Compassionate Use Clause Samples
The Compassionate Use clause allows for the use of an investigational drug or medical device outside of a clinical trial for patients with serious or life-threatening conditions who have no other treatment options. Typically, this clause outlines the criteria under which such access may be granted, such as regulatory approval, physician oversight, and patient eligibility requirements. Its core function is to provide a pathway for patients in critical need to access potentially life-saving therapies before they are fully approved, addressing urgent medical needs when standard treatments are unavailable or ineffective.
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Compassionate Use. The use of a Medicinal Product for an unapproved indication, in circumstances where a Party has supplied it for that use in response to a bona fide unsolicited request from a healthcare professional assuming responsibility for that use by their patient.
Compassionate Use. Bayer may make Product available non-commercially to patients on compassionate use grounds; provided, however, the quantity of Doses of Product per calendar year available on such grounds shall be determined by [...*...].
Compassionate Use. Promptly after the Pre-Registrational Meeting with the FDA, EMA, and PMDA for a particular Product (or in the case in which a Product is only being developed for the US or the EU, but not both, after the applicable FDA, EMA or PMDA Pre-Registrational Meeting) or at a time otherwise agreed by the Parties, the JRDC shall decide on a procedure for managing Product requests for compassionate use.
Compassionate Use. Compassionate use of the drug tested after the period of the study can be covered only if: • Insured give us written notice describing the drug or material for which coverage is requested; • Company agree to issue an endorsement to provide coverage in connection with the drug or material, in accordance with the terms, conditions and additional premiums determined by us; and • Insured accept such terms and conditions.
Compassionate Use. Unimed shall supply the Product on a compassionate use basis as requested for the treatment of Fanconi's Anemia. Upon execution of this Agreement, Syntex shall send a letter to the Fanconi's Anemia Society informing them that Unimed now owns the Registrations and that further inquiries and requests with respect to the Product should be directed to Unimed. In addition, Syntex shall forward all Compassionate Use requests to Unimed and send a letter to the inquirer informing the inquirer of the same. Unimed shall continue to fulfill this obligation regardless of whether the NDA Supplement is approved for so long as tablets are available; provided, however, that once tablets are available for commercial sale, Unimed may cease distribution under the Compassionate Use Program.
Compassionate Use. Promptly after the EOP2 Meeting with both the FDA and EMA for a particular Product (or in the case in which a Product is only being developed for the US or the EU, but not both, after the applicable FDA or EMA EOP2 Meeting), the Parties shall mutually agree on a procedure for managing Product requests for compassionate use.
Compassionate Use. 7 4.4 NDA...................................................... 7 4.5 NDA Supplement........................................... 7 4.6 Litigation............................................... 7 4.7 Infringement............................................. 7 4.8
Compassionate Use. Bayer may make Metabolic Program Drugs available non-commercially to patients on compassionate use grounds. If Bayer makes Metabolic Program Drugs available on such a basis, the Cost of Goods Sold associated with such drugs shall be subtracted from the Operating Income calculated for such drug.
Compassionate Use. In addition to Faulding's obligation to pursue Registration as provided in paragraph 5.1, Faulding shall also pursue opportunities to supply Formulated Product through Compassionate Use or other programs allowing sale of the Formulated Product in the Field in the Territory prior to Registration.
Compassionate Use. Prior to Regulatory Approval, if a patient, physician or other Person notifies Affimed or LLS that such Person would like to have established a program to accommodate requests for expanded access and individual patient (including emergency) use, as those terms are used by the U.S. Food and Drug Administration (“FDA”) (collectively, “Compassionate Use”) of the Product, then Affimed agrees to enter with LLS into good-faith discussions about possible ways to provide such Compassionate Use for AFM13. Notwithstanding the preceding sentence, Affimed shall have the authority to make the final decision with respect to any Compassionate Use of the Product. In the event of a Transfer Event, the documents providing for such transfer shall require the transferee to comply with the requirements of this Section 2.10.