Common use of Commercialization Plan Clause in Contracts

Commercialization Plan. (a) Not later than three [***] after submission of Regulatory Filings for each Product in each country of the Territory, Licensee will provide to the JCC for review its initial Commercialization Plan for each Product for each country in the Territory. Such initial Commercialization Plan will describe Licensee’s plans for activities to be conducted for such Product for such country. Each Commercialization Plan shall include the details of obligations to be performed by Licensee to achieve the specific activities that are applicable to the stage of [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. Commercialization (e.g., pre-launch, launch planning, launch, or post-launch) of the applicable Product during the time period covered by such Commercialization Plan and subsequent time periods. (b) Prior to the First Commercial Sale for such Product in such country, Licensee will provide to the JCC for review an updated Commercialization Plan for such Product for such country. Such updated Commercialization Plan will include, but not be limited to, Licensee’s updated plans for activities to be conducted for such Product for such country prior to launch as well as activities to be conducted in connection with such launch. (c) Promptly after each anniversary of the First Commercial Sale of such Product during the Term, Licensee will provide to the JCC for review updated Commercialization Plans for such Product for such country. Such further updated Commercialization Plan will include, but not be limited to, Licensee’s plans for Commercialization activities for such Product and such country for the twelve (12) month period following the date of delivery of such Commercialization Plan. No Commercialization Plan may be implemented by Licensee if [***]. Each Commercialization Plan shall be consistent with and shall not contradict the terms of this Agreement [***], and in the event of any inconsistency between the Commercialization Plan and this Agreement, the terms of this Agreement shall prevail. Notwithstanding the foregoing, if a [***], Licensee shall [***] and shall promptly [***].

Commercialization Plan. At such times as the JGC will deem appropriate, the JGC will direct the Parties to mutually prepare a Worldwide Commercialization Plan, and the JGC will review and approve such initial Worldwide Commercialization Plan. Thereafter, the JGC will have one or the other Party (or both) update the Worldwide Commercialization Plan each calendar year, and the JGC will review and approve any such update or any other amendment to the Worldwide Commercialization Plan. Notwithstanding anything in this CCPS Agreement to the contrary, the Parties acknowledge and agree that (i) Bluebird may decline to perform any Commercialization activity proposed to be conducted by Bluebird in the Worldwide Commercialization Plan (other than Manufacturing of Vectors and associated Payloads), and (ii) the Worldwide Commercialization Plan will not include, and Bluebird will have no obligation to perform, any such Commercialization activity that Bluebird has declined to perform, provided that once Bluebird has agreed to perform a Commercialization activity, it will be obligated to perform, and cannot decline to perform, such activity. In addition, either Party may request at any time that the JGC consider and approve other updates to the Worldwide Commercialization Plan. Further: (a) Not later than three The JGC will set the required form and contents of the Worldwide Commercialization Plan. The Worldwide Commercialization Plan will reflect a singular marketing and sales approach worldwide, and will specify, among other things, the number of sales reps in the U.S. for each Party, allocation of regions in the U.S. for each Parties’ sales force, creation of marketing materials, planning for conferences, and other marketing activities. CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***] after submission of Regulatory Filings for each Product in each country of the Territory]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, Licensee will provide to the JCC for review its initial Commercialization Plan for each Product for each country in the Territory. Such initial Commercialization Plan will describe Licensee’s plans for activities to be conducted for such Product for such country. Each Commercialization Plan shall include the details of obligations to be performed by Licensee to achieve the specific activities that are applicable to the stage of [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. Commercialization (e.g., pre-launch, launch planning, launch, or post-launch) of the applicable Product during the time period covered by such Commercialization Plan and subsequent time periodsAS AMENDED. (b) Prior to Neither Party (itself or by or through any others, including any Affiliates or Sublicensees) will take any material action regarding the First Commercial Sale for such Commercialization of Licensed Product unless described in such country, Licensee will provide to the JCC for review an updated Worldwide Commercialization Plan for such Product for such country. Such updated Commercialization Plan will include, but not be limited to, Licensee’s updated plans for activities to be conducted for such Product for such country prior to launch as well as activities to be conducted in connection with such launchor approved by the JGC. (c) Promptly after each anniversary All Commercialization of Licensed Product for U.S. Administration will be conducted under the supervision of the First Commercial Sale JGC and as part of such Product during the Term, Licensee U.S. Development & Commercialization Program. (d) Celgene will provide to the JCC have final decision making authority for review updated Commercialization Plans for such Product for such country. Such further updated Commercialization Plan will include, but not be limited to, Licensee’s plans for all Commercialization activities for such Product worldwide, including timing of launch and such country for pricing and the twelve (12) month period following the date of delivery of such Commercialization Worldwide Development Plan. No Commercialization Plan may be implemented by Licensee if [***]. Each Commercialization Plan shall be consistent with and shall not contradict the terms of this Agreement [***], and in the event of any inconsistency between the Commercialization Plan and this Agreement, the terms of this Agreement shall prevail. Notwithstanding the foregoing, if a [***], Licensee shall [***] and shall promptly [***].

