Clinical Costs definition
Clinical Costs means all costs and expenses incurred by Eton or its Affiliates in connection with any preclinical, clinical or bioequivalence studies for Product less the *** Development Costs.
Clinical Costs means the costs incurred by a Party or for its account, during the term and pursuant to this Agreement, in connection with clinical studies of a Product, whether alone or in combination with another product or agent, including the following: (a) the preparation for and conduct of clinical trials (except for related Manufacturing Costs otherwise included in Development Costs); (b) data collection and analysis, and report writing; and (c) clinical laboratory work. The Clinical Costs shall exclude costs incurred in connection with Phase IV Clinical Trials and investigator * Certain information on this page has been omitted and filed separately with the SEC. Confidential treatment has been requested with respect to the omitted portions. sponsored clinical trials, and post-marketing surveillance activities, which shall be considered Sales and Marketing Costs.
Clinical Costs means the costs incurred by a Party or for its account, during the term and pursuant to this Agreement, in connection with clinical studies of a Co-Developed Product in the Co-Development Territory, including the following: (a) the preparation for and conduct of clinical trials (except for related Manufacturing Costs otherwise included in Development Costs); (b) data collection and analysis, and report writing; and (c) clinical laboratory work. The Clinical Costs shall exclude costs incurred in connection with [*].
Examples of Clinical Costs in a sentence
Reports before the First Commercial Sale of such Product will only detail amounts Eton has spent on Clinical Costs and Recovery Amounts.
As used herein, the “Recoupable Costs” of a Product(s) shall mean the Reimbursable Clinical Costs with respect to such Product(s) actually paid by Taiho under Section 9.1.4 (less any amounts repaid to Taiho under Section 9.1.4(b) above).
It is understood, however, that MG shall not be obligated to incur any costs in performing the Plans and Budgets that are not reimbursed by Taiho, except that it is understood that Taiho shall be obligated to reimburse only the Reimbursable Clinical Costs of the Approved Clinical Studies.
Organization Name: .▇▇▇▇ Year: Total: $ [Enter Total Budget Amount] FC02N Cost Center: Clinical Costs Justification Total Clinical: $ Enter FC02N Total.
TALi shall calculate and maintain records of the direct out-of-pocket costs incurred by TALi for conducting the Pilot Study and the Pivotal Study (“Clinical Costs”) and provide to ▇▇▇▇▇ an invoice and report within [***] ([***]) Business Days after the end of each [***], in reasonable detail and format, of all Clinical Costs incurred during such [***] (each, a “Clinical Cost Report”).
More Definitions of Clinical Costs
Clinical Costs means all costs incurred by or on behalf of a Party that are directly attributable and reasonably allocated to the conduct of Clinical Trials of a Collaboration Product, or Clinical Trials of a [ * ] that were [ * ] to the [ * ] to the extent that such costs [ * ] the [ * ] for in the [ * ] that was [ * ] on the [ * ], in the Field in the Territory, whether alone or in combination with another product or agent. [ * ], Clinical Costs shall consist of the following: (a) the preparation for and conduct of Clinical Trials (except for related Manufacturing Costs otherwise included in Development Costs); (b) data collection and analysis, and report writing; and (c) clinical laboratory work. Notwithstanding the above, Clinical Costs shall exclude costs [ * ] = 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 24b-2 of the Securities Exchange Act of 1934, as amended. incurred in connection with Phase IV Clinical Studies for purposes other than label expansion and Regulatory Approval, and post-marketing surveillance activities, which shall be considered Sales and Marketing Costs. Clinical Costs shall be calculated in accordance with GAAP, consistently applied with allocations by a Party calculated in accordance with a methodology [ * ] (which methodology shall be consistent with GAAP) and based upon [ * ] by [ * ] (i.e., not to [ * ] costs to [ * ] of [ * ] when [ * ] to costs for [ * ] by [ * ]).
