components. ****** - Material has been omitted and filed separately with 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 ProductsCommission.
Appears in 1 contract
Sources: License and Collaboration Agreement (Amicus Therapeutics Inc)
Commercialization. (a) Novartis will be solely responsible for all aspects of Commercialization of the Product Unless this Agreement expires by its terms or pursuant to Section 13.4, Galderma, its Affiliates and its Sublicensees shall continue to market, promote, distribute and otherwise commercialize Products in each country 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’ thenthe terms and conditions of this Agreement, until three (3) months after the date on which ZARS notifies Galderma in writing that ZARS has secured an alternative distributor or licensee for such Product(s) in such country, but in no event for more than nine (9) months after the effective date of any termination of this Agreement (the “Wind-current Commercialization Plan.
(c) Novartis down Period”); provided that Galderma, its Affiliates and its Sublicensees shall itselfcease such activities, or through its Affiliates any portion thereof, in a given country upon sixty (60) days notice by ZARS requesting that such activities (or Sublicensees, use Commercially Reasonable Efforts in pursuing the Commercialization of the Products in the Territoryportion thereof) be ceased. Notwithstanding any other provision of this Agreement, during the foregoingWind-down Period, subject (A) Galderma’s and its Affiliates’ and Sublicensees’ rights with respect 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 Galderma 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 ZARS shall have the right to make Named Patient Sales engage one or more other distributor(s) and/or licensee(s) of a Product in such country; provided, however, that within sixty all or part of the Galderma Territory and (60B) days after each Calendar Quarter in which GW has made any Named Patient Sales Galderma shall be relieved of its obligations under Section 6.4. Any Product sold or disposed in the Territory, GW will provide to Novartis a written report showing the Net Sales of each Product in each country in the Galderma Territory during the reporting period by GW, which report Wind-down Period shall be accompanied by subject to the other applicable payment to Novartis obligations under Article 5 and Article 6 above. Within thirty (30) days of an amount expiration of the Wind-down Period, Galderma shall notify ZARS of any quantity of Product remaining in Galderma’s inventory and ZARS shall purchase from Galderma any such quantities of Product having at least twelve (12) additional months of shelf life, at a price equal to fifty percent (50%) the Galderma COGS for such Products, up to maximum amount of such Net Sales.
(g) Notwithstanding: (I) quantities equal to the territorial restrictions on the licenses granted to Novartis under Section 2.1; or (II) the exclusive rights granted to Novartis number of Products sold in the Territory under this Agreementpreceding six (6) months. ZARS shall have the right, but not the Parties agree that:
(i) Novartisobligation, its Affiliates and Sublicensees may attend and participate to purchase any additional quantities of Product remaining in international congresses or symposia outside Galderma’s inventory that do not meet the Territory with respect foregoing requirements, at a price equal to the Galderma COGS for such Products; and
(ii) GW. If any Product was manufactured by any Third Party for Galderma, its Affiliates and licensees may attend and participate in international congresses or symposia Galderma had contracts with vendors which contracts are necessary or useful for ZARS to take over responsibility for the Products in the Territory with respect Galderma Territory, then Galderma shall to the Productsextent possible and as requested in writing by ZARS, assign all of the relevant Third-Party contracts to ZARS. If Galderma or its Affiliate manufactured any Product at the time of termination, then Galderma (or its Affiliate) shall, to the extent practicable, continue to provide for manufacturing of such Product for ZARS, from the date of notice of such termination until such time as ZARS is able, using reasonable efforts to do so, to secure an acceptable alternative commercial manufacturing source from which sufficient quantities of Product may be procured and legally sold in the Galderma Territory (but in no event for longer than fifteen (15) months after notice of termination is delivered), and ZARS shall compensate Galderma for such quantities at a transfer price equal to [ * ] of Galderma COGS.
Appears in 1 contract
Sources: Development and Commercialization Agreement (Zars Inc/Ut)
Commercialization. (a) Novartis will be solely responsible Sanofi and its Affiliates and sublicensees shall continue, to the extent that Sanofi and its Affiliates and sublicensees continue to have stocks of usable Product, to fulfill orders received from customers for all aspects of Commercialization of the Product in the TerritoryField in the Territory until up to 180 days after the later of (A) the date on which MannKind notifies Sanofi in writing that MannKind intends to Commercialize such Product or has secured an alternative distributor or licensee for the Product and (B) Sanofi has initiated transition of the ▇▇▇▇ and Marketing Approvals for Product in the Field in the Territory to MannKind or such distributor or licensee, including planning and implementationbut in no event for more for than 12 months after the date of notice of termination. For Product sold by Sanofi after the effective date of a termination (i.e., distribution, booking after the expiration of sales, pricing, reimbursement, regulatory, manufacturing (limited to packaging and trade dressthe applicable termination notice period), phase IV studies, marketing and sales activities.
(b) All such Commercialization activities will be conducted the profit-or-loss provisions in accordance with Novartis’ then-current Commercialization Plan.
