Common use of Commercialization Plan Clause in Contracts

Commercialization Plan. (a) No later than [ * ] prior to the anticipated filing of an application for Regulatory Approval for a Product in the U.S., Endo shall deliver to the JSC a draft written commercialization plan setting forth anticipated material commercialization activities to be performed with respect to such Product in the U.S. by Endo or on its behalf, as well as projected timelines for such activities (the “Commercialization Plan”). The JSC shall promptly review such draft initial Commercialization Plan and may provide commercially reasonable comments to Endo for its consideration. Endo shall give good faith consideration to such comments and may revise such draft Commercialization Plan to implement such of the JSC’s comments that it shall deem necessary or advisable to include in the draft. Endo shall, thereafter, submit the Commercialization Plan with such changes, revisions and modifications that it shall deem advisable to the JSC, and the Commercialization Plan, together with such changes, revisions and modifications, as applicable, shall be deemed final. (b) No later than [ * ] prior to the anticipated launch of a Product in the U.S., Endo shall update the Commercialization Plan, and shall thereafter update the Commercialization Plan on an annual basis as follows: Endo shall provide the JSC with a draft update to the Commercialization Plan no later than December 1 of each year. Endo shall give good faith consideration to any comments provided by the JSC and may revise such Commercialization Plan to implement such of the JSC’s comments that it shall deem necessary or advisable to include in the Commercialization Plan, after which the update to the Commercialization Plan shall be deemed to be finalized. Endo shall deliver a final version of the updated Commercialization Plan no later than January 31 of the following year. (c) The Commercialization Plan shall include a marketing plan for the Product for which Regulatory Approval is being sought or obtained in the U.S. that includes plans related to the anticipated promotion and sale of such Product in the U.S., competitive analysis, including information regarding actions intended to mitigate competitive threats, a non-binding sales forecast for the following year and the marketing, promotion and advertising campaigns proposed to be conducted, including the number of detailing representatives, level of promotion and Endo’s medical education activities.

Commercialization Plan. (a) No later than [ * ] prior ], subject to Sections 9.3(d) and 9.3(e), Astellas shall prepare and provide to the anticipated filing JCC for review and discussion a written plan for the Commercialization of an application for Regulatory Approval for a such Collaboration Product in the U.S., Endo shall deliver to the JSC a draft written commercialization plan setting forth anticipated material commercialization activities to be performed with respect to such Product in the U.S. by Endo or on its behalf, as well as projected timelines for such activities an Astellas’ fiscal year (the “Commercialization Plan”). The JSC Commercialization Plan shall promptly review include a reasonably detailed description of and anticipated timeline for the Parties’, their respective Affiliates’ and sublicensees’ Commercialization activities with respect to such draft initial Collaboration Product, including pre-launch plans, launch plans, market analytics, product forecasts, pricing assumptions and competitive intelligence. It is the Parties’ understanding that, [ * ] Astellas will be the Party primarily responsible for the conduct of the Commercialization activities under the Commercialization Plan. Each Party shall use Diligent Efforts to [ * ] of the collaboration under the Commercialization Plan (including [ * ]). The Parties agree that the Commercialization Plan and may provide commercially reasonable comments to Endo for its consideration. Endo shall give good faith consideration to such comments and may revise such draft the applicable Commercialization Plan to implement such of the JSC’s comments that it shall deem necessary or advisable to include in the draft. Endo shall, thereafter, submit the Commercialization Plan with such changes, revisions and modifications that it shall deem advisable to the JSC, and the Commercialization Plan, together with such changes, revisions and modifications, as applicable, strategy shall be deemed finalconsistent. (b) No later than [ * ] prior to the anticipated launch of If Cytokinetics exercises its Co-Promotion option for a Product in the U.S.Collaboration Product, Endo shall update the Commercialization Plan, and shall thereafter update the Commercialization Plan on an annual basis as follows: Endo shall provide the JSC with a draft update to the Commercialization Plan no later than December 1 of each year. Endo shall give good faith consideration to any comments provided by the JSC and may revise such Commercialization Plan to implement such of the JSC’s comments that it shall deem necessary or advisable to include in the Commercialization Plan, after which the update to the Commercialization Plan shall also include a reasonably detailed description of and anticipated timeline for Cytokinetics’ Co-Promotion activities as well as a budget therefor, which shall be deemed to be finalized. Endo shall deliver a final version of the updated Commercialization Plan no later than January 31 of the following yearconsistent with Section 9.6 below. (c) Subject to Sections 9.3(d) and 9.3(e)(ii), Astellas shall periodically (at least on an annual basis) prepare updates and amendments to its Commercialization Plan to reflect changes in its plans, including in response to changes in the marketplaces and related product forecasts, relative success of the Collaboration Products and other relevant factors influencing such plans and activities. Subject to Sections 9.3(d) and 9.3(e)(ii), Astellas shall submit all updates and amendments to its Commercialization Plan to the JCC for review and discussion. For clarity, the Commercialization budget is subject to the final determination by the JCC, subject to [ * ], subject to Section 9.8. Cytokinetics may perform [ * ] activities within the scope of its responsibilities under the Commercialization Plan, [ * ]. (d) The Commercialization Plan (and any amendment thereto) for any Collaboration Product (i) for a [ * ] Indication, (ii) for [ * ] Indication for which Cytokinetics exercises the Cytokinetics Co-Funding Option [ * ], and (iii) subject to Section 9.3(e) and Section 9.8, for [ * ] Indication, must be agreed by the JCC by [ * ]. Neither Party shall include conduct any Commercialization activities that are inconsistent with such agreed-upon Commercialization Plan and any Co-Promotion Agreement. (e) With respect to the Commercialization of a marketing plan Collaboration Product in [ * ] Indication, subject to Section 9.8, then: (i) If Cytokinetics has an Established Commercial Infrastructure, Cytokinetics shall have [ * ] for the Commercialization strategy for such Collaboration Product for which Regulatory Approval is being sought or obtained such Indication in the U.S. that includes plans related Shared Territory (but not for the Commercialization strategies with respect to such Collaboration Product as a whole), provided however, such Commercialization strategy and the overall Commercialization Plan shall be consistent. [ * ] = Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) would likely cause competitive harm if publicly disclosed. (ii) Regardless of [ * ] as relates to the anticipated promotion portions of the Commercialization Plan for such Collaboration Product that are specific to such Indication for the Shared Territory, as well as any update and/or amendment thereof. The Commercialization strategy with respect to [ * ] Indications includes the following [ * ]. (iii) [ * ] the Shared Territory and sale of the [ * ] Astellas and Cytokinetics as well as the [ * ] such Collaboration Product for such Indication, subject to the discussion and final determination by the JCC, taking into account [ * ]. (iv) Notwithstanding anything to the contrary, the [ * ] for such Collaboration Product in such Indication in a particular country will have the U.S.decision making authority with respect [ * ] and other terms of sale for such Collaboration Product in such Indication for such country, competitive analysisprovided that the other Party may conduct, including information regarding actions intended to mitigate competitive threats[ * ]. (v) If [ * ] the Collaboration Product(s) in such [ * ] Indication, a non-binding sales forecast but the Parties have not determined which Party will [ * ] for the following year Collaboration Product(s) in such [ * ] Indication under Section 9.8(b), then [ * ] shall be responsible for the pre-commercialization activities for the Collaboration Product in such [ * ] Indication. (f) Subject to Section 9.3(c), Astellas shall be solely responsible for all costs incurred by or on behalf of either Party in performing their respective obligations under the Commercialization Plan except [ * ] (or [ * ] determined by the JCC), which shall be agreed between the Parties acting reasonably and in good faith [ * ], for its Co-Promotion activities as set forth in the marketing, promotion and advertising campaigns proposed to be conducted, including the number of detailing representatives, level of promotion and Endo’s medical education activitiesCo-Promotion Agreement.

Commercialization Plan. (a) No later than [ * ] prior to Partner shall be responsible for the anticipated filing creation and implementation of an application annual plan and budget for Regulatory Approval for a Product the commercialization of Products in the U.S., Endo shall deliver to the JSC a draft written commercialization plan setting forth anticipated material commercialization activities to be performed with respect to such Product Field in the U.S. by Endo or on its behalfTerritory, which will include any Post Marketing Studies (as well as projected timelines for such activities defined below) of Products in the Field in the Territory (the “Commercialization Plan”). The JSC shall promptly review such draft initial , which Commercialization Plan shall include, without limitation, identification of, and may provide commercially reasonable comments proposed plans to Endo for its consideration. Endo shall give good faith consideration address, potential challenges with respect to such comments and may revise such draft Commercialization Plan to implement such commercialization of the JSC’s comments that it shall deem necessary or advisable to include Products in the draft. Endo shall, thereafter, submit the Commercialization Plan with such changes, revisions and modifications that it shall deem advisable to the JSC, and the Commercialization Plan, together with such changes, revisions and modifications, as applicable, shall be deemed final. (b) No later than [ * ] prior to the anticipated launch of a Product Field in the U.S., Endo Territory. Partner shall update prepare and submit to Optimer the Commercialization Plan, and shall thereafter update the Commercialization Plan on an annual basis as follows: Endo shall provide the JSC with a draft update to the initial Commercialization Plan no later than December 1 […***…] after the first submission of a MAA for Product in the Territory for review and discussion through the JSC. Subsequent updated Commercialization Plans shall be submitted by Partner to Optimer on an annual basis on or before the end of February each yearCalendar Year for review and discussion through the JSC. Endo Through the JSC, Partner shall give regularly consult with and provide updates to Optimer regarding the commercialization strategy and the commercialization of Products in the Field in the Territory. Partner shall consider in good faith consideration to any comments provided by the JSC Optimer’s input regarding such commercialization strategy and may revise such Commercialization Plan to implement such of the JSC’s comments that it shall deem necessary or advisable to include in the Commercialization Plan; provided, after which the update however, that Partner shall have final decision-making authority with respect to the Commercialization Plan shall be deemed to be finalized. Endo shall deliver a final version commercialization of the updated Commercialization Plan no later than January 31 of the following year. (c) The Commercialization Plan shall include a marketing plan for the Product for which Regulatory Approval is being sought or obtained Products in the U.S. Field in the Territory, including the right to set the terms of sales and book all sales of Products in the Field in the Territory, subject to Section 5.1(c) below. Partner shall provide Optimer with access to KOLs as may reasonably be requested by Optimer, where “KOLs” means all healthcare providers in the Territory that includes plans related have administered a Product in clinical trials, have published academic articles relating to a Product, or are otherwise regarded by Partner, its Affiliates and Sublicensees, as the anticipated promotion and sale of such case may be, as a key opinion leader for a Product in the U.S.Territory. Optimer shall provide Partner with access to KOLs as may reasonably be requested by Partner, competitive analysiswhere “KOLs” means all healthcare providers outside the Territory and ▇▇▇▇ Territory that have administered a Product in clinical trials, including information regarding actions intended have published academic articles relating to mitigate competitive threatsa Product, or are otherwise regarded by Optimer, its Affiliates and Sublicensees, as the case may be, as a non-binding sales forecast key opinion leader for a Product outside the following year Territory and the marketing, promotion and advertising campaigns proposed to be conducted, including the number of detailing representatives, level of promotion and Endo’s medical education activities▇▇▇▇ Territory.

