Common use of Adverse Drug Events Clause in Contracts

Adverse Drug Events. The parties recognize that each may be required to submit information and file reports to various governmental agencies on compounds under clinical investigation, compounds proposed for marketing, or marketed drugs. In this regard, 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 drug. In addition, supplemental information must be provided on compounds at periodic intervals and adverse drug experiences must be reported at more frequent intervals depending on the severity of the experience. Consequently, each party agrees to: (a) provide to the other party for initial and/or periodic submission to government agencies significant information on the Licensed Product from preclinical laboratory, animal toxicology and pharmacology studies, as well as adverse drug experience reports from clinical trials and commercial experiences with the Licensed Product; (b) in connection with investigational use of the Licensed Product, report to the other party within five (5) business days of the initial receipt of a report of any unexpected Grade 3 or 4 adverse event or serious adverse event with the Licensed Product or concurrently with the reporting of such experience to a regulatory agency, if sooner than five (5) business days, or sooner if required for any party to comply with regulatory requirements; and (c) in connection with commercial use of the Licensed Product, report to the other party within five (5) business days of the initial receipt of a report of any adverse experience with the Licensed Product that is serious and unexpected or sooner if required for any party to comply with regulatory requirements. Serious adverse 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 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 United States labeling for the Licensed Product. Each party also agrees that if it contracts with a third party for research to be performed by such third party on the Licensed Product, 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, and such contracting party shall provide this information to the other party.

Adverse Drug Events. The parties recognize that each P&U, as the holder of the NDA, may be he required to submit information and file reports to various governmental agencies on compounds under clinical investigation, compounds proposed for marketing, or marketed drugs. In this regard, information 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 drug. In addition, supplemental information must be provided on compounds at periodic intervals and adverse drug experiences must be reported at more frequent intervals depending on the severity of the tile experience. Consequently, each party agrees toto follow P&U's standard operating procedures ("SOPs") for the reporting of adverse events in effect from to time to time and, to the extent not inconsistent with the SOPs, the following: (a) 12.1 provide to the other party for initial and/or periodic submission to government agencies significant information on the Licensed Product drug from preclinical laboratory, animal toxicology and pharmacology studies, as well as adverse drug experience reports from clinical trials and commercial experiences with the Licensed Productcompound; (b) 12.2 in connection with investigational use of the Licensed Productdrugs, report to the other party within five three (53) business days of the initial receipt of a report of any unexpected Grade 3 or 4 adverse event or serious adverse event experience with the Licensed Product or concurrently with the reporting of such experience to a regulatory agency, if sooner than five (5) business daysdrug, or sooner if required for any either party to comply with regulatory requirements; and (c) 12.3 in connection with commercial use of the Licensed Productmarketed drugs, report to the other party within five (5) business days of the initial receipt of a report of any adverse experience with the Licensed Product drug that is serious and unexpected or sooner if required for any either party to comply with regulatory requirements. Serious adverse experiences mean any experience that suggests a significant hazard, contraindication side-contraindication, side effect or precaution, or any experience that is fatal or life-life threatening, is permanently disabling, requires or prolongs inpatient hospitalization, or is a congenital anomaly, cancer cancer, or overdose. An unexpected adverse experience is one not identified in nature, specificity, severity or frequency in the current investigator brochure or of the United States U.S. labeling for the Licensed Productdrug. Each party also agrees that if it contracts with a third party Third Party for research to be performed by such third party Third Party on the Licensed Productdrug, that party agrees to require such third Third party to report to the contracting party the information set forth in subparagraphs (a)12.1, (b) 12.2 and (c) 12.3 above, and such contracting party shall provide this information to the other party.. -5- 100

Adverse Drug Events. The parties recognize that each may be required to submit information and file reports to various governmental agencies on compounds under clinical investigation, compounds proposed for marketing, or marketed drugs. In this regard, 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 drug. In addition, supplemental information must be provided on compounds at periodic intervals and adverse drug experiences must be reported at more frequent intervals depending on the severity of the experience. Consequently, each party agrees to: : (a) provide to the other party for initial and/or periodic submission to government agencies significant information on the Licensed Product Products from preclinical laboratory, animal toxicology and pharmacology studies, as well as adverse drug experience reports from clinical trials and commercial experiences with the Licensed Product; Products; (b) in connection with investigational use of the Licensed ProductProducts, report to the other party within five fifteen (515) business calendar days of the initial receipt of a report of any related, unexpected Grade 3 or 4 adverse event or serious adverse event with the Licensed Product Products or concurrently with the reporting of such experience to a regulatory agency, if sooner than five fifteen (515) business calendar days, or sooner if required for any party to comply with regulatory requirements; and and (c) in connection with commercial use of the Licensed ProductProducts, report to the other party within five fifteen (515) business calendar days of the initial receipt of a report of any adverse experience with the Licensed Product Products that is serious and unexpected or sooner if required for any party to comply with regulatory requirements. Serious adverse 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 hospitalization, or is a congenital anomaly, cancer . Other important medical events may be considered serious if medical or overdosesurgical intervention is required to prevent one of the outcomes listed above. An unexpected adverse experience is one not identified in nature, specificity, severity or frequency in the current investigator brochure or the United States labeling for the Licensed ProductProducts. Each party also agrees that if it contracts with a third party Third Party for research to be performed by such third party Third Party on the Licensed ProductProducts, that party agrees to require such third party Third Party to report to the contracting party the information set forth in subparagraphs (a), (b) and (c) above, and such contracting party shall provide this information to the other party. This applies equally to the parties’ Affiliates, Sublicensees and Other Licensees. In any event, notwithstanding anything express or implied in this Agreement, the parties shall report to each other on safety data and safety information on a timetable and within a scope that is sufficient to allow both parties to satisfy their reporting obligations to Regulatory Authorities having jurisdiction over such party’s activities under this Agreement. If the foregoing paragraph does not provide for sufficiently broad or sufficiently rapid disclosures so as to allow for this, then the parties shall enter into a separate pharmacovigilance/safety agreement that does meet such standard. The parties shall work mutually and in good faith to finalize such agreement well in advance of both parties sponsoring human clinical trials of Licensed Product at the same time. If they are unable to agree on the details, then they shall engage a regulatory expert not affiliated with either company, and such person shall prepare the final protocol for the data exchange addressed by this Section, and this shall be the protocol that the parties shall use, and shall replace the first paragraph of this Section. The parties shall share 50:50 the fees of such expert. Both parties recognize that such a protocol might provide for electronic transfer of data (which may be in a then-standard format for such exchanges prevailing in the industry now or at the time), and for disclosure to occur more quickly than provided for in the foregoing paragraph. As of the Effective Date, each party shall maintain its own safety database. The parties shall discuss in good faith, and may mutually agree, for either party to maintain a single global safety database for Licensed Product. If they reach subsequent written agreement for such a single global safety database, then that agreement shall be the agreement that will be followed by the parties. Any such agreement will provide all relevant details as to operational and financial responsibilities for maintaining such database, as well as each parties’ rights to access, and to maintain a “shadow” copy of the global safety database. In addition, such agreement will provide for a cost sharing arrangement for such database. Each party shall have the right to report Confidential Information of the other party to the Regulatory Authority in the reporting party’s territory in furtherance of activities for which the reporting party is licensed under this Agreement.