Data Package Review Period definition

Data Package Review Period means, with respect to an Aurigene Immuno-oncology PTP Data Package or Follow-On Molecule Profile Data Package, a period of [**] days from the delivery of such Data Package to Curis, subject to extension at Curis’ reasonable request and Aurigene’s approval (which shall not be unreasonably withheld) for up to an additional [**] days as reasonably necessary (a) for Curis to (i) review such Data Package in the event that it includes substantial data or information that has not previously been disclosed to Curis (via the SOC or otherwise), or (ii) conduct appropriate patentability analyses or freedom-to-operate searches with respect to the compounds described in such Data Package, or (b) to address other bona fide scientific or intellectual property questions or concerns raised by Curis during the [**]-day period after delivery of such Data Package. Notwithstanding the foregoing, if Curis determines during the [**]-day period after delivery of such Data Package that such Information delivered by Aurigene does not constitute a Data Package as defined by
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Data Package Review Period has the meaning provided in Section 8.6(b).
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Data Package Review Period means, on a Reserved Target-by-Reserved Target basis, the period commencing on the date on which Sangamo delivers a Data Package to Biogen with respect to such Reserved Target and ending [*] days thereafter, as such period may be extended pursuant to Section 4.7(e)(iv) (Extension of Data Package Review Period). 1.63 “Debarred” means, with respect to an individual or entity, that such individual or entity has been (a) debarred or suspended under 21 U.S.C. §335(a) or (b), (b) the subject of a conviction described in Section 306 of the Federal Food, Drug and Cosmetic Act, (c) excluded from a federal or governmental health care program, (d) debarred from federal contracting, (e) convicted of or pled nolo contendere to any felony, or to any federal or state legal violation (including misdemeanors) relating to prescription drug products or fraud, (f) the subject to OFAC sanctions or on the OFAC list of specially designated nationals or (g) the subject of any similar sanction of any Governmental Authority in the Territory. 1.64 “Defaulting Party” has the meaning set forth in Section 12.2(b) (Termination for Material Breach). 8 [*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
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Examples of Data Package Review Period in a sentence

  • If Curis informs Aurigene that it declines to select such Aurigene Immuno-oncology PTP as a Program Target Profile for a Program, or if Curis fails to inform Aurigene of Curis’ decision regarding such Aurigene Immuno-oncology PTP prior to expiration of such Data Package Review Period, Aurigene’s exclusivity obligations with respect solely to such Aurigene Immuno-oncology PTP shall cease.

  • Curis shall have until the expiration of the applicable Data Package Review Period to elect whether to add such Aurigene Immuno-oncology PTP as a Program Target Profile for the conduct of an R&D Program or Additional R&D Program, as applicable.

  • During the applicable Data Package Review Period, Aurigene shall make qualified Aurigene representatives available to Curis (at a SOC meeting or otherwise), and Curis will have the opportunity to discuss with, and request additional information (to the extent available) from, such Aurigene representatives regarding the Follow-On Molecule Data Package.

  • During the applicable Data Package Review Period, Aurigene shall make qualified Aurigene representatives reasonably available to Curis (at a SOC meeting or otherwise) for discussion of such Aurigene Immuno-oncology PTP Data Package.

  • Curis shall have until expiration of the applicable Data Package Review Period to elect whether to initiate a new Program for Follow-On Molecules for the applicable Program Target Profile.


More Definitions of Data Package Review Period

Data Package Review Period means, with respect to an Aurigene Immuno-oncology PTP Data Package or Follow-On Molecule Profile Data Package, a period of [**] days from the delivery of such Data Package to Curis, subject to extension at Curis’ reasonable request and Aurigene’s approval (which shall not be unreasonably withheld) for up to an additional [**] days as reasonably necessary (a) for Curis to (i) review such Data Package in the event that it includes substantial data or information that has not previously been disclosed to Curis (via the SOC or otherwise), or (ii) conduct appropriate patentability analyses or freedom-to-operate searches with respect to the compounds described in such Data Package, or (b) to address other bona fide scientific or intellectual property questions or concerns raised by Curis during the [**]-day period after delivery of such Data Package. Notwithstanding the foregoing, if Curis determines during the [**]-day period after delivery of such Data Package that such Information delivered by Aurigene does not constitute a Data Package as defined by Section 1.37, then Curis shall promptly call an SOC meeting, to be held within [**] days of Aurigene’s delivery of the purported Data Package. If the SOC cannot unanimously reach a determination at such meeting whether or not the Information delivered by Aurigene constitutes a Data Package as defined by Section 1.37, then the Parties shall submit the matter to an independent Third Party expert with at least 15 years of experience in pharmaceutical industry practices with respect to the development of pharmaceutical products for resolution, which expert shall be agreed upon by both Parties or, failing such agreement, designated by the International Centre for Dispute Resolution located in New York City, NY. The sole authority of such expert will be to determine whether or not the Information delivered by Aurigene constitutes a Data Package as defined by Section 1.37, and such expert’s determination shall be final and binding upon the Parties. The independent Third Party expert shall be required to make his or her determination within [**] days after selection of the independent Third Party expert. The Parties shall initially bear the fees and expenses of such expert equally, but the prevailing Party shall reimburse the other Party for the documented fees and expenses of such expert paid by the prevailing Party. The Data Package Review Period shall be tolled during the above dispute resolution procedure, and if it...
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Related to Data Package Review Period

  • Review Period has the meaning set forth in Section 2.04(c)(i).

  • Data Package has the meaning set forth in Section 2.9(a).

  • Title Review Period shall have the meaning set forth in Section 4.3.

  • Inspection Period means the period beginning on the Effective Date and expiring at 5:00 p.m. eastern time on the forty-fifth day after the Effective Date.

  • Study Period means the period commencing at 9:00 a.m. on the date hereof, and continuing through 5:00 p.m. on the Closing Date.

  • Application Review Start Date means the later date of either the date on which the District issues its written notice that the Applicant has submitted a completed Application or the date on which the Comptroller issues its written notice that the Applicant has submitted a completed Application and as further identified in Section 2.3.A of this Agreement.

  • Development Report means a written account of Licensee’s progress under the Development Plan having at least the information specified on Appendix B to this Agreement, and shall be sent to the address specified on Appendix B.

  • Phase I Study means a study in humans which provides for the first introduction into humans of a product, conducted in healthy volunteers or patients to obtain information on product safety, tolerability, pharmacological activity or pharmacokinetics, as more fully defined in 21 C.F.R. § 312.21(a) (or the non-United States equivalent thereof).

  • Phase II Study means a human clinical trial, for which the primary endpoints include a determination of dose ranges and/or a preliminary determination of efficacy in patients being studied as described in 21 C.F.R. § 312.21(b) (FDCA), as amended from time to time, and the foreign equivalent thereof.

  • project completion period means the period of sixty (60) months commencing from and expiring on for the construction and obtaining of Temporary Occupation Permit or Permits for the whole of the Development as provided in clause 3.3;

  • Asset Review Report means, with respect to any Asset Review, the report of the Asset Representations Reviewer prepared in accordance with Section 3.5.

  • Completion Period means the period starting from the date of issue of "Order" and required to complete the work in all respect.

  • Dispute Period shall have the meaning specified in Section 9.3(a).

  • Due Diligence Period has the meaning set forth in Section 4.1(a).

  • Summary Subcontract Report (SSR) Coordinator, as used in this clause, means the individual at the department or agency level who is registered in eSRS and is responsible for acknowledging or rejecting SSRs in eSRS for the department or agency.

  • Phase I Clinical Study means, as to a particular Licensed Product, an initial clinical study in humans with the purpose of assessing the Licensed Product’s safety, tolerability, toxicity, pharmacokinetics or other pharmacological properties.

  • Statement Cycle means the period of time for which our credit union provides a summary of the financial activities and transactions that post and settle to the accountholder's account.

  • Feasibility Study means the evaluation and analysis of the potential of a project, which aims at supporting the process of decision-making by objectively and rationally uncovering its strengths and weaknesses, opportunities and threats, as well as identifying the resources required to carry it through and ultimately its prospects for success;

  • SOFR Observation Period means, in respect of an Interest Accrual Period, the period from (and including) the date falling the number of SOFR Observation Shift Days prior to the first day of such Interest Accrual Period to (but excluding) the date falling the number of SOFR Observation Shift Days prior to the Interest Period Date for such Interest Accrual Period;

  • Root Cause Analysis Report means a report addressing a problem or non-conformance, in order to get to the ‘root cause’ of the problem, which thereby assists in correcting or eliminating the cause, and prevent the problem from recurring.

  • Project Management Report means each report prepared in accordance with Section 4.02 of this Agreement;

  • Response Period has the meaning set forth in Section 9.6(a).

  • Target Completion Date has the meaning given such term in Section 3.3(b).

  • Phase III Study means a human clinical trial that is prospectively designed to demonstrate statistically whether a product is safe and effective for use in humans in a manner sufficient to obtain regulatory approval to market such product in patients having the disease or condition being studied as described in 21 C.F.R. § 312.21(c) (FDCA), as amended from time to time, and the foreign equivalent thereof.

  • Objection Period has the meaning set forth in Section 2.4(d).