Development Decision-Making. Except as otherwise expressly provided in this Agreement, all matters regarding the Early Clinical Development Program and the Late Clinical Development Program will be decided by unanimous agreement by the JDC.
Early Clinical Development. Subject to the terms and conditions of this Agreement, on a Development Candidate-by-Development Candidate basis, effective as of the date on which the Collaboration Antigen of such Development Candidate becomes a Collaboration Antigen under this Agreement, during the Early Clinical Development Term, SGI hereby grants to Unum an exclusive, sublicensable (solely as permitted in accordance with Section 10.4), royalty-free, fully-paid, worldwide license, under the SGI Background Technology and SGI Program IP, to clinically Develop such Development Candidate (and Manufacture same but only for such purpose and only as provided in this Agreement), all in accordance with the Early Clinical Development Plan, save that SGI will retain such rights as are necessary to perform any activities that the Parties may agree that SGI will perform under this Agreement.
On a Development Candidate-by-Development Candidate basis, each Party will share with the other Party all safety and efficacy data generated with respect to such Development Candidate in all Clinical Trial(s) after the Qualifying Phase 1 Clinical Trial for such Development Candidate, and all correspondence to and from any Regulatory Authority regarding such Development Candidate and, upon either Partys written request, such other relevant information reasonably requested by such Party regarding the Development Candidate in the other Partys possession (but subject to Third Party confidentiality obligations) (collectively, Late Clinical Development Trial Data), following such Partys receipt of same. Each Party will in good faith seek to obtain such information and make it available to the other Party.
Joint Development Committee. In accordance with Section 6.6(c), the JDC will act as an information-sharing forum with respect to the Research and Development of each Reversion Product. The Continuing Party will provide such information and data regarding the Development of the Reversion Product as the JDC would customarily receive regarding a Product to the extent that it specifically relates to, if Unum is the Opt-Out Party, ACTR T-cells or the ACTR platform technology and, if SGI is the Opt-Out Party, the applicable SGI Antibody. In addition, the Continuing Party will provide summaries of all other material information and data regarding the Development of such Reversion Product. The Parties acknowledge and agree that the Joint Development Committee will have no decision-making authority or approval rights with respect to a Reversion Product.
BBTR System Development. Blackbox has customized and branded the BBTR System for providing Services to Customers utilizing BBTR Exchange Data, as mutually agreed by the Parties for marketing and sublicensing by BBTR. Except as mutually agreed by the Parties, BBTR shall be responsible for all costs associated with any further customization and branding of the BBTR System. Unless otherwise agreed by the Parties, BBTR shall pay within 30 calendar days of receipt of the invoice all additional customization costs which shall be negotiated in advance of any such customization services and invoiced by Blackbox via wire transfer per the instructions attached hereto as Exhibit A.
Initial Development Activities. shall perform the Initial Development Activities, and shall do so in accordance with the Initial Development Plan and Budget by allocating sufficient time, effort, equipment, and skilled personnel to complete such Initial Development Activities. shall provide [[Organization A:Organization]] with monthly high-level status reports noting project critical path activities, risks and mitigation plans. If is in material breach of its obligation to perform any Initial Development Activities and fails to remedy such breach within [ ] after written notice thereof from [[Organization A:Organization]], [[Organization A:Organization]] shall have the right, at [[Organization A:Organization]]s sole election, and without limitation to any other right or remedy available to [[Organization A:Organization]], to assume and complete some or all of such Initial Development Activities. The Parties acknowledge and agree that in the event [[Organization A:Organization]] assumes some or all of such Initial CONFIDENTIAL TREATMENT REQUESTED. INFORMATION FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED IS OMITTED AND MARKED WITH [......]. AN UNREDACTED VERSION OF THE DOCUMENT HAS ALSO BEEN FURNISHED SEPARATELY TO THE SECURITIES AND EXCHANGE COMMISSION AS REQUIRED BY RULE 406 UNDER THE SECURITIES ACT OF 1933, AS AMENDED.
Product Development Program. After the Effective Date, Zai Lab will, either by itself or through its Affiliates, licensees and/or sublicensees, be solely responsible for designing and performing all aspects of the Development Program in accordance with the Development Plan, provided that Zai Lab may undertake changes to its development plans from time to time as long as it continues to satisfy its diligence obligations under this Agreement. Zai Lab will have sole responsibility and control for the managing and the financing of the Development Plan and all Development Costs. The primary focus of the Development Program will be to Develop and obtain Regulatory Approvals for one or m`ore Products.
Government Conflict of Interest. Distribution may be accelerated as may be necessary to comply with a certificate of divestiture as defined in section 1043(b)(2) of the Code.
Government and Other Regulations. The obligation of the Company to make payment of bonuses shall be subject to all applicable laws, rules and regulations and to such approvals by governmental agencies as may be required.
“Sanctions” means economic sanctions administered or enforced by the United States Government (including without limitation, sanctions enforced by OFAC), the United Nations Security Council, the European Union or HerHis Majesty’s Treasury.
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