Allowable Commercialization Expenses definition

Allowable Commercialization Expenses shall exclude Development Costs.
Allowable Commercialization Expenses means those expenses incurred during the term of this Agreement which are specifically attributable to the actual or contemplated Commercialization of a specific Licensed Product(s), and shall consist of: (a) Costs of Goods; (b) Marketing, Sales and Distribution Costs; (c) out of pocket costs to identify potential partners and to negotiate Partnering Agreements; (d) all patent prosecution, maintenance and litigation expenses incurred under Article 9 of this Agreement; (e) Post Launch Research and Development Expenses; (f) Allocated Administrative Expenses; (g) the costs of engaging Third Parties to assist with Commercialization; and (h) Currency Gains or Losses. “Allowable Commercialization Expenses” shall exclude Development Costs.
Allowable Commercialization Expenses means those expenses (a) incurred in connection with the Commercialization of the Products pursuant to the Commercialization Plan and Budget and (b) that are consistent with the approved Commercialization Plan and Budget and are specifically attributable to Products, and shall consist of (i) Cost of Goods Sold, (ii) Marketing Expenses, (iii) Distribution Expenses, and (iv) Post-Approval Regulatory Expenses. The JFC shall establish procedures for the calculation of Allowable Commercialization Expenses, including proper allocation of FTE costs to the extent that such FTEs promote other products (including the allocation of sales force effort between first, second and third position detail) or otherwise engage in activities not solely related to the Commercialization of the Product. For clarity, subject to Section 9.5, each Party shall be responsible for and solely bear any Commercialization expenses not contemplated in, or in excess of the agreed amounts set forth in, the approved Commercialization Plan and Budget.

Examples of Allowable Commercialization Expenses in a sentence

  • If a Third Party manufactures, then the Collaboration Product shall be supplied at [*] of the price charged by the Third Party, and the time spent by Nuvelo FTEs to manage the Third Party supplier shall be excluded from the calculation of Manufacturing Costs, Development Costs and Allowable Commercialization Expenses.

  • The costs of engaging any such Third Party will be Allowable Commercialization Expenses to the extent that the engagement of the applicable Third Party is consistent with the Commercialization Plan and Budget.

  • If requested by a Party, any invoices or other supporting documentation for any payments to a Third Party in respect of Allowable Commercialization Expenses that individually exceed [***] (or such other amount as may be specified by the JEC from time to time) shall be promptly provided not more than [***] after receipt of a request therefor.

  • The auditor shall keep confidential any information obtained during such inspection and shall report to the requesting Party and the audited Party only the amounts of such Development Costs, Net Product Sales, and Allowable Commercialization Expenses.

  • Such Quarterly Report shall specify in reasonable detail all deductions allowed in the calculation of such Net Product Sales and all expenses included in Allowable Commercialization Expenses for such Product.

  • Any such Allowable Commercialization Expenses that exceed the amount of the Allowable Commercialization Expenses shall be borne by the party incurring such Allowable Commercialization Expenses, unless otherwise determined by the Joint Commercialization Committee.

  • A written summary of each meeting shall be submitted to the next scheduled meeting of the Board.

  • In addition to the reports required under Section 7.4(c)(i), on or before December 31 of each year during the Collaboration Period, each Party shall submit to the other Party a report of its Allowable Commercialization Expenses, Net Sales and Product Profit (Loss) (if any, in the case of Non-Lead) in October and November of the 4th quarter of such year, for informational purposes.

  • Each Party shall report to the other Party, within [***] after the end of each Quarter, the actual Net Product Sales and Allowable Commercialization Expenses incurred by such Party for each Product during such Calendar Quarter in each country in the Territory in a manner sufficient to enable the other Party to comply with its Finance and Accounting Compliance and on a line item basis consistent with the budgetary line items set forth in the Commercialization Plan and Budget (the “Quarterly Report”).

  • WENA Ltd Care Coordinator and managers must be informed immediately so that individual risk assessments can be updated and the care plan modified.


