Qualified Study definition

Qualified Study means the first Phase IIa Trial for a Licensed Product anywhere in the world that is completed following the filing of a US IND for the Licensed Product wherein the doses in such Phase IIa Trial are based on the results of one or more Phase I Trials for the Licensed Product.
Sample 1Sample 2Sample 3
Qualified Study means a well-controlled, blinded efficacy study in a standard animal model with well-accepted endpoints showing a dose response that is relevant to one or more Option Indications identified in the protocol for such study. For purposes of illustration, an example is set forth on Exhibit D.
Sample 1

Examples of Qualified Study in a sentence

  • Amorfix will provide any additional information requested by Biogen Idec that is available concerning the Qualified Study, including its objectives, methods, key findings and outcomes.

  • Within ninety (90) days of the receipt of a properly submitted Notice to Partner, Biogen Idec will, if it wishes to exercise its Option Right, designate one or more Option Indications, which shall be reasonably related to the Qualified Study, and notify Amorfix as to whether it has elected to exercise the Option Right with respect to the applicable Option Indication(s).

  • Enviro-Clean further covenants and agrees that, on or prior to February 1, 2001, it and/or Third Party financing sources it identifies will invest an aggregate of $2,250,000 in equity in exchange for 15% of the capital stock of the Company (the "Additional Financing").

Related to Qualified Study

  • Qualified student means a resident of this state who:

  • Qualified Stock means all Capital Stock of a Person other than Disqualified Stock.

  • Qualified school means a nongovernmental primary or secondary

  • Disqualified Stock means, with respect to any Person, any Capital Stock of such Person which by its terms (or by the terms of any security into which it is convertible or for which it is exchangeable) or upon the happening of any event:

  • Qualified Sale means a sale made by a qualified person through a charitable auction.

  • Qualified Securities means securities of a reporting issuer that carry the right to participate in voting on the appointment or removal of the reporting issuer’s auditor;

  • Qualified Stockholder means: (a) the record holder of a share of Class B Common Stock as of the IPO Date; (b) the initial registered holder of any shares of Class B Common Stock that are originally issued by the Corporation after the IPO Date pursuant to the exercise or conversion of any Option or Convertible Security that, in each case, was outstanding as of the IPO Date; (c) each natural person who, prior to the IPO Date, Transferred shares of capital stock of the Corporation to a Permitted Entity that is or becomes a Qualified Stockholder; (d) each natural person who Transferred shares of, or equity awards for, Class B Common Stock (including any Option exercisable or Convertible Security exchangeable for or convertible into shares of Class B Common Stock) to a Permitted Entity that is or becomes a Qualified Stockholder; and (e) a Permitted Transferee.

  • Qualified Securitization Financing means any Securitization Financing of a Securitization Subsidiary that meets the following conditions: (a) the Board of Directors shall have determined in good faith that such Qualified Securitization Financing (including financing terms, covenants, termination events and other provisions) is in the aggregate economically fair and reasonable to the Issuer and the Securitization Subsidiary, (b) all sales of Securitization Assets and related assets to the Securitization Subsidiary are made at fair market value (as determined in good faith by the Issuer) and (c) the financing terms, covenants, termination events and other provisions thereof shall be market terms (as determined in good faith by the Issuer) and may include Standard Securitization Undertakings. The grant of a security interest in any Securitization Assets of the Issuer or any of its Subsidiaries (other than a Securitization Subsidiary) to secure Indebtedness under the Credit Agreement and any Refinancing Indebtedness with respect thereto shall not be deemed a Qualified Securitization Financing.

