Designated Costs definition

Designated Costs means the direct costs and expenses, in Dollars, excluding any general and administrative overhead costs and expenses, actually incurred from and after the Effective Date in performing those activities that are necessary or advisable to Obtain Regulatory Approval for a commercially viable formulation of HepeX-B for the prevention of recurrent Hepatitis B infections in liver transplant patients in the Territory. Subject to the foregoing provisions of this definition, Designated Costs shall include: internal human resources costs of either Party (calculated using actual local salary and employee benefit rates for each Full Time Equivalent), expenses paid to contractors, consultants or other third parties (such as testing laboratories, clinical consultants, clinical research organizations, contract manufacturing organizations and preclinical laboratories), including costs and expenses associated with regulatory fees (such as PDUFA fees), laboratory supplies, office supplies, travel expenses, and reasonable allocations of facility and information technology costs. Designated Costs shall not include expenses for corporate overhead, profit margin, expenses for market research, manufacture or supply for commercial use, commercial launch and other Commercialization activities, post-marketing studies not required as a condition to Obtaining Regulatory Approval in the Territory, or participation on the Joint Alliance Team. If the Parties are unable to agree whether a particular cost or expense is a Designated Cost, either Party may submit the matter to the dispute resolution procedures set forth in Section 14.
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Examples of Designated Costs in a sentence

  • Each Party shall keep or cause to be kept full and accurate books of account and records containing all particulars that may be necessary to determine, in a manner consistent with generally accepted accounting principles in the United States, the sums or credits due under this Agreement, including, but not limited to Designated Costs, Net Sales and Sublicensee Revenues.

  • The rate of exchange to be used in computing Designated Costs, Net Sales and Sublicensee Revenues in each country within the Territory shall be made at the average rate of exchange for such country’s currency published in the Wall Street Journal (New York Edition) for the last business day of each month in the applicable period.

  • The available capital of the special purpose reinsurance vehicle or protected cell has fallen below the applicable initial capital requirement without the approval of the superintendent; or[PL 2007, c.

  • In addition, the HepeX-B Plan will indicate whether any budgeted costs are Designated Costs.

  • For the avoidance of doubt, XTL’s obligation to share in any Designated Costs under this Section 7.4 shall be limited to HepeX-B, unless otherwise agreed by the Parties in writing.

  • CUBIST shall not be responsible for any costs set forth in an invoice that are not Designated Costs.

  • CUBIST shall deliver an invoice to XTL for such amount, which invoice shall set forth in reasonable detail the CUBIST Designated Costs for the immediately preceding calendar quarter.

  • The Parties shall use Commercially Reasonable Efforts to minimize the Designated Costs.

  • If the undisputed CUBIST Designated Costs for such quarter are greater than fifty percent (50%) of the Aggregate Designated Costs for such quarter, then XTL shall pay to CUBIST an amount equal to (I) the CUBIST Designated Costs for such quarter minus (II) the result of the Aggregate Designated Costs for such quarter divided by two (2).

  • First, all amounts necessary, in accordance with the Program Budget, to deliver housing subsidies that are designated as PFS Designated Costs for the three (3) months immediately following termination of this Agreement shall be paid to the appropriate third party (taking into account amounts already disbursed prior to termination of this Agreement).

Related to Designated Costs

  • Related Costs means lodging and, if necessary, physical protection for the Covered Person during or while waiting for Transport to the Nearest Place of Safety. Related Costs will include temporary lodging, if necessary, while a Covered Person is waiting to be transported back to the Host Country, Home Country or other country where the Policyholder that sponsored the Covered Person’s Trip is located. Benefits will not be payable for Related Costs unless We (or Our authorized assistance provider) authorize in writing, or by an authorized electronic or telephonic means, all expenses in advance, and services are rendered by Our assistance provider.

  • Associated Costs means, in respect of each Preference Share, an amount (subject to a minimum of zero) equal to its pro rata share (calculated on the basis of the proportion of the aggregate number of Preference Shares outstanding as at the Early Preference Share Valuation Date) as determined by the Calculation Agent of:

  • Approved costs means the eligible costs or expenditures2 as approved by the Provider, and as defined in the Agreement or Decision on Grant Funding to carry out the Grant Project.

  • Estimated Costs means costs estimated by the Authority as likely to be:

  • Fixed Costs means costs which do not vary with consumption or volume produced;

  • Recovered Costs means any amounts referred to in clauses (d) and/or (e) of the definition of “Defaulted Mortgage Loan Purchase Price” that, at the time of determination, had been previously paid or reimbursed to any Servicer from sources other than collections on or in respect of the Mortgage Loan or the Mortgaged Property (including, without limitation, from collections on or in respect of loans other than the Mortgage Loan).

  • Direct Costs means the sum of the following:

  • Overhead costs means the actual costs incurred or the estimated costs to be

  • Hard Costs means all costs and expenses payable for supplies, materials, labor and profit with respect to the Improvements under any Construction Contract.

  • 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.

  • Increased Costs Any amounts required to be paid by the Borrower to an Indemnified Party pursuant to Section 2.12.

  • Qualified Costs means an electric utility's regulatory assets as determined by the commission, adjusted by the applicable portion of related investment tax credits, plus any costs that the commission determines that the electric utility would be unlikely to collect in a competitive market, including, but not limited to, retail open access implementation costs and the costs of a commission approved restructuring, buyout or buy-down of a power purchase contract, together with the costs of issuing, supporting, and servicing securitization bonds and any costs of retiring and refunding the electric utility's existing debt and equity securities in connection with the issuance of securitization bonds. Qualified costs include taxes related to the recovery of securitization charges.

  • Service Fees means all fees payable by Party B to Party A pursuant to Article 3 of this Agreement in respect of the Services provided by Party A.

  • Routine patient care costs means Covered Medical Expenses which are typically provided absent a clinical trial and not otherwise excluded under the Policy. Routine patient care costs do not include:

  • Third Party Costs means all such third party costs (including legal and other professional fees) in respect of each Individual Scheme as a Partner reasonably and properly incurs in the proper performance of its obligations under this Agreement and as agreed by the Partnership Board. Working Day means 8.00am to 6.00pm on any day except Saturday, Sunday, Christmas Day, Good Friday or a day which is a bank holiday (in England) under the Banking & Financial Dealings Act 1971.

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

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

  • Transfer Costs means the cost of registration of Transfer arising herefrom calculated with reference to the fee chargeable in terms of the recommended guideline of conveyancing fees, and all incidental disbursements necessary to effect registration, together with VAT on such costs and disbursements, but specifically excluding any costs relating to mortgage bond registration;

  • 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.

  • Estimated Cost , for the purposes of rule 22, means the estimated cost to maintain, repair or replace a major capital item;

  • Services Fees means the agreed upon fees in an Order for the Services Offerings.

  • Eligible Costs means the actual costs reasonably incurred by the Recipient:

  • Service Costs has the meaning ascribed thereto in Section 3.01.

  • Restructuring related costs means reasonably incurred costs

  • Advanced Services refers to high speed, switched, broadband, wireline Telecommunications capability that enables users to originate and receive high-quality, voice, data, graphics or video Telecommunications using any technology.

  • Eligible patient means an individual who meets all of the following conditions: