Commercialization Cost definition

Commercialization Cost means the sum of direct and allocated FTE Costs for (a) Development Costs and Personnel Costs related to the Co-Development of a Development Lead or Clinical Candidate, (b) Promotion Expense; (c) Pre-Marketing Expenses; (d) Distribution Expenses; (e) Working Capital Charges; (f) Sales and Marketing Expenses; (g) Post-Approval Research and Regulatory Expenses; (h) License Fees and (i) any other out-of-pocket cost or expense stated to be a Commercialization Cost in this Agreement or under the Product Commercialization Plan. For purposes of clarity, Commercialization Cost shall not include any internal and out-of-pocket costs, expenses and fees incurred in prosecuting, and maintaining, the Product Trademark, Licensed Patent Rights, ARCHEMIX Patent Rights and/or ELAN Patent Rights covering a Co-Developed Product.
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Commercialization Cost means all costs incurred by or on behalf of the Commercialization Party and its Affiliates that are reasonably allocable to the Commercialization of CD38 Product in the Field in the Territory, including Distribution Costs, Sales and Marketing Costs, Manufacturing Costs for CD38 Product for commercial sale, costs for Phase 4 Clinical Trials, and the associated taxes. Commercialization Costs shall include the Commercialization Party and its Affiliates’ internal costs related to the Commercialization efforts, which shall be itemized and subject to the other Party’s annual audit in accordance with Section 4.8.
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Commercialization Cost means those costs associated with the Commercialization of the Product under this Agreement set forth in the Commercialization Plan prepared by Cipla and approved by the JSC and shall include reasonable travel expenses of the Parties in connection with meetings of the JSC or for other travel necessary for the Commercialization.
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Examples of Commercialization Cost in a sentence

  • Reata acknowledges and agrees that (x) it solely shall pay all amounts and other consideration payable or issuable to Third Parties pursuant to any Existing Reata License, and no such payment shall constitute a Development Cost or Commercialization Cost hereunder and (y) it shall not grant to any Third Party any sublicense under any Existing Reata License to Exploit any product in the New Collaboration Field.

  • ChemTrak shall file for and pursue trademark protection for the Aware(TM) mark xx countries in the Territory where HIV Products are sold, at Selfcare's expense, subject to recovery as a Commercialization Cost.

  • If the Senior Executives are unable to resolve any matter set forth in an Escalation Notice within thirty (30) days after the applicable Party receives such Escalation Notice, then Otsuka shall have final decision-making authority with respect to all matters within the responsibilities of the JCC; provided that, Otsuka shall not have the right to use such final decision-making authority to require Acucela to fund any Initial Commercialization Costs in excess of the Aggregate Commercialization Cost Cap.

  • Trubion shall have the right to purchase from Facet [ * ] (less any portion of the cost previously shared by Trubion as a Development Cost or Commercialization Cost) any or all of the inventory of Bulk API and/or Products held by or for Facet or its Affiliates as of the effective date of termination pursuant to the terms of this Agreement or the Commercial Supply Agreement, as applicable.

  • In the event that Selfcare exercises its right to use alternate sources of supply, the cost of securing Sample Collection Kits (or components thereof) from alternate sources of supply shall be deemed to be a Commercialization Cost.

  • Conversion into United States Dollars from other currencies for purposes of calculating Net Profits and of setting and adjusting the Product Participation Models shall be calculated using average rates published by the ECB for the calendar month in which the sale of the Product occurred or the relevant Development Cost or Commercialization Cost was incurred, as the case may be.

  • The Increased Net Commercialization Cost Budget may only become effective after being approved by the JSC and the shareholders of I-Mab in accordance with the Applicable Listing Rules and such approved Increased Net Commercialization Cost Budget shall replace or supplement, as appropriate, the prior Net Commercialization Cost Budget.

  • If the Shared Product Damage arises from the Commercialization of the CD38 Product, the Parties shall share such Shared Product Damage as Commercialization Cost (as calculated in accordance with Section 4.).

  • Any Losses, other than those Losses for which indemnification is provided in Section 14.1, Section 14.2 or Section 14.6, in connection with any Third Party Claim brought against either Party resulting directly or indirectly from the Development, Manufacture or Commercialization of Joint Products (or joint Development of New Collaboration Compounds that have not yet been Commercialized) hereunder shall be included as a Development Cost or a Commercialization Cost, as applicable.

