Advertising and Promotional Materials. As between the Parties, Cubist will be responsible for the creation, preparation, production, reproduction and filing with the applicable Regulatory Authorities, of relevant written sales, promotion and advertising materials relating to Licensed Product (“Promotional Materials”) for use in the Territory. All such Promotional Materials will be compliant with all applicable Laws, and in the Profit Share Territory shall be consistent with the Commercialization Plan. Subject to any limitations imposed by applicable Law, all such Promotional Materials and all documentary information and oral presentations (where practicable) regarding the marketing and promotion of Licensed Product in the Field in the Territory shall (a) acknowledge the Parties’ license arrangement and collaboration on Licensed Product, and (b) in the Profit-Share Territory, shall display the Cubist and Alnylam names and logos with equal prominence. Copies of all Promotional Materials used in the Territory will be archived by Cubist in accordance with applicable Law. Upon Alnylam’s reasonable request, copies of the core Promotional Materials used by Cubist in the Profit-Share Territory shall be translated into English (where applicable) and provided to Alnylam, and the costs of such translations shall be Commercialization Costs. Upon Alnylam’s reasonable request and cost, copies of the core Promotional Materials used by Cubist in the Royalty Territory shall be translated into English (where applicable) and provided to Alnylam. Upon Cubist’s reasonable request and cost, copies of the core Promotional Materials for Licensed Product used by Alnylam or any of its Related Parties in the Field for Asia shall be translated into English (where applicable) and provided to Cubist.
Appears in 2 contracts
Samples: License and Collaboration Agreement (Alnylam Pharmaceuticals, Inc.), License and Collaboration Agreement (Cubist Pharmaceuticals Inc)
Advertising and Promotional Materials. As between the Parties, Cubist will be responsible The Commercial Lead for the creation, preparation, production, reproduction a particular Collaboration Program and filing with the applicable Regulatory Authorities, of territory shall develop relevant written sales, promotion promotion, market access and advertising materials relating to Licensed Product the Optioned Products within such Collaboration Program and territory (collectively, “Promotional Materials”) in each case consistent with Applicable Law, the applicable Commercialization Plans and any determinations made by the JPT with respect to such matters pursuant to Section 2.2.2(c)(ix). The Commercial Lead shall be responsible for the medical, regulatory and legal review of Promotional Materials and for the interpretation and Confidential 57 *** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request. adherence to the Applicable Law governing the preparation and use of such Promotional Materials, including any advance review of the Promotional Materials required by the applicable Regulatory Authority. Notwithstanding the foregoing, in the event the Non-Commercial Lead is co-Commercializing the Optioned Products in any country within the Co-Commercialization Territory, the Non-Commercial Lead shall have the right to review and comment on the Promotional Materials to be used in such markets prior to the implementation of such Promotional Materials, in accordance with the process established by the JPT, and the Commercial Lead shall give good faith consideration to the Non-Commercial Lead’s comments regarding the Promotional Materials, including any comments related to the Promotional Materials’ compliance with Applicable Law. The Commercial Lead for each market will own all right, title and interest in and to any and all Promotional Materials for an Optioned Product for use in such market (except with respect to any Corporate Names of the Territoryother Party included in any Promotional Materials). All The Non-Commercial Lead will execute all documents and take all actions as are reasonably requested by the Commercial Lead to vest title to such Promotional Materials will be compliant with all applicable Laws, and in the Profit Share Territory shall be consistent with the Commercialization Plan. Subject to any limitations imposed by applicable Law, all such Promotional Materials and all documentary information and oral presentations (where practicable) regarding the marketing and promotion of Licensed Product in the Field in the Territory shall (a) acknowledge the Parties’ license arrangement and collaboration on Licensed Product, and (b) in the Profit-Share Territory, shall display the Cubist and Alnylam names and logos with equal prominence. Copies of all Promotional Materials used in the Territory will be archived by Cubist in accordance with applicable Law. Upon Alnylam’s reasonable request, copies of the core Promotional Materials used by Cubist in the Profit-Share Territory shall be translated into English (where applicable) and provided to Alnylam, and the costs of such translations shall be Commercialization Costs. Upon Alnylam’s reasonable request and cost, copies of the core Promotional Materials used by Cubist in the Royalty Territory shall be translated into English (where applicable) and provided to Alnylam. Upon Cubist’s reasonable request and cost, copies of the core Promotional Materials for Licensed Product used by Alnylam or any of its Related Parties in the Field for Asia shall be translated into English (where applicable) and provided to CubistCommercial Lead.
