Common use of Commercialization Plan Clause in Contracts

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) 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 “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED. (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 as 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 Worldwide Development Plan.

Appears in 3 contracts

Sources: Master Collaboration Agreement (Bluebird Bio, Inc.), Master Collaboration Agreement (Bluebird Bio, Inc.), Master Collaboration Agreement (Bluebird Bio, Inc.)

Commercialization Plan. At (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 times 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 JGC First Commercial Sale of such Product during the Term, Licensee will deem appropriateprovide 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 JGC will direct twelve (12) month period following the Parties to mutually prepare a Worldwide Commercialization Plan, and the JGC will review and approve date of delivery of such initial Worldwide Commercialization Plan. Thereafter, the JGC will have one or the other Party (or both) update the Worldwide No 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 implemented 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) 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 “Licensee if [***]. 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 1933Each Commercialization Plan shall be consistent with and shall not contradict the terms of this Agreement [***], AS AMENDED. (b) Neither Party (itself or by or through and in the event of any others, including any Affiliates or Sublicensees) will take any material action regarding inconsistency between the Commercialization Plan and this Agreement, the terms of Licensed Product unless described in this Agreement shall prevail. Notwithstanding the Worldwide Commercialization Plan or approved by the JGCforegoing, if a [***], Licensee shall [***] and shall promptly [***]. (c) All Commercialization of Licensed Product for U.S. Administration will be conducted under the supervision of the JGC and as 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 Worldwide Development Plan.

Appears in 3 contracts

Sources: License Agreement (Coherus BioSciences, Inc.), License Agreement (Coherus BioSciences, Inc.), License Agreement (Coherus BioSciences, Inc.)

Commercialization Plan. At such times as the JGC will deem appropriate(a) Unless and until either Party has exercised its Opt-Out Right, 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 commencing no later than [**] prior to the Worldwide Commercialization Plan. Notwithstanding anything in this CCPS Agreement to anticipated launch of the contraryfirst Licensed Product, the Parties acknowledge shall prepare and agree deliver to the JCT an initial written plan and budget that describes in detail the Commercialization activities (iincluding pre-launch and launch activities, if applicable, but excluding Manufacturing activities which shall be addressed as set forth in Article VI) Bluebird may decline to perform any Commercialization activity proposed to be conducted by Bluebird undertaken with respect to Licensed Product(s) in the Worldwide 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 (other than Manufacturing of Vectors and associated Payloads)including the budget) shall allocate activities between the Parties, and (ii) shall contain sufficient detail with respect to Commercialization tactics and other matters to enable the Worldwide Commercialization Plan will not include, and Bluebird will have no obligation JCT to perform, any such Commercialization activity that Bluebird has declined to perform, provided that once Bluebird has agreed to perform conduct 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 meaningful review of the Worldwide Commercialization Plan. The Worldwide Parties shall seek to finalize the initial Commercialization Plan for the United States no later than [**] prior to launch of the first Licensed Product in the United States. It is intended that the Commercialization Plan will reflect a singular marketing and sales approach worldwide, and contemplate that the Parties will specify, among other things, the number of sales reps co-promote Licensed Product in the U.S. for each Party, allocation of regions United States in the U.S. for a manner that reflects each Parties’ capabilities and that is consistent with each Parties’ promotional efforts for its own products of similar market potential. The Parties shall negotiate in good faith a co-promotion agreement that is consistent with the terms of this Agreement, taking into account the Parties’ respective capabilities, including terms related to term of co-promotion activities, auditing of sales forcedetails, creation of marketing materialsmechanisms to address underperformance and failure to perform details at agreed upon levels, planning for conferencessales force training, and other marketing activities. CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933customary terms, AS AMENDEDwith a view to finalizing and entering into such co-promotion agreement as soon as reasonably practicable. (b) Neither Party (itself In addition to annual updates or by or through any others, including any Affiliates or Sublicensees) will take any material action regarding modifications to the Commercialization of Licensed Product unless described in Plan decided by the Worldwide JCT pursuant to Section 2.2(c), either Party may develop and submit to the JCT from time to time proposed amendments to the Commercialization Plan or approved (excluding any amendment to the budget, which amendment shall require the approval of both Parties outside the JCT). Upon approval of such proposed amendments by the JGCJCT (subject to the limitations set forth in Section 2.2(d)), the Commercialization Plan shall be amended accordingly. (c) All Commercialization of Licensed Product for U.S. Administration will be conducted under the supervision of the JGC and as 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 Worldwide Development Plan.