Commercialization Plan. (a) Not On an annual basis, ACADIA shall prepare a Commercialization plan with respect to the Commercialization of each Product in the Field in the Territory pursuant to this Agreement (as may be amended by ACADIA, the “Commercialization Plan”). The Commercialization Plan for the first full year following commercial launch of the first Product for which an NDA is filed with the FDA will be provided to Neuren by ACADIA as soon as it is available but, in any event, no later than three […***…] days after submission of Regulatory Filings for each Product in each country the filing of the Territory, Licensee will provide to NDA for such Product with the JCC for review its initial Commercialization Plan for each Product for each country in the TerritoryFDA. Such initial Commercialization Plan will describe shall provide a reasonably detailed plan for ACADIA’s (or its Affiliate’s or Sub-Licensee’s plans for ’s) Commercialization activities to be conducted for such Product for such country. Each Commercialization Plan shall include the details of obligations to be performed by Licensee to achieve the specific activities that are applicable to the stage of [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. Commercialization (e.g.such Product, including pre-launchlaunch plans and launch plans, launch planningpricing, launch, or post-launch) of label expansion and market positioning (which information may be preliminary). ACADIA may amend the applicable Product during the time period covered by such Commercialization Plan and subsequent from time periodsto time in its discretion. (b) Prior Throughout the Term, at each JSC meeting pursuant to clause 4.4, ACADIA shall update the First Commercial Sale for such JSC of progress in the Marketing Authorisations of the Product in such countrythe Territory, Licensee will and Neuren shall provide to the JCC for review an updated Commercialization Plan for such JSC updates of progress in the Marketing Authorisations of the Product for such country. Such updated Commercialization Plan will include, but not be limited to, Licensee’s updated plans for activities to be conducted for such Product for such country prior to launch as well as activities to be conducted in connection with such launchoutside the Territory. (c) Promptly after each anniversary of During the First Commercial Sale of such Product during the Term, Licensee will provide to the JCC for review updated Commercialization Plans for such Product for such country. Such further updated Commercialization Plan will include, but not be limited to, Licensee’s plans for Commercialization activities for such Product and such country for the twelve (12) month period following the date of delivery of such Commercialization Plan. No Commercialization Plan may be implemented by Licensee if first […***]. Each Commercialization Plan …] years after launch, appropriate executives of Neuren and ACADIA shall be consistent with and shall not contradict the terms of this Agreement meet at least […***]…] per calendar year to discuss and review the Commercialization Plan, if provided, and in the event ACADIA’s progress towards achievement of any inconsistency between the Commercialization Plan and this Agreementto discuss and review the marketing and sales of each Product in the Territory. Unless the parties otherwise agree, the terms of this Agreement shall prevail. Notwithstanding the foregoing, if a [***], Licensee shall [***] and shall promptly [***]meetings will take place in San Diego.

Commercialization Plan. (a) Not later than three [***] after submission of Regulatory Filings for each Product in each country of the Territory, Licensee will provide to the JCC for review its initial Commercialization Plan for each Product for each country in the Territory. Such initial Commercialization Plan will describe Licensee’s plans for activities to be conducted for such Product for such country. Each Commercialization Plan shall include the details of obligations to be performed by Licensee to achieve the specific activities that are applicable to the stage of [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. Commercialization (e.g., pre-launch, launch planning, launch, or post-launch) of the applicable Product during the time period covered by such Commercialization Plan and subsequent time periods. (b) Prior to the First Commercial Sale for such Product in such country, Licensee will provide to the JCC for review an updated Commercialization Plan for such Product for such country. Such updated Commercialization Plan will include, but not be limited to, Licensee’s updated plans for activities to be conducted for such Product for such country prior to launch as well as activities to be conducted in connection with such launch. (c) Promptly after each anniversary of the First Commercial Sale of such Product during the Term, Licensee will provide to the JCC for review updated Commercialization Plans for such Product for such country. Such further updated Commercialization Plan will include, but not be limited to, Licensee’s plans for Commercialization activities for such Product and such country for the twelve (12) month period following the date of delivery of such Commercialization Plan. No Commercialization Plan may be implemented by Licensee if [***], the Parties, under the direction of the JGC, will mutually prepare a Worldwide Commercialization Plan, and the JGC will review and approve such initial Worldwide Commercialization Plan. Each Thereafter, the JGC will have one or the other Party (or both) update the Worldwide Commercialization Plan shall be consistent with and shall not contradict the terms of this Agreement each calendar year [***], and the JGC will review and approve any such update or any other amendment to the Worldwide Commercialization Plan. Notwithstanding anything in this CCPS Agreement to the contrary, the Parties acknowledge and agree that (i) Bluebird may decline to perform any Commercialization activity proposed to be conducted by Bluebird in the event Worldwide Commercialization Plan (other than Manufacturing of Vectors and associated Payloads), and (ii) the Worldwide Commercialization Plan will not include, and Bluebird will have no obligation to perform, any inconsistency between such Commercialization activity that Bluebird has declined to perform, provided that once Bluebird has agreed to perform a Commercialization activity, it will be obligated to perform, and cannot decline to perform, such activity. In addition, either Party may request at any time that the JGC consider and approve other updates to the Worldwide Commercialization Plan. Further: (a) The JGC will set the required form and contents of the Worldwide Commercialization Plan. The Worldwide Commercialization Plan will reflect a singular Commercialization approach worldwide, and will specify, among other things, the number of sales reps in the U.S. for each Party, allocation of regions in the U.S. for each Parties’ sales force, creation of marketing materials, planning for conferences, and other marketing activities. (b) Neither Party (itself or by or through any others, including any Affiliates or Sublicensees) will take any material action regarding the Commercialization of Licensed Product unless described in the Worldwide Commercialization Plan or approved by the JGC. (c) All Commercialization of Licensed Product for U.S. Administration will be conducted under the supervision of the JGC and this Agreementas part of the U.S. Development & Commercialization Program. (d) Celgene will have final decision-making authority for all Commercialization activities worldwide, including timing of launch and pricing and the terms of this Agreement shall prevail. Notwithstanding the foregoing, if a Worldwide Commercialization Plan. (e) [***], Licensee the Parties shall [***] negotiate and enter into a co-promotion agreement that will set forth the terms upon which the Parties shall promptly [***]co-promote the Licensed Product in the U.S., which terms shall be consistent with this Article 5.

