Diligent Efforts definition

Diligent Efforts means, with respect to the Product, efforts of a Person to carry out its obligations, and to cause its controlled Affiliates and Product licensees, if any, to carry out their respective obligations, using such efforts and employing such resources normally used by Persons in the pharmaceutical business similar in size and resources to Parent relating to seeking regulatory approval for a product candidate or commercialization of an approved product that is of similar market potential at a similar stage in its development or product life, taking into account issues of market exclusivity, product profile, including efficacy, safety, tolerability and convenience, the competitiveness of alternate products in the marketplace or under development, the availability of existing forms or dosages of the Product for other indications, the launch or sales of a generic or biosimilar product, the regulatory environment and the profitability of the Product (including pricing and reimbursement status) and other relevant considerations, including technical, commercial, legal, scientific and/or medical factors.
Diligent Efforts means, with respect to a Party’s obligations under this Agreement to Manufacture, Develop or Commercialize a Licensed Product, the carrying out of such obligations or tasks with a level of efforts and resources consistent with the efforts of such Party with respect to the research, development or commercialization of a similar pharmaceutical product as such Licensed Product with similar market potential, profit potential or strategic value resulting from its own research efforts, taking into account technical and regulatory factors, target product profiles, product labeling, past performance, costs, economic return, the regulatory environment and competitive market conditions in the therapeutic market or niche, all based on conditions then prevailing. Diligent Efforts requires that the Party: (a) promptly assign responsibility for such obligations or tasks 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.
Diligent Efforts means the carrying out of obligations in a sustained manner consistent with the efforts a party would be expected to devote (and which in no event shall be less than the level of effort and resources standard in the pharmaceutical industry for a company similar in size and scope to such party) to a lead product of similar market potential, profit potential or strategic value resulting from its own research efforts, based on conditions then prevailing, in respect of a Core Indication. Without limiting the foregoing, Diligent Efforts in all cases requires at least that (i) each Party promptly assigns responsibility for such obligations to specific employee(s) who are held accountable for progress and monitor such progress on an ongoing basis; (ii) each Party sets and consistently seeks to achieve specific and meaningful objectives for carrying out such obligations; and (iii) each Party consistently makes and implements decisions and allocates resources designed to advance progress with respect to such objectives.

Examples of Diligent Efforts in a sentence

  • Parent shall use, and shall cause its Subsidiaries to use, Diligent Efforts to obtain regulatory approval and clearance for the Existing Products; provided, however, that such obligation to use Diligent Efforts shall terminate upon the earlier of (i) the End Date and (ii) such time as the data generated in an appropriate clinical trial does not support further development of such Product.

  • Parent shall use, and shall cause its Subsidiaries to use, Diligent Efforts to Sell and commercialize Products of Parent and its Subsidiaries that are included in the definition of Covered Products and Services, in each case in the Field utilizing any Methylation-based Technology; provided, however, that such obligation to use Diligent Efforts shall terminate upon the End Date.

  • Supernus already submitted Diligent Efforts Reports to Reich.39 Reich’s specific performance claim is therefore moot.4013.

  • Reich also complains that Supernus’s Diligent Efforts Reports were delayed.

  • To the extent Reich seeks an order compelling Supernus to submit better or more detailed Diligent Efforts Reports, Reich has not met its burden to show specific performance is appropriate as a matter of fact, contract, or law.4114.


More Definitions of Diligent Efforts

Diligent Efforts means carrying out those obligations and tasks that comprise a level of effort and expenditure of resources that is consistent with commercially reasonable practices normally and typically devoted by Parent in connection with the development and commercialization of a product owned or controlled by Parent which is, at the time of measurement of the level of effort and expenditure of resources, similarly situated (including with respect to market potential and sales potential), and at a stage of development or commercialization similar, to the Product, based on conditions then prevailing and reasonably expected to occur and reasonably taking into account, without limitation, issues of safety and efficacy, anticipated pricing and reimbursement rates, costs, labeling, pricing reimbursement, the competitiveness of alternative products in the marketplace, the patent and other proprietary position of the Product and such other competitive products (including applicable intellectual property rights), the likelihood of and requirements for regulatory approval and other relevant scientific, technical, legal and commercial factors. For the avoidance of doubt, a failure to achieve a Milestone in and of itself may be consistent with Diligent Efforts.
Diligent Efforts means [***].
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.
Diligent Efforts means reasonable and good faith efforts by a Party to accomplish such objective as that Party would normally use to accomplish a similar objective under similar circumstances, it being understood and agreed that, with respect to the Development or Commercialization of a Collaboration Product or Royalty Product, as the case may be, such efforts shall be similar to those efforts and resources commonly used by a Party for a similar pharmaceutical product owned by it or to which it has rights, which product is at a similar stage in its development or product life and is of similar market potential in the applicable market taking into account efficacy, safety, approved labeling, the competitiveness of all products in the applicable market, the *Certain information on this page has been omitted and filed separately with the commission. Confidential treatment has been requested with respect to the omitted portions. patent and other proprietary position of the product, the likelihood of regulatory approval given the regulatory structure involved, the profitability of the product including the royalties payable to licensors of patent or other intellectual property rights, alternative products and other relevant factors. Diligent Efforts shall be determined on a market-by-market and Indication-by-Indication basis for a particular Product, and it is anticipated that the level of effort shall be different for different markets, and shall change over time, reflecting changes in the status of the Product and the market(s) involved.
Diligent Efforts means, with respect to a Party’s obligation under this Agreement, the level of efforts and resources reasonably required to diligently develop, manufacture, and/or Commercialize (as applicable) each Synthetic Product in a sustained manner, consistent with the efforts and resources a similarly situated company working in the Field would typically devote to a product of similar market potential, profit potential, strategic value and/or proprietary protection, based on market conditions then prevailing. With respect to a particular task or obligation, Diligent Efforts requires that the applicable Party promptly assign responsibility for such task and consistently make and implement decisions and allocate resources designed to advance progress with respect to such task or obligation. Portions herein identified by [*****] have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. A complete copy of this document has been filed separately with the Securities and Exchange Commission.