DEFINITIONS1.1 AFFILIATE definition

DEFINITIONS1.1 AFFILIATE means, with respect to any Person, any other Person that controls, is controlled by or is under common control with, such Person. A Person shall be regarded as in control of another Person if such Person owns, or directly or indirectly controls, more than fifty percent (50%) of the voting securities (or comparable equity interests) or other ownership interests of the other Person, or if such Person directly or indirectly possesses the power to direct or cause the direction of the management or policies of the other Person, whether through the ownership of voting securities, by contract or any other means whatsoever.1.2 BUFFER SOLUTION shall mean the buffer solution used for the manufacture of the Drug Product.1.3 BULK DRUG SUBSTANCE shall mean the active ingredients in the Drug Product.1.4 cGMP or GMP shall have the meaning set forth in Schedule I.1.5 CONFIDENTIAL INFORMATION shall have the meaning set forth in Article 9.1.6 DEVELOPMENT shall mean all work necessary to develop a process to manufacture the Drug Product in full accord with cGMP and to supply the Drug Product conforming to the Specifications. Development activities shall include, but not be limited to, pilot batches, scale- up batches, validation of the manufacturing process, and successful completion of the Drug Product manufacture and delivery as defined in Schedule I attached hereto. 1.7 DRUG PRODUCT shall mean the N-Acetylcysteine pharmaceutical product developed by CUMBERLAND and marketed under the trade name ACETADOTE or any other trade name selected by CUMBERLAND.1.8 EXCIPIENT shall mean any inert substance selected by CUMBERLAND and used to give the Drug Product proper consistency.1.9 FACILITY shall mean the manufacturing facility and the real property underlying such manufacturing facility operated by Bioniche Teoranta, an Affiliate of BIONICHE, located at Inverin, Co. Galway, Republic of Ireland.1.10 FDA shall mean the United States Food and Drug Administration (FDA) or any successor entity thereto.1.11 IN-PROCESS SOLUTION shall mean all Buffer Solutions and Excipients needed to produce Drug Product in the finished dosage form set forth in Schedule I.1.12 INVENTION shall have the meaning set forth in Paragraph 9.4.1.13 LABELING shall mean all labels and other written, printed, or graphic matter upon: (i) the Drug Product or any container or wrapper utilized with the Drug Product and (ii) any written material accompanying the Drug Product, including without limitation, package insert...

Related to DEFINITIONS1.1 AFFILIATE

  • definition of Monthly Advance" in Article I is hereby amended in its entirety to read as follows:

  • Definition means a provision of this Law (however expressed) that —

  • Definitions In this Agreement:

  • FBF Definitions means the definitions set out in the June 2013 FBF Master Agreement relating to transactions on forward financial instruments as supplemented by the Technical Schedules (Additifs Techniques) as published by the Fédération Bancaire Française (together the FBF Master Agreement) as may be supplemented or amended as at the Issue Date.

  • Other Definitional Provisions set forth in Section 1.2 of the Basic Servicing Agreement are incorporated by reference into this 2017-3 Servicing Supplement.

  • Defined Terms As used herein:

  • Three-Month Term SOFR means the rate for Term SOFR for a tenor of three months that is published by the Term SOFR Administrator at the Reference Time for any interest period, as determined by the Calculation Agent after giving effect to the Three-Month Term SOFR Conventions. All percentages used in or resulting from any calculation of Three-Month Term SOFR shall be rounded, if necessary, to the nearest one-hundred-thousandth of a percentage point, with 0.000005% rounded up to 0.00001%.

  • Master Definitions Schedule means the amended and restated schedule of definitions relating to the Programme originally dated the Programme Effective Date and as most recently amended and restated on 18 December 2020 (as further amended, supplemented and/or replaced from time to time).

  • BHC Act Affiliate of a party means an “affiliate” (as such term is defined under, and interpreted in accordance with, 12 U.S.C. 1841(k)) of such party.

  • Three-Month Term SOFR Conventions means any determination, decision or election with respect to any technical, administrative or operational matter (including with respect to the manner and timing of the publication of Three-Month Term SOFR, or changes to the definition of “Floating Interest Period”, timing and frequency of determining Three-Month Term SOFR with respect to each Floating Interest Period and making payments of interest, rounding of amounts or tenors, and other administrative matters) that the Company decides may be appropriate to reflect the use of Three-Month Term SOFR as the Benchmark in a manner substantially consistent with market practice (or, if the Company decides that adoption of any portion of such market practice is not administratively feasible or if the Company determines that no market practice for the use of Three-Month Term SOFR exists, in such other manner as the Company determines is reasonably necessary).

