Development and Planning Team. Within thirty (30) days following the Effective Date, the Parities will establish a development project team (the “Development Project Team”), which shall consist of an equal number of personnel from each Party who are appropriately skilled and knowledgeable in relation to the Development and Manufacturing of the Product. The Development Project Team shall serve as the coordinating body for the Development and Manufacturing Services to be provided under this Agreement and for the transfer of information between the Parties relating to the Services. The Development Project Team shall serve in an advisory capacity to the Parties to assist each Party in its planning of the overall development plan, allocation of resources, and planning and execution of Work Orders. However, the Development Project Team shall have no authority to bind either Party with respect to planning, allocation of resources, or execution of Work Orders, or any other matter.
Development, Manufacturing and Commercialization. Regeneron shall have the right to grant one or more sublicenses under the licenses granted to Regeneron under Section 4.1, in full or in part, by means of written agreement to Affiliates or Third Parties (with the right to sublicense through multiple tiers), without the prior written consent of CytomX, for the performance of Regeneron’s Development, Manufacturing and Commercialization activities related to Licensed Products or for the performance of any other activities related to the Exploitation of a Licensed Product. As a condition precedent to and requirement of any such sublicense: # Regeneron shall furnish a redacted copy of such sublicense agreement to CytomX; # any such permitted sublicense shall be consistent with and subject to the terms and conditions of this Agreement (including for the avoidance of doubt, that if sales by such Sublicensee are included in Net Sales hereunder, such Sublicensee shall permit audit rights with respect to its reporting of Net Sales that are consistent with those given by Regeneron hereunder with respect to its sales included in Net Sales); # Regeneron will continue to be responsible for full performance of its obligations under this Agreement and will be responsible for all actions of such Sublicensee as if such Sublicensee were Regeneron hereunder; and # Regeneron’s grant of any sublicense will not relieve Regeneron or its Affiliates from any of its obligations under this Agreement.
Development and Commercialization Activities. Arcus shall use Commercially Reasonable Efforts to Develop and Commercialize Licensed Products. Arcus shall use Commercially Reasonable Efforts to manufacture or otherwise obtain supply of its requirements of packaged and labeled Licensed Products in connection with its Development and Commercialization obligations hereunder, in accordance with all Applicable Laws, GMP (as applicable) and this Agreement. For so long as Arcus is conducting Development activities under this Agreement, Arcus shall provide to WuXi, no later than on June 30 and December 31 of each calendar year, with written summaries of the Development activities it performed, or caused to be performed, in respect of Licensed Products since the preceding report (or, with respect to the first such report, since the Effective Date), and the future Development activities it CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.
The terms under which SGI will supply clinical supplies of SGI Antibodies to Unum for use as part of the Development Candidates in the Territory under the Late Clinical Development Plan will be set forth in a supply agreement to be entered into between the Parties no later than days prior to the date of initiation of a Clinical Trial of the first Development Candidate in the Territory (the SGI Antibodies Clinical Supply Agreement). Such SGI Antibodies Clinical Supply Agreement will contain terms and conditions that are consistent with this Agreement.
Selection of Development Candidates. For each Collaboration Antigen, during the Research Term for the applicable Research Candidates and following review of the data from activities under the applicable Research Plan, the JSC will select a Research Candidate that specifically targets such Collaboration Antigen to be a Development Candidate for Development pursuant to an Early Clinical Development Program in accordance with the terms and conditions of this Agreement. For each Collaboration Antigen, the date upon which the JSC selects a Development Candidate will be the Development Candidate Selection Date. If, following the review of data from activities under the INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED
Research and Development Milestones. Subject to the terms and conditions of this Agreement Merck shall pay to Ablynx the following milestone payments:
Ownership of Development IP. Zai Lab shall own all rights, title and interests in or to any Development Patents and Development Know-How.
Development and Commercialization Activities. Arcus shall use Commercially Reasonable Efforts to Develop and Commercialize Patented Products in the Field. Notwithstanding the foregoing, Arcus is obligated to file an IND in the United States on a Patented Product no later than months from the Effective Date; provided that Stage 2 Technology Transfer, as defined in Section 3.3.1 below, is completed no later than days following the Effective Date. The deadline for Arcus to file an IND in the United States on a Patented Product shall be extended by one (1) day for each day that Abmuno is late in completing Stage 2 Technology Transfer. Any delay or postponement in the filing of an IND in the United States on a Patented Product beyond the deadline for such filing will be subject to approval by Abmuno, which approval shall not be unreasonably withheld, conditioned or delayed.
Development and Regulatory Milestones. In partial consideration of the rights granted to Allena under Section 2.1, Allena shall pay to Althea, by wire transfer to an account designated by Althea, the applicable milestone payment listed below within thirty (30) days after the first achievement of each milestone event by the first Licensed Product Covered by a Valid Claim:
Development and Approval Milestones. Subject to the terms of this Agreement (including Section 5.1.3), within days after the first achievement by Allergan, its Affiliates or Sublicensees of a Milestone Event set forth below for Licensed Products, Allergan shall make a one-time, non-creditable, non-refundable Milestone Payment to UroGen in the amount below corresponding to such Milestone Event:
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