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Common use of Advertising and Promotional Materials Clause in Contracts

Advertising and Promotional Materials. The Commercial Lead for a particular Collaboration Program and territory shall develop relevant sales, promotion, market access and advertising materials relating to 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 other Party included in any Promotional Materials). 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 in the Commercial Lead.

Appears in 2 contracts

Samples: Option and Collaboration Agreement (Denali Therapeutics Inc.), Option and Collaboration Agreement (Denali Therapeutics Inc.)

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Advertising and Promotional Materials. The Commercial Lead As between the Parties, Cubist will be responsible for a particular Collaboration Program the creation, preparation, production, reproduction and territory shall develop filing with the applicable Regulatory Authorities, of relevant written sales, promotion, market access promotion and advertising materials relating to the Optioned Products within such Collaboration Program and territory Licensed Product (collectively, “Promotional Materials”) for use in each case the Territory. All such Promotional Materials will be compliant with all applicable Laws, and in the Profit Share Territory shall be consistent with Applicable the Commercialization Plan. Subject to any limitations imposed by applicable Law, the applicable Commercialization Plans and any determinations made by the JPT with respect to all 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 all documentary information and oral presentations (where practicable) regarding the interpretation marketing and Confidential 57 *** Certain information promotion of Licensed Product in this agreement has been omitted the Field in the Territory shall (a) acknowledge the Parties’ license arrangement and filed separately collaboration on Licensed Product, and (b) in the Profit-Share Territory, shall display the Cubist and Alnylam names and logos with the Securities and Exchange Commissionequal prominence. [***] indicates that text has been omitted and is the subject Copies 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 all Promotional Materials required by the applicable Regulatory Authority. Notwithstanding the foregoing, used 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 Territory will be used in such markets prior to the implementation of such Promotional Materials, archived by Cubist in accordance with applicable Law. Upon Alnylam’s reasonable request, copies of the process established core Promotional Materials used by Cubist in the JPTProfit-Share Territory shall be translated into English (where applicable) and provided to Alnylam, and the Commercial Lead costs of such translations shall give good faith consideration 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 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 core Promotional Materials for an Optioned Licensed Product for use in such market (except with respect to used by Alnylam or any Corporate Names of the other Party included in any Promotional Materials). 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 its Related Parties in the Commercial LeadField for Asia shall be translated into English (where applicable) and provided to Cubist.

Appears in 2 contracts

Samples: License and Collaboration Agreement (Cubist Pharmaceuticals Inc), License and Collaboration Agreement (Alnylam Pharmaceuticals, Inc.)

Advertising and Promotional Materials. The Commercial Lead for a particular Collaboration Program [ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED. (a) EXISTING PROMOTIONAL MATERIALS. At Aspreva's request, Roche shall, at its sole cost and territory shall develop relevant expense, provide and ship to Aspreva reasonable quantities of those promotional, sales, promotionmarketing, market access and advertising educational materials relating to for the Optioned Products within Product and all other written communications that describe the features or benefits of the Product, as such Collaboration Program and territory materials or communications then currently exist (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"EXISTING PROMOTIONAL MATERIALS"). The Commercial Lead shall be responsible for the medical, regulatory and legal review of Such Existing Promotional Materials shall include, by way of example, [ * ] As between Roche 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 MaterialsAspreva, 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 Roche 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 title, and interest in and to any such Existing Promotional Materials provided to Aspreva hereunder, including applicable copyrights and trademarks. Roche hereby grants to Aspreva the right, during the Term, to use all Existing Promotional Materials in conjunction with Aspreva Commercialization Activities under this Agreement, and to make derivative works based thereon as provided in Section 6.5(b), in all cases as provided in the Commercialization Plan. (b) ASPREVA PROMOTIONAL MATERIALS. Aspreva will be responsible for development of all advertising and promotional materials related to the use of the Product and all Promotional Materials for an Optioned Product for use other written communications that describe the features or benefits of the Product, in each case in the Field and in the Territory (the "ASPREVA PROMOTIONAL MATERIALS"), in accordance with Roche's style and branding guidelines, provided that Roche shall have the right to approve such market (except materials with respect to any Corporate Names determination of whether or not messages and methods contained in such materials meet all requisite medical, legal, and regulatory requirements, in accordance with the other Party included in any Promotional Materials)approval process set forth below. The Non-Commercial Lead will execute all documents and take all actions as are reasonably requested As a general principle, to the extent allowed by applicable law, Aspreva shall have the Commercial Lead right to vest title to such Promotional Materials include the Aspreva House Marks in the Commercial LeadAspreva Promotional [ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.

