NovaDel Obligations Sample Clauses

NovaDel Obligations. During the Term: 3.10.1 NovaDel shall at its own cost and expense and no later than thirty (30) days after the Effective Date, designate ECR as its authorized agent for all communications with FDA on all matters relative to the NDA and the Product and take all steps that may be necessary to effectuate such designation; 3.10.2 NovaDel shall provide ECR with complete copies of the NDA for the Product and all other applications and correspondence to FDA and other Governmental Authorities in the Territory related to the Product; 3.10.3 NovaDel shall not directly or indirectly: (i) seek FDA approval with respect to any Competitive Product (ii) manufacture or have manufactured any Competitive Product in the Territory, (iii) market or have marketed any Competitive Product in the Territory or (iv) license any Third Party to do any of the foregoing; (v) import, or enter into any agreement which would result in the reimportation of the Product into the Territory; or (vi) promote, distribute, advertise or deal with the reimportation of the Product into the Territory; 3.10.4 NovaDel shall be solely responsible for and pay any royalties or other amounts due to Third Parties under agreements in existence as of the Effective Date related to the Product and shall indemnify and hold ECR harmless from any claims arising from or related thereto; and 3.10.5 NovaDel, at its sole cost and expense, shall use Commercially Reasonable Efforts to develop a 2.5ml presentation for the Product, which such presentation shall be covered under the terms and conditions of this Agreement. Such efforts shall be initiated within sixty (60) days of the execution date of this Agreement.
Sample 1
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NovaDel Obligations. During the Term: 3.12.1 NovaDel shall at its own cost and expense and no later than thirty (30) days after the Effective Date, designate Mist (or its designated Affiliate) as its authorized agent for all communications with FDA on all matters relative to the NDA and the Product and take all steps that may be necessary to effectuate such designation; 3.12.2 NovaDel shall provide Mist or its designated Affiliate, as applicable, with complete copies of the NDA for the Product and all other applications and correspondence to FDA and other Governmental Authorities in the Primary Territory related to the Product; 3.12.3 NovaDel shall at its own cost and expense maintain and update the NDA for the Product in the Primary Territory and pay any maintenance, facility or other fees related thereto so as to enable Mist and/or its Affiliates to Manufacture and Commercialize the Product in the Primary Territory. NovaDel shall not withdraw the NDA for the Product in the Primary Territory unless required by the FDA or if mutually agreed upon by the Parties; 3.12.4 NovaDel shall not: (i) seek FDA approval with respect to any Competitive Product in the Primary Territory; (ii) Develop, manufacture or have manufactured any Competitive Product in the Territory, (iii) market or have marketed any Competitive Product in the Territory or (iv) license any Third Party to do any of the foregoing; 3.12.5 NovaDel shall be solely responsible for and pay any royalties or other amounts due to Third Parties under agreements in existence as of the Effective Date related to the Product and shall indemnify and hold Mist and its Affiliates harmless from any claims arising from or related thereto; 3.12.6 NovaDel shall maintain the NovaDel Trademark in full force and effect and pay all maintenance and other fees as and when due; and 3.12.7 NovaDel will provide notice to Mist of any defaults by NovaDel under the Security Agreement and, subject to any confidentiality restrictions, provide Mist with copies of any communications received from the parties to such Security Agreement the extent such communication would have a material adverse effect on the NovaDel Technology, the NovaDel Trademark or the rights and licenses granted to Mist under this Agreement.
Sample 1

Related to NovaDel Obligations

  • Third Party Obligations 3.1. The THIRD PARTY shall:- 3.1.1. not divulge the Confidential Information to any party other than as provided for in this Confidentiality Agreement; 3.1.2. use the Confidential Information only for the purposes necessary in providing the services for which he is engaged by the AUTHORITY; and 3.1.3. make no commercial use of the Confidential Information or any part thereof. 3.2. Notwithstanding the foregoing, the THIRD PARTY shall be entitled to make any disclosure required by law of the Confidential Information and shall notify the AUTHORITY of so doing in accordance with the provisions of paragraph 6.