(c) Novartis Section 6.3 shall itself, or through its Affiliates or Sublicensees, use Commercially Reasonable Efforts in pursuing the Commercialization of the Products in the Territorycontinue to apply. Notwithstanding the foregoing, subject to Section 6.4, Novartis’ application of Commercially Reasonable Efforts Sanofi and its Affiliates and sublicensees 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 cease 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 activities in the Territory in conjunction or otherwise together with, upon 60 days written notice given by MannKind at 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 time after 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 effective date of a number of items without a separate price i.e. Novartis will not sell a Product as part termination requesting that such activities (or portion thereof) cease. In the case of a bundled transaction.
(e) Subject termination of this Agreement in its entirety, within 30 days after MannKind has given notice to compliance with Sections 6.2(b)Sanofi requesting the cessation of activities pursuant to the provision of this Section, (c) and (d), the Commercialization Sanofi shall notify MannKind of an estimate of the Products quantity of Product and its shelf life remaining 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 Sanofi’s inventory and MannKind shall have the right to make Named Patient Sales in purchase any such country; providedquantities of Product from Sanofi at a price mutually agreed by the Parties. To the extent MannKind does not purchase such quantities, however, that within sixty (60) Sanofi may sell such quantities during the 180 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%) effective date of such Net Salestermination within the shelf life remaining for Product.
(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
Sources: License and Collaboration Agreement (Mannkind Corp)
Commercialization. Licensee is authorized to, and covenants and agrees to use its commercially reasonable efforts to, bring about ultimately (awith the protection of Taurus’ interests intact) Novartis will the development of Antibody Products, the obtaining of regulatory approval for Antibody Products and the manufacturing, commercialization and sale of units of Antibody Products and to generate Net Sales therefrom, source and, when relevant, enter into agreements to authorize Permittees and/or to license Post-Taurus Patents to commercial third parties (in each case, and inclusive of agreements and arrangements which grant such Person an option or right to become a Permittee with respect to one or more specific Taurus Antibodies to specific targets or with respect to one or more specific Antibody Products and/or to obtain a license to Post-Taurus Patents with respect to one or more specific Taurus Antibodies to specific targets or with respect to one or more specific Antibody Products, or any equivalent arrangement, a “Permittee-Enabling Agreement”; it being understood that any such an agreement or arrangement with respect to an Other Licensed Product would also be solely responsible within the defined term “Permittee-Enabling Agreement”). Licensee is authorized to bring about ultimately (with the protection of Taurus’ interests intact) the development of Other Licensed Products, the obtaining of regulatory approval for all aspects Other Licensed Products and the manufacturing, commercialization and sale of Commercialization units of Other Licensed Products and the Product in the Territorygeneration of Net Sales therefrom, including planning by entering into Permittee-Enabling Agreements therefor. It is understood, however, that Licensee shall also itself have the right to (for and implementationon its own account) directly research, distributiondevelop, booking of salesobtain regulatory approval for, pricingmake, reimbursementhave made, regulatoryuse, manufacturing sell, offer for sale, distribute, promote, import, export, and (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 this Section 6.43.1 and Section 3.3) out-license or otherwise commercially exploit units of Taurus Antibodies or Products directly, Novartis’ application as well as to (for and on its own account) directly file, prosecute, maintain, defend and enforce any and all Post-Taurus Patents for each particular Taurus Antibody and/or Product. Licensee covenants and agrees not to enter into any Permittee-Enabling Agreement which purports to grant a Permittee rights as to all Taurus Antibodies/ Antibody Products or as to a set of Commercially Reasonable Efforts shall not require Novartis to Commercialize a Product in any country in which Novartis (acting reasonably) determines it Taurus Antibodies/ Antibody Products that 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 Territorybona fide specific, 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 except as part of a bundled transaction.
(e) Subject bona fide partnership, collaboration or co-research or co-development arrangement expressly permitted pursuant 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 Sales3.5.
(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
Sources: Commercial License Agreement (Ligand Pharmaceuticals Inc)
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
Sources: License and Collaboration Agreement (Travere Therapeutics, Inc.)
