Rights of Reference definition

Rights of Reference means rights of reference, as contemplated under, inter alia, 21 CFR §314.50, to the Product NDA.
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Rights of Reference means: (a) in the U.S., a “right of reference or use,” as such term is defined in 21 C.F.R. 314.3(b); or (b) in any other country or jurisdiction, the equivalent authority to rely upon, and otherwise use, an investigation for the purpose of filing, and conducting a clinical trial under, an IND, or obtaining Marketing Approval or other Regulatory Approval, including the ability to make available the underlying raw data from the investigation for audit by the applicable Regulatory Authority in such country or other jurisdiction, if necessary.
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Rights of Reference means, with regard to a Party, a grant of rights (including through a Third Party) that allows the applicable Regulatory Authority in a country to have access to relevant information (by cross‐reference, incorporation by reference or otherwise) contained in a Regulatory Dossier (and any data contained therein) filed with another Regulatory Authority by or on behalf of the other Party (its Affiliate or sublicensee).
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Examples of Rights of Reference in a sentence

  • Upon the expiration of the Royalty Term for a given Licensed Product in a given Region in the Territory, the licenses and rights of reference granted to Lian pursuant to Section 2.1 (License Grants; Rights of Reference) will become perpetual, irrevocable, fully paid-up, royalty free, fully sublicensable, and transferable with respect to such Licensed Product in such Region.

  • The Party granting the right of reference under this Section 7.4 (Rights of Reference; Further Assurances) will execute and deliver, or will cause to be executed and delivered, to the non-granting Party such endorsements, assignments, and other documents as may be reasonably necessary to effect the foregoing right to reference.

  • Depomed has provided to Santarus all excerpts from the Existing Rights of Reference Agreements that contain provisions with respect to the Existing Rights of Reference or the right of access to data described in Section 3.4, and all such excerpts are true and accurate.

  • Without limiting the foregoing, the Parties agree to grant each other such Rights of Reference as are necessary, and to otherwise cooperate in good faith, to enable the conduct of Independent Additional Studies in accordance with the terms of this Agreement, including to with respect to submission of Regulatory Filings, applications for Regulatory Approvals and the maintenance thereof.

  • Effective only as of the NDA Transfer Date, Depomed shall, and it hereby does, assign to Santarus all right, title and interest in the Product NDA, subject to the Existing Rights of Reference and any Additional Rights of Reference granted by Depomed during the Pre-Transfer Period, and the Product IND.

  • Depomed may provide all such Regulatory Communications and Regulatory Data to the applicable Third Parties under the Existing Rights of Reference Agreements and Additional Rights of Reference Agreements as Depomed determines is reasonably necessary to comply with the Existing Rights of Reference Agreements and Additional Rights of Reference Agreements.

  • Santarus hereby covenants that neither it nor any of its Affiliates, nor any Third Party acting on behalf of Santarus or any of its Affiliates, will withdraw, revoke or terminate any Existing Rights of Reference or any Additional Rights of Reference without Depomed’s express prior written authorization to do so.

  • As of the effective date of such termination, (a) all licenses and Rights of Reference granted by BioNTech hereunder shall immediately terminate other than the license set forth in Section 9.1.2, and (b) all licenses and Rights of Reference granted by Genentech hereunder shall immediately terminate other than the license set forth in Section 9.2.2; except to the extent reasonably necessary for the licensee Party to fulfill its post-termination obligations under this Section 14.5.

  • TXMD shall allow the EMA (if required) and all other applicable Regulatory Authorities in the Territory to have access to information (by cross-reference, incorporation by reference or otherwise) contained in Regulatory Materials owned or Controlled by TXMD as of the Effective Date and during the Term for Product to the extent necessary to effectuate the Rights of Reference described above in Section 2.5.1 no later than thirty (30) days after written request by Licensee.

  • For avoidance of doubt, a Party’s submission of information of the other Party to which such Party obtains access pursuant to this Section 5.4 (Rights of Reference) to a Regulatory Authority shall be governed by and subject to the terms of ARTICLE 10 (Confidentiality; Publication).

Related to Rights of Reference

  • Terms of Reference (TOR) means the document included in the RFP as Section 5 which explains the objectives, scope of work, activities, tasks to be performed, respective responsibilities of the Client and the Consultant, and expected results and deliverables of the assignment.

  • Right of Reference means the “right of reference” defined in 21 CFR 314.3(b), including with regard to a Party, allowing the applicable Regulatory Authority in a country to have access to relevant information (by cross-reference, incorporation by reference or otherwise) contained in Regulatory Documentation (and any data contained therein) filed with such Regulatory Authority with respect to a Party’s Compound, only to the extent necessary for the conduct of the Study in such country or as otherwise expressly permitted or required under this Agreement to enable a Party to exercise its rights or perform its obligations hereunder.