Appears in 2 contracts

Sources: Collaboration Agreement (Arrowhead Research Corp), Collaboration Agreement (Alnylam Pharmaceuticals, Inc.)

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) 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 “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED. (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 as 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 Worldwide Development Plan.

Appears in 2 contracts

Sources: Master Collaboration Agreement (2seventy Bio, Inc.), Master Collaboration Agreement (Bluebird Bio, Inc.)

Commercialization Plan. At such times as the JGC will deem appropriate[***], the JGC Parties, under the direction of 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 yearyear [***], 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) 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 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. CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED. (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 as part of the U.S. Development & Commercialization Program. (d) Celgene will have final decision decision-making authority for all Commercialization activities worldwide, including timing of launch and pricing and the Worldwide Development Commercialization Plan. (e) [***], the Parties shall negotiate and enter into a co-promotion agreement that will set forth the terms upon which the Parties shall co-promote the Licensed Product in the U.S., which terms shall be consistent with this Article 5.

Appears in 2 contracts

Sources: Co Development, Co Promote and Profit Share Agreement (2seventy Bio, Inc.), Co Development, Co Promote and Profit Share Agreement (Bluebird Bio, Inc.)

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) 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 JGC will set Commercialization Plan for the required form and contents first full year following commercial launch of the Worldwide Commercialization Plan. The Worldwide Commercialization Plan first Product for which an NDA is filed with the FDA will reflect a singular marketing and sales approach worldwidebe provided to Neuren by ACADIA as soon as it is available but, and will specifyin any event, 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 “no later than [***]”…] days after the filing of the NDA for such Product with the FDA. 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 1933Such initial Commercialization Plan shall provide a reasonably detailed plan for ACADIA’s (or its Affiliate’s or Sub-Licensee’s) Commercialization activities with respect to such Product, AS AMENDEDincluding pre-launch plans and launch plans, pricing, label expansion and market positioning (which information may be preliminary). ACADIA may amend the Commercialization Plan from time to time in its discretion. (b) Neither Party (itself or by or through any othersThroughout the Term, including any Affiliates or Sublicensees) will take any material action regarding at each JSC meeting pursuant to clause 4.4, ACADIA shall update the Commercialization JSC of Licensed Product unless described progress in the Worldwide Commercialization Plan or approved by Marketing Authorisations of the JGCProduct in the Territory, and Neuren shall provide the JSC updates of progress in the Marketing Authorisations of the Product outside the Territory. (c) All During the first […***…] years after launch, appropriate executives of Neuren and ACADIA shall meet at least […***…] per calendar year to discuss and review the Commercialization of Licensed Product for U.S. Administration will be conducted under the supervision Plan, if provided, and ACADIA’s progress towards achievement of the JGC Commercialization Plan and as part to discuss and review the marketing and sales of each Product in the U.S. Development & Commercialization ProgramTerritory. Unless the parties otherwise agree, the meetings will take place in San Diego. (d) Celgene will have final decision making authority for all Commercialization activities worldwide, including timing of launch and pricing and the Worldwide Development Plan.

Appears in 2 contracts

Sources: Licence Agreement (Acadia Pharmaceuticals Inc), Licence Agreement (Acadia Pharmaceuticals Inc)

Commercialization Plan. At such times as The Parties will discuss, through the JGC will deem appropriateJoint Commercialization Subcommittee, the JGC Commercialization of the Products as provided in Section 4.2.2(b) and this Article VI and will direct agree upon a global commercialization plan (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 ****** prior to the first projected Launch of a Product in the Territory, the Joint Commercialization Subcommittee shall develop and the Parties to shall mutually prepare agree upon a Worldwide Global Commercialization Plan, and Plan in accordance with the JGC will review and approve such initial Worldwide Global Commercialization PlanPlan guiding principles set forth on Schedule 6.1. Thereafter, the JGC will have one or the other Party (or both) update the Worldwide Joint Commercialization Plan each calendar year, and the JGC Subcommittee will review and approve make any such update or any other amendment necessary mutually-agreed upon changes 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 then-current Global 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 provide quarterly updates to the Worldwide Commercialization PlanJSC with respect thereto in accordance with Section 4.2.2(c). Further: (a) The JGC will set the required form and contents development of the Worldwide Commercialization Plan. The Worldwide Global Commercialization Plan will reflect a singular marketing and sales approach worldwideany changes thereto must be made by mutual agreement of the Parties, 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 “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED. (b) Neither 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 as part of the U.S. Development & Commercialization Program. (d) Celgene will 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 all review 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, the then-current Global Commercialization Plan shall 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 worldwidein their respective territories, including timing coordination of launch marketing and pricing branding activities, via the 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 Products in its respective territory pursuant to 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 Global Commercialization Plan. ****** - Material has been omitted and filed separately with the Worldwide Development PlanCommission.

Appears in 1 contract

Sources: License and Collaboration Agreement (Amicus Therapeutics Inc)

Commercialization Plan. At such times as Within sixty (60) days after completion of the JGC will deem appropriatelast clinical trial for the NDA for the first country in which an NDA is to be made, the JGC will direct the Parties to mutually prepare CONFORMA shall provide SUMITOMO with a Worldwide three (3) year commercialization plan (“Commercialization Plan”) which will be updated by the end of third quarter every year. 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 Product as well as annual sales forecast of 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 demonstrate to SUMITOMO’s reasonable satisfaction that there are reasonable commercial reasons for the material delay of the Launch date such as reasons related to pricing and reimbursement, SUMITOMO may terminate the 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 Agreement only with respect to Europe, and upon such termination, all 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) The JGC will set the required form and contents member states of the Worldwide Commercialization Plan. The Worldwide Commercialization Plan will reflect a singular marketing and sales approach worldwideEurope shall be excluded from the Territory If the delay is attributable to CONFORMA’s negligence or willful misconduct with respect to this Section 5.2., and will specifySUMITOMO may, among other thingsat its discretion, the number terminate this Agreement in its entirety pursuant to Section 14.3., but upon shorter notice period 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 “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDEDthirty (30) days. (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 as 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 Worldwide Development Plan.

Appears in 1 contract

Sources: License Agreement (Pharmion Corp)

Commercialization Plan. At such times as (a) All Commercialization of the JGC will deem appropriate, Licensed Product by or on behalf of Bayer in the JGC will direct Licensed Territory under this Agreement shall be conducted in accordance with a written plan that is submitted to the Parties to mutually prepare a Worldwide JCC for review by Bayer (the “Commercialization Plan, and the JGC will review and approve such ”) as amended from time to time. The 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 submitted by Bayer to the Worldwide Commercialization Plan. Further: JCC no later than twelve (a12) The JGC will set months before the required form and contents anticipated date of the Worldwide Commercialization Plansubmission of the first NDA for the Licensed Product in the Field in the Licensed Territory. The Worldwide Commercialization Plan will reflect a singular marketing and sales approach worldwide, and will specify, among other things, any updates or amendments to 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 “Commercialization Plan shall [***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED. (b) Neither Party (itself From time to time, [*] Bayer shall prepare updates or by or through any othersamendments to the Commercialization Plan to reflect changes in such plans, including any Affiliates or Sublicensees) will take 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 action regarding updates or amendments to the Commercialization Plan to JCC for review 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 shall not be [*] with the Global Commercialization Concepts, meaning that Bayer’s Commercialization activities in the Licensed Territory will not deviate from the Global Commercialization Concepts in a manner that [*] impact on Exploitation of Compound and Licensed Product unless described in the Worldwide Commercialization Plan or approved by Field outside the JGCLicensed Territory. (c) All Bayer shall notify Cytokinetics in case of any concern that any Commercialization activities contemplated in the Commercialization Plan may be in violation of Applicable Law, and the Parties shall discuss any 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 Cytokinetics shall be solely responsible for U.S. Administration will be conducted under ensuring that Cytokinetics’ and its Affiliates’ and Sublicensees’ Commercialization of any Licensed Product outside the supervision of the JGC and as part of the U.S. Development & Commercialization ProgramLicensed Territory is in accordance with Applicable Law. (d) Celgene will have final decision making authority for all Commercialization activities worldwide, including timing of launch and pricing and the Worldwide Development Plan.

