Joint Commercialization Costs definition

Joint Commercialization Costs means […***…].
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Joint Commercialization Costs means, with respect to a particular Product, all costs and expenses incurred by or on behalf of either Party or any of its Affiliates or subcontractors that are directly allocable to (a) the Commercialization of Products in the Shared Territory, including CME Costs, Detail Costs, Distribution Costs, Sales and Marketing Costs and costs associated with Voluntary Phase 4 Clinical Trials, whether prior to or after receipt of Regulatory Approvals, (b) Manufacturing Costs to be treated as Joint Commercialization Costs pursuant to Section 9.4; (c) Third Party Payments to the extent treated as Joint Commercialization Costs pursuant to Section 10.7, including, to the extent not already addressed in the Manufacturing Costs, any royalties or Third Party Payments attributable to Manufacture of ACTR T-cells or SGI Antibodies (as applicable) for Commercialization; (d) costs associated with the defense of Patents within the Program IP to be treated as Joint Commercialization Costs pursuant to Section 12.5; (e) Trademark Costs to be treated as Joint Commercialization Costs pursuant to Section 12.8; and (f) Shared Program Damages from Third Party Claims to be treated as Joint Commercialization Costs pursuant to Section 14.4. However, in all cases, including with respect to clauses (a) through (f) of the previous sentence, Joint Commercialization Costs exclude Research Costs and Development Costs. Joint Commercialization Costs will also exclude costs included as deductions in calculating Net Sales of a Product and each of the following (except to the extent included in Manufacturing Costs): (i) taxes, duties and other governmental charges, including income taxes, sales taxes, value added taxes and import duty, (ii) capital expenditures incurred by either Party to obtain or maintain manufacturing capacity for Products, and (iii) overhead and other indirect cost allocations from either Party.
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Joint Commercialization Costs means (a) Commercialization Costs to the extent approved by the JCC and reasonably and directly allocable to activities conducted pursuant to the Agreement and the Joint Commercialization Plan then in effect, incurred by the Parties in support of Commercialization of Products in the Shared Territory in accordance with the Joint Commercialization Budget (subject to any overages permitted pursuant to Section 6.4), [*] = 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. whether prior to or after receipt of Regulatory Approvals, including Detail Costs to compensate each Party for the activities performed by their respective sales field forces in the Shared Territory (in the case of Medivation, if Medivation is co-promoting Products pursuant to the exercise of a Co-Promotion Option); (b) recall expenses to be treated as Joint Commercialization Costs pursuant to Section 4.2(a); (c) Manufacturing Costs to be treated as Joint Commercialization Costs pursuant to Section 7.5, including the cost of Samples; (d) royalty payments under the UCLA Agreement payable with respect to the Shared Territory to be treated as Joint Commercialization Costs pursuant to Section 8.8(a); (e) Third Party Payments to be treated as Joint Commercialization Costs pursuant to Section 8.8(b)(ii); (f) costs associated with the defense of Collaboration Patents to be treated as Joint Commercialization Costs pursuant to Section 10.5; (g) Trademark Costs to be treated as Joint Commercialization Costs pursuant to Section 10.9; and (h) Damages from Third Party Claims to be treated as Joint Commercialization Costs pursuant to Section 12.4. However, in all cases, including with respect to clauses (a) through (h) of the previous sentence, Joint Commercialization Costs exclude Development Costs and Joint Medical Affairs Costs. Joint Commercialization Costs shall also exclude costs included as deductions in calculating Net Sales of Product in the Shared Territory and each of the following (except to the extent included in Manufacturing Costs): (i) [*], (ii) tax liabilities, (iii) capital expenditures incurred by either Party to obtain or maintain manufacturing capacity for Products, and (iv) overhead and other indirect cost allocations from either Party. For clarity, Joint Commercialization Costs exclude any costs or e...
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Examples of Joint Commercialization Costs in a sentence

  • All calculations of Joint Commercialization Costs and Operating Profit and Operating Loss hereunder shall be made in accordance with GAAP, including the provisions thereof regarding expense recognition, as applied by Galapagos and Gilead consistently with their application in their respective financial reporting.

  • The Finance Officers shall compare each Party’s Joint Commercialization Costs against the budget for the applicable activities assigned to such Party in the Shared Territory Commercialization Plan and Budget.

  • For the avoidance of doubt, no cost or expense shall be counted more than once in calculating the Cost of Goods Sold or Joint Commercialization Costs, even if such cost or expense falls into more than one of the cost categories that comprise the Cost of Goods Sold or Joint Commercialization Costs.

