Orphan Drug Designations definition

Orphan Drug Designations means (i) the Orphan Product Designation from the Department of Health and Human Services, Food and Drug Administration Office of Orphan Products Development for Cholic Acid, designated as of 07-18-2003, under the name “Cholbam” as a “drug for a rare disease or condition” for the treatment of inborn errors of cholesterol and bile acid synthesis and metabolism under the Orphan Drug Act, as amended, and implementing regulations at 21 C.F.R. Part 316, and (ii) the designation of Cholic Acid as an orphan medicinal product under Regulation (EC) No 141/2000 of the European Parliament and of the Council by the Commission of the European Communities (EU orphan designation number: EU/3/09/683) to Seller’s wholly-owned subsidiary, ASK Pharmaceuticals GmbH ▇▇▇▇▇▇▇▇▇▇▇▇▇▇ ▇▇, ▇-▇▇▇▇▇ ▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇▇▇, for the treatment of inborn errors of primary bile acid synthesis responsive to treatment with Cholic Acid.

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Orphan Drug Designations means an orphan product designation from the Department of Health and Human Services, Food and Drug Administration Office of Orphan

Orphan Drug Designations means an orphan product designation from the Department of Health and Human Services, Food and Drug Administration Office of Orphan Products Development for UDCA as the active pharmaceutical ingredient for treating an Indication under the Orphan Drug Act, as amended, and implementing regulations at 21 C.F.R. Part 316.

Examples of Orphan Drug Designations in a sentence

As soon as possible following the expiration or earlier termination of this Agreement, Celltech shall take all necessary steps to ensure expeditious assignment of all Marketing Authorizations and Orphan Drug Designations which are in Celltech's name to Orphan Medical.
As soon as possible following the expiration or earlier termination of this Agreement, Celltech shall take all necessary steps to ensure expeditious assignment of all Marketing Authorizations and Orphan Drug Designations which are in Celltech’s name to Orphan Medical.
LICENSEE will own all INDs, Orphan Drug Designations, BLAs and related documentation submitted to any Regulatory Authority and all Regulatory Approvals with respect to the Products.
Lumasiran has received both U.S. and EU Orphan Drug Designations, a Breakthrough Therapy Designation and pediatric rare disease designation from the U.S. Food and Drug Administration (FDA), and a Priority Medicines (PRIME) designation from the European Medicines Agency (EMA).
Biogen will own all INDs, Orphan Drug Designations, Marketing Applications and related documentation submitted to any Regulatory Authority and all Regulatory Approvals with respect to the Discovery Products.
As soon as possible following the expiration or earlier termination of this Agreement, UCB shall take all necessary steps to ensure expeditious assignment of all Marketing Authorizations and Orphan Drug Designations which are in UCB’s name to Jazz Pharmaceuticals.
ABI has provided to Atrix all information submitted to the FDA in connection with its request for the Orphan Drug Designations and all materials received from the FDA in relation thereto.
Relmada has received two FDA Orphan Drug Designations for mepivacaine, one each for “the treatment of painful HIV-associated neuropathy” and for “the management of postherpetic neuralgia,” or PHN.
Pursuant to the Transfer Plan Genmab will transfer to TenX (i) all INDs for a Product, (ii) the Orphan Drug Designations for a Product, and (iii) any pending clinical trial applications for a Product (taking into account the health and safety of the patients enrolled therein), in each case that are available to Genmab, and for which Genmab has the right to transfer, at TenX’s sole cost and expense.
Within ten days after the Effective Date, ABI shall submit a letter to the FDA with a copy to Atrix assigning all of its right, title and interest in and to the Orphan Drug Designations to Atrix, and shall take such other actions necessary or desirable to transfer ownership in the Orphan Drug Designations to Atrix in accordance with Applicable Laws, including 21 CFR Section 316.27.

More Definitions of Orphan Drug Designations

Orphan Drug Designations means the Oral Wart Orphan Drug Designation or the Behcet's Orphan Drug Designation or both, as the context requires.

Orphan Drug Designations means all orphan drug designations for Product that have been granted to Seller by Governmental Entities, including (a) the orphan drug designation, dated June 15, 2017, granted by the FDA to the Seller for Product for treatment of growth hormone deficiency and (b) the orphan drug designation, dated May 12, 2017, granted by the European Medicines Agency to the Seller for Product for treatment of growth hormone deficiency.