Commercialization. (a) Novartis will be solely responsible for all aspects To avoid disruption of Commercialization supply of any Terminated Products to patients if this Agreement is terminated after the Launch of a Terminated Product in the TerritoryAffected Area, including planning GSK, its Affiliates and implementationSublicensees shall continue to sell the Terminated Products in each country of the Affected Area for which Marketing Approval of such Terminated Product has been obtained, 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 Amicus notifies GSK that Amicus has secured an alternative distributor or through its Affiliates or Sublicensees, use Commercially Reasonable Efforts licensee for such Terminated Product in pursuing the Commercialization such country of the Affected Area, but in no event more than ****** after the effective date of any such termination of this Agreement (“Wind-Down Period”); provided that Amicus may terminate the Wind-Down Period in any country(ies) of the Affected Area upon ****** written notice to GSK; provided further that GSK shall not be obligated to promote the sale of Terminated Products in the TerritoryAffected Area during the Wind-Down Period. Notwithstanding any other provision of this Agreement, during the Wind-down Period, GSK’s and its Affiliates’ and Sublicensees’ rights with respect to the Terminated Products in the Affected Area shall be non-exclusive and, without limiting the foregoing, 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 Amicus shall have the right to make Named Patient Sales engage one or more other distributor(s) and/or licensee(s) of any Terminated Product in such countryall or part of the Affected Area; 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 event that Amicus does so engage one or more other distributor(s) and/or licensee(s) of each any Terminated Product in each country all or part of the Affected Area, GSK shall have no further obligation to continue to sell the Terminated Products in the Territory Affected Area or such part thereof, as applicable. Any Terminated Product sold or disposed by GSK in the Affected Area during the reporting period by GW, which report Wind-down Period shall be accompanied by subject to applicable royalty 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 obligations under Section 2.1; 3.4 above, and for such purposes, Sections 3.4, 3.5, 3.7, 3.8, 3.9 and 3.11 shall survive. Within ****** following the expiration of the Wind-Down Period, GSK shall notify Amicus of any quantities of Compound or (IITerminated Product(s) remaining in GSK’s or its Affiliate’s inventory, as well as any components necessary for the exclusive rights granted Manufacture of the Compound and Terminated Product(s) in GSK’s or its Affiliate’s inventory, and Amicus shall have the option, upon notice to Novartis in GSK, to repurchase any such quantities of the Territory under this AgreementCompound and/or Terminated Product(s) and/or components from GSK at a price to be mutually agreed by the Parties. If Amicus so elects to purchase any remaining quantities of Compound or Terminated Products or components from GSK as set forth herein, GSK will transfer to Amicus such quantities of inventory of Compound or Terminated Product(s) or components. ****** - Material has been omitted and filed separately with 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.Commission. 63
Appears in 1 contract
Sources: Licensing, Development, Manufacturing and Marketing Agreement
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
Sources: Licensing Agreement (Xenoport Inc)
Commercialization. (a) Novartis will be solely responsible SKINMEDICA shall use reasonable commercial efforts to diligently undertake market development, launch, and sales and marketing activities for all aspects of Commercialization of the Licensed Product in the TerritoryTerritory and shall promptly notify DOW in writing of the *** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission. Launch Date. In the event SKINMEDICA does not launch the Licensed Product in the Territory within *** after FDA approval of the Licensed Product: (i) SKINMEDICA shall provide DOW notice of delay and the reasons for the delay; and (ii) SKINMEDICA shall, including planning and implementationupon notice to DOW, distribution, booking have the option of sales, pricing, reimbursement, regulatory, manufacturing extending the Launch Date by a period of not more than *** beyond such *** post-FDA-approval period (limited to packaging and trade dressthe “Extended Period”), 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 itselfIf, or through its Affiliates or Sublicensees, use Commercially Reasonable Efforts in pursuing at the Commercialization end 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)Extended Period, the Commercialization of the Products in the Territory shall be in Novartis’ sole discretion.
(f) Notwithstanding the exclusive licenses granted to Novartis under Section 2.1Launch Date has still not occurred, 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 DOW shall have the right to make Named Patient Sales in such country; terminate this Agreement pursuant to Section 6.2, provided, however, that within sixty (60) days if such delay is due to a Force Majeure Event the provisions of Section 13.4 shall apply. In the event DOW terminates this Agreement after each Calendar Quarter the conclusion of the Extended Period due to SKINMEDICA’s failure to launch the Licensed Product and successfully licenses a third party to commercialize the Licensed Product under the Licensed Patent in which GW has made any Named Patient Sales the Field in the Territory, GW will provide to Novartis a written report showing DOW shall pay SKINMEDICA *** of any license fees and royalty revenue based on sales of the Net Sales of each Licensed Product in each country the Field in the Territory during that are received by DOW under such third-party license until the reporting period by GW, which report shall be accompanied by payment to Novartis of an amount equal to fifty percent (50%) aggregate of such Net Salespayments to SKINMEDICA totals *** of Development Fees paid to DOW by SKINMEDICA.
(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 be solely responsible GSK, its Affiliates and Sublicensees, shall continue, to the extent that GSK, its Affiliates and Sublicensees continue to have stocks of usable Product, to fulfill orders received from customers for all aspects of Commercialization of the Product in the TerritoryGSK Territory (or, including planning and implementation, distribution, booking of sales, pricing, reimbursement, regulatory, manufacturing (if the termination is limited to packaging a specific country, within such country) until up to [**] days after the later of (A) the date on which Sepracor notifies GSK in writing that Sepracor has secured an alternative distributor or licensee for the Product in the GSK Territory and trade dress(B) GSK has initiated transition of the ▇▇▇▇ and Marketing Approvals for the Product in the GSK Territory (or, if the termination is limited to a specific country, within such country) to such distributor or licensee, but in no event for more for than [**] after the date of notice of termination. For the Products sold by GSK after the effective date of a termination (i.e., after the expiration of the applicable termination notice period), phase IV studies, marketing and GSK shall continue to pay royalties on the amount of Net Sales from such 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 Territorypursuant to Section 7.3. Notwithstanding the foregoing, subject GSK, its Affiliates and its Sublicensees shall cease such activities in the GSK Territory (or, if termination is limited to Section 6.4a specific country, Novartis’ application within such country), as the case may be, upon [**] written notice given by Sepracor at any time after the effective date of Commercially Reasonable Efforts a termination requesting that such activities (or portion thereof) cease. In the case of a termination of this Agreement in its entirety, within [**] after Sepracor has given notice to GSK requesting the cessation of activities pursuant to the provision of this Section, GSK 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 notify Sepracor of an estimate of the quantity of the Product and its shelf life remaining in a particular country in the Territory, Novartis shall promptly notify GW of such determination GSK’s inventory 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 Sepracor shall have the right to make Named Patient Sales in purchase any such country; providedquantities of the Product from GSK for [**], howeverbeing the amount [**]. To the extent Sepracor does not purchase such quantities, that within sixty (60) days after each Calendar Quarter in which GW has made any Named Patient Sales GSK may sell such quantities in the Territory, GW will provide to Novartis a written report showing the Net Sales of each Product in each country in the GSK Territory during the reporting period by GW, which report shall be accompanied by payment to Novartis of an amount equal to fifty percent (50%) [**] after the effective date of such Net Salestermination within the shelf life remaining for the Product.
(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
Sources: Development, License and Commercialization Agreement (Sepracor Inc /De/)
Commercialization. (aTo avoid disruption of supply of any Terminated Product(s) Novartis will be solely responsible for all aspects to patients if termination occurs after the Launch of Commercialization of the Product a Terminated Product(s) in the Territoryrelevant Affected Area, 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) NovartisGSK, its Affiliates and Sublicensees shall continue to sell the Terminated Product(s) in the relevant Affected Area, in accordance with the terms and conditions of this Agreement, for up to ****** or such shorter period of time as requested by Amicus as provided below, after the effective date of any such termination of any such Terminated Product(s) (“GSK Wind-Down Period”); provided that Amicus may attend and participate terminate the GSK Wind-Down Period in international congresses or symposia outside any country of the relevant Affected Area upon ****** written notice to GSK; provided further that GSK shall not be obligated to promote the sale of Terminated Products in the Affected Area during the GSK Wind-Down Period. Subject to the foregoing obligations of GSK, during the GSK Wind-Down Period, GSK may transfer any remaining inventory of Terminated Product(s) from the Affected Area to a country within the GSK Territory for which GSK’s rights with respect to such Product(s) have not been terminated. Within ****** following the expiration of the GSK Wind-Down Period, GSK shall notify Amicus of any quantities of Terminated Product(s) for the Affected Area remaining in GSK’s or its Affiliates’ inventory and Amicus shall have the option, upon notice to GSK, to repurchase any such quantities of the Terminated Product(s) from GSK at a price equal to GSK’s Manufacturing Costs. If Amicus so elects to purchase any remaining quantities of Terminated Product(s) from GSK as set forth herein, GSK will transfer to Amicus such quantities of inventory of Terminated Products; and
(ii. If Amicus does not elect to purchase any such remaining quantities of inventory of Terminated Products, GSK may transfer any such remaining inventory of Terminated Product(s) GW, its Affiliates and licensees may attend and participate in international congresses or symposia in to a country within the GSK Territory for which GSK’s rights with respect to the Productssuch Product(s) have not been terminated.
Appears in 1 contract
Sources: License and Collaboration Agreement (Amicus Therapeutics Inc)
Commercialization. (a) Novartis will be Subject to the terms and conditions of this Agreement, GSK shall have the exclusive right, and sole responsibility and decision-making authority (either itself or through one or more Affiliates, Sublicensees or other Third Parties selected by GSK), in all matters relating to the Commercialization of any Compound and any Product for the GSK Territory as of and following the Effective Date (except for the Scynexis Transitional Commercialization Rights). Without limiting the generality of the foregoing and except for the Scynexis Transitional Commercialization Rights, GSK, at its sole expense, is solely responsible for and has full control over, all aspects sales, marketing and other Commercialization activities for any Product for the GSK Territory as of and following the Effective Date, including sole responsibility for (i) any decisions and negotiations with relevant Regulatory Authorities regarding price and reimbursement status of any Product for the GSK Territory, and (ii) the creation, preparation, production, reproduction, and filing with the applicable Regulatory Authorities of relevant written sales, promotion and advertising materials relating to any Product for use in the GSK Territory. GSK shall, except for the Scynexis Transitional Commercialization Rights, sell, distribute, and book all sales of all Products in the GSK Territory. Subject to its diligence obligations set forth in Section 4.6, GSK has the sole right, in its discretion, to decide whether to launch or continue to sell any Product in any market in the GSK Territory. During the Commercialization Transition Period, the Parties shall complete their respective activities under the Commercialization Transition Plan to enable GSK to efficiently initiate Commercialization in the United States of the Product marketed by Scynexis as of the Execution Date under the Trademark BREXAFEMME® (including, the assignment by Scynexis or its Affiliates to GSK and the assumption by GSK of all of Scynexis’s post-Effective Date obligations thereunder, (x) of all distribution, commercialization, payor and similar agreements, to the extent relating to any Product in the TerritoryGSK Territory (the “Scynexis Commercial Contracts”) to the extent such agreements are assignable and (y) all Scynexis Websites and Copyrights) and Scynexis shall consult with GSK on the activities allocated to Scynexis under the Commercialization Transition Plan and consider in good faith any and all feedback and reasonable instructions provided by GSK with respect thereto; provided that either Party may propose amendments to the Commercialization Transition Plan at any time during the Commercialization Transition Period by delivering a written notice to the other Party for review and discussion; provided, including planning further, that the Commercialization Transition Plan may only be amended by mutual written agreement of the Parties. Scynexis shall make Scynexis Personnel reasonably available to accomplish the activities set forth in such Commercialization Transition Plan, provided Scynexis shall have no obligation to retain or employ any Scynexis Personnel to fulfill this obligation. Any and implementationall reasonable and documented FTE Costs and Out-of-Pocket Costs incurred by Scynexis or its Representatives under this Section 4.4 (except to the extent that such FTE Costs or Out-of-Pocket Costs are incurred by Scynexis or its Representatives in connection with CMC activities required to be conducted to remedy any identified errors in existence as of the Effective Date that are necessary to be remedied in order to obtain or maintain the applicable Regulatory Approval) shall be reimbursed by GSK, distributionand shall be due and payable within [***] ([***]) from the date on which GSK receives a Valid Invoice; provided further that (A) a good faith estimate of such FTE Costs and Out-of-Pocket Costs and any good faith material updates of these good faith estimates of such FTE Costs and Out-of-Pocket Costs shall be approved by GSK prior to such FTE Costs and Out-of-Pocket Costs being incurred and if GSK does not provide such approval within [***] ([***]) of receipt from Scynexis of the estimate or updated estimate of the relevant FTE Costs and Out-of-Pocket Costs, booking then Scynexis shall not be obligated to perform the applicable activity, and (B) to the extent GSK approves such estimate or updated estimate, GSK shall be obligated to pay the amount of sales, pricing, reimbursement, regulatory, manufacturing such FTE Costs and Out-of-Pocket Costs set forth in such Valid Invoice so long as such amount does not exceed such approved estimate or updated estimate by more than [***] percent (limited to packaging and trade dress[***]%), phase IV studies, marketing and sales activities.
