Common use of Commercialization Plan Clause in Contracts

Commercialization Plan. (a) Agendia shall use Commercially Reasonable Efforts to Commercialize CMPBP in the Territory pursuant to a plan approved by the JSC in accordance with Section 3.6 (“Commercialization Plan”). Such plan shall include: (i) a reasonably detailed description of the key elements of its Commercialization strategy (including messaging, branding, marketing, advertising, sales force positioning, and pricing); and (ii) a reasonably detailed description and commercially reasonable timeline of its implementation tactics (including sales force training, promotional activities, distribution channels, and customer service) for such Commercialization strategy for the next Annual Period. (b) In connection with the Commercialization Plan, the Parties agree and acknowledge as follows: (i) Agendia shall be solely responsible [***]for specific aspects of the 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 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 sale and distribution of CMPBP [***], 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. Within the geographies that may be selected by the JSC for commercialization outside of the 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 is not commercially reasonable for such Party to sell or 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 sell or distribute such CMPBP in the proposed country or territory. (c) [***]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 enter into a 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 day-to-day conduct of activities implementing the Commercialization Plan [***], unless expressly reserved in this Agreement for the JSC’s determination or approval; provided that all such decisions must be consistent with the Collaboration’s purpose and objectives, the terms and conditions of this Agreement, and applicable Law.

Commercialization Plan. (a) Agendia shall use Commercially Reasonable Efforts No later than [ * ] prior to Commercialize CMPBP the anticipated filing of an application for Regulatory Approval for a Product in the Territory pursuant U.S., Endo shall deliver to a plan approved by the JSC a draft written commercialization plan setting forth anticipated material commercialization activities to be performed with respect to such Product in accordance with Section 3.6 the U.S. by Endo or on its behalf, as well as projected timelines for such activities (the “Commercialization Plan”). Such plan The JSC shall include: (i) a reasonably detailed description 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 key elements of its JSC’s comments that it shall deem necessary or advisable to include in the draft. Endo shall, thereafter, submit the Commercialization strategy (including messagingPlan with such changes, branding, marketing, advertising, sales force positioningrevisions and modifications that it shall deem advisable to the JSC, and pricing); and (ii) a reasonably detailed description the Commercialization Plan, together with such changes, revisions and commercially reasonable timeline of its implementation tactics (including sales force trainingmodifications, promotional activitiesas applicable, distribution channels, and customer service) for such Commercialization strategy for the next Annual Periodshall be deemed final. (b) In connection with 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 Parties agree and acknowledge Commercialization Plan on an annual basis as follows: (i) Agendia : Endo shall be solely responsible [***]for specific aspects provide the JSC with a draft update to the Commercialization Plan no later than December 1 of the 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 each year. Endo shall give good faith consideration 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 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 sale and distribution of CMPBP [***], 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. Within the geographies that may be selected any comments provided by the JSC for commercialization outside and may revise such Commercialization Plan to implement such of the initial TerritoryJSC’s comments that it shall deem necessary or advisable to include in the Commercialization Plan, as after which the update to the Commercialization Plan shall be deemed to be finalized. Endo shall deliver a final version of the Effective Date updated Commercialization Plan no later than January 31 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 is not commercially reasonable for such Party to sell or 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 sell or distribute such CMPBP in the proposed country or territoryfollowing year. (c) [***]before 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 date promotion and sale of such Product in the First Commercial Sale hereunderU.S., 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 enter into a quality agreement in connection with CMPBP and in accordance with the applicable Lawscompetitive analysis, including but not limited information regarding actions intended to mitigate competitive threats, a non-binding sales forecast for the International Standards Organization (“ISO”), the In Vitro Diagnostic Medical Device Regulation (“IVDR”) following year and the U.S. FDAmarketing, promotion and advertising campaigns proposed to be conducted, including the number of detailing representatives, level of promotion and Endo’s medical education activities. (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 day-to-day conduct of activities implementing the Commercialization Plan [***], unless expressly reserved in this Agreement for the JSC’s determination or approval; provided that all such decisions must be consistent with the Collaboration’s purpose and objectives, the terms and conditions of this Agreement, and applicable Law.

