Development Costs and Expenses definition

Development Costs and Expenses means the costs and expenses relating to research and development for the Product for the Territory, namely costs and expenses related to materials (e.g., API), analytical testing (e.g., outside laboratory expenses), process development costs, exhibit batch and validation costs, costs of stability studies, processing and conversion costs of materials required for regulatory filings but excluding, costs and expenses associated with legal due diligence, litigation, and ANDA submissions and prosecutions.

Examples of Development Costs and Expenses in a sentence

  • IPC shall be responsible for all Development Costs and Expenses for the Product, except as provided for in Section 2.4, 2.5 and 2.6 below.

  • APP shall invoice MDCO for Development Costs and Expenses within [**] days of being spent or incurred by APP and MDCO shall pay all such invoices within [**] days of the date thereof.

  • Spectrum shall be responsible for all Development Costs and Expenses for each Product, including any bioequivalence or bioavailability studies that are needed for the filing and approval of an ANDA for a Product.

  • If a site is in close proximity to residential neighborhoods, alternatives need to be explored.

  • MDCO shall reimburse APP for the Development Costs and Expenses actually spent or incurred by APP during the term of this Agreement that are listed on Schedule D; provided that MDCO shall not pay APP more than [**] U.S. Dollars ($[**]) pursuant to this Section 3.2. MDCO will not reimburse APP for expenses incurred by APP before the Effective Date.

Related to Development Costs and Expenses

  • 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:

  • 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.

  • Costs and Expenses means any actual, provable, reasonable, customary and direct out-of-pocket costs and expenses incurred by such Fund. Costs and Expenses shall not include, and in no event shall BNY Mellon be liable under this Agreement for, any lift-out expenses or platform development costs for the successor service provider or any wind-down costs of the Fund or any Fund Affiliate, including, without limitation, non-cancelable payments or termination charges regarding hosting and/or any other subcontracted services. The Fund must provide BNY Mellon with written evidence of the Costs and Expenses before BNY Mellon is obligated to pay them. The Fund also has a duty to mitigate, and must exercise its duty to mitigate, such Costs and Expenses.

  • Direct Costs means the sum of the following:

  • 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.

  • Improvement Costs means any additional expenditure on a fixed asset that materially increases the capacity of the asset or materially improves its functioning or represents more than 10% of the initial depreciation base of the asset;

  • FTE Costs means, for any period, the FTE Rate multiplied by the number of FTEs in such period.

  • Settlement Costs means: (a) any award of attorneys’ fees, expenses, and costs to Class Counsel approved by the Court; (b) all costs of printing and providing Class Notice to persons in the Settlement Class (including, but not limited to, costs for Mail Notice, Publication Notice, Website Notice, and any different or additional notice that might be ordered by the Court); (c) all costs of administering the Settlement; and (e) the fees, expenses, and all other costs of the Notice Administrator.

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

  • Soft Costs means the costs of professional work and fees, interim costs, financing fees and expenses, syndication costs, soft costs and Developer’s fees as shown in the Applicant’s properly completed UniApp, Section C - Uses of Funds. Soft Costs do not include operating or replacement reserves.

  • 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.

  • Project Costs means all allowable costs, as set forth in the applicable Federal cost principles, incurred by a recipient and the value of the contribu- tions made by third parties in accom- plishing the objectives of the award during the project period.

  • Legal Expenses means the fees, costs and expenses of any kind incurred by any Person indemnified herein and its counsel in investigating, preparing for, defending against or providing evidence, producing documents or taking other action with respect to any threatened or asserted Claim.

  • Patent Costs means the reasonable fees and expenses paid to outside legal counsel, and filing, maintenance and other reasonable out-of-pocket expenses paid to Third Parties, incurred in connection with the Prosecution and Maintenance of Patent Rights.

  • 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.

  • Operational Expenses means expenses of the clerk of court used to maintain the clerk's office and includes, but is not limited to, (i) computer support, maintenance, enhancements, upgrades, and replacements and office automation and information technology equipment, including software and conversion services; (ii) preserving, maintaining, and enhancing court records, including, but not limited to, the costs of repairs, maintenance, consulting services, service contracts, redaction of social security numbers from certain records, and system replacements or upgrades; and (iii) improving public access to records maintained by the clerk, including locating technology in an offsite facility for such purposes or for implementation of a disaster recovery plan.

  • 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.

  • Costs For any Person, any claims, losses, damages, penalties, fines, forfeitures, reasonable and necessary legal fees and related costs, judgments, and other costs and expenses of such Person.

  • Legal Costs means, with respect to any Person, (a) all reasonable fees and charges of any counsel, accountants, auditors, appraisers, consultants and other professionals to such Person, (b) the reasonable allocable cost of internal legal services of such Person and all reasonable disbursements of such internal counsel and (c) all court costs and similar legal expenses.

  • Replacement Costs means the expenditures for obtaining and installing equipment, accessories or appurtenances which are necessary during the useful life of the treatment works to maintain the capacity and performance for which such works were designed and constructed.

  • Cleanup costs means expenses (including but not limited to legal and professional fees) incurred in testing for, monitoring, cleaning up, removing, containing, treating, neutralizing, detoxifying or assessing the effects of Pollutants.

  • Costs of the Project means Recipient’s actual costs (including any financing costs properly allocable to the Project) that are (a) reasonable, necessary and directly related to the Project, (b) permitted by generally accepted accounting principles to be Costs of the Project, and (c) are eligible or permitted uses of the Financing Proceeds under applicable state or federal statute and rule.

  • 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.

  • O&M Expenses means expenses incurred by or on behalf of the Developer or by the Authority, as the case may be, for all O&M including (a) cost of salaries and other compensation to employees, (b) cost of materials, supplies, utilities and other services, (c) insurance premium, (d) all taxes, duties, cess and fees due and payable for O&M, (e) all repair, replacement, reconstruction, reinstatement, improvement and maintenance costs, (f) payments required to be made under the O&M Contract, or any other contract in connection with or incidental to O&M, and (g) all other expenditure required to be incurred under Applicable Laws, Applicable Permits or this Agreement.

  • Claim Expenses means reasonable documented attorneys’ fees and all other reasonable documented out-of-pocket costs, expenses and obligations (including experts’ fees, travel expenses, court costs, retainers, transcript fees, duplicating, printing and binding costs, as well as telecommunications, postage and courier charges) paid or incurred in connection with investigating, defending, being a witness in or participating in (including on appeal), or preparing to investigate, defend, be a witness in or participate in, any Claim, including any Action relating to a claim for indemnification or advancement brought by an Indemnified Party as contemplated in Section 7.5.