Initial Development Activities. Ablynx 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. Ablynx shall provide AbbVie with monthly high-level status reports noting project critical path activities, risks and mitigation plans. If Ablynx 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 AbbVie, AbbVie shall have the right, at AbbVie’s sole election, and without limitation to any other right or remedy available to AbbVie, to assume and complete some or all of such Initial Development Activities. The Parties acknowledge and agree that in the event AbbVie assumes some or all of such Initial Development Activities, given the underlying material breach, AbbVie, after using Commercially Reasonable Efforts, may not be able to complete such Initial Development Activities in accordance with the Initial Development Plan and Budget. If AbbVie so elects to assume and complete any of the Initial Development Activities, to the extent requested by AbbVie (i) Ablynx shall assign to AbbVie any or all Third Party agreements relating to such Initial Development Activities (including agreements with contract research organizations, clinical sites, investigators and manufacturing providers), and (ii) AbbVie shall use Commercially Reasonable Efforts to perform the Initial Development Activities that AbbVie has elected to assume and complete under this Section 3.1.2. In such event, with respect to all such Initial Development Activities that involve Clinical Studies, at AbbVie’s option, Ablynx shall either (i) end such Clinical Studies with respect to enrolled subjects in an orderly and prompt manner in accordance with Applicable Law, including any required follow up treatment with previously enrolled subjects, or (ii) transfer Control to AbbVie or its designee of such Clinical Studies and cooperate with AbbVie to ensure a smooth and orderly transition thereof that will not involve any disruption of such Clinical Studies. In the event AbbVie elects to assume and complete Initial Development Activities under this Section 3.1.2, Ablynx shall bear the responsibility for all costs and expenses of the Initial Development Activities (including supply costs and any costs associated with the transfer), regardless ...
Initial Development Activities. The Parties acknowledge that during the thirty (30)-day period immediately following the Effective Date, Coherus will undertake the activities set forth in Exhibit 1.29 (Initial Development Activities), pursuant to which Coherus will incur the Reimbursable Costs included therein.
Initial Development Activities. Licensee will be solely responsible for the conduct of all Initial Development Activities and all expenses, including Third Party expenses, related to such Initial Development Activities. Notwithstanding anything to the contrary set forth herein, Licensee will complete all such Initial Development Activities and provide to Takeda all data, reports, and other Information generated in the performance thereof on or prior to [***].
Initial Development Activities. Licensor shall perform the Initial Development Activities, and shall do so in accordance with the Initial Development Plan (including the budget set forth therein, subject to Section 3.4.4) by allocating sufficient time, effort, equipment, and skilled personnel to complete such Initial Development Activities successfully and promptly. If Licensor is in material breach of its obligation to perform any Initial Development Activities and fails to remedy such breach within [***] days after written notice thereof from Licensee, Licensee shall have the right, at Licensee’s sole election, to assume and
Initial Development Activities. Galapagos shall perform the Initial Development Activities, and shall do so in accordance with the Initial Development Plan and Budget (including the budget set forth therein) by allocating sufficient time, effort, equipment, and skilled personnel to complete such Initial Development Activities successfully and promptly. If Galapagos is in material breach of its obligation to perform any Initial Development Activities and fails to remedy such breach within […***…] ([…***…]) days after written notice thereof from Xxxxxx, Xxxxxx shall have the right, at Xxxxxx’x sole election, and without limitation to any other right or remedy available to Xxxxxx, to assume and complete some or all of such Initial Development Activities. If Xxxxxx so elects to assume and complete any of the Initial Development Activities, to the extent requested by Xxxxxx in writing, Galapagos shall assign to Xxxxxx any or all Third Party agreements relating to such Initial Development Activities (including agreements with contract research organizations, clinical sites and investigators). In such event, with respect to all such Initial Development Activities that involve Clinical Studies, at Xxxxxx’x option, Galapagos shall either (i) end such Clinical Studies with respect to enrolled subjects in an orderly and prompt manner in accordance with Applicable Law, including any required follow up treatment with previously enrolled subjects, or (ii) transfer control to Xxxxxx or its designee of such Clinical Studies and cooperate with Xxxxxx to ensure a smooth and orderly transition thereof that will not involve any disruption of such studies. Galapagos shall bear the responsibility for the direct out-of-pocket costs and expenses of the Initial Development Activities (including supply costs), regardless of which Party undertakes such Initial Development Activities.
