Party Specific Regulations definition

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.
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Party Specific Regulations has the meaning set forth in Section 11.6.3.
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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).
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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 to which they relate.

  • The Parties agree to cooperate with each other as may reasonably be required to ensure that each is able to fully meet its obligations with respect to the Party Specific Regulations applicable to it.

  • In carrying out their respective obligations under this Agreement, the Parties agree to cooperate with each other as may reasonably be required to help ensure that each is able to fully meet its obligations with respect to the Party Specific Regulations applicable to it.

  • 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.

  • All Internal Compliance Codes and Party Specific Regulations are binding only in accordance with their terms and only upon the Party to which they relate.

  • For purposes of this Section 12.4, “Internal Compliance Codes” shall mean a Party’s internal policies and procedures intended to ensure that a Party complies with applicable laws, Party Specific Regulations, and such Party’s internal ethical, medical and similar standards.

  • Neither Party shall be obligated to pursue any course of conduct that would result in such Party being in material breach of any Internal Compliance Codes or Party Specific Regulations applicable to it.

  • The Parties agree to cooperate with each other to insure that each Party is able to comply with the substance of its respective Internal Compliance Codes and Party Specific Regulations and, to the extent practicable, to operate in a manner consist with its usual Compliance related processes.

  • For purposes of this Section 11.6.4, “Internal Compliance Codes” shall mean a Party’s internal policies and procedures intended to ensure that a Party complies with Applicable Laws, Party Specific Regulations, and such Party’s internal ethical, medical and similar standards.


More Definitions of Party Specific Regulations

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.
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Party Specific Regulations mean 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.
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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
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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...
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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
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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. “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.
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Related to Party Specific Regulations

  • HIPAA Regulations means the regulations promulgated under HIPAA by the United States Department of Health and Human Services, including, but not limited to, 45 C.F.R. Part 160 and 45 C.F.R. Part 164.

  • Applicable MREL Regulations means, at any time, the laws, regulations, requirements, guidelines and policies then in effect in Norway giving effect to any MREL Requirement or any successor regulations then applicable to the Issuer, including, without limitation to the generality of the foregoing, CRD, the BRRD and those regulations, requirements, guidelines and policies giving effect to any MREL Requirement or any successor regulations then in effect (whether or not such requirements, guidelines or policies have the force of law and whether or not they are applied generally or specifically to the Issuer or to the Issuer and its subsidiaries);

  • Applicable Technical Requirements and Standards means those certain technical requirements and standards applicable to interconnections of generation and/or transmission facilities with the facilities of an Interconnected Transmission Owner or, as the case may be and to the extent applicable, of an Electric Distributor, as published by Transmission Provider in a PJM Manual provided, however, that, with respect to any generation facilities with maximum generating capacity of 2 MW or less (synchronous) or 5 MW or less (inverter-based) for which the Interconnection Customer executes a Construction Service Agreement or Interconnection Service Agreement on or after March 19, 2005, “Applicable Technical Requirements and Standards” shall refer to the “PJM Small Generator Interconnection Applicable Technical Requirements and Standards.” All Applicable Technical Requirements and Standards shall be publicly available through postings on Transmission Provider’s internet website.

  • Privacy Regulations means the Privacy and Electronic Communications (EC Directive) Regulations 2003 as amended in 2004, 2011, 2015 and 2016 and as may be further amended from time to time;

  • CFTC Regulations means the rules and regulations promulgated by the CFTC, as amended.

  • PPPFA Regulations means the Preferential Procurement Regulations, 2017 published in terms of the PPPFA.

  • health and safety specification means a site, activity or project specific document prepared by the client pertaining to all health and safety requirements related to construction work;

  • ISA Regulations means The Individual Savings Account Regulations 1998, as amended or replaced from time to time.

  • SEBI Regulations means the Securities and Exchange Board of India (Listing Obligations and Disclosure Requirements) Regulations, 2015 together with the circulars issued thereunder, including any statutory modification(s) or re-enactment(s) thereof for the time being in force.

  • CDM Regulations means the Construction (Design and Management) Regulations 2015;

  • ERCOT Protocols means the document adopted by ERCOT, including any attachments or exhibits referenced in that document, as amended from time to time, that contains the scheduling, operating, planning, reliability, and Settlement (including Customer registration) policies, rules, guidelines, procedures, standards, and criteria of ERCOT. For the purposes of determining responsibilities and rights at a given time, the ERCOT Protocols, as amended in accordance with the change procedure(s) described in the ERCOT Protocols, in effect at the time of the performance or non-performance of an action, shall govern with respect to that action.

  • Web Site Accessibility Standards/Specifications means standards contained in Title 1 Texas Administrative Code Chapter 206.

  • Web Site Accessibility Standards/Specifications means standards contained in Title 1 Texas Administrative Code Chapter 206.

  • the 1997 Regulations means the Zebra, Pelican and Puffin Pedestrian Crossing Regulations 1997.

  • Property Rates Act means the Local Government: Municipal Property Rates Act, 2004 (Act No 6 of 2004);

  • Applicable water quality standards means all water quality standards to which a discharge is subject under the federal Clean Water Act and which has been (a) approved or permitted to remain in effect by the Administrator following submission to the Administrator pursuant to Section 303(a) of the Act, or (b) promulgated by the Director pursuant to Section 303(b) or 303(c) of the Act, and standards promulgated under (APCEC) Regulation No. 2, as amended.

  • FCC Regulations means the regulations duly and lawfully promulgated by the FCC, as in effect from time to time.

  • OFAC Regulations means the regulations promulgated by OFAC, as amended from time to time.

  • EP Regulations means The Environmental Permitting (England and Wales) Regulations SI 2016 No.1154 and words and expressions used in this permit which are also used in the Regulations have the same meanings as in those Regulations.

  • National Road Traffic Act means the National Road Traffic Act, 1996 (Act 93 of 1996);

  • Accessibility Standards means accessibility standards and specifications for Texas agency and institution of higher education websites and EIR set forth in 1 TAC Chapter 206 and/or Chapter 213.

  • Market Abuse Regulation means Regulation (EU) No 596/2014 of the European Parliament and of the Council of 16 April 2014, as amended or replaced from time to time;

  • National Ambient Air Quality Standards or “NAAQS” means national ambient air quality standards that are promulgated pursuant to Section 109 of the Act, 42 U.S.C. § 7409.

  • EEA Regulations means the Immigration (European Economic Area) Regulations 2006.

  • the 2000 Regulations means the Water Supply (Water Quality) Regulations 2000(b); "the 2001 Regulations" means the Water Supply (Water Quality) Regulations 2001(c);

  • Technical Specifications A specification in a document defining the characteristics of a product or a service, such as the quality levels, the environmental and climate performance levels, the design for all needs, including accessibility for people with disabilities, and the evaluation of conformity, of product performance, of the use of the product, safety or dimensions, as well as requirements applicable to the product as regards the name by which it is sold, terminology, symbols, testing and test methods, packaging, marking or labelling, instructions for use, the production processes and methods at every stage in the life cycle of the supply or service, as well as the evaluation and conformity procedures;