definiens: shall mean any rig hts to which a Licensed Product may be eligible in addition to or in lieu of rights under the Licensed Patents including rights to exclusivity provided in 21 USC § 505, 21 USC § 360aa -ee, the Orphan Drug Act, the marketing exclusivity provisions of Article 8(a ) of Directive 65/65 / EEC Relating to Medicinal Products and any other legislation on regulations as amended from time to time in the Territory applicable to this Agreement providing for non -patent marketing exclusivity for any Licensed Product whether su ch legislation or regulation is operative on the Effective Date of this Agreement or becomes operative thereafter ; 1.12 shall mean a breach of this Agreement which is specified in this Agreement as being a mate rial breach, and in addition, any breach of this Agreement which is so 3 injurious to the relationship between the Parties that this Agreement should reasonably be subject to immediate Termination by the non -breaching Party