Conduct of Funded Work Sample Clauses

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Conduct of Funded Work 

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• Conduct of the Study 3.1 Syndax shall act as the sponsor of the Study and shall hold the IND relating to the Study. Merck acknowledges that Syndax intends to file a separate IND covering the clinical evaluation of the Syndax Compound to treat melanoma and lung-related indications and to perform the Study under such IND. This separate IND will not be a combination IND. If a Regulatory Authority requests a separate combination IND for the Study the Parties will meet and mutually agree on an approach to address such requirement. 3.2 Syndax shall ensure that the Study is performed in accordance with this Agreement, the Protocol and all Applicable Law, including GCP. 3.3 Syndax shall ensure that all directions from any Regulatory Authority and/or ethics committee with jurisdiction over the Study are followed. Further, Syndax shall ensure that all necessary Regulatory Approvals from any Regulatory Authority and/or ethics committee with jurisdiction over the Study are obtained prior to initiating performance of the Study. Syndax shall participate in and lead all discussions with any Regulatory Authority regarding the Study, provided, however, that Merck shall have the right (but no obligation) to participate in any discussions with a Regulatory Authority regarding matters related to the Merck Compound. Notwithstanding anything to the contrary in this Agreement, neither Party shall have any right to access the other Party’s CMC data with respect to its Compound. Merck will authorize FDA and other applicable Regulatory Authorities to cross-reference the appropriate Merck Compound CTA to provide data access to Syndax sufficient to support conduct of the Study, which authorization will take the form of a cross-reference letter or similar communication to the applicable Regulatory Authority to effectuate a “right of reference” (as defined in US FDA 21 CFR 314.3(b)), or similar “right of reference” as defined in applicable regulations in the relevant part of the Territory. If an appropriate Merck Compound CTA is not available in a given country, Merck will file its CMC data as appropriate and grant right of reference to such CMC data; provided, however, that Syndax shall have no right to directly access the CMC data. 3.4 Syndax shall maintain reports and all related documentation relating to the Study in good scientific manner and in compliance with Applicable Law. Each Party shall provide to the other all Study information and documentation (excluding information and documentation relating to the Sample Testing other than the Sample Testing Results themselves) reasonably requested by such other Party to enable it to (i) comply with any of its legal and regulatory obligations, or any request by any Regulatory Authority, in each case, to the extent related to the Study or such Party’s Compound, or (ii) conduct the Sample Testing. 3.5 Each Party shall provide to the other Party copies of all Clinical Data, in electronic form or other mutually agreeable alternate form, and on the timelines specified in the Data Sharing and Sample Testing Schedule (if applicable) or upon mutually agreeable timelines. Syndax shall ensure that all patient authorizations and consents required under HIPAA, the EU Data Protection Directive, GCP or any other Applicable Law in connection with the Study permit such sharing of Clinical Data with Merck. 3.6 Syndax shall provide Samples to Merck as specified in the Protocol or as agreed to by the Joint Development Committee. Each Party shall use the Samples only for the Sample Testing and each Party shall be responsible for conducting the Sample Testing related to its own Compound. Merck shall own all data arising from the Sample Testing conducted by or on behalf of Merck. Merck shall provide to Syndax the Sample Testing Results for the Sample Testing conducted by or on behalf of Merck, in electronic form or other mutually agreeable alternate form, and on the timelines specified in the Data Sharing and Sample Testing Schedule or other mutually agreed timelines. Likewise, Syndax shall own all data arising from the Sample Testing conducted by or on behalf of Syndax. Syndax shall provide to Merck the Sample Testing Results for the Sample Testing conducted by or on behalf of Syndax, in electronic form or other mutually agreeable alternate form, and on the timelines specified in the Data Sharing and Sample Testing Schedule or other mutually agreed timelines. Except to the extent otherwise agreed in a writing signed by authorized representatives of each Party, each Party shall use the other Party’s Sample Testing Results only for the purposes of ***. Further, Merck covenants not to ***, and Syndax covenants not ***; provided, however, that the foregoing shall not prevent either Party from ***. 3.7 All Clinical Data, including raw data and results, generated under this Agreement shall be jointly owned by Syndax and Merck. It is understood and acknowledged by the Parties that positive Clinical Data could be used to obtain label changes for the Compounds. In such event, the Parties will enter into good faith negotiations to determine a regulatory submission strategy for the Compounds, and cost structure of the next part of the Study and/or future study(ies) that may be needed for regulatory submission for the Compounds. Merck covenants not to ***, and Syndax covenants not to ***; provided, however, that the foregoing shall not prevent either Party from ***.

• Conduct of the Business (a) From the date hereof until the Closing Date, or the earlier termination of this Agreement pursuant to Article IX, except to the extent described in Schedule 5.01 or otherwise required or specifically permitted by this Agreement, the Company shall: (i) conduct the Business in the ordinary course of business consistent with past practice in all material respects (including with respect to capital expenditures, the timely making of any budgeted or emergency capital expenditures or capital expenditures that are required to maintain the Business in compliance with any applicable Laws), unless the Parent shall have otherwise consented in writing (which consent will not be unreasonably withheld, conditioned or delayed); (ii) maintain in effect the insurance coverage described on Schedule 7.16 (or reasonably equivalent replacement coverage); (iii) use its commercially reasonable efforts to preserve the present relationships of the Business with suppliers, vendors, licensees and other Persons with which the Business has business relations; (iv) maintain in effect the Business Licenses (if any) in accordance with the terms thereof and renew any Business License that would otherwise expire pursuant to the terms thereof between the date of this Agreement and the Closing; (v) use its commercially reasonable efforts to keep, or to cause Spoonful to keep, available the services of the Business Employees subject to the normal hiring and firing of Business Employees in the ordinary course of business consistent with past practice and (vi) use commercially reasonable efforts to preserve intact its business organization, value as a going concern and relationships with third parties (including lessors, licensors, suppliers, distributors and customers) and employees. (b) From the date hereof until the Closing Date, or the earlier termination of this Agreement pursuant to Article IX, except to the extent described in Schedule 5.01 or otherwise required or specifically permitted by this Agreement or consented to in writing by the Parent (which consent will not be unreasonably withheld, conditioned or delayed), the Company shall refrain from: (i) issuing, selling or delivering any of its Company LLC Interests or other Equity Interests or issuing or selling any securities convertible into, or options with respect to, or warrants to purchase or rights to subscribe for, any of its Company LLC Interests or other Equity Interests (or amending any term of any of the foregoing); (ii) effecting any recapitalization, reclassification, dividend, split or like change in its capitalization other than dividends in the in the ordinary course of business consistent with past practice and the terms and conditions of the Company’s Organizational Documents; (iii) amending its Organizational Documents; (iv) making any redemption or purchase of any of its of its Company LLC Interests or other Equity Interests; (v) (A) merging, consolidating or combining with any Person or (B) acquiring any material assets, except for acquisitions of inventory, equipment and supplies in the ordinary course of business consistent with past practice; (vi) permitting any of the assets of the Company to become subject to a Lien (other than a Permitted Lien) or selling, leasing, licensing or otherwise disposing of any assets or securities, including by merger, consolidation, asset sale or other business combination, other than in the ordinary course of business consistent with past practice; (vii) making any loans or advances to, or any investments in, any other Person (in the case of loans or advances to employees, in excess of $100,000 in the aggregate for all such loans and advances); (viii) pledging or otherwise encumbering of its Company LLC Interests or other Equity Interests; (ix) excepting as required or specifically permitted by this Agreement, entering into or amending any Contract with the Manager or any officer of the Company; (x) increasing any benefits under any Employee Benefit Plan or increasing the compensation payable or paid, whether conditionally or otherwise, to any employee, officer, manager or consultant of Company (other than (A) any increase adopted in the ordinary course of business consistent with past practice in respect of the compensation of any employee whose annual base compensation does not exceed $125,000 after giving effect to such increase or (B) any increase in benefits or compensation required by Law or required pursuant to the terms of an existing Employee Benefit Plan); (xi) becoming liable in respect of any guarantee (other than a guarantee by the Company of a Liability of the Company that is made in the ordinary course of business consistent with past practice) or incur, assume or otherwise become liable in respect of any Indebtedness; (xii) repaying, prepaying or otherwise discharging or satisfying any Indebtedness or other material Liabilities, other than in the ordinary course of business consistent with past practice, or waiving, cancelling or assigning any claims or rights of substantial value other than in the ordinary course of business consistent with past practice; (xiii) making any capital expenditures that are in the aggregate in excess of $100,000 (other than capital expenditures contemplated by the capital expenditure budget attached to Schedule 5.01, emergency capital expenditures or capital expenditures that are required to maintain the Business in compliance with any applicable Laws); (xiv) making any change in its methods of accounting or accounting practices (including with respect to reserves) or any Tax election; filing any amended Tax Return; electing or changing any method of accounting for Tax purposes; settling any Action or claim in respect of Taxes; or consenting to any extension or waiver of the limitations period for the assessment of any Tax; (xv) settling, agreeing to settle, waiving or otherwise compromising any pending or threatened Actions or claims (A) involving potential payments by or to the Company of more than $100,000 in aggregate, (B) that admit Liability or consent to non-monetary relief, or (C) that otherwise are or would reasonably be expected to be material to the Company or the Business; (xvi) entering into, adopt, terminate, modify, renew or amend in any material respect (including by accelerating material rights or benefits under) any Contract unless such Contract requires payments by the Company of less than $10,000 per month and that can be terminated by the Company upon 60 days’ or less notice without penalty; (xvii) writing up or writing down any of its material assets of the Company or revalue its inventory or reserves in respect of its accounts receivable; (xviii) taking any action or failing to take any action that would result in any of the representations and warranties set forth in this Agreement becoming false or inaccurate in any material respect; or (xix) authorizing, agreeing or committing or entering into a Contract to do any of the foregoing.

