1.10 Insolvency Event means (i) if Histogen is declared insolvent or bankrupt by a court of competent jurisdiction, (ii) if a voluntary or involuntary petition in bankruptcy is filed in any court of competent jurisdiction against Histogen and such petition is not dismissed within ninety (90) days after filing or (iii) if Histogen shall make or execute an assignment of substantially all of its assets for the benefit of creditors.
1.11 Intellectual Property Rights means any and all patent rights, copyright rights, trade secret rights, sui generis database rights and all other intellectual and industrial property rights of any sort throughout the world (including, but not limited to, any application therefor) whether now known or hereafter existing.
1.12 Manufacture, Manufactured or Manufacturing means all operations in the manufacturing, production, packaging, labeling, warehousing, quality control testing (including in-process release and stability testing, when applicable) and release of Bulk CCM.
1.13 Materials means any and all components, labels, packaging materials, and other consumable materials to be used by Histogen in the Manufacturing of the Bulk CCM in accordance with the Specifications.
1.14 Non-Conforming CCM means any Bulk CCM that fails to comply with the Specifications or any other requirements of this Agreement.
1.15 Person means an individual, corporation, partnership, limited liability company, trust, business trust, association, joint venture, non-profit organization, sole proprietorship, unincorporated organization, university, governmental authority or any other form of entity not specifically listed herein.
1.16 Quality Agreement means a mutually agreed-upon, written Quality Agreement that shall be entered into by the parties which will set forth the roles and responsibilities of Histogen and Suneva with respect to the quality assurance for the Bulk CCM.
1.17 Registration means all permits, licenses, approvals and authorizations granted by any Regulatory Authority with regard to a Finished Product.
1.18 Regulatory Authority means any administrative agency responsible for the regulation of cosmetic or pharmaceutical products intended for human use, including, but not limited to, the FDA, and any other applicable administrative agency in the Territory having the aforementioned responsibilities and any successor entities thereto.
1.19 Specifications means the quality assurance and other requirements, procedures, guidelines and specifications for the manufacturing, packaging, labeling, handling, dating and storage of the Bulk CCM, each as may be required pursuant to any Regulatory Requirements or Applicable Law, and further including specifications attached hereto as Appendix A, as may be amended from time to time as required by any Regulatory Requirements or Applicable Law or by the mutual approval of the parties, provided that any amendment to the Specifications that will require a material increase in the Manufacturing costs for Histogen will require a mutually approved increase in the Manufacturing fee.