(b) All such GSK acknowledges that ▇▇▇▇▇▇▇▇’s performance of 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 pursuant to the Commercialization Transition Plan is for the sole benefit of GSK and the sole purpose of furthering GSK’s Exploitation of Compounds and 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 Field in the GSK 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 1 contract
Commercialization. The parties shall mutually agree to those Joint Development Products, if any, that shall be commercialized. A condition precedent to any commercialization shall be an agreement between NANX and SCOA for the manufacture by NANX of the Joint Development Product on behalf of SCOA and/or its Affiliates. Any such agreement shall include (without limitation):
(a) Novartis will be solely responsible for all aspects A royalty payment to NANX of Commercialization [***] percent ([***]%) of gross profit from the sale of the Joint Development Product (the “Royalty”) where “gross profit” is defined as the sales price less “cost of production” discounts, product returns, rebates;
(b) NANX shall sell the Joint Development Product to SCOA or an Affiliate at NANX cost of production, where “cost of production” is defined as the total cost of manufacturing the product to include all raw materials, direct and indirect labor costs, packaging and labeling, consumables associated with quality assurance testing, utilities, maintenance, and depreciation associated with the unit operations required to produce the Joint Development Product;
(c) A minimum term of ten (10) years terminable (i) for cause and (ii) a right to terminate in the event SCOA or an Affiliate acquires a Competing Product;
(d) A mutual audit right permitting access to books and records to confirm sales and costs of production;
(e) NANX shall sell the joint development products to SCOA or an Affiliate based on firm PO’s placed by SCOA or an Affiliate and receipt of quarterly Rolling, Non-Binding annual forecasts, with no associated minimum purchase obligation;
(f) SCOA and its Affiliates shall have the exclusive right to purchase the Joint Development Product and NANX shall not sell any Joint Development Product to any other party; and
(g) NANX appointed as the exclusive manufacturer for sales 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 if NANX lacks the Territorycapacity to produce a sufficient quantity of a Joint development Product, 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 NANX shall be accompanied by payment required to Novartis of an amount equal contract with one or more third party manufacturers to fifty percent (50%) of such Net Salesmake up any shortfall.
(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
Sources: Joint Development Agreement (NANOPHASE TECHNOLOGIES Corp)
Commercialization. (aArticle 6(b) Novartis will be solely responsible for all aspects of Commercialization of the Product Agreement is hereby amended with the addition of the following paragraph: “Notwithstanding the provisions above and elsewhere in the TerritoryAgreement, including planning any decision to (i) file for regulatory approval of Licensed Products and/or to (ii) launch 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 Commercialize Licensed 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 of the Additional Licensed Territory shall be at the sole discretion of the LICENSEE, which shall consider any input from LICENSOR, including through the JSC. The LICENSEE shall not be obligated to (i) file for regulatory approval of Licensed Products and/or to (ii) launch and Commercialize Licensed Products in which Novartis (acting reasonably) any given country in the Additional Licensed Territory if LICENSEE determines it is would not be commercially reasonable to do so in such country; provided that, if (i) LICENSEE does not file for such Product. Should Novartis determine that it is not commercially reasonable to Commercialize the regulatory approval for a Licensed 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 TerritoryAdditional Licensed Territory within [***] following the Amendment Effective Date, GW or, (ii) if filing for pricing and reimbursement approval is a requirement in order to Commercialize, LICENSEE does not file for pricing and reimbursement approval for a Licensed Product in any given country in the Additional Licensed Territory within [***] following regulatory approval, or (iii) LICENSEE does not launch and Commercialize a Licensed Product in any given country in the Additional Licensed Territory within [***] following receipt of regulatory approval and, if required to Commercialize, pricing and reimbursement approval, in such country assuming that sufficient quantities of Licensed Products in good quality and complying with the specifications set forth in the regulatory approvals are available for clause (iii) to be applicable, then LICENSOR shall have the right to make Named Patient Sales in terminate the License and all rights granted to LICENSEE hereunder related to such country; provided, however, that within sixty (60) days after each Calendar Quarter in which GW has made any Named Patient Sales and the rights related to such country shall revert to LICENSOR and such country shall no longer be included in the Territory. In such a case and following a specific discussion at JSC upon the expiration of the applicable [***] period, GW will provide to Novartis LICENSOR may exercise such right by sending 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 notice to Novartis of an amount equal LICENSEE to fifty percent (50%) of such Net Sales.
