CLINICAL AND NON Sample Clauses

CLINICAL AND NON. CLINICAL TERMS OF AWARD BARDA has a responsibility to obtain documentation concerning mechanisms and procedures that are in place to protect the safety of participants and animals in BARDA funded clinical trials and non-clinical studies. Therefore, the Contractor shall develop a protocol for each clinical trial and non-clinical study funded under this contract and submit all such protocols and protocol amendments to the Contracting Officer’s Representative (COR) for evaluation and comment. Approval by the COR is required before work under a protocol may begin. The COR comments will be forwarded to the Contractor within ten (10) business days. The Contractor must address, in writing, all concerns (e.g. study design, safety, regulatory, ethical, and conflict of interest) noted by the COR. If the draft protocols are to be submitted to the FDA, the COR review shall occur before submission, pursuant to the terms set forth by Section F.2 of this contract. The Contractor shall revise their protocols to address BARDA’s concerns and recommendations prior to FDA submission. The Contractor must provide BARDA with a copy of FDA submissions, within the time frame set forth by Section F.2 of this contract. Execution of clinical and non-clinical studies occurring after contract award and funded by the Government requires written authorization from the Government. The Government will provide written authorization to the Contractor upon either 1) receiving documentation in which all COR comments have been satisfactorily addressed; or 2) receiving documentation that the FDA has reviewed and commented on the protocol. The Government shall have rights to all protocols developed with USG funding under the contract, data resulting from execution of these protocols, and final reports funded by BARDA under this contract as set forth in FAR clauses 52.227-14 and 52.227-14 Alt. II of this contract. The Government reserves the right, subject to the provisions of FAR 52.227-14, FAR 52.227-14 Alt II and HHSAR 352.224-71, to request that the Contractor provide any contract deliverable in a non-proprietary form to ensure the Government has the ability to review and distribute the deliverables as the Government deems necessary except that the Government will not release or otherwise publicly disclose any protocol, data resulting from execution of these protocols or final reports prior to its initial release and public disclosure by Contractor, and all proprietary and confidential marking...
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Related to CLINICAL AND NON

  • Cooperation and Non-Disparagement The Executive agrees that, during the twelve-month period following his or her cessation of employment, he or she shall cooperate with the Company in every reasonable respect and shall use his or her best efforts to assist the Company with the transition of Executive’s duties to his or her successor. The Executive further agrees that, during this twelve-month period, he or she shall not in any way or by any means disparage the Company, the members of the Company’s Board of Directors or the Company’s officers and employees.

  • Non Competition and Non Interference During the period of his employment with the Company or its affiliates and for the one-year period after the termination of his employment with the Company and its affiliates, Employee will not, directly or indirectly: 1. without the express prior written consent of the Board of Directors, own an interest in, manage, operate, join, control, lend money or render financial or other assistance to or participate in or be connected with, as an officer, employee, partner, stockholder, consultant or otherwise, any person that competes with the Company in the field of neurostimulation in a matter covered by a patent assigned to or held by the Company; provided, however, that following Employee's termination of employment with the Company the foregoing restriction shall apply only to those areas where the Company is actually doing business on the date of such termination of employment; provided, further, that Employee may purchase or otherwise acquire for passive investment up to 3% of any class of securities of any such enterprise if such securities are listed on any national or regional securities exchange or have been registered under Section 12(g) of the Securities Exchange Act of 1934; 2. whether for Employee's own account or for the account of any other person, (except for the account of the Company and its affiliates), solicit Business from any person known by Employee to be a customer of the Company or its affiliates, whether or not Employee had personal contact with such person during Employee's employment with the Company and its affiliates; 3. whether for Employee's own account or the account of any other person, (i) solicit, employ, or otherwise engage as an employee, independent contractor, or otherwise, any person who is an employee of the Company or an affiliate, or in any manner induce, or attempt to induce, any employee of the Company or its affiliate to terminate his employment with the Company or its affiliate; or (ii) interfere with the Company's or its affiliate's relationship with any person who at any time during the Term, was an employee, contractor, supplier, or customer of the Company or its affiliate; or 4. at any time after the termination of his employment, disparage the Company or its affiliates or any shareholders, directors, officers, employees, or agents of the Company or any of its affiliates, so long as the Company does not disparage Employee.

