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 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. 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. 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. Treating Physician Agreement REGARDING Pre-Approval Access/Compassionate Use of Entrectinib for Patients with Solid Tumors harboring a NTRK Gene Fusion or Patients with Non-Small Cell Lung Cancer (NSCLC) harboring a ROS1 Gene Fusion (AG40852) THIS AGREEMENT (hereinafter referred to as this “Agreement”) dated below is made by and between the following Parties: SPECIFICKÝ LÉČEBNÝ PROGRAM – smlouva s ošetřujícím lékařem VE VĚCI Specifický léčebný program přípravkem Entrectinib v léčbě pacientů se solidními tumory s fúzí genu NTRK nebo pacientů s nemalobuněčným plicním karcinomem (NSCLC) s fúzí genu ROS1 (AG40852) TATO SMLOUVA (dále jen „Smlouva“) ze dne uvedeného níže se uzavírá mezi následujícími Stranami: Klinika plicních nemocí a TBC, Fakultní nemocnice Brno, Jihlavská adresa pracoviště: Klinika plicních nemocí a TBC, Fakultní nemocnice 340/20, 625 00 Brno Brno, Jihlavská 340/20, 625 00 (Hereinafter known as “PHYSICIAN”) (dále jen „LÉKAŘ“) AND Fakultní nemocnice Brno A Fakultní nemocnice Brno with its registered office at Xxxxxxxxx 000/00, 000 00 Xxxx, XX Xx. 00000000, xxxxxxxxxxx by xxxx. XXXx. Xxxxxxxx Xxxxxx, Ph.X., Director se sídlem Xxxxxxxxx 000/00, 000 00 Xxxx, XXX: 65269705, zastoupená prof. MUDr. Xxxxxxxxxx Xxxxxxx, Ph.X., ředitelem (Hereinafter known as “INSTITUTION”) (dále jen “POSKYTOVATEL”) on the one hand na straně jedné AND XXXXX s.r.o. with its registered office at Xxxxxxxxxx 000/000x, Xxxxxx, 000 00 Praha 8, ID no. 49617052 (Hereinafter known as “ROCHE”) A ROCHE s.r.o. se sídlem Xxxxxxxxxx 000/000x, Xxxxxx, 000 00 Xxxxx 0, IČO: 49617052 (dále jen “ROCHE”) on the other hand na straně druhé CONTENTS OF SECTIONS 1. Responsibilities of PHYSICIAN and INSTITUTION 2. ROCHE Responsibilities 3. Confidentiality
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. 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.
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.