(g) Notwithstanding: (I) the territorial restrictions on the licenses granted that effect. *** Certain Confidential Information Omitted Amendment No. 2 to Novartis under Section 2.1; or (II) the exclusive rights granted to Novartis in the Territory under this License and Collaboration 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
Sources: License and Collaboration Agreement (Travere Therapeutics, 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 Partner shall have the right final say with respect to make Named Patient Sales decisions regarding the following activities for the Shared Territory: the JCC Final Decision Exceptions set forth in such country[*] but not those set forth in [*], which shall be referred to the Executive Officers for final decision pursuant to Section 2.7(c); 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 decisions regarding the Products; and
Shared Territory Commercialization Budget under [*], if (iix) GW, its Affiliates and licensees may attend and participate in international congresses or symposia the amended Shared Territory Commercialization Budget at issue is for a Calendar Year included in the Initial Shared Territory Commercialization Budget and such amended total aggregate Shared Territory Commercialization Budget for such Calendar Year exceeds by more than [*] the total aggregate budget for such Calendar Year set forth in the Initial Shared Territory Commercialization Budget attached hereto (or if such total aggregate budget has been updated and approved by the JSC, the total aggregate budget approved by the JSC), in all cases excluding [*], and (y) the JSC does not reach consensus on such amended total aggregate Budget, then such issue shall not be referred to the Executive Officers, but rather Partner shall have final say with respect to such proposed Budget and Medivation’s forty percent (40%) share of the Productsamount in excess of such [*] amount of the total aggregate budget for such Calendar Year (“Excess Initial Shared Territory Commercialization Budget Amount”) in the Initial Shared Territory Commercialization Budget attached hereto (or if such total aggregate budget has been updated and approved by consensus of the JSC, the total aggregate budget approved by the JSC) not approved by Medivation, shall be paid by Partner but deducted from Medivation’s share of Operating Profit or otherwise any sales milestone payable under Sections 8.2 and 8.4, respectively, in accordance with the procedure set forth in Section 8.2 and 8.4, as appropriate. All other decisions or disputes regarding the Shared Territory Commercialization Budget shall be handled by the Executive Officers as set forth in Section 2.7(c)(ii). For the avoidance of doubt, decisions with respect to Manufacturing Costs shall be subject to Section 2.7(b)(iii) above.
Appears in 1 contract
Commercialization. (a) Novartis Upon the execution of this Agreement, LICENSEE agrees to review and consider such alternatives as it determines to be available and practicable to enable it to market the Product as promptly as practicable subsequent to FDA approval of the ANDA for the Product [***].
(b) Subject to Section 16.1, LICENSEE shall commence marketing the Product to customers in the United States within [***] after all of the following have occurred for the Product (and LICENSEE will be solely responsible use diligent efforts to cause or to facilitate such occurrences): (i) FDA approval has been obtained of the ANDA filed for the Product; (ii) all aspects other Regulatory Approvals have been obtained and other legal and regulatory requirements have been met for the Product, and the manufacture, use, marketing, and sale thereof, in the Territory [*CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT. EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK [***], HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.] (including without limitation with respect to Manufacturing and storage facilities and technology of Commercialization Nastech); [***]. After the initial commercial introduction, marketing and sale of the Product in the TerritoryUnited States, including planning LICENSEE will market, promote and implementation, distribution, booking sell the Product in the United States using such efforts and resources consistent with LICENSEE's other generic products of sales, pricing, reimbursement, regulatory, manufacturing (limited equivalent commercial potential to packaging the Product [***]. LICENSEE may engage in such efforts directly or through Affiliates or sublicensees and trade dress), phase IV studies, may enter into co-promotion or other marketing agreements with Third Parties in the United States to extend the marketing and sales activities.
(b) All such Commercialization activities will be conducted promotion of the Product hereunder, provided that in accordance all cases LICENSEE remains responsible for the compliance of its Affiliates, sublicensees and Third Party co-promotion partners with Novartis’ then-current Commercialization Planthe terms and conditions of this Agreement.
