RA Development Prior to In-Licensing Sample Clauses

RA Development Prior to In-Licensing. In the event AbbVie does not proceed with the In-Licensing in respect of RA after delivery of the RA Complete Data Package, then Ablynx, in its sole discretion, shall have the option, at its sole cost and expense, to further Develop the Licensed Compound for RA; provided, that Ablynx provides to AbbVie and the Parties mutually agree upon (i) a final budget incorporating all costs associated for such Development, (ii) the final protocol and a detailed synopsis for each Clinical Study for RA, (iii) the relevant success criteria for such Clinical Studies, and (iv) the tentative timelines to complete CONFIDENTIAL TREATMENT REQUESTED. INFORMATION FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED IS OMITTED AND MARKED WITH “[...***...]”. AN UNREDACTED VERSION OF THE DOCUMENT HAS ALSO BEEN FURNISHED SEPARATELY TO THE SECURITIES AND EXCHANGE COMMISSION AS REQUIRED BY RULE 406 UNDER THE SECURITIES ACT OF 1933, AS AMENDED.
AutoNDA by SimpleDocs
RA Development Prior to In-Licensing. In the event AbbVie does not proceed with the In-Licensing in respect of RA after delivery of the RA Complete Data Package, then Ablynx, in its sole discretion, shall have the option, at its sole cost and expense, to further Develop the Licensed Compound for RA; provided, that Ablynx provides to AbbVie and the Parties mutually agree upon (i) a final budget incorporating all costs associated for such Development, (ii) the final protocol and a detailed synopsis for each Clinical Study for RA, (iii) the relevant success criteria for such Clinical Studies, and (iv) the tentative timelines to complete such Clinical Studies (collectively, the “RA Phase 3 Development Plan”). In the event the Parties are unable to agree despite good faith discussions upon the RA Phase 3 Development Plan, neither Party shall have the right to resolve the dispute unilaterally or through ADR and the proposed RA Phase 3 Development Plan shall be deemed rejected. Following initiation of the RA Phase 3 Development Plan (a) as part of the JDC meetings, Ablynx shall keep AbbVie regularly updated regarding the status, progress, timelines and clinically validated results for each Clinical Study for RA, and (b) any amendment to the RA Phase 3 Development Plan shall be discussed in good faith between the Parties, with Ablynx having the right to make the final determination with respect to such amendment, unless the amendment would affect or could reasonably be expected to affect AbbVie’s interests in the Initial Indications pursuant to this Agreement. If the Parties are unable to agree on whether an amendment to the RA Phase 3 Development Plan would affect or could reasonably be expected to affect AbbVie’s interests in the Initial Indications pursuant to this Agreement, then such amendment shall be referred to the JDC for further discussion. In the event the JDC is unable to agree upon a resolution for such amendment, then the dispute shall be resolved pursuant to Section 13.8. In the event AbbVie (1) proceeds with the In-Licensing following the receipt of the SLE Complete Data Package, and (2) subject to Section 6.2.1(iii)(c), moves forward with the Development of the Licensed Compound for RA (subsections (1) and (2), collectively, the “RA Election”), then, in addition to the milestone and royalty payment obligations set forth in Article 6 related to RA, AbbVie shall be required to pay Ablynx the RA Phase 3 Payment pursuant to Section 6.2.

Related to RA Development Prior to In-Licensing

  • Commercialization License Subject to the terms of this Agreement, including without limitation Section 2.2 and Theravance's Co-Promotion rights in Section 5.3.2, Theravance hereby grants to GSK, and GSK accepts, an exclusive license under the Theravance Patents and Theravance Know-How to make, have made, use, sell, offer for sale and import Alliance Products in the Territory.

  • Evaluation License If You are licensing the Software for evaluation purposes, Your use of the Software is only permitted in a non-production environment and for the period limited by the License Key. Notwithstanding any other provision in this XXXX, an Evaluation License of the Software is provided “AS-IS” without indemnification, support or warranty of any kind, expressed or implied.

