Diligent Development Efforts definition

Diligent Development Efforts means efforts and resources reasonably comparable to those commonly used in the research-based pharmaceutical industry for a medical device, pharmaceutical product or pharmaceutical compound at a similar stage in its development of similar market potential, taking into account safety and efficacy, product profile, difficulty in developing the product, competitiveness of alternative products in the marketplace, the patent and other proprietary position of the product, the likelihood of regulatory approval given the regulatory structure involved, the potential profitability of the product and alternative products and other relevant factors affecting the cost, risk and timing of development and total potential reward to be obtained if a Licensed Product is commercialized, provided, however, that the fact that the Parties are required to share revenues with respect to the Licensed Products shall not be a factor taken into account in determining whether Diligent Development Efforts were satisfied.
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Diligent Development Efforts means that the Party: (a) promptly assign responsibility for such development obligations to specific employee(s) who are held accountable for progress and monitor such progress on an on-going basis, (b) set and consistently seek to achieve specific and meaningful objectives for carrying out such obligations, and (c) consistently make and implement decisions and allocate resources designed to advance progress with respect to such objectives.
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Diligent Development Efforts means, with respect to the overall efforts to be expended by Janssen to Develop a [**] Product under this Agreement, expending a commercially reasonable level of efforts, by or on behalf of Janssen (through its and its Affiliates’ and Third Party subcontractors’ collective activities), to conduct the applicable Development activities (including in the event of any [**], expending efforts to seek to [**], if, and to the extent, it is commercially reasonable to do so), which efforts are those that are consistent with the level of efforts typically (from an objective standpoint) expended in the human pharmaceutical industry by similarly resourced companies under similar circumstances considering all relevant factors that may affect Development, such as the stage of Development, product profile (including in comparison with the Key Profile Targets and the profiles of competitive products and regimens), costs, technical challenges, market potential, regulatory requirements and approvability, patient population, freedom to operate hurdles, legal issues, safety and tolerability data, manufacturing issues, competitive position, projected profitability and return on investment (but excluding consideration of clinical milestone payments to Achillion hereunder), in each case using reasonable business judgment at the time such efforts are to be expended.
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Examples of Diligent Development Efforts in a sentence

  • Discovery shall use Diligent Development Efforts to develop at least one Licensed Product and to otherwise carry out its responsibilities under this Agreement relating to such Licensed Product promptly and expeditiously in accordance with all Laws.

  • Xxxxxxx shall also use Diligent Development Efforts to initiate or have initiated, at a commercially reasonable time, any Additional Study of a Licensed Product for each other Indication to the extent specified in the then-current CDP, considering at such time circumstances such as the evolving data and other results from prior or ongoing clinical studies of the Licensed Product and other data pertaining to the developability of the Licensed Product.

  • Section 4.2.1, each Party shall use Diligent Development Efforts to perform its respective Development activities under the CDP.

  • Janssen shall use Diligent Development Efforts to Develop a [**] Product toward Regulatory Approval in Major Market Countries, and if such Development is successful, to seek Regulatory Approvals of a [**] Product in Major Market Countries.

  • The Group adjusts the measure of progression as circumstances change and records the impact as a change in estimate on a prospective basis.

  • Chrysalis shall use Diligent Development Efforts to achieve the Development Milestone by the Milestone Date.


