Common use of Commercialization Clause in Contracts

Commercialization. Novartis shall have the right to determine whether it is willing to Manufacture Regional Antibody Candidates and Regional Licensed Products for use in Commercialization of such Regional 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, however that Surface may not require of Novartis more than [***] such transfers for any Regional Licensed Product. Further, in the case of a Novartis Election, Novartis shall remain responsible for Manufacturing Commercial supply for use in the Surface Territory until the earlier of (x) such time as 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, the terms of supply of such Regional Antibody Candidates and Regional Licensed Products for use in Commercialization of such Regional Antibody Candidates and Regional Licensed Products in the Surface Territory will be set forth in the RLP Supply Agreement.

Appears in 3 contracts

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

Commercialization. Novartis BMS, its Affiliates and Sublicensees shall be entitled to continue to sell (but not to actively promote after the effective date of termination) any existing inventory of Products in each terminated Region of the Territory for which Regulatory Approval and all pricing and reimbursement approvals therefor have been obtained (provided that such Products shall have the right to determine whether it is willing to Manufacture Regional Antibody Candidates and Regional Licensed Products for use launched in Commercialization of each such Regional Antibody Candidates and Regional Licensed Products in the Surface Territory and shall communicate such determination by written notice to Surface no later than Initiation terminated country as of the first Phase 3 Study. If Novartis CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “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). 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 1933Any Products sold or disposed of by BMS, AS AMENDEDits 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). notifies Surface After the Commercialization Wind-Down Period, BMS, its Affiliates and Sublicensees shall not sell such terminated Products in such terminated Region(s) or make any representation regarding BMS’s status as a licensee of such Product in such Region(s). Either (i) at the request of BN at the end of the Commercialization Wind-Down Period or (ii) prior to the end of the Commercialization Wind-Down Period, if BN has assumed responsibilities for regulatory activities under the Regulatory Approval, has received all clearances and Regulatory Approvals needed to sell and import the terminated Product in a given terminated country, and provides written notice to BMS that it wishes to assume sale of the terminated Product in a terminated country, then, in either case (i) or (ii), at BN’s election, BMS shall sell and transfer to BN such portion of the terminated Product inventory then held by BMS or its Affiliates which is in a saleable condition (including that it is willing to Manufacture Regional Antibody Candidates undamaged, has been stored in proper conditions 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 has no later less than [***] after its receipt of such notice from Novartis whether shelf-life remaining) as had been allocated to utilize Novartis for such Commercial Manufacturing in the Surface Territory or to retain a Third Party contract manufacturer(s) for such purpose. If either Novartis is not willing to provide such Commercial supply (a “Novartis Election”) or Surface elects not to utilize Novartis for such Commercial supply (a “Surface Election”), then Novartis shall effect a technology transfer to a Third Party contract manufacturer(s) to enable such Third Party to provide Commercial supply of Regional Antibody Candidates and Regional Licensed Products for use in the Surface Territory, provided that such Third Party contract manufacturer(s) is approved by Novartis, such approval not to be unreasonably withheld, conditioned or delayed. The cost of such technology transfer shall be borne by (a) Novartis in the case of a Novartis Election; and (b) Surface in the case of either (i) a Surface Election or (ii) any request for a second technology transfer, whether in the case of a Novartis Election or Surface Election; provided, however that Surface may not require of Novartis more than [***] such transfers for any Regional Licensed Product. Further, in the case of a Novartis Election, Novartis shall remain responsible for Manufacturing Commercial supply for use in the Surface Territory until the earlier of (x) such time as the technology transfer is completed or (yterminated Region(s) [***] If Novartis is willing to Manufacture Regional Antibody Candidates and Regional Licensed Products for use in Commercialization ]. This Section 12.7(b) shall not apply in the Surface Territory and Surface elects to utilize Novartis for such Commercial Manufacturing in the Surface Territory, the terms case of supply of such Regional Antibody Candidates and Regional Licensed Products for use in Commercialization of such Regional Antibody Candidates and Regional Licensed Products in the Surface Territory will be set forth in the RLP Supply Agreementtermination 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 determine whether it is willing 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 Manufacture Regional Antibody Candidates and Regional Licensed Products for use Novartis a written report showing the Net Sales of each Product in Commercialization 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 Regional Antibody Candidates and Regional Licensed Products in Net Sales. (g) Notwithstanding: (I) the Surface Territory and shall communicate such determination by written notice to Surface no later than Initiation of territorial restrictions on 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 licenses granted to Novartis no later than [***] after its receipt of such notice from Novartis whether under Section 2.1; or (II) the exclusive rights granted 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 Territory under this Agreement, the case of either Parties agree that: (i) a Surface Election Novartis, its Affiliates and Sublicensees may attend and participate in international congresses or symposia outside the Territory with respect to the Products; and (ii) any request for a second technology transferGW, whether its Affiliates and licensees may attend and participate in international congresses or symposia in the case of a Novartis Election or Surface Election; provided, however that Surface may not require of Novartis more than [***] such transfers for any Regional Licensed Product. Further, in Territory with respect to 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, the terms of supply of such Regional Antibody Candidates and Regional Licensed Products for use in Commercialization of such Regional Antibody Candidates and Regional Licensed Products in the Surface Territory will be set forth in the RLP Supply AgreementProducts.

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. Novartis Provided that the termination of this Agreement is not a termination by Galderma pursuant to Section 12.2.4, if requested by NovaBay, Galderma and its Affiliates and Marketing Partners shall continue to distribute and sell Collaboration Products in the Field in each country of the Galderma Territory for which Marketing Approval therefor has been obtained, in accordance with the terms and conditions of this Agreement, for a period requested by NovaBay not to exceed two (2) years from the effective date of such expiration or termination (for purposes of this Section 12.6.3, the Agreement Wind-Down Period); provided that NovaBay may terminate the Agreement Wind-Down Period upon sixty (60) days’ notice to Galderma. Notwithstanding any other provision of this Agreement, during the Agreement Wind-Down Period, Galderma’s, its Affiliates’ and its Marketing Partners’ rights with respect to Collaboration Products (including the licenses granted under Section 7.1.1) shall be non-exclusive and NovaBay shall have the right to determine whether it is willing to Manufacture Regional Antibody Candidates and Regional Licensed Products for use in Commercialization engage one or more other partner(s) or distributor(s) of such Regional Antibody Candidates and Regional Licensed Collaboration Products in the Surface Territory and shall communicate such determination by written notice to Surface no later than Initiation Field in all or part of the first Phase 3 StudyGalderma Territory. If Novartis CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[Any Collaboration Products sold or disposed by Galderma or its Affiliates or Marketing Partners during the Agreement Wind-Down Period shall be subject to the applicable royalties under Section 8.5. After the Agreement Wind-Down Period, Galderma and its Affiliates and 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 other customer information relating to Collaboration Products reasonably necessary in Galderma’s reasonable opinion for NovaBay to continue to Commercialize such Collaboration Products, which NovaBay shall have the right to use and disclose for any purpose during the Agreement Wind-Down Period and thereafter. ***]”. 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 Confidential treatment requested pursuant to Manufacture Regional Antibody Candidates and Regional Licensed Products a request for use in Commercialization in the Surface Territory in accordance confidential treatment filed 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 Securities and Exchange Commission. Omitted portions have been filed separately with the Surface Territory or to retain a Third Party contract manufacturer(s) for such purpose. If either Novartis is not willing to provide such Commercial supply (a “Novartis Election”) or Surface elects not to utilize Novartis for such Commercial supply (a “Surface Election”), then Novartis shall effect a technology transfer to a Third Party contract manufacturer(s) to enable such Third Party to provide Commercial supply of Regional Antibody Candidates and Regional Licensed Products for use in the Surface Territory, provided that such Third Party contract manufacturer(s) is approved by Novartis, such approval not to be unreasonably withheld, conditioned or delayed. The cost of such technology transfer shall be borne by (a) Novartis in the case of a Novartis Election; and (b) Surface in the case of either (i) a Surface Election or (ii) any request for a second technology transfer, whether in the case of a Novartis Election or Surface Election; provided, however that Surface may not require of Novartis more than [***] such transfers for any Regional Licensed Product. Further, in the case of a Novartis Election, Novartis shall remain responsible for Manufacturing Commercial supply for use in the Surface Territory until the earlier of (x) such time as 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, the terms of supply of such Regional Antibody Candidates and Regional Licensed Products for use in Commercialization of such Regional Antibody Candidates and Regional Licensed Products in the Surface Territory will be set forth in the RLP Supply AgreementCommission.

Appears in 2 contracts

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

Commercialization. Novartis (a) Except as otherwise set forth in this Agreement, Inspire shall have the right to determine whether it is willing to Manufacture Regional Antibody Candidates and Regional Licensed Products be solely responsible for use in Commercialization commercialization of such Regional Antibody Candidates and Regional Inspire Licensed Products in the Surface Territory Field in the Territory, including without limitation with respect to: (i) sales and shall communicate marketing; (ii) advertising, marketing and promotional materials; (iii) sales representatives and sales force matters; (iv) distribution; (v) regulatory compliance and communications and regulatory fees (e.g., adverse event reporting programs, establishment and product fees under the Prescription Drug User Fee Act), in each case to the extent such determination by written notice to Surface no later than Initiation responsibilities or fees arise following Regulatory Approval 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 Current Product and Regional Licensed Products transfer of the Regulatory Dossier for use in Commercialization the Current Product in the Surface applicable country of the Territory as provided above in accordance with Section 3.3(a); and (vi) product inquiries and complaints. (b) 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 Inspire Licensed Product in the 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) Without limiting the foregoing, then, Surface may elect, by written notice to Novartis Inspire agrees that it shall effect a First Commercial Sale of the Current Product in the United States no later than [***] calendar days after its receipt of such notice from Novartis whether to utilize Novartis Launch Approval for such Commercial Manufacturing the Current Product is obtained 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”)United States; provided, 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 Territoryhowever, provided that such Third Party contract manufacturer(sobligation shall be suspended during any period in which [***]. (d) is approved by NovartisInspire shall not include in promotional kits any Subject Products intended for sale without InSite’s consent, such approval consent not to be unreasonably withheld, conditioned or delayed. The cost of such technology transfer shall be borne by (a) Novartis in the case of a Novartis Election; and (b) Surface in the case of either (i) a Surface Election or (ii) any request for a second technology transfer, whether in the case of a Novartis Election or Surface Election; provided, however however, that Surface may the foregoing limitation shall not require affect or restrict any sampling practices of Novartis more than [***] such transfers for any Regional Licensed Product. Further, in the case of a Novartis Election, Novartis shall remain responsible for Manufacturing Commercial supply for use in the Surface Territory until the earlier of (x) such time as 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, the terms of supply of such Regional Antibody Candidates and Regional Licensed Products for use in Commercialization of such Regional Antibody Candidates and Regional Licensed Products in the Surface Territory will be set forth in the RLP Supply AgreementInspire.

