Pinney Associates, Inc.

ALERRT

Providing analysis in the field of pharmaceuticals, namely, preparation of reports, statistical analysis, studies and ratings with regard to the labor, effort and resources required to achieve separation of ingredients contained in abuse-deterrent formulations and or new chemical entities with abuse-deterrent features; Management services in the field of drug development, namely, pharmaceutical drug development screening related to potential for abuse by various routes of drug administration of abuse-deterrent formulations and or new chemical entities with abuse-deterrent features;

ALERRT

Providing comparative analysis of pharmaceuticals, namely, preparation of reports, statistical analysis, studies and ratings comparing abuse-deterrent features of abuse-deterrent formulations and or new chemical entities with abuse-deterrent features with comparator products and similar prototype abuse-deterrent formulations; providing analysis in the field of pharmaceuticals, namely, preparation of reports, statistical analysis, studies and ratings with regard to the labor, effort and resources required to alter and or tamper with abuse-deterrent formulations and or new chemical entities with abuse-deterrent features; providing analysis in the field of pharmaceuticals, namely, preparation of reports, statistical analysis, studies and ratings with regard to the labor, effort and resources required to alter by means of tampering abuse-deterrent formulations and or new chemical entities with abuse-deterrent features;Regulatory compliance consulting services in the field of abuse-deterrent formulations and or new chemical entities with abuse-deterrent features to ensure compliance with government standards concerning labeling, advertising and marketing, risk management and strategic communications, namely, translation of information to regulatory agencies;Consulting services in the field of pharmaceuticals, namely, quantitative assessment of drug tamperability and manipulation as it relates to abuse by various routes of drug administration; scientific and medical research and development related to pharmaceuticals formulated for abuse-deterrent applications and the abuse and diversion of pharmaceutical preparations; contract research services, namely, laboratory in vitro assessment as it relates to Food and Drug Administration Category 1 studies in the field of the alteration and tampering of abuse-deterrent formulations and or new chemical entities with abuse-deterrent features; quality and safety management services, namely, evaluation and scientific analysis concerning the physical and chemical properties of abuse-deterrent formulations and or new chemical entities with abuse-deterrent features; product development consultation, namely, assessment and analysis of abuse-deterrent formulations and or new chemical entities with abuse-deterrent features as it relates to labor, effort and resources required to manipulate and alter abuse-deterrent formulations and or new chemical entities with abuse-deterrent features;