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.

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.

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.

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.

Commercialization. Novartis (a) Teva and its Affiliates shall have be solely responsible for and shall possess the sole and exclusive right and authority 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 Commercialize all Collaboration Products in the Surface Territory, in accordance with the Marketing Plans, but except as otherwise provided in Section 3.5(c)(iv). Teva and its Affiliates shall use commercially reasonable efforts to Commercialize all Collaboration Products in the Territory, including taking, processing and fulfilling all orders for Collaboration Products in the Territory on a timely basis and in accordance with applicable industry standards. Teva shall also be solely responsible for, and shall communicate such determination by written notice to Surface no later than Initiation of the first Phase 3 Studyassess and address, all Collaboration Product quality control issues. If Novartis CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[Acorda receives any Collaboration Product Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [ ] and an asterisk***]”, have been separately filed with the Commission. 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 1933orders, AS AMENDEDit shall use reasonable efforts to forward such orders to Teva within one (1) Business Day after Acorda’s receipt thereof. notifies Surface Teva shall provide to the CSC written reports, in a format and on a schedule established by the CSC, summarizing the Commercialization activities undertaken by Teva (or its Affiliate) and the results thereof and any significant developments or results of such Commercialization. Teva shall consult with Acorda regarding its Commercialization efforts and methods and shall answer and seek to accommodate all reasonable questions and comments of Acorda. (b) All sales of Collaboration Products shall be recorded, invoiced and collected by Teva. All terms regarding Collaboration Product sales, including, without limitation, terms respecting credit, pricing, cash discounts, rebates, chargebacks, bad debt write-offs, and other fees, charges, returns and allowances shall be set by Teva in accordance with applicable guidelines established by the Marketing Committee. (c) Teva and its Affiliates shall use commercially reasonable efforts, consistent with good pharmaceutical industry practices, to ensure that it is willing to Manufacture Regional Antibody Candidates clinical trial supplies and Regional Licensed Collaboration Products for use are manufactured in Commercialization accordance with the then-current Good Manufacturing Practices, as specified by the applicable laws and regulations in the Surface Territory, and the relevant specifications as determined in writing by the Parties. Teva and its Affiliates shall use commercially reasonable efforts, consistent with good pharmaceutical industry practices, to conduct all manufacturing of Collaboration Products so that Teva can supply Collaboration Products in sufficient quantities to meet all accepted firm purchase orders for Collaboration Products in the Territory in accordance with the foregoingthen-current Marketing Plans, thenas determined by the Marketing Committee, Surface may elect, by written notice to Novartis no later than and which purchase orders do not exceed [***] after its receipt of such notice from Novartis whether to utilize Novartis for such Commercial Manufacturing the quantity of Collaboration Product that is in the Surface Territory relevant Forecast (as defined below). Not less than six (6) months prior to any Launch Date, and thereafter on or before the first day of September of each year, the Marketing Committee shall provide to retain Teva a Third Party contract manufacturer(sthree (3) year forecast, with an annual breakdown, of the anticipated Collaboration Product requirements (by quantity, NDC number and SKU) for such purposethe next succeeding three (3) calendar years. If either Novartis is not willing Furthermore, within ten (10) Business Days of the beginning of each calendar quarter, the Marketing Committee shall provide to provide such Commercial supply Teva a forecast of the anticipated Collaboration Product requirements (by quantity, NDC number and SKU) for the next four (4) calendar quarters on a quarterly basis, which quarterly forecasts will be the basis for firm orders to Teva. (Each three (3) year forecast and quarterly forecast, including allowances for Product Samples and Free Products, a “Novartis ElectionForecast.”) or Surface elects not The Parties shall use their diligent efforts to utilize Novartis for such Commercial supply (a “Surface Election”), then Novartis adjust to changes in any Forecast. Each Forecast 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 also specify Collaboration Product quantities required for use in the Surface Territory, provided that such Third Party contract manufacturer(sas Product Samples. (d) 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; If Teva and (b) Surface in the case of either its Affiliates (i) a Surface Election fail to manufacture and supply Collaboration Products in accordance with the provisions of Section 6.2(c), or (ii) any request for are otherwise unwilling or unable to manufacture Collaboration Products or experiencing difficulties with manufacturing Collaboration Products such that it may be unable to meet Collaboration Product requirements as provided under Section 6.2(c) (in either case, a second technology transfer“Supply Disruption”), whether in the case Teva shall provide prompt written notice of a Novartis Election or Surface Election; provided, however that Surface may not require of Novartis more than [***] such transfers for any Regional Licensed Productsituation to Acorda. FurtherTeva shall, in any event, use its reasonable commercial efforts to resolve any Supply Disruption and avoid any inability to supply the case of a Novartis Election, Novartis shall remain responsible market demands 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 Collaboration Products in the Surface Territory will be set forth in the RLP Supply AgreementTerritory, and shall keep Acorda fully informed of all such efforts.

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.

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.

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.