Appears in 2 contracts

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

Commercialization. Novartis Except to the extent the applicable termination was made in accordance with Section 14.6, if this Agreement is terminated after the First Commercial Sale of a Terminated Product and Takeda is the Commercial Lead with respect to the applicable Terminated Product, Takeda, its Affiliates and its Sublicensees shall have the right continue to determine whether it is willing to Manufacture Regional Antibody Candidates and Regional Licensed Products for use in Commercialization of distribute such Regional 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 1933Terminated Product, 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 foregoingterms and conditions of this Agreement, thenin each country for which Regulatory Approval therefor has been obtained, Surface may elect, by written notice to Novartis no later than until [***] after its receipt the effective date of such notice from Novartis whether to utilize Novartis for such Commercial Manufacturing in termination (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 ElectionCommercialization Wind-down Period”), 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 Takeda, its Affiliates and its Sublicensees shall cease such Third Party contract manufacturer(s) is approved by Novartisactivities, such approval not to be unreasonably withheldor any portion thereof, conditioned or delayed. The cost of such technology transfer shall be borne by (a) Novartis in the case of a Novartis Election; and (b) Surface in the case of either (i) a Surface Election or (ii) any request for a second technology transfer, whether in the case of a Novartis Election or Surface Election; provided, however that Surface may not require of Novartis more than given country upon [***] days’ notice by Denali requesting that such transfers for activities (or portion thereof) be ceased. Notwithstanding any Regional Licensed Productother provision of this Agreement, during the Commercialization Wind-down Period, Takeda’s and its Affiliates’ and Sublicensees’ rights with respect to Terminated Products shall be non-exclusive and, without limiting the foregoing, Denali shall have the right to engage one or more other distributor(s) and/or licensee(s) of the Terminated Product in all or part of the Territory. FurtherAny Terminated Product sold or disposed of by Takeda, its Affiliates or its Sublicensees in the case Territory during the Commercialization Wind-down Period shall be subject to applicable payment obligations under Article 8. Unless [***], any Terminated Product sold or disposed of a Novartis Electionby Denali, Novartis shall remain responsible its Affiliates or its Sublicensees (but not, for Manufacturing Commercial supply for use clarity any sales during such period by Takeda, its Affiliates, or Sublicensees) in the Surface Territory until during the earlier of (x) such time as the technology transfer is completed or (y) Commercialization Wind-down Period shall be subject to applicable payment obligations to Takeda under Section 14.7.1. Within [***] If Novartis is willing 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 option, upon notice to Manufacture Regional Antibody Candidates and Regional Licensed Products for use in Commercialization in Takeda, to repurchase any such quantities of the Surface Territory and Surface elects Terminated Product from Takeda at a price equal to utilize Novartis for such Commercial Manufacturing in the Surface Territory, the terms of supply [***] of such Regional Antibody Candidates and Regional Licensed Products for use in Commercialization of such Regional Antibody Candidates and Regional Licensed Products in quantities (to the Surface Territory will be set forth in the RLP Supply Agreementextent [***]).

Appears in 2 contracts

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

Commercialization. Novartis To avoid disruption in the availability of Licensed Product to patients, if this Agreement is terminated after the First Commercial Sale of the Licensed Product in the Territory, then to the extent requested by Licensor, Licensee and Related Parties shall continue to distribute the Licensed Product, in accordance with the terms and conditions of this Agreement, in each country of the Territory for which Regulatory Approval therefor has been obtained, [***] following the effective date of termination (the “Wind-down Period”); provided that Licensee and Related Parties shall cease such activities, or any portion thereof, in a given country upon [***] notice by Licensor requesting that such activities be ceased. In the event that the Licensor will not have secured an alternative distributor or licensee for the Licensed Product in a country within the Wind-down Period, the Parties shall cooperate reasonably to execute and deliver such commercially reasonable agreements as may be necessary to preserve for Licensor the benefit of distribution of the Licensed Product in such country for a period of up [***] additional months, provided that such period shall, upon Licensor’s request, be extended for an additional [***] (for a total of [***] from the effective date of termination) in the event that Licensor will not have secured an alternative distributor or licensee for the Licensed Product in such country [***] from the effective date of termination despite having used Commercially Reasonable Efforts to do so. Such agreement shall provide that Licensee will fulfill orders for Licensed Product in the Territory on a contract basis, with Licensor booking all sales and retaining the revenue from such sales while indemnifying and holding the Licensee Indemnities harmless from all costs and expenses of such distribution and any Liabilities from a Third Party Claim arising from, out of or in connection with such distribution. Notwithstanding any other provision of this Agreement, during the Wind-down Period, Licensee’s and its Affiliates’ and, subject to Section 2.3(b) above, Non-Affiliate Sublicensees’ rights with respect to the Licensed Product in the Territory shall be non-exclusive and, without limiting the foregoing, Licensor shall have the right to determine whether it is willing engage one or more other distributor(s) and/or licensee(s) of the Licensed Product in all or part of the Territory. Any Licensed Product sold or disposed by Licensee, its Affiliates and, subject to Manufacture Regional Antibody Candidates and Regional Licensed Products for use in Commercialization of such Regional Antibody Candidates and Regional Licensed Products Section 2.3(b) above, its Non-Affiliate Sublicensees in the Surface Territory and during the Wind-down Period shall communicate such determination by written notice be subject 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 delayedapplicable payment obligations under Article 6 above. The cost of such technology transfer shall be borne by (a) Novartis in the case of a Novartis Election; and (b) Surface in the case of either (i) a Surface Election or (ii) any request for a second technology transfer, whether in the case of a Novartis Election or Surface Election; provided, however that Surface may not require of Novartis more than [***] such transfers for any Regional Licensed Product. Further, in the case of a Novartis Election, Novartis shall remain responsible for Manufacturing Commercial supply for use in the Surface Territory until the earlier of (x) such time as 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, the terms of supply of such Regional Antibody Candidates and Regional Licensed Products for use in Commercialization of such Regional Antibody Candidates and Regional Licensed Products in the Surface Territory will be obligations set forth in this Section 11.5(d)(i)(B) shall not apply in any country or jurisdiction in which, as of the RLP Supply effective date of termination of this Agreement, the Royalty Term with respect to the applicable Licensed Product has expired or Generic Competition with respect to such License Product exists.

Appears in 2 contracts

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

Commercialization. Novartis 3.7.1 Prometheus shall have solely control and assume all responsibility, at its own cost, for conducting all commercialization activities within the right Prometheus Territory relating to determine whether it is willing the Product, including marketing, promotion, sales detailing and any other activities relating to Manufacture Regional Antibody Candidates 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 Regional Licensed Products for use in Commercialization of such Regional Antibody Candidates and Regional Licensed Products sell the Product in the Surface Prometheus Territory under either or both of the Alizyme Trademark or another trademark owned or Controlled by Prometheus and may register upon notice to Alizyme one or more domain names in the Prometheus Territory utilizing the Alizyme Trademark alone (to the extent not registered to Alizyme in which case, if requested by Prometheus, Alizyme shall communicate place a link from such determination 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) or in combination with another trademark owned or Controlled by Prometheus ("Prometheus Product Trademark") provided that Prometheus shall use Commercially Reasonable Efforts to ensure that its use of the Alizyme Trademark shall in no way reduce or diminish the reputation, image or prestige of the Alizyme Trademark. For the avoidance of doubt, Prometheus shall not be obligated to use any Alizyme Trademark in connection with the packaging, labeling, marketing, promotion or selling of the Product. Prometheus shall be responsible for the selection, registration, and maintenance of the Prometheus Product Trademarks throughout the Prometheus Territory, as well as all expenses associated therewith; provided, however, that Prometheus shall provide advanced written notice to Surface no later than Initiation Alizyme of the first Phase 3 Studyname under which it intends to market the Product. 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 With respect 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 Prometheus shall use good faith efforts to provide six (6) months advanced notice to Novartis no later than [***] after its receipt of any such use of such notice from Novartis whether to utilize Novartis for such Commercial Manufacturing in the Surface Territory or to retain a Third name. 3.7.3 Each Party contract manufacturer(s) for such purpose. If either Novartis is not willing to provide such Commercial supply (a “Novartis Election”) or Surface elects not to utilize Novartis for such Commercial supply (a “Surface Election”), then Novartis shall effect a technology transfer to a Third Party contract manufacturer(s) to enable such Third Party to provide Commercial supply of Regional Antibody Candidates and Regional Licensed Products for use in the Surface Territory, provided that such Third Party contract manufacturer(s) is approved by Novartis, such approval not to be unreasonably withheld, conditioned or delayed. The cost of such technology transfer shall be borne by (a) Novartis in the case of a Novartis Election; and (b) Surface in the case of either (i) a Surface Election or (ii) any request for a second technology transfer, whether in the case of a Novartis Election or Surface Election; provided, however that Surface may not require of Novartis more than [***] such transfers for any Regional Licensed Product. Furthermay, in its sole discretion, share marketing plans and materials with the case other Party with the object of coordinating a Novartis Election, Novartis shall remain responsible for Manufacturing Commercial supply for use in world-wide marketing effort to maximize the Surface Territory until commercial potential of 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, the terms of supply of such Regional Antibody Candidates and Regional Licensed Products for use in Commercialization of such Regional Antibody Candidates and Regional Licensed Products in the Surface Territory will be set forth in the RLP Supply AgreementProduct.

Appears in 2 contracts

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

Commercialization. Novartis shall have the right to determine whether it is willing to Manufacture Regional Antibody Candidates and Regional Licensed Products for use in Commercialization of such Regional Antibody Candidates and Regional Licensed Products To avoid disruption in the Surface Territory availability of Terminated Products to patients, if this Agreement is terminated after the First Commercial Sale of a Terminated Product, AbbVie, its Affiliates and its Sublicensees shall communicate continue to distribute such determination by written notice to Surface no later than Initiation Terminated Product, in accordance with the terms and conditions of the first Phase 3 Study. If Novartis CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “this Agreement, in each country for which Regulatory Approval therefor has been obtained, until [***]”. 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] 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, AS AMENDED. notifies Surface that it is willing to Manufacture Regional Antibody Candidates and Regional Licensed Products but in no event more 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 the effective date of such notice from Novartis whether to utilize Novartis for such Commercial Manufacturing in any expiration or termination of this Agreement (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 ElectionCommercialization Wind-down Period”), 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 AbbVie, its Affiliates and its Sublicensees shall cease such Third Party contract manufacturer(s) is approved by Novartisactivities, such approval not to be unreasonably withheldor any portion thereof, conditioned or delayed. The cost of such technology transfer shall be borne by (a) Novartis in the case of a Novartis Election; and (b) Surface in the case of either (i) a Surface Election or (ii) any request for a second technology transfer, whether in the case of a Novartis Election or Surface Election; provided, however that Surface may not require of Novartis more than given country upon [***] notice by Licensor requesting that such transfers for activities (or portion thereof) be ceased. Notwithstanding any Regional Licensed Productother provision of this *** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. Further, in the case of a Novartis Election, Novartis shall remain responsible for Manufacturing Commercial supply for use in the Surface Territory until the earlier of (x) such time as the technology transfer is completed or (y) [***] If Novartis indicates that text has been omitted and is willing the subject of a confidential treatment request. Agreement, during the Commercialization Wind-down Period, AbbVie’s and its Affiliates’ and Sublicensees’ rights with respect to Manufacture Regional Antibody Candidates and Regional Licensed Terminated Products for use shall be non-exclusive and, without limiting the foregoing, Licensor shall have the right to engage one or more other distributor(s) and/or licensee(s) of the Product in Commercialization all or part of the Territory. Any Product sold or disposed of by AbbVie, its Affiliates or its Sublicensees in the Surface Territory during the Commercialization Wind-down Period shall be 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 Surface elects Licensor shall have the option, upon notice to utilize Novartis for AbbVie, to repurchase any such Commercial quantities of the Product from AbbVie at a price equal to AbbVie’s Manufacturing in the Surface Territory, the terms of supply Cost of such Regional Antibody Candidates and Regional Licensed Products for use in Commercialization of such Regional Antibody Candidates and Regional Licensed Products in the Surface Territory will be set forth in the RLP Supply Agreementquantities.