• Maintenance of Existence; Conduct of Business Except as permitted by Section 11.3, the Borrower will, and will cause each Subsidiary of the Borrower to, preserve and maintain (a) its corporate existence and (b) all of its leases, privileges, Permits, franchises, qualifications and rights that are necessary in the ordinary conduct of its business. The Borrower will, and will cause each Subsidiary of the Borrower to, conduct its business in an orderly and efficient manner in accordance with good business practices.

• Conduct of Logging Unless otherwise specifi- cally provided herein, Purchaser shall fell trees desig- nated for cutting and shall remove the portions that meet Utilization Standards, as provided in B2.2, prior to accep- tance of subdivision for completion of logging under B6.36. Forest Service may make exceptions for occa- sional trees inadvertently not cut or trees or pieces not removed for good reason, including possible damage to forest resources or gross economic impracticability at the time of removal of other timber. Logging shall be con- ducted in accordance with the following, unless C6.4 pro- visions set forth requirements to meet special or unusual logging conditions:

• CONDUCT OF THE AUCTION Conduct of the auction and increments of bidding are at the discretion of the Auctioneer. The Auctioneer's decision is final in the event of a dispute over any matter. The Auctioneer reserves the right to accept bids in any increments he deems to be in the best interest of his client, and reserves the right to waive any previously announced requirements. Bid rigging and bid suppression schemes are violations of the Xxxxxxx Antitrust Act and are deemed illegal and punishable as a federal felony.

• Maintenance of Existence and Conduct of Business Each Credit Party shall: do or cause to be done all things necessary to preserve and keep in full force and effect its corporate existence and its rights and franchises; continue to conduct its business substantially as now conducted or as otherwise permitted hereunder; at all times maintain, preserve and protect all of its assets and properties used or useful in the conduct of its business, and keep the same in good repair, working order and condition in all material respects (taking into consideration ordinary wear and tear) and from time to time make, or cause to be made, all necessary or appropriate repairs, replacements and improvements thereto consistent with industry practices; and transact business only in such corporate and trade names as are set forth in Disclosure Schedule (5.1).

• Conduct of Local Church Operations From the date of this Disaffiliation Agreement through and until the Closing, the Local Church: (a) will conduct its operations substantially in accordance with past practice and will use commercially reasonable efforts, subject to the foregoing, to maintain and preserve its operations and organization consistent with past practice and efficient and economical management, (b) will not take any action that is inconsistent with its charitable purposes under Section 501(c)(3) of the Code or that otherwise adversely affects its tax-exempt status, and (c) will not take any action that would cause its representations and warranties in this Disaffiliation Agreement not to remain true and correct as of Closing, except with the prior written consent of the Annual Conference.

• Conduct of Business and Maintenance of Existence (a) Continue to engage in its principal line of business as now conducted by it, (b) preserve, renew and keep in full force and effect its corporate existence and (c) take all reasonable action to maintain all rights, privileges and franchises necessary or desirable in the normal conduct of its principal line of business, except, in any such case, as otherwise permitted pursuant to subsection 6.5 or to the extent that failure to do so would not have a Material Adverse Effect.

• Conduct of Business and Maintenance of Existence, etc (a) (i) Preserve, renew and keep in full force and effect its corporate existence and (ii) take all reasonable action to maintain all rights, privileges and franchises necessary or desirable in the normal conduct of its business, except, in each case, as otherwise permitted by Section 7.4 and except, in the case of clause (ii) above, to the extent that failure to do so could not reasonably be expected to have a Material Adverse Effect; and (b) comply with all Contractual Obligations and Requirements of Law except to the extent that failure to comply therewith could not, in the aggregate, reasonably be expected to have a Material Adverse Effect.

• Conduct of Mediation In consultation with the mediator, the parties will determine a location, timetable and procedure for the mediation or, if the parties cannot agree on these matters within 7 Working Days of the appointment of the mediator these matters will be determined by the mediator.