Commercialization Plan. Partner shall be responsible for the creation and implementation of an annual plan and budget for the commercialization of Products in the Field in the Territory, which will include any Post Marketing Studies (aas defined below) Agendia shall use Commercially Reasonable Efforts to Commercialize CMPBP of Products in the Field in the Territory pursuant to a plan approved by (the JSC in accordance with Section 3.6 (“Commercialization Plan”). Such plan , which Commercialization Plan shall include: (i) a reasonably detailed description of the key elements of its Commercialization strategy (including messaging, brandingwithout limitation, marketing, advertising, sales force positioningidentification of, and pricing); and (ii) a reasonably detailed description and commercially reasonable timeline proposed plans to address, potential challenges with respect to commercialization of its implementation tactics (including sales force training, promotional activities, distribution channels, and customer service) for such Commercialization strategy for the next Annual Period. (b) In connection with the Commercialization Plan, the Parties agree and acknowledge as follows: (i) Agendia shall be solely responsible [***]for specific aspects of the 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 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 sale and distribution of CMPBP [***], 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. Within the geographies that may be selected by the JSC for commercialization outside of the 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 is not commercially reasonable for such Party to sell or 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 sell or distribute such CMPBP Products in the proposed country or territory. (c) [***]before Field in the anticipated date of the First Commercial Sale hereunder, Agendia Territory. Partner shall prepare and present submit to the JSC Optimer 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 enter into a 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) no later than […***], Agendia shall prepare updates …] after the first submission of a MAA for Product in the Territory for review and amendments, as appropriate, to the then-current Commercialization Plan and present such updates and amendments to discussion through the JSC. Any material amendments Subsequent updated Commercialization Plans shall be submitted by Partner to Optimer on an annual basis on or before the end of February each Calendar Year for review and discussion through the JSC. Through the JSC, Partner shall 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 Optimer’s input regarding such commercialization strategy and the Commercialization Plan (including any acceleration of the First Commercial Sale date for CMPBPPlan; provided, any changes to Product Trademarkshowever, 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 that Partner shall have final decision-making authority for with respect to commercialization of Products in the day-to-day conduct of activities implementing Field in the Commercialization Plan [***]Territory, unless expressly reserved in this Agreement for including the JSC’s determination or approval; provided that all such decisions must be consistent with the Collaboration’s purpose and objectives, right to set the terms of sales and conditions book all sales of this AgreementProducts 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 have administered a Product in clinical trials, have published academic articles relating to a Product, or are otherwise regarded by Partner, its Affiliates and applicable LawSublicensees, as the case may be, as a key opinion leader for a Product in the Territory. Optimer shall provide Partner with access to KOLs as may reasonably be requested by Partner, where “KOLs” means all healthcare providers outside the Territory and XXXX Territory that have administered a Product in clinical trials, have published academic articles relating to a Product, or are otherwise regarded by Optimer, its Affiliates and Sublicensees, as the case may be, as a key opinion leader for a Product outside the Territory and XXXX Territory.

Commercialization Plan. (a) Agendia shall use Commercially Reasonable Efforts to Commercialize CMPBP As further described in this section 7.4, the Territory pursuant to a plan approved by strategy for the JSC in accordance with Section 3.6 (“Commercialization Plan”). Such plan shall include: (i) a reasonably detailed description of the key elements of its Commercialization strategy (including messaging, branding, marketing, advertising, sales force positioningcommercial launch of, and pricing); and subsequent Commercialization of, each Joint Product in each Commercialization Territory shall be described in a comprehensive plan (ii) a reasonably detailed description and commercially reasonable timeline of its implementation tactics (including sales force training, promotional activities, distribution channelseach such plan, and customer serviceany revisions thereto, a “ Commercialization Plan ”) for such Commercialization strategy Territory that describes: (a) the pre-launch, launch and subsequent Commercialization activities for the next Annual Period. (b) In connection with such Joint Product in the Commercialization Plan, Territory Specific terms in this Exhibit have been redacted because such terms are both not material and are of the Parties agree and acknowledge type that the Company treats as follows: (i) Agendia shall be solely responsible private or confidential. These redacted terms have been marked in this Exhibit with three asterisks [***]for specific aspects of the commercial strategy for CMPBP . (including positioning and promotional messaging, publications, generation of marketing materials, pricing and payor contracts, Third Party non-provider relationships branding (including but not limited to pharmaceutical companiesProduct Trademarks), and distributor selection. pricing, advertising, planning, marketing, sales force training); (iib) Agendia shall also be solely responsible [***]key tactics for the commercial strategy for CMPBP including geographic market selection, target market segments and accounts, marketing and publicity. Agendia shall collaborate with 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 sale and distribution of CMPBP [***], 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. Within the geographies that may be selected by the JSC for commercialization outside of the 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 is not commercially reasonable for such Party to sell or 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 