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. 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. 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. 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. 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. The Parties agree that after the Effective Date of this License Agreement, Shionogi shall retain all rights to initiate and conduct a Compassionate Use or comparable early access program using Licensed Product Manufactured by Shionogi in all countries in the Territory. Once Licensed Product manufactured by a Sublicensee (including Licensed Product from the initial validation batch) can be used for such purposes under applicable laws and regulations, the conduct of Compassionate Use or comparable early access programs shall be transitioned to GARDP and/or applicable Sublicensee(s) for the Territory; provided that Shionogi may, in coordination with GARDP, choose to continue to conduct Compassionate Use or comparable early access programs for one or more countries in the Territory. Notwithstanding the foregoing, Shionogi and GARDP may agree on a case-by-case basis on an alternative approach for one or more countries in the Territory taking into account relevant criteria, such as the sustainable availability of sufficient quantities of Licensed Product for the applicable country(ies) (Manufactured by Shionogi), the agreement of Sublicensees to conduct such activities, and relevant regulatory considerations.
Compassionate Use. 36 11.5 Bayer Acquisition or Merger ................................... 36
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. 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.
