GDUFA Fees definition

GDUFA Fees means the fees imposed under the Generic Drug Users Fee Act and the Generic Drug User Fee Amendments of 2012, as amended to date or as further amended.
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GDUFA Fees has the meaning set out in Clause 9.2.1.
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Examples of GDUFA Fees in a sentence

  • GDUFA Fees are assessed by the FDA annually and shall be paid by Palatin annually, where applicable.

  • GDUFA Fees are assessed by the FDA on October 1st of each year and shall be paid by Client annually, where applicable.

  • A Catalent facility incurs GDUFA Fees when that Catalent facility is referenced in an approved ANDA.

  • Palatin shall reimburse Catalent for any fees Catalent may be required to pay pursuant to the US Generic Drug User Fee Amendments of 2012 (“GDUFA Fees”), *** GDUFA Fees are assessed on Catalent when an Abbreviated New Drug Application (“ANDA”) applicant identifies Catalent in an ANDA application filed with FDA.

  • Palatin shall reimburse Catalent for any fees Catalent may be required to pay pursuant to the US Generic Drug User Fee Amendments of 2012 ("GDUFA Fees"), [***] .

  • Generic Drug User Fee Amendments of 2012 (“GDUFA Fees”), [***] GDUFA Fees are assessed on Catalent when an Abbreviated New Drug Application (“ANDA”) applicant identifies Catalent in an ANDA application filed with FDA.

  • For generic drugs, GDUFA Fees apply when the ANDA is filed and are due thereafter on an annual basis, unless otherwise specifically agreed in a supply agreement between Catalent and Client.

  • Palatin shall reimburse Catalent for any fees Catalent may be required to pay pursuant to the US Generic Drug User Fee Amendments of 2012 (“GDUFA Fees”), [***] GDUFA Fees are assessed on Catalent when an Abbreviated New Drug Application (“ANDA”) applicant identifies Catalent in an ANDA application filed with FDA.

  • Catalent will invoice Client for Client’s pro-rata share of the annual GDUFA Fees Catalent incurs for each Catalent manufacturing or packaging facility identified in Client’s ANDA(s) pursuant to FDA regulations (this includes but is not limited to any Catalent facility which manufactured or packaged Client’s registration batches).

  • GDUFA Fees are assessed on Catalent when an Abbreviated New Drug Application ("ANDA") applicant identifies Catalent in an ANDA application filed with FDA.

Related to GDUFA Fees

  • Monthly Fees means, collectively, [INSERT FOR HFS: the Monthly Food and Beverage Fee,] the Monthly Program Fee and the Monthly Royalty Fee, each of which is set forth in the Addendum. [INSERT FOR HFS: “Monthly Food and Beverage Fee” means the fee we require from you in Subsection 8.2, which is set forth in the Addendum.]

  • L/C Fees has the meaning set forth in Section 3.4(c).

  • Tuition Fees means a sum specified in the Offer Letter, payable by the Student to cover tuition, access to College facilities, enrolment procedures and orientation meetings, use of Information Technology facilities, exam sitting and a Kaplan award on successful completion of the Programme; and

  • Tax Fees means the aggregate fees billed in each of the last two fiscal years for professional services rendered by the Company’s external auditor for tax compliance, tax advice and tax planning.

  • License Fees means all non-refundable fees payable by Licensee to OT with respect to the granting of Software Licenses; “License Model” means the description of the conditions, limitations and restrictions associated with the Software License which govern the use of the Software, as set out in the applicable License Model Schedule;

  • Processing Fees means all routine, generally applicable City-wide fees required by the City for processing applications and permits including, but not limited to, fees for land use applications, building applications, building permits, and certificates of occupancy.

  • Maintenance Fees means the non-refundable fees payable annually by Licensee to OT for Support Services;

  • Expense Fees As to each Mortgage Loan, the sum of the Servicing Fee and the Trustee Fee.

  • Admin Fees means the costs incurred by the Authority in dealing with MI Failures calculated in accordance with the tariff of administration charges published by the Authority;

  • User fees or "tolls" means the rates, tolls, fees, or

  • Annual Fees means the annual fees charged by the Trustee for services provided as the trustee and paying agent under the Indenture.

  • Licence Fees the fees to be paid by the Licensee to HKEX-IS pursuant to clause 5.2.

  • School Fees means the money payable by the Parent/s to the School in connection with a Student’s education, excluding any Enrolment Fee, Deposit or Additional Fees.

  • Origination Fees means the fee payable to the Advisor pursuant to Section 8.02 plus all other fees and commissions, excluding Acquisition Expenses, paid by any Person to any Person in connection with making or investing in any Loan by the Company.

  • Transaction Fees means fees paid or payable by the Service Recipients, which are on market terms, with respect to financial advisory services ordinarily carried out by investment banks in the context of mergers and acquisitions transactions.

  • Late Fees shall have the meaning set forth in Section 2(d).

  • Development Fees means fees imposed to offset capital costs of providing public infrastructure, public safety or other public services to a development and authorized pursuant to A.R.S. Section 9-463.05, A.R.S. Section 11-1102 or A.R.S. Title 48 regardless of the jurisdiction to which the fees are paid.

  • Royalty Fee “Royalty Fee” means a royalty fee in the amount of $0.00 of Actual Production payable by BC Hydro to the Province for each year of the Term in accordance with Article 6 of the Master Agreement.

  • Sublicense Fees shall have the meaning set forth in Section 7.3 below.

  • 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.

  • Upfront Fees means, with respect to any Receivable, the sum of any fees charged by Holdings or the Receivables Account Bank, as the case may be, to a Receivables Obligor in connection with the disbursement of a loan, as set forth in the Receivables Agreement related to such Receivable, which are deducted from the initial amount disbursed to such Receivables Obligor, including the “Origination Fee” set forth on the applicable Receivable Agreement.

  • Liquidation Fees shall have the meaning assigned to such term in the Servicing Agreement or such other analogous term used in the Servicing Agreement.

  • Impact Fees means those fees imposed so that developments bear a proportionate share of the cost of public facilities and service improvements that are reasonably related to the impacts and burdens of the Project, adopted pursuant to Morgan Hill Municipal Code Chapter 3.56 and California Government Code Section 66001 et seq.

  • Support Fees means the fees, if any, payable by the State for Maintenance and Support Services as set forth in the Maintenance and Support Schedule.

  • Acquisition Fees means the fee payable to the Advisor pursuant to Section 8.01 plus all other fees and commissions, excluding Acquisition Expenses, paid by any Person to any Person in connection with making or investing in any Property or other Permitted Investment or the purchase, development or construction of any Property by the Company. Included in the computation of such fees or commissions shall be any real estate commission, selection fee, Development Fee, Construction Fee, nonrecurring management fee, loan fees or points or any fee of a similar nature, however designated. Excluded shall be Development Fees and Construction Fees paid to Persons not Affiliated with the Advisor in connection with the actual development and construction of a Property.

  • Tuition Fee means the basic tuition fee applicable to specific programmes and shall include auxiliary fees which are for required instruction but shall exclude any other fees such as international student differential fees, co-op fees, and student union fees.