definiens: means know - how, trade secrets, procedure, technology, experimental data, pre - clinical, non - clinicaland clinical data, clinical safety, post - market safety, efficacy or comparative data, including without limitation raw orpatient data, and any and all material information or reports relating to the development, registration, manufacture andcommercialization of Product and/or Pre - Commercial Product, including but not limited to, copies of, whether draft orfinal, all NDAs and INDs that are to be submitted or have been submitted by the Seller and the Seller or its Affiliatesto any Governmental Authority including without limitation the FDA for regulatory approval for PRO 140 and/or Pre - Commercial Product, any information and data that are reasonably required for regulatory approval for PRO 140,Product and/or Pre - Commercial Product and that are included in other NDAs and INDs for PRO 140, Product and / orPre - Commercial Product filed by the Seller or its Affiliates together with all material subsequent correspondence anddata submissions relating to the foregoing, and all improvements or inventions made or obtained by the Seller or itsAffiliates, which relate to the formulation of PRO 140, Product and/or Pre - Commercial Product or are otherwise usefulfor the manufacture, development and registration of PRO 140, Product and/or Pre - Commercial Product