sell or distribute such CMPBP in the proposed country or territory. implementing those activities; (c) [***]before the anticipated date responsibilities for implementing those activities assigned to each of the First Commercial Sale hereunderParties; (d) the Detailing plan (including the number of Sales 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, Agendia 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 the projected costs for executing such activities for such Joint Product in the Commercialization Territory (which budget shall prepare and present include required amounts of promotional funds to be expended by the JSC the initial Parties). The Parties may agree on a single Commercialization Plan to cover multiple Joint Products. Each Commercialization Plan and all 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 CMPBPJoint Product. Following such presentation, Agendia will consider the JSC’s comments regarding The Parties acknowledge that certain items of the Commercialization Plan and adopt them as Agendia determines in its sole discretion. (d) Prior may not be amenable to any commercial CMPBP launch and/or determination at the filing with any Governmental Authority, as part of time the Commercialization strategyPlan is initially drafted. In such event, the Parties shall enter into amend such plan pursuant to Section 7.4(b) to include such items when appropriate. In the event of any inconsistency between a 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 day-to-day conduct of activities implementing the Commercialization Plan [***], unless expressly reserved in this Agreement for the JSC’s determination or approval; provided that all such decisions must be consistent with the Collaboration’s purpose and objectivesAgreement, the terms and conditions of this Agreement, and applicable LawAgreement shall control.

Commercialization Plan. (a) Agendia No later than 12 months prior to the anticipated Launch Date, Cardiome shall use Commercially Reasonable Efforts prepare and deliver to Commercialize CMPBP SteadyMed for review a reasonably detailed written plan for the Commercialization of the Product in the Territory pursuant during the period beginning six (6) months prior to a plan approved by the JSC in accordance with Section 3.6 anticipated Launch Date and ending on the fifth (5th) anniversary thereof (the “Commercialization Plan”). Such plan The Commercialization Plan shall include: (i) a reasonably detailed description include information regarding planned Commercialization activities for Supplied Item in the Territory, including, without limitation, pre-launch activities, establishment of the key elements government or private payor and reimbursement capabilities and pharmaceutical logistics capabilities, supply and inventory-related activities, Promotion, anticipated number and geographic distribution/coverage of its Commercialization strategy (including messaging, branding, marketing, advertising, sales force positioningSales Representatives by country, and pricingSales Force and tactical marketing activities (such as market research to develop Product positioning key messages); and (ii) a reasonably detailed description and commercially reasonable timeline of its implementation tactics (including sales force training, promotional activities, distribution channels. Cardiome may amend or update the Commercialization Plan from time to time to reflect changes in Cardiome’s Commercialization plans, and customer service) for such Commercialization strategy for the next Annual Period. (b) In connection shall in any event provide SteadyMed with annual updates to the Commercialization Plan, in each case, subject to the Parties agree and acknowledge as follows: (i) Agendia shall be solely responsible [***]for specific aspects of the 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 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 sale and distribution of CMPBP [***], 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. Within the geographies that may be selected by the JSC for commercialization outside of the initial Territory, as of the Effective Date requirements of this Agreement, Paige shall have a non-exclusive right to distribute CMPBP directly to Third Parties via the Paige PlatformArticle 6. Notwithstanding the foregoing, if either Party determines that it is not commercially reasonable for such Party to sell or distribute CMPBP in a proposed country or territory, that Party will notify the other Party in writing, SteadyMed may provide comments and the Parties agree that such Party will not be in material breach of this Agreement for being unable to sell or distribute such CMPBP in the proposed country or territory. (c) [***]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 suggestions regarding the Commercialization Plan and adopt them as Agendia determines any amendment or update thereto to Cardiome, and Cxxxxxxx agrees to consider such comments and suggestions in its sole discretion. (d) Prior to any commercial CMPBP launch and/or good faith. As used herein, the filing with any Governmental Authority, as part term “Commercialization Plan” means the version of the Commercialization strategyPlan most recently provided by Cardiome to SteadyMed. Cardiome shall deliver annual written reports to SteadyMed of the Commercialization activities and efforts conducted by or on behalf of Cardiome and its Affiliates for Supplied Item in the Territory during each Quarter, which shall include such detail regarding the Parties shall enter into a quality agreement matters described in connection with CMPBP and in accordance with the applicable Laws, including but not limited to the International Standards Organization (“ISO”Sections 3.2(c), the In Vitro Diagnostic Medical Device Regulation (“IVDR”and Sections 3.2(c) and the U.S. FDA. (e) [***], Agendia shall prepare updates and amendmentsthrough 3.2(g), 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 may request or require or as may be reasonably required for SteadyMed to assess Cardiome’s compliance with Section 3.6. Upon such approval, each amended Commercialization Plan will be effective its obligations under Sections 6.3 and supersede the previous Commercialization Plan as of the date of such approval6.4. (f) For clarity, Agendia has full control and decision-making authority for the day-to-day conduct of activities implementing the Commercialization Plan [***], unless expressly reserved in this Agreement for the JSC’s determination or approval; provided that all such decisions must be consistent with the Collaboration’s purpose and objectives, the terms and conditions of this Agreement, and applicable Law.

