PDUFA Fees definition

PDUFA Fees means all user fees and other prescription drug program fees payable to the FDA for the fiscal year ended September 30, 2018 that relate exclusively to the Products or the facility included in the Transferred Real Property (and not to any of Seller’s other products, facilities or operations) under the FDCA, as amended by the Prescription Drug User Fee Amendments of 2017, in each case to the extent transferrable to a purchaser of the Products or that facility.
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PDUFA Fees means all fees payable with respect to the Products under the Prescription Drug User Fee Act.
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PDUFA Fees means all user fees and other prescription drug program fees payable to the FDA for the fiscal year ended September 30, 2020 that relate exclusively to the Products (and not to any of Seller’s other products) under the FDCA, as amended by the Prescription Drug User Fee Amendments of 2019, in each case to the extent transferrable to a purchaser of the Products.
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Examples of PDUFA Fees in a sentence

  • Seller shall retain full responsibility and liability for the PDUFA Fees due and payable on or prior to the Effective Date.

  • Following the Effective Date, Buyer shall assume and have responsibility for fees or charges associated with the Product due and payable to the FDA after the Effective Date pursuant to the Prescription Drug User Fee, and any reauthorization thereto ("PDUFA Fees").

  • At the Closing, Buyer shall pay or cause to be paid to Seller, or Seller’s applicable Subsidiary or assignee, by wire transfer of immediately available funds to one or more accounts designated by Seller at least four (4) Business Days prior to the Closing Date, an amount equal to the Purchase Price plus the Buyer Portion of PDUFA Fees.

  • For income Tax purposes the Parties intend that the transactions pursuant to this Agreement shall be treated as a taxable sale of the Transferred Assets in exchange for the Closing Cash Consideration, the Assumed Liabilities, the Purchaser Portion of PDUFA Fees and the right to receive Milestone Payment (except the portion thereof that may be reported as imputed interest) (the “Intended Tax Treatment”).

  • In consideration for the purchase and sale of the Transferred Assets and the consummation of the transactions contemplated by this Agreement or the Ancillary Agreements, the Purchaser hereby agrees to pay the Seller an amount equal to (i) the Closing Cash Consideration, plus (ii) the Purchaser Portion of PDUFA Fees, less (iv) the RWI Payment.

  • BUSDOCS/1504906.3 Liabilities ULURU shall pay any PDUFA fees (the "PDUFA Fees") payable by Access to the FDA on September 30, 2005.

  • Notwithstanding the foregoing, Cadence shall reimburse Grifols for that portion of any payments of PDUFA Fees made by Grifols that are directly related to the manufacture of the Product, but shall not be required to reimburse Grifols for (a) any PDUFA Fees related to changes to the manufacture or supply of Product proposed by Grifols, or (b) any PDUFA Fees, or portions thereof, related to the manufacture of products other than the Product.


More Definitions of PDUFA Fees

PDUFA Fees shall have the meaning provided in Section 3.6(c) of this Agreement.
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Related to PDUFA 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.]

  • 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

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

  • 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;

  • 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 the license fees, including all taxes thereon, paid or required to be paid by Licensee for the license granted under this Agreement.

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

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

  • 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.

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

  • Annual Fees means the annual fees determined by the Council in terms of section 27;

  • 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.

  • 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.

  • Other Fees means amounts owed by the Borrower hereunder pursuant to Sections 2.09, 2.10, 2.11, 2.12, 8.01 and 10.10.

  • 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.

  • Fees means all amounts payable pursuant to, or referred to in, Section 4.1.

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

  • 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;

  • 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.

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

  • Related Expenses means any and all costs, liabilities, and expenses (including, without limitation, losses, damages, penalties, claims, actions, reasonable attorney's fees, legal expenses, judgments, suits and disbursements) reasonably incurred by, or imposed upon, or asserted against, Lender in any attempt by Lender:

  • Administration Fees The sum of (i) the Servicing Fee, (ii) the Master Servicing Fee and (iii) the Credit Risk Management Fee.

  • Upfront Fees shall have the meaning assigned to such term in Section 2.05.

  • 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.

  • Closing Fees means those fees required to be paid on the Closing Date pursuant to the Fee Letter.