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

  • Express Waiver I desire to expressly waive any claim of confidentiality as to any and all information contained within our response to the competitive procurement process (e.g. RFP, CSP, Bid, RFQ, etc.) by completing the following and submitting this sheet with our response to Education Service Center Region 8 and TIPS. Signature Date

  • 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

  • bond waiver means an agreement with a developer for the provision of a form of financial security as a substitute for a bond; "calendar year" means the twelve months ending with 31st December;

  • 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 Amendment No. 2 to Credit Agreement, dated as of November 22, 2017, among Holdings, the Borrower, the other Loan Parties 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.

  • Standard Amendment Coversheet refers to the form used by the Judicial Council to amend agreements with other parties. Several originally signed, fully executed versions of a Standard Amendment, together with the integrated Contract Documents, shall each represent an Amendment as an individual contract counterpart.

  • 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 that certain Amendment No. 9 to Credit Agreement, dated as of March 27, 2019, among the Original BV Borrower, the Original US Borrower, the Parent, the other Guarantors party thereto, Xxxxxx Xxxxxxx Senior Funding, Inc., as Administrative Agent, the L/C Issuer and the Swingline Lender, and the Revolving Credit Lenders party thereto.

  • 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 Increase Joinder and Seventh Amendment to Credit Agreement dated as of the Seventh Amendment Effective Date by and among the Borrowers, the other Loan Parties party thereto, the Lenders party thereto and Agent.

  • First Amendment means that certain First Amendment to Credit Agreement, dated as of September 19, 2016, among the Borrower, the Administrative Agent and the Lenders party thereto.

  • 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 that certain Reaffirmation Agreement, dated as of the date hereof, between the Loan Parties and the Administrative Agent, for the benefit of the Administrative Agent and the Lenders and the other holders of the Secured Obligations.

  • 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.