FDA OAI Matter definition

FDA OAI Matter means the Company’s FDA Official Action Indicated (OAI) status, the FDA inspections relating to the Company’s Davie, Florida manufacturing facilities and matters related thereto.

Related to FDA OAI Matter

  • foreign matter means anything that is not part of the cotton plant.

  • Collaborative matter means a dispute, transaction, claim, problem, or issue for resolution, including a dispute, claim, or issue in a proceeding, that is described in a collaborative law participation agreement and arises under the family or domestic relations law of this state, including any of the following:

  • Excluded Matter means any action, suit or proceeding by the Corporation or one of its subsidiaries against any Indemnitee who is or was an employee, but not an officer, of the Corporation, or is or was serving at the request of the Corporation as an employee, but not as a director or officer, of another corporation, partnership, joint venture, trust, employee benefit plan or other enterprise.

  • transitional matter means a matter that needs to be dealt with for the purpose of effecting the transition from the provisions of the Acts amended by this Act as in force before this Act comes into operation to the provisions of those Acts as in force after this Act comes into operation.

  • Specified Matter means any Amendment of a Portfolio Investment that (a) reduces the principal amount of such Portfolio Investment, (b) reduces the rate of interest payable on such Portfolio Investment, (c) postpones the due date of any scheduled payment or distribution in respect of such Portfolio Investment, (d) alters the pro rata allocation or sharing of payments or distributions required by any related underlying instrument in a manner adverse to the Company, (e) releases any material guarantor of such Portfolio Investment from its obligations, (f) terminates or releases any lien on a material portion on the collateral securing such Portfolio Investment, (g) changes any of the provisions of any such underlying instrument specifying the number or percentage of lenders required to effect any of the foregoing or (h) materially changes any financial maintenance covenant.

  • Licensed Subject Matter means Patent Rights and/or Technology Rights.

  • Environmental Matter means any past, present or future activity, event or circumstance in respect of the environment, health or safety including the Release of any Hazardous Substance including any substance which is hazardous to Persons, animals, plants, or which has a detrimental effect on the soil, air or water, or the generation, treatment, storage, use, manufacture, holding, collection, processing, treatment, presence, transportation or disposal of any Hazardous Substances.

  • Particulate matter means any airborne finely divided solid or liquid material with an aerodynamic diameter smaller than 100 micrometers.

  • Victim or target of Nazi persecution means any individual persecuted or targeted for persecution by

  • Tax Matter has the meaning set forth in Section 7.01.

  • Collaborative drug therapy management means participation by an authorized pharmacist and a physician in the management of drug therapy pursuant to a written community practice protocol or a written hospital practice protocol.

  • Third Party Acquisition has the meaning set forth in Section 4.7(a).

  • Material Compliance Matter has the same meaning as the term defined in Rule 38a-1, and includes any compliance matter that involves: (1) a violation of the federal securities laws by Distributor (or its officers, directors, employees, or agents); (2) a violation of Distributor's Rule 38a-1 policies and procedures; or (3) a weakness in the design or implementation of Distributor's Rule 38a-1 policies and procedures.

  • Unresolved Claims has the meaning set forth in Section 7.6(c).

  • Excluded Matters shall have the meaning given such term in Section 13.3 hereof.

  • Indemnified Matter has the meaning specified in Section 11.4 (Indemnities).

  • Particulate matter emissions (PM) means the mass of any particulate material from the vehicle exhaust quantified according to the dilution, sampling and measurement methods as specified in this UN GTR.

  • COVID-19 symptoms means fever of 100.4 degrees Fahrenheit or higher, chills, cough, shortness of breath or difficulty breathing, fatigue, muscle or body aches, headache, new loss of taste or smell, sore throat, congestion or runny nose, nausea or vomiting, or diarrhea, unless a licensed health care professional determines the person’s symptoms were caused by a known condition other than COVID-19.

  • Third Party Claims has the meaning set forth in Section 11.1.

  • Tax Proceeding has the meaning set forth in Section 5.2(a).

  • Tax Contest means an audit, review, examination, or any other administrative or judicial proceeding with the purpose or effect of redetermining Taxes (including any administrative or judicial review of any claim for refund).

  • Joint Remediation Committee has the meaning set forth in Section II.A.2.

  • Transaction Litigation has the meaning set forth in Section 5.2(d).

  • Collaboration has the meaning set forth in Section 2.1.

  • Collaborative pharmacy practice agreement means a written and signed

  • COVID-19 Pandemic means the SARS-Cov2 or COVID-19 pandemic, including any future resurgence or evolutions or mutations thereof and/or any related or associated disease outbreaks, epidemics and/or pandemics.