Commercialization Plan. (a) Agendia The JCC will oversee the Commercialization of Products in the Field in the Territory. A designated Party or its relevant Affiliate shall use Commercially Reasonable Efforts to Commercialize CMPBP be the lead Commercializing Party for Products in the Field in the Territory pursuant (the “Lead Commercialization Party”)2. The Lead Commercialization Party shall be agreed to a plan approved 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 first commercial launch of a Product in the first country in the Territory, the JCC, will develop and submit to the JSC in accordance with Section 3.6 for approval, a Commercialization plan (as may be amended, the “Commercialization Plan”)) that sets forth the Commercialization activities to be undertaken by the Parties with respect to the Commercialization of such Product in the Field in the Territory. Such plan shall include: In allocating responsibilities between the Parties, the JCC will take into consideration each Party’s expertise, capabilities, staffing and 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 (ior more frequently as needed) a reasonably detailed description of and submit it to the key elements of its JSC for approval. The Commercialization strategy Plan will include (including messaginga) the Global Branding Strategy, branding, marketing, advertising, sales force positioning, and pricing); and (ii) a reasonably detailed description and commercially reasonable timeline of its implementation tactics (including sales force training, promotional activities, distribution channels, and customer service) for such Commercialization strategy for the next Annual Period. (b) In 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 Plan, the Parties agree and acknowledge as follows: (i) Agendia shall be solely responsible [***]for specific aspects of the 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 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 sale and distribution of CMPBP [***], 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. Within the geographies that may be selected by the JSC for commercialization outside of the 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 is not commercially reasonable for such Party to sell or 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 sell or distribute such CMPBP Product in the proposed country or territory. Field in the Territory and (ch) [***]before the anticipated date of the First Commercial Sale hereunder, Agendia shall prepare and present to the JSC the initial Commercialization Plan a budget 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 enter into a 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 activities conducted under 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 approvalBudget”). (f) For clarity, Agendia has full control and decision-making authority for the day-to-day conduct of activities implementing the Commercialization Plan [***], unless expressly reserved in this Agreement for the JSC’s determination or approval; provided that all such decisions must be consistent with the Collaboration’s purpose and objectives, the terms and conditions of this Agreement, and applicable Law.

