definiens: shall mean ( a ) all information and data now or hereafter contained in any Drug ApprovalApplication or otherwise submitted in support of any Regulatory Approval to which either Party shall have the right underapplicable law, regulations and administrative decisions to refer to, to authorize third parties to refer to and to prohibit thirdparties from referring to the Initial Indications and, if applicable, Additional Indications and/or New Formulations in theInitial Territory ; ( b ) all data concerning any serious or unexpected adverse events, side effects and contra - indications of theProduct which may come to the attention of either Party, its Affiliates or any sublicensee ; ( c ) all data and information in thepossession of either Party or any permitted sublicensee of a Party relating to ( i ) the pharmacological or toxicologicalproperties of a Product, ( ii ) pre - clinical or clinical testing and experience in relation to a Product which is not included in anyDrug Approval Application and ( iii ) to the extent reasonably required for purposes of any application for Drug ApprovalApplication, the chemical composition, manufacturing processes and quality control testing of a Product and ( d ) all otherinformation and data now or hereafter in existence and not in the public domain, which is in the possession of either Party andits Affiliates and which relates in any way to the Development, testing, manufacture, marketing, use or sale of the Products, including, without limitation, all such information or data that is developed as a result of the Development and / orCommercialization of the Products hereunder . Notwithstanding the foregoing, any data and information developed orobtained by a Party or its Affiliates or any sublicensee that not based upon the other Party ’s confidential or proprietaryinformation shall not be deemed to be Proprietary Product Information