Appears in 2 contracts
Samples: Option and Collaboration Agreement (Denali Therapeutics Inc.), Option and Collaboration Agreement (Denali Therapeutics Inc.)
Advertising and Promotional Materials. As between the PartiesAll marketing and ------------------------------------- promotional materials related to PRODUCT shall be prepared by ALZA, Cubist will be responsible for the creation, preparation, production, reproduction and filing subject to review by USB in accordance with the applicable Regulatory Authoritiesprocedures adopted by the COLLABORATION COMMITTEE. With respect to written and visual promotional or educational materials, to the extent such materials identify or otherwise make reference to either of relevant written salesthe parties, promotion USB and advertising materials relating to Licensed Product (“Promotional Materials”) for use ALZA shall both be presented and described with equal prominence and emphasis as having joined and participated in the Territorydevelopment and joint commercialization of PRODUCT, as permitted by applicable laws and regulations. All such Promotional Materials will be compliant with all applicable Lawsdocumentary information, and in the Profit Share Territory shall be consistent with the Commercialization Plan. Subject to any limitations imposed by applicable Law, all such Promotional Materials and all documentary information promotional material and oral presentations (where practicablepractical) regarding the marketing detailing and promotion promoting of Licensed Product in the Field in the Territory shall (a) acknowledge the Parties’ license arrangement and collaboration on Licensed Product, and (b) in the Profit-Share Territory, PRODUCT shall display the Cubist and Alnylam names and logos of USB and ALZA with equal prominence. Copies of ALZA shall provide USB with all Promotional Materials used in promotional material for timely filing with the Territory will be archived by Cubist FDA in accordance with applicable Lawthe then current FDA requirements, (e.g. launch materials must be submitted to the FDA prior to launch, and other promotional material must be submitted at first use). Upon Alnylam’s Promptly after the EFFECTIVE DATE, USB shall designate ALZA to the FDA as the contact for review and discussion of all promotional material, after which time ALZA will so timely file with the FDA all promotional materials. In the event that USB determines that, in USB's reasonable requestjudgment, copies any advertising or promotional materials prepared by ALZA are in violation of the core Promotional Materials used by Cubist law, rules, regulations or FDA guidelines or guidance, USB shall have the right to so advise ALZA in writing (the "USB Notice") and if ALZA is in disagreement, the parties shall review the matter with the COLLABORATION COMMITTEE to see if a resolution can be quickly achieved. In the event that resolution is not achieved in the ProfitCOLLABORATION COMMITTEE, the parties shall submit such advertising or promotional materials to an independent regulatory expert mutually acceptable to the parties. The parties shall expeditiously select such an expert and shall request expedited review. The parties shall meet with such expert within 10 days of selection of the expert to review such advertising and promotion and resolve the underlying dispute. From the date of the USB Notice, ALZA shall refrain from using such material and both parties shall fully comply with the final resolution of the dispute resolution process. USB shall have the right to reproduce, distribute and otherwise use all PRODUCT-Share Territory shall be translated into English (where applicable) related advertising and provided to Alnylam, promotional materials prepared by ALZA during the COPROMOTION PERIOD and any EXTENSION PERIOD and after the costs expiration or termination of such translations period (but without the use of ALZA's name). USB shall be Commercialization Costs. Upon Alnylam’s reasonable request have the right to provide such materials to THIRD PARTIES for use in developing their own similar materials (but without the use of ALZA's name) for use outside the TERRITORY during and cost, copies after the term of this AGREEMENT and within the TERRITORY after expiration or termination of the core Promotional Materials used COPROMOTION PERIOD and any EXTENSION PERIOD only for use in marketing the PRODUCT. USB shall, to the extent permitted by Cubist its agreements with THIRD PARTIES, allow ALZA to use such THIRD PARTY'S PRODUCT- related promotional materials in the Royalty Territory TERRITORY during the COPROMOTION PERIOD and any EXTENSION PERIOD. To the extent that USB enters into new agreements for commercialization of PRODUCT outside the TERRITORY, USB shall be translated into English (where applicable) and provided use reasonable efforts to Alnylamobtain such right. Upon Cubist’s reasonable request and costNothing contained in this Section 4.1 is intended to prevent either party from using any COMMERCIAL KNOW-HOW, copies of such as a similar design, format, medium, etc., as used in or with the core Promotional Materials promotional materials for Licensed Product used by Alnylam or any of the PRODUCT, with its Related Parties in the Field for Asia shall be translated into English (where applicable) and provided to Cubistother products.
Appears in 1 contract
Samples: Distribution and Marketing Collaboration Agreement (U S Bioscience Inc)