  • Sub-licensing CytRx shall be entitled to grant sub-licences of its rights under the terms and conditions of Clause 2.1 of this Agreement to any person, provided that: (a) the sub-licence shall include performance and financial obligations on the sub-licensee which are at least equivalent to the obligations on CytRx under this Agreement; (b) the sub-licence shall continue following the termination of this Agreement for any reason as a licence between ICIL and the sub-licensee pursuant to clause 14.5.2, provided that if the royalties and other consideration provided for in the sub-licence are less that that provided for in this Agreement such royalties or other consideration shall be increased to be the same as provided for in this Agreement and further provided that the sub-licensee agrees in writing to such new financial terms and to the substitution of CytRx by ICIL; (c) within thirty (30) days of the grant of any sub-licence CytRx shall provide to ICIL a summary of the material terms of the sub-licence and a written agreement from the sub-licensee to be bound by the provisions of this Agreement to the extent applicable; (d) except in the case of the continuation of the licence pursuant to Clause 2.5(b) CytRx shall be responsible for any breach of the sub-licence by the sub-licensee, as if the breach had been that of CytRx under this Agreement, and CytRx shall indemnify ICIL against any loss, damages, costs, claims or expenses which are awarded against or suffered by ICIL as a result of any such breach by the sub-licensee; and (e) no sub-licence shall carry any right to sub-sub-licence all of the rights granted to CytRx under this Agreement without the consent of ICIL (such consent not to be unreasonably withheld) save that a sub-licence can be sub-licensed for the purposes of manufacture or co-marketing without the consent of ICIL.

  • Development License Subject to the terms and conditions of this XXXX, You are licensed to perform an installation of the SOFTWARE for an unlimited use in designing, testing and creating Developed Software by unlimited Developers on one or more computers.

  • Condominiums/Planned Unit Developments If the Mortgaged Property is a condominium unit or a planned unit development (other than a de minimis planned unit development) such condominium or planned unit development project such Mortgage Loan was originated in accordance with, and the Mortgaged Property meets the guidelines set forth in the Originator's Underwriting Guidelines;

  • Licensing a. Distributor and Dealer each represent and warrant to each other that: (i) it is a broker-dealer registered with the Securities and Exchange Commission (“SEC”); (ii) it is a member in good standing of the Financial Industry Regulatory Authority (“FINRA”); (iii) it is licensed by the appropriate regulatory agency of each state or other jurisdiction in which it will offer and sell Shares of the Fund; and (iv) each of its principals, directors, officers, employees, and agents who will participate or otherwise be involved in the offer or sale of the Shares or the performance of its duties and activities under this Agreement is either appropriately licensed or exempt from such licensing requirements by the appropriate regulatory agency of each state or other jurisdiction in which it will offer and sell Shares. b. Distributor and Dealer agree that: (i) termination or suspension of its registration with the SEC; (ii) termination or suspension of its membership with FINRA; or (iii) termination or suspension of its license to do business by any state or other jurisdiction in which the Fund is offered shall cause the termination of this Agreement. Each party further agrees to notify the other party promptly in writing of any such action or event. c. Distributor and Dealer agree that this Agreement is in all respects subject to the Conduct Rules of FINRA and such Conduct Rules shall control any provision to the contrary in this Agreement. Without limiting the generality of the foregoing, Distributor and Dealer acknowledge that, subject to the indemnification described in Section 9 of this Agreement, neither party has responsibility for the manner of the other party’s performance of, or for acts or omissions in connection with, the duties and activities performed by the other party under this Agreement. d. Distributor and Dealer agree to be bound by, and to comply with, all applicable federal and state laws and all rules and regulations promulgated thereunder generally affecting the sale or distribution of shares of registered investment companies, including anti-money laundering laws and regulations and applicable guidance issued by the Department of the Treasury, the SEC and FINRA.

  • Conduct of Business; Regulatory Permits Neither the Company nor any of its Subsidiaries is in violation of any term of or in default under its Certificate of Incorporation, any certificate of designation, preferences or rights of any other outstanding series of preferred stock of the Company or any of its Subsidiaries or Bylaws or their organizational charter, certificate of formation, memorandum of association, articles of association, Certificate of Incorporation or certificate of incorporation or bylaws, respectively. Neither the Company nor any of its Subsidiaries is in violation of any judgment, decree or order or any statute, ordinance, rule or regulation applicable to the Company or any of its Subsidiaries, and neither the Company nor any of its Subsidiaries will conduct its business in violation of any of the foregoing, except in all cases for possible violations which could not, individually or in the aggregate, have a Material Adverse Effect. Without limiting the generality of the foregoing, the Company is not in violation of any of the rules, regulations or requirements of the Principal Market and has no knowledge of any facts or circumstances that could reasonably lead to delisting or suspension of the Common Stock by the Principal Market in the foreseeable future. During the two years prior to the date hereof, (i) the Common Stock has been listed or designated for quotation on the Principal Market, (ii) trading in the Common Stock has not been suspended by the SEC or the Principal Market and (iii) the Company has received no communication, written or oral, from the SEC or the Principal Market regarding the suspension or delisting of the Common Stock from the Principal Market. The Company and each of its Subsidiaries possess all certificates, authorizations and permits issued by the appropriate regulatory authorities necessary to conduct their respective businesses, except where the failure to possess such certificates, authorizations or permits would not have, individually or in the aggregate, a Material Adverse Effect, and neither the Company nor any such Subsidiary has received any notice of proceedings relating to the revocation or modification of any such certificate, authorization or permit. There is no agreement, commitment, judgment, injunction, order or decree binding upon the Company or any of its Subsidiaries or to which the Company or any of its Subsidiaries is a party which has or would reasonably be expected to have the effect of prohibiting or materially impairing any business practice of the Company or any of its Subsidiaries, any acquisition of property by the Company or any of its Subsidiaries or the conduct of business by the Company or any of its Subsidiaries as currently conducted other than such effects, individually or in the aggregate, which have not had and would not reasonably be expected to have a Material Adverse Effect on the Company or any of its Subsidiaries.

