Common use of Procedures for Recording and Reporting AEs and SAEs Clause in Contracts

Procedures for Recording and Reporting AEs and SAEs. All adverse events spontaneously reported by the subject and/or in response to an open question from study personnel or revealed by observation, physical examination or other diagnostic procedures must be recorded in the source document and on the appropriate page of the case report form. Any clinically relevant deterioration in laboratory assessments or other clinical findings is considered an adverse event and must be recorded on the appropriate pages of the case report form. When possible, signs and symptoms indicating a common underlying pathology should be noted as one comprehensive event. All SAEs that occur during the course of the study, as defined by the protocol, must be reported by the Investigator to the Study Safety Officer by completing and transmitting the SAE Form within one working day from the point in time when the Investigator becomes aware of the SAE. In addition, all SAEs including all deaths, which occur up to and including 30 days after administration of the last dose of study drug, must be reported to the Study Safety Officer within one working day. All SAEs and deaths must be reported whether or not considered causally related to the study drug. SAE forms will be provided to the study site. The information collected will include a minimum of the following: subject number, a narrative description of the event, and an assessment by the Investigator as to the intensity of the event, and relatedness to study drug. Follow-up information on the SAE may be requested by the CRO, the Study Safety Officer or the Sponsor Medical Monitor. Contact information for reporting SAEs to the Study Safety Officer is provided on the SAE form. Study Safety Officer Contact Information PLEASE SEE SERIOUS ADVERSE EVENT REPORTING FORM FOR DETAILED REPORTING OF SAEs, INCLUDING CONTACT INFORMATION (e.g., FAX, EMAIL OR TELEPHONE CONTACT NUMBERS) It is the responsibility of the Investigator to promptly notify the Institutional Review Board (IRB)/Independent Ethics Committee (IEC) of all serious adverse drug reactions involving risk to human subjects in accordance with the requirements of the IRB/IEC. An unexpected event is one that is not reported in the Investigator’s Brochure. Planned hospital admissions or surgical procedures for an illness or disease that existed before the subject was enrolled in the trial or before study drug was given are not to be considered AEs unless they occur at a time other than the planned date. Fractures identified during the study are not to be recorded as AEs unless the patient is hospitalized, the fracture is complicated, or the Investigator considers the fracture to be unrelated to the patient’s underlying osteoporosis. All fractures will be identified and evaluated as part of the disease assessment and will be documented in the case report forms and source documents. For both serious and non-serious adverse events, the Investigator must determine the intensity of the event and the relationship of the event to study drug administration. Attachment 2, Attachment E-52 Intensity for each AE will be defined according to the following criteria: Intensity Definition Mild Awareness of sign or symptom, but easily tolerated. Moderate Discomfort enough to cause interference with normal daily activities. Severe Inability to perform normal daily activities If the intensity of an adverse event changes within a day, the maximum intensity should be recorded. If the intensity changes over a longer period of time, the changes should be recorded as separate events (having separate onset and stop dates for each intensity). Relationship to study drug administration will be determined by the Investigator according to the following criteria: Relationship Definition None No relationship between the event and the administration of study drug. The event is related to other etiologies, such as concomitant medications or subject’s clinical state. Unlikely The current state of knowledge indicates that a relationship to study drug is unlikely or the temporal relationship is such that study drug would not have had any reasonable association with the observed event. Possible A reaction that follows a plausible temporal sequence from administration of the study drug and follows a known response pattern to the suspected study drug. The reaction might have been produced by the subject’s clinical state or other modes of therapy administered to the subject. Probable A reaction that follows a plausible temporal sequence from administration of the study drug and follows a known response pattern to the suspected study drug. The reaction cannot be reasonably explained by the known characteristics of the subject’s clinical state or other modes of therapy administered to the subject. For the purpose of safety analyses, all AEs that are classified with a relationship to study medication administration of possible or probable will be considered treatment-related events. Attachment 2, Attachment E-53

Procedures for Recording and Reporting AEs and SAEs. All adverse events spontaneously reported by the subject and/or in response to an open question from study personnel or revealed by observation, physical examination or other diagnostic procedures must be recorded in the source document and on the appropriate page of the case report form. Any clinically relevant deterioration in laboratory assessments or other clinical findings is considered an adverse event and must be recorded on the appropriate pages of the case report form. When possible, signs and symptoms indicating a common underlying pathology should be noted as one comprehensive event. All SAEs that occur during the course of the study, as defined by the protocol, must be reported by the Investigator to the Study Safety Officer by completing and transmitting the SAE Form within one working day from the point in time when the Investigator becomes aware of the SAE. In addition, all SAEs including all deaths, which occur up to and including 30 days after administration of the last dose of study drug, must be reported to the Study Safety Officer within one working day. All SAEs and deaths must be reported whether or not considered causally related to the study drug. SAE forms will be provided to the study site. The information collected will include a minimum of the following: subject Subject number, a narrative description of the event, and an assessment by the Investigator as to the intensity of the event, and relatedness to study drug. Follow-up information on the SAE may be requested by the CRO, the Study Safety Officer or the Sponsor Medical Monitor. Contact information for reporting SAEs to the Study Safety Officer is provided on the SAE form. Study Safety Officer Contact Information PLEASE SEE SERIOUS ADVERSE EVENT REPORTING FORM FOR DETAILED REPORTING OF SAEs, INCLUDING CONTACT INFORMATION (e.g., FAX, EMAIL OR TELEPHONE CONTACT NUMBERS) It is the responsibility of the Investigator to promptly notify the Institutional Review Board (IRB)/Independent Ethics Committee (IEC) of all serious adverse drug reactions involving risk to human subjects in accordance with the requirements of the IRB/IEC. An unexpected event is one that is not reported in the Investigator’s Brochure. Planned hospital admissions or surgical procedures for an illness or disease that existed before the subject was enrolled in the trial or before study drug was given are not to be considered AEs unless they occur at a time other than the planned date. Fractures identified during the study are not to be recorded as AEs unless the patient subject is hospitalized, the fracture is complicated, or the Investigator considers the fracture to be unrelated to the patientsubject’s underlying osteoporosis. All fractures will be identified and evaluated as part of the disease assessment and will be documented in the case report forms and source documents. For both serious and non-serious adverse events, the Investigator must determine the intensity of the event and the relationship of the event to study drug administration. Attachment 2, Attachment E-52 Intensity for each AE will be defined according to the following criteria: Intensity Definition Mild Awareness of sign or symptom, but easily tolerated. Moderate Discomfort enough to cause interference with normal daily activities. Severe Inability to perform normal daily activities If the intensity of an adverse event changes within a day, the maximum intensity should be recorded. If the intensity changes over a longer period of time, the changes should be recorded as separate events (having separate onset and stop dates for each intensity). Relationship to study drug administration will be determined by the Investigator according to the following criteria: Relationship Definition None No relationship between the event and the administration of study drug. The event is related to other etiologies, such as concomitant medications or subject’s clinical state. Unlikely The current state of knowledge indicates that a relationship to study drug is unlikely or the temporal relationship is such that study drug would not have had any reasonable association with the observed event. Possible A reaction that follows a plausible temporal sequence from administration of the study drug and follows a known response pattern to the suspected study drug. The reaction might have been produced by the subject’s clinical state or other modes of therapy administered to the subject. Probable A reaction that follows a plausible temporal sequence from administration of the study drug and follows a known response pattern to the suspected study drug. The reaction cannot be reasonably explained by the known characteristics of the subject’s clinical state or other modes of therapy administered to the subject. For the purpose of safety analyses, all AEs that are classified with a relationship to study medication administration of possible or probable will be considered treatment-related events. Attachment 2, Attachment E-53.

