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 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 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 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.

  • Explain the difference between Macbeth's and Lady Macbeth'sstates of mind in this extract.

  • Better packets analysis percentage of virtual platform is due to the fact that the Snort analyzed considerably lesser amount of packets whereas the packets captured for analysis at host level are significantly more thus by no means virtual platform performed better than the fully resourceful host.

  • POST-LAUNCH PRODUCT R&D EXPENSES Post-Launch Product R&D Expenses shall include certain research and development costs incurred by a Party in relation to a Collaboration Product after the first commercial launch and shall exclude administrative expenses.


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 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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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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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 a pharmaceutical product containing or comprising Compound in any dosage form alone, or in combination with, one or more other pharmaceutically active ingredients, and any and all Improvements thereto.

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

  • Patent Expenses means the fees and expenses of outside counsel and payments to Third Parties incurred after the Effective Date in connection with the preparation, filing, prosecution and maintenance of the Licensed Patents, the Joint Collaboration Patents, and the Shire Patents covering Compound and Collaboration Products, including the costs of patent interference and opposition proceedings, net of any reimbursement of such expenses by Third Parties.

  • 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 is defined in Section 5.3.

  • Final Product means a product that is not used in producing other products and is built and intended for use outdoors, provided the final product has not deteriorated or has otherwise become a potential source of contaminants.

  • Licensed Product means a product, method or service in the Licensed Field of Use, the making, having made, using, importing or selling of which, absent this license, infringes, induces infringement, or contributes to infringement of a Licensed Patent.

  • Back Ordered Products If product is not expected to ship within the time provided to the TIPS member by the Vendor, customer is to be notified within 3 business days and appropriate action taken based on customer request. Vice-President of O 3/28/19 Xxxxxxxx Xxxxxx perations erations The Interlocal Purchasing System (TIPS Cooperative) Supplier Response Bid Information Contact Information Ship to Information Bid Creator Xxxx Xxxxxx General Address Region VIII Education Address Counsel/Procurement Service Center Compliance Officer 0000 XX Xxxxxxx 000 Email xxxx.xxxxxx@xxxx-xxx.xxx North Contact Phone (000) 000-0000 Pittsburg, TX 75686 Fax Contact Xxxxxxx Xxxxxxx, Department Contracts Compliance Building Bid Number 190101 Specialist Title Safety Equipment, Supplies Floor/Room and Services Department Telephone Bid Type RFP Building Fax Issue Date 1/7/2019 08:01 AM (CT) Email Close Date 2/15/2019 03:00:00 PM (CT) Floor/Room Telephone +0 (000) 000-0000 Fax +0 (000) 000-0000 Email xxxx@xxxx-xxx.xxx Supplier Information Company Northern Imports (Work Wear Safety Shoes) Address 6318 Airport Freeway Suite C Fort Worth, TX 76117 Contact Department Building Floor/Room Telephone (000) 000-0000 Fax (000) 000-0000 Email Submitted 2/13/2019 11:58:28 AM (CT) Total $0.00 By submitting your response, you certify that you are authorized to represent and bind your company. Signature Xxxxxx X Xxxxxxxx Email xxxxx.xxxxxxxx@xxxxxxxxxxxxx.xxx Supplier Notes Work Wear Safety Shoes has enjoyed our vendor relationship with TIPS Coop and the governmental agencies that have used the TIPS Coop to make safety boot purchases. By submitting this bid we seek to strengthen and grow our business with the TIPS Coop. Thank you for the business! Xxxxxx X Xxxxxxxx Bid Notes Bid Activities Bid Messages Bid Attributes Please review the following and respond where necessary # Name Note Response 1 Yes - No Disadvantaged/Minority/Women Business Enterprise - D/M/WBE (Required by some participating governmental entities) Vendor certifies that their firm is a D/M/WBE?Vendor must upload proof of certification to the ”Response Attachments” D/M/WBE CERTIFICATES section. NO 2 Yes - No Historically Underutilized Business - HUB (Required by some participating governmental entities) Vendor certifies that their firm is a HUB as defined by the State of Texas at xxxxx://xxxxxxxxxxx.xxxxx.xxx/purchasing/vendor/hub/ No or in a HUBZone as defined by the US Small Business Administration at xxxxx://xxx.xxx.xxx/offices/headquarters/ohp Proof of one or both may be submitted. Vendor must upload proof of certification to the “Response Attachments” HUB CERTIFICATES section.

  • Development Milestone Event has the meaning set forth in Section 7.1.

  • 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.

  • 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 13.5.

  • Development Activities means any activity, including the discharge of dredged or fill material, which results directly in a more than de minimus change in the hydrologic regime, bottom contour, or the type, distribution or diversity of hydrophytic vegetation, or which impairs the flow, reach, or circulation of surface water within wetlands or other waters;

  • 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, if applicable, must be completed by the relevant Milestone Date;

  • 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):

  • Milestone Payments has the meaning set forth in Section 4.2.

  • Phase III Clinical Study means a human clinical study of a product on a sufficient number of subjects that is designed to establish that such product is safe and efficacious for its intended use, and to determine warnings, precautions, and adverse reactions that are associated with such product in the dosage range to be prescribed, which trial is intended to support Regulatory Approval of such product, as described in 21 C.F.R. 312.21(c). 1.185. [***] 1.186. [***]