STAGE 2 DEVELOPMENT. After completing Stage 1 Development, BioStar shall conduct development efforts under the BEAR Program with the goal to [ * ] which means [ * ] [ * ] Biostar will supply [ * ] to Asahi as shown in Stage 2 Criteria.
STAGE 2 DEVELOPMENT. 3.5.1. If both Parties exercise the Stage 1 Radioconjugate Option for a given Joint Radioconjugate, the Parties (through the JRC) will prepare and submit to the JSC for approval a detailed development plan for the cGMP Manufacture, IND preparation and Clinical Studies (including SAD/MAD Studies) primarily aimed at establishing safety for the applicable Joint Radioconjugate (a “Stage 2 Development Plan”). Each Stage 2 Development Plan shall include (i) detailed work streams and budgets (including FTE Costs) for the activities to be conducted and (ii) a summary of the data that should be included in the applicable Stage 2 Data Package. Upon approval by the JSC, the JSC will amend the De Novo Radioconjugate Collaboration Plan to incorporate each Stage 2 Development Plan.
STAGE 2 DEVELOPMENT. The development phase will be directed at generating a robust and reproducible process at Agenus aligned with the controlling source documentation deriving from Stage 1. Development will include, but may not be limited to the following — a review of the current facility design and parameters, and based on OvaScience requirements, the design, management and implementation of any required modifications to the Agenus facility to accommodate OvaScience equipment or modifications to align with compliance standards*. Any needed facility modifications will be assessed and require agreement between the Parties. All costs associated with required modifications would be borne by OvaScience. Also included in the development phase will be the specification, procurement and installation of any required equipment at OvaScience’s expense. Additional services will include required management of reagent generation, characterization and aligned documentation for required reagents including enzymes and monoclonal antibodies. Development will also entail staff training, manufacturing process development and aligned analytical development. OvaScience will provide for training of Agenus staff on the operation of the FACS & aligned instrumentation by the vendor. Agenus will develop working documentation, procedures etc. across the following areas based on documents/discussion and work directed developmental efforts to outline all required CMC Program deliverables including those related to Facility, Materials & Materials Logistics, Manufacture, Quality Control and Product Logistics, and collaborate with OvaScience on the development of risks evaluation and management/mitigation plans. Additional activities may be agreed to by the Parties. Costing is $[**]/hr per FTE plus pass through costs.