Commercialization Plan. (a) No later than [ * ] prior to The JCC shall develop and approve a rolling multi-year plan and budget for commercializing the Product (the "Commercialization Plan"). The Commercialization Plan shall include a comprehensive market development, marketing, sales, supply and distribution strategy, including an overall budget for anticipated filing of an application for Regulatory Approval for a Product marketing, promotion and sales efforts in the U.S.calendar year. The Commercialization Plan will specify which Target Populations and distribution channels each Party shall devote its Co-Promotion efforts towards, Endo shall deliver the personnel and other resources to be devoted by each Party to such efforts, the JSC a draft written commercialization plan setting forth anticipated material commercialization activities number and positioning of details to be performed with respect to such Product in the U.S. by Endo or on its behalfeach Party, as well as projected timelines market and sales forecasts and related operating expenses, for such activities (the “Commercialization Plan”). The JSC shall promptly review such draft initial Commercialization Plan and may provide commercially reasonable comments to Endo for its consideration. Endo shall give good faith consideration to such comments and may revise such draft Commercialization Plan to implement such of the JSC’s comments that it shall deem necessary or advisable to include Product in the draft. Endo shall, thereafter, submit the Commercialization Plan with such changes, revisions and modifications that it shall deem advisable to the JSCTerritory, and budgets for projected Commercialization Expenses and Sales and Marketing Expenses. In preparing the Commercialization Plan, together with the JCC will take into consideration factors such changesas market conditions, revisions regulatory issues and modifications, as applicable, shall be deemed finalcompetition. The Commercialization Plan will include the general strategy and operating guidelines for the commercialization of the Product. (b) No later than [ * ] prior It is the intention of the Parties that Aviron's sales and marketing organization shall concentrate on a specific market segment or segments, to be agreed upon by the JCC, and that Aviron's marketing efforts shall include the development of an electronic-based selling infrastructure to support sales of the Product. It is also the intention of the Parties that, assuming regulatory approval therefor, Wyeth-Ayerst shall focus its initial sales and marketing efforts of the Product to the anticipated launch of a healthy pediatric Target Population, giving the Product first detail position for the Flu Season in which occurs the Launch Date. Further, the Parties intend that, if the Product is approved in the U.S.Field in the Territory for the adult Target Population, Endo shall update the Commercialization Plan, and shall thereafter update the Commercialization Plan on an annual basis as follows: Endo then Wyeth-Ayerst shall provide (including hiring, if necessary) sufficient personnel in its sales and marketing organization to market and sell the JSC with a draft update Product to the Commercialization Plan no later than December 1 of each year. Endo shall give good faith consideration to any comments provided by the JSC and may revise such Commercialization Plan to implement such of the JSC’s comments that it shall deem necessary or advisable to include in the Commercialization Plan, after which the update to the Commercialization Plan shall be deemed to be finalized. Endo shall deliver a final version of the updated Commercialization Plan no later than January 31 of the following yearadult Target Population. (c) The first Commercialization Plan shall include a marketing plan for be prepared and approved as promptly as possible after the Product for which Regulatory Approval is being sought or obtained Effective Date and shall thereafter be immediately in effect. Annually thereafter, the U.S. that includes plans related to JCC shall update and amend the anticipated promotion and sale of Commercialization Plan with such Product in process as the U.S., competitive analysis, including information regarding actions intended to mitigate competitive threats, a non-binding sales forecast for the following year and the marketing, promotion and advertising campaigns proposed to be conducted, including the number of detailing representatives, level of promotion and Endo’s medical education activitiesJCC shall determine. [***] = CONFIDENTIAL TREATMENT REQUESTED.