Commercialization Plan. At such times as the JGC will deem appropriate, the JGC will direct the Parties to mutually prepare a Worldwide Commercialization Plan, and the JGC will review and approve such initial Worldwide Commercialization Plan. Thereafter, the JGC will have one or the other Party (or both) update the Worldwide Commercialization Plan each calendar year, and the JGC will review and approve any such update or any other amendment to the Worldwide Commercialization Plan. Notwithstanding anything in this CCPS Agreement to the contrary, the Parties acknowledge and agree that (i) Bluebird may decline to perform any Commercialization activity proposed to be conducted by Bluebird in the Worldwide Commercialization Plan (other than Manufacturing of Vectors and associated Payloads), and (ii) the Worldwide Commercialization Plan will not include, and Bluebird will have no obligation to perform, any such Commercialization activity that Bluebird has declined to perform, provided that once Bluebird has agreed to perform a Commercialization activity, it will be obligated to perform, and cannot decline to perform, such activity. In addition, either Party may request at any time that the JGC consider and approve other updates to the Worldwide Commercialization Plan. Further: (a) Not later than three [***] after submission of Regulatory Filings for each Product in each country The JGC will set the required form and contents of the Territory, Licensee will provide to the JCC for review its initial Worldwide Commercialization Plan for each Product for each country in the TerritoryPlan. Such initial The Worldwide Commercialization Plan will describe Licensee’s plans reflect a singular marketing and sales approach worldwide, and will specify, among other things, the number of sales reps in the U.S. for activities to be conducted each Party, allocation of regions in the U.S. for such Product each Parties’ sales force, creation of marketing materials, planning for such country. Each Commercialization Plan shall include the details of obligations to be performed by Licensee to achieve the specific activities that are applicable to the stage of [***] Certain information in this document has been omitted conferences, and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. Commercialization (e.g., pre-launch, launch planning, launch, or post-launch) of the applicable Product during the time period covered by such Commercialization Plan and subsequent time periodsother marketing activities. (b) Prior to Neither Party (itself or by or through any others, including any Affiliates or Sublicensees) will take any material action regarding the First Commercial Sale for such Commercialization of Licensed Product unless described in such country, Licensee will provide to the JCC for review an updated Worldwide Commercialization Plan for such Product for such country. Such updated Commercialization Plan will include, but not be limited to, Licensee’s updated plans for activities to be conducted for such Product for such country prior to launch as well as activities to be conducted in connection with such launchor approved by the JGC. (c) Promptly after each anniversary All Commercialization of Licensed Product for U.S. Administration will be conducted under the supervision of the First Commercial Sale JGC and as part of such Product during the Term, Licensee U.S. Development & Commercialization Program. (d) Celgene will provide to the JCC have final decision making authority for review updated Commercialization Plans for such Product for such country. Such further updated Commercialization Plan will include, but not be limited to, Licensee’s plans for all Commercialization activities for such Product worldwide, including timing of launch and such country for pricing and the twelve (12) month period following the date of delivery of such Commercialization Worldwide Development Plan. No Commercialization Plan may be implemented by Licensee if [***]. Each Commercialization Plan shall be consistent with and shall not contradict the terms of this Agreement [***], and in the event of any inconsistency between the Commercialization Plan and this Agreement, the terms of this Agreement shall prevail. Notwithstanding the foregoing, if a [***], Licensee shall [***] and shall promptly [***].

Commercialization Plan. (a) Not Unless and until either Party has exercised its Opt-Out Right, commencing no later than three [***] after submission of Regulatory Filings for each Product in each country prior to the anticipated launch of the Territoryfirst Licensed Product, Licensee will provide the Parties shall prepare and deliver to the JCC for JCT an initial written plan and budget that describes in detail the Commercialization activities (including pre-launch and launch activities, if applicable, but excluding Manufacturing activities which shall be addressed as set forth in Article VI) to be undertaken with respect to Licensed Product(s) in the United States in the next Calendar Year and the dates by which such activities are targeted to be accomplished (as such plan may be updated or amended from time to time in accordance with this Agreement, the “Commercialization Plan”). The Commercialization Plan (including the budget) shall allocate activities between the Parties, and shall contain sufficient detail with respect to Commercialization tactics and other matters to enable the JCT to conduct a meaningful review its of the Commercialization Plan. The Parties shall seek to finalize the initial Commercialization Plan for each the United States no later than [**] prior to launch of the first Licensed Product for each country in the TerritoryUnited States. Such initial It is intended that the Commercialization Plan will describe Licensee’s plans contemplate that the Parties will co-promote Licensed Product in the United States in a manner that reflects each Parties’ capabilities and that is consistent with each Parties’ promotional efforts for activities to be conducted for such Product for such countryits own products of similar market potential. Each Commercialization Plan The Parties shall include the details of obligations to be performed by Licensee to achieve the specific activities negotiate in good faith a co-promotion agreement that are applicable to the stage of [***] Certain information in this document has been omitted and filed separately is consistent with the Securities terms of this Agreement, taking into account the Parties’ respective capabilities, including terms related to term of co-promotion activities, auditing of sales details, mechanisms to address underperformance and Exchange Commission. Confidential treatment has been requested failure to perform details at agreed upon levels, sales force training, and other customary terms, with respect a view to the omitted portions. Commercialization (e.g., prefinalizing and entering into such co-launch, launch planning, launch, or post-launch) of the applicable Product during the time period covered by such Commercialization Plan and subsequent time periodspromotion agreement as soon as reasonably practicable. (b) Prior In addition to annual updates or modifications to the First Commercial Sale for such Product in such countryCommercialization Plan decided by the JCT pursuant to Section 2.2(c), Licensee will provide either Party may develop and submit to the JCC for review an updated JCT from time to time proposed amendments to the Commercialization Plan for such Product for such country(excluding any amendment to the budget, which amendment shall require the approval of both Parties outside the JCT). Such updated Commercialization Plan will include, but not be limited to, Licensee’s updated plans for activities to be conducted for such Product for such country prior to launch as well as activities to be conducted in connection with such launch. (c) Promptly after each anniversary of the First Commercial Sale Upon approval of such Product during proposed amendments by the Term, Licensee will provide JCT (subject to the JCC for review updated Commercialization Plans for such Product for such country. Such further updated Commercialization Plan will includelimitations set forth in Section 2.2(d)), but not be limited to, Licensee’s plans for Commercialization activities for such Product and such country for the twelve (12) month period following the date of delivery of such Commercialization Plan. No Commercialization Plan may be implemented by Licensee if [***]. Each Commercialization Plan shall be consistent with and shall not contradict the terms of this Agreement [***], and in the event of any inconsistency between the Commercialization Plan and this Agreement, the terms of this Agreement shall prevail. Notwithstanding the foregoing, if a [***], Licensee shall [***] and shall promptly [***]amended accordingly.

