Common use of Adverse Drug Experiences Clause in Contracts

Adverse Drug Experiences. The Parties recognize that ------------------------ the holder of a Drug Approval Application may be required to submit information and file reports to various governmental agencies on Collaboration Products under clinical investigation, Collaboration Products proposed for marketing, or marketed Collaboration Products. Information must be submitted at the time of initial filing for investigational use in humans and at the time of a request for market approval of a new Collaboration Product. In addition, supplemental information must be provided on Collaboration Products at periodic intervals and adverse drug experiences must be reported at more frequent intervals depending on the severity of the experience and whether or not the event is unexpected. Consequently, each Party agrees to: (a) Provide to the other for initial and/or periodic submission to government agencies significant information on the Collaboration Product from preclinical laboratory, animal toxicology and pharmacology studies, as well as adverse drug experience reports from clinical trials and commercial experiences with the Collaboration Product; (b) In connection with investigational Collaboration Products, report to the other within three (3) days of the initial receipt of a report of any unexpected or serious experience with the drug, if required for either Party to comply with regulatory requirements; and (c) In connection with marketed Collaboration Products, report to the other within five (5) business days of the initial receipt of a report of any adverse experience with the drug that is serious and unexpected or sooner if required for either Party to comply with regulatory requirements. Serious adverse experience means any experience that suggests a significant hazard, contraindication, side effect or precaution, or any experience that is fatal or life threatening, is permanently disabling, requires or prolongs inpatient hospitalization, or is a congenital anomaly, cancer, or overdose. An unexpected adverse experience is one not identified in nature, specificity, severity or frequency in the current investigator brochure or the U.S. labeling for the drug. Each Party also agrees that if it contracts with a Third Party for research to be performed by such Third Party on the drug, that Party agrees to require such Third Party to report to the contracting Party the information set forth in subparagraphs (a), (b), and (c) above. The Parties agree that at all times after the approval of any Drug Approval Application or equivalent thereof, ORTHO shall be responsible for collecting, collating and reporting to the appropriate regulatory authority all adverse drug experiences.

Adverse Drug Experiences. The Parties recognize that the ------------------------ the holder of a Drug Approval Application may be required to submit information and file reports to various governmental agencies on Collaboration Products under clinical investigation, Collaboration Products proposed for marketing, or marketed Collaboration Products. Information must be submitted at the time of initial filing for investigational use in humans and at the time of a request for market approval of a new Collaboration Product. In addition, supplemental information must be provided on Collaboration Products at periodic intervals and adverse drug experiences must be reported at more frequent intervals depending on the severity of the experience and whether or not the event is unexpected. Consequently, each Party agrees to: (a) Provide to the other for their use in making initial and/or periodic submission submissions to government agencies significant information on the Collaboration Product from preclinical laboratory, animal toxicology and pharmacology studies, as well as adverse drug experience reports from clinical trials and commercial experiences with the Collaboration Product; (b) In connection with investigational Collaboration ProductsCompounds, report to the other within three (3) days of the initial receipt of a report of any unexpected or serious experience with the drug, if required for either Party to comply with regulatory requirements; each party will also provide to the other within one (1) month, copies of any safety submission (e.g. IND expedited reports or annual reports) submitted to any regulatory agencies and (c) In connection with marketed Collaboration Products, report each party will send to the other within five one (51) business days of the initial receipt of a report month, copies of any adverse experience with the drug that is serious and unexpected single or sooner if required for either Party to comply periodic safety submissions filed with regulatory requirements. Serious adverse experience means any experience that suggests a significant hazardagencies, contraindicatione.g., side effect or precaution15 day expedited reports, or any experience that is fatal or life threateningannual updates, is permanently disabling, requires or prolongs inpatient hospitalization, or is a congenital anomaly, cancer, or overdose. An unexpected adverse experience is one not identified in nature, specificity, severity or frequency in the current investigator brochure or the U.S. labeling for the drug. Each Party also agrees that if etc. (d) If it contracts with a Third Party for research to be performed by such Third Party on the drug, that the contracting Party agrees to require such Third Party to report to the contracting Party the information set forth in subparagraphs (a), (b), and (c) above. The Parties agree that at all times after the approval of any Drug Approval Application or equivalent thereof, ORTHO shall be responsible for collecting, collating and reporting to the appropriate regulatory authority all adverse drug experiences.

Adverse Drug Experiences. The Parties recognize that ------------------------ SCHERING as the owner and holder of a Drug Approval Application Applications may be required to submit information and file reports to various governmental agencies on Collaboration Human Therapeutic Products under clinical investigation, Collaboration Human Therapeutic Products proposed for marketing, marketing or marketed Collaboration Human Therapeutic Products. Information must be submitted at the time of initial IND filing for investigational use in humans and at the time of a request for market approval Regulatory Approval of a new Collaboration Human Therapeutic Product. In addition, supplemental information must be provided on Collaboration Human Therapeutic Products at periodic intervals and adverse drug experiences must be reported at more frequent intervals depending on the severity of the experience and whether or not the event is unexpected. Consequently, each Party MYRIAD agrees tothat, except with respect to MYRIAD Products, it will: (a) Provide to the other SCHERING for initial and/or periodic submission to government agencies significant information on the Collaboration Product Human Therapeutic Products from preclinical laboratory, animal toxicology and pharmacology studies, as well as adverse drug experience reports from clinical trials and commercial experiences with the Collaboration Human Therapeutic Product; (b) In connection with investigational Collaboration Human Therapeutic Products, report to the other SCHERING within three (3) days of the initial receipt of a report of any unexpected or serious experience with the drug, if required for either Party SCHERING to comply with regulatory requirements; and (c) In connection with marketed Collaboration Human Therapeutic Products, report to the other SCHERING within five (5) business days Business Days of the initial receipt of a report of any adverse experience with the drug that is serious and unexpected or sooner if required for either Party SCHERING to comply with regulatory requirements. Serious adverse experience means experiences mean any experience that suggests a significant hazard, contraindication, side effect or precaution, or any experience that is fatal or life threatening, is permanently disabling, requires or prolongs inpatient impatient hospitalization, or is a congenital anomaly, cancer, or overdose. An unexpected adverse experience is one not identified in nature, specificity, severity or frequency in the current investigator brochure or the U.S. labeling for the drug. Each Party MYRIAD also agrees that if it contracts with a Third Party for research to be performed by such Third Party on the drug, that Party MYRIAD agrees to require such Third Party to report to the contracting Party SCHERING the information set forth in subparagraphs subparagraph (a), (b), and (c) above. The Parties agree that at all times after the approval of any Drug Approval Application or equivalent thereof, ORTHO shall be responsible for collecting, collating and reporting to the appropriate regulatory authority all adverse drug experiences.