Commercialization Plan. (a) No later than [ * ] prior [*], subject to Sections 9.3(d) and 9.3(e), Astellas shall prepare and provide to the anticipated filing JCC for review and discussion a written plan for the Commercialization of an application for Regulatory Approval for a such Collaboration Product in the U.S., Endo shall deliver to the JSC a draft written commercialization plan setting forth anticipated material commercialization activities to be performed with respect to such Product in the U.S. by Endo or on its behalf, as well as projected timelines for such activities an Astellas’ fiscal year (the “Commercialization Plan”). The JSC Commercialization Plan shall promptly review include a reasonably detailed description of and anticipated timeline for the Parties’, their respective Affiliates’ and sublicensees’ Commercialization activities with respect to such draft initial Collaboration Product, including pre-launch plans, launch plans, market analytics, product forecasts, pricing assumptions and competitive intelligence. It is the Parties’ understanding that, [*] Astellas will be the Party primarily responsible for the conduct of the Commercialization activities under the Commercialization Plan. Each Party shall use Diligent Efforts to [*] of the collaboration under the Commercialization Plan (including [*]). The Parties agree that the Commercialization Plan and may provide commercially reasonable comments to Endo for its consideration. Endo shall give good faith consideration to such comments and may revise such draft the applicable Commercialization Plan to implement such of the JSC’s comments that it shall deem necessary or advisable to include in the draft. Endo shall, thereafter, submit the Commercialization Plan with such changes, revisions and modifications that it shall deem advisable to the JSC, and the Commercialization Plan, together with such changes, revisions and modifications, as applicable, strategy shall be deemed finalconsistent. (b) No later than [ * ] prior to the anticipated launch of If Cytokinetics exercises its Co-Promotion option for a Product in the U.S.Collaboration Product, Endo shall update the Commercialization Plan, and shall thereafter update the Commercialization Plan on an annual basis as follows: Endo shall provide the JSC with a draft update to the Commercialization Plan no later than December 1 of each year. Endo shall give good faith consideration to any comments provided by the JSC and may revise such Commercialization Plan to implement such of the JSC’s comments that it shall deem necessary or advisable to include in the Commercialization Plan, after which the update to the Commercialization Plan shall also include a reasonably detailed description of and anticipated timeline for Cytokinetics’ Co-Promotion activities as well as a budget therefor, which shall be deemed to be finalized. Endo shall deliver a final version of the updated Commercialization Plan no later than January 31 of the following yearconsistent with Section 9.6 below. (c) Subject to Sections 9.3(d) and 9.3(e)(ii), Astellas shall periodically (at least on an annual basis) prepare updates and amendments to its Commercialization Plan to reflect changes in its plans, including in response to changes in the marketplaces and related product forecasts, relative success of the Collaboration Products and other relevant factors influencing such plans and activities. Subject to Sections 9.3(d) and 9.3(e)(ii), Astellas shall submit all updates and amendments to its Commercialization Plan to the JCC for review and discussion. For clarity, the Commercialization budget is subject to the final determination by the JCC, subject to [*], subject to Section 9.8. Cytokinetics may perform [*] activities within the scope of its responsibilities under the Commercialization Plan, [*]. (d) The Commercialization Plan (and any amendment thereto) for any Collaboration Product (i) for a [*] Indication, (ii) for [*] Indication for which Cytokinetics exercises the Cytokinetics Co-Funding Option [*], and (iii) subject to Section 9.3(e) and Section 9.8, for [*] Indication, must be agreed by the JCC by [*]. Neither Party shall include conduct any Commercialization activities that are inconsistent with such agreed-upon Commercialization Plan and any Co-Promotion Agreement. (e) With respect to the Commercialization of a marketing plan Collaboration Product in [*] Indication, subject to Section 9.8, then: (i) If Cytokinetics has an Established Commercial Infrastructure, Cytokinetics shall have [*] for the Commercialization strategy for such Collaboration Product for which Regulatory Approval is being sought or obtained such Indication in the U.S. that includes plans related Shared Territory (but not for the Commercialization strategies with respect to such Collaboration Product as a whole), provided however, such Commercialization strategy and the overall Commercialization Plan shall be consistent. (ii) Regardless of [*] as relates to the anticipated promotion portions of the Commercialization Plan for such Collaboration Product that are specific to such Indication for the Shared Territory, as well as any update and/or amendment thereof. The Commercialization strategy with respect to [*] Indications includes the following [*]. (iii) [*] the Shared Territory and sale of the [*] Astellas and Cytokinetics as well as the [*] such Collaboration Product for such Indication, subject to the discussion and final determination by the JCC, taking into account [*]. (iv) Notwithstanding anything to the contrary, the [*] for such Collaboration Product in such Indication in a particular country will have the U.S.decision making authority with respect [*] and other terms of sale for such Collaboration Product in such Indication for such country, competitive analysisprovided that the other Party may conduct, including information regarding actions intended to mitigate competitive threats[*]. (v) If [*] the Collaboration Product(s) in such [*] Indication, a non-binding sales forecast but the Parties have not determined which Party will [*] for the following year Collaboration Product(s) in such [*] Indication under Section 9.8(b), then [*] shall be responsible for the pre-commercialization activities for the Collaboration Product in such [*] Indication. (f) Subject to Section 9.3(c), Astellas shall be solely responsible for all costs incurred by or on behalf of either Party in performing their respective obligations under the Commercialization Plan except [*] (or [*] determined by the JCC), which shall be agreed between the Parties acting reasonably and in good faith and [*], for its Co-Promotion activities as set forth in the marketing, promotion and advertising campaigns proposed to be conducted, including the number of detailing representatives, level of promotion and Endo’s medical education activitiesCo-Promotion Agreement.