Commercialization Plan. Within [***], the Parties shall prepare and present to the JSC for review a preliminary commercialization plan for the ADC-MDT System, which plan will include identification of the initial target jurisdictions within the Territory (aeach an “Initial Launch Country”), target release dates and other actions necessary to achieve Commercial Launch in each Initial Launch Country (the “Initial Commercialization Plan”). Throughout the Term, the Parties or the JSC may identify additional target jurisdictions within the Territory (together with the Initial Launch Country, each a “Launch Country” and collectively, the “Launch Countries”) Not later than three for Commercial Launch and [***] after submission of Regulatory Filings for each Product in each country of the Territory, Licensee will provide prior to the JCC for review its initial Commercialization Plan for each Product for each country in the Territory. Such initial Commercialization Plan will describe Licensee’s plans for activities to be conducted respective Target Launch Date, prepare and approve a commercialization plan for such Product for such country. Each additional Launch Country (each, a “Launch Country Commercialization Plan shall include the details of obligations to be performed by Licensee to achieve the specific activities that are applicable to the stage of [***] Certain information in this document has been omitted Plan”, and filed separately together with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. Commercialization (e.g., pre-launch, launch planning, launch, or post-launch) of the applicable Product during the time period covered by such Commercialization Plan and subsequent time periods. (b) Prior to the First Commercial Sale for such Product in such country, Licensee will provide to the JCC for review an updated Commercialization Plan for such Product for such country. Such updated Commercialization Plan will include, but not be limited to, Licensee’s updated plans for activities to be conducted for such Product for such country prior to launch as well as activities to be conducted in connection with such launch. (c) Promptly after each anniversary of the First Commercial Sale of such Product during the Term, Licensee will provide to the JCC for review updated Commercialization Plans for such Product for such country. Such further updated Commercialization Plan will include, but not be limited to, Licensee’s plans for Commercialization activities for such Product and such country for the twelve (12) month period following the date of delivery of such Initial Commercialization Plan, the “Commercialization Plans”). No Commercialization Plan may The Parties agree that the first Launch Countries shall be implemented by Licensee if [***]. Each Commercialization Plan shall The following markets will be consistent with and shall not contradict the terms of this Agreement considered Launch Countries: [***]. Thereafter, additional Launch Countries will be mutually agreed through the JSC. The Commercialization Plans shall each include, with respect to each Launch Country, (i) identification of target markets, (ii) the Designated MDT Device(s) and ADC MDT Glucose Sensor(s) to be launched as a ADC-MDT System in such Launch Country, (iii) agreed launch date(s) for the applicable ADC-MDT System in such Launch Country (the “Target Launch Date”, for such country), and (iv) other actions necessary to achieve Commercial Launch in such Launch Country and ensure that any such Commercial Launch activities are coordinated with the activities and deliverables in the event of any inconsistency between the Integration Plan and Regulatory Plan. For clarity, each Commercialization Plan will focus solely on the activities necessary for the Parties to coordinate timing and this Agreementannouncement of Commercial Launch within each Launch Country, and will not otherwise dictate, control, or govern MDT’s marketing, sale, and Commercialization of the terms of ADC MDT Glucose Sensors or the ADC-MDT System. If any amendments to this Agreement are needed to ensure compliance with Data Protection Laws or other Applicable Laws or otherwise needed in connection with the determination by the Parties to launch the ADC-MDT System in a Launch Country, then the Parties shall prevail. Notwithstanding the foregoing, if a [***], Licensee shall [***] and shall promptly [***]negotiate in good faith an amendment to this Agreement prior to Commercial Launch.

