Post-Launch Product R&D Expenses definition

Post-Launch Product R&D Expenses means the reasonable costs, excluding administrative expenses and costs that are included within Costs of Goods Sold, of Phase 4 clinical trials and ongoing product support (including manufacturing and quality assurance technical support, and laboratory and clinical efforts directed toward the further understanding of product safety and efficacy) and medical affairs (including regulatory support necessary for product maintenance), in each case that are (a) specifically attributable to a ZIOPHARM Product in the countries of the Territory where such ZIOPHARM Product has been launched and (b) approved by both Parties in writing.
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Post-Launch Product R&D Expenses means the reasonable costs, excluding administrative expenses and costs that are included within Costs of Goods Sold, of Phase 4 clinical trials and ongoing product support (including manufacturing and quality assurance technical support, and laboratory and clinical efforts directed toward the further understanding of product safety and efficacy) and medical affairs (including regulatory support necessary for product maintenance), in each case that are (a) specifically attributable to a Product in the countries of the Territory where such Product has been launched and (b) approved by both Parties in writing.
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Post-Launch Product R&D Expenses shall include certain research and development costs incurred by a Party in relation to a Licensed Product after the first commercial launch and shall exclude administrative expenses and costs that are included within Costs of Goods or Development Costs. Such post-launch research and development costs shall include the following expenses only if such expenses are directly attributable to a Licensed Product:
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Examples of Post-Launch Product R&D Expenses in a sentence

  • Development Expenses shall further include costs of Phase IV Trials and Post-Launch Product R&D Expenses.

  • All Phase IIIb Costs and Phase IV Costs shall be Post-Launch Product R&D Expenses, which are taken into account in the calculation of Product Profit, except for those Phase IIIb Costs incurred with respect to a Phase IIIb Trial that the Parties mutually agree to include within the scope of Development pursuant to Section 3.2(e).

  • Product and specifically attributable to the Commercialization of such ZIOPHARM Product: (a) Cost of Goods Sold, (b) Marketing Expenses, (c) Distribution Expenses, (d) Post-Launch Product R&D Expenses, and (e) Additional Commercialization Expenses, in each case as such terms are defined and calculated in this Article 1 and in Exhibit A.


More Definitions of Post-Launch Product R&D Expenses

Post-Launch Product R&D Expenses shall have the meaning set forth in Exhibit A.
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Post-Launch Product R&D Expenses means certain research and development costs incurred by a Party in relation to a Collaboration Product for the Shared Territory in the Field after the First Commercial Sale in the Shared Territory of such Collaboration Product and required to obtain or maintain a Regulatory Approval in the Shared Territory. Such post-launch research and development costs shall include Phase IV Clinical Trials and ongoing medical affairs.
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Post-Launch Product R&D Expenses means the reasonable costs, excluding administrative expenses and costs that are included within Costs of Goods Sold, of Phase 4
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Post-Launch Product R&D Expenses means the costs of Phase IV Clinical Trials and ongoing product support (including manufacturing and quality assurance technical support, and laboratory and clinical efforts directed toward the further understanding of product
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Post-Launch Product R&D Expenses means the following research and development costs and expenses, including the cost of FTEs, incurred or accrued (as applicable in accordance with Article 1 of this Financial Appendix) by a Party in direct relation to a Collaboration Product after the first commercial launch of a Collaboration Product: Phase 4 Trials, ongoing Collaboration Product support, ongoing medical affairs (meaning pharmacoeconomic studies, outcomes studies and extramural studies), preclinical research (including without limitation investigation of additional therapeutic uses), and fees and expenses of outside counsel in respect of regulatory affairs unrelated to obtaining Regulatory Approvals.
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Post-Launch Product R&D Expenses means the costs of Phase IIIB Clinical ---------------------------------- Trials and Phase IV Clinical Trials and ongoing product support (including manufacturing and quality assurance technical support, and laboratory and clinical efforts directed toward the further understanding of product safety and efficacy) and medical affairs (including regulatory support safety and surveillance necessary for product maintenance) which are specifically attributable to a Collaboration Product in the Profit/Loss Sharing Territory where such Collaboration Product has been launched, excluding costs that are included within Costs of Goods Sold or Development Expenses and any costs reasonably associated with maintaining Regulatory Approval of Collaboration Compounds and Products. Post-Launch Product R&D Expenses shall be calculated in the manner set forth in Exhibit A. Notwithstanding the foregoing, with respect to Phase IIIB Clinical Trials for Bromocriptine specifically identified in Exhibit E, the costs of such trials shall not be a Post-Launch Product R&D Expense, but shall instead be treated as a Development Expense for the purposes of this Agreement, but ORTHO may elect for its internal purposes to treat such expenses as commercialization expenses.
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Related to Post-Launch Product R&D Expenses