  • Parallel Operation Obligations Once the Small Generating Facility has been authorized to commence parallel operation, the Interconnection Customer shall abide by all rules and procedures pertaining to the parallel operation of the Small Generating Facility in the applicable control area, including, but not limited to: (1) the rules and procedures concerning the operation of generation set forth in the NYISO tariffs or ISO Procedures or the Connecting Transmission Owner’s tariff; (2) any requirements consistent with Good Utility Practice or that are necessary to ensure the safe and reliable operation of the Transmission System or Distribution System; and (3) the Operating Requirements set forth in Attachment 5 of this Agreement.

  • Maintenance Obligations Local Agency shall maintain and operate the Work constructed under this Agreement at its own cost and expense during their useful life, in a manner satisfactory to the State and FHWA. Local Agency shall conduct such maintenance and operations in accordance with all applicable statutes, ordinances, and regulations pertaining to maintaining such improvements. The State and FHWA may make periodic inspections to verify that such improvements are being adequately maintained.

  • Development Obligations 1. The College supports the development, production, and dissemination of copyrightable, trademarkable, patentable, and other intellectual properties by its employees. 2. It is understood that intellectual property developed by employees on or off College time, except for those materials for which the College had specifically contracted prior to June 9, 1998, shall remain the property of such employees, but shall continue to be used for the benefit of the College while the employee remains an employee of the College.

  • Joint Obligations A. The University and the student share the responsibility for ensuring the quality of life within the residence halls, their maintenance, furnishings and facilities, and for a physical environment secure from fire and other hazards. The University will work with students to promote effective security of persons and property in the residence halls.

  • Client Obligations 3.1 The Client warrants and represents that: 3.1.1 it shall co-operate with Centaur as required for the proper performance of the Services; 3.1.2 it shall provide, for Centaur, its agents, subcontractors, consultants and employees, in a timely manner and at no charge, access to the Client's premises during normal office hours (being Monday – Friday 8am – 6pm), office accommodation, data and other facilities as is reasonably required by Centaur or any of them for the proper performance of the Services; 3.1.3 all information it has provided to Centaur in relation to the Services as at the date of the Order Form is accurate, complete and is not misleading and it shall provide, in a timely manner, such further information and Client Material as Centaur may require for the proper performance of the Services, and ensure that such information and Client Material is accurate, complete and not misleading; 3.1.4 it shall be responsible (at its own cost) for preparing and maintaining the relevant premises for the supply of the Services; 3.1.5 it shall inform Centaur of all health and safety rules and regulations and any other reasonable security requirements that apply at any of the Client's premises; 3.1.6 it shall only use the Services for internal business purposes and, without prejudice to the foregoing, shall not use the Services, the Deliverables or any Centaur Materials to develop a product or service that competes with any of the products or services provided by Centaur; 3.1.7 the Client Materials shall not infringe any third party rights, including any third party Intellectual Property Rights; and 3.1.8 it shall obtain and maintain all necessary licences and consents and comply with all relevant legislation in relation to the Services, before the date on which the Services are to start. 3.2 If Centaur's performance of its obligations under this Agreement is prevented or delayed by any act or omission of the Client, its agents, subcontractors, consultants or employees, Centaur shall not be liable for any costs, charges or losses sustained or incurred by the Client that arise directly or indirectly from such prevention or delay.

  • Surety Obligations No Borrower or Subsidiary is obligated as surety or indemnitor under any bond or other contract that assures payment or performance of any obligation of any Person, except as permitted hereunder.

  • Valid Obligations The execution, delivery and performance of the Loan Documents have been duly authorized by all necessary corporate action and each represents a legal, valid and binding obligation of Borrower and is fully enforceable according to its terms, except as limited by laws relating to the enforcement of creditors' rights.

