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 [***].

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, 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 [***].

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. (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.

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) 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 [***].

Appears in 2 contracts

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

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.

Appears in 2 contracts

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

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.

Appears in 1 contract

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

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 [***].

Appears in 1 contract

Sources: License and Collaboration Agreement (Amicus Therapeutics Inc)

Commercialization Plan. All Commercialization with respect to a Product under this Agreement shall be conducted pursuant to a Commercialization Plan, which shall set forth the plan for the Commercialization of such Product and the activities to be carried out with respect thereto, together with a proposed budget for such activities (a) Not later than three [***] after submission of Regulatory Filings for each Product in each country of each, a “Commercialization Plan”). The Parties, through the TerritoryJSC, Licensee will provide to the JCC for review its initial shall agree upon a preliminary Commercialization Plan for each Product for each country in the Territory. Such initial Commercialization Plan will describe Licensee’s plans for activities at least ************ prior to be conducted anticipated Regulatory Approval for such Product for such countryProduct. Each A copy of each Commercialization Plan shall include be attached hereto as part of Exhibit C. During the details of obligations Commercialization Phase with respect to be performed by Licensee each Product, the Parties, through the JSC, shall update the Commercialization Plan with respect to achieve the specific activities that are applicable such Product on an annual basis prior to the stage commencement of [the next calendar year, or more often as determined by the JSC. Each updated Commercialization Plan shall include, for the subsequent ***] Certain information *********, the projection of the plan for Commercialization Activities for the Product in this document has been omitted each Territory and filed separately timelines for performing such activities, the projected Net Sales and other revenues from the sale of the Product, together with an updated Commercialization budget. The Commercialization Plan shall contain an estimation of the resources that each Party intends to employ in connection with the Securities Commercialization of the relevant Product. In addition, the JSC will review performance against the Commercialization Plan for each Product on a quarterly basis, and Exchange Commission. Confidential treatment has been requested with respect will report any variations to the omitted portionsParties in writing. If, in any quarter, there is a variation of ************ or greater from the budget or from projected Net Sales and other revenues, the JSC will revise the Commercialization (e.g., pre-launch, launch planning, launch, or post-launch) of Plan and budget for the applicable Product during ************ prior to the time period covered by such commencement of the second quarter following the quarter in which the variation occurred. For example, if a ************ variation is reported in quarter one of a calendar year, a revised Commercialization Plan and subsequent time periods. (b) Prior budget must be prepared at least ************ prior to the First Commercial Sale for commencement of quarter three of such Product in calendar year. Until such country, Licensee will provide to the JCC for review time as an updated Commercialization Plan for such Product for such country. Such updated is approved in accordance with this Section 6.1, the preceding Commercialization Plan will include(including, but without limitation, all budget projections therein) shall remain in effect. The JSC shall 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 approve any 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 that is inconsistent with and shall not contradict or contradicts 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 [***].

Appears in 1 contract

Sources: Joint Development and Commercialization Agreement (GTC Biotherapeutics Inc)

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.

Appears in 1 contract

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

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 [***].

Appears in 1 contract

Sources: License Agreement (Pharmion Corp)