Commercialization Plan. (a) Not later than three [***] after submission The strategy for the Commercialization of Regulatory Filings for each Licensed Product shall be described in each country of a comprehensive plan that describes the Territory, Licensee will provide to the JCC for review its initial Commercialization Plan for each Product for each country in the Territory. Such initial Commercialization Plan will describe Licensee’s plans for activities to be conducted for such Product for such country. Each Commercialization Plan shall include the details of obligations to be performed by Licensee to achieve the specific activities that are applicable to the stage of [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. Commercialization (e.g., pre-launch, launch and subsequent Commercialization activities for such Licensed Product in the Territory, which shall include, without limitation, (i) the annual anticipated number of details to be conducted in each country within the Territory, (ii) the annual anticipated marketing expenses to be incurred in each of the countries within the Territory, (iii) the annual anticipated number of FTEs to be assigned to Commercialize in each of the countries within the Territory, and (iv) a report on pricing, advertising, education, planning, launchmarketing, or post-launchand sales force training (the “Commercialization Plan”). An initial Commercialization Plan for Biovance shall be prepared by Alliqua and presented to the JSC as soon as practicable, but in any event, within ninety (90) days of the applicable Product during Effective Date or such other time agreed to by the time period covered by such JSC. In addition, Alliqua shall submit an initial Commercialization Plan and subsequent time periods. (b) Prior for ECMs to the First Commercial Sale JSC no later than ninety (90) days prior to anticipated 510(k) or other Regulatory Clearance and/or Approval in each relevant jurisdiction within the Territory. The Parties shall, and shall cause their respective members of the JSC to, cooperate with each other in good faith to promptly finalize a mutually acceptable Commercialization Plan for such Product in such country, Licensee will provide to the JCC for review each Licensed Product. Alliqua shall deliver an updated Commercialization Plan for such Product for such country. Such updated Commercialization Plan will includeeach Licensed Product, but not be limited toas applicable, Licensee’s updated plans for activities to be conducted for such Product for such country prior to launch as well as activities to be conducted in connection with such launch. (c) Promptly after at each anniversary meeting of the First Commercial Sale of JSC or at such Product during times as agreed to by the TermJSC. THE COMPANY HAS REQUESTED AN ORDER FROM THE SECURITIES AND EXCHANGE COMMISSION (THE “COMMISSION”) PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, Licensee will provide to the JCC for review updated Commercialization Plans for such Product for such countryAS AMENDED, GRANTING CONFIDENTIAL TREATMENT TO SELECTED PORTIONS. Such further updated Commercialization Plan will includeACCORDINGLY, but not be limited toTHE CONFIDENTIAL PORTIONS HAVE BEEN OMITTED FROM THIS EXHIBIT, Licensee’s plans for Commercialization activities for such Product and such country for the twelve (12) month period following the date of delivery of such Commercialization PlanAND HAVE BEEN FILED SEPARATELY WITH THE COMMISSION. No Commercialization Plan may be implemented by Licensee if [OMITTED PORTIONS ARE INDICATED IN THIS EXHIBIT WITH “***]. Each Commercialization Plan shall be consistent with and shall not contradict the terms of this Agreement [***], and in the event of any inconsistency between the Commercialization Plan and this Agreement, the terms of this Agreement shall prevail. Notwithstanding the foregoing, if a [***], Licensee shall [***] and shall promptly [***]”.

Commercialization Plan. (a) Not No later than three [***] after submission prior to the anticipated First Commercial Sale of Regulatory Filings for each a DT Co-Co Product in each country of the Territory, Licensee will provide Moderna and Metagenomi shall prepare and submit to the JCC for review its JCC, an initial Commercialization Plan for such DT Co-Co Product, which will set forth a reasonably detailed description of anticipated Commercialization activities for the applicable DT Co-Co Products in the Territory, including the corresponding Commercialization Budget. The Commercialization Plan shall also contain a [***] rolling annual plan for the global Commercialization activities for the DT Co-Co Product in the Territory and the Commercialization Budget shall include a [***] financial forecast reflecting reasonably anticipated Commercialization Costs in accordance with the Commercialization Plan. Subject to comments and proposed changes by the other Party, each Party will be responsible for the Commercialization Plan for its respective Region. The Commercialization Plans for each Region will be incorporated into the overall Commercialization Plan. The Commercialization Plan may discuss certain matters on an Indication-by-Indication basis and shall address (to the extent applicable given the stage of Commercialization and estimated anticipated First Commercial Sale) (a) the Product Marks, global usage guidelines for the Product Marks, global key positioning, and messaging strategy for such DT Co-Co Product in such Indication, and guidelines for the Product Materials prepared in accordance with Section 6.7.9 (Product Materials) and (b) the general pricing and market access strategy (including discounts, rebates and other price reductions) globally and for each DT Co-Co Product for such Indication in each country in the Territory. Such initial The JCC shall prepare, review, and discuss, and the JSC shall review, discuss, and determine whether to approve, each Commercialization Plan will describe Licensee’s plans for activities a DT Co-Co Product. Moderna shall have the sole right to select the Product Marks for each DT Co-Co Product to be conducted for such Product for such country. Each Commercialization Plan shall include the details of obligations to be performed by Licensee to achieve the specific activities that are applicable to the stage of [***] Certain information used in this document has been omitted Moderna’s Region and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. Commercialization (e.g., pre-launch, launch planning, launch, or post-launch) of included in the applicable Product during the time period covered by such Commercialization Plan and subsequent time periods. may decide to develop and adopt certain distinctive colors, logos, images, symbols, and trade dress to be used (b) Prior in addition to the First Commercial Sale for such Product Marks) in connection with the Commercialization of each DT Co-Co Product in such countryModerna’s Region. The Parties shall jointly select the Product Marks for each DT Co-Co Product to be used in Metagenomi’s Region and included in the applicable Commercialization Plan and may jointly decide to develop and adopt certain distinctive colors, Licensee will provide logos, images, symbols, and trade dress to be used (in addition to the Product Marks) in connection with the Commercialization of each DT Co-Co Product in Metagenomi’s Region. The JCC shall prepare, review, and discuss, and the JSC shall review, discuss, and determine whether to approve, each Commercialization Plan and Commercialization Budget. On an annual basis during the Term (or more frequently as may be required), the JCC shall review and update each Commercialization Plan and Commercialization Budget based on the currently available information and data, including for review an updated any applicable new formulations or Indications that that were added to a Development Plan pursuant to Section 6.4.7(b) (JDC and JSC Decision Regarding New Development Activities) or new Combination Products approved by the JSC in accordance with Section 6.4.8 (Combination Products), in each case, that are not included in the then-current Commercialization Plan for the applicable DT Co-Co Product. The JSC shall review, discuss, and determine whether to approve any such Product for such country. Such updated Commercialization Plan will include, but not be limited to, Licensee’s updated plans for activities to be conducted for such Product for such country prior to launch as well as activities to be conducted in connection with such launch. (c) Promptly after each anniversary of the First Commercial Sale of such Product during the Term, Licensee will provide update to the JCC for review updated Commercialization Plans for such Product for such country. Such further updated Commercialization Plan will include, but not be limited to, Licensee’s plans for Commercialization activities for such Product and such country for the twelve (12) month period following the date of delivery of such Commercialization Plan. No Commercialization Plan may be implemented by Licensee if [***]. Each Commercialization Plan shall be consistent with and shall not contradict the terms of this Agreement [***], and in the event of any inconsistency between the applicable Commercialization Plan and this Agreement, the terms of this Agreement corresponding Commercialization Budget. Each such update to a Commercialization Plan and corresponding Commercialization Budget shall prevail. Notwithstanding the foregoing, if a [***], Licensee shall [***] become effective and shall promptly [***]supersede the previous Commercialization Plan and corresponding Commercialization Budget upon approval thereof by the JSC.

