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Clinical Trial Privacy Statement

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Revised: January 22, 2021

Prolacta Bioscience, Inc. is a life sciences company that develops specialty formulations made from human milk for the nutritional needs of premature infants in neonatal intensive care units (NICU). We believe that protecting the personal information of those we may interact with is vitally important. We believe that you should know what we do with your information, who we share it with, and the business reason for sharing.

Prolacta Bioscience, Inc. will not sell your personal information. We are the world’s leading hospital provider of 100% human milk-based nutritional products. We are dedicated to advancing the science of human milk, not selling personal information.

This “Privacy Policy” describes the privacy practices of Prolacta Bioscience, Inc. and all of our subsidiaries and affiliates (collectively, “Prolacta”, “we”, “us”, or “our”) and applies to the Prolacta.com website and all other sites owned by Prolacta and its subsidiaries. For ease of use,” when we refer to “Site or “Sites” we are referring to any and all of the Prolacta owned sites.

Prolacta Bioscience, Inc. (“Prolacta”, “we”, or the “company”) has certified that we comply with and adhere to the EU-U.S. Privacy Shield Framework Principles and the Swiss-U.S. Privacy Shield Framework as set forth by the U.S. Department of Commerce (collectively, the “Privacy Principles“) with respect to the collection, use, and retention of personal data that Prolacta in the US receives about participants of Prolacta-sponsored clinical trials (“Participants”) from the European Economic Area (“EEA”) or Switzerland (“Personal Data”). If there is a conflict between the terms in this Privacy Shield Statement and the Privacy Principles, the Privacy Principles shall govern.

This Privacy Shield Statement explains how Prolacta complies with the Privacy Principles in handling Personal Data. To learn more about the Privacy Shield and to view Prolacta’s Privacy Shield certifications, please visit www.privacyshield.gov.

To the extent our Participants are children who are below the age at which they may exercise their rights under applicable laws, this Privacy Shield Statement is intended to provide information to the Participants’ legal guardians, who may also exercise the Participants’ privacy rights and choices.

The Privacy Principles are:

  • Notice
  • Choice
  • Accountability for Onward Transfer
  • Security
  • Data Integrity and Purpose Limitation
  • Access
  • Recourse, Enforcement, and Liability

Scope of Privacy Shield Certification

Prolacta’s Privacy Shield certification and this Privacy Shield Statement apply to Personal Data – information that relates to Participants in the clinical trials that we sponsor in the EEA or Switzerland.

Prolacta’s Role in Processing Personal Data

Prolacta is a life sciences company that develops and manufactures standardized human milk-based nutritional products for premature infants. As part of our product development work, Prolacta sponsors clinical trials. When conducting clinical trials, Prolacta does not have direct contact with Participants. Instead, consistent with industry practice, Prolacta engages health care providers and other vendors (collective, the “Study Team”) to conduct clinical trials on Prolacta’s behalf. The health care providers are the Participants’ primary point of contact.

Notice

Prolacta notifies Participants about the collection, use, and disclosure of Personal Data in the Informed Consent Form (“ICF”) that Participants must sign to participate in the clinical trial. The Study Team provides the ICF to the Participants. Prolacta follows the laws and regulations in the EEA and Switzerland that govern the content and form of the ICF. In addition, relevant European regulators review and approve the ICF for each clinical trial.

Choice

Prolacta does not use Personal Data for purposes other than those described in the ICF for the relevant clinical trial. Typically, these purposes may include conducting the clinical trial, quality assurance, compliance with applicable legal and industry requirements, regulatory and commercial drug approval, adverse event reporting, future research, and other purposes set out in the ICF. We may also de-identify Personal Data and use the de-identified data for other purposes.

Prolacta does not share Personal Data with third parties for those parties’ own purposes, except as set out in the ICF and the clinical trial study protocol. Typically, the Personal Data may be disclosed (i) to government agencies and self-regulatory organizations in countries where the study is being conducted or where the study product (or drug) may be considered for approval, (ii) to independent auditors for the purposes of confirming participation in the study, monitoring Participants’ safety during the study, and monitoring the conduct of the study, (iii) when the disclosure is required by industry standards, law or legal process, (iv) in response to a valid request by law enforcement authorities, or (v) when Prolacta believes disclosure is necessary or appropriate either to prevent physical harm or financial loss, or in connection with an investigation of suspected or actual illegal activity. In these situations, Prolacta may disclose Personal Data without offering Participants a choice. Prolacta also reserves the right to transfer Personal Data in the event Prolacta sells, merges, or transfers all or a portion of our business or assets.