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.

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 [***]).

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.

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.

Commercialization. Novartis 5.1. TTY, at its own expense, will be responsible for all sales and marketing activities related to the Licensed Product in the Territory. 5.2. TTY agrees to use Commercially Reasonable Efforts to promote the sale, marketing, and distribution of, and otherwise commercialize and sell, the Licensed Product in the Territory for all indications that have received Governmental Approval. TTY shall have provide BDSI with quarterly written reports of TTY’s commercialization efforts and activities for such quarter and a description of its plans for future commercialization efforts and activities. In addition, TTY shall provide such other information, financial or otherwise, BDSI may reasonably request relating to the right marketing, sale or distribution of the Product. 5.3. Beginning on the date of First Commercial Sale, TTY shall use Commercially Reasonable Efforts to determine whether it is willing deploy its sales representatives to Manufacture Regional Antibody Candidates and Regional sell the Licensed Product in the Territory, who will target physicians reasonably identified by TTY as potentially high volume prescribing physicians for the Licensed Product. 5.4. No rights to the trademark ONSOLIS, BREAKYL, or any other trademarks, trade dress, or logos used with respect to the Licensed Product outside the Territory are granted to TTY under this Agreement, and, notwithstanding anything to the contrary, BDSI shall not be required to include any such trademark, trade dress or logo on any packaging or related materials concerning any Licensed Product supplied to TTY. Any trademark, logo, design and/or trade dress for the Licensed Products for use in Commercialization of such Regional Antibody Candidates and Regional Licensed Products used by TTY, its Affiliates, or Sublicensees in the Surface Territory and shall communicate such determination by be subject to BDSI’s prior 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 Novartisapproval, such approval not to be unreasonably withheld, conditioned comply with Applicable Laws, and not infringe or delayedmisappropriate the intellectual property rights of any Third Party. The cost of such technology transfer shall be borne Any trademark filing or registered by (a) Novartis TTY and/or logo, trade dress designed by TTY in the case of a Novartis Election; and (b) Surface in Territory shall solely belong to TTY, excluding any trademarks owned or used by BDSI any affiliate thereof, or the case licensee of either (i) a Surface Election or (ii) any request for a second technology transfer, whether in of the case foregoing prior to the Effective Date 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 this Agreement.

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.

Commercialization. Novartis 5.1.1 Subject to oversight by the JSC, Astellas shall have be responsible for: (a) launching and commercializing, and shall use Diligent Efforts to launch and commercialize, the right to determine whether it is willing to Manufacture Regional Antibody Candidates and Regional Licensed Products for use Product in Commercialization of such Regional Antibody Candidates and Regional Licensed Products each country in the Surface Territory in accordance with a commercialization plan submitted by Astellas to the JSC (“Commercialization Plan”); and (b) manufacturing, and shall communicate such determination by written notice use Diligent Efforts to Surface no later than Initiation manufacture, the Compound and Product necessary to support the launching and commercialization of the first Phase 3 StudyProduct in each country in the Territory in accordance with the Commercialization Plan. If Novartis Without limiting the foregoing, Astellas agrees to use Diligent Efforts to launch the Product as soon as practicable in the Territory, and thereafter to manufacture, market, promote and sell such Product and to maximize the Net Sales of the Product in the Territory. Astellas agrees to provide to the JSC updated versions of the Commercialization Plan at least annually, and any material modification or addition to the Commercialization Plan within a reasonable period of time prior to adoption and implementation thereof. Astellas shall keep XenoPort reasonably informed as to the progress of its launch, manufacturing and commercialization activities relating to the Product in the Territory, by way of updates to the JSC at its meetings and as otherwise reasonably requested by XenoPort. It is understood and agreed that, subject to oversight by the JSC, and consistent with the other provisions of this Agreement, all commercialization and manufacturing efforts for the Product in the Territory shall be at the sole discretion and expense of Astellas, its Affiliates or Subdistributors. 5.1.2 XenoPort or its licensee(s) shall be responsible for launching, manufacturing and commercializing the Product outside the Territory. XenoPort shall keep Astellas reasonably informed as to the progress of its and/or [… * …] its other licensees’ launch, manufacturing and commercialization activities relating to Product outside the Territory, by way of updates to the JSC at its meetings and as otherwise reasonably requested by Astellas but no more often than once annually other than at the JSC meeting. It is understood and agreed that all manufacturing and commercialization efforts for the Product outside the Territory shall be at the sole discretion and expense of XenoPort, its Affiliates or its other licensees. * CERTAIN CONFIDENTIAL PORTIONS OF INFORMATION CONTAINED IN THIS EXHIBIT WERE OMITTED AND REPLACED DOCUMENT, MARKED BY BRACKETS, IS FILED 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 24B-2 OF THE SECURITIES EXCHANGE ACT OF 19331934, 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.

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.

Commercialization. Novartis 5.1.1 Subject to oversight by the JSC, Astellas shall have be responsible for launching and commercializing, and shall use Diligent Efforts to launch and commercialize, the right to determine whether it is willing to Manufacture Regional Antibody Candidates and Regional Licensed Products for use Product in Commercialization of such Regional Antibody Candidates and Regional Licensed Products each country 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 a commercialization plan submitted by Astellas to the JSC (“Commercialization Plan”). Without limiting the foregoing, thenAstellas agrees to use Diligent Efforts to launch the Product as soon as practicable in the Territory, Surface may electand thereafter to market, promote and sell such Product and to maximize the Net Sales of the Product in the Territory. Astellas agrees to provide to the JSC updated versions of the Commercialization Plan at least annually, and any material modification or addition to the Commercialization Plan within a reasonable period of time prior to adoption and implementation thereof. Astellas shall keep XenoPort reasonably informed as to the progress of its launch and commercialization activities relating to the Product in the Territory, by written notice way of updates to Novartis no later than [***] after the JSC at its receipt meetings and as otherwise reasonably requested by XenoPort. It is understood and agreed that, subject to oversight by the JSC, and consistent with the other provisions of such notice from Novartis whether to utilize Novartis this Agreement, all commercialization efforts for such Commercial Manufacturing the Product in the Surface Territory shall be at the sole discretion and expense of Astellas, its Affiliates or Subdistributors. 5.1.2 XenoPort or its licensee(s) shall be responsible for launching and commercializing the Product outside the Territory. XenoPort shall keep Astellas reasonably informed as to retain a Third Party contract manufacturer(s) for such purpose. If either Novartis is not willing the progress of its and/or [... * ...] its other licensees’ launch and commercialization activities relating 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 Product outside the Surface Territory, provided by way of updates to the JSC at its meetings and as otherwise reasonably requested by Astellas but no more often than once annually other than at the JSC meeting. It is understood and agreed that such Third Party contract manufacturer(s) is approved all commercialization efforts for the Product outside * Certain confidential information contained in this document, marked by Novartisbrackets, such approval not has been omitted and filed separately with the Securities and Exchange Commission pursuant to be unreasonably withheldRule 24b-2 of the Securities Exchange Act of 1934, conditioned or delayedas amended. The cost of such technology transfer the Territory shall be borne by (a) Novartis in at the case sole discretion and expense of a Novartis Election; and (b) Surface in the case of either (i) a Surface Election XenoPort, its Affiliates 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 Agreementits other licensees.

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... * ...].

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]

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.

Commercialization. Novartis shall have 5.1. TTY, at its own expense, will be responsible for all sales and marketing activities related to 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 Product in the Surface Territory. 5.2. TTY agrees to use Commercially Reasonable Efforts to promote the sale, marketing, and distribution of, and otherwise commercialize and sell, the Licensed Product in the Territory for all indications that have received Governmental Approval. TTY shall provide BDSI with quarterly written reports of TTY’s commercialization efforts and activities for such quarter and a description of its plans for future commercialization efforts and activities. In addition, TTY shall communicate provide such determination by written notice other information, financial or otherwise, BDSI may reasonably request relating to Surface no later than Initiation the marketing, sale or distribution of the first Phase 3 StudyProduct. 5.3. If Novartis Beginning on the date of First Commercial Sale, TTY shall use Commercially Reasonable Efforts to deploy its sales representatives to sell the Licensed Product in the Territory, who will target physicians reasonably identified by TTY as potentially high volume prescribing physicians for the Licensed Product. 5.4. No rights to the trademark ONSOLIS, BREAKYL, or any other trademarks, trade dress, or logos used with respect to the Licensed Product outside the Territory are granted to TTY under this Agreement, and, notwithstanding anything to the contrary, BDSI shall not be required to CONFIDENTIAL TREATMENT REQUESTED WITH RESPECT TO CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED HEREOF DENOTED WITH “[***]”” include any such trademark, trade dress or logo on any packaging or related materials concerning any Licensed Product supplied to TTY. 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 trademark, AS AMENDED. notifies Surface that it is willing to Manufacture Regional Antibody Candidates and Regional logo, design and/or trade dress for the Licensed Products for use in Commercialization used by TTY, its Affiliates, or Sublicensees in the Surface Territory in accordance with the foregoing, then, Surface may elect, by shall be subject to BDSI’s prior 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 Novartisapproval, such approval not to be unreasonably withheld, conditioned comply with Applicable Laws, and not infringe or delayedmisappropriate the intellectual property rights of any Third Party. The cost of such technology transfer shall be borne Any trademark filing or registered by (a) Novartis TTY and/or logo, trade dress designed by TTY in the case of a Novartis Election; and (b) Surface in Territory shall solely belong to TTY, excluding any trademarks owned or used by BDSI any affiliate thereof, or the case licensee of either (i) a Surface Election or (ii) any request for a second technology transfer, whether in of the case foregoing prior to the Effective Date 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 this Agreement.

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.

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.

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.