1.49 Governmental Authority means any court, agency, authority, department, regulatory body or other instrumentality of any government or country or of any national, federal, state, provincial, regional, county, city or other political subdivision of any such government or any supranational organization of which any such country is a member, which has competent and binding authority to decide, mandate, regulate, enforce or otherwise control the activities of the Parties or their Affiliates contemplated by this Agreement.
1.50 GSK Competitor means a pharmaceutical company that has [*].
1.51 GSK Data Sharing Initiative means the policy initiative(s) of GSK and its Affiliates (as may be amended from time to time), known as of the Execution Date as the SHaring Anonymised REsearch data (SHARE) Initiative, to provide researchers with access to Clinical Trial information, including coded or anonymized patient level data.
1.52 GSK Patent means any Patent that claims a Sole Invention owned by GSK.
1.53 GSK Program means a GSK Development Program for a Collaboration Target and all activities of GSK, its Affiliates and any Sublicensees with respect to the manufacture, Development, Commercialization or other exploitation of a Compound or Product directed to such Collaboration Target.
1.54 Human Biological Samples means any human biological material (including any derivative or progeny thereof), including any portion of an organ, any tissue, skin, bone, muscle, connective tissue, blood, cerebrospinal fluid, cells, gametes, or sub-cellular structures such as DNA, or any derivative of such biological material such as stem cells or cell lines, and any human biological product, including hair, nail clippings, teeth, urine, feces, breast milk and sweat.
1.55 ICH means International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use.
1.56 IND means (a) an Investigational New Drug Application (including any amendments thereto) as defined in the FD&C Act and applicable regulations promulgated thereunder by the FDA, or (b) the equivalent application to the applicable Regulatory Authority in any other regulatory jurisdiction, the filing of which is necessary to initiate or conduct clinical testing of a pharmaceutical product in humans in such jurisdiction.
1.57 IND Enabling Studies means, with respect to Products, toxicology studies evaluating such Products that are conducted in accordance with then-current good laboratory practices, as set forth in 21 C.F.R. Part 58 and as interpreted by relevant ICH guidelines, in each case, as amended from time to time, for purposes of including such results in an IND.
1.58 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, 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.