Commercialization Plan. (a) No later than [ * ] prior Agendia shall use Commercially Reasonable Efforts to the anticipated filing of an application for Regulatory Approval for a Product Commercialize CMPBP in the U.S., Endo shall deliver Territory pursuant to a plan approved by the JSC a draft written commercialization plan setting forth anticipated material commercialization activities to be performed in accordance with respect to such Product in the U.S. by Endo or on its behalf, as well as projected timelines for such activities Section 3.6 (the “Commercialization Plan”). The JSC Such plan shall promptly review such draft initial include: (i) a reasonably detailed description of the key elements of its Commercialization Plan strategy (including messaging, branding, marketing, advertising, sales force positioning, and may provide pricing); and (ii) a reasonably detailed description and commercially reasonable comments to Endo for timeline of its consideration. Endo shall give good faith consideration to such comments and may revise such draft Commercialization Plan to implement such of the JSC’s comments that it shall deem necessary or advisable to include in the draft. Endo shallimplementation tactics (including sales force training, thereafterpromotional activities, submit the Commercialization Plan with such changes, revisions and modifications that it shall deem advisable to the JSCdistribution channels, and customer service) for such Commercialization strategy for the Commercialization Plan, together with such changes, revisions and modifications, as applicable, shall be deemed finalnext Annual Period. (b) No later than [ * ] prior to the anticipated launch of a Product in the U.S., Endo shall update In connection with the Commercialization Plan, the Parties agree and shall thereafter update the Commercialization Plan on an annual basis acknowledge as follows: Endo : (i) Agendia shall provide be solely responsible [***]for specific aspects of the JSC commercial strategy for CMPBP including positioning and messaging, publications, generation of marketing materials, pricing and payor contracts, Third Party non-provider relationships (including but not limited to pharmaceutical companies), and distributor selection. (ii) Agendia shall also be solely responsible [***]for the commercial strategy for CMPBP including geographic market selection, target market segments and accounts, marketing and publicity. Agendia shall collaborate with a draft update Paige [***]in other aspects of commercial operations such as account-level engagement, contracting with clinical providers, and service and support for ordering physicians. (iii) If and when the Parties elect to expand the Commercialization Plan no later than December 1 sale and distribution of each yearCMPBP [***], Agendia and Paige shall be jointly responsible for specific aspects of the commercial strategy for CMPBP including geographic market selection, regulatory jurisdictions, regulatory strategy, target market segments, account-level strategy, contracting with clinical providers, marketing and publicity. Endo shall give good faith consideration to any comments provided Within the geographies that may be selected by the JSC and may revise such Commercialization Plan to implement such for commercialization outside of the JSC’s comments initial Territory, as of the Effective Date of this Agreement, Paige shall have a non-exclusive right to distribute CMPBP directly to Third Parties via the Paige Platform. Notwithstanding the foregoing, if either Party determines that it shall deem necessary is not commercially reasonable for such Party to sell or advisable distribute CMPBP in a proposed country or territory, that Party will notify the other Party in writing, and the Parties agree that such Party will not be in material breach of this Agreement for being unable to include sell or distribute such CMPBP in the Commercialization Plan, after which the update to the Commercialization Plan shall be deemed to be finalized. Endo shall deliver a final version of the updated Commercialization Plan no later than January 31 of the following yearproposed country or territory. (c) The [***]before the anticipated date of the First Commercial Sale hereunder, Agendia shall prepare and present to the JSC the initial Commercialization Plan for such CMPBP. Following such presentation, Agendia will consider the JSC’s comments regarding the Commercialization Plan and adopt them as Agendia determines in its sole discretion. (d) Prior to any commercial CMPBP launch and/or the filing with any Governmental Authority, as part of the Commercialization strategy, the Parties shall include enter into a marketing plan quality agreement in connection with CMPBP and in accordance with the applicable Laws, including but not limited to the International Standards Organization (“ISO”), the In Vitro Diagnostic Medical Device Regulation (“IVDR”) and the U.S. FDA. (e) [***], Agendia shall prepare updates and amendments, as appropriate, to the then-current Commercialization Plan and present such updates and amendments to the JSC. Any material amendments to the Commercialization Plan (including any acceleration of the First Commercial Sale date for CMPBP, any changes to Product Trademarks, or other material changes) must be approved by the JSC in accordance with Section 3.6. Upon such approval, each amended Commercialization Plan will be effective and supersede the previous Commercialization Plan as of the date of such approval. (f) For clarity, Agendia has full control and decision-making authority for the Product for which Regulatory Approval is being sought or obtained day-to-day conduct of activities implementing the Commercialization Plan [***], unless expressly reserved in the U.S. that includes plans related to the anticipated promotion and sale of such Product in the U.S., competitive analysis, including information regarding actions intended to mitigate competitive threats, a non-binding sales forecast this Agreement for the following year JSC’s determination or approval; provided that all such decisions must be consistent with the Collaboration’s purpose and objectives, the marketingterms and conditions of this Agreement, promotion and advertising campaigns proposed to be conducted, including the number of detailing representatives, level of promotion and Endo’s medical education activitiesapplicable Law.

