Specified Studies definition

Specified Studies means, with respect to a Licensed Product, (i) all clinical trials currently underway in the Territory for such Licensed Product in the applicable Development Plan and (ii) all clinical trials in the applicable Development Plan to be Initiated after the Effective Date which are global in nature, including Phase 3b Clinical Trials.
Specified Studies means the preclinical and clinical studies, the details of which are set forth in Schedule F.
Specified Studies is defined in Section 2.2.1.

Examples of Specified Studies in a sentence

  • Reason: Having regard to the environmental impact of the propsed development.

  • In performing the Specified Studies, IDEA shall consult with ALPHARMA and shall keep ALPHARMA promptly informed on an ongoing basis regarding all aspects of the Specified Studies.

  • IDEA shall cooperate, at its own expense, with the exercise of ALPHARMA's step-in right (including without limitation procuring the cooperation of its employees and contractors and providing all relevant information), and all costs and expenses of conducting the Specified Studies will remain IDEA's sole responsibility.

  • IDEA shall assist ALPHARMA, as reasonably requested by ALPHARMA, in connection with any NDA filings or other regulatory matters or submissions relating to the Specified Studies in the Territory at ALPHARMA's cost (other than internal personnel costs of IDEA).

  • If IDEA is in breach of any of its obligations under this Section 5.1 and such breach remains uncured for [**] days after ALPHARMA gives written notice to IDEA of such breach, ALPHARMA shall have the right to step-in and take over the management and direction of the Specified Studies (including without limitation the right to manage and direct the activities of all third party contractors engaged to perform any aspects of the Specified Studies).

  • All such reports and other data and information resulting from or related to the Specified Studies shall belong to ALPHARMA and constitute Confidential Information of ALPHARMA for purposes of this Agreement and IDEA hereby assigns all of its right, title and interest therein to ALPHARMA.

  • Recognizes certain Institutions for Specified Studies / Specialized Studies and Research – by its Statute 2008.2..

  • Institutions and Research Foundations, other than Colleges which have already been Recognized as Research Centres shall get into MoU/ MoA with the University as per the provisions of “Recognition of Certain Institutions for Specified Studies/ Specialized Studies and Research-Statutes 2008”, and to seek renewal separately for each program.

  • As of the Execution Date, the IND for the Specified Studies is held by IDEA and ALPHARMA hereby authorizes IDEA, until ALPHARMA instructs it otherwise, to continue to be the owner of such IND and, until IDEA no longer holds such IND, to communicate with the FDA regarding such regulatory issues, subject to the prior approval of ALPHARMA in relation to each communication, which will not be unreasonably withheld or delayed.

  • IDEA shall use commercially reasonable efforts to complete the Specified Studies within the timeframes set forth in Schedule I (which timeframes shall start as to the Phase 3 clinical trials included in the Specified Studies on the date on which milestone 2 (as defined in Section 3.2) is achieved).


More Definitions of Specified Studies

Specified Studies means, with respect to a Licensed Product, (i) all clinical trials currently underway in the Territory for such Licensed Product in the applicable Development Plan and (ii) all clinical trials in the applicable Development Plan to be Initiated after the Effective Date which are global in nature, including Phase 3b Clinical Trials. Note: Redacted portions have been marked with [*]. The redacted portions are subject to a request for confidential treatment that has been filed with the Securities and Exchange Commission.

Related to Specified Studies

  • Qualified student means a resident of this state who:

  • 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.

  • Specified sexual activities means any of the following:

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

  • Specified Subsidiaries means any of (i) Intermediate, (ii) Dell, (iii) Denali Finance, (iv) Dell International (until such time as the MD Stockholders and the SLP Stockholders otherwise agree), (v) EMC, (vi) any successors and assigns of any of Intermediate, Dell, Denali Finance, Dell International (until such time as the MD Stockholders and the SLP Stockholders otherwise agree) and EMC, (vii) any other borrowers under the senior secured indebtedness and/or issuer of the debt securities, in each case, incurred or issued to finance the Merger and the transactions contemplated thereby and by the related transactions entered into in connection therewith and (viii) each intermediate entity or Subsidiary between the Corporation and any of the foregoing.

