Implementation of Good Regulatory Practice Sample Clauses

Implementation of Good Regulatory Practice. 1. Each Party shall encourage its respective regulatory authorities to subject proposed amendments and new draft regulatory measures to a public consultation process, for a reasonable period of time, to allow interested parties to comment on and consider the appropriateness of the proposed amendments and new draft regulatory measures. 2. Each Party shall encourage its regulatory authorities to conduct, in accordance with its legal system, to the extent possible, an RIA prior to the adoption of proposed amendments and new draft regulatory measures, which have a significant impact. 3. When conducting the RIA, each Party may take into consideration the potential impact of the proposed regulation on MSMEs. 4. Each Party shall encourage its regulatory measures to be clear, concise, and easy to understand, notwithstanding that specialized knowledge may be required if technical issues are involved. 5. In accordance with its legal system, each Party shall endeavour to ensure that regulatory authorities provide public access to new draft regulations and proposed amendments to existing regulatory measures and, to the extent possible, make this information available online. 6. Each Party shall seek to maintain or establish domestic procedures for the review of existing regulatory measures, as often as it considers appropriate, to determine whether they should be modified, expanded, simplified or repealed, with the objective of making its regulatory regime more effective.
AutoNDA by SimpleDocs
Implementation of Good Regulatory Practice. 1. Each Party shall encourage its respective competent regulatory authorities to subject draft and proposed amendments to regulatory measures to public consultation, for a reasonable period of time, to allow interested parties to comment. 2. Each Party shall encourage its competent regulatory authorities to conduct, in accordance with its legal system, a regulatory impact analysis (RIA) prior to the adoption and proposed modification of regulatory measures that have a significant economic impact, or, where appropriate, another criterion established by that Party. 3. Recognizing that institutional, social, cultural and legal differences may result in specific regulatory approaches, regulatory impact assessments conducted should, inter alia: (a) identify the problem to be solved, the actors or groups affected, the legal basis for the proposed action, existing international references and the objectives to be achieved; (b) describe the feasible alternatives for addressing the identified problem, including the no action option, and outline their potential impacts; (c) compare the alternatives proposed, indicating, with justification, the solution or combination of solutions considered most appropriate to achieve the objectives pursued; (d) be based on the best available scientific, technical, economic or other relevant information available to the respective regulatory authorities within their competence, mandate, capacity and resources; and (e) describe the strategy for the implementation of the suggested solution, including monitoring and enforcement where appropriate, as well as the need for modification or repeal of existing regulatory measures. 4. Each Party shall encourage its competent regulatory authorities, when developing regulatory measures, to take into consideration international benchmarks, to the extent appropriate and consistent with their respective legal systems. 5. Each Party shall seek to ensure that new regulatory measures are clearly written, concise, organized and easy to understand, recognizing the possibility of involving technical issues that require specialized knowledge for their correct understanding and application. 6. Each Party shall endeavour to ensure that its competent regulatory authorities, in accordance with its legal system, facilitate public access to information on draft and proposed regulatory measures and make such information available on the Internet. 7. Each Party shall seek to maintain or establish domestic proced...

Related to Implementation of Good Regulatory Practice

  • SAFETY PRACTICES (a) i Employees requiring glasses must wear glasses, preferably with safety lenses instead of contact lenses while on the job site. ii W.C.B. approved safety footwear must be worn at all times while on the job site. iii Employee attire will be in conformance with W.C.B. Regulation and the Employer’s policy.

  • Development Standards For any structure built on the Property following the Effective Date, it shall comply with the requirements contained in Exhibit B, “Building Materials,” attached hereto and incorporated herein. The Parties agree and acknowledge that the provisions of this Paragraph shall apply to any structure constructed subsequent to the execution of this Agreement. Nothing in this Agreement shall be deemed to modify or otherwise amend any zoning regulation duly adopted by the Town, previously or in the future.

  • Technical Standards The Generation System shall be installed and operated by the Interconnection Customer consistent with the requirements of this Agreement; the Technical Requirements; the applicable requirements located in the National Electrical Code (NEC); the applicable standards published by the American National Standards Institute (ANSI) and the Institute of Electrical and Electronic Engineers (IEEE); and local building and other applicable ordinances in effect at the time of the installation of the Generation System.

  • Commercialization Plan (a) Not later than three [***] after submission of Regulatory Filings for each Product in each country of the Territory, Licensee will provide to the JCC for review its initial Commercialization Plan for each Product for each country in the Territory. Such initial Commercialization Plan will describe Licensee’s plans for activities to be conducted for such Product for such country. Each Commercialization Plan shall include the details of obligations to be performed by Licensee to achieve the specific activities that are applicable to the stage of [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. Commercialization (e.g., pre-launch, launch planning, launch, or post-launch) of the applicable Product during the time period covered by such Commercialization Plan and subsequent time periods. (b) Prior to the First Commercial Sale for such Product in such country, Licensee will provide to the JCC for review an updated Commercialization Plan for such Product for such country. Such updated Commercialization Plan will include, but not be limited to, Licensee’s updated plans for activities to be conducted for such Product for such country prior to launch as well as activities to be conducted in connection with such launch. (c) Promptly after each anniversary of the First Commercial Sale of such Product during the Term, Licensee will provide to the JCC for review updated Commercialization Plans for such Product for such country. Such further updated Commercialization Plan will include, but not be limited to, Licensee’s plans for Commercialization activities for such Product and such country for the twelve (12) month period following the date of delivery of such Commercialization Plan. No Commercialization Plan may be implemented by Licensee if [***]. Each Commercialization Plan shall be consistent with and shall not contradict the terms of this Agreement [***], and in the event of any inconsistency between the Commercialization Plan and this Agreement, the terms of this Agreement shall prevail. Notwithstanding the foregoing, if a [***], Licensee shall [***] and shall promptly [***].

