Qualified drug definition

Qualified drug means a drug that has a United States Food and Drug Administration approved indication to treat multiple sclerosis.
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Qualified drug means a drug developed by Buyer or any of its Affiliates (but excluding any Person that would be deemed an Affiliate solely by virtue of its status as a controlling stockholder of Buyer and to whom neither Buyer or any of its Affiliates or any of its or their licensees or sublicensees has assigned or transferred any rights in, under or to, or otherwise given access to, the Transferred Assets or any portion thereof), or any of its or their licensees or sublicensees, utilizing patents included within the Transferred Assets, provided, however, that in no event will Buyer’s compound known as RXI-109 (incorporating the active pharmaceutical ingredient identified in the Buyer’s Investigational New Drug Application filed with the FDA) constitute a Qualified Drug; provided, further, that any combination drug incorporating RXI-109 and another active pharmaceutical ingredient other than RXI-109 that utilizes Intellectual Property included within the Transferred Assets shall be deemed to be a Qualified Drug.
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Qualified drug means a drug that has a United States Food and Drug Administration approved
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Examples of Qualified drug in a sentence

  • Buyer shall pay Seller up to $50,000,000 in one-time development and commercialization milestones for the successful development and commercialization of each Qualified Drug, which milestone payments shall be payable solely in cash.

  • In the event that Seller has a reasonable basis to believe that Buyer has failed to use exercise commercially reasonable efforts to cause all of the milestones to be achieved with respect to at least one Qualified Drug, then Seller may provide written notice of such alleged failure to the Buyer (a “Diligence Notice”) and requesting a description of Buyer’s diligence efforts.

Related to Qualified drug

  • controlled drug means an article or substance prescribed under a regulation to be a controlled drug.

  • Covered drug means any prescription drug that:

  • New drug means: (i) any drug, except a new animal drug or an animal feed bearing or containing

  • Generic Drug means any Prescription Drug approved by the FDA that has the same bio-equivalency as a specific Brand Name Drug.

  • Legend drug or "prescription drug" means any drug or device that has been determined to be unsafe for self- medication or any drug or device that bears or is required to bear the legend:

  • Qualified GIC A guaranteed investment contract or surety bond providing for the investment of funds in the Custodial Account and insuring a minimum, fixed or floating rate of return on investments of such funds, which contract or surety bond shall:

  • Narcotic drug means any of the following, whether produced directly or indirectly by extraction from substances of vegetable origin, or independently by means of chemical synthesis, or by a combination of extraction and chemical synthesis:

  • Qualified Nurse means a person who holds a valid registration from the Nursing Council of India or the Nursing Council of any state in India.

  • Legend drugs means any drugs which are required by state

  • New Drug Application means a New Drug Application filed with the FDA in accordance with Applicable Law.

  • FFDCA means the United States Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 301 et seq., as amended from time to time, together with any rules, regulations and requirements promulgated thereunder (including all additions, supplements, extensions, and modifications thereto).

  • Invalid Drug Test means the result of a drug test for an oral fluid specimen that contains an unidentified adulterant, or an unidentified substance, that has abnormal physical characteristics, or that has an endogenous substance at an abnormal concentration preventing the laboratory from completing or obtaining a valid drug test result.

  • low protein modified food product means a food product that is specially formulated to have less than one gram of protein per serving and is intended to be used under the direction of a Practitioner for the dietary treatment of an inherited metabolic disease, but does not include a natural food that is naturally low in protein; and

  • FDCA shall have the meaning ascribed to such term in Section 3.1(hh).

  • Qualified wages means wages you paid during the one-year period beginning with the date an ex-offender begins working for you. Only wages that are subject to unemployment tax under IRC Section 3306 qualify. This includes amounts in excess of the maximum taxable wage. Wages paid during any period for which you received federally funded payments for on-the-job training for the ex-offender do not qualify.

  • FD&C Act means the U.S. Federal Food, Drug and Cosmetic Act, as amended, and the regulations promulgated thereunder.

  • Prescription drug means any drug required by federal law or regulation to be dispensed only

  • Therapeutically equivalent drug products means drug products that contain the same active ingredients and are identical in strength or concentration, dosage form, and route of administration and that are classified as being therapeutically equivalent by the U.S. Food and Drug Administration pursuant to the definition of "therapeutically equivalent drug products" set forth in the most recent edition of the Approved Drug Products with Therapeutic Equivalence Evaluations, otherwise known as the "Orange Book."

  • Qualified United States financial institution means an institution that:

  • Qualified veteran means a person who meets the following requirements:

  • New manufactured home park or subdivision means a manufactured home park or subdivision for which the construction of facilities for servicing the lots on which the manufactured homes are to be affixed (including at a minimum, the installation of utilities, the construction of streets, and either final site grading or the pouring of concrete pads) is completed on or after the effective date of this ordinance or the effective date of the initial floodplain management ordinance and includes any subsequent improvements to such structure.

  • Qualified health plan means a health benefit plan that has in effect a certification that the plan

  • Drug abuse means any pattern of pathological use of drugs that causes impairment in social or occupational functioning, or that produces physiological dependency evidenced by physical tolerance or by physical symptoms when it is withdrawn.

  • Existing manufactured home park or subdivision means a manufactured home park or subdivision for which the construction of facilities for servicing the lots on which the manufactured homes are to be affixed (including, at a minimum, the installation of utilities, the construction of streets, and either final site grading or the pouring of concrete pads) is completed before the effective date of the floodplain management regulations adopted by a community.

  • inherited metabolic disease means a disease caused by an inherited abnormality of body chemistry for which testing is mandated by law;

  • Drug addiction means a disease characterized by a