  • Commercial Driver’s License As a result of recent Federal statutory requirements, the State of Michigan enacted Act 346 of 1988. The parties agree that as a result of these statutory requirements some employees within the Technical Bargaining Unit may be required to obtain and retain a Commercial Drivers License (CDL) to continue to perform certain duties for the State. Whenever a CDL is referred to in this Section, it is understood to mean the CDL and any required endorsements. In order to implement this provision, the parties agree to the following: A. The Employer will reimburse the cost of obtaining and renewing the required CDL group license and endorsements for those employees in positions where such license and endorsements are required. B. The Employer will reimburse, on a one time basis, the fee for the skills test, if required, provided the skills test is not being required because of the employee's poor driving record. In that case, the employee is responsible for the cost of the skills test. Where a skills test is required, the employee will be permitted to utilize the appropriate state vehicle. C. Employees shall be eligible for one grant of administrative leave to take the test to obtain or renew the CDL. Should the employee fail the test initially, the employee shall complete the necessary requirements on non-work time. D. Employees reassigned to a position requiring a CDL shall be eligible for reimbursement and administrative leave in accordance with paragraphs 1, 2, and 3 of this Section. E. Employees desiring to transfer, promote, bump or be recalled to a position requiring a CDL are not eligible for reimbursement for obtaining the initial CDL but shall be eligible for reimbursement for renewals. F. Employees who fail to obtain, or retain, a CDL may be subject to removal from their positions. Employees who fail required tests may seek a 90 day extension of their current license, during which the Employer will retain the employee in his or her current or equivalent position. The Employer shall not be responsible for any fees associated with such extensions. At the end of the 90 day extension, if the employee fails to pass all required tests, the employee may be reassigned at the Employer's discretion, in accordance with applicable contractual provisions, to an available position not requiring a CDL for which the employee is qualified, or, if no position is available the employee will be laid off without bumping rights and will be placed on the Departmental Recall List, subject to recall in accordance with this Agreement. Those employees not choosing to extend their license for the 90 day period will be removed from their positions at the expiration of their current license and may be reassigned at the Employer's discretion, in accordance with applicable contractual provisions, to an available position not requiring a CDL for which the employee qualifies, or if no position is available, he or she will be laid off without bumping rights and will be placed on the Departmental Recall list. G. Employees required to obtain a medical certification of fitness shall have the "Examination to Determine Physical Condition of Drivers" form filed in their medical file. A copy of the medical "Examiners Certificate" shall be placed in their personnel file. The Employer agrees to pay for the examination and to grant administrative leave for the time necessary to complete the examination. The fitness standards for a CDL are unchanged from current Federal Department of Transportation Standards and Michigan Motor Carrier Standards. H. Employees who do not meet the required physical standards but who are otherwise qualified for a CDL may apply for a waiver to the Motor Carrier Appeal Board. I. Those employees employed by the State as intra-state drivers prior to June 10, 1984 shall be grandparented into the process and thereby be exempt from the medical certification requirement.

  • Staff Development ‌ The County and the Association agree that the County retains full authority to determine training needs, resources that can be made available, and the method of payment for training authorized by the County. Nothing in this subsection shall preclude the right of an employee to request specific training.

  • Sustainable Development 4.1 The Authority will review the Contractor’s Sustainable Development Policy Statement and Sustainable Development Plan submitted by the Contractor in accordance with the Schedule (Sustainable Development Requirements) and then at least annually thereafter. 4.2 Sustainable Procurement Risk Assessment Methodology (SPRAM) is a tool used by the Authority to identify and mitigate any potential risks to sustainability in contracts. The process requires that each Contract be assessed for its potential social, economic and environmental risks, throughout the various stages of its lifetime. Where risks are identified, appropriate mitigation action is required to reduce or eliminate the risk to sustainability. The Authority may at times require input from the Contractor in order to ensure that this process is given the required levels of consideration.

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