Commercialization Plan. The JCC will oversee the Commercialization of Products in the Field in the Territory. A designated Party or its relevant Affiliate shall be the lead Commercializing Party for Products in the Field in the Territory (a) the “Lead Commercialization Party”)2. The Lead Commercialization Party shall be agreed to by the Parties after holding good faith discussions regarding which Party is best positioned to serve in the function during the negotiation of the Joint Development & Commercialization Agreement as set forth in Section 4.1.1 of the Research Collaboration Agreement. No later than [ * ] twelve months prior to the anticipated filing of an application for Regulatory Approval for a Product in the U.S., Endo shall deliver to the JSC a draft written commercialization plan setting forth anticipated material commercialization activities to be performed with respect to such Product in the U.S. by Endo or on its behalf, as well as projected timelines for such activities (the “Commercialization Plan”). The JSC shall promptly review such draft initial Commercialization Plan and may provide commercially reasonable comments to Endo for its consideration. Endo shall give good faith consideration to such comments and may revise such draft Commercialization Plan to implement such of the JSC’s comments that it shall deem necessary or advisable to include in the draft. Endo shall, thereafter, submit the Commercialization Plan with such changes, revisions and modifications that it shall deem advisable to the JSC, and the Commercialization Plan, together with such changes, revisions and modifications, as applicable, shall be deemed final. (b) No later than [ * ] prior to the anticipated first commercial launch of a Product in the U.S.first country in the Territory, Endo shall update the JCC, will develop and submit to the JSC for approval, a Commercialization plan (as may be amended, the “Commercialization Plan”) that sets forth the Commercialization Planactivities to be undertaken by the Parties with respect to the Commercialization of such Product in the Field in the Territory. In allocating responsibilities between the Parties, the JCC will take into consideration each Party’s expertise, capabilities, staffing and shall thereafter available resources to take on such activities. The Commercialization Plan may include activities on a region-by-region or country-by-country basis, as determined by the JCC. The JCC will update the Commercialization Plan on an annual basis (or more frequently as follows: Endo shall provide needed) and submit it to the JSC for approval. The Commercialization Plan will include (a) the Global Branding Strategy, (b) a marketing strategy, (c) a communications strategy that includes plans for public relations, conferences and exhibitions and other external meetings, internal meetings and communications, publications and symposia, internet activities and core brand package, (d) a high level operating plan for the implementation of such strategies on an annual basis, including information related to Product positioning, core messages to be communicated and pricing strategies, (e) a detailing strategy, (f) a pricing strategy, (g) all other material activities to be conducted in connection with the Commercialization of the Product in the Field in the Territory and (h) a draft update to budget for activities conducted under the Commercialization Plan no later than December 1 of each year. Endo shall give good faith consideration to any comments provided by (the JSC and may revise such “Commercialization Plan to implement such of the JSC’s comments that it shall deem necessary or advisable to include in the Commercialization Plan, after which the update to the Commercialization Plan shall be deemed to be finalized. Endo shall deliver a final version of the updated Commercialization Plan no later than January 31 of the following yearBudget”). (c) The Commercialization Plan shall include a marketing plan for the Product for which Regulatory Approval is being sought or obtained in the U.S. that includes plans related to the anticipated promotion and sale of such Product in the U.S., competitive analysis, including information regarding actions intended to mitigate competitive threats, a non-binding sales forecast for the following year and the marketing, promotion and advertising campaigns proposed to be conducted, including the number of detailing representatives, level of promotion and Endo’s medical education activities.

