Orphan Disease definition

Orphan Disease means (a) PD; (b) any disease or condition with a patient prevalence of (i) less than 200,000 in the United States, or (ii) not more than 5 in 10,000 in Europe, or (iii) less than 50,000 in Japan, in each case, whether or not a product intended to treat such disease or condition has achieved an orphan drug designation; or (c) any disease or condition for which a product intended to treat such disease or condition has received orphan drug designation from any Regulatory Authority in the United States, Europe or Japan. For clarity, Orphan Disease shall not include Alzheimer’s disease.
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Orphan Disease means a disease or condition for which in any given country a pharmaceutical treatment meets, as of the Effective Date, the definition of an “orphan product” or “orphan drug” for treatment of a “rare disease” under the U.S. Orphan Drug Act or Regulation No. 141/2000 of the European Parliament and of the Council of 16 December 1999 on orphan medicinal products, each as amended, or any successor laws or regulations thereto.
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Orphan Disease means a disease or condition for which in any given country a pharmaceutical treatment meets, as of the Effective
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Examples of Orphan Disease in a sentence

  • Genzyme shall have [***] days from receipt of such written notice (the “Notice Period”) to provide Voyager with a Future Collaboration Designation Notice with respect to such Voyager CNS Orphan Disease Program.

  • For clarity, Orphan Disease shall not include Alzheimer’s disease.

  • At any time during the Designation Period, if Genzyme is considering designating a Voyager CNS Orphan Disease Program as the Future Collaboration Program, Genzyme may request that Voyager prepare a proposed Collaboration R&D Plan for such potential CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”.

  • In addition, Genzyme shall have the right, exercisable in accordance with Section 2.2.4 (Designation of Future Collaboration Program), to designate any one Voyager CNS Orphan Disease Program as a Collaboration Program under this Agreement (the Future Collaboration Program).

  • During the Notice Period, Voyager shall provide Genzyme with such information regarding such Voyager CNS Orphan Disease Program as Genzyme may reasonably request, which information shall be Voyager Confidential Information for the purposes of Section 10 (Confidentiality and Publication).

  • Voyager shall not enter into a Third Party CNS Agreement with respect to such Voyager CNS Orphan Disease Program during the Notice Period.

  • If Genzyme does not deliver a Future Collaboration Designation Notice with respect to such Voyager CNS Orphan Disease Program during the Notice Period then, upon expiration of the Notice Period, Voyager shall have the right to enter into a Third Party CNS Agreement with respect to such Voyager CNS Orphan Disease Program for a period of [***].

  • Genzyme shall be entitled to provide input to Voyager through the DAC regarding Voyager’s ongoing and potential CNS Orphan Disease programs and related development activities to which the Future Collaboration Program designation right under this Section 2.2 (Future Collaboration Program) applies and Voyager shall consider Genzyme’s input in good faith.

  • If Genzyme then designates such Voyager CNS Orphan Disease Program as the Future Collaboration Program, then such revised draft Collaboration R&D Plan shall become the Collaboration R&D Plan for the Future Collaboration Program and such plan (the “Future Collaboration R&D Plan”) shall be attached as Schedule 4.3.1-5 hereto.

  • Genzyme shall have the right, exercisable in its sole discretion in accordance with Section 2.2.4 (Designation of Future Collaboration Program) to designate any one Voyager CNS Orphan Disease Program as a Collaboration Program to which the Split Territory Program Option applies (the “Future Collaboration Program”).


More Definitions of Orphan Disease

Orphan Disease means (a) PD; (b) any disease or condition with a patient prevalence of (i) less than 200,000 in the United States, or
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Orphan Disease means a condition that affects fewer than 200,000 people nationwide. This includes diseases such as cystic fibrosis, ▇▇▇ ▇▇▇▇▇▇’▇ disease, Tourette’s syndrome, Hamburger disease, Job syndrome, and acromegaly, or “gigantism.”
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Related to Orphan Disease

  • orphan means a child who has no surviving parent caring for him or her;

  • 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;

  • Disease means an alteration in the state of the body or of some of its organs, interrupting or disturbing the performance of the functions, and causing or threatening pain and weakness or physical or mental disorder and certified by a Medical Practitioner.

  • Diagnosis means the definition of the nature of the Client's disorder. When formulating the Diagnosis of Client, CONTRACTOR shall use the diagnostic codes and axes as specified in the most current edition of the DSM published by the American Psychiatric Association. DSM diagnoses will be recorded on all IRIS documents, as appropriate.

  • Rare disease means any disease or condition that affects less