The term “Drug Substance” shall mean drug substance of Product in formulated bulk form that meets the applicable Specifications.

Drug Classification. If the NMPA provides guidance that the Licensed Product will be classified as a drug, then, ​.

“FMC US Dialysis Clinics” means mean Majority Owned Clinics and Formulary Clinics (in each case, as defined below), and home hemodialysis and peritoneal-dialysis programs administered through Majority Owned Clinics or Formulary Clinics.

The term “New Drug Application” shall mean the application, including all necessary documents, data, and other information concerning a Product, required for Regulatory Approval of the Product as a pharmaceutical product by the applicable Regulatory Authority in any country or group of countries (e.g. the marketing authorization application (MAA) with the EMA/European Commission).

. Except as otherwise expressly provided herein, as between the Parties, INNOCOLL shall be responsible for the Manufacture and supply of the Licensed Product to support its and its Affiliates’ and sublicensees’ activities hereunder, including all related regulatory matters associated therewith.

22 Article 6 ECONOMIC TERMS

Drug Application Documentation. Purchaser shall maintain all Drug Applications with respect to the Finished Products. Upon request from FIS, Purchaser shall provide FIS with information regarding the CMC sections of such Drug Applications, or discrete sections thereof.

Section # (Supply of Drug Substance) shall be modified to add the following paragraphs after the existing (unnumbered) paragraph (which, for clarity, shall remain):

Drug-Free Workplace. Compliance with the Drug-Free Workplace Act of 1988 (45 CFR 82).

Adverse Drug Events. The Parties will, within 90 days after the Effective Date, finalize and enter into a reasonable and customary Safety Data Exchange Agreement. Such Safety Data Exchange Agreement will provide for the exchange by the Parties of any information that a Party becomes aware of in the Licensed Territory concerning any adverse event in or involving a research patient or subject or, in the case of non-clinical studies, an animal in a toxicology study, and the seriousness thereof, whether or not determined to be attributable to the Compound or any Licensed Product, including any such safety information received by either Party from a Third Party (subject to receipt of any required consents from such Third Party) (such information, the “Safety Data”). Cara will own all of the Safety Data, and the Safety Data Exchange Agreement will include provisions requiring the establishment of a global safety database owned and maintained by Cara. It is understood that each Party and its Affiliates or licensees/sublicensees will have the right to disclose such information if such disclosure is reasonably necessary to comply with applicable laws and regulations and requirements of Regulatory Authorities within its respective territory with respect to its filings and activities related to the Compound and the Licensed Products.