Therapeutic Area Sample Clauses

Therapeutic Area. In addition to reviewing the overall Budget as provided above, the DT shall also review the Budget as it relates to (A) the Oncology Indications (the “Oncology Budget”) and (B) the Non-Oncology Indications (the “Non-Oncology Budget”) [***]. The DT may at any time propose amendments to the Oncology Budget and/or Non-Oncology Budget, such amendments to take into consideration [***] factors that may affect the Development Plan with respect to the applicable indications. The Financial Representatives will be responsible for identifying, analysing and reporting to the DT all significant Line Item variances between each of the Oncology Budget and the Non-Oncology Budget and the applicable Development Costs and all overall, total variances between each of the Oncology Budget and the Non-Oncology Budget and the Development Costs. The DT may reallocate funds as required within the Oncology Budget or within the Non-Oncology Budget without seeking the approval of the JSC. Notwithstanding the foregoing, (x) if any costs for Development activities result in a budget overrun of either the [***] approved Oncology Budget or Non-Oncology Budget, as the case may be, in excess of [***] percent [***], then the JSC shall have the right to review such excess costs and have the discretion to designate them as Development Costs, if the JSC determines that incurring such costs was in the best interests of the collaboration or (y) if the DT determines that funds should be reallocated from the Oncology Budget to the Non-Oncology Budget or from the Non-Oncology Budget to the Oncology Budget, then the JSC shall have the right to review such reallocation and such reallocation may not occur without JSC approval. Where the JSC does not designate excess costs as Development Costs as described under (x) above, then any such unapproved excess costs shall [***]
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Related to Therapeutic Area

  • Competing Products The provisions of Section 21 are set forth on attached Exhibit H and are incorporated in this Section 21 by this reference.

  • Licensed Product The term “Licensed Product” shall mean any product (a) the manufacture, use, importation, sale or offer for sale of which would, in the absence of the license granted by this Agreement, infringe a Valid Claim of any of the Licensed Patent Rights, or (b) that is comprised of, utilizes or incorporates Licensed Biological Materials, or (c) that is discovered, developed or made using a Licensed Process.

  • Clinical Trials The studies, tests and preclinical and clinical trials conducted by or on behalf of, or sponsored by, the Company, or in which the Company has participated, that are described in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus, or the results of which are referred to in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus, were and, if still pending, are being conducted in all material respects in accordance with protocols, procedures and controls pursuant to, where applicable, accepted professional and scientific standards for products or product candidates comparable to those being developed by the Company and all applicable statutes, rules and regulations of the FDA, the EMEA, Health Canada and other comparable drug and medical device (including diagnostic product) regulatory agencies outside of the United States to which they are subject; the descriptions of the results of such studies, tests and trials contained in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus do not contain any misstatement of a material fact or omit a material fact necessary to make such statements not misleading; the Company has no knowledge of any studies, tests or trials not described in the Disclosure Package and the Prospectus the results of which reasonably call into question in any material respect the results of the studies, tests and trials described in the Registration Statement, the Time of Sale Disclosure Package or Prospectus; and the Company has not received any notices or other correspondence from the FDA, EMEA, Health Canada or any other foreign, state or local governmental body exercising comparable authority or any Institutional Review Board or comparable authority requiring or threatening the termination, suspension or material modification of any studies, tests or preclinical or clinical trials conducted by or on behalf of, or sponsored by, the Company or in which the Company has participated, and, to the Company’s knowledge, there are no reasonable grounds for the same. Except as disclosed in the Registration Statement, the Time of Sale Disclosure Package and the Prospectus, there has not been any violation of law or regulation by the Company in its respective product development efforts, submissions or reports to any regulatory authority that could reasonably be expected to require investigation, corrective action or enforcement action.

  • Territory 33.1 This Agreement applies to the territory in which CenturyLink operates as an ILEC in the State. CenturyLink shall be obligated to provide services under this Agreement only within this territory. 33.2 Notwithstanding any other provision of this Agreement, CenturyLink may terminate this Agreement as to a specific operating territory or portion thereof pursuant to Section 6.7 of this Agreement.

  • RE-WEIGHING PRODUCT Deliveries are subject to re- weighing at the point of destination by the Authorized User. If shrinkage occurs which exceeds that normally allowable in the trade, the Authorized User shall have the option to require delivery of the difference in quantity or to reduce the payment accordingly. Such option shall be exercised in writing by the Authorized User.

  • Diagnostic procedures to aid the Provider in determining required dental treatment.

  • Competitive Products Competitive Products" means products that serve the same function as, or that could be used to replace, products the Company provided to, offered to, or was in the process of developing for a present, former, or future possible customer/partner at any time during the twelve (12) months immediately preceding the last day of Participant's employment (or at any time during Participant's employment if Participant was employed for less than 12 months), with which Participant had direct responsibility for the sale or development of such products or managing those persons responsible for the sale or development of such products.

  • Research Use The Requester agrees that if access is approved, (1) the PI named in the DAR and (2) those named in the “Senior/Key Person Profile” section of the DAR, including the Information Technology Director and any trainee, employee, or contractor1 working on the proposed research project under the direct oversight of these individuals, shall become Approved Users of the requested dataset(s). Research use will occur solely in connection with the approved research project described in the DAR, which includes a 1-2 paragraph description of the proposed research (i.e., a Research Use Statement). Investigators interested in using Cloud Computing for data storage and analysis must request permission to use Cloud Computing in the DAR and identify the Cloud Service Provider (CSP) or providers and/or Private Cloud System (PCS) that they propose to use. They must also submit a Cloud Computing Use Statement as part of the DAR that describes the type of service and how it will be used to carry out the proposed research as described in the Research Use Statement. If the Approved Users plan to collaborate with investigators outside the Requester, the investigators at each external site must submit an independent DAR using the same project title and Research Use Statement, and if using the cloud, Cloud Computing Use Statement. New uses of these data outside those described in the DAR will require submission of a new DAR; modifications to the research project will require submission of an amendment to this application (e.g., adding or deleting Requester Collaborators from the Requester, adding datasets to an approved project). Access to the requested dataset(s) is granted for a period of one (1) year, with the option to renew access or close-out a project at the end of that year. Submitting Investigator(s), or their collaborators, who provided the data or samples used to generate controlled-access datasets subject to the NIH GDS Policy and who have Institutional Review Board (IRB) approval and who meet any other study specific terms of access, are exempt from the limitation on the scope of the research use as defined in the DAR.

  • Commercialization License Subject to the terms of this Agreement, including without limitation Section 2.2 and Theravance's Co-Promotion rights in Section 5.3.2, Theravance hereby grants to GSK, and GSK accepts, an exclusive license under the Theravance Patents and Theravance Know-How to make, have made, use, sell, offer for sale and import Alliance Products in the Territory.

  • Speech Therapy This plan covers speech therapy services when provided by a qualified licensed • loss of speech or communication function; or • impairment as a result of an acute illness or injury, or an acute exacerbation of a chronic disease. Speech therapy services must relate to: • performing basic functional communication; or • assessing or treating swallowing dysfunction. See Autism Services when speech therapy services are rendered as part of the treatment of autism spectrum disorder. The amount you pay and any benefit limit will be the same whether the services are provided for habilitative or rehabilitative purposes.

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