  • Galapagos and Gilead shall share all Joint Commercialization Costs with respect to Licensed Products and Gilead Combination Products in the Shared Territory, which shall be included in the calculation of Operating Profit (or Loss) under this Agreement and calculated in accordance with Section 8.9(a)(ii); provided, however, that for Gilead Combination Products, the Parties shall agree […***…].

  • To qualify as a DGR, an organisation must either be endorsed by the ATO or listed by name in the income tax law.

  • All calculations of Joint Commercialization Costs, Operating Profit and Operating Loss hereunder shall be made in accordance with GAAP, including the provisions thereof regarding expense recognition, as applied by Galapagos and Gilead consistently with their application in their respective financial reporting.

  • The ecosystem should be able to be monitored for uptime, performance issues, and impending problems (such as running low on disk space or maximizing CPU/GPU usage).

  • Within […***…] Business Days after the end of the second (2nd) month of each calendar quarter beginning with the calendar quarter in which the First Commercial Sale of a Licensed Product occurs in the Shared Territory, Galapagos shall provide to Gilead a report in reasonable detail of any Costs of Goods Sold and Joint Commercialization Costs incurred by Galapagos in the last calendar month of the preceding quarter and the first two calendar months of the current quarter for each Licensed Product.

  • In such circumstances, each Party shall also continue to bear its share of all Development Costs, and Joint Commercialization Costs incurred during the Termination Notice Period.

  • Previous participation in focus groups dictated the third wave in Miami and included previous focus group participants and two sections, A and B, of new focus group participants.


More Definitions of Joint Commercialization Costs

Joint Commercialization Costs means [**].
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Joint Commercialization Costs has the meaning set forth in Exhibit A. ​ ​ ​ ​
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Joint Commercialization Costs means, with respect to a Product in a given time period, the sum of the following:
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Joint Commercialization Costs means […***…]. Amended and Restated License and Collaboration Agreement
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Related to Joint Commercialization Costs

  • 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 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;

  • Commercialization or “Commercialize” means activities directed to marketing, promoting, research and development as required, manufacturing for sale, offering for sale, distributing, importing or selling a product, including sub-licensing or sub-contracting of these activities.

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

  • Joint Commercialization Committee or “JCC” has the meaning set forth in Section 2.1(a).

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

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

  • 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.

  • Development Activity means any activity defined as Development which will necessitate a Floodplain Development Permit. This includes buildings, structures, and non-structural items, including (but not limited to) fill, bulkheads, piers, pools, docks, landings, ramps, and erosion control/stabilization measures.

  • Development Program means the implementation of the development plan.

  • Development Phase means the period before a vehicle type is type approved.

  • 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:

  • Research Budget has the meaning set forth in Section 3.2.

  • 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.

  • Commercializing means to engage in Commercialization and “Commercialized” has a corresponding meaning.

  • 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.

  • 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.

  • Research Plan shall have the meaning set forth in Section 2.1.

  • Clinical Trials means a controlled study in humans of the safety or efficacy of a Product, and includes, without limitation, such clinical trials as are designed to support expanded labeling or to satisfy the requirements of an Agency in connection with any Product Approval and any other human study used in research and Development of a Product.

  • Collaboration Compound means any of the following: (a) FG-4592, (b) any HIF Compound (other than FG-4592) that is added to this Agreement pursuant to Section 3.6, and (c) any salts, esters, complexes, chelates, crystalline and amorphous morphic forms, pegylated forms, enantiomers (excluding regioisomers), prodrugs, solvates, metabolites and catabolites of any of the foregoing ((a) or (b)).

  • Phase III Study means a human clinical trial that is prospectively designed to demonstrate statistically whether a product is safe and effective for use in humans in a manner sufficient to obtain regulatory approval to market such product in patients having the disease or condition being studied as described in 21 C.F.R. § 312.21(c) (FDCA), as amended from time to time, and the foreign equivalent thereof.

  • Development Project means a project for the development of land within a

  • Research Program has the meaning set forth in Section 2.1.

  • Phase III Clinical Trials means a Clinical Trial for the Product on sufficient numbers of patients to generate safety and efficacy data to support Regulatory Approval in the proposed therapeutic indication, conducted in accordance with current good clinical practices and in accordance with a protocol that has been reviewed by the FDA and reflects any comments or concerns raised by the same.

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

  • Medical Affairs Activities means, with respect to any country or other jurisdiction in the Territory, the coordination of medical information requests and field based medical scientific liaisons with respect to Licensed Compounds or Licensed Products, including activities of medical scientific liaisons and the provision of medical information services with respect to a Licensed Compound or Licensed Product.