definiens: means, on a country - by - country basis in the Territo ry, ( a ) the Reference Product, ( b ) a therapeutic product other than the P roduct that contains the active pharmaceutical ingredient of the Reference Product ( including the Drug Substance or a modified or derivative version thereof ) as its sole active pharmaceutical ingredient or ( c ) any revised formulation, strength, presentation or delivery method of any product desc ribed in ( a ) or ( b ), where the Regulatory Materials with respect thereto reference or would b e required to reference the Reference Product, in the case of ( c ), to the extent such product is labe led for use for the same indication as the Referenc e Product as of the Effective Date . For clarity, Comp eting Product excludes any therapeutic product incorporating PTH 1 - 34 intended for the treatment, prophylaxis or management of any condition resulting from [ * * * ] ( as shown by course of develop ment or labeling ), provided that the NDA for such therapeutic product does not reference the NDA for the Product, but for clarity, such therapeutic product shall not be deemed a Product p rovided that the NDA for such therapeutic product ( ) does not reference the NDA for t he Product, except that [COMPANY] may reference the NDA for the Product in its TP NDA to the extent needed to use cell banks, production processes or supporting analytical methods that were conceive d, generated or reduced to practice in the course of developing the Product . ” 2.2 Product . The definition of in Article I of the D & L Agreement is hereby deleted in its entirety and replaced with the following : [ * * * ] Certain confidential information contained in this document, marked by brackets, has been omitted because it is both ( i ) not material and ( ii ) would be compe titively harmful if publicly disclosed