Diligence Clause Samples
The Diligence clause requires one or both parties to exercise a certain standard of care, effort, or thoroughness in performing their obligations under the agreement. In practice, this may involve conducting background checks, verifying information, or ensuring that all necessary steps are taken to fulfill contractual duties. The core function of this clause is to set expectations for responsible behavior and to help prevent negligence or oversight that could lead to disputes or losses.
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Diligence. Licensee agrees to use Commercially Reasonable Efforts to diligently Develop, Manufacture and Commercialize the Product in the Territory for use in the Field for all commercially reasonable Indications, including without limitation, the Initial Two Indications; except to the extent that the responsibility for doing so, as specifically set forth in Sections 4.2 and 4.3 of this Agreement and in the CMC Development, Manufacture and Supply Agreement, belongs to Bayer. Without limiting the foregoing, Licensee shall:
4.1.1.1 use Commercially Reasonable Efforts to diligently carry out its respective obligations and activities specified in the Development Plan including, without limitation, adhering to the timelines set forth therein;
4.1.1.2 prepare and file with the applicable Governmental Authorities those regulatory filings deemed necessary or desirable by Licensee to undertake Development activities including, without limitation, all INDs and IND Equivalents, in the Territory;
4.1.1.3 conduct all Preclinical Development and Clinical Development in good scientific manner, and in compliance in all material respects with all requirements of Applicable Laws to achieve the objectives of this Agreement efficiently and expeditiously;
4.1.1.4 maintain records, in sufficient detail and in good scientific manner, which shall be complete and accurate and shall fully and properly reflect all work done and results achieved in connection with its Development efforts in the form required under all Applicable Laws;
4.1.1.5 use Commercially Reasonable Efforts to prepare and file those NDAs and NDA Equivalents and other regulatory filings deemed necessary or desirable by Licensee with the appropriate Governmental Authorities in the Territory and obtain all Regulatory Approvals that Licensee deems necessary or desirable to Commercialize the Product in the Territory for use in the Field;
4.1.1.6 own all INDs, IND Equivalents, NDAs and NDA Equivalents submitted for the Product in the Territory for use in the Field, together with all Regulatory Approvals and other regulatory filings and approvals for the Product in Territory for use in the Field;
4.1.1.7 be solely responsible for all activities in connection with the Regulatory Approvals for the Product in the Territory for use in the Field, including, without limitation, communicating with, and preparing and filing all reports (including, without limitation, adverse event reports) with the Governmental Authorities in the Territor...
Diligence. Licensee shall use Commercially Reasonable Efforts to Develop and obtain and maintain Regulatory Approvals for [***] Licensed Product for use in the Field in each of the Major Markets.
Diligence. LICENSEE shall itself use, or shall cause its sublicensees to use, commercially reasonable efforts, consistent with sound and reasonable business practices and judgment, to diligently proceed to introduce at least one Licensed Product into the commercial market. Demonstration of such commercially reasonable efforts shall include, but not be limited to:
(i) Annual report provided to BCM describing LICENSEE’s or its sublicensees’ progress and activities related to research and development, securing regulatory approvals, manufacturing, sublicensing, marketing, and sales of Licensed Products;
(ii) Initiation of a first Phase II clinical trial of a first Licensed Product within […***…] of the Agreement Date;
(iii) Initiation of a first pivotal clinical trial and/or Phase III clinical trial of a first Licensed Product within […***…] of the Agreement Date; and
(iv) The production of the commercialized Licensed Products and the marketing and support of the commercialized Licensed Products with at least a substantially similar level of effort as LICENSEE employs for comparable products and services marketed by LICENSEE. Timely achievement of the foregoing items (i-iv) shall be deemed to satisfy and fully discharge LICENSEE’s obligations under this Section 3. BCM recognizes that there are many uncertainties associated with the development and commercialization of therapeutic products and the regulatory process required by the FDA (and foreign regulatory authorities that are equivalent to the FDA). Accordingly, in the event that LICENSEE can demonstrate to BCM its commercially reasonable efforts (with reasonable supporting documentation) to fulfill items (ii) and (iii) above, LICENSEE and BCM will negotiate in good faith a reasonable revision to items (ii) and (iii) above; provided that BCM shall not unreasonably withhold such revision. If LICENSEE anticipates that it will not fulfill a revised item (ii) or (iii), LICENSEE may obtain a […***…] extension of time in which to achieve these milestones, by paying to BCM a one-time, […***…] dollars ($[…***…] US) extension fee.
Diligence. Tenant shall prosecute such Contest with reasonable diligence and in good faith.
Diligence. (a) Synthetic shall use, and shall require its sublicensees to use, Diligent Efforts to develop and commercialize Synthetic Products.
(b) Without limiting the generality of the foregoing, Intrexon may, from time to time, notify Synthetic that it believes it has identified a Superior Therapy, and in such case Intrexon shall provide to Synthetic its then-available information about such therapy and reasonable written support for its conclusion that the therapy constitutes a Superior Therapy. Synthetic shall have the following obligations with respect to such proposed Superior Therapy: (i) within sixty (60) days after such notification, Synthetic shall prepare and deliver to the JSC for review and approval a development plan detailing how Synthetic will pursue the Superior Therapy (including a proposed budget); (ii) Synthetic shall revise the development plan as directed by the JSC; and (iii) following approval of the development plan by the JSC, Synthetic shall use Diligent Efforts to pursue the development of the Superior Therapy under the Anti-Infectives Program in accordance with such development plan. If Synthetic fails to comply with the foregoing obligations, or if Synthetic unreasonably exercises its casting vote at the JSC to either (x) prevent the approval of a development plan for a Superior Therapy; (y) delay such 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. approval more than sixty (60) days after delivery of the development plan to the JSC; or (z) approve a development plan that is insufficient in view of the nature and magnitude of the opportunity presented by the Superior Therapy, then Intrexon shall have the termination right set forth in Section 10.2(c) (subject to the limitation set forth therein). For clarity, any dispute arising under this 4.5, including any dispute as to whether a proposed project constitutes a Superior Therapy (as with any other dispute under this Agreement) shall be subject to dispute resolution in accordance with Article 11.