Commercialization Plan. (a) No later than [ * ] prior to Without limiting the anticipated filing generality of an application Auxilium’s sole responsibility and decision-making authority for Regulatory Approval for a Commercializing the Product in the U.S.Field in the Auxilium Territory as set forth in Section 4.2, Endo shall deliver Auxilium will use its Commercially Reasonable Efforts to carry out the JSC Commercialization of the Product in accordance with a draft written commercialization plan setting forth Commercialization Plan, as such may be amended or revised by Auxilium from time to time, that describes the anticipated material commercialization Commercialization activities to be performed with respect to such Product in the U.S. Auxilium Territory by Endo Auxilium or on its behalf, as well as projected timelines for such activities behalf by permitted Third Parties (the “Commercialization Plan”). The JSC shall promptly review such draft initial Each Commercialization Plan and may provide commercially shall address, in reasonable comments to Endo for its consideration. Endo shall give good faith consideration to such comments and may revise such draft Commercialization Plan to implement such of the JSC’s comments that it shall deem necessary or advisable to include in the draft. Endo shalldetail, thereafter, submit the Commercialization Plan with such changes, revisions and modifications that it shall deem advisable to the JSCextent applicable, call plans for Detailing of Product, Sales Force training, Product sampling strategies and quantities, Product positioning and scientific communication strategy, and the Commercialization Plan, together with such changes, revisions DTC and modifications, as applicable, shall be deemed finalnon-DTC advertising. (b) No later than [ * ] prior Attached hereto as Exhibit A is a Commercialization Plan covering activities to the anticipated launch be conducted in preparation of a Product Launch in the U.S., Endo shall update Auxilium Territory and during the Commercialization Plan, and first full calendar year following the Product Launch. (c) Auxilium shall thereafter update the Commercialization Plan (together with the Medical Affairs Plan described in Section 4.7) on an annual basis as follows: Endo Auxilium shall provide the JSC with a draft update to preliminary drafts of the Commercialization Plan and Medical Affairs Plan no later than December 1 [**] of each year for the JSC’s review and comment and Auxilium shall provide the JSC with the final Commercialization Plan and Medical Affairs Plan no later than [**] of the year immediately following such year. Endo In preparing the updated versions of the Commercialization Plan and Medical Affairs Plan, Auxilium shall analyze the effectiveness of the elements of the prior year Commercialization Plan and Medical Affairs Plan and shall use updated sales forecasts to develop the new Commercialization Plan. Auxilium agrees to give good faith due consideration to any comments the input provided by the JSC but Auxilium at all times will retain responsibility and may revise such decision-making authority for the Commercialization Plan to implement such of the JSC’s comments that it shall deem necessary or advisable to include Product in the Commercialization Plan** CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND WILL BE FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO A CONFIDENTIAL TREATMENT REQUEST. Field in the Auxilium Territory. Auxilium may, after which the at its election, update to the Commercialization Plan shall be deemed to be finalized. Endo shall deliver a final version of the updated Commercialization and Medical Affairs Plan no later than January 31 of the between annual updates by following yearthis same procedure. (cd) The Each Party shall use Commercially Reasonable Efforts in performing its obligations under this Section 4.3 concerning (as applicable) the Commercialization Plan and Medical Affairs Plan. (e) In the event of any inconsistency between, on the one hand, the Commercialization Plan or Medical Affairs Plan and, on the other hand, this Agreement, the terms of this Agreement shall include a marketing plan for the Product for which Regulatory Approval is being sought or obtained in the U.S. that includes plans related to the anticipated promotion and sale of such Product in the U.S., competitive analysis, including information regarding actions intended to mitigate competitive threats, a non-binding sales forecast for the following year and the marketing, promotion and advertising campaigns proposed to be conducted, including the number of detailing representatives, level of promotion and Endo’s medical education activitiesprevail.

Commercialization Plan. (a) No later than [ * At least [***] prior to before the anticipated filing First Commercial Sale of an application for Regulatory Approval for a the Product in the U.S.Field in a country in the Territory, Endo shall deliver to MTPC will provide a strategic commercialization plan for the Products in the Field in the Territory for review and approval by the JSC a draft written commercialization plan setting forth anticipated material commercialization activities to be performed with respect to (any such Product in the U.S. by Endo or on its behalfapproved plan, as well as projected timelines for such activities (the “Commercialization Plan”). The JSC shall promptly review such draft initial Commercialization Plan will set forth, among other things, (a) [***] marketing strategy that includes plans for market research, health economics, pricing and may provide commercially reasonable comments to Endo for its consideration. Endo shall give good faith consideration to such comments reimbursement, medical affairs and may revise such draft Commercialization Plan to implement such of the JSC’s comments that it shall deem necessary or advisable to include in the draft. Endo shall, thereafter, submit the Commercialization Plan with such changes, revisions and modifications that it shall deem advisable to the JSC, and the Commercialization Plan, together with such changes, revisions and modifications, as applicable, shall be deemed final. value added initiatives; (b) No later than [ * [***] prior communications strategy that includes plans for public relations, conferences and exhibitions and other external meetings and communications, publications and symposia, and internet activities; (c) a high level operating plan for the implementation of such strategies on [***] basis, including, without limitation, information related to the anticipated launch of a Product product positioning, core messages to be communicated, and pricing strategies; (d) revenue targets and unit forecasts, planned for Products in the U.S., Endo shall update Territory and the timelines for achieving such activities; and (e) all other activities to be conducted by MTPC in connection with the Commercialization Planof Products in the Territory. During the Term, and shall thereafter update MTPC will amend the Commercialization Plan on an annual ongoing basis as follows: Endo shall provide necessary, any amendments (other than amendments required to comply with Applicable Laws or written requirements imposed by Regulatory Authorities) being subject to review and approval by the JSC JSC, and any amendments required to comply with a draft update Applicable Laws or written requirements imposed by Regulatory Authorities being subject to report to the Commercialization Plan no later than December 1 of each yearJSC. Endo shall give good faith consideration to any comments provided by the JSC and may revise such Commercialization Plan to implement such of the JSC’s comments that it shall deem necessary or advisable to include in the Commercialization Plan, after which the update to the Commercialization Plan shall be deemed to be finalized. Endo shall deliver a final version of the updated Commercialization Plan no later than January 31 of the following year. (c) The Commercialization Plan shall include a marketing plan for must at all times contain terms that reflect the Product for which use of Commercially Reasonable Efforts to Commercialize all Products that have Regulatory Approval is being sought or obtained in the U.S. that includes plans related Territory and, except as otherwise expressly allocated to the anticipated promotion and sale of such Product Viela in the U.S., competitive analysisthis Agreement, including information regarding actions intended to mitigate competitive threatsin Section 4.6.3 (Commercialization Cooperation), a non-binding sales forecast for the following year and the marketing, promotion and advertising campaigns proposed may not include any activities to be conductedconducted by Viela, including the number of detailing representativeswithout Viela’s prior consent, level of promotion and Endo’s medical education activitieswhich shall not be unreasonably withheld.