  • Diligence Obligations (a) Subject to Section 2.5(b) below, Proprius agrees to use commercially reasonable efforts (directly and/or through one or more Affiliates and Sublicenses) to bring one or more initial Products to market in the Field in the Territory and, following first commercial sale, to promote such Initial Product(s) in the Field in the Territory during the Term. Without limiting the generality of the foregoing (but subject to Section 2.5(b)), Proprius shall achieve first commercial sale of an Initial Product by December 31, 2008. If, despite its commercially reasonable efforts, Proprius fails to achieve first commercial sale of an Initial Product by December 31, 2008, the parties shall discuss in good faith an appropriate extension of such deadline and/or other modification of such diligence milestone. If the parties are unable to reach mutual agreement on such extension or modification, ORGENTEC shall have the right to convert Proprius’ license under Section 2.1 to a co-exclusive license upon written notice to Proprius. (b) Proprius’ diligence obligations under Section 2.5(a) are subject to ORGENTEC using commercially reasonable efforts to obtain U.S. Food and Drug Administration clearance or approval of its Anti-MCV (autoantibodies against mutated citrullinated vimentin) E XXXX technology by December 31, 2009. Proprius shall, if available and to the extent permitted by applicable laws and commercially reasonable, the protocols approved by the respective IRBs/ Ethic Committees of the institutions through which samples were collected, and any informed consents obtained by Proprius from sample donors, transfer (or cause to be transferred) available patient samples to ORGENTEC to support the FDA approval process. Proprius hereby grants to ORGENTEC, to the extent permitted by applicable laws a non-exclusive license, to use the transferred samples for FDA approval purposes for Initial Products or Additional Products In the Field in the Territory. Should ORGENTEC not act diligently to achieve the FDA approval before or no later then December 31, 2009, Proprius has the right, at its own discretion, to solely oversee and manage the FDA approval. In such case ORGENTEC would continue to carry the costs for the FDA approval process.

  • Recipient Obligations 2.1 The Recipient agrees to support the Project in accordance with this Agreement. 2.2 In supporting the Project, the Recipient must: (a) exercise reasonable diligence, care and skill; (b) administer the Funding in accordance with the Agreement to support the Fellow to complete the Project; (c) not replace the Fellow named in the Application with another person; (d) complete the Project Deliverables by the relevant Deliverable due dates. This includes the provision of the required Reports, Financial Acquittal Statements and valid tax invoices; (e) ensure that the Fellow completes the Project Milestones annually; (f) ensure it makes the Recipient Contribution to the Project as per the Application and summarised in Item 11 of Schedule 1; (g) ensure the Partners provide the Partner Contributions to the Project as per the Application and summarised in Item 12 of Schedule 1; (h) ensure that the Project expenditure is managed in accordance with the project expenditure table in the Application; (i) notify the Department within 20 Business Days of any matter that may affect the Fellow or Recipient’s eligibility for funding under the Guidelines, including but not limited to: (i) the Fellow ceasing employment with the Recipient; (ii) the Fellow moving residence to outside of Queensland; (iii) the Fellow travelling outside of Queensland for more than six weeks; (iv) the Fellow taking extended leave or being unable to undertake the Project for an extended period; (v) the Fellow changing the proportion of their time committed to the Project; (vi) the Recipient Contributions or Partner Contributions changing; (vii) the Project Partner organisations changing; and (viii) the Project expenditure changing. (j) ensure that (where relevant): (i) the Project complies with National Health and Medical Research Council Guidelines; (ii) the Project complies with the Code of Ethical Practice for Biotechnology in Queensland; (iii) the Project is cleared by all relevant ethical committees prescribed by the Recipient organisation’s research rules; and (iv) evidence of compliance with this clause is provided, if requested by the Department; (k) not assign, transfer or subcontract its obligations, without prior written consent of the Department; (l) notify the Department of any breach of these terms or any matter that may affect the performance of the Agreement; and (m) comply with all relevant laws.

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