Rights of Reference; Ownership of Regulatory Documentation Sample Clauses

Rights of Reference; Ownership of Regulatory Documentation. 9.2.1 Alfa shall own all Regulatory Documentation on a worldwide basis for all Rifaximin Products within the Field other than the Salix Designated Indication Product and the Other New Formulation Products. Salix shall have a right of reference (with the right to grant further rights of reference through multiple tiers in accordance with Section 4.1.6) to (a) all Regulatory Documentation Controlled by Alfa (or its Affiliates or its future Sublicensees (to the extent Alfa obtains the right to share Regulatory Documentation controlled by future Sublicensees with Salix (as set forth below)) that relates to the Compound or Rifaximin Products within the Field and (b) all Regulatory Documentation relating to safety data with respect to the Compound or Rifaximin Products outside the Field Controlled by Alfa (or its Affiliates or its future Sublicensees (to the extent Alfa obtains the right to share Regulatory Documentation controlled by future Sublicensees with Salix (as set forth below)), in each case, that is necessary or useful to support any applications for Regulatory Approvals or other regulatory filings that Salix or its Affiliates or Sublicensees may make in respect of Rifaximin Products within the Field in the Salix Territory or pursuant to or in exercise of Salix’s rights under this Agreement. For clarification, Alfa’s ownership of Regulatory Documentation pursuant to this Section 9.2.1 does not in any way affect Salix’s obligations to develop Regulatory Documentation for submission to the FDA. For clarification, Salix’s right of reference provided for in this Section 9.2.1 shall also apply to Regulatory Documentation Controlled by future Sublicensees of Alfa, provided that Alfa is able to obtain such rights from its Sublicensee. Alfa shall use good faith Commercially Reasonable Efforts to obtain its Sublicensees’ agreement to grant such rights, along with the right to sublicense to Salix such Sublicensees’ Know-How and Patents that are relevant to Salix’s Exploitation of the licenses granted to it in this Agreement, but will not be prohibited from entering into a sublicense agreement if the prospective Sublicensee refuses to grant such rights.
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Related to Rights of Reference; Ownership of Regulatory Documentation

  • Rights of Reference Upon mutual agreement, Regeneron will grant to the Government a right of reference to any Regulatory Application submitted in support of this Project Agreement, solely for the purpose of the Government conducting a clinical trial with the drug product supplied under this Project Agreement under a protocol approved by Regeneron for performance by the Government. In such a case, Regeneron agrees to provide a letter of cross-reference to the Government and file such letter with the appropriate FDA office. Nothing in this paragraph reduces the Government’s data rights as articulated in other provisions of this award.

  • Purpose; Incorporation by Reference of Auction Procedures and Settlement Procedures (a) On each Auction Date, the provisions of the Auction Procedures will be followed by the Auction Agent for the purpose of determining the Applicable Rate for the of APS, for the next Dividend Period therefor. Each periodic operation of such procedures is hereinafter referred to as an "Auction."

  • Purpose; Incorporation by Reference of Auction Procedures (a) On each Auction Date, the provisions of the Auction Procedures will be followed by the Auction Agent for the purpose of determining the Applicable Rate for each series of Preferred Shares, for each Dividend Period. Each periodic operation of such procedures is hereinafter referred to as an "Auction."

  • Incorporation by Reference of TIA Whenever this Indenture refers to a provision of the TIA, such provision is incorporated by reference in, and made a part of, this Indenture. The following TIA terms used in this Indenture have the following meanings:

  • Rights of Registration and Voting Rights Except as provided in the Investors’ Rights Agreement, the Company is not under any obligation to register under the Securities Act any of its currently outstanding securities or any securities issuable upon exercise or conversion of its currently outstanding securities. To the Company’s knowledge, except as contemplated in the Voting Agreement, no stockholder of the Company has entered into any agreements with respect to the voting of capital shares of the Company.

  • Incorporation By Reference; Plan Document Receipt This Agreement is subject in all respects to the terms and provisions of the Plan (including, without limitation, any amendments thereto adopted at any time and from time to time unless such amendments are expressly intended not to apply to the Award provided hereunder), all of which terms and provisions are made a part of and incorporated in this Agreement as if they were each expressly set forth herein. Any capitalized term not defined in this Agreement shall have the same meaning as is ascribed thereto in the Plan. The Participant hereby acknowledges receipt of a true copy of the Plan and that the Participant has read the Plan carefully and fully understands its content. In the event of any conflict between the terms of this Agreement and the terms of the Plan, the terms of the Plan shall control.

  • Transferability of Registration Rights The registration rights set forth in this Agreement are transferable to each transferee of Registrable Securities. Each subsequent holder of Registrable Securities must consent in writing to be bound by the terms and conditions of this Agreement in order to acquire the rights granted pursuant to this Agreement.

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