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. 9.2.2 Salix shall own all Regulatory Documentation on a worldwide basis for the Salix Designated Indication Product and the Other New Formulation Products. Alfa shall have a right of reference (with the right to grant further rights of reference through multiple tiers in accordance with Section 4.2.6) to (a) all R...
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Related to Rights of Reference; Ownership of Regulatory Documentation

  • Ownership, Use and Return of Offering Materials The Offering Materials shall continue to be the property of the Owner and JLL. The Offering Materials will be used by the Potential Investor solely for the purpose of evaluating the possible acquisition of the Property and not for any purpose unrelated to the possible acquisition of the Property. The Offering Materials may not be copied or duplicated without the Owner's and JLL’s prior written consent, and must be returned to JLL (or with JLL’s permission, destroyed by Potential Investor and any Related Party, and in such instance Potential Investor shall certify in writing to JLL and Owner that such information has been so destroyed) immediately upon request or when the Potential Investor declines to make an offer for the Property or terminates any discussions or negotiations with respect to the Property.

  • Ownership and License in Deliverables Unless otherwise specified in a specific Purchase Order concerning procurement of a SaaS product:

  • Technical Feasibility of String While ICANN has encouraged and will continue to encourage universal acceptance of all top-­‐level domain strings across the Internet, certain top-­‐level domain strings may encounter difficulty in acceptance by ISPs and webhosters and/or validation by web applications. Registry Operator shall be responsible for ensuring to its satisfaction the technical feasibility of the TLD string prior to entering into this Agreement.

  • Regulatory References A reference in this Agreement to a section in the HIPAA Rules means the section as in effect or as amended.

  • Ownership of Software and Related Material All computer programs, magnetic tapes, written procedures, and similar items purchased and/or developed and used by Price Associates in performance of this Agreement shall be the property of Price Associates and will not become the property of the Funds.

  • Contract (Rights of Third Parties) Xxx 0000 22.1 No person who is not a party to this Grant Agreement shall have the right to enforce any of its terms.

  • Parent Right to Access and Challenge Student Data The LEA shall establish reasonable procedures pursuant to which a parent, as that term is defined in 105 ILCS 10/2(g), may inspect and/or copy Student Data and/or challenge the accuracy, relevance or propriety of Student Data, pursuant to Sections 5 and 7 of ISSRA (105 ILCS 10/5; 105 ILCS 10/7) and Section 33 of SOPPA (105 ILCS 85/33). The Provider shall respond to any request by the LEA for Student Data in the possession of the Provider when Provider cooperation is required to afford a parent an opportunity to inspect and/or copy the Student Data, no later than 5 business days from the date of the request. In the event that a parent contacts the Provider directly to inspect and/or copy Student Data, the Provider shall refer the parent to the LEA, which shall follow the necessary and proper procedures regarding the requested Student Data.

  • Ownership of Software The Parties acknowledge that any software provided by the Authority is and remains the property of the Authority.

  • Product References a. “Or Equal” In all Solicitations or Bid Specifications, the words “or equal” are understood to apply where a copyrighted, brand name, trade name, catalog reference, or patented Product is referenced. References to such specific Product are intended as descriptive, not restrictive, unless otherwise stated. Comparable Product will be considered if proof of compatibility is provided, including appropriate catalog excerpts, descriptive literature, specifications and test data, etc. The Commissioner’s decision as to acceptance of the Product as equal shall be final. b. Discrepancies in References In the event of a discrepancy between the model number referenced in the Solicitation or Bid Specifications and the written description of the Products that cannot be reconciled, then the written description shall prevail.

  • Certain Additional Actions Regarding Intellectual Property If any Event of Default shall have occurred and be continuing, upon the written demand of the Collateral Agent, each Pledgor shall execute and deliver to the Collateral Agent an assignment or assignments of the registered Patents, Trademarks and/or Copyrights and Goodwill and such other documents as are necessary or appropriate to carry out the intent and purposes hereof. Within five (5) Business Days of written notice thereafter from the Collateral Agent, each Pledgor shall make available to the Collateral Agent, to the extent within such Pledgor’s power and authority, such personnel in such Pledgor’s employ on the date of the Event of Default as the Collateral Agent may reasonably designate to permit such Pledgor to continue, directly or indirectly, to produce, advertise and sell the products and services sold by such Pledgor under the registered Patents, Trademarks and/or Copyrights, and such persons shall be available to perform their prior functions on the Collateral Agent’s behalf.

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