(c) The activities of Synthetic’s Affiliates and any permitted sublicensees shall be attributed to Synthetic for the purposes of evaluating Synthetic’s fulfillment of the obligations set forth in this Section 4.5.
Diligence. The parties hereto agree that each shall with reasonable diligence proceed to take all action which may be reasonably required to consummate the transaction herein contemplated.
Diligence. 6.1. Licensee, upon execution of this Agreement, will diligently proceed with the development, manufacture, and Sale of Licensed Products, Licensed Services, and Licensed Methods, and will diligently market them in quantities sufficient to meet the market demand.
6.2. In addition to its obligations under Paragraph 6.1, Licensee specifically commits to achieving the following milestones (either itself, or through its Sublicensees) in its activities under this Agreement:
(a) Milestone #1: Greenhouse Proof of Concept — on or before […*…];
(b) Milestone #2: Field Proof of Concept — on or before […*…];
(c) Milestone #3: Regulatory Submission — on or before […*…];
(d) Milestone #4: Regulatory Approval — on or before […*…]; and
(e) Milestone #5: Commercial Launch of a Licensed Product — on or before […*…].
6.3. If The Regents believes that Licensee has failed to meet any milestone set forth in Paragraphs 6.1 and 6.2 by the date set forth therein (if applicable), The Regents will provide written notice to Licensee of the same within a reasonable time. License will have one hundred and twenty (120) days from the date of such written notice (“Cure Period”) to complete the stated milestone or otherwise fulfill the stated diligence obligations. If Licensee is unable to complete the stated milestone or otherwise fulfill the stated diligence obligations within the Cure Period, Licensee may extend the completion date of such milestone or diligence obligation for a period of six (6) months from the expiration of the Cure Period upon the payment of […*…], due within ten (10) days of expiration of the Cure Period. Licensee may further extend the completion date of any milestone or diligence obligation for an additional six (6) months upon payment of an additional […*…]. Additional extensions may be granted only by mutual written agreement of the Parties. All such payments to extend deadlines are in addition to the annual License Maintenance Fee payment specified in Paragraph 4.2. Should Licensee opt not to pay to extend the completion date or if Licensee should fail to complete the stated milestone or otherwise fulfill the stated diligence obligations by any extended target date, then The Regents may provide written notice to Licensee that the license granted in Paragraph 2.1 has been converted to a non-exclusive license, effective as of the date of expiration of the Cure Period or any extended target date, whichever is later.
(a) Unless earlier terminated in accordance wit...
Diligence. 9.1 LICENSEE shall use efforts at least sufficient to meet the requirements of the ▇▇▇▇-▇▇▇▇ Act to manufacture, market and sell the Licensed Products in the Territory, and to create a demand to the Products.
9.2 LICENSEE agrees to submit reports, upon LICENSOR’s request but no more than every 6 months as to its efforts to develop markets for the Licensed Products. Such reports shall include assurance by LICENSEE of its intent to actively develop commercial embodiments of Licensed Products and a summary of its efforts in this regard.
9.3 Unless LICENSEE has introduced a Licensed Product into the commercial marketplace in one of the three major markets (European Union, Japan and the United States) or has made best efforts (for avoidance of doubt it will be presumed that LICENSEE has used best efforts fi it has a Licensed Product in a phase III clinical trial) to achieve the same prior to December 31, 2020. LICENSEE agrees that LICENSOR may terminate this Agreement by providing LICENSEE ninety (90) advanced written notice of tis intent to terminate this Agreement. In the event the payment of earned royalties, once begun and if any are due, ceases for more than two (2) calendar quarters, and LICENSEE fails to cure this breach within two (2) months after being provided written notice of same, LICENSOR may terminate this Agreement.
Diligence. Licensee shall use commercially reasonable efforts and shall cause its Sublicensees to use commercially reasonable efforts: (a) to develop Licensed Products in accordance with the Development and Commercialization Plan, which may be amended from time to time by mutual agreement of the Parties; (b) to introduce Licensed Products into the commercial market; and (c) to market Licensed Products following such introduction into the market. In addition, Licensee, by itself or through its Affiliates or Sublicensees, shall use commercially reasonable efforts to achieve the Development and Commercialization Milestones.
Diligence. 1. Licensee shall use its best efforts to bring Licensed Patent Rights to market through a thorough, vigorous, and diligent program and to continue active, diligent marketing efforts throughout the life of this agreement.
2. Licensee shall permit an in-house inspection of Licensee facilities by Licensor and its agents on an annual basis commencing upon the execution of this Agreement upon reasonable notice by Licensor.
3. Licensee’s failure to perform in accordance with either paragraph 1, 2 and/or 3.of this ARTICLE VI shall be grounds for Licensor to terminate this agreement.