Changes to Diligence Requirements. In the event that COMPANY anticipates that a failure to meet an obligation set forth in Section 3.1(f), Section 3.3(a)(ii)-(v) or Section 3.4(c)-(f) will occur, COMPANY will promptly notify M.I.T. in writing, and representatives of each party will meet to review the reasons for anticipated failure and discuss in good faith a potential revision to the applicable diligence schedule. In addition to the foregoing, if COMPANY provides written notice and reasonably demonstrates to M.I.T. that the anticipated failure to meet any one of the diligence obligations set forth in Section 3.1(f) Section, 3.3(a)(ii)-(v) or Section 3.4(c)-(f) is due to (i) an action, inaction, delay or ruling by the United States Food and Drug Administration or any comparable regulatory agency, or (ii) the existence of material technical or scientific difficulties or delays in pre-clinical or clinical studies (e.g., unfavorable toxicological or pharmacological test results or an adverse clinical event with respect to LICENSED PRODUCTS or LICENSED PROCESSES) that COMPANY or a SUBLICENSEE could not reasonably have predicted and/or avoided (each of (i) and (ii), a “DEVELOPMENT ISSUE”), then the parties shall meet to review the cause and nature of the DEVELOPMENT ISSUE as well as COMPANY’s proposed plan and timeline to address same, and the parties shall reasonably amend the relevant aspects of the diligence schedule to account for such DEVELOPMENT ISSUE. COMPANY and M.I.T. will enter into a written amendment to this Agreement with respect to any mutually agreed upon change(s) to the relevant obligation.
6. The following new Section 3.4 shall be added to Article 3, COMPANY DILIGENCE OBLIGATIONS, of the License Agreement:
Changes to Diligence Requirements. In the event that COMPANY anticipates that a failure to meet an obligation set forth in Section 3.1(f) will occur, COMPANY will promptly notify M.I.T. in writing, and representatives of each party will meet to review the reasons for anticipated failure and discuss in good faith a potential revision to the diligence schedule. In addition to the foregoing, if COMPANY provides written notice and reasonably demonstrates to M.I.T. that the anticipated failure to meet any one of the diligence obligations set forth in Section 3.1(f) is due to (i) an action, inaction, delay or ruling by the United States Food and Drug Administration or any comparable regulatory agency, or (ii) the existence of material technical or scientific difficulties or delays in pre-clinical or clinical studies (e.g., unfavorable toxicological or pharmacological test results or an adverse clinical event with respect to LICENSED PRODUCTS or LICENSED PROCESSES) that COMPANY or a SUBLICENSEE could not reasonably have predicted and/or avoided (each of (i) and (ii), a “DEVELOPMENT ISSUE”), then the parties shall meet to review the cause and nature of the DEVELOPMENT ISSUE as well as COMPANY’s proposed plan and timeline to address same, and the parties shall reasonably amend the relevant aspects of the diligence schedule to account for such DEVELOPMENT ISSUE. COMPANY and M.I.T. will enter into a written amendment to this Agreement with respect to any mutually agreed upon change(s) to the relevant obligation.
Changes to Diligence Requirements. In the event that COMPANY anticipates that a failure to meet an obligation set forth in Section 3.1(d) or (e) will occur, COMPANY will promptly notify M.I.T. in writing, and representatives of each party will meet to review the reasons for anticipated failure. If, after good faith discussion, COMPANY and M.I.T. are unable to agree upon an amendment to the obligation, COMPANY, at its discretion, may elect to extend the due date to meet the obligation for such diligence by [**] by providing written notice to M.I.T. along with payment in the amount of [**] Dollars ($[**]). COMPANY may extend the due date of one diligence obligation set forth in each of Sections 3.1(d) and (e) pursuant to this Section 3.2 [**] during the TERM. In addition to the foregoing, if COMPANY provides written notice and reasonably demonstrates to M.I.T. that the anticipated failure to meet any one of the diligence obligations set forth in Section 3.1(d) or Section 3.1(e) is due to (i) an action, inaction, delay or ruling by the FDA or any comparable regulatory agency, (ii) the existence of substantial technical difficulties or delays in pre-clinical or clinical studies (e.g., negative toxicological or pharmacological test results or an adverse clinical event with respect to LIPID PRODUCTS and/or LICENSED PRODUCTS) that COMPANY could not reasonably have predicted and/or avoided; or (iii) the issuance of an injunction or the grant of other equitable relief by a court of competent jurisdiction preventing COMPANY, its AFFILIATES or SUBLICENSEES from practicing the PATENT RIGHTS (each of (i)-(iii), a “DEVELOPMENT ISSUE”), then the parties shall meet to review the cause and nature of the DEVELOPMENT ISSUE as well as COMPANY’s proposed plan and timeline to address same, and the parties shall reasonably amend the relevant aspects of the diligence schedule to account for such DEVELOPMENT ISSUE. COMPANY and M.I.T. will enter into a written amendment to this Agreement with respect to any mutually agreed upon change(s) to the relevant obligation(s) in accordance with this Section 3.2. For clarity, if the due date of a particular diligence obligation for a specific LICENSED PRODUCT is extended and/or amended in accordance with this Section 3.2, the timing of any subsequent diligence obligations with respect to such LICENSED PRODUCT will be adjusted accordingly.
Changes to Diligence Requirements. Notwithstanding the foregoing, in the event that COMPANY anticipates that a failure to meet an obligation set forth in Section 3.1 (d) will occur, COMPANY will promptly give written notice to M.I.T. which will set forth the reasons for the delay and a projected new diligence schedule that COMPANY believes can be achieved. Representatives of each party will meet to review the reasons for anticipated failure and discuss in good faith a revision to the diligence schedule. COMPANY and M.I.T. will enter into a written amendment to the license with respect to any mutually agreed upon change(s) to the diligence schedule. [***] Certain information in this document has been excluded pursuant to Regulation S-K, Item 601(b)(10). Such excluded information is not material and would likely cause competitive harm to the registrant if publicly disclosed.
Changes to Diligence Requirements. Notwithstanding the foregoing, in the event that COMPANY anticipates that a failure to meet an obligation set forth in Section 3 will occur, COMPANY will promptly give written notice to M.I.T. which will set forth the reasons for the delay and a projected new diligence schedule that COMPANY believes can be achieved. Representatives of each party will meet to review the reasons for anticipated failure and discuss in good faith a revision to the diligence schedule. COMPANY and M.I.T. will enter into a written amendment to the license with respect to any mutually agreed upon change(s) to the diligence schedule.”
5. Section 3.3 shall be amended to add subsections 3.3 (c) and (d) as follows:
