Common use of Safety Information Clause in Contracts

Safety Information. The safeguarding of human subjects participating in clinical trials and patients who use devices or take investigational or licensed medicinal products, certain consumer healthcare products, vaccines, or biological products (the foregoing collectively referred to as the “Products”) is of paramount importance. Products would also include blinded, placebo, or control agents used in clinical studies. Therefore, the Parties require a framework for management of Human Safety Information. The framework includes, but is not limited to: · Safety reviews of Products to evaluate emergent safety data · Creation of appropriate committees and safety departments to proactively address human safety throughout Product development · Reporting of Human Safety Information to safety departments in a timely fashion. This includes any information relating to human health and/or wellbeing arising following exposure of humans to products including reports of drug abuse or overdose, reports of drug interaction, or information received as part of product complaints · Animals should be used in research only when required by regulatory authorities or where there are no alternatives through adherence to the “3R” Principles—reducing the Confidential treatment has been requested with respect to portions of this agreement as indicated by “[***]” and such confidential portions have been deleted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. number of animals used, replacing animals with non-animal methods whenever possible and refining the research techniques used. In addition, the Parties include two more R’s: Responsibility and Respect for animals involved in animal research. · The Parties believe in using the highest standards for the humane care and treatment of all animals used in research, development and testing, including adherence to the principles (listed below), and all applicable legal and regulatory requirements, with a default to which ever is more stringent. · Access to species appropriate food and water · Access to species specific housing, including species appropriate temperature and humidity levels · Access to humane care and a program of veterinary care · Animal housing that minimizes the development of abnormal behaviors and allows for normal species specific behavior, · Adherence to principles of replacement, reduction and refinement in the design of in vivo studies · Study design reviewed by institutional ethical review panel Commitment to minimizing pain and distress during in vivo studies · Work performed by appropriately trained staff · No Great Apes should be used for research

Safety Information. The safeguarding of human subjects participating in clinical trials and patients who use devices or take investigational or licensed medicinal products, certain consumer healthcare products, vaccines, or biological products (the foregoing collectively referred to as the “Products”) is of paramount importance. Products would also include blinded, placebo, or control agents used in clinical studies. Therefore, the Parties require a framework for management of Human Safety Information. The framework includes, but is not limited to: · Safety reviews of Products to evaluate emergent safety data · Creation of appropriate committees and safety departments to proactively address human safety throughout Product development · Reporting of Human Safety Information to safety departments in a timely fashion. This includes any information relating to human health and/or wellbeing arising following exposure of humans to products including reports of drug abuse or overdose, reports of drug interaction, or information received as part of product complaints · Animals should be used in research only when required by regulatory authorities or where there are no alternatives through adherence to the “3R” Principles—reducing the Confidential treatment has been requested with respect to portions of this agreement as indicated by “[***]” and such confidential portions have been deleted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. number of animals used, replacing animals with non-animal methods whenever possible and refining the research techniques used. In addition, the Parties include two more R’s: Responsibility and Respect for animals involved in animal research. · The Parties believe in using the highest standards for the humane care and treatment of all animals used in research, development and testing, including adherence to the principles (listed below), and all applicable legal and regulatory requirements, with a default to which ever is more stringent. · Access to species appropriate food and water · Access to species specific housing, including species appropriate temperature and humidity levels · Access to humane care and a program of veterinary care · Animal housing that minimizes the development of abnormal behaviors behaviours and allows for normal species specific behaviorbehaviour, · Adherence to principles of replacement, reduction and refinement in the design of in vivo studies · Study design reviewed by institutional ethical review panel · Commitment to minimizing pain and distress during in vivo studies · Work performed by appropriately trained staff · No Great Apes should be used for research