  • Non-Use and Non-Disclosure The Receiving Party agrees not to use any Confidential Information for any purpose except to evaluate and engage in discussions concerning a potential business relationship between the parties hereto. Receiving Party agrees not to disclose any Confidential Information to third parties or to its employees, except to those employees who are required to have the information in order to evaluate or engage in discussions concerning the contemplated business relationship. The Receiving Party shall not reverse engineer, disassemble or decompile any prototypes, software or other tangible objects which embody the Disclosing Party's Confidential Information and which are provided to the Receiving Party hereunder.

  • NON-COMPETITION AND NON-DISCLOSURE (a) Upon any termination of Executive's employment hereunder pursuant to Section 4 hereof, Executive agrees not to compete with the Holding Company or its Subsidiaries for a period of one (1) year following such termination in any city, town or county in which the Executive's normal business office is located and the Holding Company or any of its Subsidiaries has an office or has filed an application for regulatory approval to establish an office, determined as of the effective date of such termination, except as agreed to pursuant to a resolution duly adopted by the Board. Executive agrees that during such period and within said cities, towns and counties, Executive shall not work for or advise, consult or otherwise serve with, directly or indirectly, any entity whose business materially competes with the depository, lending or other business activities of the Holding Company or its Subsidiaries. The parties hereto, recognizing that irreparable injury will result to the Holding Company or its Subsidiaries, its business and property in the event of Executive's breach of this Subsection 10(a) agree that in the event of any such breach by Executive, the Holding Company or its Subsidiaries, will be entitled, in addition to any other remedies and damages available, to an injunction to restrain the violation hereof by Executive, Executive's partners, agents, servants, employees and all persons acting for or under the direction of Executive. Executive represents and admits that in the event of the termination of his employment pursuant to Section 7 hereof, Executive's experience and capabilities are such that Executive can obtain employment in a business engaged in other lines and/or of a different nature than the Holding Company or its Subsidiaries, and that the enforcement of a remedy by way of injunction will not prevent Executive from earning a livelihood. Nothing herein will be construed as prohibiting the Holding Company or its Subsidiaries from pursuing any other remedies available to the Holding Company or its Subsidiaries for such breach or threatened breach, including the recovery of damages from Executive. (b) Executive recognizes and acknowledges that the knowledge of the business activities and plans for business activities of the Holding Company and its Subsidiaries as it may exist from time to time, is a valuable, special and unique asset of the business of the Holding Company and its Subsidiaries. Executive will not, during or after the term of his employment, disclose any knowledge of the past, present, planned or considered business activities of the Holding Company and its Subsidiaries thereof to any person, firm, corporation, or other entity for any reason or purpose whatsoever unless expressly authorized by the Board of Directors or required by law. Notwithstanding the foregoing, Executive may disclose any knowledge of banking, financial and/or economic principles, concepts or ideas which are not solely and exclusively derived from the business plans and activities of the Holding Company. In the event of a breach or threatened breach by the Executive of the provisions of this Section, the Holding Company will be entitled to an injunction restraining Executive from disclosing, in whole or in part, the knowledge of the past, present, planned or considered business activities of the Holding Company or its Subsidiaries or from rendering any services to any person, firm, corporation, other entity to whom such knowledge, in whole or in part, has been disclosed or is threatened to be disclosed. Nothing herein will be construed as prohibiting the Holding Company from pursuing any other remedies available to the Holding Company for such breach or threatened breach, including the recovery of damages from Executive.

