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 ***.
Election Procedures Each holder of record of shares of Company Common Stock (“Holder”) shall have the right, subject to the limitations set forth in this Article III, to submit an election with respect to the shares of Company Virginia Sub Common Stock to be received by such holder in the Reincorporation Merger in accordance with the following procedures: (a) Each Holder may specify in a request made in accordance with the provisions of this Section 3.1 (herein called an “Election”) (i) the number of shares of Company Virginia Sub Common Stock to be owned by such Holder as a result of the Reincorporation Merger with respect to which such Holder desires to make a Share Election and (ii) the number of shares of Company Virginia Sub Common Stock to be owned by such Holder as a result of the Reincorporation Merger with respect to which such Holder desires to make a Cash Election. (b) Parent shall prepare a form reasonably acceptable to the Company (the “Form of Election”) which shall be mailed to record holders of Company Common Stock so as to permit those holders to exercise their right to make an Election prior to the Election Deadline. (c) Parent shall make the Form of Election initially available not less than twenty (20) business days prior to the anticipated Election Deadline and shall use all reasonable efforts to make available as promptly as possible a Form of Election to any stockholder of the Company who requests such Form of Election following the initial mailing of the Forms of Election and prior to the Election Deadline. The Form of Election shall contain instructions for effecting the surrender of Company Certificates (which, following the Reincorporation Merger shall represent Company Virginia Sub Common Stock) in exchange for receipts representing the Parent ADSs, as well as the Cash Consideration and cash in lieu fractional shares and, if any Holder so elects and subject to the proviso to the last sentence of Section 2.4(a)(iv), Parent Ordinary Shares in account entry form in lieu of Parent ADSs. (d) Any Election shall have been made properly only if the person authorized to receive Elections and to act as exchange agent under this Agreement, which person shall be a bank or trust company selected by Parent and reasonably acceptable to the Company (the “Exchange Agent”), pursuant to an agreement (the “Exchange Agent Agreement”) entered into prior to the mailing of the Form of Election to Company stockholders, shall have received, by the Election Deadline, a Form of Election properly completed and signed and accompanied by Company Certificate(s) (which, following the Reincorporation Merger shall represent Company Virginia Sub Common Stock) to which such Form of Election relates or by an appropriate customary guarantee of delivery of such certificates, as set forth in such Form of Election, from a member of any registered national securities exchange or a commercial bank or trust company in the United States; provided, that such Company Certificates are in fact delivered to the Exchange Agent by the time required in such guarantee of delivery. Failure to deliver shares of Company Common Stock covered by such a guarantee of delivery within the time set forth on such guarantee shall be deemed to invalidate any otherwise properly made Election, unless otherwise determined by Parent, in its sole discretion. As used herein, unless otherwise agreed in advance by the parties, “Election Deadline” means 5:00 p.m. local time (in the city in which the principal office of the Exchange Agent is located) on the date that Parent and the Company shall agree is as near as practicable to five (5) business days prior to the expected Closing Date. Parent and the Company shall cooperate to issue a press release reasonably satisfactory to each of them announcing the date of the Election Deadline not more than twenty (20) business days before, and at least ten (10) business days prior to, the Election Deadline.
Selection Procedure 10.2.4.1 Internal applicants shall be defined as all applicants with seniority in accordance with Article 12.5. 10.2.4.2 In filling a posted vacancy, first consideration shall be given to internal applicants who meet the stated qualifications. All Faculty members who meet the stated qualifications for the posted vacancy shall be interviewed by the Selection Committee. Past service and evaluations shall be considered by the Committee. The best qualified candidate shall be recommended for appointment to the position. 10.2.4.3 Where the qualifications of two or more of the applicants are relatively equal, the applicant with the greatest seniority shall be recommended for appointment to the position. 10.2.4.4 In establishing the qualifications, and in evaluating the qualifications and past performance of the applicants, the committee shall act in good faith, in a fair and reasonable manner, and shall not act in an arbitrary or discriminatory fashion. 10.2.4.5 Following the interviews, the committee will submit its recommendations containing a list of qualified candidates in order of preference, through the appropriate Xxxx to the President or delegate. 10.2.4.6 New faculty members shall be appointed only when there are no qualified internal applicants. 10.2.4.7 If there are no qualified internal applicants, the selection committee may consider external applications, in accordance with the procedure outlined above. 10.2.4.8 Internal applicants will be advised as soon as possible of the selection committee's decision that the committee will be considering external applications in accordance with Article 10.2.4.7.