Appears in 2 contracts

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

Commercialization. Novartis Licensee is authorized to, and covenants and agrees to use its commercially reasonable efforts to, bring about ultimately (with the protection of Taurus’ interests intact) 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 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 Other Licensed Products and the manufacturing, commercialization and sale of units of Other Licensed Products and the generation of Net Sales therefrom, including by entering into Permittee-Enabling Agreements therefor. It is understood, however, that Licensee shall also itself have the right to determine whether it is willing (for and on its own account) directly research, develop, obtain regulatory approval for, make, have made, use, sell, offer for sale, distribute, promote, import, export, and (subject to Manufacture Regional this Section 3.1 and Section 3.3) out-license or otherwise commercially exploit units of Taurus Antibodies or Products directly, 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 Candidates and/or Product. Licensee covenants and Regional Licensed agrees not to enter into any Permittee-Enabling Agreement which purports to grant a Permittee rights as to all Taurus Antibodies/ Antibody Products for use in Commercialization or as to a set of such Regional Taurus Antibodies/ 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”)bona fide specific, 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 except as part of a Novartis Election; and (b) Surface in bona fide partnership, collaboration or co-research or co-development arrangement expressly permitted pursuant to the case provisions of either (i) a Surface Election or (ii) any request for a second technology transfer, whether in the case of a Novartis Election or Surface Election; provided, however that Surface may not require of Novartis more than [***] such transfers for any Regional Licensed Product. Further, in the case of a Novartis Election, Novartis shall remain responsible for Manufacturing Commercial supply for use in the Surface Territory until the earlier of (x) such time as 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, the terms of supply of such Regional Antibody Candidates and Regional Licensed Products for use in Commercialization of such Regional Antibody Candidates and Regional Licensed Products in the Surface Territory will be set forth in the RLP Supply AgreementSection 3.5.

Appears in 1 contract

Sources: Commercial License Agreement (Ligand Pharmaceuticals Inc)

Commercialization. Novartis 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 the Product in the GSK Territory (or, if the termination is limited to a specific country, within such country) until up to [**] days after the later of (A) the date on which Sepracor notifies GSK in writing that Sepracor has secured an alternative distributor or licensee for the Product in the GSK Territory and (B) GSK has initiated transition of the ▇▇▇▇ 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), GSK shall continue to pay royalties on the amount of Net Sales from such sales pursuant to Section 7.3. Notwithstanding the foregoing, GSK, its Affiliates and its Sublicensees shall cease such activities in the GSK Territory (or, if termination is limited to a specific country, within such country), as the case may be, upon [**] written notice given by Sepracor at any time after the effective date of 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 notify Sepracor of an estimate of the quantity of the Product and its shelf life remaining in GSK’s inventory and Sepracor shall have the right to determine whether it is willing to Manufacture Regional Antibody Candidates and Regional Licensed Products for use in Commercialization of purchase any such Regional Antibody Candidates and Regional Licensed Products in the Surface Territory and shall communicate such determination by written notice to Surface no later than Initiation quantities of the first Phase 3 Study. If Novartis CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “Product from GSK for [**], being the amount [**]. 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 1933To the extent Sepracor does not purchase such quantities, AS AMENDED. notifies Surface that it is willing to Manufacture Regional Antibody Candidates and Regional Licensed Products for use in Commercialization GSK may sell such quantities in the Surface GSK Territory in accordance with during the foregoing, then, Surface may elect, by written notice to Novartis no later than [***] after its receipt the effective date of such notice from Novartis whether to utilize Novartis termination within the shelf life remaining for such Commercial Manufacturing in the Surface Territory or to retain a Third Party contract manufacturer(s) for such purpose. If either Novartis is not willing to provide such Commercial supply (a “Novartis Election”) or Surface elects not to utilize Novartis for such Commercial supply (a “Surface Election”), then Novartis shall effect a technology transfer to a Third Party contract manufacturer(s) to enable such Third Party to provide Commercial supply of Regional Antibody Candidates and Regional Licensed Products for use in the Surface Territory, provided that such Third Party contract manufacturer(s) is approved by Novartis, such approval not to be unreasonably withheld, conditioned or delayed. The cost of such technology transfer shall be borne by (a) Novartis in the case of a Novartis Election; and (b) Surface in the case of either (i) a Surface Election or (ii) any request for a second technology transfer, whether in the case of a Novartis Election or Surface Election; provided, however that Surface may not require of Novartis more than [***] such transfers for any Regional Licensed Product. Further, in the case of a Novartis Election, Novartis shall remain responsible for Manufacturing Commercial supply for use in the Surface Territory until the earlier of (x) such time as 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, the terms of supply of such Regional Antibody Candidates and Regional Licensed Products for use in Commercialization of such Regional Antibody Candidates and Regional Licensed Products in the Surface Territory will be set forth in the RLP Supply Agreement.

Appears in 1 contract

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

Commercialization. Novartis shall have To avoid disruption of supply of any Terminated Product(s) to patients if termination occurs after the right to determine whether it is willing to Manufacture Regional Antibody Candidates and Regional Licensed Products for use in Commercialization Launch of such Regional Antibody Candidates and Regional Licensed Products a Terminated Product(s) in the Surface Territory relevant Affected Area, GSK, its Affiliates and Sublicensees shall communicate such determination by written notice continue to Surface no later than Initiation of sell 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 Terminated Product(s) in the Surface Territory relevant Affected Area, in accordance with the foregoingterms and conditions of this Agreement, thenfor up to ****** or such shorter period of time as requested by Amicus as provided below, Surface after the effective date of any such termination of any such Terminated Product(s) (“GSK Wind-Down Period”); provided that Amicus may elect, by terminate the GSK Wind-Down Period in any country of the relevant Affected Area upon ****** written notice to Novartis no later than [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 ***] after its receipt *** following the expiration 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(sGSK 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 purposequantities of the Terminated Product(s) from GSK at a price equal to GSK’s Manufacturing Costs. If either Novartis is not willing Amicus so elects to provide such Commercial supply (a “Novartis Election”purchase any remaining quantities of Terminated Product(s) or Surface elects not to utilize Novartis for such Commercial supply (a “Surface Election”)from GSK as set forth herein, then Novartis shall effect a technology GSK will transfer to a Third Party contract manufacturer(sAmicus such quantities of inventory of Terminated Products. If Amicus does not elect to purchase any such remaining quantities of inventory of Terminated Products, GSK may transfer any such remaining inventory of Terminated Product(s) to enable a country within the GSK Territory for which GSK’s rights with respect to 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(sProduct(s) is approved by Novartis, such approval have not to be unreasonably withheld, conditioned or delayed. The cost of such technology transfer shall be borne by (a) Novartis in the case of a Novartis Election; and (b) Surface in the case of either (i) a Surface Election or (ii) any request for a second technology transfer, whether in the case of a Novartis Election or Surface Election; provided, however that Surface may not require of Novartis more than [***] such transfers for any Regional Licensed Product. Further, in the case of a Novartis Election, Novartis shall remain responsible for Manufacturing Commercial supply for use in the Surface Territory until the earlier of (x) such time as 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, the terms of supply of such Regional Antibody Candidates and Regional Licensed Products for use in Commercialization of such Regional Antibody Candidates and Regional Licensed Products in the Surface Territory will be set forth in the RLP Supply Agreementbeen terminated.

Appears in 1 contract

Sources: License and Collaboration Agreement (Amicus Therapeutics Inc)

Commercialization. Novartis 6.1 Ortho as Marketing Party. Ortho will be the marketing Party with respect to all Collaboration Products. As marketing Party Ortho shall have full and exclusive decision making authority with respect to all Commercialization Activities for all Collaboration Products, provided that such decisions are consistent with this Agreement and except as otherwise set forth in this Agreement. 6.2 GTx's Option to Co-Promote in the United States. GTx shall have an option to provide Details in the United States for each Collaboration Product Developed pursuant to the GTx/Ortho Development to urologists who are licensed to practice in the United States, provided that GTx meets the requirements set forth in this Article VI, and subject to the provisions of Section 6.3 and 6.7. Any such activities conducted by GTx pursuant to this Article VI, if GTx exercises such option, shall be deemed "Co-Promotion." GTx may exercise its option to Co-Promote on a Product by Product basis, and a decision not to Co-Promote a specific Product shall not affect GTx's rights to Co-Promote any other Product under this Agreement. However, if GTx fails to exercise its option to Co-Promote any specific Product, or later terminates its Co-Promotion of such Product, such non-exercise or termination shall be irrevocable as for such Product. Additional Collaboration Products will be Co-Promoted under the same terms as recited herein with respect to the first Collaboration Product. 6.3 GTx to Notify Ortho of its Election to Co-Promote; Changes in the GTx Audience. (a) GTx may exercise its option by informing Ortho in writing of its decision to exercise the Co-Promotion option for a Collaboration Product [ * ] after [ * ]. Upon GTx's exercise of such option, the United States shall become the Co-Promotion Territory with respect to such Collaboration Product, GTx shall have the right to determine whether perform Details targeting the GTx Audience (determined in accordance with Section 6.3(b)) with respect to such Collaboration Product, and the provisions of Article VII shall be used in determining additional compensation to be paid to GTx. (b) GTx shall have the right to Co-Promote Collaboration Products to all of the practicing urologists in the United States, and to elect to include a portion of, or all of, such physicians in the GTx Audience, subject to Section 6.7 and this Section 6.3. Within [ * ] after GTx first exercises its right to Co-Promote, GTx shall provide to Ortho a list of urologists licensed to practice in the United States that will constitute the GTx Audience, for Ortho's approval thereof, which shall not be unreasonably withheld or delayed, and which approval or disapproval shall be consistent with this Agreement. GTx shall periodically [ * ] update the list of urologists that constitute the GTx Audience, provided that any such change shall not become effective until [ * ] after Ortho receives any updated list from GTx, and further provided that such changes shall be in accordance with Section 6.3(c). Ortho shall have [ * ], and [ * ] consistent with this Agreement. Except as provided in Section 6.7, GTx shall have the exclusive right to provide Details for the GTx Audience. (c) During the time GTx is Co-Promoting a Product, GTx shall not have the right to alter the number of physicians included in the GTx Audience for a given Product by [ * ] in any given [ * ] commencing after GTx begins to Co-Promote such Product without Ortho's approval, which shall not be unreasonably withheld or delayed and which shall be consistent with this Agreement. GTx shall notify Ortho in writing of any such change in the number of physicians included in the GTx Audience [ * ] before the end of any relevant [ * ] for which it is willing desires such increase to Manufacture Regional Antibody Candidates apply. Additionally, if GTx has elected to Co-Promote Products pursuant to this Article VI but has not performed its obligations under Section 6.6(a)(iv), and Regional Licensed Products for use therefore has [ * ], then GTx shall have the right to increase the proportion of the GTx Audience to which it has the right to provide Details by [ * ] in Commercialization each [ * ] following the [ * ] of GTx's commencement of Co-Promotion of such Regional Antibody Candidates and Regional Licensed Products in the Surface Territory and shall communicate such determination by Products, provided that GTx gives written notice to Surface no later Ortho [ * ] before the end of any relevant [ * ] during which it is then Co-Promoting such Product to less than Initiation all of the GTx Audience stating the proportion of the GTx Audience by which GTx desires to increase its Detailing efforts during the [ * ]. For clarity, GTx may only increase the proportion of the GTx Audience to which it will Co-Promote if GTx has [ * ]. 6.4 Marketing and Sales Committee. Ortho and GTx will form a Marketing and Sales Committee [ * ] to the first Phase 3 Studyanticipated Launch Date. If Novartis CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***The Marketing and Sales Committee shall meet from time to time [ * ], at mutual agreeable times and locations, to discuss and coordinate the Marketing and Co-Promotion of the Collaboration Product, including but not limited to, the assignment of Details and to discuss the Marketing and Sales Plan. 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 1933Ortho will have the final responsibility (subject to GTx's rights to Co-Promote), 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 foregoingcooperation and assistance of GTx for defining the resources required for the marketing and sale of the Collaboration Product, thenand for establishing Detailing, Surface may electMarketing, by written notice pricing and promotion strategies with respect to Novartis no later than [***] after its receipt of such notice the Collaboration Product and budgets therefor. Any disagreements or disputes arising 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 Marketing 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 Sales Committee shall be borne by (a) Novartis resolved in the case of a Novartis Election; and (b) Surface in the case of either (i) a Surface Election or (ii) any request for a second technology transfer, whether in the case of a Novartis Election or Surface Election; provided, however that Surface may not require of Novartis more than [***matter consistent with [ * ] such transfers for any Regional Licensed Product. Further, in the case of a Novartis Election, Novartis shall remain responsible for Manufacturing Commercial supply for use in the Surface Territory until the earlier of (x) such time as 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, the terms of supply of such Regional Antibody Candidates and Regional Licensed Products for use in Commercialization of such Regional Antibody Candidates and Regional Licensed Products in the Surface Territory will be set forth in the RLP Supply this Agreement.