  • Non-Competition, Non-Solicitation and Non-Disparagement (a) During the Term, the Executive shall not (1) provide any services, directly or indirectly, to any other business or commercial entity without the consent of the Board or (2) participate in the formation of any business or commercial entity without the consent of the Board; provided, however, that nothing contained in this Section 5(a) shall be deemed to prohibit the Executive from acquiring, solely as an investment, shares of capital stock (or other interests) of any corporation (or other entity) not exceeding two percent (2%) of such corporation’s (or other entity’s) then-outstanding shares of capital stock (or other interests). (b) If this Agreement is terminated by the Company for Cause (as defined in Section 6(c)) or if the Executive terminates this Agreement other than in accordance with Section 7 or 8 hereof, or if the Executive is receiving Severance Payments in accordance with Section 9(c) or payments under Section 9(d), then for a period of one (1) year following the date of termination the Executive shall not (1) provide any services, directly or indirectly, to any other business or commercial entity in the Company’s Field of Interest (as defined in Section 12), (2) solicit any customers or suppliers of the Company, (3) attempt to persuade or encourage customers or suppliers of the Company not to do business with the Company and/or to do business with a competitor of the Company, (4) participate in the formation of any business or commercial entity engaged primarily in the Company’s Field of Interest, or (5) directly or indirectly employ, or seek to employ or secure the services in any capacity of, any person employed at that time by the Company or any of its Affiliates, or otherwise encourage or entice any such person to leave such employment; provided, however, that nothing contained in this Section 5(b) shall be deemed to prohibit the Executive from acquiring, solely as an investment, shares of capital stock (or other interests) of any corporation (or other entity) in the Company’s Field of Interest not exceeding two percent (2%) of such corporation’s (or other entity’s) then outstanding shares of capital stock (or other interests). This Section 5(b) shall be subject to written waivers, which may be obtained by the Executive from the Company. (c) At no time during the Term of this Agreement or thereafter will the Executive knowingly make any written or oral untrue statement or any statement that disparages the Company or its Affiliates or will the Company knowingly make any written or oral untrue statement or any statement that disparages the Executive. (d) If the Executive commits a breach, or threatens to commit a breach, of any of the provisions of this Section 5, the Company shall have the right and remedy to have the provisions of this Agreement, as the case may be, specifically enforced by any court having equity jurisdiction, it being acknowledged and agreed that any such breach or threatened breach will cause irreparable injury to the Company and that money damages will not provide an adequate remedy to the Company. (e) If any of the covenants contained in this Section 5 or any part hereof or thereof, is hereafter construed to be invalid, illegal or unenforceable by a court or regulatory agency or tribunal of competent jurisdiction, such court, agency or tribunal shall have the power, and hereby is directed, to substitute for or limit such provision(s) in order as closely as possible to effectuate the original intent of the parties with respect to such invalid, illegal or unenforceable covenant(s) generally and so to enforce such substituted covenant(s). Subject to the foregoing, the invalidity, illegality or unenforceability of any one or more of the covenants contained in this Section 5 shall not affect the validity of any other provision hereof, which shall be given full effect without regard to the invalid portions. (f) If any of the covenants contained in this Section 5, or any part hereof or thereof, is held to be unenforceable because of the duration of such provision, the area covered thereby or the extent thereof, the parties agree that the tribunal making such determination shall have the power, and hereby is directed, to reduce the duration, area and/or extent of such provision and, in its reduced form, such provision shall then be enforceable. (g) Anything else contained in this Agreement to the contrary notwithstanding, the parties hereto intend to and hereby do confer jurisdiction to enforce the covenants contained in this Section 5 A upon the courts of any state within the geographical scope of such covenants. In the event that the courts of any one or more of such states shall hold any such covenant wholly unenforceable by reason of the breadth of such scope or otherwise, it is the intention of the parties hereto that such determination not bar or in any way affect the Company’s right to the relief provided above in the courts of any other state within the geographical scope of such other covenants, as to breaches of such covenants in such other jurisdictions, the above covenants as they relate to each state being, for this purpose, severable into diverse and independent covenants.

  • Confidentiality, Non-Competition and Non-Solicitation Employee agrees, as a condition to Employee’s employment with the Company, to execute the Company’s standard form of Employee Non-Disclosure, Invention Release and Non-Competition Agreement attached hereto as Exhibit A.

  • Primary and Non-Contributory Contractor's insurance coverage shall apply as primary insurance with respect to any other insurance or self-insurance programs afforded to City, its officers, agents, employees, and volunteers. There shall be no endorsement or modification of the CGL to make it excess over other available insurance; alternatively, if the CGL states that it is excess or pro rata, the policy shall be endorsed to be primary with respect to the additional insured. Any insurance or self-insurance maintained by City, its officers, employees, or volunteers shall be excess of Contractor's insurance and shall not contribute with it in any way.