OBJECT OF THE CONTRACT The present Contract’s object regulates the activity developed within the framework of doctoral studies, regulating the relationship between XXXXX - XXXX, PhD student and PhD supervisor, specifying the rights and obligations of the implied parties in accordance with the University’s Charter, Regulation for the organization and conduct of doctoral studies within BUES and legislation in force. The title of the selected research topic is: ………………………………………………………………………………………………………………………………………
LIMITATIONS ON REVERSE ENGINEERING, DECOMPILATION AND DISASSEMBLY You may not reverse engineer, decompile, or disassemble the Software, except and only to the extent that such activity is expressly permitted by applicable law notwithstanding this limitation.
Site Selection 5.1.1 If the parties have not designated the street address of the Franchised Location on Exhibit A on the Effective Date, Franchisee shall identify, submit and obtain Franchisor’s prior written approval of the Franchised Location meeting the requirements of this Agreement prior to entering a lease or sublease for the Franchised Location. Franchisee shall provide Franchisor all information required by Franchisor, as determined by Franchisor in Franchisor’s sole determination, necessary for Franchisor to evaluate the Franchised Location. Franchisor shall have ten (10) business days to review Franchisee’s written site proposal for the Franchised Location and notify Franchisee of its approval or disapproval in writing. Franchisor’s failure to respond within ten (10) business days shall signify Franchisor’s disapproval of the site. Franchisor shall not unreasonably withhold Franchisor’s approval of a proposed site for the Franchised Location. 5.1.2 Franchisee must have a site for the Franchised Location approved by Franchisor, receive the opening notice from Franchisor described in Section 5.4 below, and open Franchisee’s Franchised Business for business within six (6) months from the Effective Date, except as otherwise provided in Section 5.1.3 All matters related in any way to Franchisee’s site are Franchisee’s sole responsibility, regardless of any assistance Franchisor may choose to provide. Franchisee is responsible for obtaining any architectural and engineering services required for Franchisee’s facility and for ensuring its compliance with local law. Neither Franchisor, nor any other person or company associated with Franchisor shall have any liability for any site‐related matter. Xxxxxxxxxx agrees not to make any claims against Franchisor and/or any of Franchisor’s affiliates or associates with regard to such matters. 5.1.4 If Franchisor makes a loan to Franchisee for (i) Franchisee’s purchase of the franchise for the Franchised Business; (ii) the remodeling of the Franchised Location; (iii) the transfer of any interest in this franchise or this Agreement; or (iv) any other purpose; Franchisee shall open (or re‐open, as the case may be), the Franchised Business for business within sixty (60) days from the loan origination date.
Examination of Implementation 1. Without prejudice to the procedures set out in Article 188 (Compensation), once the period of time set out in paragraph 3 of Article 186 (Implementation of the Report) has expired, and there is disagreement between the disputing Parties as to the existence or consistency of the measures taken to comply with the Panel report, such dispute shall be referred to the original Panel wherever possible. If not possible, the procedure pursuant to Article 179 (Panel Selection) shall be followed to appoint a new Panel, in which event the periods set out thereof shall be reduced by half (22). 2. This Panel shall issue its report on the matter within 60 days after the date of the referral of the matter to it. When the Panel considers that it cannot provide its report within this timeframe, it shall inform the Parties in writing of the reasons for the delay together with an estimate of the period within which it will submit its report. Any delay shall not exceed a further period of 30 days unless the Parties otherwise agree.
Collection Procedure Escrow Agent is hereby authorized to deposit the proceeds of each wire in the Escrow Account.
Election and Term The President, Treasurer and Secretary shall, and the Chairman of the Board may, be appointed by and shall hold office at the pleasure of the Manager or the Board. The Manager, the Board, or the President may each appoint such other officers and agents as such person shall deem desirable, who shall hold office at the pleasure of the Manager, the Board, or the President, and who shall have such authority and shall perform such duties as from time to time shall, subject to the provisions of Section 5(d) hereof, be prescribed by the Manager, the Board, or the President.
Selection Process The Mortgage Loans were selected from among the outstanding one- to four-family mortgage loans in the Seller's portfolio at the related Closing Date as to which the representations and warranties set forth in Subsection 9.02 could be made and such selection was not made in a manner so as to affect adversely the interests of the Purchaser;