Clinical Costs shall have the meaning set forth in Section 5.3. --------------
Clinical Costs means the costs incurred by a Party or for its account, during the term and pursuant to this Agreement, in connection with clinical studies of a Co-Developed Product in the Co-Development Territory, including the following: (a) the preparation for, and conduct of, clinical trials (except for related Manufacturing Costs otherwise included in Development Costs); (b) data collection and analysis, and report writing; (c) clinical laboratory work; and (d) the preparation for, and conduct of, clinical pharmacology studies (including ADME studies, food-effect studies, hepatic interference studies, QT assessments, bioequivalence studies, and drug-drug interaction studies). The Clinical Costs shall exclude costs incurred in connection with [ * ].
Clinical Costs means the FTE Costs (charged in accordance with Section 3.8(f)) and out-of-pocket costs incurred by a Party or any of its Affiliates in accordance with GAAP after the Effective Date during the term of and pursuant to this Agreement (which costs may include costs accrued in accordance with GAAP [*] services and/or supplies to [*] to the extent [*] by Corgentech in connection with (i) Phase I, Phase I/II, Phase II and Phase III Clinical Trials of a Licensed Product [*] and (ii) Phase IIIB Clinical Trials [*]. Subject to the foregoing, Clinical Costs shall include, without limitation, such costs in connection with the following activities:
(a) the preparation for and conduct of clinical trials (except for related Manufacturing Costs otherwise included in Development Costs);
(b) data collection and analysis, and report writing; and
(c) clinical laboratory work. Clinical Costs shall not include costs incurred [*] in connection with [*].
Clinical Costs means, subject to the other provisions of this Agreement, the FTE Costs (charged in accordance with Section 3.7.2) and direct out-of-pocket costs recorded as an expense in accordance with GAAP by or on behalf of (a) Medarex or any of its Affiliates prior to the Execution Date to the extent specifically identifiable or reasonably allocable to the Melanoma Trial for the Lead Product and to the extent such expenses have been Previously Disclosed, and (b) a Party or any of its Affiliates after the Execution Date, during the term of and pursuant to this Agreement, that are specifically identifiable or reasonably allocable to Clinical Trials of a Product for an Indication, conducted in any country throughout the world, but excluding Regulatory Expenses. Subject to the foregoing, Clinical Costs shall include such costs in connection with the following activities: (i) the preparation for and conduct of clinical trials (except for related Manufacturing Costs otherwise included in Development Costs); (ii) data collection and analysis, and report writing; and (iii) clinical laboratory work. For the avoidance of doubt, Clinical Costs shall not include costs incurred (whether or not accrued as of, on or after the Execution Date) in connection with (x) Phase IV Studies, or (y) Clinical Trials that are intended solely to support Approval in the Royalty Territory.
Clinical Costs. The program funds expenses for clinical activities that are directly associated with cancer screening and diagnosis, such as purchase of care payment for screening and diagnostic procedures, including reimbursement of healthcare provider time or fees and related co-pays and deductibles for clients receiving clinical services. Cancer treatment costs are disallowed. Clinical staffing and related costs may include the following: ● Conducting client intake ● Determining client program eligibility ● Tracking to ensure clients are successfully linked to and complete cancer screening services ● Arranging re-call and follow-up screenings and procedures ● Consulting with medical case managers or providers ● Placing patient reminder/recall calls ● Program related follow-up with patient and providers (including results, appointments) ● Client referral to other services to address barriers (including medical home, insurance, translation, transportation to and/from appointments) ● Providing individual client education and reassurance ● Providing interpretation services as it relates to: ▪ Collecting intake information ▪ Scheduling appointments ▪ Reporting results ▪ During an appointment ● Providing patient navigation services such as: ▪ Written assessment of barriers ▪ Communication with healthcare ▪ Support services to address barriers to screening:interpretation or transportation providers ▪ Communication with other navigators regarding a specific client’s needs Non-Clinical: Budget no more than 40% the total award for non-clinical costs. These costs include all non-clinical expenditures, such as personnel, education and outreach-related expenditures.
Clinical Costs means the costs incurred by a Party or for its account, during the term and pursuant to this Agreement, in connection with clinical studies of a Product, whether alone or in combination with another product or agent, including the following: (a) the preparation for and conduct of clinical trials (except for related Manufacturing Costs otherwise included in Development Costs); (b) data collection and analysis, and report writing; and