More Definitions of Allowable Commercialization Expenses

Allowable Commercialization Expenses has the meaning set forth in the Financial Appendix.
Allowable Commercialization Expenses means the following expenses incurred or accrued (as applicable in accordance with Article 1 of this Financial Appendix) pursuant to the Collaboration that are generally consistent with the applicable Commercialization Plan and Budget and are specifically attributable and properly allocable to the actual or contemplated Commercialization of a Collaboration Product in accordance with GAAP or GAAP Counterpart, as applicable: (a) Costs of Goods; (b) Marketing, Sales and Distribution Costs; (c) Partnering Costs; (d) Post Launch R&D Expenses; (e) Patent Costs, with respect to Patents covering a Collaboration Compound, Collaboration Product, or a formulation, method of manufacture or method of use of any of the foregoing; and (f) any expenses expressly and specifically deemed to be Allowable Commercialization Expenses in the Agreement, including without limitation costs and expenses of booking sales, stocking inventory for the Lead and any of its sublicensees and collection of accounts receivable and bad debt; but in all cases excluding Excluded Costs (as defined in Section 2.7 of this Financial Appendix). Allowable Commercialization Expenses excludes Development Costs and any amounts deducted from gross sales to arrive at Net Sales in accordance with the definition of Net Sales. Overhead Charges for Commercialization (other than Manufacturing) shall be accounted for, Shared and otherwise reimbursed between the Parties solely as they are incorporated into the FTE Rate (without limiting Section 2.2).
Allowable Commercialization Expenses shall exclude Research Costs and Development Costs.
Allowable Commercialization Expenses means those expenses incurred during the Collaboration which are generally consistent with a Commercialization Plan and Budget that has been approved by the JSC, and are specifically attributable to the actual or contemplated Commercialization of Collaboration Products, and shall consist of: (a) Costs of Goods; (b) Marketing, Sales and Distribution Costs; (c) Partnering Costs; (d) Patent Costs; (e) Post Launch R&D Expenses; (f) Allocated Administrative Expense; (g) the costs of engaging Third Parties to assist with the Commercialization; and (h) Currency Gains or Losses (as the terms set forth in subsections (a) through (h) above are defined in this Article 1 or in Exhibit A). “Allowable Commercialization Expenses” shall exclude Research Costs and Development Costs.
Allowable Commercialization Expenses means those expenses (a) incurred in connection with the Commercialization of the Products pursuant to the Commercialization Plan and Budget and the Global Pricing and Reimbursement Plan and Budget, each as mutually agreed by the Parties and approved by the JCC in accordance with Section 8.3 and (b) that are consistent with the approved budget set forth in the Commercialization Plan and Budget and the Global Pricing and Reimbursement Plan and Budget, as relevant, and are specifically attributable to Products, and shall consist of (i) Cost of Goods Sold, (ii) the market access and reimbursement and patient support costs mutually agreed by the Parties and approved by the JCC under the Global Pricing [***] Certain confidential portions (indicated by brackets and asterisks) have been omitted from the exhibit in accordance with the rules of the Securities and Exchange Commission. and Reimbursement Plan and Budget, in accordance with Section 8.3, (iii) Marketing Expenses, (iv) Distribution Expenses, and (v) Post-Approval Regulatory Expenses. The JFC shall establish procedures for the calculation of Allowable Commercialization Expenses, including proper allocation of FTE costs to the extent that such FTEs promote other products (including the allocation of sales force effort between first, second and third position detail) or otherwise engage in activities not solely related to the Commercialization of the Product. For clarity, subject to Section 9.5, each Party shall be responsible for and solely bear any Commercialization expenses not contemplated in, or in excess of the agreed amounts set forth in, the approved budget set forth in the Commercialization Plan and Budget or the Global Pricing and Reimbursement Plan and Budget, as applicable.”
Allowable Commercialization Expenses means the sum of (a) Product Supply Costs, (b) the aggregate fees and expenses paid by Organon and Cypress to outside consultants and counsel in respect of filing, prosecution and maintenance of Cypress Patents, Organon Patents and Joint Patents with respect to Approved Products in the Shared Territory from and after the Date of First Commercial Sale of such Approved Product, (c) the aggregate payments made by Organon or Cypress to Third Parties as milestone, royalty or similar payments that the parties agree is required for the sale or other transfer of Approved Products in the Field in the Shared Territory and (d) the aggregate payments made by Organon and Cypress to Third Parties for the launch, promotion, marketing, distribution and sale of a Approved Product in the Field in the Shared Territory, including, without limitation, Post-Approval Study Expenses, Selling Expenses, Marketing Management, Market and Consumer Research, Advertising, Trade Promotion, Consumer Promotion, Education and Freight and Transportation–Out, using the defined terms set forth below. For clarification, Allowable Commercialization Expenses shall not include (1) any internal costs of Organon or Cypress for the promotion, marketing, distribution and sale of Approved Product in the Field in the Shared Territory, including any amounts paid to Third Parties for the Cypress Sales Force or (2) any expenses incurred before execution of any agreement entered into by the parties with regard to joint commercialization of an Approved Product in the Field in the Shared Territory. The costs of activities which promote Organon’s or Cypress’ business as a whole without being specific to Approved Products (such as corporate image advertising) are specifically excluded from Allowable Commercialization Expenses. To the extent multiple products are involved and some of such products are not Approved Products, then such amounts will be allocated on a pro rata basis to be negotiated between the parties that is designed to account for the respective contributions made to the marketing efforts for each product. Within 60 days of the end of a Calendar Year, the parties will make reconciling payments, if any are required, to reflect any difference between actual costs and such allocation for such year.