Procedures for Recording and Reporting AEs and SAEs. All adverse events spontaneously reported by the subject and/or in response to an open question from study personnel or revealed by observation, physical examination or other diagnostic procedures must be recorded in the source document and on the appropriate page of the case report form. Any clinically relevant deterioration in laboratory assessments or other clinical findings is considered an adverse event and must be recorded on the appropriate pages of the case report form. When possible, signs and symptoms indicating a common underlying pathology should be noted as one comprehensive event. All SAEs that occur during the course of the study, as defined by the protocol, must be reported by the Investigator to the Study Safety Officer by completing and transmitting the SAE Form within one working day from the point in time when the Investigator becomes aware of the SAE. In addition, all SAEs including all deaths, which occur up to and including 30 days after administration of the last dose of study drug, must be reported to the Study Safety Officer within one working day. All SAEs and deaths must be reported whether or not considered causally related to the study drug. SAE forms will be provided to the study site. The information collected will include a minimum of the following: subject Subject number, a narrative description of the event, and an assessment by the Investigator as to the intensity of the event, and relatedness to study drug. Follow-up information on the SAE may be requested by the CRO, the Study Safety Officer or the Sponsor Medical Monitor. Contact information for reporting SAEs to the Study Safety Officer is provided on the SAE form. Study Safety Officer Contact Information PLEASE SEE SERIOUS ADVERSE EVENT REPORTING FORM FOR DETAILED REPORTING OF SAEs, INCLUDING CONTACT INFORMATION (e.g., FAX, EMAIL OR TELEPHONE CONTACT NUMBERS) It is the responsibility of the Investigator to promptly notify the Institutional Review Board (IRB)/Independent Ethics Committee (IEC) of all serious adverse drug reactions involving risk to human subjects in accordance with the requirements of the IRB/IEC. An unexpected event is one that is not reported in the Investigator’s Brochure. Planned hospital admissions or surgical procedures for an illness or disease that existed before the subject was enrolled in the trial or before study drug was given are not to be considered AEs unless they occur at a time other than the planned date. Fractures identified during the study are not to be recorded as AEs unless the patient subject is hospitalized, the fracture is complicated, or the Investigator considers the fracture to be unrelated to the patientsubject’s underlying osteoporosis. All fractures will be identified and evaluated as part of the disease assessment and will be documented in the case report forms and source documents. For both serious and non-serious adverse events, the Investigator must determine the intensity of the event and the relationship of the event to study drug administration. Attachment 2, Attachment E-52 Intensity for each AE will be defined according to the following criteria: Intensity Definition Mild Awareness of sign or symptom, but easily tolerated. Moderate Discomfort enough to cause interference with normal daily activities. Severe Inability to perform normal daily activities If the intensity of an adverse event changes within a day, the maximum intensity should be recorded. If the intensity changes over a longer period of time, the changes should be recorded as separate events (having separate onset and stop dates for each intensity). Relationship to study drug administration will be determined by the Investigator according to the following criteria: Relationship Definition None No relationship between the event and the administration of study drug. The event is related to other etiologies, such as concomitant medications or subject’s clinical state. Unlikely The current state of knowledge indicates that a relationship to study drug is unlikely or the temporal relationship is such that study drug would not have had any reasonable association with the observed event. Possible A reaction that follows a plausible temporal sequence from administration of the study drug and follows a known response pattern to the suspected study drug. The reaction might have been produced by the subject’s clinical state or other modes of therapy administered to the subject. Probable A reaction that follows a plausible temporal sequence from administration of the study drug and follows a known response pattern to the suspected study drug. The reaction cannot be reasonably explained by the known characteristics of the subject’s clinical state or other modes of therapy administered to the subject. For the purpose of safety analyses, all AEs that are classified with a relationship to study medication administration of possible or probable will be considered treatment-related events. Attachment 2, Attachment E-53from