More Definitions of Diligent Development Efforts

Diligent Development Efforts means, with respect to the efforts to be expended by a designated Party regarding its Development obligations under this Agreement, expending commercially reasonable efforts, by or on behalf of such Party (through its and its Affiliates’ and Third Party subcontractors’ collective activities) to conduct the applicable Development activities (including in the event of any clinical hold imposed by any Regulatory Authority on any particular IND or clinical trial for a Licensed Product under the Global Development Plan, expending efforts to seek to remove such clinical hold, if, and to the extent, it is commercially reasonable to do so) that are consistent with the efforts typically expended in the human pharmaceutical industry by similarly resourced companies under similar circumstances (considering, for example, technical challenges, market potential, regulatory requirements, patient population, and competitive position).
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Diligent Development Efforts means, with respect to the overall efforts to be expended by Xxxxxxx to Develop a [**] Product under this Agreement, expending a commercially reasonable level of efforts, by or on behalf of Xxxxxxx (through its and its Affiliates’ and Third Party subcontractors’ collective activities), to conduct the applicable Development activities (including in the event of any [**], expending efforts to seek to [**], if, and to the extent, it is commercially reasonable to do so), which efforts are those that are consistent with the level of efforts typically (from an objective standpoint) expended in the human pharmaceutical industry by similarly resourced companies under similar circumstances considering all relevant factors that may affect Development, such as the stage of Development, product profile (including in comparison with the Key Profile Targets and the profiles of competitive products and regimens), costs, technical challenges, market potential, regulatory requirements and approvability, patient population, freedom to operate hurdles, legal issues, safety and tolerability data, manufacturing issues, competitive position, projected profitability and return on investment (but excluding consideration of clinical milestone payments to Achillion hereunder), in each case using reasonable business judgment at the time such efforts are to be expended.
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Related to Diligent Development Efforts

  • Diligent Efforts means, with respect to a Party’s obligations hereunder, the carrying out of obligations or tasks in a sustained manner consistent with the efforts a Party devotes to a research, development or marketing project for a pharmaceutical product or products of similar market potential, profit potential or strategic value resulting from its own research efforts, based on conditions then prevailing, which efforts shall in any event be no less than those which would be considered reasonable in the pharmaceutical or biotechnology industries.

  • Development Activities means those activities which are normally undertaken for the development, construction, repair, renovation, rehabilitation or conversion of buildings for residential purposes, including the acquisition of property;

  • Development Program means the implementation of the development plan.

  • Development Works means the external development works and internal development works on immovable property;

  • Development Term means the period commencing on the Closing Date and ending on the earlier of (a) the Option Closing Date or (b) the date the Option terminates or expires other than by exercise.

  • Development Team means the entities and professionals assembled to develop and manage the Project, typically including the Applicant, Owner, Developer(s), Co-Developer(s) and general partner or any other related entities in which the Developer or Co-Developer has an identity of interest or a Controlling Interest.

  • Development Phase means the period before a vehicle type is type approved.

  • Development Work means the conduct of preclinical and clinical trials, the compilation of the regulatory dossier concerning Licensed Products and the conduct of other work necessary or useful for obtaining Regulatory Approval of Licensed Products.

  • Medical Affairs Activities means, with respect to any country or other jurisdiction in the Territory, the coordination of medical information requests and field based medical scientific liaisons with respect to Licensed Compounds or Licensed Products, including activities of medical scientific liaisons and the provision of medical information services with respect to a Licensed Compound or Licensed Product.

  • site development plan means a dimensioned plan drawn to scale that indicates details of the proposed land development, including the site layout, positioning of buildings and structures, property access, building designs and landscaping;

  • Development Plan has the meaning set forth in Section 3.2.

  • Development Activity means any activity defined as Development which will necessitate a Floodplain Development Permit. This includes buildings, structures, and non-structural items, including (but not limited to) fill, bulkheads, piers, pools, docks, landings, ramps, and erosion control/stabilization measures.

  • Development Consent means the consent granted to the Development Application for the Development and includes all modifications made under section 4.55 of the Act.

  • Commercialization or “Commercialize” means activities directed to marketing, promoting, research and development as required, manufacturing for sale, offering for sale, distributing, importing or selling a product, including sub-licensing or sub-contracting of these activities.

  • Research Program Term has the meaning set forth in Section 2.2.

  • Research Program has the meaning set forth in Section 2.1.

  • Development Site means any parcel or lot on which exists or which is intended for building development other than the following:

  • Research Term has the meaning set forth in Section 3.2.

  • Commercial Development Plan means the written commercialization plan attached as Appendix E.

  • Development Plans has the meaning set forth in Section 3.2.

  • Initial Development Plan has the meaning set forth in Section 3.2(b).

  • Collaboration Term has the meaning set forth in Section 2.2.

  • Research means a methodical investigation into a subject.

  • Research Plan shall have the meaning set forth in Section 2.1.

  • Development Period means the period from the date of this Agreement until the Appointed Date;

  • Development Schedule shall have the meaning set forth in Section 1.1.