  • Management of Special and Technical Environment Each certificated support person demonstrates an acceptable level of performance in managing and organizing the special materials, equipment and environment essential to the specialized programs.

  • Confidential Information and Non-Competition 13.1 The Executive acknowledges and agrees that in performing the duties and responsibilities of her employment pursuant to this Agreement, she will occupy a position of high fiduciary trust and confidence with the Corporation, pursuant to which she will develop and acquire wide experience and knowledge with respect to all aspects of the Business carried on by the Corporation and its Related Corporations, and the manner in which such Business is conducted. It is the express intent and agreement of the Executive and the Corporation that such knowledge and experience shall be used solely and exclusively in furtherance of the Business interests of the Corporation and its Related Corporations, and not in any manner detrimental to them. The Executive therefore agrees that, so long as she is engaged by the Corporation pursuant to this Agreement, she shall not engage in any practice or business that competes with the Business of the Corporation or its Related Corporations. It shall not be considered a violation of this Section 13.1 for the Executive to be involved as an investor or shareholder in securities issued by corporations that compete directly or indirectly with the Business, provided that such investment does not constitute more than 5% of the outstanding securities of a business or corporation whose shares trade on a recognized stock exchange. 13.2 The Executive agrees that during the Term, and following the termination of the Executive's employment for any reason, she shall treat confidentially all Confidential Information belonging to the Corporation or its Related Corporations, and shall not use or disclose the Confidential Information to any unauthorized persons, except with the prior express written consent of the Corporation, or otherwise as required by law. 13.3 The Executive further acknowledges and agrees that pursuant to the terms of this Agreement, she will acquire Company Property which is and shall remain the sole and exclusive property of the Corporation. Upon termination of the Executive's employment and this Agreement for any reason, the Executive shall return to the Corporation all Company Property, together with any copies or reproductions thereof, which may have come into the Executive's possession during the course of or pursuant to this Agreement, and shall delete or destroy all computer files on her personal computer which may contain any Confidential Information belonging to the Corporation, or its Related Corporations. 13.4 Notwithstanding the provision of 13.2 and 13.3, the Executive shall be permitted to disclose Confidential Information as required by law, regulation, government body or authority or by court order. 13.5 The Executive acknowledges and agrees that the Corporation would suffer irreparable harm in the event that any Confidential Information or other knowledge and experience acquired by the Executive in relation to the business of the Corporation were disclosed to a competitor of the Corporation or used for a competitive purpose for a reasonable period of time following the termination of her employment. Accordingly, the Executive agrees that in the event her employment with the Corporation is terminated for Cause by the Corporation, or in the event that the Executive voluntarily resigns her employment with the Corporation, neither she nor any employee or agent of the Executive shall, for a period of three (3) months from the Termination Date: (a) be engaged, either directly or indirectly in any manner including, without limitation, as an officer, director, shareholder, owner, partner, member, joint venturer, employee, independent contractor, consultant, advisor or sales representative, in any business or enterprise which competes with the Business of the Corporation or any Related Corporation, as such business was conducted as of the Termination Date, with the exception that the Executive may be involved as an investor or shareholder in securities issued by corporations that compete directly or indirectly with the Business, provided that such investment does not constitute more than 5% of the outstanding securities of a business or corporation whose shares trade on a recognized stock exchange; (b) solicit, entice or attempt to solicit or entice, either directly or indirectly, any customer or prospective customer of the Corporation or any Related Corporation as at the Termination Date, to become a customer of any business or enterprise which competes with the Corporation or any Related Corporation for any business as such business was conducted by the Corporation or any Related Corporation as at the Termination Date; or (c) solicit or entice, or attempt to solicit or entice, either directly or indirectly, any employee of the Corporation or any Related Corporation as at the Termination Date, to become employed by or connected with any business or enterprise which competes with the Corporation or any Related Corporation for any business as such business was conducted by the Corporation or any Related Corporation as at the Termination Date. The restrictions set out in this Section 13.5 shall apply only within North America or to any business that directly relates to North America. 13.6 The Executive acknowledges and agrees that the Corporation will suffer harm in the event that the Executive breaches any of the obligations under this Article 13, and that monetary damages would be difficult to quantify and may be inadequate to compensate the Corporation for such a breach. Accordingly, the Executive agrees that in the event of a breach or a threatened breach by the Executive of any of the provisions of this Article 13, the Corporation shall be entitled to seek, in addition to any other rights, remedies or damages available to the Corporation at law or in equity, an interim and permanent injunction, in order to prevent or restrain any such breach or threatened breach by the Executive. 13.7 The Executive hereby agrees that all restrictions contained in this Article 13 are reasonable and necessary to protect the legitimate proprietary interests of the Corporation, and will not unduly restrict her ability to secure comparable alternative employment following the termination of her employment for any reason. If any covenant or provision of this Article 13 is determined to be void or unenforceable in whole or in part, for any reason, it shall be deemed not to affect or impair the validity of any other covenant or provision of this Agreement, which shall remain in full force and effect. 13.8 The provisions of this Article 13 shall remain in full force and effect notwithstanding the termination of this Agreement for any reason.