Procedures for Recording and Reporting AEs and SAEs. All adverse events spontaneously reported by the subject and/or in response to an open question from study personnel or revealed by observation, physical examination or other diagnostic procedures must be recorded in the source document and on the appropriate page of the case report form. Any clinically relevant deterioration in laboratory assessments or other clinical findings is considered an adverse event and must be recorded on the appropriate pages of the case report form. When possible, signs and symptoms indicating a common underlying pathology should be noted as one comprehensive event. All SAEs that occur during the course of the study, as defined by the protocol, must be reported by the Investigator to the Study Safety Officer by completing and transmitting the SAE Form within one working day from the point in time when the Investigator becomes aware of the SAE. In addition, all SAEs including all deaths, which occur up to and including 30 days after administration of the last dose of study drug, must be reported to the Study Safety Officer within one working day. All SAEs and deaths must be reported Radius Health, Inc. Confidential whether or not considered causally related to the study drug. SAE forms will be provided to the study site. The information collected will include a minimum of the following: subject Subject number, a narrative description of the event, and an assessment by the Investigator as to the intensity of the event, and relatedness to study drug. Follow-up information on the SAE may be requested by the CRO, the Study Safety Officer or the Sponsor Medical Monitor. Contact information for reporting SAEs to the Study Safety Officer is provided on the SAE form. Study Safety Officer Contact Information PLEASE SEE SERIOUS ADVERSE EVENT REPORTING FORM FOR DETAILED REPORTING OF SAEs, INCLUDING CONTACT INFORMATION (e.g., FAX, EMAIL OR TELEPHONE CONTACT NUMBERS) It is the responsibility of the Investigator to promptly notify the Institutional Review Board (IRB)/Independent Ethics Committee (IEC) of all serious adverse drug reactions involving risk to human subjects in accordance with the requirements of the IRB/IEC. An unexpected event is one that is not reported in the Investigator’s Brochure. Planned hospital admissions or surgical procedures for an illness or disease that existed before the subject was enrolled in the trial or before study drug was given are not to be considered AEs unless they occur at a time other than the planned date. Fractures identified during the study are not to be recorded as AEs unless the patient subject is hospitalized, the fracture is complicated, or the Investigator considers the fracture to be unrelated to the patientsubject’s underlying osteoporosis. All fractures will be identified and evaluated as part of the disease assessment and will be documented in the case report forms and source documents. For both serious and non-serious adverse events, the Investigator must determine the intensity of the event and the relationship of the event to study drug administration. Attachment 2, Attachment E-52 Intensity for each AE will be defined according to the following criteria: Intensity Definition Mild Awareness of sign or symptom, but easily tolerated. Moderate Discomfort enough to cause interference with normal daily activities. Severe Inability to perform normal daily activities If the intensity of an adverse event changes within a day, the maximum intensity should be recorded. If the intensity changes over a longer period of time, the changes should be recorded as separate events (having separate onset and stop dates for each intensity). Relationship to study drug administration will be determined by the Investigator according to the following criteria: Relationship Definition None No relationship between the event and the administration of study drug. The event is related to other etiologies, such as concomitant medications or subject’s clinical state. Unlikely The current state of knowledge indicates that a relationship to study drug is unlikely or the temporal relationship is such that study drug would not have had any reasonable association with the observed event. Possible A reaction that follows a plausible temporal sequence from administration of the study drug and follows a known response pattern to the suspected study drug. The reaction might have Radius Health, Inc. Confidential been produced by the subject’s clinical state or other modes of therapy administered to the subject. Probable A reaction that follows a plausible temporal sequence from administration of the study drug and follows a known response pattern to the suspected study drug. The reaction cannot be reasonably explained by the known characteristics of the subject’s clinical state or other modes of therapy administered to the subject. For the purpose of safety analyses, all AEs that are classified with a relationship to study medication administration of possible or probable will be considered treatment-related events. Attachment 2, Attachment E-53.