  • the book of reference means the book of reference certified by the Secretary of State as the book of reference for the purposes of this Order;

  • Terms of Reference (TORs) means the Terms of Reference that explains the objectives, scope of work, activities, and tasks to be performed, respective responsibilities of the Procuring Entity and the Consultant, and expected results and deliverables of the assignment.

  • Terms of Reference (TOR) means the document included in the RFP as Section 5 which explains the objectives, scope of work, activities, tasks to be performed, respective responsibilities of the Client and the Consultant, and expected results and deliverables of the Assignment/job.

  • unit of Reference Property shall have the meaning specified in Section 14.07(a).

  • Performance References has the meaning set forth for such term in the definition of Derivative Instrument.

  • Underlying Reference means as set out in §26(a) above.

  • Other Definitional Provisions set forth in Section 1.2 of the Basic Servicing Agreement are incorporated by reference into this 2017-3 Servicing Supplement.

  • similar stage of construction means the stage at which:

  • Underlying Referencek means as set out in §26(a) above.

  • Governance Rights means all of a Member's rights as a Member in the Company other than Financial Rights and the right to assign Financial Rights.

  • Public Rights-of-Way means the area on, below, or above a public roadway, highway, street, public sidewalk, alley, waterway, or utility easements dedicated for compatible uses.

  • Miscellaneous Interests means the interests of the Optionor in all property, assets and rights (other than the Property) ancillary to the Property to which the Optionor is entitled including, but not limited to, the interests of the Optionor in:

  • Certain Defined Terms As used in this Agreement, the term "Prospectus" means the applicable Portfolio's prospectus and related statement of additional information, whether in paper format or electronic format, included in the Portfolio's then currently effective registration statement (or post-effective amendment thereto), and any information that we or the Portfolio may issue to you as a supplement to such prospectus or statement of additional information (a "sticker"), all as filed with the Securities and Exchange Commission (the "SEC") pursuant to the Securities Act of 1933.

  • Miscellaneous unit means a hazardous waste management unit where hazardous waste is treated, stored, or disposed of and that is not a container, tank, surface impoundment, pile, land treatment unit, landfill, incinerator, boiler, industrial furnace, underground injection well with appropriate technical standards under 40 CFR Part 146, containment building, corrective action management unit, or unit eligible for a research, development, and demonstration permit under § 270.65, or staging pile.

  • Access Code means the Railways (Access) Code 2000;

  • angle of repose means the steepest angle of a surface at which a mass of loose or fragmented material will remain stationary in a pile on the surface, rather than sliding or crumbling away;

  • Nodal Reference Price at each location shall mean the 97th percentile price differential between day-ahead and real-time prices experienced over the corresponding two-month reference period in the prior calendar year. Reference periods will be Jan-Feb, Mar-Apr, May- Jun, Jul-Aug, Sept-Oct, Nov-Dec. For any given current-year month, the reference period months will be the set of two months in the prior calendar year that include the month corresponding to the current month. For example, July and August 2003 would each use July- August 2002 as their reference period.

  • Architect of Record means the architect licensed by the State who has the contract responsibility for the Project, who designs and prepares the construction documents from which the building is constructed, and who signs the required documents.

  • Other Secured Claims means any Secured Claim against the Debtors that is not an Administrative

  • Use Rights means the license terms and terms of service for each Product published on the Licensing Site and updated from time to time. The Use Rights supersede the terms of any end user license agreement that accompanies a Product. License terms for all Products are published in the Product Terms. Terms of service for Online Services are published in the Online Services Terms.

  • Original Reference Rate means the originally-specified benchmark or screen rate (as applicable) used to determine the Rate of Interest (or any component part thereof) on the Notes.

  • Adjustment Provisions means all relevant provisions of these Conditions which provide for any adjustment, delay, modification, cancellation or determination in relation to an Index, the valuation procedure for an Index or the Preference Shares. This shall include the provisions of Condition 11 (Calculation Agent Modifications) and all subsequent Conditions.

  • Rights-of-Way means easements, licenses, rights-of-way, permits, servitudes, leasehold estates, instruments creating an interest in real property, and other similar real estate interests.

  • General Unsecured Claims means any unsecured claim (other than an Administrative Claim, a Priority Tax Claim, an Other Priority Claim, a Prepetition Term Loan Claim, or an Intercompany Claim) against one or more of the Debtors including (a) Claims arising from the rejection of Unexpired Leases and Executory Contracts to which a Debtor is a party, and (b) Claims arising from any litigation or other court, administrative or regulatory proceeding, including damages or judgments entered against, or settlement amounts owing by a Debtor related thereto.