1.1.59 Initial Trial Report has the meaning set forth in Section 2.5.2, below.
1.1.60 Inventions means all inventions, whether or not patentable, that are designed, discovered, generated, invented or conceived by or on behalf of either Party or its respective Affiliates or both Parties or their respective Affiliates, whether solely or jointly with any Third Party, in the course of activities performed under this Agreement in the Field.
1.1.61 Joint Collaboration IP means, collectively:
(a) Joint Collaboration Know-How, which means all Know-How related to the Field, including physical embodiments of a Product, that is jointly created, invented, or otherwise made by or on behalf of both Parties or their respective Affiliates by at least one employee, consultant, or agent of Amerimmune and at least one employee, consultant, or agent of Histogen, whether solely or jointly with any Third Party, pursuant to the conduct of activities under the Collaboration at any time during the Research Term; and
(b) Joint Collaboration Patents, which means Patents that cover any Joint Collaboration Know-How.
1.1.62 Joint Development Committee or JDC has the meaning set forth in Section 3.1.1, below.
1.1.63 Joint Partnering Committee or JPC has the meaning set forth in Section 3.3, below.
1.1.64 Know-How means any tangible or intangible trade secrets, know-how, expertise, discoveries, information, Inventions, data or materials, including ideas, concepts, formulas, methods, procedures, designs, technologies, compositions, plans, applications, scientific or technical data, assays, manufacturing information or data, samples, chemical and biological materials and all derivatives, modifications, and improvements of any of the foregoing, as well as financial and commercial data, business and commercial information, and non-public information about or belonging to a Partys customers, collaborators, suppliers, employees, agents, or other representatives.
1.1.65 Law means any law, statute, rule, regulation, ordinance or other pronouncement having the effect of law, of any federal, national, multinational, state, provincial, county, city or other political subdivision, as from time to time enacted, repealed or amended, including Good Clinical Practices and adverse event reporting requirements, guidance from the International Conference on Harmonization or other generally accepted conventions, the FDCA and similar laws and regulations in countries outside the United States, and all other rules, regulations and requirements of the FDA and other applicable Regulatory Authorities.
1.1.66 License Effective Date has the meaning set forth in Section 5.1.1, below.
1.1.67 Manufacture or Manufacturing means, as applicable, all activities associated with the production, manufacture, processing, filling, packaging, labeling, shipping and storage of a drug product or drug substance in the Field, and/or any components thereof, including process and formulation development, process validation, stability testing, manufacturing scale-up, preclinical, clinical and commercial manufacture and analytical methods development and validation, product characterization, quality assurance and quality control development, testing and release.
1.1.68 Manufacturing Costs means, with respect to a Product, the reasonable FTE Costs and Out-of-Pocket Costs of a Party or any of its Affiliates or sublicensees incurred in Manufacturing a Product, excluding Manufacturing Scale-Up Costs, but including:
(a) to the extent that a Product is manufactured by a Party or any of its Affiliates or sublicensees, direct material and direct labor costs, plus manufacturing overhead attributable to the Product (including facility start-up costs, all directly incurred manufacturing variances, and a reasonable allocation