1.52 First Commercial Sale means the first sale of Symproic by or on behalf of BDSI, its Affiliates, or a BDSI Licensee, for end use or consumption, in the Territory. A First Commercial Sale excludes any sale or distribution for use in any clinical trial or other Development activity, promotional use (including samples) or for compassionate use or on a named patient basis.
1.53 Generic Competition means, on a Calendar Quarterly basis, a fraction (expressed as a percentage), the numerator of which shall be the aggregate number of units of Generic Equivalents sold by Third Parties in the Territory during such Calendar Quarter, and the denominator of which shall be the aggregate number of units of all such Generic Equivalents plus the aggregate number of units of Symproic (including AG Products) sold by BDSI, its Affiliates, and BDSI Licensees under this Agreement in the Territory during such Calendar Quarter, based on independent market data published by IQVIA, or if such data is not available from such source, such other reliable data source as is reasonably agreed to by the Parties.
1.54 Generic Equivalent means, with respect to Symproic in the Territory, a product, other than an AG Product, that (a) contains Naldemedine as its sole API in the same dosage(s) as Symproic, (b) is bioequivalent to Symproic, (c) may be legally substituted by pharmacies in the Territory for Symproic when filling a prescription written therefor without, as a legal requirement, having to seek authorization to do so from the physician or other health care provider writing such prescription, (d) is not marketed or sold under the approval of the Assigned NDA (but instead is sold under the authorization of a Third Partys ANDA or NDA submitted by a Third Party under §505(b)(2) of the FD&C Act with reference to, in either case, the Assigned NDA), and (e) is sold in the Territory by any Third Party.
1.55 Governmental Authority means any multi-national, federal, state, local, municipal or other government authority of any nature (including any governmental division, subdivision, department, agency, bureau, branch, office, commission, council, court or other tribunal).
1.56 Hatch-Waxman Act has the meaning set forth in Section 10.3(c).
1.57 [***] Service Agreement means the Services Agreement, effective as of September 1, 2017, by and between Shionogi and [***], as amended by the Amendment and Change Order No. 1, effective as of [***], a copy of which has been provided to BDSI.
1.58 H-W Suit Notice has the meaning set forth in Section 10.3(c).
1.59 IND means an Investigational New Drug Application as defined in the FD&C Act and applicable regulations promulgated thereunder by the FDA.
1.60 Information means any data, results, and information of any type whatsoever, in any tangible or intangible form, including know-how, trade secrets, practices, techniques, methods, processes, inventions, developments, specifications, formulations, formulae, materials or compositions of matter of any type or kind (patentable or otherwise), software, algorithms, marketing reports, expertise, stability, technology, test data including pharmacological, biological, chemical, biochemical, toxicological, and clinical test data, analytical and quality control data, stability data, studies and procedures.