The ICF sets out additional choices Participants may have under laws and regulations that govern clinical trials, such as the choice to withdraw consent for further participation in a clinical trial.

Accountability for Onward Transfer of Personal Data

Prolacta and the Study Team may share Personal Data with third-party service providers that perform services on Prolacta’s behalf. Prolacta does not authorize these third parties to use or disclose the Personal Data except as necessary to perform services on Prolacta’s behalf or to comply with legal requirements. Prolacta maintains contracts with service providers restricting their access, use, and disclosure of Personal Data in compliance with the Privacy Principles, and requiring the providers to appropriately safeguard the privacy and security of Personal Data. Prolacta may be liable if these service providers fail to meet those obligations, and Prolacta is responsible for the event giving rise to the damage.

If Prolacta is aware that a third party that receives Personal Data subject to this Privacy Shield Statement processes Personal Data in a way that is inconsistent with the Privacy Principles or is no longer capable of processing such Personal Data consistent with the Privacy Principles, Prolacta will take reasonable and appropriate steps to prevent or stop and remediate such processing.

Security

Prolacta takes reasonable and appropriate measures designed to protect Personal Data from loss, misuse, unauthorized access, disclosure, alteration, and destruction.

Data Integrity and Purpose Limitation

Prolacta limits the Personal Data we collect to the Personal Data that is relevant for the purposes for which it is being processed. Prolacta does not use Personal Data for purposes incompatible with the purposes for which it was collected. In addition, Prolacta takes reasonable steps to ensure that the Personal Data we process is reliable for its intended use and is accurate, complete, and current. Prolacta depends on the Study Team to provide accurate Personal Data to Prolacta and to correct and keep such Personal Data up to date.

Access

Participants have the right to request access to and correction of their Personal Data, as set out in the ICF. Participants should submit their request to the healthcare provider that is their point of contact for the clinical trial in which they participate. Because Prolacta’s access to Personal Data is generally limited to data that has been key-coded and does not identify the Participant, Prolacta does not have the ability to provide information in response to access requests. Instead, we direct the Participant to contact the Study Team directly to request access to their Personal Data. Prolacta or the Study Team may limit or deny access to Personal Data where providing such access is unreasonably burdensome or expensive under the circumstances, where the rights of other persons would be violated, or as otherwise permitted by the Privacy Principles, or laws or regulations that govern clinical trials.

Participants may also have the right to request deletion of certain data. However, Prolacta and the Study Team may retain data collected from the study to comply with applicable laws, for the purposes of future research, or as otherwise described in the ICF.

Recourse, Enforcement, and Liability

Prolacta has established procedures for periodically reviewing and verifying the accuracy of this Privacy Shield Statement, for verifying the company’s implementation of and compliance with the Privacy Principles, and for remedying any issues identified during such reviews. Prolacta conducts an annual self-assessment of its Personal Data practices to verify that the attestations and assertions Prolacta makes about our privacy practices are true, that Prolacta’s privacy practices have been implemented as represented, and that any identified issues have been remedied. Prolacta personnel with access to the Personal Data covered by this policy are responsible for conducting themselves in accordance with the policies described in this Privacy Shield Statement, the failure of which may result in disciplinary action up to and including termination.

In compliance with the Privacy Principles, Prolacta commits to resolve complaints about our collection or use of Personal Data. EEA and Swiss Participants with inquiries or complaints regarding our Privacy Shield Statement should first contact Prolacta at privacy@prolacta.com. Prolacta has further committed to refer unresolved Privacy Shield complaints to JAMS, an alternative dispute resolution provider located in the United States. If a Participant does not receive timely acknowledgment of their complaint from us, or if Prolacta has not addressed the complaint to the Participant’s satisfaction, the Participant may learn more information or file a complaint at https://www.jamsadr.com/eu-us-privacy-shield. The JAMS services are provided at no cost to Participants. If neither Prolacta nor JAMS resolves the complaint, a Participant may have the ability to engage in binding arbitration through the Privacy Shield Panel. Additional information on the arbitration process is available on the Privacy Shield website at www.privacyshield.gov.

U.S. Federal Trade Commission Jurisdiction

Prolacta’s commitments under the Privacy Principles are subject to the jurisdiction and the investigatory and enforcement authority of the U.S. Federal Trade Commission.

Required Disclosure

Prolacta may be required to disclose Personal Data in response to lawful requests by public authorities, including to meet national security or law enforcement requirements.

How to Contact Us

If you have any questions, comments, or concerns about this Privacy Shield Statement, please contact us at privacy@prolacta.com.

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