Research and Development Programs: Development Stages and Diligence Requirements Sample Clauses

Research and Development Programs: Development Stages and Diligence Requirements. (a) The individual Development Stages for the development of the Licensed Product under this Agreement, the Stage Periods for each Stage, extension periods available and Extension Fees are set forth in Table 2.2. Two (2) alternative diligence conditions, detailed in Sections 2.2(b) and 2.2(c), below, will govern the requirement of Naia to diligently progress the Licensed Product through the four (4) Development Stages in order to avoid Amunix having a right to cause termination of the Agreement and reversion of rights to Amunix under Section 8.5(g). Naia can meet the diligence requirement by fulfilling either condition during each Development Stage. For clarity, however, if the Stage End Event has been achieved, the next Development Stage and its diligence conditions automatically initiate.
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Research and Development Programs: Development Stages and Diligence Requirements. (a) The individual development Stages for the development of the Licensed Product in each Territory Portion under this Agreement, the Stage Periods for each Stage, extension periods available and Extension Fees are set forth in Table 2.4. Two (2) alternative diligence conditions, detailed in Sections 2.4(b) and 2.4(c), below, govern the requirement of Naia to diligently progress the Licensed Product through the five (5) Development Stages for a given Territory Portion in order to avoid Amunix having a right to cause termination of the Agreement and reversion of rights to Amunix under Section 8.5(g). Naia can meet the diligence requirement by fulfilling either condition during each Development Stage. For clarity, however, if the Stage End Event has been achieved, the next Development Stage and its diligence conditions automatically initiate. China Sublicensees will collectively be separately required by the Naia Sublicense Agreements to meet at least one of the alternative diligence conditions of Sections 2.4(b) or 2.4(c), below, with respect to the Greater China Territory, with the starting date for the earliest Stage that has not had its Stage End Event achieved for the Greater China Territory at the execution of the earliest Naia Sublicense Agreement therefor being the effective date of the sublicense. Korea Sublicensees will collectively be required by the applicable Naia Sublicense Agreements to meet at least one of the alternative diligence conditions of Sections 2.4(b) or 2.4(c), below, , with respect to the Korea Territory, with the starting date for the earliest Stage that has not had its Stage End Event achieved for the Korea Territory at the execution of the earliest Naia Sublicense Agreement therefor being the effective date of the sublicense. For the sake of clarity, the fulfillment of a given diligence condition by Naia in the Primary Territory will not relieve the obligations of China Sublicensees or the Korea Sublicensees, respectively, to meet the diligence conditions for the Greater China Territory or the Korea Territory, respectively, and vice versa.

Related to Research and Development Programs: Development Stages and Diligence Requirements

  • Research and Development (i) Advice and assistance in relation to research and development of Party B;

  • Development Diligence Pfizer will use its Commercially Reasonable Efforts to Develop and seek Regulatory Approval for [ * ] Product [ * ] in the Field [ * ]. Pfizer will [ * ] with respect to the Development or Regulatory Approval of Products under this Agreement.

  • Development and Regulatory Milestones With respect to each of the following milestones, Ikaria shall pay BioLineRx the corresponding payment set forth below within [**] days after the achievement by Ikaria, its Affiliates or Licensees of such milestone: MILESTONE PAYMENT

  • Development Activities NovaDel shall not be required to commence any Development Activities until Licensee has paid at least twenty-five percent (25%) of the non-refundable License Fee described in Section 4.4.

  • Clinical Development (a) Stellartech shall design, develop and construct a Clinical Unit for each of the Thermage Disposable Device and the Thermage Generator, and any required component or subassembly thereof and shall deliver such Clinical Units to Thermage in accordance with the Development Program; (b) Stellartech shall deliver to Thermage such other Deliverables as are contemplated by the Development Program in accordance with the Development Program; and (c) as requested by Thermage and automatically at the conclusion of the Development Program, Stellartech, so long as Thermage is not in breach of its material obligation hereunder, shall deliver in writing to Thermage any and all data and information held by or in the control of Stellartech which is necessary or useful to obtain regulatory approval of the Products in the United States or any foreign country.

  • Information Systems Acquisition Development and Maintenance a. Client Data – Client Data will only be used by State Street for the purposes specified in this Agreement.

  • Manufacturing Technology Transfer With respect to each Technology Transfer Product, upon AbbVie’s written request after the Inclusion Date for the Included Target to which such Technology Transfer Product is Directed, Morphic shall effect a full transfer to AbbVie or its designee (which designee may be an Affiliate or a Third Party manufacturer) of all Morphic Know-How and Joint Know-How relating to the then-current process for the Manufacture of such Technology Transfer Product (the “Manufacturing Process”) and to implement the Manufacturing Process at facilities designated by AbbVie (such transfer and implementation, as more fully described in this Section 5.3, the “Manufacturing Technology Transfer”). To assist with the Manufacturing Technology Transfer, Morphic will make its personnel reasonably available to AbbVie during normal business hours for up to [***] FTE hours with respect to each Included Target (in each case, free of charge to AbbVie) to transfer and implement the Manufacturing Process under this Section 5.3. Thereafter, if requested by AbbVie, Morphic shall continue to perform such obligations; provided, that AbbVie will reimburse Morphic for its full-time equivalent (FTE) costs (for clarity, in excess of [***] FTE hours) and any reasonable and verifiable out-of-pocket costs incurred in providing such assistance. CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE IT IS NOT MATERIAL AND WOULD LIKELY CAUSE COMPETITIVE HARM TO THE COMPANY IF PUBLICLY DISCLOSED.

  • Manufacturing and Marketing Rights The Company has not granted rights to manufacture, produce, assemble, license, market, or sell its products to any other person and is not bound by any agreement that affects the Company's exclusive right to develop, manufacture, assemble, distribute, market, or sell its products.

  • Development Program A. Development Activities to be Undertaken (Please break activities into subunits with the date of completion of major milestones)

  • Tests and Preclinical and Clinical Trials The preclinical studies and clinical trials conducted by or, to the Company’s knowledge, on behalf of the Company, that are described in the Registration Statement, the Pricing Disclosure Package and the Prospectus, as applicable, and are intended to be submitted to the U.S. Food and Drug Administration (the “FDA”) or other comparable government entities, were and, if still ongoing, are being conducted in all material respects in accordance with experimental protocols, procedures and controls pursuant to accepted professional scientific standards and all Authorizations and Applicable Laws, including, without limitation, current Good Clinical Practices and Good Laboratory Practices and any applicable rules and regulations of the jurisdiction in which such trials and studies are being conducted; the descriptions of the results of such studies and trials contained in the Registration Statement, the Pricing Disclosure Package and the Prospectus are, to the Company’s knowledge, accurate and complete in all material respects and fairly present the data derived from such studies and trials; except to the extent disclosed in the Registration Statement, the Pricing Disclosure Package and the Prospectus, the Company is not aware of any studies or trials, the results of which the Company believes reasonably call into question the study or trial results described or referred to in the Registration Statement, the Pricing Disclosure Package and the Prospectus when viewed in the context in which such results are described and the clinical stage of development; and, except to the extent disclosed in the Registration Statement, the Pricing Disclosure Package or the Prospectus, the Company has not received any written notices or written correspondence from the FDA or any governmental entity requiring the termination or suspension of any preclinical studies or clinical trials conducted by or on behalf of the Company, other than ordinary course communications with respect to modifications in connection with the design and implementation of such trials, copies of which communications have been made available to you.

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