Appears in 1 contract

Sources: Joint Collaboration and License Agreement (GTX Inc /De/)

Commercialization. Novartis If this Agreement is terminated after the First Commercial Sale of a Terminated Denali Product in the Terminated Area, Sanofi, its Affiliates and its Sublicensees shall have continue to fulfill orders for the right to determine whether it is willing to Manufacture Regional Antibody Candidates Terminated Area through their respective then-existing distribution network of internal and Regional Licensed Products for use in Commercialization external distributors of such Regional 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 1933Terminated Denali Product, 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 foregoingterms and conditions of this Agreement, thenin each country for which Regulatory Approval therefor has been obtained, Surface may elect, by written notice to Novartis no later than for [***] after its receipt the effective date 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 termination (a Novartis Election”) or Surface elects not to utilize Novartis for such Commercial supply (a “Surface ElectionCommercialization Wind-down Period”), then Novartis shall effect a technology transfer to a Third Party contract manufacturer(s) to enable such Third Party to provide Commercial supply of Regional Antibody Candidates and Regional Licensed Products for use in the Surface Territory, provided that such Third Party contract manufacturer(s) is approved by Novartis, such approval not to be unreasonably withheld, conditioned or delayed. The cost of such technology transfer shall be borne by (a) Novartis in the case of a Novartis Election; and (b) Surface in the case of either (i) a Surface Election or (ii) any request for a second technology transfer, whether in the case of a Novartis Election or Surface Election[***]; provided, however further, that Surface may not require of Novartis more than Sanofi, its Affiliates and its Sublicensees shall cease any such activities being conducted pursuant to this Section (f)(ii), or any portion thereof, in a given country within the Terminated Area upon [***] notice by Denali requesting that such transfers for activities (or portion thereof) be ceased. Notwithstanding any Regional Licensed Product. Furtherother 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 case Terminated Area shall be non-exclusive and, without limiting the foregoing, Denali shall have the right to engage one or more other distributor(s) or licensee(s) of such Terminated Denali Product(s) in any country within the Terminated Area. Any Terminated Denali Product sold or disposed of by Sanofi, its Affiliates or its Sublicensees in any country within the Terminated Area during the Commercialization Wind-down Period shall be subject to applicable payment obligations under Article 7 (Payments). In addition, if at the effective time of such termination, Sanofi or its Affiliates are undertaking Detailing or MSL Activities with respect to a Novartis Electionparticular Terminated Denali Product in any country within the Terminated Area, Novartis shall remain responsible then, at Denali’s request, the Parties will negotiate and agree upon a plan for Manufacturing Commercial supply the orderly wind down of such activities for use in the Surface Territory until the earlier of (x) such time as the technology transfer is completed or (y) a period not to exceed [***] If Novartis ]. Any FTE Costs or Out-of-Pocket Costs incurred by Sanofi or its Affiliates in accordance with such plan for the wind down of Sanofi’s activities shall be (a) reimbursed by Denali if the relevant Terminated Denali Product is willing not, immediately prior 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, the terms of supply effective date of such Regional Antibody Candidates and Regional Licensed Products for use in Commercialization termination, a Cost Profit Sharing Product; or (b) continue to be allocated towards Allowable Expenses until such wind down is complete, if the relevant Terminated Denali Product is a Cost Profit Sharing Product immediately prior to the effective date of such Regional Antibody Candidates and Regional Licensed Products in the Surface Territory will be set forth in the RLP Supply Agreementtermination.

Appears in 1 contract

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

Commercialization. Novartis shall have the right to determine whether it is willing to Manufacture Regional Antibody Candidates and Regional Licensed Products for use in Commercialization of such Regional 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 Solely in the case of a Novartis Electiontermination of this Agreement by GSK pursuant to Section 13.2, to avoid disruption of supply of any Terminated Product(s) to patients if termination occurs after the Launch of a Terminated Product(s) in the Affected Area, Amicus, its Affiliates and Sublicensees shall continue to sell the Terminated Product(s) in the Affected Area in accordance with the terms and conditions of this Agreement, for up to ****** or such shorter period of time as requested by GSK as provided below, after the effective date of any such termination of this Agreement with respect to any such Terminated Product(s) (“Amicus Wind-Down Period”); provided that GSK may terminate the Amicus Wind-Down Period in the Affected Area upon ****** written notice to Amicus; 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 (b) Surface in the case of either (i) a Surface Election or (ii) any request if the Terminated Product is a Co-Formulation Product, then GSK shall continue to supply Amicus with its (and its Affiliates’ and sublicensees’) reasonable requirements of such Terminated Product for a second technology transfer, whether in the case of a Novartis Election or Surface Election; provided, however that Surface may not require of Novartis more than [such purposes. Within ***] such transfers for any Regional Licensed Product. Further, in the case of a Novartis Election, Novartis shall remain responsible for Manufacturing Commercial supply for use in the Surface Territory until the earlier of (x) such time as the technology transfer is completed or (y) [***] * following the expiration of the Amicus Wind-Down Period, Amicus shall notify GSK of any quantities of the Terminated Product(s) remaining in Amicus’ or its Affiliates’ inventory and GSK shall have the option, upon notice to Amicus, to repurchase any such quantities of the Terminated Product(s) from Amicus at a price equal to Amicus’ Manufacturing Costs. If Novartis is willing to Manufacture Regional Antibody Candidates and Regional Licensed Products for use in Commercialization in the Surface Territory and Surface GSK so elects to utilize Novartis for such Commercial Manufacturing in purchase any remaining quantities of the Surface Territory, the terms of supply of such Regional Antibody Candidates and Regional Licensed Products for use in Commercialization of such Regional Antibody Candidates and Regional Licensed Products in the Surface Territory will be Terminated Product(s) from Amicus as set forth in herein, Amicus will transfer to GSK such quantities of inventory of the RLP Supply AgreementTerminated Product(s).

Appears in 1 contract

Sources: License and Collaboration Agreement (Amicus Therapeutics Inc)

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

Appears in 1 contract

Sources: Collaboration Agreement (Regeneron Pharmaceuticals Inc)

Commercialization. Novartis To avoid a disruption in the supply of XenoPort Products to patients, if this Agreement is terminated after the first commercial sale of any XenoPort Product in the Territory, Xanodyne and its Affiliates shall continue to market, promote, distribute and otherwise commercialize (including 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 in accordance with the terms and conditions of this Agreement, until the date on which XenoPort notifies Xanodyne in writing that XenoPort has secured an alternative distributor or licensee for 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 any other provision of this Agreement, during the Wind-down Period, Xanodyne's rights with respect to the Compound and XenoPort Products in the Territory shall be non-exclusive and, without limiting the foregoing, XenoPort shall have the right to determine whether it is willing to Manufacture Regional Antibody Candidates and Regional Licensed Products for use in Commercialization engage one or more other distributor(s) and/or licensee(s) of such Regional Antibody Candidates and Regional Licensed Products the Compound and/or any XenoPort Product in the Surface Territory and shall communicate such determination Territory. Any Products sold or disposed 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 Xanodyne in the Surface Territory during the Wind-down Period shall be subject to the applicable payment obligations under Article 6 above and all relevant deductions or credits due to Xanodyne in accordance with this Agreement. Within thirty (30) days of expiration of the foregoingWind-down Period, thenXanodyne shall notify XenoPort of any quantity of the Intermediate, Surface may electCompound and/or XenoPort Products remaining in Xanodyne's inventory and XenoPort shall have the option, by written upon notice to Novartis no later than [***] after its receipt Xanodyne, to repurchase any such quantities of the Intermediate, Compound and/or XenoPort Products, as applicable, from Xanodyne at a price equal to the fully burdened costs (excluding overhead) incurred by Xanodyne to manufacture or have manufactured such notice from Novartis whether to utilize Novartis Intermediate, Compound and/or XenoPort Products, as applicable, calculated in accordance with GAAP and Xanodyne's then-prevailing standard procedures for such Commercial Manufacturing in calculating costs of good sold. For 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 sake 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 Novartisclarity, such approval fully burdened costs shall not to be unreasonably withheld, conditioned include any margins or delayed. The cost of such technology transfer shall be borne by (a) Novartis in the case of a Novartis Election; and (b) Surface in the case of either (i) a Surface Election or (ii) any request for a second technology transfer, whether in the case of a Novartis Election or Surface Election; provided, however that Surface may not require of Novartis more than [***] such transfers for any Regional Licensed Product. Further, in the case of a Novartis Election, Novartis shall remain responsible for Manufacturing Commercial supply for use in the Surface Territory until the earlier of (x) such time as 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, the terms of supply of such Regional Antibody Candidates and Regional Licensed Products for use in Commercialization of such Regional Antibody Candidates and Regional Licensed Products in the Surface Territory will be set forth in the RLP Supply Agreementother markup.

Appears in 1 contract

Sources: Licensing Agreement (Xanodyne Pharmaceuticals Inc)

Commercialization. Novartis Exactus BioSolutions and its Affiliates shall be entitled to continue to sell (but not to actively promote after the effective date of termination) any existing inventory of Products in each terminated country of the Territory for which Regulatory Approval therefor has been obtained (provided that such Products shall have the right to determine whether it is willing to Manufacture Regional Antibody Candidates and Regional Licensed Products for use launched in Commercialization of each such Regional Antibody Candidates and Regional Licensed Products in the Surface Territory and shall communicate such determination by written notice to Surface no later than Initiation terminated country as 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 1933applicable effective date of termination), 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 foregoingterms and conditions of this Agreement, for a period not to exceed twelve (12) months from the effective date of such termination (the “Commercialization Wind-Down Period”). Any Products sold or disposed of by Exactus BioSolutions or its Affiliates or during the Commercialization Wind-Down Period shall be subject to the same royalties under Section 8.4 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, Exactus BioSolutions and 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 in such country(ies). Either (i) at the request of Digital Diagnostics at the end of the Commercialization Wind-Down Period or (ii) prior to the end of the Commercialization Wind-Down Period, if Digital Diagnostics has assumed responsibilities for regulatory activities under the Regulatory Approval, has received all clearances and Regulatory Approvals needed to sell and import the terminated Product in a given terminated country, and provides written notice to Exactus BioSolutions that it is wishes to assume sale of the terminated Product in a terminated country, 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 case (a “Novartis Election”i) or Surface elects not to utilize Novartis for such Commercial supply (a “Surface Election”ii), then Novartis Exactus BioSolutions shall effect a technology sell and transfer to Digital Diagnostics such portion of the terminated Product inventory then held by Exactus BioSolutions or its Affiliates’ as had been allocated to the terminated country(ies) at a Third price equal to the lowest price at which such Product was sold to a non-Related Party contract manufacturer(sin such terminated country during the preceding twelve (12) 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(smonth period. This Section 13.7(b) is approved by Novartis, such approval shall not to be unreasonably withheld, conditioned or delayed. The cost of such technology transfer shall be borne by (a) Novartis apply in the case of a Novartis Election; and (btermination by Exactus BioSolutions under Section 13.2(b) Surface in the case of either (i) a Surface Election or (ii) any request for a second technology transfer, whether in the case of a Novartis Election or Surface Election; provided, however that Surface may not require of Novartis more than [***] such transfers for any Regional Licensed Product. Further, in the case of a Novartis Election, Novartis shall remain responsible for Manufacturing Commercial supply for use in the Surface Territory until the earlier of (x) such time as 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, the terms of supply of such Regional Antibody Candidates and Regional Licensed Products for use in Commercialization of such Regional Antibody Candidates and Regional Licensed Products in the Surface Territory will be set forth in the RLP Supply Agreementbased on Safety Reasons.