  • Qualified Servicer means any nationally recognized commercial mortgage loan servicer (1) rated at least “CSS3,” in the case of a special servicer, or at least “CMS2,” in the case of a master servicer, by Fitch, (2) on the S&P Select Servicer List as a U.S. Commercial Mortgage Master Servicer or a U.S. Commercial Mortgage Special Servicer, as applicable, (3) as to which neither Moody’s nor KBRA has cited servicing concerns of such servicer as the sole or material factor in any qualification, downgrade or withdrawal of the ratings (or placement on “watch status” in contemplation of a ratings downgrade or withdrawal) of securities in any CMBS transaction rated by Moody’s or KBRA, as applicable, and serviced by such servicer prior to the time of determination, (4) a servicer that (i) during the 12-month period prior to the date of determination, acted as master servicer or special servicer, as applicable, in a commercial mortgage loan securitization rated by Morningstar and (ii) Morningstar has not qualified, downgraded or withdrawn the then-current rating or ratings of one or more classes of such certificates citing servicing concerns with the servicer or special servicer, as applicable, as the sole or material factor in such rating action and (5) in the case of DBRS, that within the twelve (12) month period prior to the date of determination such servicer was acting as servicer or special servicer, as applicable, in a commercial mortgage loan securitization that was rated by DBRS and DBRS has not downgraded or withdrawn the then-current rating on any class of commercial mortgage securities or placed any class of commercial mortgage securities on watch citing the continuation of such servicer as servicer or special servicer, as applicable, of such commercial mortgage securities as a material reason for such downgrade or withdrawal (or placement on watch status). For purposes of this definition, for so long as any Note is included in a Securitization, the ratings or actions of any Rating Agency that is not rating any such Securitization(s) shall not be considered.

  • 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:

  • Qualified shares means all shares entitled to be voted with respect to the transaction except for shares that the secretary or other officer or agent of the corporation authorized to count votes either knows, or under subsection 4 is notified, are held by:

  • Qualified Subsidiary means a Subsidiary that meets the definition of “a company controlled by its parent company” as defined in Rule 3a-5 under the 1940 Act.

  • 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.

  • Qualified Securitization Facility means any Securitization Facility (1) constituting a securitization financing facility that meets the following conditions: (a) the Board of Directors will have determined in good faith that such Securitization Facility (including financing terms, covenants, termination events and other provisions) is in the aggregate economically fair and reasonable to the Borrower and the applicable Restricted Subsidiary or Securitization Subsidiary and (b) all sales or contributions of Securitization Assets and related assets to the applicable Person or Securitization Subsidiary are made at fair market value (as determined in good faith by the Borrower) or (2) constituting a receivables financing facility.

  • qualified supplier means a supplier that a procuring entity recognises as having satisfied the conditions for participation;

  • Qualified third party means 1 or more of the following:

  • Domestic partnership means an association of two or more persons to carry on as co-owners a

  • Qualified small business means an entity, whether organized as a corporation, partnership, or proprietorship, organized for profit with its principal place of business located within this state and which meets the following criteria:

  • Certified seed means seed produced from plants grown directly from FOUNDATION SEED or REGISTERED SEED, cultivated according to certification regulations and that meets the specifications of the official seed certifying agency of the jurisdiction in which the seed is/was produced.

  • Occupied structure means any building, vehicle, or other place suitable for human occupancy or

  • Specified sexual activities means any of the following:

  • Permitted Junior Securities means Equity Interests in the Company or debt securities of the Company or the relevant Guarantor that are subordinated to all Senior Debt (and any debt securities issued in exchange for Senior Debt) or Guarantor Senior Debt (and any debt securities issued in exchange for Guarantor Senior Debt), as applicable, to substantially the same extent as, or to a greater extent than, the Notes are subordinated to Senior Debt or the Subsidiary Guarantees are subordinated to Guarantor Senior Debt, as applicable, pursuant to this Indenture.

  • Qualified Securitization Transaction means any transaction or series of transactions that may be entered into by the Company or any of its Restricted Subsidiaries pursuant to which the Company or any of its Restricted Subsidiaries may sell, convey or otherwise transfer to:

  • Qualified project means the construction or expansion of any capital project of the Borrower or any of its Restricted Subsidiaries, the aggregate actual or budgeted capital cost of which (in each case, including capital costs expended by the Borrower or any such Restricted Subsidiaries prior to the construction or expansion of such project) exceeds $50,000,000.

  • Specified Sales means (a) the sale, transfer, lease or other disposition of inventory and materials in the ordinary course of business and (b) the sale, transfer or other disposition of Permitted Investments described in clause (i) of the definition thereof.

  • Certified system means any X-ray system which has one or more certified component(s).