Commercialization Plan. (a) Agendia shall Without limiting the generality of Licensee’s sole responsibility and decision-making authority for Commercializing the Product in the Field in the Licensee Territory as set forth in Section ‎4.2, Licensee will use its Commercially Reasonable Efforts to Commercialize CMPBP in carry out the Territory pursuant to a plan approved by Commercialization of the JSC Product in accordance with Section 3.6 a written Commercialization Plan, as such may be amended or revised by Licensee from time to time, that describes the anticipated Commercialization activities to be performed with respect to Product in the Licensee Territory by Licensee or on its behalf by permitted Third Parties (the “Commercialization Plan”). Such plan Each Commercialization Plan shall include: (i) a reasonably detailed description of address, in reasonable detail, to the key elements of its Commercialization strategy (including messagingextent applicable, branding, marketing, advertising, sales force positioning, and pricing); and (ii) a reasonably detailed description and commercially reasonable timeline of its implementation tactics (including sales force training, promotional activities, distribution channels, and customer service) for such Commercialization strategy for the next Annual Period***. (b) In connection with the Commercialization Plan, the Parties agree and acknowledge as follows: (i) Agendia shall be solely responsible [Within ***]for specific aspects of the 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 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 sale and distribution of CMPBP [***], 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. Within the geographies that may be selected by the JSC for commercialization outside of the initial Territory, as * of the Effective Date Date, Licensee shall deliver to VIVUS a Commercialization Plan covering activities to be conducted in preparation 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 is not commercially reasonable for such Party to sell or 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 sell or distribute such CMPBP any Product Launch in the proposed Licensee Territory on a country-by-country or territorybasis and during the first full calendar year following such Product Launch. (c) [***]before Licensee shall thereafter update the anticipated date of Commercialization Plan (together with the First Commercial Sale hereunder, Agendia Medical Affairs Plan described in Section ‎4.7) on an annual basis as follows: Licensee shall prepare and present to provide the JSC (or VIVUS in the initial Commercialization Plan for such CMPBP. Following such presentation, Agendia will consider the absence of a JSC’s comments regarding ) with preliminary drafts of the Commercialization Plan and adopt them as Agendia determines Medical Affairs Plan no later than *** of each year for the JSC’s (or VIVUS’ in its sole discretion. the absence of a JSC) review and comment and Licensee shall provide the JSC (dor VIVUS in the absence of a JSC) Prior to any commercial CMPBP launch and/or with the filing with any Governmental Authority, as part final Commercialization Plan and Medical Affairs Plan no later than *** of the year immediately following such year. In preparing the updated versions of the Commercialization strategyPlan and Medical Affairs Plan, the Parties Licensee shall enter into a 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, . Licensee agrees to give due consideration 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 input provided by the JSC (or VIVUS in accordance with Section 3.6. Upon such approval, each amended Commercialization Plan the absence of a JSC) but Licensee at all times will be effective and supersede the previous Commercialization Plan as of the date of such approval. (f) For clarity, Agendia has full control retain responsibility and decision-making authority for the day-to-day conduct Commercialization of activities implementing the Product in the Field in the Licensee Territory. Licensee may, at its (d) 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, unless expressly reserved in on the one hand, the Commercialization Plan or Medical Affairs Plan and, on the other hand, this Agreement for the JSC’s determination or approval; provided that all such decisions must be consistent with the Collaboration’s purpose and objectivesAgreement, the terms and conditions of this Agreement, and applicable LawAgreement shall prevail.

Commercialization Plan. (a) Agendia No later than 12 months prior to the anticipated Launch Date, Cardiome shall use Commercially Reasonable Efforts prepare and deliver to Commercialize CMPBP SteadyMed for review a reasonably detailed written plan for the Commercialization of the Product in the Territory pursuant during the period beginning six (6) months prior to a plan approved by the JSC in accordance with Section 3.6 anticipated Launch Date and ending on the fifth (5th) anniversary thereof (the “Commercialization Plan”). Such plan The Commercialization Plan shall include: (i) a reasonably detailed description include information regarding planned Commercialization activities for Supplied Item in the Territory, including, without limitation, pre-launch activities, establishment of the key elements government or private payor and reimbursement capabilities and pharmaceutical logistics capabilities, supply and inventory-related activities, Promotion, anticipated number and geographic distribution/coverage of its Commercialization strategy (including messaging, branding, marketing, advertising, sales force positioningSales Representatives by country, and pricingSales Force and tactical marketing activities (such as market research to develop Product positioning key messages); and (ii) a reasonably detailed description and commercially reasonable timeline of its implementation tactics (including sales force training, promotional activities, distribution channels. Cardiome may amend or update the Commercialization Plan from time to time to reflect changes in Cardiome’s