Appears in 1 contract

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

Commercialization. Novartis (a) Subject to anything stated to the contrary herein, LICENSEE shall have be solely responsible, at its own cost and expense, for the right to determine whether it is willing to Manufacture Regional Antibody Candidates and Regional Licensed Products for use in Commercialization of such Regional Antibody Candidates and Regional Licensed Products in the Surface Field in the Licensed Territory, including, without limitation, (i) commercial launch and pre-launch planning; (ii) market access and pricing; (iii) marketing and promotion activities; (iv) medical education and other medical activities for supporting sales such as publications, ad boards, etc.; (v) sales, logistics and distribution of Licensed Products; (vi) pre-sale and post-sale customer handling and support; (vii) order processing, invoicing and debt collection; and (viii) accounting for inventory and receivables. (b) LICENSEE shall use Commercially Reasonable Efforts to (A) launch Licensed Products in the Field in each country or territory within the Licensed Territory for which it has received regulatory approval and, if applicable, pricing 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 “reimbursement approval within [***]”. 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 *] ([***] *]) months after its receipt of obtaining 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”approval(s), 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 such launch is consistent with LICENSEE’s exercise of Commercially Reasonable Efforts, and (ii) sufficient quantities of Licensed Products in good quality are available and (B) Commercialize such Licensed Products in such countries or territories thereafter. Such launches of Licensed Products are intended to take place in each Major Market, it being understood and agreed that LICENSEE may elect further countries within the Licensed Territory to launch and Commercialize Licensed Products. Notwithstanding the foregoing, LICENSEE shall not be obligated to launch Licensed Products in a particular country if it determines, in its sole discretion, that based on the pricing and reimbursement approval obtained for such country such launch would negatively affect the profitability of the Commercialization of Licensed Products in such or any request for a second technology transfer, whether other country in the case Licensed Territory. (c) In any case, LICENSOR will use Commercially Reasonable Efforts to fully support LICENSEE’s Commercialization activities and the commercially successful exploitation of a Novartis Election the License at LICENSEE’s reasonable request. (d) Any and all transactions with respect to the Commercialization of Licensed Products between LICENSEE and its Affiliates and sublicensees, on the one hand, and Fresenius Medical Care AG & Co. KGaA or Surface Election; providedany member of the Fresenius Medical Care group of companies, however that Surface may not require of Novartis more than on the other hand, shall be on arm’s-length terms. [***] such transfers for any Regional Licensed Product. Further, in the case of a Novartis Election, Novartis shall remain responsible for Manufacturing Commercial supply for use in the Surface Territory until the earlier of (x) such time as 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, the terms of supply of such Regional Antibody Candidates and Regional Licensed Products for use in Commercialization of such Regional Antibody Candidates and Regional Licensed Products in the Surface Territory will be set forth in the RLP Supply Agreement.= [CONFIDENTIAL PORTION HAS BEEN OMITTED BECAUSE IT (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED]

Appears in 1 contract

Sources: License Agreement (Angion Biomedica Corp.)

Commercialization. Novartis MEI and its Affiliates and Sublicensees shall continue to distribute (but shall not be obligated to market or promote) such Product(s) in the Territory if Regulatory Approval therefor has been obtained, in accordance with the terms and conditions of this Agreement, for up to twelve (12) months following the effective date of any such termination (the “Wind down Period”); provided, that, the Parties shall enter into a transition services agreement pursuant to which MEI will continue to distribute such Product(s) in such country(ies) [*CONFIDENTIAL*]. At Presage’s request, such transition services agreement shall be negotiated in good faith during the applicable notice period preceding termination of this Agreement. In any event, MEI shall, and shall cause its Affiliates and Sublicensees to, cease distribution of the Product, or any portion thereof, upon [*CONFIDENTIAL*] notice by Presage requesting that such activities (or portion thereof) be ceased at any time following the expiration of Wind down Period). Notwithstanding any other provision of this Agreement, during the Wind down Period, MEI’s rights with respect to Compound and Product in the Territory shall be non-exclusive and Presage shall have the right to determine whether it is willing to Manufacture Regional Antibody Candidates engage one or more other distributor(s) and/or licensee(s) of the Compound and Regional Licensed Products for use in Commercialization of such Regional Antibody Candidates and Regional Licensed Products Product in the Surface Territory and shall communicate such determination Territory. Any Products sold or disposed 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 1933MEI, AS AMENDED. notifies Surface that it is willing to Manufacture Regional Antibody Candidates and Regional Licensed Products for use in Commercialization its Affiliates and/or Sublicensees, in the Surface Territory during the Wind down Period shall be subject to payments under and in accordance with the foregoing, then, Surface may elect, by written notice to Novartis no later than Section 5 above. Within [**CONFIDENTIAL*] after its receipt of 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 the supply price paid by MEI for such Compound and/or Product plus [*CONFIDENTIAL*]; except with respect to any such quantities of such notice from Novartis whether Compound and/or Product manufactured by MEI (or its contract manufacturer), in respect of which the price shall be equal to utilize Novartis MEI’s actual costs for such Commercial Manufacturing in the Surface Territory or quantities of Compound and/or Product, as applicable, plus [*CONFIDENTIAL*]. In addition, MEI shall use Commercially Reasonable Efforts to retain a Third Party contract manufacturer(s) for such purpose. If either Novartis is not willing cooperate, at Presage’s sole cost and expense, to provide such Commercial supply (a “Novartis Election”) or Surface elects not transition 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 Presage upon Presage’s request any arrangement with any contractor from which MEI was obtaining supply of Regional Antibody Candidates any Compound and/or Product to the extent such arrangement solely pertains to the Compound and/or Product and Regional Licensed Products for use no other products of MEI. Notwithstanding anything to the contrary in the Surface Territory, provided that such Third Party contract manufacturer(s) is approved by Novartis, such approval not to be unreasonably withheld, conditioned or delayed. The cost of such technology transfer shall be borne by (a) Novartis in the case of a Novartis Election; and (b) Surface in the case of either (i) a Surface Election or (ii) any request for a second technology transfer, whether in the case of a Novartis Election or Surface Election; provided, however that Surface may not require of Novartis more than [***] such transfers for any Regional Licensed Product. Furtherthis Section 10.4(c)(iii), in the case event of a Novartis Electionsafety or ethical concern regarding the continued Commercialization or use of the Product, Novartis MEI shall remain responsible for Manufacturing Commercial supply for use in not be obligated to continue Commercializing 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, the terms of supply of such Regional Antibody Candidates and Regional Licensed Products for use in Commercialization of such Regional Antibody Candidates and Regional Licensed Products in the Surface Territory will be set forth in the RLP Supply AgreementProduct.

Appears in 1 contract

Sources: License Agreement (MEI Pharma, Inc.)

Commercialization. Novartis To avoid a disruption in the supply of XenoPort Products to patients, if this Agreement is terminated after the first commercial sale of any XenoPort Product in the Territory, Xanodyne and its Affiliates shall continue to market, promote, distribute and otherwise commercialize (including 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 in accordance with the terms * Certain confidential information contained in this document, marked by brackets, is filed with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. and conditions of this Agreement, 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 any portion thereof, upon [... * ...] notice by XenoPort requesting that such activities (or portion thereof) be ceased. Notwithstanding any other provision of this Agreement, during the Wind-down Period, Xanodyne’s rights with respect to the Compound and XenoPort Products in the Territory shall be non-exclusive and, without limiting the foregoing, XenoPort shall have the right to determine whether it is willing to Manufacture Regional Antibody Candidates and Regional Licensed Products for use in Commercialization engage one or more other distributor(s) and/or licensee(s) of such Regional Antibody Candidates and Regional Licensed Products the Compound and/or any XenoPort Product in the Surface Territory and shall communicate such determination Territory. Any Products sold or disposed 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 Xanodyne in the Surface Territory during the Wind-down Period shall be subject to the applicable payment obligations under Article 6 above and all relevant deductions or credits due to Xanodyne in accordance with this Agreement. Within [... * ...] of expiration of the foregoingWind-down Period, thenXanodyne shall notify XenoPort of any quantity of the Intermediate, Surface may electCompound and/or XenoPort Products remaining in Xanodyne’s inventory and XenoPort shall have the option, by written upon notice to Novartis no later than Xanodyne, to repurchase any such quantities of the Intermediate, Compound and/or XenoPort Products, as applicable, from Xanodyne at a price equal to [***... * ...] after its receipt calculated in accordance with GAAP and Xanodyne’s then-prevailing standard procedures for calculating costs of such notice from Novartis whether to utilize Novartis for such Commercial Manufacturing in good sold. For 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 sake 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 Novartisclarity, such approval not to be unreasonably withheld, conditioned or delayed. The cost of such technology transfer shall be borne by (a) Novartis in the case of a Novartis Election; and (b) Surface in the case of either (i) a Surface Election or (ii) any request for a second technology transfer, whether in the case of a Novartis Election or Surface Election; provided, however that Surface may not require of Novartis more than [***] such transfers for any Regional Licensed Product. Further, in the case of a Novartis Election, Novartis shall remain responsible for Manufacturing Commercial supply for use in the Surface Territory until the earlier of (x) such time as 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, the terms of supply of such Regional Antibody Candidates and Regional Licensed Products for use in Commercialization of such Regional Antibody Candidates and Regional Licensed Products in the Surface Territory will be set forth in the RLP Supply Agreement... * ...].

Appears in 1 contract

Sources: Licensing Agreement (Xenoport Inc)

Commercialization. Novartis (a) SKINMEDICA shall use reasonable commercial efforts to diligently undertake market development, launch, and sales and marketing activities for the Licensed Product in the Territory 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, upon notice to DOW, have the option of extending the Launch Date by a period of not more than *** beyond such *** post-FDA-approval period (the “Extended Period”). (b) If, at the end of the Extended Period, the Launch Date has still not occurred, DOW shall have the right to determine whether it terminate this Agreement pursuant to Section 6.2, provided, however, that if such delay is willing due to Manufacture Regional Antibody Candidates a Force Majeure Event the provisions of Section 13.4 shall apply. In the event DOW terminates this Agreement after the conclusion of the Extended Period due to SKINMEDICA’s failure to launch the Licensed Product and Regional successfully licenses a third party to commercialize the Licensed Products for use Product under the Licensed Patent in Commercialization the Field in the Territory, DOW shall pay SKINMEDICA *** of any license fees and royalty revenue based on sales of the Licensed Product in the Field in the Territory that are received by DOW under such third-party license until the aggregate of such Regional Antibody Candidates and Regional Licensed Products in the Surface Territory and shall communicate such determination by written notice payments 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 “[SKINMEDICA totals ***]”. 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 * of Development Fees paid 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, DOW 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, however that Surface may not require of Novartis more than [***] such transfers for any Regional Licensed Product. Further, in the case of a Novartis Election, Novartis shall remain responsible for Manufacturing Commercial supply for use in the Surface Territory until the earlier of (x) such time as 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, the terms of supply of such Regional Antibody Candidates and Regional Licensed Products for use in Commercialization of such Regional Antibody Candidates and Regional Licensed Products in the Surface Territory will be set forth in the RLP Supply AgreementSKINMEDICA.

