definiens: shall mean any material change to the [COMPANY] Deve lopment Plan . Without limiting the generality of the forego ing the following kinds of changes are always consi dered material ( and therefore always require JDC approval ): ( 1 ) any change to the dosage ; ( 2 ) any stop of do se escalation in any Phase 1 Trial ; ( 3 ) any change to trial design, trial endpoints and/or protocols ( or selection of them in the first instance ) ; ( 4 ) any change to the manufacturing process of the Licensed Antibody and/ or Licensed Product being pursued ; ( 5 ) any change to p roduct specifications communicated to Regulatory Authorities ; ( 6 ) any change to release assays for L icensed Antibody and/or Licensed Products ; ( 7 ) any change to the formulation of the Licensed Antibody and/or Lic ensed Product being pursued ; ( 8) inclusion or exclu sion of clinical sites ; ( 9 ) change of the clinical CRO and/ or any changes to contracts with CROs ; ( 10 ) change of Manufacturer ; and ( 11 ) change to the Licensed Antib ody and/or Licensed Product being pursued