  • Clinical Data and Regulatory Compliance The preclinical tests and clinical trials, and other studies (collectively, “studies”) that are described in, or the results of which are referred to in, the Registration Statement or the Prospectus were and, if still pending, are being conducted in all material respects in accordance with the protocols, procedures and controls designed and approved for such studies and with standard medical and scientific research procedures; each description of the results of such studies is accurate and complete in all material respects and fairly presents the data derived from such studies, and the Company and its subsidiaries have no knowledge of any other studies the results of which are inconsistent with, or otherwise call into question, the results described or referred to in the Registration Statement or the Prospectus; the Company and its subsidiaries have made all such filings and obtained all such approvals as may be required by the Food and Drug Administration of the U.S. Department of Health and Human Services or any committee thereof or from any other U.S. or foreign government or drug or medical device regulatory agency, or health care facility Institutional Review Board (collectively, the “Regulatory Agencies”); neither the Company nor any of its subsidiaries has received any notice of, or correspondence from, any Regulatory Agency requiring the termination, suspension or modification of any clinical trials that are described or referred to in the Registration Statement or the Prospectus; and the Company and its subsidiaries have each operated and currently are in compliance in all material respects with all applicable rules, regulations and policies of the Regulatory Agencies.

  • Manufacturing Standards All forest products except poles, produced and sold under this contract will be manufactured to maximize the amount of logs meeting preferred log lengths and to achieve the average log length listed. 97318 3 WS "WS" indicates that west side scaling rules apply. Minimum trim is 8 inches per scaling segment for west side scaling rules. "ES" indicates that east side scaling rules apply. Minimum trim is 4 inches per scaling segment for east side scaling rules. Poles produced under this contract will be manufactured to ANSI specifications (American National Standard Specifications and Dimensions for Wood Poles), in force at the time of signing this contract. a. Sweep will be limited to within the bole of the log as measured using a tape stretched between the centers of each end of the log. b. Logs approved by the state for peelers shall be chuckable with no more than a 2 inch diameter area of rot within a 5 inch diameter circle located at the center of either end of the log. c. Limbs and knots shall be cut flush, with no more than 15 percent of a log having limbs or knots over 2 inches in diameter extending more than 2 inches above the surface of the log.

  • Protocols Each party hereby agrees that the inclusion of additional protocols may be required to make this Agreement specific. All such protocols shall be negotiated, determined and agreed upon by both parties hereto.

  • Procurement of Goods and Services (a) If the HSP is subject to the procurement provisions of the BPSAA, the HSP will abide by all directives and guidelines issued by the Management Board of Cabinet that are applicable to the HSP pursuant to the BPSAA. (b) If the HSP is not subject to the procurement provisions of the BPSAA, the HSP will have a procurement policy in place that requires the acquisition of supplies, equipment or services valued at over $25,000 through a competitive process that ensures the best value for funds expended. If the HSP acquires supplies, equipment or services with the Funding it will do so through a process that is consistent with this policy.

  • Research Use Reporting To assure adherence to NIH GDS Policy, the PI agrees to provide annual Progress Updates as part of the annual Project Renewal or Project Close-out processes, prior to the expiration of the one (1) year data access period. The PI who is seeking Renewal or Close-out of a project agree to complete the appropriate online forms and provide specific information such as how the data have been used, including publications or presentations that resulted from the use of the requested dataset(s), a summary of any plans for future research use (if the PI is seeking renewal), any violations of the terms of access described within this Agreement and the implemented remediation, and information on any downstream intellectual property generated from the data. The PI also may include general comments regarding suggestions for improving the data access process in general. Information provided in the progress updates helps NIH evaluate program activities and may be considered by the NIH GDS governance committees as part of NIH’s effort to provide ongoing stewardship of data sharing activities subject to the NIH GDS Policy.

  • Commercialization Reports Throughout the term of this Agreement and during the Sell-Off Period, and within thirty (30) days of December 31st of each year, Company will deliver to University written reports of Company’s and Sublicensees’ efforts and plans to develop and commercialize the innovations covered by the Licensed Rights and to make and sell Licensed Products. Company will have no obligation to prepare commercialization reports in years where (a) Company delivers to University a written Sales Report with active sales, and (b) Company has fulfilled all Performance Milestones. In relation to each of the Performance Milestones each commercialization report will include sufficient information to demonstrate achievement of those Performance Milestones and will set out timeframes and plans for achieving those Performance Milestones which have not yet been met.

Draft better contracts in just 5 minutes Get the weekly Law Insider newsletter packed with expert videos, webinars, ebooks, and more!