Appears in 1 contract

Sources: Development and License Agreement (Skinmedica Inc)

Commercialization. Novartis Article 6(b) of the Agreement is hereby amended with the addition of the following paragraph: “Notwithstanding the provisions above and elsewhere in the Agreement, any decision to (i) file for regulatory approval of Licensed Products and/or to (ii) launch and Commercialize Licensed Products 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 any given country in the Additional Licensed Territory if LICENSEE determines it would not be commercially reasonable to do so in such country; provided that, if (i) LICENSEE does not file for regulatory approval for a Licensed Product in any given country in the Additional Licensed Territory within [***] following the Amendment Effective Date, 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 determine whether it is willing terminate the License and all rights granted to Manufacture Regional Antibody Candidates LICENSEE hereunder related to such country, and Regional Licensed Products for use in Commercialization of the rights related to such Regional Antibody Candidates country shall revert to LICENSOR and Regional Licensed Products such country shall no longer be included in the Surface Territory Territory. In such a case and shall communicate such determination by written notice to Surface no later than Initiation following a specific discussion at JSC upon the expiration 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 applicable [***] after its receipt of period, LICENSOR may exercise such right by sending a written notice from Novartis whether to utilize Novartis for such Commercial Manufacturing in the Surface Territory or LICENSEE to retain a Third Party contract manufacturer(s) for such purposethat effect. If either Novartis is not willing to provide such Commercial supply (a “Novartis Election”) or Surface elects not to utilize Novartis for such Commercial supply (a “Surface Election”), then Novartis shall effect a technology transfer to a Third Party contract manufacturer(s) to enable such Third Party to provide Commercial supply of Regional Antibody Candidates and Regional Licensed Products for use in the Surface Territory, provided that such Third Party contract manufacturer(s) is approved by Novartis, such approval not to be unreasonably withheld, conditioned or delayed. The cost of such technology transfer shall be borne by (a) Novartis in the case of a Novartis Election; and (b) Surface in the case of either (i) a Surface Election or (ii) any request for a second technology transfer, whether in the case of a Novartis Election or Surface Election; provided, however that Surface may not require of Novartis more than [***] such transfers for any Regional Licensed Product* Certain Confidential Information Omitted Amendment No. Further, in the case of a Novartis Election, Novartis shall remain responsible for Manufacturing Commercial supply for use in the Surface Territory until the earlier of (x) such time as the technology transfer is completed or (y) [***] If Novartis is willing 2 to Manufacture Regional Antibody Candidates License 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, the terms of supply of such Regional Antibody Candidates and Regional Licensed Products for use in Commercialization of such Regional Antibody Candidates and Regional Licensed Products in the Surface Territory will be set forth in the RLP Supply Collaboration Agreement.

Appears in 1 contract

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

Commercialization. Novartis 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 Product in the Field 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, but 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., after the expiration of the applicable termination notice period), the profit-or-loss provisions in Section 6.3 shall continue to apply. Notwithstanding the foregoing, Sanofi and its Affiliates and sublicensees shall cease such activities in the Territory upon 60 days written notice given by MannKind at any time after the effective date of a termination requesting that such activities (or portion thereof) cease. In the case of a termination of this Agreement in its entirety, within 30 days after MannKind has given notice to Sanofi requesting the cessation of activities pursuant to the provision of this Section, Sanofi shall notify MannKind of an estimate of the quantity of Product and its shelf life remaining in Sanofi’s inventory and MannKind shall have the right to determine whether it is willing to Manufacture Regional Antibody Candidates and Regional Licensed Products for use in Commercialization purchase any such quantities of Product from Sanofi at a price mutually agreed by the Parties. To the extent MannKind does not purchase such quantities, Sanofi may sell such quantities during the 180 days after the effective date of such Regional Antibody Candidates and Regional Licensed Products in termination within 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 shelf life remaining 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, however that Surface may not require of Novartis more than [***] such transfers for any Regional Licensed Product. Further, in the case of a Novartis Election, Novartis shall remain responsible for Manufacturing Commercial supply for use in the Surface Territory until the earlier of (x) such time as 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, the terms of supply of such Regional Antibody Candidates and Regional Licensed Products for use in Commercialization of such Regional Antibody Candidates and Regional Licensed Products in the Surface Territory will be set forth in the RLP Supply Agreement.

Appears in 1 contract

Sources: License and Collaboration Agreement (Mannkind Corp)

Commercialization. Novartis (a) Subject to anything stated to the contrary herein, LICENSEE shall have be solely responsible, at its own cost and expense, for the right to determine whether it is willing to Manufacture Regional Antibody Candidates and Regional Licensed Products for use in Commercialization of such Regional 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 Field 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 including, without limitation, (i) commercial launch and pre-launch planning; (ii) market access and pricing and reimbursement approval of Licensed Products; (iii) marketing and promotion activities; (iv) medical education and other medical activities for supporting sales such Third Party contract manufacturer(sas publications, ad boards, etc., subject to Article 8.5; (v) is approved by Novartissales, such approval not to be unreasonably withheldlogistics and distribution of Licensed Products; (vi) pre-sale and post-sale customer handling and support; (vii) order processing, conditioned or delayed. The cost of such technology transfer shall be borne by (a) Novartis in the case of a Novartis Electioninvoicing and debt collection; and (viii) accounting for inventory and receivables. (b) Surface in the case of either (i) a Surface Election or (ii) any request for a second technology transfer, whether in the case of a Novartis Election or Surface Election; provided, however that Surface may not require of Novartis more than [***] such transfers for any Regional Licensed Product. Further, in the case of a Novartis Election, Novartis LICENSEE 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 Commercially Reasonable Efforts to Manufacture Regional Antibody Candidates launch 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, the terms of supply of such Regional Antibody Candidates and Regional Licensed Products for use in Commercialization of such Regional Antibody Candidates and Regional Commercialize Licensed Products in the Surface Licensed Territory will be to the extent it has obtained regulatory approval and, if applicable, pricing and reimbursement approval, within six (6) months after obtaining such approval(s), provided that sufficient quantities of Licensed Products in good quality and complying with the specifications set forth in the RLP Supply Agreementregulatory approvals are available. Any decision by LICENSEE not to launch and Commercialize Licensed Products in any country in the Licensed Territory within such six (6) month period is subject to the review of the JSC. LICENSEE shall not be obligated to launch Licensed Products in any particular country if the JSC, upon LICENSEE’s request, determines that it would not be commercially reasonable to launch in such country. (c) LICENSOR will use Commercially Reasonable Efforts to fully support LICENSEE's Commercialization activities at LICENSEE’s reasonable request. (d) Any and all transactions with respect to the Commercialization of Licensed Products be-tween LICENSEE and its Affiliates and sub-licensees, on the one hand, and Fresenius Medical Care AG & Co. KGaA or any member of the Fresenius Medical Care group of companies, on the other hand, shall be on arm’s-length terms.

Appears in 1 contract

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

Commercialization. Novartis To avoid a disruption in the supply of XenoPort Products to patients, if this Agreement is terminated after the first commercial sale of any XenoPort Product in the Territory, Xanodyne and its Affiliates shall continue to market, promote, distribute and otherwise commercialize (including 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 in 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 any portion thereof, upon [**] notice by XenoPort requesting that such activities (or portion thereof) be ceased. Notwithstanding any other provision of this Agreement, during the Wind-down Period, Xanodyne's rights with respect to the Compound and XenoPort Products in the Territory shall be non-exclusive and, without limiting the foregoing, XenoPort shall have the right to determine whether it is willing to Manufacture Regional Antibody Candidates and Regional Licensed Products for use in Commercialization engage one or more other distributor(s) and/or licensee(s) of such Regional Antibody Candidates and Regional Licensed Products the Compound and/or any XenoPort Product in the Surface Territory. Any Products sold or disposed by Xanodyne in the Territory during the Wind-down Period shall be subject to the applicable payment obligations under Article 6 above and shall communicate such determination by written notice all relevant deductions or credits due to Surface no later than Initiation of the first Phase 3 StudyXanodyne in accordance with this Agreement. If Novartis CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “Within [**] of 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 [*]”. 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 *] calculated in accordance with GAAP and Xanodyne's then-prevailing standard procedures for calculating costs of good sold. For the foregoingsake of clarity, then, Surface may elect, by written notice to Novartis no later than such [***] 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, however that Surface may not require of Novartis more than [***] such transfers for any Regional Licensed Product. Further, in the case of a Novartis Election, Novartis shall remain responsible for Manufacturing Commercial supply for use in the Surface Territory until the earlier of (x) such time as 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, the terms of supply of such Regional Antibody Candidates and Regional Licensed Products for use in Commercialization of such Regional Antibody Candidates and Regional Licensed Products in the Surface Territory will be set forth in the RLP Supply Agreement].

Appears in 1 contract

Sources: Licensing Agreement (Xanodyne Pharmaceuticals Inc)

Commercialization. Novartis (a) Subject to the terms and conditions of this Agreement, GSK shall have the right 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 determine whether it 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 willing solely responsible for and has full control over, all sales, marketing and other Commercialization activities for any Product for the GSK Territory as of and following the Effective Date, including sole responsibility for (i) any decisions and negotiations with relevant Regulatory Authorities regarding price and reimbursement status of any Product for the GSK Territory, and (ii) the creation, preparation, production, reproduction, and filing with the applicable Regulatory Authorities of relevant written sales, promotion and advertising materials relating to Manufacture Regional Antibody Candidates and Regional Licensed Products any Product for use in the GSK Territory. GSK shall, except for the Scynexis Transitional Commercialization Rights, sell, distribute, and book all sales of such Regional Antibody Candidates and Regional Licensed all Products in the Surface GSK Territory. Subject to its diligence obligations set forth in Section ‎4.6, GSK has the sole right, in its discretion, to decide whether to launch or continue to sell any Product in any market in the GSK Territory. During the Commercialization Transition Period, the Parties shall complete their respective activities under the Commercialization Transition Plan to enable GSK to efficiently initiate Commercialization in the United States of the Product marketed by Scynexis as of the Execution Date under the Trademark BREXAFEMME® (including, the assignment by Scynexis or its Affiliates to GSK and the assumption by GSK of all of Scynexis’s post-Effective Date obligations thereunder, (x) of all distribution, commercialization, payor and similar agreements, to the extent relating to any Product in the GSK Territory (the “Scynexis Commercial Contracts”) to the extent such agreements are assignable and (y) all Scynexis Websites and Copyrights) and Scynexis shall communicate such determination 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 Surface no later than Initiation the other Party for review and discussion; provided, further, that the Commercialization Transition Plan may only be amended by mutual written agreement of the first Phase 3 StudyParties. If Novartis CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “Scynexis shall make Scynexis Personnel reasonably available to accomplish the activities set forth in such Commercialization Transition Plan, provided Scynexis shall have no obligation to retain or employ any Scynexis Personnel to fulfill this obligation. Any and all reasonable and documented FTE Costs and Out-of-Pocket Costs incurred by Scynexis or its Representatives under this Section ‎4.4 (except to the extent that such FTE Costs or Out-of-Pocket Costs are incurred by Scynexis or its Representatives in connection with CMC activities required to be conducted to remedy any identified errors in existence as of the Effective Date that are necessary to be remedied in order to obtain or maintain the applicable Regulatory Approval) shall be reimbursed by GSK, and shall be due and payable within [***] ([***]”. 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 ) from the date on which GSK receives a Valid Invoice; provided further that it is willing (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 Manufacture Regional Antibody Candidates such FTE Costs 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 Out-of-Pocket Costs being incurred and if GSK does not provide such approval within [***] after its ([***]) of receipt from Scynexis of the estimate or updated estimate of the relevant FTE Costs and Out-of-Pocket Costs, then Scynexis shall not be obligated to perform the applicable activity, and (B) to the extent GSK approves such estimate or updated estimate, GSK shall be obligated to pay the amount of such notice from Novartis whether to utilize Novartis for FTE Costs and Out-of-Pocket Costs set forth in such Commercial Manufacturing in the Surface Territory Valid Invoice so long as such amount does not exceed such approved estimate 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 updated estimate by Novartis, such approval not to be unreasonably withheld, conditioned or delayed. The cost of such technology transfer shall be borne by (a) Novartis in the case of a Novartis Election; and (b) Surface in the case of either (i) a Surface Election or (ii) any request for a second technology transfer, whether in the case of a Novartis Election or Surface Election; provided, however that Surface may not require of Novartis more than [***] such transfers for any Regional Licensed Product. Further, in the case of a Novartis Election, Novartis shall remain responsible for Manufacturing Commercial supply for use in the Surface Territory until the earlier of percent (x) such time as the technology transfer is completed or (y) [***] If Novartis ]%). (b) GSK acknowledges that ▇▇▇▇▇▇▇▇’s performance of Commercialization activities pursuant to the Commercialization Transition Plan is willing to Manufacture Regional Antibody Candidates for the sole benefit of GSK and Regional Licensed Products for use in Commercialization in the Surface Territory sole purpose of furthering GSK’s Exploitation of Compounds and Surface elects to utilize Novartis for such Commercial Manufacturing in the Surface Territory, the terms of supply of such Regional Antibody Candidates and Regional Licensed Products for use in Commercialization of such Regional Antibody Candidates and Regional Licensed Products in the Surface Territory will be set forth Field in the RLP Supply AgreementGSK Territory.