  • It is acknowledged that, upon the Listing of I-Mab, in order for I-Mab to approve any additional Commercialization Cost that is higher than the Net Commercialization Cost Budget (“Increased Net Commercialization Cost Budget”), I-Mab shall comply with the Applicable Listing Rules and submit such Increased Net Commercialization Cost Budget for the approval of its shareholders who are not otherwise connected with Everest (to be determined by the Applicable Listing Rules).


More Definitions of Commercialization Cost

Commercialization Cost means the sum of (a) Sales and Marketing Cost; (b) any reasonable internal and out-of-pocket costs, expenses and fees incurred in prosecuting, maintaining, enforcing and defending the Product Trademark, or MERCK Patent Rights covering a Product; (c) subject to Section 10.2.1(g), License Fees, (d) any internal or out-of-pocket cost or expense expressly relating to Commercialization of a Product and (e) any internal or out-of-pocket cost or expense incurred in the performance of the Commercialization Transition Plan; provided that no internal or out-of-pocket cost or expense incurred by ARIAD after the Restated Effective Date shall be a Commercial Cost unless it is incurred in the conduct of an ARIAD Commercialization Activity.
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Related to Commercialization Cost

  • 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 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:

  • 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 Cost means the total of all costs incurred in the completion of a Development excluding Developer Fee, operating deficit reserves, and total land cost as typically shown in the Development Cost line item on the development cost pro forma.

  • 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.

  • 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;

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

  • Manufacturing Cost means ***

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

  • 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 Plan has the meaning set forth in Section 6.2.

  • Manufacturing Costs means, with respect to a given AquaBounty Product, the full-time equivalent costs (under a reasonable accounting mechanism to be agreed upon by the Parties) and out-of-pocket costs that AquaBounty or any of its Affiliates incurred in manufacturing such products, including costs and expenses incurred in connection with (a) the development or validation of any manufacturing process, formulations or delivery systems, or improvements to the foregoing; (b) manufacturing scale-up; (c) in-process testing, stability testing and release testing; (d) quality assurance/quality control development; (e) internal and Third Party costs and expenses incurred in connection with qualification and validation of Third Party contract manufacturers, including scale up, process and equipment validation, and initial manufacturing licenses, approvals and inspections; (f) packaging development and final packaging and labeling; (g) shipping configurations and shipping studies; and (h) overseeing the conduct of any of the foregoing. “Manufacturing Costs” shall further include: (i) to the extent that any such AquaBounty Product is manufactured by a Third Party manufacturer, the out-of-pocket costs incurred by AquaBounty or any of its Affiliates to the Third Party for the manufacture and supply (including packaging and labeling) thereof, and any reasonable out-of-pocket costs and direct labor costs incurred by AquaBounty or any of its Affiliates in managing or overseeing the Third Party relationship determined in accordance with the books and records of such Party or its Affiliates maintained in accordance with US GAAP; and (ii) to the extent that any such AquaBounty Product is manufactured by AquaBounty or any of its Affiliates, direct material and direct labor costs attributable to such product, as well as reasonably allocable overhead expenses, determined in accordance with the books and records of AquaBounty or its Affiliates maintained in accordance with US GAAP.

  • 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.

  • 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)).

  • Research Budget has the meaning set forth in Section 2.2.

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

  • Development Program means the implementation of the development plan.

  • Development Budget has the meaning set forth in Section 3.1.

  • Licensed Product means a product or part of a product in the Licensed Field of Use: (A) the making, using, importing or selling of which, absent this license, infringes, induces infringement, or contributes to infringement of a Licensed Patent; or (B) which is made with, uses or incorporates any Technology.

  • Development Plans means a coherent set of operations defined and financed exclusively by the OCTs in the framework of their own policies and strategies of development, and those agreed upon between an OCT and the Member State to which it is linked;

  • Development Work means any work carried out in relation to the physical construction of a mine;

  • Fully Burdened Manufacturing Cost means, with respect to any Licensed Product supplied by or on behalf of NVCR to Zai hereunder if such Licensed Product (or any precursor or intermediate thereof) is manufactured by a Third Party manufacturer [***].

  • Massive Multiauthor Collaboration Site (or “MMC Site”) means any World Wide Web server that publishes copyrightable works and also provides prominent facilities for anybody to edit those works. A public wiki that anybody can edit is an example of such a server. A “Massive Multiauthor Collaboration” (or “MMC”) contained in the site means any set of copyrightable works thus published on the MMC site.

  • Diagnostic Product means any test or assay for diagnosing or detecting a disease, disorder, medical condition, or symptom.

  • Development Period means the period from the date of this Agreement until the Appointed Date;

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