15 reform measures in the future. Further, on December 7, 2023, the Biden administration announced an initiative to control the price of prescription drugs r through the use of march-in rights under the Bayh-Dole Act. On December 8, 2023, the National Institute of Standards and Technology published for comment a Draftf Interagency Guidance Framework for Considering the Exercise of March-In Rights which for the first time includes the price of a product as one factor an agency can use when deciding to exercise march-in rights. While march-in rights have not previously been exercised, it is uncertain if that will continue under the new framework. At the state level, legislatur t es have increasingly passed legislation and implemented regulations designed to control pharmaceutical product pricing, including price or patient reimbursement constraints, discounts, restrictions on certain product access and marketing cost disclosure and transparency measures, and, in some cases, designed to encourage importation from other countries and bulk purchasing. For example, on January 5, 2024, the FDA approved Florida’s Section 804 Importation Program (SIP) proposal to import certain drugs r from Canada for specific state healthcare programs. It is unclear how this program will be implemented, including which drugs r will be chosen, and whether it will be subj u ect to legal challenges in the United States or Canada. Other states have also subm u itted SIP proposals that are pending review by the FDA. U.S. Patent-T t er T m r Restor t atio t n and Marketin t g Exclusivity Depending upon the timing, duration and specifics of FDA approval of any future product candidates, some of our U.S. patents may be eligible for limited patent term extension under the Drug r Price Competition and Patent Term Restoration Act of 1984, commonly referred to as the Hatch-Waxman Act. The Hatch-Waxman Act permits restoration of the patent term of up to five years as compensation for patent term lost during product development and FDA regulatory r review process. Patent- term restoration, however, cannot extend the remaining term of a patent beyond a total of 14 years from the product’s approval date. The patent-term restoration period is generally one-half the time between the effe f ctive date of an IND and the subm u ission date of an NDA or BLA plus the time between the subm u ission date of an NDA or BLA and the approval of that application, except that the review period is reduced by any time during which the applicant failed to exercise due diligence. Only one patent applicable to an approved drug r is eligible for the extension and the application for the extension must be subm u itted prior to the expiration of the patent. The USPTO, in consultation with the FDA, reviews and approves the application for any patent term extension or restoration. In the future, we may apply for restoration of patent term for our currently owned or licensed patents to add patent life beyond its current expiration date, depending on the expected length of the clinical trials and other fact f ors involved in the filing of the relevant NDA or BLA. Market exclusivity provisions under the FDCA also can delay the subm u ission or the approval of certain applications. The FDCA provides a five-year period of non-patent marketing exclusivity within the United States to the first applicant to gain approval of a NDA for a new chemical entity. A drug r is a new chemical entity if the FDA has not previously approved any other new drug r containing the same active moiety, which is the molecule or ion responsible for the action of the drug r subs u tance. During the exclusivity period, the FDA may not accept for review an abbreviated new drug r application, or ANDA, or a 505(b)(2) NDA subm u itted by another company for another version of such drug r where the applicant does not own or have a legal right of reference to all the data required for approval. However, an application may be subm u itted afte f r four years if it contains a certific f ation of patent invalidity or non-infringement. The FDCA also provides three years of marketing exclusivity for a NDA, 505(b)(2) NDA or suppl u ement to an existing NDA if new clinical investigations, other than bioavailability studi t es, that were conducted or sponsored by the applicant are deemed by the FDA to be essential to the approval of the application, for example, new indications, dosages or strengths of an existing drug. r This three-year exclusivity covers only the conditions of use associated with the new clinical investigations and does not prohibit the FDA from approving ANDAs for drugs r containing the original active agent. Five-year and three-year exclusivity will not delay the subm u ission or approval of a full NDA. However, an applicant subm u itting a full NDA would be required to conduct or obtain a right of reference to all of the preclinical studi t es and adequate and well-controlled clinical trials necessary to demonstrate safety and effe f ctiveness. A reference biological product is granted twelve years of data exclusivity from the time of first licensure of the product, and the FDA will not accept an appl a ication for a biosimilar or interchangeable product based on the reference biological product until four years afte f r the date of first licensure of the reference product. “First licensure” typically means the initial date the particular product at issue was licensed in the United States. Date of first licensure does not include the date of licensure of (and a new period of exclusivity is not availabl a e for) a biological product if the licensure is for a suppl u ement for the biological product or for a subs u equent application by the same sponsor or manufact f ur t er of the biological product (or licensor, predecessor in interest, or other related entity) for a change (not including a modification to the structur t e of the biological product) that results in a new indication, route of administration, dosing schedule, dosage form, delivery r system, delivery r device or strength, or for a modification to the structur t e of the biological product that does not result in a change in safety, purity, or potency. Therefor f e, one must determine whether a new product includes a modification to the structur t e of a previously licensed product that results in a change in safety, purity, or potency to assess whether the licensure of the new product is a first licensure that triggers its own period of exclusivity. Whether a subs u equent application, if approved, warrants exclusivity as the “fir f st licensure” of a biological product is determined on a case-by-case basis with data subm u itted by the sponsor. Europe o an Union Drug Developm l ent As in the United States, medicinal products can be marketed only if a marketing authorization from the competent regulatory r agencies has been obtained.