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. 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. KKC wishes, and MEI hereby consents, to create a Compassionate Use program (as defined below). Notwithstanding anything to the contrary in the Original Agreement and without limiting Section 2(a) of this Termination Agreement, during the time period starting from the Termination Effective Date and ending on the earlier of (a) the date of completion for Compassionate Use (as defined below) or (b) November 30, 2027 (“Compassionate Use End Date”), MEI hereby grants to KKC an non-exclusive and royalty-free license under the MEI Technology to Package, have Packaged, transfer, have transferred and use Compound and Product in the Field to the extent necessary for the Compassionate Use. Upon KKC’s reasonable request, MEI shall provide KKC with information in relation to the Product set forth in Exhibit C
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.