(c) Novartis LICENSEE 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 undertake promotional activities ("Promotional Activities") 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 promote the Product in a particular country in using the Territory, Novartis shall promptly notify GW of such determination efforts and the basis on which Novartis has made that determination.resources required by Section 7.1(b) above:
(d) Novartis Nastech and LICENSEE shall not Commercialize form a Product Development Committee which shall meet on a recurring basis to establish a timeline for Commercial Launch, including regulatory requirements to be fulfilled, and to review marketing and sales efforts and programs on an on-going basis. Notwithstanding the foregoing LICENSEE shall have sole control in determining 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 timing of a number of items without a separate price i.e. Novartis will not sell a Product as part of a bundled transactionlaunch.
(e) Subject LICENSEE shall not use Product as a loss leader or bundle Product with any other products in any fashion that decreases revenue otherwise directly attributable to compliance with Sections 6.2(b), (c) and (d), the Commercialization of the Products Product disproportionately 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 comparison 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 Salesother bundled products.
(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
Sources: License and Supply Agreement (Nastech Pharmaceutical Co Inc)
Commercialization. MEI and its Affiliates and Sublicensees shall continue to distribute (abut shall not be obligated to market or promote) Novartis will be solely responsible for all aspects of Commercialization of the Product such Product(s) in the TerritoryTerritory if Regulatory 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 up to twelve (c12) Novartis months following the effective date of any such termination (the “Wind down Period”); provided, that, the Parties shall itselfenter into a transition services agreement pursuant to which MEI will continue to distribute such Product(s) in such country(ies) [*CONFIDENTIAL*]. At Presage’s request, such transition services agreement shall be negotiated in good faith during the applicable notice period preceding termination of this Agreement. In any event, MEI shall, and shall cause its Affiliates and Sublicensees to, cease distribution of the Product, or through its Affiliates any portion thereof, upon [*CONFIDENTIAL*] notice by Presage requesting that such activities (or Sublicensees, use Commercially Reasonable Efforts in pursuing portion thereof) be ceased at any time following the Commercialization expiration of the Products in the TerritoryWind down Period). 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 GWprovision of this Agreement, during the Wind down Period, MEI’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 rights with respect to Compound and 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 non-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 Presage 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 any Named Patient Sales and/or licensee(s) of the Compound and Product in the Territory. Any Products sold or disposed by MEI, GW will provide to Novartis a written report showing the Net Sales of each Product in each country its Affiliates and/or Sublicensees, in the Territory during the reporting period by GW, which report Wind down Period shall be accompanied by payment subject to Novartis payments under and in accordance with Section 5 above. Within [*CONFIDENTIAL*] of an amount expiration of the Wind down Period, MEI shall notify Presage of any quantity of Compound and/or Product remaining in MEI’s inventory and Presage shall repurchase any such quantities of Compound and/or Product, as applicable, from MEI at a price equal to fifty percent (50%) of the supply price paid by MEI for such Net Sales.
(g) Notwithstanding: (I) the territorial restrictions on the licenses granted to Novartis under Section 2.1Compound and/or Product plus [*CONFIDENTIAL*]; 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 except with respect to any such quantities of such Compound and/or Product manufactured by MEI (or its contract manufacturer), in respect of which the Products; and
(ii) GWprice shall be equal to MEI’s actual costs for such quantities of Compound and/or Product, its Affiliates as applicable, plus [*CONFIDENTIAL*]. In addition, MEI shall use Commercially Reasonable Efforts to cooperate, at Presage’s sole cost and licensees may attend expense, to transition to Presage upon Presage’s request any arrangement with any contractor from which MEI was obtaining supply of any Compound and/or Product to the extent such arrangement solely pertains to the Compound and/or Product and participate no other products of MEI. Notwithstanding anything to the contrary in international congresses or symposia this Section 10.4(c)(iii), in the Territory with respect event of a safety or ethical concern regarding the continued Commercialization or use of the Product, MEI shall not be obligated to continue Commercializing the ProductsProduct.
Appears in 1 contract
Sources: License Agreement (MEI Pharma, 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
Sources: 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, 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.
Appears in 1 contract
Commercialization. (a) Novartis will be solely responsible for all aspects If this Agreement is terminated after the First Commercial Sale of Commercialization of the a Terminated Denali Product in the TerritoryTerminated Area, including planning Sanofi, its Affiliates and implementationits Sublicensees shall continue to fulfill orders for the Terminated Area through their respective then-existing distribution network of internal and external distributors of such Terminated Denali 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, for [***] after the effective date of termination (“Commercialization Wind-current Commercialization Plan.
down Period”); [***]; provided, further, that Sanofi, its Affiliates and its Sublicensees shall cease any such activities being conducted pursuant to this Section (c) Novartis shall itselff)(ii), 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 within the Terminated Area upon [***] notice by Denali requesting that such activities (or portion thereof) be ceased. Notwithstanding any other provision of this Agreement, during the Commercialization Wind-down Period, Sanofi’s and its Affiliates’ and Sublicensees’ rights with respect to applicable Terminated Denali Product(s) in the TerritoryTerminated Area shall be non-exclusive and, GW without limiting the foregoing, Denali 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 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%or licensee(s) of such Net Sales.