  • Non-Competition and Non-Solicitation Covenants a. The Executive acknowledges that i) he will be employed as a high-level employee in an executive and managerial capacity; ii) his employment with the Company gives him access to confidential and proprietary information concerning the Company; iii) his prior employment with South West gave him access to confidential and proprietary information concerning South West; iv) the agreements and covenants contained in this Section 6 (the "Covenants") are essential to protect the business of the Company and to protect the Company's investment in South West; and v) the Executive is to receive consideration pursuant to this Agreement and the Merger Agreement. b. During the period of the Executive's employment, the Executive agrees that he will not, on behalf of anyone other than the Company, engage in any managerial, executive, sales, or marketing activities related to any business in which the Company is or becomes engaged during the Executive's employment. The Executive acknowledges the competitive nature of the business and the extensive geographic markets served by the Company. The Executive acknowledges that because of his position with the Company his duties will require him to perform, supervise, or assist in performing work throughout the markets served by the Company. The Executive further acknowledges that because of his position with the Company and the broad scope of his duties, he will be in a position to cause substantial harm to the Company were he to compete in the business of the Company or any other business in which the Company is or becomes engaged during Executive's employment in the Company's markets. Given the broad scope of Executive's duties, he acknowledges that the geographic scope of the covenants in this paragraph shall be limited to the continental United States. c. Should the Executive (i) be terminated with or without cause following the first 90 days of this Agreement, or (ii) resign from his employment or otherwise terminate this Agreement at any time, he agrees that for a twelve (12) month period following the termination of his employment with the Company, the Executive shall not hire or solicit any employee of the Company employed at the time of his termination, or encourage any such employee to leave such employment. d. If the Executive commits a material breach of, the Covenants, the Company shall have the rights and remedy (in addition to, and not in lieu of, any other rights and remedies available to the Company at law or in equity) to seek injunctive relief, including permanent injunctions; (ii) to have the Covenants specifically enforced by any court of competent jurisdiction (it being agreed that any breach or threatened breach of the Covenants would cause irreparable injury to the Company and that money damages would not provide an adequate remedy to the Company; and (iii) to cease any severance payments or benefits which the Executive or his eligible dependents may otherwise be due. e. The Executive agrees that the Covenants are necessary for the reasonable and proper protection of the Company and that the Covenants are reasonable in respect of subject matter, length of time, and geographic scope. The Executive further acknowledges that the Covenants will not unreasonably restrict him from earning a livelihood following the termination of his employment with the Company. f. If any court of competent jurisdiction determines that the Covenants, or any part thereof, are invalid or unenforceable, the remainder of the Covenants shall not thereby be affected and shall be given full effect, without regard to the invalid portions. In such event, the court shall have the power (and the parties hereto request the court) to reduce or modify the duration or scope, or any other unenforceable aspect of such provision, as the case may be, and, in its reduced or modified form, enforce such provision to the maximum extent permissible. g. The provisions of this Section 6 so far as they relate to the period after the end of the term of this Agreement shall continue to have effect and shall operate as a separate agreement between the Company and the Executive; provided, however, that the provisions of Section 6 (b) shall terminate.

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