Promotional Materials. The Lead Party will be responsible, , the Global Commercialization Plan and the Country/Region Commercialization Plans (as applicable), including the U.S. Commercialization Plans (as applicable), for the creation, preparation, production and reproduction of all Promotional Materials and for filing, as appropriate, all Promotional Materials with all Regulatory Authorities in the world. Without limiting [Section 10.11], the JCC shall review and comment on .
Contributed Materials. To facilitate the conduct of activities hereunder, a Party shall provide the , collectively, “Materials”). Except as is set forth in the Product R&D Plan with respect to a Regeneron Co-Funding Product or a Party agrees to provide Materials to the other Party as set forth in a Plan, neither Party shall be obligated to provide any Materials to the other Party. Neither Party shall use the Materials of the other Party except in accordance with a Plan. All such Materials will remain the sole property of the providing Party. The receiving Party will # itself retain control of all such Materials, # use such Materials only in the fulfillment of obligations or exercise of rights under this Agreement, # not use such Materials or deliver the same to, or for the benefit of, any Third Party, without the providing Party’s prior written consent and # not use such Materials in research or testing involving human subjects, without the providing Party’s prior written . The Materials supplied under this [Section 7.7] are supplied “as is”, and accordingly the receiving Party agrees to use prudence and appropriate caution in the use, handling, storage, transportation and disposition and containment of all such Materials, as not all of their characteristics may be known. .
Hazardous Materials. The term "Hazardous Materials" means any substance, material, or waste which is now or hereafter classified or considered to be hazardous, toxic, or dangerous under any Law relating to pollution or the protection or regulation of human health, natural resources or the environment, or poses or threatens to pose a hazard to the health or safety of persons on the Premises or in the Project. Subject to Section 9(c), Tenant shall not use, generate, store, or dispose of, or permit the use, generation, storage or disposal of Hazardous Materials on or about the Premises or the Project except in a manner and quantity necessary for the ordinary performance of Tenant's business, and then in compliance with all Laws. If Tenant breaches its obligations under this Section 25(w), Landlord may immediately take any and all action reasonably appropriate to remedy the same, including taking all appropriate action to clean up or remediate any contamination resulting from Tenant's use, generation, storage or disposal of Hazardous Materials. Tenant shall not undertake, nor shall Tenant permit any Tenant Party to undertake, any invasive investigation, drilling or sampling of the soil or groundwater at the Premises, the Building, the Project or the Complex without the prior written consent of Landlord, which consent shall be in Landlord's sole discretion. TENANT SHALL DEFEND, INDEMNIFY, AND HOLD HARMLESS LANDLORD AND ITS REPRESENTATIVES AND AGENTS FROM AND AGAINST ANY AND ALL CLAIMS, DEMANDS, LIABILITIES, CAUSES OF ACTION, SUITS, JUDGMENTS, DAMAGES AND EXPENSES (INCLUDING REASONABLE ATTORNEYS' FEES AND COST OF CLEANUP AND REMEDIATION) ARISING FROM TENANT'S FAILURE TO COMPLY WITH THE PROVISIONS OF THIS SECTION 25(W). THIS INDEMNITY PROVISION SHALL SURVIVE TERMINATION OR EXPIRATION OF THIS LEASE.
Promotional Materials. Novos shall be responsible managing and supervising the Sales Forces’ promotion of the Product in the Territory in accordance with the Commercialization Plan, including without limitation, designing and producing promotional, marketing and educational materials (in any form or medium), such as printed brochures, videos, and other materials for use by Sales Force representatives, distributors or medical providers or in advertisements or web sites ("Promotional Materials"). Notwithstanding the foregoing, Evoke shall retain final approval rights over the Promotional Materials, which approval rights shall not be unreasonably withheld, and final responsibility for the compliance of, and for monitoring for compliance of, all Commercialization activities and the Sales Force with Applicable Law. Novos shall provide Evoke with copies of all Promotional Materials in a timely manner to pursue regulatory review where appropriate. No Promotional Materials will be distributed without prior written consent by Evoke.
During the course of a Collaboration Program, either Party (or such Party’s designee) (the “Materials Transferring Party”) may transfer to the other Party or its designee (the “Materials Receiving Party”) certain Materials for use in connection with activities contemplated under a particular Collaboration Plan; provided, that for clarity any Material transfer contemplated in connection with the conduct of the [[Unknown Identifier]] Combination Study shall be as set forth in the [[Unknown Identifier]] CTCSA. Such Materials will be provided under the terms and conditions of this Agreement and in such amount as described in the material transfer record for the particular transfer (“MTR”), in the form attached hereto as [Schedule 3.2.5], which MTR shall set forth the type and name of the Materials transferred, the amount of the Materials transferred, the date of the transfer of such Materials and the proposed use of such Materials by the Material Receiving Party.
Active Materials. Except as expressly set forth in [Section 2.2], under no circumstances will [[Organization A:Organization]] be responsible for any loss or damage to the Active Materials. [[Organization A:Organization]]’s maximum responsibility for loss or damage to the Active Materials will not exceed the Maximum Credit Value set forth in [Schedule D] of a Product Agreement.
Raw Materials. Lonza shall procure all required Raw Materials as well as consumables. Customer shall be responsible for payment for all consumables and Raw Materials ordered or irrevocably committed to be procured by Lonza hereunder for the manufacture of Batches pursuant to Binding Orders. If agreed by the Parties, upon advance payment by Customer, Lonza shall purchase and hold a minimum of [Redacted] to serve as safety stock, as well as [Redacted]. Upon cancellation of any Batch pursuant to a Binding Order or termination of the Agreement, all such unused Raw Materials shall be [Redacted].
Materials Certifications. FIS shall prepare or cause to be prepared by FISs, as the case may be, certifications as to any Materials required by cGMPs or Laws (each, a “Materials Certification”), as detailed in the Quality Agreement.
Offering Materials. None of the Company, its officers and directors has distributed or will distribute prior to the Closing Date any offering material, including any “free writing prospectus” (as defined in Rule 405 promulgated under the Securities Act), in connection with the offering and sale of the Notes.
Regulatory Materials. Ji Xing shall provide [[Cytokinetics:Organization]] with drafts in English of all Regulatory Materials in a reasonable time (in any event no less than for Regulatory Materials other than an NDA or other application for Regulatory Approval, which shall be drafted and reviewed based on a schedule to be agreed by the Parties) prior to submission for review and comment, and shall consider in good faith any comments received from [[Cytokinetics:Organization]], which shall be provided within of receipt. For clarity, . In addition, Ji Xing shall notify [[Cytokinetics:Organization]] of any Regulatory Materials submitted to or received from any Regulatory Authority in the Territory and shall provide [[Cytokinetics:Organization]] with copies thereof within after submission or receipt, and shall notify [[Cytokinetics:Organization]] of any other material communication with any Regulatory Authority in the Territory within after such communication. If any such Regulatory Material is not in the English language, Ji Xing shall also, provide [[Cytokinetics:Organization]] with an English summary at the time of provision and a true, complete, accurate and certified English translation thereof as soon as practicable. If necessary, [[Cytokinetics:Organization]] shall assist Ji Xing in addressing any additional requirements requested by any Regulatory Authority in the Territory within a reasonable time (depending on the events), including providing existing supplementary data or documentation.
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