Appears in 1 contract

Sources: Collaboration and License Agreement (Cytokinetics Inc)

Commercialization Plan. At such times as Within [***] the JGC will deem appropriatefirst Approval Application for a Product in the Co-Promote Territory is filed, the JGC will direct Steering Committee, or appropriate JPT, shall meet to discus 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 strategy for commercialization of Product in the Worldwide Commercialization Plan (other than Manufacturing of Vectors and associated Payloads), and (ii) Co-Promote Territory. Within [***] 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) The JGC will set the required form and contents foregoing meeting of the Worldwide Commercialization Plan. The Worldwide Commercialization Plan will reflect a singular marketing and sales approach worldwideSteering Committee or appropriate JPT, 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 Genentech PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS HAVE BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN THE COMPANY'S APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO UNDER RULE 406 PROMULGATED UNDER 24B-2 OF THE SECURITIES ACT OF 1933EXCHANGE ACT. shall submit to the Steering Committee, AS AMENDED. or appropriate JPT, an annual plan for the commercialization of such Product in the Co-Promote Territory (b) Neither Party (itself 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 Genentech shall reasonably consider Altus's comments with respect to the Commercialization Plan. Genentech shall update the Commercialization Plan on [***]. 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 be kept apprised of the commercialization activity by and through the Steering Committee, or through any othersappropriate JPT. In addition, including any Affiliates Genentech shall, as reasonably practicable, inform Altus between meetings of the Steering Committee, or Sublicensees) will take appropriate JPT, of significant changes to the Commercialization Plan and any material action regarding the Commercialization of Licensed Product unless described events in the Worldwide Commercialization Plan or approved by marketing and sales of Products in the JGCCo-Promote Territory. (c) All Commercialization of Licensed Product for U.S. Administration will be conducted under the supervision of the JGC and as 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 Worldwide Development Plan.

Appears in 1 contract

Sources: Collaboration and License Agreement (Altus Pharmaceuticals Inc.)

Commercialization Plan. At such times (a) 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 carry out the JGC will deem appropriate, Commercialization of the JGC will direct the Parties to mutually prepare Product in accordance with a Worldwide 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”). Each Commercialization Plan shall address, in reasonable detail, to the extent applicable, call plans for Detailing of Product, Sales Force training, Product sampling strategies and quantities, Product positioning and scientific communication strategy, and DTC and non-DTC advertising. (b) Attached hereto as Exhibit A is a Commercialization Plan covering activities to be conducted in preparation of Product Launch in the JGC will Auxilium Territory and during the first full calendar year following the Product Launch. (c) Auxilium shall thereafter update the Commercialization Plan (together with the Medical Affairs Plan described in Section 4.7) on an annual basis as follows: Auxilium shall provide the JSC with preliminary drafts of the Commercialization Plan and Medical Affairs Plan no later than [**] of each year for the JSC’s review and approve 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 initial Worldwide year. In preparing the updated versions of the Commercialization Plan and Medical Affairs Plan, Auxilium shall analyze the effectiveness of the elements of the prior year Commercialization Plan and Medical Affairs Plan and shall use updated sales forecasts to develop the new Commercialization Plan. 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 Auxilium agrees to give due consideration to the Worldwide input provided by the JSC but Auxilium at all times will retain responsibility and decision-making authority for the Commercialization Plan. Notwithstanding anything in this CCPS Agreement to of the contrary, the Parties acknowledge and agree that (i) Bluebird may decline to perform any Commercialization activity proposed to be conducted by Bluebird Product 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) 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 “[***]”. A COMPLETE VERSION OF INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND WILL BE FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING A CONFIDENTIAL TREATMENT PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933REQUEST. Field in the Auxilium Territory. Auxilium may, AS AMENDED. (b) Neither Party (itself or by or through any othersat its election, including any Affiliates or Sublicensees) will take any material action regarding update the Commercialization of Licensed Product unless described in the Worldwide Commercialization Plan or approved and Medical Affairs Plan between annual updates by the JGC. (c) All Commercialization of Licensed Product for U.S. Administration will be conducted under the supervision of the JGC and as part of the U.S. Development & Commercialization Programfollowing this same procedure. (d) Celgene will have final decision making authority for all Each Party shall use Commercially Reasonable Efforts in performing its obligations under this Section 4.3 concerning (as applicable) the Commercialization activities worldwide, including timing of launch Plan and pricing and the Worldwide Development Medical Affairs Plan. (e) In the event of any inconsistency between, on the one hand, the Commercialization Plan or Medical Affairs Plan and, on the other hand, this Agreement, the terms of this Agreement shall prevail.

