definiens: means a cancerous condition resulting from a sepa rate and distinct hematologicalcancer, tumor type or other cancer that is the basi s for a separate and distinct Regulatory Approval . Non - limitingexamples of distinct Oncology Indications include : chronic lymphocytic leukemia, indolent non - Hodgkin lymphoma, follicular lymphoma, mantle cell lymphoma, diffuse large B - cell lymphoma, peripheral T - cell lymphomas, acutemyeloid leukemia, acute lymphoblastic leukemia, Hod gkin lymphoma, renal cell carcinoma, non - small cell lungcancer, colon cancer, breast cancer, pancreatic can cer, etc . On a Product - by - Product and country - by - co untry basis, once a Product has received Regulatory Approval in an Oncology Indication ( a ) where such Regulatory Ap proval is forthe use of such Product alone or in combination wit h other treatment modalities, the subsequent receip t of RegulatoryApproval of such Product in combination with other treatment modalities or alone, respectively, for su ch OncologyIndication shall not be considered a different Onco logy Indication but shall be considered a Label Exp ansion withrespect to such Oncology Indication for such Produc t, ( b ) where such Regulatory Approval is for use of such Productin one line of therapy, the subsequent receipt of R egulatory Approval of such Product in another line of therapy forsuch Oncology 19Indication shall not be considered a different Onco logy Indication but shall be considered a Label Exp ansion withrespect to such Oncology Indication for such Produc t or ( c ) where such Regulatory Approval is for the use of suchProduct within a defined subset of patients within an Oncology Indication, the subsequent receipt of R egulatoryApproval of such Product within a different defined subset of patients within such Oncology Indication ( e.g., elderly, orgenetically defined patients subgroups such as chro nic lymphocytic leukemia patients with a 17 p delet ion ) shall notbe considered a different Oncology Indication but s hall be considered a Label Expansion with respect t o suchOncology Indication for such Product