Commercialization Plan. (a) Not later than three [***] after submission of Regulatory Filings for each Product in each country All Commercialization of the Territory, Licensee will provide Licensed Product by or on behalf of Bayer in the Licensed Territory under this Agreement shall be conducted in accordance with a written plan that is submitted to the JCC for review its initial by Bayer (the “Commercialization Plan for each Product for each country in the TerritoryPlan”) as amended from time to time. Such The initial Commercialization Plan will describe Licensee’s plans be submitted by Bayer to the JCC no later than twelve (12) months before the anticipated date of the submission of the first NDA for activities the Licensed Product in the Field in the Licensed Territory. The Commercialization Plan and any updates or amendments to be conducted for such Product for such country. Each the Commercialization Plan shall include the details of obligations to be performed by Licensee to achieve the specific activities that are applicable to the stage of [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. Commercialization (e.g., pre-launch, launch planning, launch, or post-launch) of the applicable Product during the time period covered by such Commercialization Plan and subsequent time periods]. (b) Prior From time to time, [*] Bayer shall prepare updates or amendments to the First Commercial Sale for such Product Commercialization Plan to reflect changes in such countryplans, Licensee will provide including those in response to changes in the marketplace, relative success of the Licensed Product, and other relevant factors influencing such plan and activities, and submit any material updates or amendments to the Commercialization Plan to JCC for review an updated and discussion, provided that, for clarity, notwithstanding any further changes that may result from the Parties’ discussion, such updates and amendments shall be immediately effective; and provided, further, that [*]. Subject to Applicable Law, except as expressly agreed by Cytokinetics in writing or to the extent required by the applicable Regulatory Authority or to address specific operational requirements or local needs and preferences in the Licensed Territory, the Commercialization Plan for such Product for such country. Such updated Commercialization Plan will include, but shall not be limited to[*] with the Global Commercialization Concepts, Licenseemeaning that Bayer’s updated plans for Commercialization activities to be conducted for such in the Licensed Territory will not deviate from the Global Commercialization Concepts in a manner that [*] impact on Exploitation of Compound and Licensed Product for such country prior to launch as well as activities to be conducted in connection with such launchthe Field outside the Licensed Territory. (c) Promptly after each anniversary Bayer shall notify Cytokinetics in case of the First Commercial Sale of such Product during the Term, Licensee will provide to the JCC for review updated Commercialization Plans for such Product for such country. Such further updated Commercialization Plan will include, but not be limited to, Licensee’s plans for any concern that any Commercialization activities for such Product and such country for contemplated in the twelve (12) month period following the date of delivery of such Commercialization Plan. No Commercialization Plan may be implemented by Licensee if [***]. Each Commercialization Plan shall be consistent with and shall not contradict the terms in violation of this Agreement [***]Applicable Law, and in the event of Parties shall discuss any inconsistency between necessary revisions to the Commercialization Plan proposed by either Party to ensure that Commercialization of any Licensed Products is conducted in accordance with Applicable Law. For the avoidance of doubt, Bayer shall be solely responsible for ensuring that Bayer Parties’ Commercialization of any Licensed Product in the Licensed Territory is in accordance with Applicable Law, and this Agreement, Cytokinetics shall be solely responsible for ensuring that Cytokinetics’ and its Affiliates’ and Sublicensees’ Commercialization of any Licensed Product outside the terms of this Agreement shall prevail. Notwithstanding the foregoing, if a [***], Licensee shall [***] and shall promptly [***]Licensed Territory is in accordance with Applicable Law.

Commercialization Plan. (a) Not later than three Within [***] after submission of Regulatory Filings the first Approval Application for each a Product in each country the Co-Promote Territory is filed, the Steering Committee, or appropriate JPT, shall meet to discus the strategy for commercialization of the Territory, Licensee will provide to the JCC for review its initial Commercialization Plan for each Product for each country in the Co-Promote Territory. Such initial Commercialization Plan will describe Licensee’s plans for activities to be conducted for such Product for such country. Each Commercialization Plan shall include the details of obligations to be performed by Licensee to achieve the specific activities that are applicable to the stage of Within [***] Certain information the foregoing meeting of the Steering Committee or appropriate JPT, Genentech PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE BEEN FILED SEPARATELY WITH THE SECRETARY OF THE COMMISSION PURSUANT TO THE COMPANY'S APPLICATION REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24B-2 OF THE EXCHANGE ACT. shall submit to the Steering Committee, or appropriate JPT, an annual plan for the commercialization of such Product in this document has been omitted the Co-Promote Territory (the "Commercialization Plan"). Although Genentech shall be responsible for the creation of the Commercialization Plan, Altus, through the Steering Committee, or appropriate JPT, shall have the opportunity to comment on the Commercialization Plan, and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested Genentech shall reasonably consider Altus's comments with respect to the omitted portions. Commercialization (e.g., pre-launch, launch planning, launch, or post-launch) of the applicable Product during the time period covered by such Commercialization Plan and subsequent time periods. (b) Prior to the First Commercial Sale for such Product in such country, Licensee will provide to the JCC for review an updated Commercialization Plan for such Product for such country. Such updated Commercialization Plan will include, but not be limited to, Licensee’s updated plans for activities to be conducted for such Product for such country prior to launch as well as activities to be conducted in connection with such launch. (c) Promptly after each anniversary of the First Commercial Sale of such Product during the Term, Licensee will provide to the JCC for review updated Commercialization Plans for such Product for such country. Such further updated Commercialization Plan will include, but not be limited to, Licensee’s plans for Commercialization activities for such Product and such country for the twelve (12) month period following the date of delivery of such Commercialization Plan. No Genentech shall update the Commercialization Plan may be implemented by Licensee if on [***]. Each Commercialization Plan shall be consistent with and shall not contradict the terms of this Agreement [***], and in the event of any inconsistency between the Commercialization Plan and this Agreement, the terms of this Agreement shall prevail. Notwithstanding the foregoing, if a [***], Licensee shall Prior to each [***] of the Commercialization Plan, the Steering Committee, or appropriate JPT, shall meet to broadly review the past year's commercialization of Products in the Co-Promote Territory and discuss plans for commercialization of Products in the Co-Promote Territory in the upcoming year. Altus shall promptly [***]be kept apprised of the commercialization activity by and through the Steering Committee, or appropriate JPT. In addition, Genentech shall, as reasonably practicable, inform Altus between meetings of the Steering Committee, or appropriate JPT, of significant changes to the Commercialization Plan and any material events in the marketing and sales of Products in the Co-Promote Territory.

