Party Specific Regulations means all judgments, decrees, orders or similar decisions issued by any Governmental Authority specific to a Party, and all consent decrees, corporate integrity agreements, or other agreements or undertakings of any kind by a Party with any Governmental Authority, in each case as the same may be in effect from time to time and applicable to a Party’s activities contemplated by this Agreement.
Party Specific Regulations means all non-monetary judgments, decrees, orders or similar decisions issued by any Governmental Authority specific to a Party, and all consent decrees, corporate integrity agreements, or other agreements or undertakings of any kind by a Party with any Governmental Authority, in each case as the same may be in effect from time to time and applicable to a Party’s activities contemplated by this Agreement.
Party Specific Regulations has the meaning set forth in Section 12.5.3.
Examples of Party Specific Regulations in a sentence
All Party Specific Regulations are binding only in accordance with their terms and only upon the Party or its Affiliate to which they relate.
The Parties agree to cooperate with each other (and cause their Affiliates to cooperate) as may reasonably be required to ensure that each Party and its Affiliates is able to fully meet its obligations with respect to the Party Specific Regulations applicable to it.
More Definitions of Party Specific Regulations
Party Specific Regulations means all Applicable Laws specific to a Party, and all consent decrees, corporate integrity agreements, or other agreements or undertakings of any kind by a Party with any governmental authority, in each case as the same may be in effect from time to time and applicable to a Party’s activities contemplated by this Agreement. This Section 11.6.3 shall apply subject to notification by a Party to the other Party of any such applicable Party Specific Regulation (for clarity, Schedule 3.6 shall be deemed notification hereof to NextCure of the Lilly Party Specific Regulations contained therein).
Party Specific Regulations means all judgments, decrees, orders or similar decisions issued by any Government Official specific to a Party, and all consent decrees, corporate integrity agreements, or other agreements or undertakings of any kind by a Party with any Government Official, in each case as the same may be in effect from time to time and applicable to a Party’s activities contemplated by this Agreement.
Party Specific Regulations has the meaning set forth in Section 13.4.2. "Pharmacovigilance Agreement" has the meaning set forth in Section 5.1. "Project Manager(s)" has the meaning set forth in Section 3.8. "Protocol" means the written documentation that describes the Study and sets forth specific activities to be performed as part of the Study conduct, a summary of which is attached hereto as Appendix A. "Quality Agreement" means that certain Quality Agreement entered into between Sponsor and Lilly which governs the essential quality obligations of each party in the manufacture, testing and release of the Compounds, as the same may be amended from time to time. "Regulatory Approvals" means any and all permissions (other than approvals that are required to Manufacture a Party's Compound in accordance with Applicable Law) required to be obtained from Regulatory Authorities and any other competent authority for the development, registration, importation and distribution of a Compound in the United States, Europe or other applicable jurisdictions for use in humans. "Regulatory Authorities" has the meaning set forth in the definition of Applicable Law. "Related Agreements" means the Pharmacovigilance Agreement and the Quality Agreement. "Samples" means urine, blood or tissue samples from patients participating in the Study. "Sample Testing" means the analyses to be performed by either Party using the applicable Samples, as described in the Sample Testing Schedule. "Sample Testing Results" means those results arising from the Sample Testing which are to be shared between Lilly and Sponsor, as set forth in the Sample Testing Schedule. "Sample Testing Schedule" means the schedule attached hereto as Appendix B. "Specifications" means, with respect to a given Compound, the set of requirements for such Compound as set forth in the Quality Agreement. "Sponsor" has the meaning set forth in the preamble. "Sponsor Class Compound" means any one or more bi- or multi- specific molecule that agonizes CD137 (4-1BB). "Sponsor Compound" means cinrebafusp alfa (PRS-343), a bivalent, bispecific fusion protein targeting CD137 (4-1BB) and HER2 excluding, however, any biosimilar of PRS-343 other than a biosimilar owned or controlled by Sponsor or its Affiliates. CONFIDENTIAL Pieris Study PRS‐343‐PCS_09_20 and Lilly’ I4T-NS-I025 Page 5 [***] = Certain confidential information contained in this document, marked by brackets, has been omitted because the information (I) is not material and (II) would be competit...
Party Specific Regulations means all judgments, decrees, orders or similar decisions issued by any Governmental Authority specific to a Party, and all consent decrees, corporate integrity agreements, or other agreements or undertakings of any kind by a Party with
Party Specific Regulations means all judgments, decrees, orders or similar decisions issued by any Governmental Authority specific to a Party, and all consent decrees, corporate integrity agreements, or other agreements or undertakings of any kind by a Party with any Governmental Authority, in each case as the same may be in effect from time to time and applicable to a Party’s activities contemplated by this Agreement. THE SYMBOL “[***]” DENOTES PLACES WHERE CERTAIN IDENTIFIED INFORMATION HAS BEEN EXCLUDED FROM THE EXHIBIT BECAUSE IT IS BOTH (i) NOT MATERIAL, AND (ii) WOULD LIKELY CAUSE COMPETITIVE HARM TO THE COMPANY IF PUBLICLY DISCLOSED “Patent” means: (a) issued and unexpired letters patent, including any extension, registration, confirmation, reissue, continuation, supplementary protection certificate, divisional, continuation-in-part, re-examination or renewal thereof, (b) pending applications for all of the foregoing, and (c) foreign counterparts of any of the foregoing; in each case to the extent the same has not been held, by a Governmental Authority of competent jurisdiction, to be invalid or unenforceable in a decision from which no appeal can be taken or from which no appeal was taken within the time permitted for appeal.
Party Specific Regulations means all non-monetary judgments, decrees, orders or similar decisions issued by any Governmental Authority specific to a Party, and all consent decrees, corporate integrity agreements, or other agreements or undertakings of any kind by a Party with any Governmental Authority, in each case as the same may be in effect from time to time and applicable to a Party’s activities contemplated by this Agreement. 1.62 “Patent Rights” means any and all (a) issued patents, (b) pending patent applications, including all provisional applications, substitutions, continuations, continuations-in- part, divisions and renewals, and all patents granted thereon, (c) patents-of-addition, reissues, reexaminations and extensions or restorations by existing or future extension or restoration mechanisms, including patent term adjustments, patent term extensions, supplementary protection certificates or the equivalent thereof, (d) inventor’s certificates, (e) other forms of government- issued rights substantially similar to any of the foregoing and (f) United States and foreign counterparts of any of the foregoing. 1.63 “Person” means any individual, partnership, limited liability company, firm, corporation, association, trust, unincorporated organization or other entity. 1.64 “Pfizer Diligence Obligations” means Pfizer’s Development and Marketing Approval diligence obligations under Section 8.1(a) and Pfizer’s Commercialization diligence obligations under Section 8.2. 1.65 “Pfizer Manufacturing Improvement” means any Invention made solely by Pfizer, its Affiliates or Sublicensees or its or their employees, agents or independent contractors that are improvements to the manufacturing-related Know-How and Patent Rights included in the Licensed Technology. 1.66 “Pfizer Manufacturing Technology” means: (a) all manufacturing methods, processes and other Know-How that (i) are Controlled by Pfizer or any of its Affiliates, (ii) are directly related to the Manufacture of any Product (including any components of such Products) [*], including any step in the manufacturing process for a Product that [*], and (iii) [*], or [*]; provided, however, that any such methods, processes or Know-How that [*]; and (b) all Patent Rights Controlled by Pfizer or any of its Affiliates to the extent claiming any of the foregoing.
Party Specific Regulations means all non-monetary judgments, decrees, orders or similar decisions issued by any Governmental Authority specific to a Party, and all consent decrees, corporate integrity agreements, or other agreements or undertakings of any kind by a Party with any Governmental Authority, in each case as the same may be in effect from time to time and applicable to a Party’s activities contemplated by this Agreement. [***] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) CUSTOMARILY AND ACTUALLY TREATED BY THE REGISTRANT AS PRIVATE OR CONFIDENTIAL.