Commercialization plans, and customer service) for such Commercialization strategy for the next Annual Period. (b) In connection shall in any event provide SteadyMed with annual updates to the Commercialization Plan, in each case, subject to the Parties agree and acknowledge as follows: (i) Agendia shall be solely responsible [***]for specific aspects of the 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 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 sale and distribution of CMPBP [***], 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. Within the geographies that may be selected by the JSC for commercialization outside of the initial Territory, as of the Effective Date requirements of this Agreement, Paige shall have a non-exclusive right to distribute CMPBP directly to Third Parties via the Paige PlatformArticle 6. Notwithstanding the foregoing, if either Party determines that it is not commercially reasonable for such Party to sell or distribute CMPBP in a proposed country or territory, that Party will notify the other Party in writing, SteadyMed may provide comments and the Parties agree that such Party will not be in material breach of this Agreement for being unable to sell or distribute such CMPBP in the proposed country or territory. (c) [***]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 suggestions regarding the Commercialization Plan and adopt them as Agendia determines any amendment or update thereto to Cardiome, and Cardiome agrees to consider such comments and suggestions in its sole discretion. (d) Prior to any commercial CMPBP launch and/or good faith. As used herein, the filing with any Governmental Authority, as part term “Commercialization Plan” means the version of the Commercialization strategyPlan most recently provided by Cardiome to SteadyMed. Cardiome shall deliver annual written reports to SteadyMed of the Commercialization activities and efforts conducted by or on behalf of Cardiome and its Affiliates for Supplied Item in the Territory during each Quarter, which shall include such detail regarding the Parties shall enter into a quality agreement matters described in connection with CMPBP and in accordance with the applicable Laws, including but not limited to the International Standards Organization (“ISO”Sections 3.2(c), the In Vitro Diagnostic Medical Device Regulation (“IVDR”and Sections 3.2(c) and the U.S. FDA. (e) [***], Agendia shall prepare updates and amendmentsthrough 3.2(g), 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 may request or require or as may be reasonably required for SteadyMed to assess Cardiome’s compliance with Section 3.6. Upon such approval, each amended Commercialization Plan will be effective its obligations under Sections 6.3 and supersede the previous Commercialization Plan as of the date of such approval6.4. (f) For clarity, Agendia has full control and decision-making authority for the day-to-day conduct of activities implementing the Commercialization Plan [***], unless expressly reserved in this Agreement for the JSC’s determination or approval; provided that all such decisions must be consistent with the Collaboration’s purpose and objectives, the terms and conditions of this Agreement, and applicable Law.

Commercialization Plan. (a) Agendia shall Without limiting the generality of Auxilium’s sole responsibility and decision-making authority for Commercializing the Product in the Field in the Auxilium Territory as set forth in Section 4.2, Auxilium will use its Commercially Reasonable Efforts to Commercialize CMPBP in carry out the Territory pursuant to a plan approved by Commercialization of the JSC Product in accordance with Section 3.6 a written Commercialization Plan, as such may be amended or revised by Auxilium from time to time, that describes the anticipated Commercialization activities to be performed with respect to Product in the Auxilium Territory by Auxilium or on its behalf by permitted Third Parties (the “Commercialization Plan”). Such plan Each Commercialization Plan shall include: (i) a reasonably detailed description address, in reasonable detail, to the extent applicable, call plans for Detailing of the key elements of its Commercialization strategy (including messagingProduct, brandingSales Force training, marketingProduct sampling strategies and quantities, advertising, sales force positioningProduct positioning and scientific communication strategy, and pricing); and (ii) a reasonably detailed description DTC and commercially reasonable timeline of its implementation tactics (including sales force training, promotional activities, distribution channels, and customer service) for such Commercialization strategy for the next Annual Periodnon-DTC advertising. (b) In connection with the Attached hereto as Exhibit A is a Commercialization Plan, the Parties agree and acknowledge as follows: (i) Agendia shall Plan covering activities to be solely responsible [***]for specific aspects conducted in preparation of the 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 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 sale and distribution of CMPBP [***], 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. Within the geographies that may be selected by the JSC for commercialization outside of the 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 is not commercially reasonable for such Party to sell or 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 sell or distribute such CMPBP Product Launch in the proposed country or territoryAuxilium Territory and during the first full calendar year following the Product Launch. (c) [***]before Auxilium shall thereafter update the anticipated date of Commercialization Plan (together with the First Commercial Sale hereunder, Agendia Medical Affairs Plan described in Section 4.7) on an annual basis as follows: Auxilium shall prepare and present to provide the JSC the initial Commercialization Plan for such CMPBP. Following such presentation, Agendia will consider the JSC’s comments regarding with preliminary drafts of the Commercialization Plan