Orphan Designation definition

Orphan Designation means the designation of a drug as a drug for a rare disease or condition pursuant to Section 526 of the Act.

Split View

AI-Powered Contracts

Draft, Review & Redline at the Speed of AI

Get StartedBook a Demo

Orphan Designation means a special status granted, under the Orphan Drug Act, to a drug or biological product to treat a rare disease or condition,

Orphan Designation means the grant by FDA of a request for orphan-drug designation under Section 526 of the Act, as amended (or its successor regulation), for a drug for a particular Orphan Indication.

Examples of Orphan Designation in a sentence

• RUSH shall assist and cooperate with ACORDA in the submission of any letters or other documents to the FDA required or requested in connection with the change in ownership of the Rush Orphan Designation from RUSH to ACORDA.

• To the extent not previously assigned to ACORDA, RUSH hereby conveys, assigns and transfers to ACORDA, free and clear of all claims, liens and encumbrances and contractually imposed restrictions, all right, title and interest in and to the Rush Orphan Designation.

• OSIRIS grants to JCR, during the term of this Agreement, a right of first negotiation to obtain from OSIRIS the exclusive right, in the Territory, to develop, register, use, make, have made, import, export, offer to sell, sell and have sold Products for a use that has an Orphan Designation in the Territory.

• The European Medicines Authority, or the EMA, has granted anabasum Orphan Designation for both cystic fibrosis and systemic sclerosis.

• The United States Food and Drug Administration, or the FDA, has granted anabasum Orphan Designation as well as Fast Track Status for both cystic fibrosis and systemic sclerosis.

• For purposes of the Agreement, Orphan Designation shall mean that the FDA or other foreign regulatory body has granted the Company market exclusivity with respect to the Licensed Product.

• After the successful transfer of the Orphan Designation to Partner, except as expressly set out in this Agreement, Partner shall be solely responsible for compliance with and performance of any and all obligations related to upholding the Orphan Designation or orphan status in the Partner Territory.

• Promptly after the Closing (but in no event later than two (2) Business Days following the Closing), Seller shall file, or cause to be filed, with the FDA the Seller FDA Letter, the Americas 92425100 Buyer FDA Letter, the Seller Orphan Designation Letter and the Buyer Orphan Designation Letter and shall provide an as‑filed copy of each such letter to Buyer.

• Schedule 1(a) Marketing Materials Schedule 1(b) Product Trademark Schedule 2.1(a)(ii) Domain Names Schedule 4.3 Marketing Commitment Schedule 5.1(b) FDA NDA Letter Schedule 5.1(b) FDA NDA Letter Schedule 5.1(b) Orphan Designation Acceptance Letter Schedule 5.1(b) FDA IND Letter CONFIDENTIAL TREATMENT REQUESTED UNDER C.F.R. SECTIONS 200.80(b)(4), 200.83 AND 230.406.

• All rights to develop and commercialize Orphan Designation #10-3142 are now the responsibility of, Strongbridge US Inc.

More Definitions of Orphan Designation

Orphan Designation means any treatment of a disease which afflicts less than 50,000 patients per year in the Territory and /or the use in such patients and that meets the criteria for orphan designation application established by the governing health care authority in the Territory other than the Field.

Orphan Designation means the orphan designation EU/3/16/1778 granted by the European Commission on 18 November 2016.

Orphan Designation means orphan status provided to pharmaceuticals, biologics, medical devices and medical food intended for the safe and effective treatment, diagnosis or prevention of rare diseases/disorders meeting certain criteria in the United States specified in the Orphan Drug Act and FDA’s implementing regulations at 21 CFR Part 316, and including foreign equivalents thereof, including, criteria provided by the European Medicine’s Agency’s Committee for Orphan Medicinal Products (COMP), the Australian Government’s Department of Health, Therapeutic Goods Administration, and the Ministry of Health, Labour and Welfare of Japan.