1.41. HIPAA has the meaning set forth in the definition of Applicable Law.
1.42. IND means any Investigational New Drug Application filed or to be filed with the FDA as described in Title 21 of the U.S. Code of Federal Regulations, Part 312, and the equivalent application in the jurisdictions outside the United States, including an Investigational Medicinal Product Dossier filed or to be filed with Regulatory Authorities in the European Union.
1.43. [***] has the meaning set forth in Section [***].
1.44. Inventions means all inventions and discoveries, whether or not patentable, that are made, conceived, or first actually reduced to practice by or on behalf of a Party, or by or on behalf of the Parties together, (a) in the design or performance of the Study or in the design or performance of any Subsequent Study performed pursuant to Section 3.15, (b) through use of unpublished Clinical Data, or (c) through use of Sample Testing Results that are shared between the Parties pursuant to the Data Sharing and Sample Testing Schedule.
1.45. Joint Development Committee or JDC has the meaning set forth in Section 3.11.1.
1.46. Joint Patent Application has the meaning set forth in Section 10.1.1(c).
1.47. Joint Patent means a Patent that issues from a Joint Patent Application.
1.48. Jointly Owned Invention has the meaning set forth in Section 10.1.1(a).
1.49. Know-How means any proprietary invention, innovation, improvement, development, discovery, computer program, device, trade secret, method, know-how, process, technique or the like, including manufacturing, use, process, structural, operational and other data and information, whether or not written or otherwise fixed in any form or medium, regardless of the media on which contained and whether or not patentable or copyrightable, that is not generally known or otherwise in the public domain.
1.50. Liability has the meaning set forth in Section 14.2.1.
1.51. Manufacture, Manufactured, or Manufacturing means all activities related to the manufacture of a Compound, including planning, purchasing, manufacture, processing, compounding, storage, filling, packaging, waste disposal, labeling, leafleting, testing, quality assurance, sample retention, stability testing, release, dispatch and supply, as applicable.
1.52. Manufacturers Release or Release has the meaning ascribed to such term in the Clinical Quality Agreement.
1.53. Manufacturing Site means the facilities where a Compound is Manufactured by or on behalf of a Party, as such Manufacturing Site may change from time to time in accordance with Section 8.7.
1.54. Merck has the meaning set forth in the preamble.