Product Information/Adverse Event Reporting. To the extent any Services performed by Consultant pursuant to this Agreement result in Consultant’s collection, receipt or other form of knowledge of any information about Company’s medicinal or biological product(s) (“Product(s)”), from any source, in any form, relating to a Medication Error, Product Adverse Events, Product Quality Complaints, and/or Pregnancy Information (“Reportable Information”), Consultant represents and warrants that it shall cooperate with Company as set

Product Information/Adverse Event Reporting. To the extent any Services performed by Consultant pursuant to this Agreement result in Consultant’s collection, receipt or other form of knowledge of any information about Company’s medicinal or biological product(s) (“Product(s)”), from any source, in any form, relating to a Medication Error, Product Adverse Events, Product Quality Complaints, and/or Pregnancy Information (“Reportable Information”), Consultant represents and warrants that it shall cooperate with Company as set forth in this

provision. Consultant shall preserve the original record of such Reportable Information and within one (1) business day of the day on which such Reportable Information was received or otherwise became known to Consultant, submit a copy of such records and information to Company: # identifying and providing full contact information for both the person receiving the Reportable Information and the Consultant personnel submitting it to Company; # stating the date on which the Reportable Information was received by Consultant, and # describing the Product(s) in question and the event underlying the Reportable Information, including identifying the subject thereof. For purposes of this Section, the capitalized terms used herein shall have the following definitions: # an “Adverse Event” is any undesirable event or experience associated with the use of Product(s) in humans, whether or not expected, and whether or not considered related to or caused by the Product(s), including, but not limited to, an event or experience that occurs in the course of the use of the Product(s) in professional medical practice, including without limitation, from overdose whether accidental or intentional, from abuse, from withdrawal, from a failure of expected pharmacological or biological therapeutic action of the Product(s); # a “Medication Error” is any preventable event that may cause or lead to inappropriate medication use or patient harm while the medication is in the control of the health care professional, patient, or consumer (whether related to professional medical practice, health care products, procedures, and systems including: prescribing, order communication, product labeling, packaging, and nomenclature, compounding, dispensing, distribution, administration, education, monitoring; and use of Product(s) or otherwise); # “Pregnancy Information” is any information pertaining to a patient’s experience with Product(s) during or affecting pregnancy and # a “Product Quality Complaint” is any expression of dissatisfaction with the quality of a Product(s) or a reported failure of Product(s) attributes or specifications.

forth in this provision. Consultant shall preserve the original record of such Reportable Information and within one (1) business day of the day on which such Reportable Information was received or otherwise became known to Consultant, submit a copy of such records and information to Company: # identifying and providing full contact information for both the person receiving the Reportable Information and the Consultant personnel submitting it to Company; # stating the date on which the Reportable Information was received by Consultant, and # describing the Product(s) in question and the event underlying the Reportable Information, including identifying the subject thereof. For purposes of this Section, the capitalized terms used herein shall have the following definitions: # an “Adverse Event” is any undesirable event or experience associated with the use of Product(s) in humans, whether or not expected, and whether or not considered related to or caused by the Product(s), including, but not limited to, an event or experience that occurs in the course of the use of the Product(s) in professional medical practice, including without limitation, from overdose whether accidental or intentional, from abuse, from withdrawal, from a failure of expected pharmacological or biological therapeutic action of the Product(s); # a “Medication Error” is any preventable event that may cause or lead to inappropriate medication use or patient harm while the medication is in the control of the health care professional, patient, or consumer (whether related to professional medical practice, health care products, procedures, and systems including: prescribing, order communication, product labeling, packaging, and nomenclature, compounding, dispensing, distribution, administration, education, monitoring; and use of Product(s) or otherwise); # “Pregnancy Information” is any information pertaining to a patient’s experience with Product(s) during or affecting pregnancy and # a “Product Quality Complaint” is any expression of dissatisfaction with the quality of a Product(s) or a reported failure of Product(s) attributes or specifications.