  • Affiliate Agreement has the meaning set forth in Section 3.21.

  • BHC Affiliate has the meaning assigned to the term “affiliate” in, and shall be interpreted in accordance with, 12 U.S.C. §1841(k).

  • Management Fee Subordination Agreement means that certain Amended and Restated Management Fee Subordination Agreement, dated as of the Closing Date, by and between the Sponsor and Agent and acknowledged by the Borrower.

  • Certain Defined Terms As used in this Agreement, the term "Prospectus" means the applicable Portfolio's prospectus and related statement of additional information, whether in paper format or electronic format, included in the Portfolio's then currently effective registration statement (or post-effective amendment thereto), and any information that we or the Portfolio may issue to you as a supplement to such prospectus or statement of additional information (a "sticker"), all as filed with the Securities and Exchange Commission (the "SEC") pursuant to the Securities Act of 1933. 2.

  • Group Member Agreement means the partnership agreement of any Group Member, other than the Partnership, that is a limited or general partnership, the limited liability company agreement of any Group Member that is a limited liability company, the certificate of incorporation and bylaws or similar organizational documents of any Group Member that is a corporation, the joint venture agreement or similar governing document of any Group Member that is a joint venture and the governing or organizational or similar documents of any other Group Member that is a Person other than a limited or general partnership, limited liability company, corporation or joint venture, as such may be amended, supplemented or restated from time to time.

  • Non-Affiliate means, for any specified Person, any other Person that is not an Affiliate of the specified Person.

  • Additional Xxxx of Sale means each document, in the form of Attachment D hereto, executed by an authorized officer of VL Funding, the VL Funding Eligible Lender Trustee on behalf of VL Funding, Funding and the Interim Eligible Lender Trustee on behalf of Funding which shall: (i) set forth the list and certain terms of (a) Additional Loans offered by VL Funding and the VL Funding Eligible Lender Trustee on behalf of VL Funding and accepted for purchase by the Interim Eligible Lender Trustee for the benefit of Funding, including the Additional Loans Purchase Price for the Additional Loans being sold thereunder or (b) Substituted Loans substituted by VL Funding and (ii) sell, assign and convey to Funding and the Interim Eligible Lender Trustee, for the benefit of Funding, and their assignees, all right, title and interest of VL Funding and of the VL Funding Eligible Lender Trustee on behalf of VL Funding in the Additional Loans or Substituted Loans, as applicable, listed on the related Additional Xxxx of Sale and (iii) certify that the representations and warranties made by VL Funding and the VL Funding Eligible Lender Trustee on behalf of VL Funding pursuant to Sections 5(A) and (B) of these Master Terms, by the Servicer as set forth in Section 5(C) and by the Interim Eligible Lender Trustee as set forth in Section 5(D) are true and correct.

  • Adjusted Term SOFR Rate means, for any Interest Period, an interest rate per annum equal to (a) the Term SOFR Rate for such Interest Period, plus (b) 0.10%; provided that if the Adjusted Term SOFR Rate as so determined would be less than the Floor, such rate shall be deemed to be equal to the Floor for the purposes of this Agreement.

  • Long-term contract means a contract with a duration period exceeding one year;

  • Long Term Supply Assignment means, in relation to an employee,

  • The definition of Pass-Through Rate" set forth in Section 1.01 of the Pooling Agreement is hereby amended and restated to read as follows:

  • Affiliated business entity relationship means a relationship, other than a parent- subsidiary relationship, that exists when

  • (b) As used in this section, claim' means a bill or an invoice submitted to a governmental entity for goods or services.

  • 2021 ISDA Definitions means, in relation to a Series of Notes, the latest version of the 2021 ISDA Interest Rate Derivatives Definitions (including each Matrix (and any successor Matrix thereto), as defined in such 2021 ISDA Interest Rate Derivatives Definitions) as at the date of issue of the first Tranche of Notes of such Series, as published by ISDA on its website (www.isda.org);

  • Affiliate Subordination Agreement means an Affiliate Subordination Agreement substantially in the form of Exhibit C pursuant to which intercompany obligations and advances owed by any Loan Party are subordinated to the Obligations.