Appears in 1 contract

Sources: License and Commercialization Agreement (Auxilium Pharmaceuticals Inc)

Commercialization Plan. At No later than [***] prior to the anticipated First Commercial Sale of a DT Co-Co Product in the Territory, Moderna and Metagenomi shall prepare and submit to the JCC, an initial Commercialization Plan for such times as DT Co-Co Product, which will set forth a reasonably detailed description of anticipated Commercialization activities for the JGC will deem appropriateapplicable DT Co-Co Products in the Territory, including the JGC will direct corresponding Commercialization Budget. The Commercialization Plan shall also contain a [***] rolling annual plan for the Parties to mutually prepare global Commercialization activities for the DT Co-Co Product in the Territory and the Commercialization Budget shall include a Worldwide [***] 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. The JCC shall prepare, review, and discuss, and the JGC will review JSC shall review, discuss, and approve such initial Worldwide Commercialization Plan. Thereafterdetermine whether to approve, the JGC will have one or the other Party (or both) update the Worldwide each Commercialization Plan for a DT Co-Co Product. Moderna shall have the sole right to select the Product Marks for each calendar yearDT Co-Co Product to be used in Moderna’s Region and included in the applicable Commercialization Plan and may decide to develop and adopt certain distinctive colors, 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 Moderna’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, 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 JGC will 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 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 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 applicable Commercialization Plan (other than Manufacturing of Vectors and associated Payloads), and (ii) the Worldwide corresponding Commercialization Budget. Each such update to a Commercialization Plan will not include, and Bluebird will have no obligation to perform, any such corresponding 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, Budget shall become effective and cannot decline to perform, such activity. In addition, either Party may request at any time that shall supersede 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 previous 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 “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED. (b) Neither Party (itself or by or through any others, including any Affiliates or Sublicensees) will take any material action regarding the corresponding Commercialization of Licensed Product unless described in the Worldwide Commercialization Plan or approved Budget upon approval thereof by the JGCJSC. (c) All Commercialization of Licensed Product for U.S. Administration will be conducted under the supervision of the JGC and as 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 Worldwide Development Plan.

Appears in 1 contract

Sources: Strategic Collaboration and License Agreement (Metagenomi Technologies, LLC)

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) 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 “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 (each an “Initial Launch Country), target release dates and other actions necessary to achieve Commercial Launch in each Initial Launch Country (the “Initial Commercialization Plan”). A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933Throughout the Term, AS AMENDED. the Parties or the JSC may identify additional target jurisdictions within the Territory (btogether with the Initial Launch Country, each a “Launch Country” and collectively, the “Launch Countries”) Neither Party for Commercial Launch and [***] prior to the respective Target Launch Date, prepare and approve a commercialization plan for such additional Launch Country (itself each, a “Launch Country Commercialization Plan”, and together with the Initial Commercialization Plan, the “Commercialization Plans”). The Parties agree that the first Launch Countries shall be [***]. The following markets will be 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 Integration Plan and Regulatory Plan. For clarity, each Commercialization Plan will focus solely on the activities necessary for the Parties to coordinate timing and announcement of Commercial Launch within each Launch Country, and will not otherwise dictate, control, or by or through any othersgovern MDT’s marketing, including any Affiliates or Sublicensees) will take any material action regarding the sale, and Commercialization of Licensed Product unless described the 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 Worldwide Commercialization Plan or approved determination by the JGCParties to launch the ADC-MDT System in a Launch Country, then the Parties shall negotiate in good faith an amendment to this Agreement prior to Commercial Launch. (c) All Commercialization of Licensed Product for U.S. Administration will be conducted under the supervision of the JGC and as 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 Worldwide Development Plan.

Appears in 1 contract

Sources: Integration, Supply and Distribution Agreement (MiniMed Group, Inc.)