The following words and terms when used in this subchapter shall have the following meaning unless the context clearly indicates otherwise.

1. (1) Department--Department of State Health Services.
2. (2) Calendar year--January 1 through December 31 of each year.
3. (3) Exclusivity--A Federal Drug Administration (FDA) granted delay on approval of competitor drugs that attaches upon FDA's approval of a drug.
4. (4) Patent--A property right issued by the United States Patent and Trademark Office to exclude others from making, using, offering for sale, or selling an invention for a limited time.
5. (5) Patent exclusivity--Rights resulting from a drug manufacturer holding an unexpired patent, or exclusivity, or both.

Source Note:The provisions of this §229.2 adopted to be effective January 17, 2022, 47 TexReg 86.