Data Exclusivity Period definition

Data Exclusivity Period means the period during which the FDA (or, in countries other than the United States, an equivalent regulatory agency) prohibits reference, without the consent of the owner of the regulatory submission materials, to the clinical and other data that is contained in such materials, and that is not published or publicly available outside of such submission.

Data Exclusivity Period means any period of clinical trial data or other regulatory exclusivity, together with any such periods under national implementations in the European Union of Article 10.1 of Directive 2001/EC/83 and all equivalents elsewhere in the Territory.

Data Exclusivity Period means, with respect to a Product in a country, the period during which the Regulatory Authority responsible for approval or authorization of the sale of drugs confers exclusive marketing rights or data exclusivity rights to the owner of the regulatory submission materials for such Product in such country, including the prohibition of reference, without the consent of the owner, to the clinical and other data that is contained in such regulatory submission materials.

Examples of Data Exclusivity Period in a sentence

• If there is no Valid Claim and a Data Exclusivity Period does not exist or has expired in such country, the royalties in such country will be reduced for the remainder of the Royalty Term to (***%**) of AEVI’s Net Sales.

• If during the Data Exclusivity Period with respect to a Product in a country, a generic version of such Product (or, with respect to orphan exclusivity, a product for use in the same indication) is approved by the applicable RegulatoryAuthority(ies) for sale in such country, then, notwithstanding the preceding sentence, the Data Exclusivity Period shall be deemed to have expired with respect to such Product in such country.

• Appropriate Data Exclusivity Period for Next Generation Biologic Molecules As scientific knowledge of underlying common mechanisms across diseases increases, next generation biologic molecules represent a key, and potential growing, component of competition in biologic markets and a valuable future source of therapy improvements for patients.

• Zuhn, BIO CEO Makes Case for 12-Year Data Exclusivity Period, Patent Docs weblog, Aug.

More Definitions of Data Exclusivity Period

Data Exclusivity Period means, with respect to a particular jurisdiction, the time period of legal protection and confidential treatment provided for clinical test data required to be submitted to a Regulatory Authority for such jurisdiction in order to demonstrate safety and efficacy of a new drug or biologic, and all similar protections on such clinical test data intended to prevent generic drug manufacturers or biosimilar manufacturers from relying on this data in their own Biosimilar applications.

Data Exclusivity Period means, with respect to any Licensed Product or Lilly Product, respectively, [**].

Data Exclusivity Period means any period of clinical trial data or other regulatory exclusivity, together with any such

Data Exclusivity Period means the period during which the FDA or KFDA (or, in countries other than the United States or South Korea, an equivalent regulatory agency) prohibits reference, without the consent of the owner of a BLA, to the clinical and other data that is contained in such BLA, and that is not published or publicly available outside of such BLA.

Data Exclusivity Period means the period, if any, during which the FDA, or other equivalent regulatory agency in the case of countries other than the United States, prohibits reference, for purposes of seeking Regulatory Approval, to clinical and other data contained in the Regulatory Approval package relating to a Drug Product, without the consent of the party holding the NDA or equivalent Regulatory Approval.

Data Exclusivity Period means the period of data exclusivity for a Product in a country that is granted when such Product first receives Product Regulatory Approval based on such Product’s status as a new chemical entity (and not based on a use or application of such Product, such as, for example, orphan drug exclusivity (unless a Product is only approved for orphan indications), new uses or pediatric exclusivity) that is, with respect to the United States, listed in the FDA’s Orange Book or outside the United States, under the national implementations of Article 10.1(a)(iii) of Directive 2001/EC/83 or other international equivalents. If during the Data Exclusivity Period with respect to a Product in a country, a generic version of such Product (or, with respect to orphan exclusivity, a product for use in the same indication) is approved by the applicable Regulatory Authority(ies) for sale in such country, then, notwithstanding the preceding sentence, the Data Exclusivity Period shall be deemed to have expired with respect to such Product in such country.

Data Exclusivity Period means the period, if any, during which the applicable Regulatory Authority (including the FDA and the NMPA) prohibits reference, without the consent of the owner of a BLA, to the clinical and other data that is contained in such BLA and that is not published or publicly available outside of such BLA.