Commercialization Plan. Within sixty (a60) Not later than three [***] days after submission of Regulatory Filings for each Product in each country completion of the Territory, Licensee will provide to last clinical trial for the JCC NDA for review its initial Commercialization Plan for each Product for each the first country in the Territory. Such initial Commercialization Plan will describe Licensee’s plans for activities which an NDA is to be conducted for such Product for such countrymade, CONFORMA shall provide SUMITOMO with a three (3) year commercialization plan (“Commercialization Plan”) which will be updated by the end of third quarter every year. Each The Commercialization Plan shall include CONFORMA’s launch plans, such as publication planning, opinion development, positioning and pricing strategies, campaign development and annual marketing strategy for the details Product as well as annual sales forecast of obligations the Product in value separately for North America and Europe. CONFORMA’s commercialization plans shall set forth that CONFORMA will launch the Finished Product in the USA within three (3) months from the date on which the Authorization is granted in the USA and launch the Finished Product at least in three of five Major European Countries within one (1) year after receipt of Authorization in each such country. If CONFORMA foresees or becomes aware of any material delay in the commercialization plan that would delay the actual Launch date of the Finished Product more than ninety (90) days, CONFORMA will provide SUMITOMO with a description of the nature of the delay and a revised Annual Commercialization Plan for the impacted countries within sixty (60) days after becoming aware of such delay. If CONFORMA is not able to be performed by Licensee demonstrate to achieve SUMITOMO’s reasonable satisfaction that there are reasonable commercial reasons for the specific activities that are applicable material delay of the Launch date such as reasons related to pricing and reimbursement, SUMITOMO may terminate the stage of [***] Certain information rights granted to CONFORMA under this Agreement pursuant to Section 14.3. However, in case such material delay would occur only in Europe, SUMITOMO may terminate this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested Agreement only with respect to Europe, and upon such termination, all the omitted portions. Commercialization (e.g., pre-launch, launch planning, launch, or post-launch) member states of the applicable Product during Europe shall be excluded from the time period covered by such Commercialization Plan and subsequent time periodsTerritory If the delay is attributable to CONFORMA’s negligence or willful misconduct with respect to this Section 5.2. (b) Prior , SUMITOMO may, at its discretion, terminate this Agreement in its entirety pursuant to the First Commercial Sale for such Product in such country, Licensee will provide to the JCC for review an updated Commercialization Plan for such Product for such country. Such updated Commercialization Plan will includeSection 14.3., but not be limited to, Licensee’s updated plans for activities to be conducted for such Product for such country prior to launch as well as activities to be conducted in connection with such launchupon shorter notice period of thirty (30) days. (c) Promptly after each anniversary of the First Commercial Sale of such Product during the Term, Licensee will provide to the JCC for review updated Commercialization Plans for such Product for such country. Such further updated Commercialization Plan will include, but not be limited to, Licensee’s plans for Commercialization activities for such Product and such country for the twelve (12) month period following the date of delivery of such Commercialization Plan. No Commercialization Plan may be implemented by Licensee if [***]. Each Commercialization Plan shall be consistent with and shall not contradict the terms of this Agreement [***], and in the event of any inconsistency between the Commercialization Plan and this Agreement, the terms of this Agreement shall prevail. Notwithstanding the foregoing, if a [***], Licensee shall [***] and shall promptly [***].

Commercialization Plan. The Parties will discuss, through the Joint Commercialization Subcommittee, the Commercialization of the Products as provided in Section 4.2.2(b) and this Article VI and will agree upon a global commercialization plan (a) Not later than three [the “Global Commercialization Plan”), which will form the guiding principles for Commercialization activities for the Products in the Amicus Territory and the GSK Territory. An initial draft of the guiding principles to be used by the Joint Commercialization Subcommittee in developing the Global Commercialization Plan is attached hereto as Schedule 6.1. Promptly after the Restatement Effective Date, and in any event within ***] after submission *** prior to the first projected Launch of Regulatory Filings for each a Product in each country of the Territory, Licensee the Joint Commercialization Subcommittee shall develop and the Parties shall mutually agree upon a Global Commercialization Plan in accordance with the Global Commercialization Plan guiding principles set forth on Schedule 6.1. Thereafter, the Joint Commercialization Subcommittee will review and make any necessary mutually-agreed upon changes to the then-current Global Commercialization Plan and will provide quarterly updates to the JCC JSC with respect thereto in accordance with Section 4.2.2(c). The development of the Global Commercialization Plan and any changes thereto must be made by mutual agreement of the Parties, and neither Party shall have final decision making authority with respect to the Global Commercialization Plan. In the event that the JCS disagrees with respect to any proposed changes to the Global Commercialization Plan, such dispute shall be submitted for review its initial by the JSC at the next regularly scheduled JSC meeting. If the Parties via the JSC are unable to mutually agree on such disputed proposed changes to the then-current Global Commercialization Plan for each Product for each country in Plan, the Territory. Such initial Commercialization Plan will describe Licensee’s plans for activities to be conducted for such Product for such country. Each then-current Global Commercialization Plan shall include remain unmodified and such disagreement shall not be subject to further escalation or to dispute resolution in accordance with Section 4.1.5 or Section 16.2. The Parties will coordinate Commercialization activities in their respective territories, including coordination of marketing and branding activities, via the details Joint Commercialization Subcommittee. Notwithstanding the foregoing, pursuant to Section 4.1.5(c), each Party shall have final decision-making authority with respect to Commercialization of obligations Products in its respective territory pursuant to be performed by Licensee to achieve this Agreement, provided that each Party shall exercise its final decision-making authority in its respective territory in a manner that is consistent with the specific activities that are applicable to the stage of [Global Commercialization Plan. ***] Certain information in this document *** - Material has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. Commercialization (e.g., pre-launch, launch planning, launch, or post-launch) of the applicable Product during the time period covered by such Commercialization Plan and subsequent time periods. (b) Prior to the First Commercial Sale for such Product in such country, Licensee will provide to the JCC for review an updated Commercialization Plan for such Product for such country. Such updated Commercialization Plan will include, but not be limited to, Licensee’s updated plans for activities to be conducted for such Product for such country prior to launch as well as activities to be conducted in connection with such launch. (c) Promptly after each anniversary of the First Commercial Sale of such Product during the Term, Licensee will provide to the JCC for review updated Commercialization Plans for such Product for such country. Such further updated Commercialization Plan will include, but not be limited to, Licensee’s plans for Commercialization activities for such Product and such country for the twelve (12) month period following the date of delivery of such Commercialization Plan. No Commercialization Plan may be implemented by Licensee if [***]. Each Commercialization Plan shall be consistent with and shall not contradict the terms of this Agreement [***], and in the event of any inconsistency between the Commercialization Plan and this Agreement, the terms of this Agreement shall prevail. Notwithstanding the foregoing, if a [***], Licensee shall [***] and shall promptly [***].

Commercialization Plan. (a) Not later than three [***] after submission Without limiting the generality of Regulatory Filings Auxilium’s sole responsibility and decision-making authority for each Commercializing the Product in each country the Field in the Auxilium Territory as set forth in Section 4.2, Auxilium will use its Commercially Reasonable Efforts to carry out the Commercialization of the TerritoryProduct in accordance with a written Commercialization Plan, Licensee will provide as such may be amended or revised by Auxilium from time to time, that describes the JCC for review its initial anticipated Commercialization Plan for each Product for each country in the Territory. Such initial Commercialization Plan will describe Licensee’s plans for activities to be conducted for such performed with respect to Product for such countryin the Auxilium Territory by Auxilium or on its behalf by permitted Third Parties (the “Commercialization Plan”). Each Commercialization Plan shall include the details of obligations to be performed by Licensee to achieve the specific activities that are applicable address, in reasonable detail, to the stage extent applicable, call plans for Detailing of [***] Certain information in this document has been omitted Product, Sales Force training, Product sampling strategies and filed separately with the Securities quantities, Product positioning and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. Commercialization (e.g.scientific communication strategy, preand DTC and non-launch, launch planning, launch, or post-launch) of the applicable Product during the time period covered by such Commercialization Plan and subsequent time periodsDTC advertising. (b) Prior to the First Commercial Sale for such Product in such country, Licensee will provide to the JCC for review an updated Attached hereto as Exhibit A is a Commercialization Plan for such Product for such country. Such updated Commercialization Plan will include, but not be limited to, Licensee’s updated plans for activities to be conducted for such Product for such country prior to launch as well as covering activities to be conducted in connection with such launchpreparation of Product Launch in the Auxilium Territory and during the first full calendar year following the Product Launch. (c) Promptly after each anniversary Auxilium shall thereafter update the Commercialization Plan (together with the Medical Affairs Plan described in Section 4.7) on an annual basis as follows: Auxilium shall provide the JSC with preliminary drafts of the First Commercial Sale of such Product during the Term, Licensee will provide to the JCC for review updated Commercialization Plans for such Product for such country. Such further updated Commercialization Plan will include, but not be limited to, Licensee’s plans for Commercialization activities for such Product and such country Medical Affairs Plan no later than [**] of each year for the twelve (12) month period 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. In preparing the date updated versions of delivery the Commercialization Plan and Medical Affairs Plan, Auxilium shall analyze the effectiveness of such the elements of the prior year Commercialization Plan and Medical Affairs Plan and shall use updated sales forecasts to develop the new Commercialization Plan. No Auxilium agrees to give due consideration to the input provided by the JSC but Auxilium at all times will retain responsibility and decision-making authority for the Commercialization of 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 may be implemented and Medical Affairs Plan between annual updates by Licensee if [***]. 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 shall be consistent with and shall not contradict the terms of this Agreement [***], and in Medical Affairs Plan. (e) In the event of any inconsistency between between, on the one hand, the Commercialization Plan and or Medical Affairs Plan and, on the other hand, this Agreement, the terms of this Agreement shall prevail. Notwithstanding the foregoing, if a [***], Licensee shall [***] and shall promptly [***].