CLINICAL DEVELOPMENT EXPENSES definition

CLINICAL DEVELOPMENT EXPENSES means all expenses incurred during development of Licensed Product(s) subsequent to analysis of the results of the Initial Clinical Trial, as directed by the Development Committee, including, without limitation, the costs of conducting ongoing research and development directly related to obtaining regulatory approvals; conducting human clinical trials other than the Initial Clinical Trial (including the cost of Clinical Product for such trials); refining the design of the Licensed Product; manufacturing process development and modifications fairly allocated to Licensed Product; cell line research; cell banking; stability studies; toxicology, carcinogenicity and immunology studies; developing QA/QC procedures and obtaining regulatory approvals (as required by this Agreement). "Clinical
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CLINICAL DEVELOPMENT EXPENSES means the expenses incurred by a Party or for its account which are paid to a Third Party, and Internal Costs, consistent with the Development Plan and Budget and are specifically attributable to the Clinical Development of a Product (excluding royalties paid to a Third Party). Clinical Development Expenses shall include, but are not limited to, the direct costs of manufacturing and packaging Oncolym for use in Clinical Development, the cost of clinical studies in humans on the toxicological, pharmacokinetic, metabolic or clinical aspects of a Product by individual investigators, of consultants necessary for the purpose of obtaining and/or maintaining Regulatory Approval of the Product in the Territory, including Third Party contractors, and costs (and related fees) for preparing, submitting, reviewing or developing data or information relating to clinical studies in humans for the purpose of submission to a governmental authority to obtain and/or maintain Regulatory Approval of a Product in the Territory.
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CLINICAL DEVELOPMENT EXPENSES means with respect to a prospective Co-Funded Product or Co-Funded Product, as applicable, to the extent incurred by Lilly or its Affiliates during the Term and in accordance with this Agreement and the applicable Lilly Clinical Development Plan:
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More Definitions of CLINICAL DEVELOPMENT EXPENSES

CLINICAL DEVELOPMENT EXPENSES means the expenses incurred by a Party or for its account which are paid to a Third Party, and Internal Costs, consistent with the Development Plan and Budget and are specifically attributable to the Clinical Development of a Product (excluding royalties paid to a Third Party). Clinical Development Expenses shall include, but are not limited to, the direct costs of manufacturing and packaging Oncolym for use in Clinical Development, the cost of clinical studies in humans on the toxicological, pharmacokinetic, metabolic or clinical aspects of a Product by individual investigators, of consultants necessary for the purpose of obtaining and/or maintaining Regulatory Approval of the Product in the Territory, including Third Party contractors, and costs (and related fees) for preparing, submitting, reviewing or developing data or information relating to clinical studies in humans for the purpose of submission to a governmental authority to obtain and/or maintain Regulatory Approval of a Product in the Territory. Clinical Development Expenses shall not include Existing Trial Expenses or CMC/Manufacturing Expenses. Each Party shall incur only those Clinical Development Expenses as are reasonably necessary to develop the Product for the indications described in the Existing Trials and such other indications as are agreed upon by the JDC. [...***...] = 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 SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
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CLINICAL DEVELOPMENT EXPENSES means the expenses incurred by a Party or for its account which are paid to a Third Party, and Internal Costs, consistent with the Development Plan and Budget and are specifically attributable to the Clinical Development of a Product (excluding royalties paid to a Third Party). Clinical Development Expenses shall include, but are not limited to, the direct costs of manufacturing and packaging Oncolym for use in Clinical Development, the cost of clinical studies in humans on the toxicological, pharmacokinetic, metabolic or clinical aspects of a Product by individual investigators, of consultants necessary for the purpose of obtaining and/or maintaining Regulatory Approval of the Product in the Territory, including Third Party contractors, and costs (and related fees) for preparing, submitting, reviewing or developing data or information relating to clinical studies in humans for the purpose of submission to a governmental authority to obtain and/or maintain Regulatory Approval of a Product in the Territory. Clinical Development Expenses shall not include Existing Trial Expenses or CMC/Manufacturing Expenses. Each Party shall incur only those Clinical Development Expenses as are reasonably necessary to develop the Product for the indications described in the Existing Trials and such other indications as are agreed upon by the JDC.
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Related to CLINICAL DEVELOPMENT EXPENSES