  • Specified Securities means ‘equity shares’ and ‘convertible securities’ as defined under clause (zj) of sub-regulation (1) of regulation 2 of the Securities and Exchange Board of India (Issue of Capital and Disclosure Requirements) Regulations, 2009;

  • Permitted Junior Secured Refinancing Debt means any secured Indebtedness issued or incurred by the Borrower or a Subsidiary Guarantor in the form of one or more series of Junior Lien secured notes or loans; provided that (i) such Indebtedness is secured by the Collateral on a Junior Lien basis (subject to Liens permitted under Section 9.1) with the Obligations and is not secured by any property or assets of the Borrower or any Subsidiary other than the Collateral, (ii) such Indebtedness constitutes Credit Agreement Refinancing Indebtedness, (iii) such Indebtedness does not mature or have scheduled amortization or scheduled payments of principal and is not subject to mandatory redemption, repurchase, prepayment or sinking fund obligation (other than customary offers to repurchase or mandatory prepayments upon a change of control, asset sale or other Disposition or casualty event or incurrence of indebtedness that is not permitted thereunder and customary acceleration rights after an event of default) prior to the Latest Maturity Date, determined at the time such Indebtedness is incurred, (iv) the security agreements relating to such Indebtedness are substantially the same as the Collateral Documents (with such differences as are reasonably satisfactory to the Administrative Agent), (v) such Indebtedness is not guaranteed by any Subsidiaries other than the Subsidiary Guarantors and (vi) a Senior Representative acting on behalf of the holders of such Indebtedness shall have become party to or otherwise subject to the provisions of the Junior Lien Intercreditor Agreement; provided that if such Indebtedness is the initial Permitted Junior Secured Refinancing Debt incurred by the Borrower or a Subsidiary Guarantor, then Holdings, the Borrower, the Subsidiary Guarantors, the Administrative Agent and the Senior Representative for such Indebtedness shall have executed and delivered a Junior Lien Intercreditor Agreement. Permitted Junior Secured Refinancing Debt will include any Registered Equivalent Notes issued in exchange therefor.

  • 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:

  • Permitted Refinancing Indebtedness means any Indebtedness of the Company or any of its Restricted Subsidiaries issued in exchange for, or the net proceeds of which are used to extend, refinance, renew, replace, defease or refund other Indebtedness of the Company or any of its Restricted Subsidiaries (other than intercompany Indebtedness); provided that:

  • Permitted Refinancing means, with respect to any Person, any modification, refinancing, refunding, renewal, replacement or extension of any Indebtedness of such Person; provided that (a) the principal amount (or accreted value, if applicable) thereof does not exceed the principal amount (or accreted value, if applicable) of the Indebtedness so modified, refinanced, refunded, renewed, replaced or extended except by an amount equal to unpaid accrued interest and premium thereon plus other reasonable amounts paid, and fees and expenses reasonably incurred, in connection with such modification, refinancing, refunding, renewal, replacement or extension and by an amount equal to any existing commitments unutilized thereunder, (b) other than with respect to a Permitted Refinancing in respect of Indebtedness permitted pursuant to Section 7.03(e), such modification, refinancing, refunding, renewal, replacement or extension has a final maturity date equal to or later than the final maturity date of, and has a Weighted Average Life to Maturity equal to or greater than the Weighted Average Life to Maturity of, the Indebtedness being modified, refinanced, refunded, renewed, replaced or extended, (c) other than with respect to a Permitted Refinancing in respect of Indebtedness permitted pursuant to Section 7.03(e), at the time thereof, no Event of Default shall have occurred and be continuing and (d) if such Indebtedness being modified, refinanced, refunded, renewed, replaced or extended is Junior Financing, (i) to the extent such Indebtedness being modified, refinanced, refunded, renewed, replaced or extended is subordinated in right of payment to the Obligations, such modification, refinancing, refunding, renewal, replacement or extension is subordinated in right of payment to the Obligations on terms at least as favorable to the Lenders as those contained in the documentation governing the Indebtedness being modified, refinanced, refunded, renewed, replaced or extended, (ii) such modification, refinancing, refunding, renewal, replacement or extension is incurred by the Person who is the obligor of the Indebtedness being modified, refinanced, refunded, renewed, replaced or extended and (iii) if the Indebtedness being modified, refinanced, refunded, renewed, replaced or extended was subject to an Intercreditor Agreement, the holders of such modified, refinanced, refunded, renewed, replaced or extended Indebtedness (if such Indebtedness is secured) or their representative on their behalf shall become party to such Intercreditor Agreement.

  • 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.

  • Permitted Acquisition means any non-hostile acquisition, whether by purchase, merger or otherwise, of all or substantially all of the assets of, or 50% or more of the voting capital stock of, or a business line or a division of, any Person; provided that:

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

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

  • Permitted Business Acquisition means any acquisition of all or substantially all the assets of, or all the Equity Interests (other than directors’ qualifying shares) in, or merger, consolidation or amalgamation with, a person or division or line of business of a person (or any subsequent investment made in a person, division or line of business previously acquired in a Permitted Business Acquisition), if immediately after giving effect thereto: (i) no Event of Default shall have occurred and be continuing or would result therefrom; (ii) all transactions related thereto shall be consummated in accordance with applicable laws; (iii) with respect to any such acquisition or investment with a fair market value (as determined in good faith by the Borrower) in excess of $50.0 million, the Borrower and its Subsidiaries shall be in Pro Forma Compliance after giving effect to such acquisition or investment and any related transactions; (iv) any acquired or newly formed Subsidiary shall not be liable for any Indebtedness except for Indebtedness permitted by Section 6.01; (v) the Borrower and the Subsidiaries are in compliance with Section 5.09 to the extent required thereby with respect to any person acquired in such acquisition, and (vi) the aggregate amount of such acquisitions and investments in assets that are not owned by the Borrower or Subsidiary Loan Parties or in Equity Interests in persons that are not Subsidiary Loan Parties or persons that do not become Subsidiary Loan Parties upon consummation of such acquisition shall not exceed the sum of (x) the greater of (I) 4.5% of Consolidated Total Assets as of the end of the fiscal quarter immediately prior to the date of such acquisition or investment for which financial statements have been delivered pursuant to Section 5.04 and (II) $500.0 million and (y) the portion of Cumulative Credit on the date of such election by the Borrower.

  • Permitted Capital Expenditures has the meaning given that term in Section 9.12(b).

  • Specified Acquisition means one or more acquisitions of assets or entities or operating lines or divisions in any rolling 12-month period for an aggregate purchase price of not less than $50,000,000.

  • Permitted Activities The primary activities of the trust created pursuant to this Agreement which shall be:

  • Motorsport Activities means any motorsport activities or Recreational Services which are permitted or approved which Motorsport Australia regulates or administers or otherwise are under the responsibility / control of Motorsport Australia;

  • Permitted Acquisition Indebtedness means Indebtedness or Disqualified Stock of the Company or any of its Restricted Subsidiaries to the extent such Indebtedness or Disqualified Stock was Indebtedness or Disqualified Stock of any other Person existing at the time (a) such Person became a Restricted Subsidiary of the Company or (b) such Person was merged or consolidated with or into the Company or any of its Restricted Subsidiaries, provided that on the date such Person became a Restricted Subsidiary or the date such Person was merged or consolidated with or into the Company or any of its Restricted Subsidiaries, as applicable, either

  • Permitted Acquired Debt shall have the meaning set forth in Section 9.04(d).

  • Specified Shares means all or, as the case may be, some of the shares specified in a disclosure notice;

  • Permitted Junior Priority Refinancing Debt means secured Indebtedness (including any Registered Equivalent Notes) incurred by the Parent Borrower, and if applicable, any Co-Borrower, in the form of one or more series of junior priority secured notes or junior priority secured loans; provided that (i) such Indebtedness is secured by the Collateral on a second priority (or other junior priority) basis to the liens securing the Obligations and the obligations in respect of any Permitted First Priority Refinancing Debt and is not secured by any property or assets of a Borrower or any Restricted Subsidiary other than the Collateral, (ii) such Indebtedness may be secured by a Lien on the Collateral that is junior to the Liens securing the Obligations and the obligations in respect of any Permitted First Priority Refinancing Debt, notwithstanding any provision to the contrary contained in the definition of “Credit Agreement Refinancing Indebtedness,” (iii) a Senior Representative acting on behalf of the holders of such Indebtedness shall have become party to or otherwise subject to the provisions of the Intercreditor Agreements, (iv) such Indebtedness does not mature or have scheduled amortization payments of principal or payments of principal and is not subject to mandatory redemption, repurchase, prepayment or sinking fund obligations (except customary asset sale or change of control provisions that provide for the prior repayment in full of the Loans and all other Obligations), in each case prior to 91 days after the Latest Maturity Date at the time such Indebtedness is incurred, (v) such Indebtedness is not at any time guaranteed by any Subsidiaries other than Subsidiaries that are Co-Borrowers or Guarantors and (vi) the security agreements relating to such Indebtedness are substantially the same as or more favorable to the Loan Parties than the Collateral Documents (with such differences as are reasonably satisfactory to the Agent). Permitted Junior Priority Refinancing Debt will include any Registered Equivalent Notes issued in exchange therefor.

  • Synthetic Debt means, with respect to any Person as of any date of determination thereof, all obligations of such Person in respect of transactions entered into by such Person that are intended to function primarily as a borrowing of funds (including any minority interest transactions that function primarily as a borrowing) but are not otherwise included in the definition of “Indebtedness” or as a liability on the consolidated balance sheet of such Person and its Subsidiaries in accordance with GAAP.

  • Permitted Bid Acquisitions has the meaning set forth in the definition of "Acquiring Person" herein.

  • Approved Capital Expenditures means Capital Expenditures incurred by Borrower and either (i) included in the Approved Annual Budget or (ii) approved by Lender, which approval shall not be unreasonably withheld or delayed.