and adopt them as Agendia determines in its sole discretion. (d) Prior to any commercial CMPBP launch and/or Medical Affairs Plan no later than [**] of each year for the filing JSC’s review and comment and Auxilium shall provide the JSC with any Governmental Authority, as part the final Commercialization Plan and Medical Affairs Plan no later than [**] of the year immediately following such year. In preparing the updated versions of the Commercialization strategyPlan and Medical Affairs Plan, Auxilium shall analyze the Parties shall enter into a quality agreement in connection with CMPBP and in accordance with effectiveness of the applicable Laws, including but not limited to elements of 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 prior year Commercialization Plan and present such updates Medical Affairs Plan and amendments shall use updated sales forecasts to develop the new Commercialization Plan. Auxilium agrees to give due consideration 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 input provided by the JSC in accordance with Section 3.6. Upon such approval, each amended Commercialization Plan but Auxilium at all times will be effective and supersede the previous Commercialization Plan as of the date of such approval. (f) For clarity, Agendia has full control retain responsibility and decision-making authority for the day-to-day conduct Commercialization of activities implementing the Product in the ** 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, at its election, update the Commercialization Plan [***]and Medical Affairs Plan between annual updates by following this same procedure. (d) 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, unless expressly reserved in on the one hand, the Commercialization Plan or Medical Affairs Plan and, on the other hand, this Agreement for the JSC’s determination or approval; provided that all such decisions must be consistent with the Collaboration’s purpose and objectivesAgreement, the terms and conditions of this Agreement, and applicable LawAgreement shall prevail.

Commercialization Plan. (a) Agendia The JCC shall use Commercially Reasonable Efforts to Commercialize CMPBP in develop and approve a rolling multi-year plan and budget for commercializing the Territory pursuant to a plan approved by Product (the JSC in accordance with Section 3.6 (“"Commercialization Plan”"). Such plan The Commercialization Plan shall include: (i) include a reasonably detailed description of the key elements of its Commercialization strategy (including messaging, brandingcomprehensive market development, marketing, advertisingsales, supply and distribution strategy, including an overall budget for anticipated marketing, promotion and sales force positioningefforts in the calendar year. The Commercialization Plan will specify which Target Populations and distribution channels each Party shall devote its Co-Promotion efforts towards, the personnel and other resources to be devoted by each Party to such efforts, the number and positioning of details to be performed by each Party, as well as market and sales forecasts and related operating expenses, for the Product in the Territory, and pricing); and (ii) a reasonably detailed description budgets for projected Commercialization Expenses and commercially reasonable timeline of its implementation tactics (including sales force trainingSales and Marketing Expenses. In preparing the Commercialization Plan, promotional activitiesthe JCC will take into consideration factors such as market conditions, distribution channels, regulatory issues and customer service) for such competition. The Commercialization Plan will include the general strategy and operating guidelines for the next Annual Periodcommercialization of the Product. (b) In connection with It is the Commercialization Planintention 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 healthy pediatric Target Population, giving the Product first detail position for the Flu Season in which occurs the Launch Date. Further, the Parties agree and acknowledge as follows: (i) Agendia intend that, if the Product is approved in the Field in the Territory for the adult Target Population, then Wyeth-Ayerst shall be solely responsible [***]for specific aspects of the commercial strategy for CMPBP including positioning and messaging, publications, generation of marketing materials, pricing and payor contracts, Third Party non-provider relationships provide (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 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 sale and distribution of CMPBP [***], 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. Within the geographies that may be selected by the JSC for commercialization outside of the 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 foregoinghiring, if either Party determines that it is not commercially reasonable for necessary) sufficient personnel in its sales and marketing organization to market and sell the Product to such Party to sell or 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 sell or distribute such CMPBP in the proposed country or territoryadult Target Population. (c) The first Commercialization Plan shall be prepared and approved as promptly as possible after the Effective Date and shall thereafter be immediately in effect. Annually thereafter, the JCC shall update and amend the Commercialization Plan with such process as the JCC shall determine. [***]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] = CONFIDENTIAL TREATMENT REQUESTED. (d) Prior to any commercial CMPBP launch and/or the filing with any Governmental Authority, as part of the Commercialization strategy, the Parties shall enter into a 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 day-to-day conduct of activities implementing the Commercialization Plan [***], unless expressly reserved in this Agreement for the JSC’s determination or approval; provided that all such decisions must be consistent with the Collaboration’s purpose and objectives, the terms and conditions of this Agreement, and applicable Law.