Limitation of Rights to Clinical Data Sample Clauses

Limitation of Rights to Clinical Data. (i) With respect to any Unilateral Activities to support an application for Regulatory Approval for (A) an Additional Indication for a Licensed Product or (B) a Combination Product for any Licensed Indication, the Opting-Out Party, notwithstanding the right of reference granted in Sections 5.1.4 and 5.1.5, or 5.2.4 and 5.2.5, or the provision of such Regulatory Data pursuant to Section 3.6.2(i), as applicable, shall not have the right to use or reference any Regulatory Data or Regulatory Documentation resulting from such Unilateral Activities unless such Party Opts-In pursuant to Section 3.7.4, provided that if the inclusion or reference of such Clinical Data or Regulatory Documentation is required solely to comply with a requirement to report worldwide clinical studies to Regulatory Authorities or safety information with respect to a Licensed Product in a filing seeking or maintaining Regulatory Approval of such Licensed Product, the Opting-Out Party shall have the right to use or reference such Regulatory Data or Regulatory Documentation solely for such reporting purpose and such use shall not trigger an Opt-In or other cost-sharing pursuant to Section 3.7.4. The Opting-Out Party shall not, unless and until it Opts-In, use or reference such Regulatory Data or Regulatory Documentation for purposes of expansion of the Product Labelling or obtaining additional Regulatory Approval of any Licensed Product in its portion of the Territory. Notwithstanding the foregoing, Licensor shall have a limited license and right to access, use and reference, solely to grant a sublicense and provide a right of access, use and reference to Kyowa with respect to any such Regulatory Data or Regulatory Documentation pertaining to any Licensed Product containing the Initial Licensed Compound or any Backup Compound, as and to the extent required under the Kyowa Agreement as determined by Licensor in good faith.
Sample 1
AutoNDA by SimpleDocs

Related to Limitation of Rights to Clinical Data

  • License of Data; Warranty; Termination of Rights A. The valuation information and evaluations being provided to the Trust by USBFS pursuant hereto (collectively, the “Data”) are being licensed, not sold, to the Trust. The Trust has a limited license to use the Data only for purposes necessary to valuing the Trust’s assets and reporting to regulatory bodies (the “License”). The Trust does not have any license nor right to use the Data for purposes beyond the intentions of this Agreement including, but not limited to, resale to other users or use to create any type of historical database. The License is non-transferable and not sub-licensable. The Trust’s right to use the Data cannot be passed to or shared with any other entity. The Trust acknowledges the proprietary rights that USBFS and its suppliers have in the Data.

  • Limitation of Rights Nothing in this Agreement or the Plan shall be construed to:

  • Clinical Data The descriptions of the results of any studies and tests conducted by or on behalf of, or sponsored by, the Company or its subsidiaries, or in which the Company has participated, that are described in the Disclosure Package and the Prospectus, or the results of which are referred to in the Disclosure Package and the Prospectus do not contain any misstatement of material fact or omit to state a material fact necessary to make such statements not misleading. The Company has no knowledge of any studies or tests not described in the Disclosure Package and the Prospectus the results of which reasonably call into question in any material respect the results of the studies, tests and trials described in the Disclosure Package or Prospectus.

  • Reversion of Rights Notwithstanding anything to the contrary set forth herein (including, but not limited to, Section 5 hereof), full responsibility for Prosecution of the Patent Rights shall, at the option of CSMC (exercisable in its sole and absolute discretion), and at its sole expense from the date of reversion, revert to CSMC upon any termination of this Agreement.

  • PROCEDURE FOR NOTIFICATION AND APPLICATION FOR INDEMNIFICATION (a) Indemnitee agrees to notify promptly the Company in writing upon being served with any summons, citation, subpoena, complaint, indictment, information or other document relating to any Proceeding, claim, issue or matter therein which may be subject to indemnification, hold harmless or exoneration rights, or advancement of Expenses covered hereunder. The failure of Indemnitee to so notify the Company shall not relieve the Company of any obligation which it may have to Indemnitee under this Agreement, or otherwise.

  • Duration of Rights If an Exchange Event does not occur within the time period set forth in the Company’s Amended and Restated Memorandum and Articles of Association, as the same may be amended from time to time, the Rights shall expire and shall be worthless.

  • Disclaimer of Rights No provision in this Option Agreement shall be construed to confer upon the Optionee the right to be employed by the Corporation or any subsidiary, or to interfere in any way with the right and authority of the Corporation or any subsidiary either to increase or decrease the compensation of the Optionee at any time, or to terminate any employment or other relationship between the Optionee and the Corporation or any subsidiary.

  • Limitation of Rights of Holders Except as set forth in Section 9.2, the death, bankruptcy, termination, dissolution or incapacity of any Person having an interest, beneficial or otherwise, in Trust Securities shall not operate to terminate this Trust Agreement, nor annul, dissolve or terminate the Trust nor entitle the legal representatives or heirs of such Person or any Holder for such Person, to claim an accounting, take any action or bring any proceeding in any court for a partition or winding up of the arrangements contemplated hereby, nor otherwise affect the rights, obligations and liabilities of the parties hereto or any of them.

  • Reservation of Right to Revise Structure Buyer may at any time change the method of effecting the business combination contemplated by this Agreement if and to the extent that it deems such a change to be desirable; provided, however, that no such change shall (a) alter or change the amount of the consideration to be issued to holders of Company Common Stock as merger consideration as currently contemplated in this Agreement, (b) reasonably be expected to materially impede or delay consummation of the Merger, (c) adversely affect the federal income tax treatment of holders of Company Common Stock in connection with the Merger, or (d) require submission to or approval of the Company’s shareholders after the plan of merger set forth in this Agreement has been approved by the Company’s shareholders. In the event that Buyer elects to make such a change, the parties agree to execute appropriate documents to reflect the change.

  • Reservation of Rights Nothing contained in this Agreement shall prevent or in any way diminish or interfere with any rights or remedies, including, without limitation, the right to contribution, which Lender may have against Borrower, Indemnitor or any other party under the Comprehensive Environmental Response, Compensation and Liability Act of 1980 (codified at Title 42 U.S.C. §9601 et seq.), as it may be amended from time to time, or any other applicable federal, state or local laws, all such rights being hereby expressly reserved.

Time is Money Join Law Insider Premium to draft better contracts faster.