Terminated Denali Product(s) in any country within the Terminated Area. Any Terminated Denali Product sold or disposed of by Sanofi, its Affiliates or its Sublicensees in any country within the Terminated Area during the Commercialization Wind-down Period shall be subject to applicable payment obligations under Article 7 (gPayments). In addition, if at the effective time of such termination, Sanofi or its Affiliates are undertaking Detailing or MSL Activities with respect to a particular Terminated Denali Product in any country within the Terminated Area, then, at Denali’s request, the Parties will negotiate and agree upon a plan for the orderly wind down of such activities for a period not to exceed [***]. Any FTE Costs or Out-of-Pocket Costs incurred by Sanofi or its Affiliates in accordance with such plan for the wind down of Sanofi’s activities shall be (a) Notwithstanding: (I) reimbursed by Denali if the territorial restrictions on relevant Terminated Denali Product is not, immediately prior to the licenses granted to Novartis under Section 2.1effective date of such termination, a Cost Profit Sharing Product; or (IIb) continue to be allocated towards Allowable Expenses until such wind down is complete, if 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 relevant Terminated Denali Product is a Cost Profit Sharing Product immediately prior 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 Productseffective date of such termination.
Appears in 1 contract
Sources: Collaboration and License Agreement (Denali Therapeutics Inc.)
Commercialization. (a) Novartis will be solely responsible At MGI’s request, if Marketing Authorization has been or is obtained for all aspects of Commercialization of the Product in the TerritoryLicensed Products, including planning then Licensee 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 shall continue to Commercialize the Commercialization of the Licensed 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 same manner in each country in the Territory during for which Marketing Authorization therefore has been obtained, in accordance with the reporting period by GW, which report shall be accompanied by payment to Novartis terms and conditions 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, for a period not to exceed two hundred forty (240) days following such termination it being understood that MGI and Licensee will work diligently to transition such activities as soon as reasonably practicable. Notwithstanding any other provision of this Agreement, during the Parties agree that:
(i) NovartisWind-down Period, Licensee’s and its Affiliates and Sublicensees may attend and participate in international congresses or symposia outside the Territory Affiliates’ rights with respect to the Products; and
(iiLicensed Products shall be non-exclusive, and MGI shall have the right to engage one or more other distributor(s) GWand/or licensee(s) to Develop and Commercialize the Licensed Products in all portions of the Territory that have been terminated. Article 3 shall continue to apply with respect to all the Licensed Products sold, used or disposed by Licensee and its Affiliates during the Wind-down Period or otherwise as set forth below. All rights of Licensee and licensees may attend and participate in international congresses or symposia in the Territory its Affiliates with respect to the ProductsLicensed Products shall be terminated at the end of the Wind-down Period, and unless otherwise mutually agreed or unless rights have been terminated only with respect to a specified country, and Licensee retains rights to Develop and Commercialize the Licensed Products for other countries, all the Licensed Products in the possession of Licensee and its Affiliates that are not sold during such Wind-down Period shall be destroyed, provided, however, that Licensee shall have a minimum of one hundred-eighty (180) days following termination of the Wind-down Period to sell its remaining inventory, without regard to the actual length of the Wind-down Period. Any remaining unsold inventory shall be transferred to MGI at cost.
Appears in 1 contract
Sources: License Agreement (Mgi Pharma 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 be solely responsible for all aspects of Commercialization of the Product Solely in the Territorycase of a termination of this Agreement by GSK pursuant to Section 13.2, including planning and implementation, distribution, booking to avoid disruption of sales, pricing, reimbursement, regulatory, manufacturing (limited supply of any Terminated Product(s) to packaging and trade dress), phase IV studies, marketing and sales activities.
(bpatients if termination occurs after the Launch of a Terminated Product(s) 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 foregoingAffected Area, 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) NovartisAmicus, its Affiliates and Sublicensees may attend shall continue to sell the Terminated Product(s) in the Affected Area in accordance with the terms and participate in international congresses conditions of this Agreement, for up to ****** or symposia outside such shorter period of time as requested by GSK as provided below, after the Territory effective date of any such termination of this Agreement with respect to any such Terminated Product(s) (“Amicus Wind-Down Period”); provided that GSK may terminate the ProductsAmicus Wind-Down Period in the Affected Area upon ****** written notice to Amicus; and
provided further that (i) Amicus shall not be obligated to promote the sale of such Terminated Products in the Affected Area during the Amicus Wind-Down Period; and (ii) GWif the Terminated Product is a Co-Formulation Product, then GSK shall continue to supply Amicus with its Affiliates (and licensees may attend its Affiliates’ and participate sublicensees’) reasonable requirements of such Terminated Product for such purposes. Within ****** following the expiration of the Amicus Wind-Down Period, Amicus shall notify GSK of any quantities of the Terminated Product(s) remaining in international congresses Amicus’ or symposia in its Affiliates’ inventory and GSK shall have the Territory with respect option, upon notice to Amicus, to repurchase any such quantities of the ProductsTerminated Product(s) from Amicus at a price equal to Amicus’ Manufacturing Costs. If GSK so elects to purchase any remaining quantities of the Terminated Product(s) from Amicus as set forth herein, Amicus will transfer to GSK such quantities of inventory of the Terminated Product(s).
Appears in 1 contract
Sources: License and Collaboration Agreement (Amicus Therapeutics Inc)