Commercialization Plan. As further described in this section 7.4, the strategy for the commercial launch of, and subsequent Commercialization of, each Joint Product in each Commercialization Territory shall be described in a comprehensive plan (each such plan, and any revisions thereto, a “ Commercialization Plan ”) for such Commercialization Territory that describes: (a) No later than [ * ] prior to the anticipated filing of an application pre-launch, launch and subsequent Commercialization activities for Regulatory Approval for a such Joint Product in the U.S., Endo shall deliver to the JSC a draft written commercialization plan setting forth anticipated Commercialization Territory Specific terms in this Exhibit have been redacted because such terms are both not material commercialization activities to be performed with respect to such Product in the U.S. by Endo or on its behalf, as well as projected timelines for such activities (the “Commercialization Plan”). The JSC shall promptly review such draft initial Commercialization Plan and may provide commercially reasonable comments to Endo for its consideration. Endo shall give good faith consideration to such comments and may revise such draft Commercialization Plan to implement such are of the JSC’s comments type that it shall deem necessary the Company treats as private or advisable to include confidential. These redacted terms have been marked in the draftthis Exhibit with three asterisks [***]. Endo shall(including promotional messaging, thereafterbranding (including Product Trademarks), submit the Commercialization Plan with such changespricing, revisions and modifications that it shall deem advisable to the JSCadvertising, and the Commercialization Planplanning, together with such changesmarketing, revisions and modifications, as applicable, shall be deemed final. sales force training); (b) No later than [ * ] prior to the anticipated launch of a Product in the U.S., Endo shall update the Commercialization Plan, and shall thereafter update the Commercialization Plan on an annual basis as follows: Endo shall provide the JSC with a draft update to the Commercialization Plan no later than December 1 of each year. Endo shall give good faith consideration to any comments provided by the JSC and may revise such Commercialization Plan to implement such of the JSC’s comments that it shall deem necessary or advisable to include in the Commercialization Plan, after which the update to the Commercialization Plan shall be deemed to be finalized. Endo shall deliver a final version of the updated Commercialization Plan no later than January 31 of the following year. key tactics for implementing those activities; (c) The Commercialization Plan shall include a marketing the responsibilities for implementing those activities assigned to each of the Parties; (d) the Detailing plan for the Product for which Regulatory Approval is being sought or obtained in the U.S. that includes plans related to the anticipated promotion and sale of such Product in the U.S., competitive analysis, including information regarding actions intended to mitigate competitive threats, a non-binding sales forecast for the following year and the marketing, promotion and advertising campaigns proposed to be conducted, (including the number of detailing representativesSales Representatives to be provided by the Parties and the number of PDEs required to be performed by the Parties in each applicable country in the Commercialization Territory during each Calendar Quarter); (e) Phase IV Studies and Medical Affairs Activities; (f) the brand elements for such Joint Product throughout the Profit Share Region, level including the applicable key distinctive colors, logos, images, and symbols, and Trademarks (including the Product Trademarks) to be used in connection therewith (consistent with Section 7.9); and (g) a comprehensive budget of promotion the projected costs for executing such activities for such Joint Product in the Commercialization Territory (which budget shall include required amounts of promotional funds to be expended by the Parties). The Parties may agree on a single Commercialization Plan to cover multiple Joint Products. Each Commercialization Plan and Endo’s medical education activitiesall subsequent revisions thereto shall contain the information described above in this Section 7.4(a) and any other information the JMC believes is necessary or useful for the successful commercial launch and subsequent Commercialization of such Joint Product. The Parties acknowledge that certain items of the Commercialization Plan may not be amenable to determination at the time the Commercialization Plan is initially drafted. In such event, the Parties shall amend such plan pursuant to Section 7.4(b) to include such items when appropriate. In the event of any inconsistency between a Commercialization Plan and this Agreement, the terms of this Agreement shall control.