MUMS Waiver definition

MUMS Waiver means any waiver from user fees granted by the FDA/CVM Office of Minor Use and Minor Species Animal Drug Development (OMUMS) under the minor use/minor species provision, pursuant to Section 740(d)(1)(D)) of the Animal Drug User Fee Act (ADUFA) of 2003, including specifically, that certain waiver no. SR1276 from user fees in fiscal year 2014, granted on November 4, 2013 to Napo for crofelemer for the treatment of chemotherapy induced diarrhea in dogs.
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Related to MUMS Waiver

  • Addendum / Amendment means any written amendment / addendum /corrigendum to this RFP, from time to time issued by NMRC to the prospective bidders

  • Waiver Agreement means an agreement between

  • Third Amendment means that certain Third Amendment to Amended and Restated Credit Agreement dated as of the Third Amendment Effective Date, among the Borrower, the Guarantors party thereto, the Administrative Agent and the Lenders party thereto.

  • Lien Waiver Agreement means an agreement which is executed in favor of Agent by a Person who owns or occupies premises at which any Collateral may be located from time to time and by which such Person shall waive any Lien that such Person may ever have with respect to any of the Collateral and shall authorize Agent from time to time to enter upon the premises to inspect or remove the Collateral from such premises or to use such premises to store or dispose of such Inventory.

  • Landlord Waiver means a letter in form and substance reasonably acceptable to the Administrative Agent and executed by a landlord in respect of Inventory of a Loan Party located at any leased premises of a Loan Party pursuant to which such landlord, among other things, waives or subordinates on terms and conditions reasonably acceptable to the Administrative Agent any Lien such landlord may have in respect of such Inventory.

  • Consent and Agreement means the Manufacturer Consent and Agreement [____], dated as of even date with the Participation Agreement, of Airframe Manufacturer.

  • Second Amendment means that certain Second Amendment to Amended and Restated Credit Agreement dated as of the Second Amendment Effective Date, among the Borrower, the Guarantors party thereto, the Administrative Agent and the Lenders party thereto.

  • Fifth Amendment means that certain Fifth Amendment to Credit Agreement, dated as of December 14, 2017, among Holdings, the Borrower, the Administrative Agent and the Lenders, Letter of Credit Issuers and other Credit Parties party thereto.

  • Sixth Amendment means the Sixth Amendment to Credit Agreement dated as of March 7, 2011 among the Borrower, the Lenders party thereto and the Administrative Agent.

  • Eleventh Amendment means that certain Eleventh Amendment to Credit Agreement, dated as of April 29, 2022, among Holdings, the Borrower, the other Credit Parties party thereto, the Administrative Agent, the Collateral Agent, the Lenders party thereto, the Revolving Letter of Credit Issuers and the various other parties party thereto.

  • Ninth Amendment means the Ninth Amendment to Amended and Restated Senior Secured Credit Agreement, dated as of February 11, 2022, by and among Administrative Agent, Collateral Agent, Lenders, the Borrower, Parent and Guarantors.

  • Supplemental Agreement means an agreement supplemental to this Agreement, substantially in the form set out in Schedule 1 to this Agreement to be entered into by the Secretary of State and the Company pursuant to which the Company agrees to establish and maintain, and to carry on or provide for the carrying on, and the Secretary of State agrees to fund, an Academy in accordance with the terms and conditions of that Supplemental Agreement and this Agreement;

  • Seventh Amendment means that certain Seventh Amendment to Revolving Credit and Security Agreement, dated as of the Seventh Amendment Date, by and among Borrowers, Lenders and Agent.

  • First Amendment means the First Amendment to Amended and Restated Credit Agreement, dated the First Amendment Effective Date, by and among the Loan Parties party thereto, the Required Lenders, the Revolving Credit Lenders and the Administrative Agent.

  • Amendment Agreement shall have the meaning assigned to such term in the recitals hereto.

  • Incremental Agreement shall have the meaning provided in Section 2.14(e).

  • Eighth Amendment means that certain Eighth Amendment to Second Amended and Restated Credit Agreement and First Amendment to Second Amended and Restated Guaranty and Collateral Agreement, dated as of the Eighth Amendment Effective Date, among the Borrower, the Guarantors, the Administrative Agent and the Lenders party thereto.

  • Tenth Amendment means that certain Tenth Amendment to Credit Agreement, dated as of November 15, 2019, among Holdings, the Borrower, the other Credit Parties party thereto, the Administrative Agent, the Collateral Agent and the Lenders party thereto.

  • Fourth Amendment means that certain Fourth Amendment to Credit Agreement, dated as of August 17, 2017, among Holdings, the Borrower, the Administrative Agent and the Lenders and other Credit Parties party thereto.

  • Waiver and Release means the Waiver and Release attached hereto as Exhibit A.

  • Reaffirmation Agreement means the Reaffirmation Agreement dated as of the Closing Date by the Borrower and the Guarantors to the Administrative Agent for the benefit of the Secured Parties.

  • Consent Agreement means this Consent Agreement, duly signed and concluded between the Commission and the Respondent, as contemplated in section 40(1) of the Act.

  • Release Agreement means an agreement, substantially in a form approved by the Company, pursuant to which Executive releases all current or future claims, known or unknown, arising on or before the date of the release against the Company, its subsidiaries and its officers.

  • Service Level Agreement (SLA means the Contractual Commitment that prevails between the Buyer and the Service Provider with regard to type of service to be provided, deliverables, desired performance level, reliability and responsiveness, monitoring process and service level reporting, response and issue resolution time-frame, repercussions / penalties / remedies for service provider not meeting its commitment. The SLA of a particular contract may carry the matrix regarding the delivery of the goods and/or services and the corresponding penalties or remedies and liquidated damages as applicable.