Appears in 1 contract

Sources: Exclusive License Agreement (Scynexis Inc)

Commercialization. Novartis To avoid disruption of supply of any Terminated Products to patients if this Agreement is terminated after the Launch of a Terminated Product in the Affected Area, GSK, its Affiliates and Sublicensees shall continue to sell the Terminated Products in each country of the Affected Area for which Marketing Approval of such Terminated Product has been obtained, in accordance with the terms and conditions of this Agreement, until the date on which Amicus notifies GSK that Amicus has secured an alternative distributor or licensee for such Terminated Product in 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 Affected Area during the Wind-Down Period. Notwithstanding any other provision of this Agreement, during the Wind-down Period, GSK’s and its Affiliates’ and Sublicensees’ rights with respect to the Terminated Products in the Affected Area shall be non-exclusive and, without limiting the foregoing, Amicus shall have the right to determine whether it is willing engage one or more other distributor(s) and/or licensee(s) of any Terminated Product in all or part of the Affected Area; provided, however, that in the event that Amicus does so engage one or more other distributor(s) and/or licensee(s) of any Terminated Product in all or part of the Affected Area, GSK shall have no further obligation to Manufacture Regional Antibody Candidates and Regional Licensed Products for use in Commercialization of such Regional Antibody Candidates and Regional Licensed continue to sell the Terminated Products in the Surface Territory Affected Area or such part thereof, as applicable. Any Terminated Product sold or disposed by GSK in the Affected Area during the Wind-down Period shall be subject to applicable royalty payment obligations under Section 3.4 above, and for such purposes, Sections 3.4, 3.5, 3.7, 3.8, 3.9 and 3.11 shall communicate such determination by written notice to Surface no later than Initiation of the first Phase 3 Studysurvive. If Novartis CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[Within ***]”. 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*** following the expiration of the Wind-Down Period, AS AMENDED. notifies Surface that it is willing to GSK shall notify Amicus of any quantities of Compound or Terminated Product(s) remaining in GSK’s or its Affiliate’s inventory, as well as any components necessary for the Manufacture Regional Antibody Candidates of the Compound and Regional Licensed Products for use Terminated Product(s) in Commercialization in GSK’s or its Affiliate’s inventory, and Amicus shall have the Surface Territory in accordance with the foregoingoption, then, Surface may elect, by written upon notice to Novartis no later than [GSK, to repurchase any such quantities of the Compound and/or Terminated Product(s) and/or components from GSK at a price to be mutually agreed by the Parties. If Amicus so elects to purchase any remaining quantities of Compound or Terminated Products 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. ***] 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, however that Surface may not require of Novartis more than [***] such transfers for any Regional Licensed Product. Further, in * - Material has been omitted and filed separately with 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, the terms of supply of such Regional Antibody Candidates and Regional Licensed Products for use in Commercialization of such Regional Antibody Candidates and Regional Licensed Products in the Surface Territory will be set forth in the RLP Supply AgreementCommission.

Appears in 1 contract

Sources: License and Collaboration Agreement (Amicus Therapeutics Inc)

Commercialization. Novartis The parties shall have 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 right to determine whether it is willing to Manufacture Regional Antibody Candidates and Regional Licensed Products for use in Commercialization of such Regional Antibody Candidates and Regional Licensed Products in the Surface Territory and shall communicate such determination manufacture by written notice to Surface no later than Initiation NANX of the first Phase 3 StudyJoint Development Product on behalf of SCOA and/or its Affiliates. If Novartis CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “Any such agreement shall include (without limitation): (a) A royalty payment to NANX of [***] percent ([***]”. 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 %) of gross profit from the Surface Territory in accordance with sale of 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 Joint Development Product (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 ElectionRoyalty”) or Surface elects not to utilize Novartis for such Commercial supply (a where 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 gross profit” is defined as 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 sales price less “cost of such technology transfer shall be borne by (a) Novartis in the case of a Novartis Election; and production” discounts, product returns, rebates; (b) Surface in NANX shall sell the case Joint Development Product to SCOA or an Affiliate at NANX cost of either 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) a Surface Election or for cause and (ii) any request for a second technology transfer, whether right to terminate in the case 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, provided, however, that if NANX lacks the capacity to produce a sufficient quantity of a Novartis Election Joint development Product, NANX shall be required to contract with one or Surface Election; provided, however that Surface may not require of Novartis more than [***] such transfers for third party manufacturers to make up any Regional Licensed Product. Further, in the case of a Novartis Election, Novartis shall remain responsible for Manufacturing Commercial supply for use in the Surface Territory until the earlier of (x) such time as 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, the terms of supply of such Regional Antibody Candidates and Regional Licensed Products for use in Commercialization of such Regional Antibody Candidates and Regional Licensed Products in the Surface Territory will be set forth in the RLP Supply Agreementshortfall.

Appears in 1 contract

Sources: Joint Development Agreement (NANOPHASE TECHNOLOGIES Corp)

Commercialization. Novartis shall have 5.1. Buyer shall, at its sole cost and expense, use commercially reasonable efforts to further and advance Cell Therapy employing the right Patents and Related Trade Secrets towards various commercial applications, including the continuance of phase I clinical studies and, if commercially reasonable, with progression to determine whether it is willing to Manufacture Regional Antibody Candidates further stages of development, regulatory approval, manufacture, product introduction, marketing and Regional Licensed Products for use distribution in Commercialization major markets. Without limiting the generality of such Regional 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, thenBuyer shall diligently perform the activities contemplated by the Development Plan attached as Exhibit B; provided, Surface however, that Buyer's performance of such activities will be subject to Section 5.2 and Buyer will not be obligated to expend the specific dollar amounts set forth in Exhibit B. Buyer shall provide GenVec such information as it may electreasonably request to enable GenVec to assess Buyer's progress toward commercialization of Cell Therapy. 5.2. In the event that, by in any twelve (12) month period during the first five (5) years after the Effective Date, Buyer expends direct funding for its program of developing and commercializing Cell Therapy products, processes and services employing the Patents and Related Trade Secrets at a level of less than one and one-half million U.S. dollars ($1,500,000), or after Buyer has sold or otherwise disposed of the Patents and Related Trade Secrets the subsequent owner thereof expends direct funding for its program of developing and commercializing Cell Therapy products, processes and services employing the Patents and Related Trade Secrets at a level of less than three million U.S. dollars ($3,000,000), GenVec may give Buyer or such subsequent owner written notice requiring it to Novartis no later than [***] after its receipt of take remedial steps. After having given such notice, GenVec may by further written notice from Novartis whether to utilize Novartis for such Commercial Manufacturing in declare 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 same to be unreasonably withheld, conditioned an Event of Default as described in Section 8.5 if (i) Buyer or delayed. The cost of such technology transfer shall be borne by subsequent owner does not promptly either (a) Novartis in commence and continue taking the case of steps required by Section 5.1 and funding such program at such level (including making up any prior deficiency within a Novartis Election; and reasonable time) or (b) Surface diligently commence searching for a buyer of Buyer or all or substantially all of Buyer's assets in a transaction that will result in payment to GenVec under Section 4.1(iii) or assumption by such buyer of all of Buyer's obligations under this Agreement, including its obligations under Section 5.1 (which the case of either (ibuyer thereafter must begin performing promptly) a Surface Election and its obligation to make payments to GenVec under Article 4, as contemplated by Section 9.7; or (ii) any request having commenced searching for a second technology transferbuyer as described in clause (i)(b) above, whether in the case of a Novartis Election Buyer or Surface Election; provided, however that Surface may not require of Novartis more than [***] such transfers for any Regional Licensed Product. Further, in the case of a Novartis Election, Novartis shall remain responsible for Manufacturing Commercial supply for use in the Surface Territory until the earlier of subsequent owner either (xa) ceases to pursue such time as the technology transfer is completed search diligently or (yb) [***] fails to close such a sale of Buyer or its assets within six (6) months after the date of GenVec's notice requiring Buyer or such subsequent owner to take remedial steps. If Novartis GenVec so declares an Event of Default, then, without limiting the provisions of Section 8.5, Buyer or such subsequent owner shall within five (5) days sign and deliver to GenVec an assignment of the entire right, title and interest in, to and under the Patents and Related Trade Secrets in substantially the form of Exhibit A, with the necessary changes in detail, and assign and delegate to GenVec the Assigned Agreements and any other licenses of the Patents that GenVec is willing prepared 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, the terms of supply of such Regional Antibody Candidates and Regional Licensed Products for use in Commercialization of such Regional Antibody Candidates and Regional Licensed Products in the Surface Territory will be set forth in the RLP Supply Agreementassume.

Appears in 1 contract

Sources: Patent Assignment and Security Agreement (Advanced Cell Technology, Inc.)

Commercialization. Novartis 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 Galderma Territory for which Marketing Approval therefor has been obtained, in accordance with the terms and conditions of this Agreement, until three (3) months after the date on which ZARS notifies Galderma in writing that ZARS has secured an alternative distributor or licensee for 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-down Period”); provided that Galderma, its Affiliates and its Sublicensees shall cease such activities, or any portion thereof, in a given country upon sixty (60) days notice by ZARS requesting that such activities (or portion thereof) be ceased. Notwithstanding any other provision of this Agreement, during the Wind-down Period, (A) Galderma’s and its Affiliates’ and Sublicensees’ rights with respect to a Product in the Galderma Territory shall be non-exclusive and, without limiting the foregoing, ZARS shall have the right to determine whether it is willing engage one or more other distributor(s) and/or licensee(s) of a Product in all or part of the Galderma Territory and (B) Galderma shall be relieved of its obligations under Section 6.4. Any Product sold or disposed in the Galderma Territory during the Wind-down Period shall be subject to Manufacture Regional Antibody Candidates the other applicable payment obligations under Article 5 and Regional Licensed Products Article 6 above. Within thirty (30) days of 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 the Galderma COGS for use in Commercialization such Products, up to maximum amount of such Regional Antibody Candidates and Regional Licensed quantities equal to the number of Products sold in the preceding six (6) months. ZARS shall have the right, but not the obligation, to purchase any additional quantities of Product remaining in Galderma’s inventory that do not meet the foregoing requirements, at a price equal to the Galderma COGS for such Products. If any Product was manufactured by any Third Party for Galderma, or Galderma had contracts with vendors which contracts are necessary or useful for ZARS to take over responsibility for the Products in the Surface Territory Galderma Territory, then Galderma shall to the extent possible and shall communicate such determination as requested in writing by written notice to Surface no later than Initiation ZARS, assign all of the first Phase 3 Studyrelevant Third-Party contracts to ZARS. 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 1933Galderma or its Affiliate manufactured any Product at the time of termination, AS AMENDED. notifies Surface that it is willing then Galderma (or its Affiliate) shall, to Manufacture Regional Antibody Candidates and Regional Licensed Products the extent practicable, continue to provide 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 manufacturing of such Product for ZARS, from the date of notice from Novartis whether to utilize Novartis for such Commercial Manufacturing in the Surface Territory or to retain a Third Party contract manufacturer(s) for such purpose. If either Novartis is not willing to provide such Commercial supply (a “Novartis Election”) or Surface elects not to utilize Novartis for such Commercial supply (a “Surface Election”), then Novartis shall effect a technology transfer to a Third Party contract manufacturer(s) to enable such Third Party to provide Commercial supply of Regional Antibody Candidates and Regional Licensed Products for use in the Surface Territory, provided that such Third Party contract manufacturer(s) is approved by Novartis, such approval not to be unreasonably withheld, conditioned or delayed. The cost of such technology transfer shall be borne by (a) Novartis in the case of a Novartis Election; and (b) Surface in the case of either (i) a Surface Election or (ii) any request for a second technology transfer, whether in the case of a Novartis Election or Surface Election; provided, however that Surface may not require of Novartis more than [***] such transfers for any Regional Licensed Product. Further, in the case of a Novartis Election, Novartis shall remain responsible for Manufacturing Commercial supply for use in the Surface Territory termination until the earlier of (x) such time as the technology transfer ZARS is completed or (y) [***] If Novartis is willing able, using reasonable efforts to Manufacture Regional Antibody Candidates do so, to secure an acceptable alternative commercial manufacturing source from which sufficient quantities of Product may be procured and Regional Licensed Products for use in Commercialization legally sold in the Surface Galderma Territory (but in no event for longer than fifteen (15) months after notice of termination is delivered), and Surface elects to utilize Novartis ZARS shall compensate Galderma for such Commercial Manufacturing in the Surface Territory, the terms quantities at a transfer price equal to [ * ] of supply of such Regional Antibody Candidates and Regional Licensed Products for use in Commercialization of such Regional Antibody Candidates and Regional Licensed Products in the Surface Territory will be set forth in the RLP Supply AgreementGalderma COGS.

Appears in 1 contract

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

Commercialization. Novartis Partner shall have the right final say with respect to determine whether it decisions regarding the following activities for the Shared Territory: the JCC Final Decision Exceptions set forth in [*] 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 with respect to decisions regarding the Shared Territory Commercialization Budget under [*], if (x) the amended Shared Territory Commercialization Budget at issue is willing 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 Manufacture Regional Antibody Candidates the Executive Officers, but rather Partner shall have final say with respect to such proposed Budget and Regional Licensed Products for use Medivation’s forty percent (40%) share of the amount in Commercialization excess of such Regional Antibody Candidates and Regional Licensed Products [*] amount of the total aggregate budget for such Calendar Year (“Excess Initial Shared Territory Commercialization Budget Amount”) in the Surface Initial Shared Territory Commercialization Budget attached hereto (or if such total aggregate budget has been updated and shall communicate such determination approved by written notice to Surface no later than Initiation consensus 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 1933JSC, AS AMENDED. notifies Surface that it is willing to Manufacture Regional Antibody Candidates 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 Regional Licensed Products for use in Commercialization in the Surface Territory 8.4, respectively, 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, however that Surface may not require of Novartis more than [***] such transfers for any Regional Licensed Product. Further, in the case of a Novartis Election, Novartis shall remain responsible for Manufacturing Commercial supply for use in the Surface Territory until the earlier of (x) such time as 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, the terms of supply of such Regional Antibody Candidates and Regional Licensed Products for use in Commercialization of such Regional Antibody Candidates and Regional Licensed Products in the Surface Territory will be procedure set forth in Section 8.2 and 8.4, as appropriate. All other decisions or disputes regarding the RLP Supply AgreementShared 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

Sources: Collaboration Agreement (Medivation, Inc.)

Commercialization. Novartis To avoid disruption of supply of any Terminated Products to patients if this Agreement is terminated after the Launch of a Terminated Product in the Affected Area, GSK, its Affiliates and Sublicensees shall continue to sell the Terminated Products in each country of the Affected Area for which Marketing Approval of such Terminated Product has been obtained, in accordance with the terms and conditions of this Agreement, until the date on which Amicus notifies GSK that Amicus has secured an alternative distributor or licensee for such Terminated Product in 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 Affected Area during the Wind-Down Period. Notwithstanding any other provision of this Agreement, during the Wind-down Period, GSK’s and its Affiliates’ and Sublicensees’ rights with respect to the Terminated Products in the Affected Area shall be non-exclusive and, without limiting the foregoing, Amicus shall have the right to determine whether it is willing engage one or more other distributor(s) and/or licensee(s) of any Terminated Product in all or part of the Affected Area; provided, however, that in the event that Amicus does so engage one or more other distributor(s) and/or licensee(s) of any Terminated Product in all or part of the Affected Area, GSK shall have no further obligation to Manufacture Regional Antibody Candidates and Regional Licensed Products for use in Commercialization of such Regional Antibody Candidates and Regional Licensed continue to sell the Terminated Products in the Surface Territory Affected Area or such part thereof, as applicable. Any Terminated Product sold or disposed by GSK in the Affected Area during the Wind-down Period shall be subject to applicable royalty payment obligations under Section 3.4 above, and for such purposes, Sections 3.4, 3.5, 3.7, 3.8, 3.9 and 3.11 shall communicate such determination by written notice to Surface no later than Initiation of the first Phase 3 Studysurvive. If Novartis CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[Within ***]”. 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*** following the expiration of the Wind-Down Period, AS AMENDED. notifies Surface that it is willing to GSK shall notify Amicus of any quantities of Compound or Terminated Product(s) remaining in GSK’s or its Affiliate’s inventory, as well as any components necessary for the Manufacture Regional Antibody Candidates of the Compound and Regional Licensed Products for use Terminated Product(s) in Commercialization in GSK’s or its Affiliate’s inventory, and Amicus shall have the Surface Territory in accordance with the foregoingoption, then, Surface may elect, by written upon notice to Novartis no later than [GSK, to repurchase any such quantities of the Compound and/or Terminated Product(s) and/or components from GSK at a price to be mutually agreed by the Parties. If Amicus so elects to purchase any remaining quantities of Compound or Terminated Products 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. ***] 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, however that Surface may not require of Novartis more than [***] such transfers for any Regional Licensed Product* - Material has been omitted and filed separately with the Commission. Further, in the case of a Novartis Election, Novartis shall remain responsible for Manufacturing Commercial supply for use in the Surface Territory until the earlier of (x) such time as 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, the terms of supply of such Regional Antibody Candidates and Regional Licensed Products for use in Commercialization of such Regional Antibody Candidates and Regional Licensed Products in the Surface Territory will be set forth in the RLP Supply Agreement.63

Appears in 1 contract

Sources: Licensing, Development, Manufacturing and Marketing Agreement

Commercialization. Novartis GSK shall have the right to determine whether grant sublicenses to Sublicensees under the license granted to it is willing under Section 8.1.1 with respect to Manufacture Regional Antibody Candidates and Regional Licensed Royalty-Bearing Products for use in Commercialization of such Regional Antibody Candidates and Regional Licensed Products sale in the Surface Territory and shall communicate Royalty-Bearing Territory; provided, that, (a) to the extent any such determination by written notice sublicense is with respect 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 except that GSK may utilize Novartis for such Commercial Manufacturing a contract sales organization in the Surface Royalty-Bearing Territory or to retain a Third Party contract manufacturer(s) for such purpose. If either Novartis is not willing and in the Co-Commercialization Territory if both GSK and SYNTA are unable to provide such Commercial supply (a “Novartis Election”) their respective requirements of Representatives necessary to conduct the GSK Co-Commercialization Activities or Surface elects not to utilize Novartis for such Commercial supply (a “Surface Election”)SYNTA Co-Commercialization Activities, 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 as the case of a Novartis Electionmay be, in its discretion upon prior notice to SYNTA; and (b) Surface it shall be a condition of any such sublicense that such Sublicensee agrees to be bound by all terms of this Agreement Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934. applicable to the Commercialization of Royalty-Bearing Products in the case Royalty-Bearing Territory (including, without limitation, Article 7); (c) GSK shall provide written notice to SYNTA of either (i) a Surface Election or (ii) any request for a second technology transfer, whether in the case of a Novartis Election or Surface Election; provided, however that Surface may not require of Novartis more than such proposed sublicense at least [***] days prior to such transfers for any Regional Licensed Product. Furtherexecution and provide material terms or redacted copies, in the case at GSK’s option, to SYNTA of a Novartis Election, Novartis shall remain responsible for Manufacturing Commercial supply for use in the Surface Territory until the earlier of (x) each such time as the technology transfer is completed or (y) sublicense within [***] If Novartis is willing days of its execution; (d) if GSK grants a sublicense to Manufacture Regional Antibody Candidates and Regional Licensed Products for use in Commercialization a Sublicensee, GSK shall be deemed to have guaranteed that such Sublicensee will fulfill all of GSK’s obligations under this Agreement applicable to the subject matter of such sublicense; (e) GSK shall not be relieved of its obligations pursuant to this Agreement as a result of such sublicense. For the avoidance of doubt, GSK shall not be required to obtain approval of SYNTA with respect to sublicenses granted to its Affiliates, or sub-contracting out its Manufacturing activities in the Surface Territory and Surface elects to utilize Novartis for such Commercial Manufacturing in the Surface Territory, the terms of supply of such Regional Antibody Candidates and Regional Licensed Products for use in Commercialization of such Regional Antibody Candidates and Regional Licensed Products in the Surface Territory will be set forth in the RLP Supply Agreement.

Appears in 1 contract

Sources: Collaborative Development, Commercialization and License Agreement (Synta Pharmaceuticals Corp)

Commercialization. Novartis At MGI’s request, if Marketing Authorization has been or is obtained for the Licensed Products, then Licensee and its Affiliates shall continue to Commercialize the Licensed Products in the same manner in each country in the Territory for which Marketing Authorization therefore has been obtained, in accordance with the terms and conditions of 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 Wind-down Period, Licensee’s and its Affiliates’ rights with respect to the Licensed Products shall be non-exclusive, and MGI shall have the right to determine whether it is willing engage one or more other distributor(s) and/or licensee(s) to Manufacture Regional Antibody Candidates Develop and Regional 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 its Affiliates with respect to the Licensed 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 use in Commercialization of such Regional Antibody Candidates and Regional other countries, all the Licensed Products in the Surface Territory possession of Licensee and its Affiliates that are not sold during such Wind-down Period shall communicate such determination by written notice to Surface no later than Initiation be destroyed, provided, however, that Licensee shall have a minimum of one hundred-eighty (180) days following termination of the first Phase 3 StudyWind-down Period to sell its remaining inventory, without regard to the actual length of the Wind-down Period. 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 Any remaining unsold inventory shall be borne by (a) Novartis in the case of a Novartis Election; and (b) Surface in the case of either (i) a Surface Election or (ii) any request for a second technology transfer, whether in the case of a Novartis Election or Surface Election; provided, however that Surface may not require of Novartis more than [***] such transfers for any Regional Licensed Product. Further, in the case of a Novartis Election, Novartis shall remain responsible for Manufacturing Commercial supply for use in the Surface Territory until the earlier of (x) such time as the technology transfer is completed or (y) [***] If Novartis is willing transferred 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, the terms of supply of such Regional Antibody Candidates and Regional Licensed Products for use in Commercialization of such Regional Antibody Candidates and Regional Licensed Products in the Surface Territory will be set forth in the RLP Supply AgreementMGI at cost.

Appears in 1 contract

Sources: License Agreement (Mgi Pharma Inc)