Rare Pediatric Disease definition

Rare Pediatric Disease means a disease that meets each of the following criteria: (A) The disease is a serious or life-threatening disease in which the serious or life-threatening manifestations primarily affect individuals aged from birth to 18 years, including age groups often called neonates, infants, children, and adolescents; (B) The disease is a rare disease or condition, within the meaning of 21 USC § 360bb.
Rare Pediatric Disease means rare pediatric disease as defined in Section 529(a)(3) of the FFDCA.
Rare Pediatric Disease means rare pediatric disease as defined in Section 529(a)(3) of the FFDCA. (mm) “Representative” means, with respect to a particular Person, any director, officer, manager, employee, agent, consultant, advisor, accountant, financial advisor, legal counsel, or other representative of that Person. (nn) “SEC” has the meeting set forth in Section 5.3. (oo) “Tax” or “Taxes” means [***]. (pp) “Third Party” means any Person other than a Party and such Party’s Affiliates.

Examples of Rare Pediatric Disease in a sentence

  • Letterhead] May 8, 2024 [***] Re: NDA 218709 – Transfer of Rare Pediatric Disease Priority Review Voucher PRV NDA 218709 (the “Voucher”) Dear Sir or Madam: Reference is made to the above-referenced NDA approval letter dated April 26, 2024 reflecting the grant of the Voucher to X4 Pharmaceuticals, Inc.

  • Seller shall, and shall cause its Affiliates and each of their respective successors in interest and assigns to, within the Marketing Period, Market in the United States the Rare Pediatric Disease product for which the Priority Review Voucher was awarded under applicable Legal Requirements to preclude the FDA from exercising its authority to revoke the Priority Review Voucher pursuant to Section 529(e)(1) of the FFDCA (the “Marketing Requirement”).

  • Letterhead] May 8, 2024 [***] [***] Re: Xolremdi (mavorixafor) capsules NDA 218709, SN:[●] Transfer of Rare Pediatric Disease Priority Review Voucher PRV NDA 218709 Dear [***]: Reference is made to the New Drug Application (NDA) 218709 approval letter dated April 26, 2024 (the “Approval Letter”) (Ref ID: 5371673) reflecting the grant of the Rare Pediatric Disease Priority Review Voucher PRV NDA 218709 (the “Voucher”) to X4 Pharmaceuticals, Inc.

  • Seller and its Affiliates have commenced, will commence, or Seller shall cause its Affiliates to commence, Marketing in the United States of the Rare Pediatric Disease product for which the Priority Review Voucher was awarded [***] period beginning on the date of the FDA Approval of such Rare Pediatric Disease product (such period, the “Marketing Period”).


More Definitions of Rare Pediatric Disease

Rare Pediatric Disease means a disease that meets each of the following criteria:

Related to Rare Pediatric Disease

  • Therapeutic diet means meals served that are soft, low-fat, low-sodium or controlled calorie.

  • inherited metabolic disease means a disease caused by an inherited abnormality of body chemistry for which testing is mandated by law;

  • Opioid antidote means any drug, regardless of dosage amount or method of administration, which has been approved by the United States Food and Drug Administration (FDA) for the treatment of an opioid overdose. “Opioid antidote” includes, but is not limited to, naloxone hydrochloride, in any dosage amount, which is administered through nasal spray or any other FDA-approved means or methods.

  • Biological diversity means the variability among living organisms from all sources including, inter alia, terrestrial, marine and other aquatic ecosystems and the ecological complexes of which they are part; this includes diversity within species, between species and of ecosystems.

  • muscular dystrophy means a group of hereditary genetic muscle disease that weakens the muscles that move the human body and persons with multiple dystrophy have incorrect and missing information in their genes, which prevents them from making the proteins they need for healthy muscles. It is characterised by progressive skeletal muscle weakness, defects in muscle proteins, and the death of muscle cells and tissue;

  • Diagnostic Product means In Vitro Diagnostics, In Vivo Diagnostic Agents and any product used for Diagnosis.

  • Phase III Clinical Trial means a large, controlled or uncontrolled Clinical Study that would satisfy the requirements of 21 CFR 312.21(c), intended to gather the additional information about effectiveness and safety that is needed to evaluate the overall benefit-risk relationship of the drug and to provide an adequate basis for physician labeling.

  • Phase II Clinical Trial means a controlled human clinical study that would satisfy the requirements of 21 CFR 312.21(b), conducted to study the effectiveness and establish the dose range of a Product for a particular Indication in patients with the disease or condition under study, including a Phase IIA Clinical Study or Phase IIB Clinical Study.

  • Collaboration Compound means any of the following: (a) FG-4592, (b) any HIF Compound (other than FG-4592) that is added to this Agreement pursuant to Section 3.6, and (c) any salts, esters, complexes, chelates, crystalline and amorphous morphic forms, pegylated forms, enantiomers (excluding regioisomers), prodrugs, solvates, metabolites and catabolites of any of the foregoing ((a) or (b)).

  • Development Milestone Event shall have the meaning set forth in Section 9.2(a).

  • Iatrogenic infertility means an impairment of fertility by surgery, radiation, chemotherapy, or other medical treatment affecting reproductive organs or processes.

  • Phase I Clinical Trial means a study in humans which provides for the first introduction into humans of a product, conducted in normal volunteers or patients to generate information on product safety, tolerability, pharmacological activity or pharmacokinetics, or otherwise consistent with the requirements of U.S. 21 C.F.R. §312.21(a) or its foreign equivalents.

  • Attack directed against any civilian population means a course of conduct involving the multiple commission of acts referred to in paragraph 1 against any civilian population, pursuant to or in furtherance of a State or organizational policy to commit such attack;