  • Commercialization Costs means the out-of-pocket costs and expenses incurred by Adapt or its Affiliates directly attributable to, or reasonably allocable to, the Commercialization of a Product. Commercialization Costs for a Product shall include, preparation of promotional, advertising, communication, medical, and educational materials relating to the Product and other Product literature and selling materials, activities directed to marketing of the Product, including purchase of market data, development and conduct of market research, advertising, public relations, public affairs and other communications with Third Parties regarding the Product; development and conduct of sales force training (including materials, programs and travel to and attendance at training programs) for medical representatives responsible for promoting the Product; and development and maintenance of sales bulletins, call reporting and other monitoring/tracking, sales force targeting, validation and alignment programs and documentation.

  • Development Milestone Payment shall have the meaning set forth in Section 9.2(a).

  • 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.

  • Collaboration Product means any pharmaceutical product in finished form that contains a Collaboration Compound, either as the sole active ingredient or in combination with one or more other active ingredients, and all present and future formulations, dosages and dosage forms thereof.

  • Manufacturing Costs means the costs of Processing that generate Manufacturing Proceeds received by Grantor.

  • 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 Milestone is defined in Section 5.3.

  • Program Costs means all necessary and incidental costs of providing program services.

  • 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:

  • Sales Milestone Payment shall have the meaning set forth in Section 8.4.

  • Final Product means a reasonably homogenous cannabis product in its final packaged form created using the same standard operating procedures and the same formulation.

  • Licensed Product means any pharmaceutical product containing a Licensed Compound (alone or with other active ingredients), in all forms, presentations, formulations and dosage forms.

  • Development Milestone Event has the meaning set forth in Section 7.2.1.

  • Milestone Payment means a payment identified in the Implementation Plan to be made following the issue of a Satisfaction Certificate in respect of Achievement of the relevant Milestone;

  • Finished Product means a cannabis product in its final form to be sold at a retail premises.

  • Phase I Clinical Study means a human clinical study of a product, the principal purpose of which is a preliminary determination of safety in healthy individuals or patients, as described in 21 C.F.R. 312.21(a).

  • Routine Patient Costs means all health care services that are otherwise covered under the Group Contract for the treatment of cancer or other Life-threatening Condition that is typically covered for a patient who is not enrolled in an Approved Clinical Trial.

  • Terminated Product has the meaning set forth in Section 11.3.1.

  • Development Activities means those Development activities undertaken by or on behalf of a Party or its Affiliates with respect to the Product in the Field.

  • Approved Product means any water fitting, plumbing product, material or component which is the subject of an existing WRAS Approval;

  • Milestone means an event or task described in the Implementation Plan which must be completed by the corresponding date set out in such plan;

  • WTO GPA country end product means an article that—

  • Milestone Payment Date has the meaning set forth in Section 2.4(a).

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

  • Tobacco product manufacturer means an entity that after the date of enactment of this act directly (and not exclusively through any affiliate) meets 1 or more of the following:

  • Milestone Payments means, collectively, the Development Milestone Payments and Sales Milestone Payments.