Appears in 2 contracts

Samples: Collaboration and Promotion Agreement (Aspreva Pharmaceuticals CORP), Collaboration and Promotion Agreement (Aspreva Pharmaceuticals CORP)

Advertising and Promotional Materials. The Commercial Lead for a particular Collaboration Program All marketing and territory ------------------------------------- promotional materials related to PRODUCT shall develop relevant salesbe prepared by ALZA, promotionsubject to review by USB in accordance with the procedures adopted by the COLLABORATION COMMITTEE. With respect to written and visual promotional or educational materials, market access and advertising materials relating to the Optioned Products within extent such Collaboration Program materials identify or otherwise make reference to either of the parties, USB and territory ALZA shall both be presented and described with equal prominence and emphasis as having joined and participated in the development and joint commercialization of PRODUCT, as permitted by applicable laws and regulations. All documentary information, promotional material and oral presentations (collectivelywhere practical) regarding the detailing and promoting of PRODUCT shall display the names and logos of USB and ALZA with equal prominence. ALZA shall provide USB with all promotional material for timely filing with the FDA in accordance with the then current FDA requirements, “Promotional Materials”) in each case consistent with Applicable Law(e.g. launch materials must be submitted to the FDA prior to launch, the applicable Commercialization Plans and any determinations made by the JPT with respect to such matters pursuant to Section 2.2.2(c)(ixother promotional material must be submitted at first use). The Commercial Lead Promptly after the EFFECTIVE DATE, USB shall be responsible designate ALZA to the FDA as the contact for the medicalreview and discussion of all promotional material, 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 after which time ALZA will so timely file with the Securities and Exchange CommissionFDA all promotional materials. [***] indicates In the event 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 MaterialsUSB determines that, including in USB's reasonable judgment, any advance review advertising or promotional materials prepared by ALZA are in violation of the Promotional Materials required by the applicable Regulatory Authority. Notwithstanding the foregoinglaw, in the event the Non-Commercial Lead is co-Commercializing the Optioned Products in any country within the Co-Commercialization Territoryrules, the Non-Commercial Lead 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 and comment on the Promotional Materials matter with the COLLABORATION COMMITTEE to see if a resolution can be used quickly achieved. In the event that resolution is not achieved in the COLLABORATION COMMITTEE, the parties shall submit such markets prior advertising or promotional materials to an independent regulatory expert mutually acceptable to the implementation 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-related advertising and promotional materials prepared by ALZA during the COPROMOTION PERIOD and any EXTENSION PERIOD and after the expiration or termination of such Promotional Materials, in accordance with period (but without the process established by use of ALZA's name). USB shall have the JPT, and the Commercial Lead shall give good faith consideration right to the Non-Commercial Lead’s comments regarding the Promotional Materials, including any comments related provide such materials 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 THIRD PARTIES for use in such market developing their own similar materials (except with respect to any Corporate Names but without the use of ALZA's name) for use outside the TERRITORY during and after the term of this AGREEMENT and within the TERRITORY after expiration or termination of the other Party included COPROMOTION PERIOD and any EXTENSION PERIOD only for use in any Promotional Materials)marketing the PRODUCT. The Non-Commercial Lead will execute all documents and take all actions as are reasonably requested USB shall, to the extent permitted by the Commercial Lead its agreements with THIRD PARTIES, allow ALZA to vest title to use such Promotional Materials THIRD PARTY'S PRODUCT- related promotional materials in the Commercial LeadTERRITORY 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 use reasonable efforts to obtain such right. Nothing contained in this Section 4.1 is intended to prevent either party from using any COMMERCIAL KNOW-HOW, such as a similar design, format, medium, etc., as used in or with the promotional materials for the PRODUCT, with its other products.

Appears in 1 contract

Samples: Distribution and Marketing Collaboration Agreement (U S Bioscience Inc)

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Advertising and Promotional Materials. The Commercial Lead for a particular Collaboration Program and territory Sanofi shall develop relevant sales, promotion, market access and advertising materials relating to 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 JCC with respect to such matters pursuant to Section 2.2.2(c)(ix‎2.3.2 (Specific Responsibilities) (as applicable). The Commercial Lead Sanofi 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 NonDenali exercises its Co‑Commercialization Option pursuant to Section 5.2.4 (Co-Commercial Lead is co-Commercializing the Optioned Products Commercialization Option in U.S. and China) in any country within the Co-Commercialization Territory, the Non-Commercial Lead Denali shall have the right to review and comment on the Promotional Materials for the applicable Co-Commercialization Product(s) to be used in such markets each applicable Co-Commercialization Country prior to the implementation of such Promotional Materials, in accordance with the process reasonable processes established by the JPTJCC, and the Commercial Lead Sanofi shall give good faith consideration to the Non-Commercial LeadDenali’s comments regarding the Promotional Materials, including any comments related to the Promotional Materials’ compliance with Applicable Law. The Commercial Lead for each market Sanofi 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 other Party Denali included in any Promotional Materials). The Non-Commercial Lead Denali will execute all documents and take all actions as are reasonably requested by the Commercial Lead Sanofi to vest title to such Promotional Materials in the Commercial LeadSanofi.

Appears in 1 contract

Samples: Collaboration and License Agreement (Denali Therapeutics Inc.)

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