  • Development Expenses means, with respect to SAIL Developments as well as HOME Developments when the HOME Development is also at least partially financed with a MMRB Loan (as defined in rule Chapter 67-21, F.A.C.), usual and customary operating and financial costs, such as the compliance monitoring fee, the financial monitoring fee, replacement reserves, the servicing fee and the debt service reserves. As it relates to SAIL Developments as well as HOME Developments when the HOME Development is also at least partially financed with a MMRB Loan (as defined in rule Chapter 67-21, F.A.C.) and to the application of Development Cash Flow described in subsections 67-48.010(5) and (6), F.A.C., as it relates to SAIL Developments or in paragraph 67-48.020(3)(b), F.A.C., as it relates to HOME Developments, the term includes only those expenses disclosed in the operating pro forma on an annual basis included in the final credit underwriting report, as approved by the Board, and maximum of 20 percent Developer Fee per year.

  • Commercialization Costs means the sum of the following costs and expenses incurred by the Parties or their respective Affiliates, in Commercializing the Shared Products (and related Manufacturing activities) in the Territory, in each case, to the extent incurred in accordance with the Commercialization Plan and Commercialization Budget:

  • Development Costs means costs incurred to obtain access to reserves and to provide facilities for extracting, treating, gathering and storing the oil and gas from reserves. More specifically, development costs, including applicable operating costs of support equipment and facilities and other costs of development activities, are costs incurred to:

  • Development Activities means those activities which are normally undertaken for the development, construction, repair, renovation, rehabilitation or conversion of buildings for residential purposes, including the acquisition of property;

  • Collaborative drug therapy management means participation by an authorized pharmacist and a physician in the management of drug therapy pursuant to a written community practice protocol or a written hospital practice protocol.

  • Commercial Development means any development on private land that is not heavy industrial or residential. The category includes, but is not limited to: hospitals, laboratories and other medical facilities, educational institutions, recreational facilities, plant nurseries, car wash facilities, mini-malls and other business complexes, shopping malls, hotels, office buildings, public warehouses and other light industrial complexes.

  • Patent Expenses means all reasonable costs (including attorneys’ and application fees) incurred by University in accordance with this Agreement to apply for, prosecute and maintain Licensed Patents, including but not limited to the costs of interferences, oppositions, inter partes review and re-examinations. Patent Expenses include reimbursement for in-house costs provided they are for activities that would otherwise have been performed by outside counsel at an equal or greater expense.

  • Development Plan has the meaning set forth in Section 3.2.

  • site development plan means a dimensioned plan drawn to scale that indicates details of the proposed land development, including the site layout, positioning of buildings and structures, property access, building designs and landscaping;

  • Development Plans has the meaning set forth in Section 3.2.

  • Clinical peer means a physician or other health care professional who holds a non-restricted license in a state of the United States and in the same or similar specialty as typically manages the medical condition, procedure or treatment under review.

  • Annual Work Plan and Budget means the work plan and budget approved by the Bank and adopted by the Borrower in accordance with the provisions of Section I.C of Schedule 2 of this Agreement, as said work plan and budget may be modified from time to time with the written agreement of the Bank.

  • municipal spatial development framework means a municipal spatial development framework adopted by the Municipality in terms of Chapter 5 of the Municipal Systems Act;

  • spatial development framework means the Mhlontlo Municipal Spatial Development Framework prepared and adopted in terms of sections 20 and 21 of the Act and Chapter 2 of this By-Law;

  • Commercialization Plan has the meaning set forth in Section 6.2.

  • Phase 4 Clinical Trial means a Clinical Study in any country which is conducted after Regulatory Approval of a product has been obtained from an appropriate Regulatory Authority, consisting of trials conducted voluntarily for enhancing marketing or scientific knowledge of an approved indication and trials conducted due to request or requirement of a Regulatory Authority.

  • Development Budget shall have the meaning set forth in Section 3.3.

  • Clinical Studies means Xxxxx 0, Xxxxx 0, Xxxxx 0, Xxxxx 3, and such other tests and studies in human subjects that are required by Applicable Law, or otherwise recommended by the Regulatory Authorities, to obtain or maintain Regulatory Approvals for a Licensed Product for one (1) or more indications, including tests or studies that are intended to expand the Product Labeling for such Licensed Product with respect to such indication.