Initial Development Activities. Harpoon shall perform the activities set forth in the Initial Development Plan in accordance with the timelines set forth therein, [***]. In the conduct of the Initial Development Activities, Harpoon shall use commercially reasonable efforts to ensure that clinical sites participating in the Phase I/IB Trial timely submit Clinical Data generated at such site into the clinical database. If at any time AbbVie has a reasonable basis to believe that Harpoon is in material breach of its obligation to perform any Initial Development Activities, then AbbVie may so notify Harpoon in writing, specifying the basis for its belief, and the Parties shall meet within [***] after such notice to discuss in good faith AbbVie’s concerns. If Harpoon [***] Notwithstanding the foregoing, if Harpoon [***], then Harpoon may seek resolution on the existence of such material breach pursuant to Section 13.7; provided that (i) Harpoon’s [***]. For clarity, if the arbitrator determines that notwithstanding [***]. The Parties acknowledge and agree that in the event AbbVie [***] Initial Development Activities in accordance with the Initial Development Plan. If AbbVie so elects to [***] permitted under the terms and conditions of the applicable agreement, Harpoon shall [***].
Initial Development Activities. Molecular Partners shall be the initial Development lead (the “Development Lead”) for the Licensed Bispecific. As Development Lead, Molecular Partners shall be responsible for oversight of all Development activities for the Licensed Bispecific, including responsibility for all preclinical Development, conducting IND-enabling activities, and conducting the Phase 1a Clinical Trial for the Licensed Bispecific, as more particularly set forth in the Development Plan. During such time that Molecular Partners is the Development Lead, Molecular Partners shall initiate the technology transfer process in accordance with Section 7.2.
Initial Development Activities. Nektar shall be responsible for all elements of the Product Development Plan delegated to it therein, including being responsible for carrying out the Phase I Study [***] for NKTR-358, and the other Initial Development Activities, in each case, as described in the initial Product Development Plan attached as Schedule 4.1; provided, that the Parties may mutually agree in writing (including in the form of an amended Product Development Plan) that Lilly should be responsible for performing certain Initial Development Activities.
Initial Development Activities. (a) Oncobiologics will initially Develop and submit for Regulatory Approval Products in the following Indications: (i) intravitreal injection of Product for the treatment of Wet AMD (the “First Indication”), and (ii) intravitreal injection of Product for the treatment of DME (the “Second Indication”). The Parties shall jointly discuss and evaluate, through the JSC, the Development of Products for treatment of Indications other than the First Indication and Second Indication (each, an “Additional Indication”). For clarity, the terms “First Indication”, “Second Indication” and “Additional Indications” may not track the actual temporal order of Development of the Product (i.e., Oncobiologics may Develop the Product in the Field for the Second Indication or an Additional Indication prior to the First Indication), as discussed by the Parties through the JSC and without limiting Section 4.3(b).
(b) Oncobiologics will use Commercially Reasonable Efforts to Develop and seek Marketing Approval of a Product in the Field for the First Indication, the Second Indication, or an Additional Indication (whichever Indication is the lead Indication at such time). Oncobiologics will not delay filing for Marketing Approval in the U.S. of a Product in the Field for the lead Indication by more than one (1) Calendar Quarter as a result of insufficient funding of the program. For clarity, in the event that Development Costs incurred specifically for (i) conducting the Pilot Study and Pivotal Study (but excluding costs incurred in manufacturing and/or supplying Products for use in such studies), and (ii) obtaining Regulatory Approval of Products in the Field in the U.S. (but excluding any PDUFA Fees and all other Development or Commercialization costs incurred by Oncobiologics) either exceed or are reasonably likely to exceed [***] U.S. Dollars ($[***]) ([***]), then Oncobiologics termination of the Development of Products shall not be considered a failure to use Commercially Reasonable Efforts.
Initial Development Activities. WuXi will perform an initial set of Development and Manufacturing activities directed to the Vir Antibodies, [***]. The Initial Development Activities will be conducted by WuXi under one or more existing or additional Development Work Order(s) entered into pursuant to the terms of the MSA, at Vir’s sole cost and expense. The Development Work Order for a portion of the Initial Development Activities has been agreed by the Parties and is attached to this Agreement as Schedule 3.1.2.
