definiens: means a Clinical Trial of an Arcus Product or Opt ioned Product ( whether a standalone trial or a stage, such as the stage of clinical trial described in t he protocol as the ) ( a ) that satisfies the requireme nts of 21 C.F.R. § 312.21(c ) or its non - U.S. equival ents and the design of which would support Regulatory Approval i n such jurisdiction for such Arcus Product or Optio ned Product for a specific indication or indications or ( b ) the design of which would support an applicati on for Regulatory Approval ( if successful ) in the applicab le jurisdiction, as evidenced by an agreement with or statement from the FDA ( whether in the form of a Special Prot ocol Assessment ( SPA ) or otherwise in writing ) . 1.150 means, for any Arcus Program, an extension of the applicable Arcus Program Period until the earliest of ( a ) deli very of an Option Exercise Notice for such Arcus Pr ogram, ( b ) the end of the applicable Option Exercise Period pr ior to delivery by [COMPANY] of an Option Exercise Not ice for such Option, and ( c ) the [ * * * ] anniversary of the end of the Collaboration Term