Use Commercially Reasonable Efforts to Market such Product in the Territory (in the case of CCP-08 following TRIS’ receipt of Regulatory Approval of such Product), regardless of whether such Product has been listed on any formulary;

“Investigational New Drug Application” means an investigational new drug application made to the U.S. Food and Drug Administration (“FDA”), or an equivalent application made in any other country.

After the Launch of a Product, AYTU shall provide, on a Fiscal Quarter basis on or before the forty-fifth (45) day following each Fiscal Quarter, a report summarizing the status of Reimbursement Approvals and Pricing Approvals and filings in terms of formulary listings and reimbursement pricing tier for such Product.

"Conjugated Drug Substance Batch" means a batch of conjugated drug substance manufactured at the Facility.

“Drug Approval Filing” means the submission to a Regulatory Authority of a Drug Approval Application.

services provided in support of Therapeutics’ drug development efforts specifically pertaining to individual and combined hormone replacement drug products (“Drug Products “) including, but not limited to, services in support of Therapeutics’ ongoing and future drug development and commercialization efforts, regulatory approval efforts, third-party investment and financing efforts, marketing efforts, chemistry, manufacturing and controls (“CMC”) efforts, drug launch and post-approval activities, and other intellectual property and know-how transfer associated therewith;

“Drug Master File” or “DMF” means # a Drug Master File filed with the FDA (and any foreign counterpart of a U.S. Drug Master File) and # all supplements and amendments that may be filed with respect to thereto.

Kimberly-Clark is a drug-free work environment. As a result, an additional condition of this offer is that you must pass a pre-employment urine drug screening. This drug screening must be completed within five days of acceptance.

“Drug Master File” or “DMF” means a drug master file, as further described in 21 C.F.R. 314.420, that is intended for submission or submitted to the FDA in support of an IND and/or NDA and containing detailed information regarding the CMC of a drug product.

. “FDA” means the United States Food and Drug Administration.