Related to Allowable Commercialization 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.

  • 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:

  • 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.

  • Allowable Costs means the costs defined as allowable in 42 CFR, Chapter IV, Part 413, as amended to October 1, 2007, except for the purposes of calculating direct medical education costs, where only the reported costs of the interns and residents are allowed. Further, costs are allowable only to the extent that they relate to patient care; are reasonable, ordinary, and necessary; and are not in excess of what a prudent and cost-conscious buyer would pay for the given service or item.

  • 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.

  • Allowable Expenses means any necessary, reasonable and customary item of expense at least a portion of which is covered under at least one of the Health Benefit Plans covering the person for whom claim is made. When a Health Benefit Plan provides benefits in the form of coverage for services, the reasonable cash value of each service rendered shall be deemed to be both an Allowable Expense and a benefit paid.

  • Program Expenses means all UHC’s expenses of administering the Program under the Indenture and the Act and shall include without limiting the generality of the foregoing; salaries, supplies, utilities, labor, materials, office rent, maintenance, furnishings, equipment, machinery and apparatus, including information processing equipment; software, insurance premiums, credit enhancement fees, legal, accounting, management, consulting and banking services and expenses; Fiduciary Expenses; remarketing fees; Costs of Issuance not paid from proceeds of Bonds; and payments to pension, retirement, health and hospitalization funds; and any other expenses required or permitted to be paid by UHC.

  • Marketing Expenses means the sum of Selling Expenses, Marketing Management Expenses, Market and Consumer Research Expenses, Advertising Expenses, Trade Promotion Expenses, and Consumer Promotion Expenses, each of which is specified below, in each case to the extent directly and reasonably attributable to the sale, promotion or marketing of the applicable ZIOPHARM Products in the countries where such ZIOPHARM Product has been launched.

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

  • Transition Expenses The reasonable costs (including reasonable attorneys’ fees) of the Backup Servicer incurred in connection with the transferring the servicing obligations under this Agreement and amending this Agreement to reflect such transfer in an amount not to exceed $100,000.

  • 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.

  • Marketing Costs which means such reasonable charge for marketing of ores and concentrates sold or of concentrates tolled as is consistent with generally accepted industry marketing practices;

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

  • Allowable Expense means a necessary, reasonable and customary item of expense for health care, which is:

  • Distribution Expenses means, with respect to all rights granted to LGF hereunder, one hundred percent (100%) of the aggregate of all actual, direct, out-of-pocket, third xxxxx costs expended or incurred by LGF in direct connection with the distribution and exploitation of the Picture throughout the Territory in all media, including, without limitation, all DLT Creation Costs, and all conversion, manufacturing, duplication, shipping, marketing, advertising, promotion and publicity costs, and all costs to complete Delivery of the Picture (to the extent (i) LGF elects to cure any failure of Grantor to complete Delivery of the Picture in accordance with the Delivery Schedule and/or (ii) LGF is required to take "access" to any Delivery Materials pursuant to the Delivery Schedule; and/or fiii) Grantor is not required to deliver such elements under the Delivery Schedule).

  • Medical Expenses means those expenses that an Insured Person has necessarily and actually incurred for medical treatment on account of Illness or Accident on the advice of a Medical Practitioner, as long as these are no more than would have been payable if the Insured Person had not been insured and no more than other hospitals or doctors in the same locality would have charged for the same medical treatment.

  • 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.

  • Exploration Expenditures means the sum of all costs of acquisition and maintenance of the Property, all exploration and development expenditures and all other costs and expenses of whatsoever kind or nature including those of a capital nature, incurred or chargeable by KRC with respect to the exploration and development of the Property and the placing of the Property into Commercial Production.

  • Allowable cost means a cost that complies with all legal requirements that apply to a particular federal education program, including statutes, regulations, guidance, applications, and approved grant awards.

  • Commercialization or “Commercialize” means any and all activities undertaken at any time for a particular Licensed Product and that relate to the manufacturing, marketing, promoting, distributing, importing or exporting for sale, offering for sale, and selling of the Licensed Product, and interacting with Regulatory Authorities regarding the foregoing.

  • Allowable Deductions means the following costs, charges, and expenses incurred or accrued by Payor:

  • Manufacturing Cost means [***].

  • Transportation Expense means the cost of Medically Necessary conveyance, personnel, and services or supplies.

  • 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.

  • Election expenses means expenses incurred, whether before, during or after the election, on account of, or in respect of, the conduct or management of the election.

  • 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.