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 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. (a) AquaBounty shall use, and shall require its sublicensees to use, Diligent Efforts to develop and Commercialize AquaBounty Products. Intrexon shall use, and shall require its sublicensees to use, Diligent Efforts in conducting any activities undertaken by Intrexon in support of any JSC-approved research plan for the Aquaculture Program.
(b) Without limiting the generality of the foregoing, Intrexon may, from time to time, notify AquaBounty that it believes it has identified a Superior Animal Product, and in such case Intrexon shall provide to AquaBounty its then-available information about such animal product and reasonable written support for its conclusion that the animal product constitutes a Superior Animal Product. AquaBounty shall have the following obligations with respect to such proposed Superior Animal Product: (i) within sixty (60) days after such notification, AquaBounty, in conjunction with the members of the JSC, shall prepare and deliver to the JSC for review and approval a development plan detailing how AquaBounty will pursue the Superior Animal Product (including a proposed budget); (ii) AquaBounty shall revise the development plan as directed by the JSC; and (iii) following approval of the development plan by the JSC, AquaBounty shall use Diligent Efforts to pursue the development of the Superior Animal Product under the Aquaculture Program in accordance with such development plan. If AquaBounty fails to comply with the foregoing obligations, or if AquaBounty unreasonably exercises its casting vote at the JSC to either (x) prevent the approval of a development plan for a Superior Animal Product; (y) delay such 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 Animal Product, then Intrexon shall have the termination right set forth in Section 10.2(b) (subject to the limitation set forth therein). For clarity, any dispute arising under this 4.4, including any dispute as to whether a proposed project constitutes a Superior Animal Product (as with any other dispute under this Agreement) shall be subject to dispute resolution in accordance with Article 11.
(c) The activities of AquaBounty’s Affiliates and any permitted sublicensees shall be attributed to AquaBounty for the purposes of evaluating AquaBounty’s fulfillment of the obligations set forth in this Section 4.4, an...
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. 9.1 LICENSEE shall use efforts at least sufficient to meet the requirements of the Xxxx-xxxx Act to manufacture, market and sell the Licensed Products in the Territory, and to create a demand for 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 if 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 its 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. 7.1 LICENSEE will use commercially reasonable and diligent efforts to research, develop and market Licensed Products and or Licensed Services for commercial sale and distribution throughout the Licensed Territory, and to such end, such efforts will include the following:
7.1.1 Within [***] after the Effective Date of this Agreement, LICENSEE will provide an updated financing and business plan for the research, development and marketing of Licensed Products and Licensed Services reasonably acceptable to REGENTS.
7.2 In addition, LICENSEE, an Affiliate of LICENSEE or a Sublicensee will meet the following milestones: [***]
7.3 No less than [***] after the Effective Date of this Agreement, LICENSEE will submit to REGENTS a written report on progress made toward the diligence objectives set forth above, including updated business plans, together with the amount of research and development monies related to Licensed Products and/or Licensed Services and expended during that time period.
7.4 Without limiting the foregoing, in the event that LICENSEE Is unable to complete the milestones and diligence requirements set forth in Paragraphs 7.1 and 7.2, despite using its diligent efforts to do so, due to delays which are out of the reasonable control of LICENSEE (e.g., changes to the regulatory pathways or other regulatory delays, problems with clinical trial protocols or designs or adverse events and the like), LICENSORS agree to grant reasonable extensions of the timeline for the applicable diligence milestones. Subject to the foregoing, failure by LICENSEE to achieve any of the diligence obligations under this Article 7 will result in LICENSORS in their sole discretion having the option of terminating all of the exclusive licenses granted under Article 3, in accordance with Article 18 of this Agreement, or converting any or all of such exclusive licenses to nonexclusive licenses; provided that prior to any such termination, LICENSORS, at LICENSEE’s request, shall negotiate in good faith for at least [***] days regarding amendment of this Agreement and maintaining the exclusive licenses granted to LICENSEE.
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.
Diligence. Agent and Lenders shall have completed their due diligence review of the Loan Parties, their assets, business, obligations and the transactions contemplated herein, the results of which shall be satisfactory in form and substance to Lenders, of Borrower, including, without limitation, (i) an examination of (A) Borrower projected Royalties for such periods as required by Lenders, (B) such valuations of Borrower and its assets as Lenders shall require (C) the terms and conditions of all obligations owed by Borrower deemed material by Lenders, the results of which shall be satisfactory in form and substance to Lenders and (D) background checks with respect to the managers, officers and owners of Borrower; (ii) an examination of the Collateral, the financial statements and the books, records, business, obligations, financial condition and operational state of Borrower, and Borrower shall have demonstrated to Lender’s satisfaction, in its sole discretion, that (x) no operations of Borrower are the subject of any governmental investigation, evaluation or any remedial action which could result in any expenditure or liability deemed material by Lenders, in their sole discretion, and (y) Borrower has no liabilities or obligations (whether contingent or otherwise) that are deemed material by Lenders, in their reasonable discretion. CERTAIN PORTIONS OF THIS EXHIBIT HAVE BEEN OMITTED BASED UPON A REQUEST FOR CONFIDENTIAL TREATMENT AND THE NON-PUBLIC INFORMATION HAS BEEN FILED WITH THE SECURITIES AND EXCHANGE COMMISSION.
