Gilead registers clinical trials on clinical trial registries such as ClinicalTrials.gov (CTgov) as required by law and/or regulation, and in accordance with local requirements.

Gilead ensures that applicable clinical trials are registered on CTgov prior to the first patient being consented for the study. Registration prior to first patient consent is aligned with the International Committee of Medical Journal Editors (ICMJE) guidelines.

In addition, Gilead voluntarily registers Phase 1 studies in patients on CTgov. While we make every effort to provide information about Gilead's clinical trials, we recognize that some trials may not appear when there are legitimate reasons to exclude them. Examples include when there exists an agreement with a third party preventing Gilead from disclosing information about the trial; when necessary to comply with medical journal requirements; or due to considerations regarding patent application filings.

Gilead discloses summary clinical trial results, regardless of the outcome of the trial, as required by law and/or regulation. This includes Gilead-sponsored clinical trials that have been registered on publicly accessible clinical trial registries.

In the USA, summary results are posted on ClinicalTrials.gov (CTgov) no later than 12 months after the study's primary completion date for all Gilead-sponsored studies related to an approved product. A full definition of primary completion date can be found in the ClinicalTrials.gov study glossary.

For studies with a primary completion date prior to January 18, 2017 and related to products that have not yet been approved or are being investigated for new uses, Gilead posts summary results on ClinicalTrials.gov (CTgov) within 30 days of receiving regulatory approval. For studies with a primary completion date after January 18, 2017 and related to products that have not yet been approved or are being investigated for new uses, Gilead posts summary results within 12 months of primary completion date regardless of approval status.

In Europe (EU and EEA), summary results are posted on the European Union Clinical Trials Information System (EU CTIS) no later than 12 months after the trial Last Patient Last Visit Date (LPLV) for trials with adult participants and no later than six months after the trial LPLV for trials with pediatric participants regardless of approval status.

In countries outside the US and the EU, Gilead adheres to all mandatory results posting requirements in accordance with the country-specific guidelines for that region.

In certain rare circumstances, Gilead may delay disclosure of study results to protect intellectual property while also adhering to applicable laws.

Gilead releases, either by submitting to Regulatory Authorities or by posting directly to clinical trial registries, clinical documents as required by law and/or regulation. Gilead redacts confidential patient information and Gilead-specific sensitive information in order to ensure patient privacy and the protection of proprietary information. Any redaction of information or data is conducted in accordance with applicable law or regulatory guidance.

Gilead is a member of the Pharmaceutical Research and Manufacturers of America (PhRMA) & the European Federation of Pharmaceutical Industries and Associations (EFPIA) and prioritizes transparency initiatives to align with the PhRMA/EFPIA Principles for Responsible Clinical Trial Data Sharing.

Sharing of Clinical Trial Data

Gilead is committed to sharing clinical trial data with external medical experts and scientific researchers in the interest of advancing public health. As such, Gilead shares anonymized Individual Patient Data (IPD) upon request or as required by law and/or regulation.

Qualified external researchers may request IPD for studies of Gilead compounds approved in the US and the EU with a marketing authorization date on or after January 1, 2014 and publicly listed on ClinicalTrials.gov, the EU Clinical Trials Register , or European Union Clinical Trials Information System (EU CTIS). For studies of approved compounds or indications the IPD will be available for request six months after FDA and EMA approval, and 18 months after study completion. Such requests are at Gilead's discretion and dependent on the nature of the request, the merit of the research proposed, availability of the data and the intended use of the data. All requests in scope of our policy will be reviewed by a Data Sharing Review Panel. In accordance with the PhRMA/EFPIA Principles for Responsible Clinical Trial Data Sharing, the panel will consist of both internal Gilead employees as well as the following 2 external reviewers:

Dr John H. Powers

Professor of Clinical Medicine at the George Washington

Dr Dave Glidden

Professor of Epidemiology & Biostatistics UCSF

If the review panel agrees to the release of clinical data for research purposes, the requestor will be required to sign a data sharing agreement (DSA) in order to ensure protection of patient confidentiality prior to the release of any data. Upon execution of the DSA, Gilead will provide access to patient-level clinical trial analysis datasets in a secured analysis environment. Gilead will also make available the CSR synopsis, protocol and statistical analysis plan (SAP). If you would like additional information or would like to request access to Gilead clinical trial data for research purposes, please contact us at [email protected]

By submitting your research proposal, you agree to the following:

At Gilead Sciences, Inc., every decision made in delivering life-changing medicines is guided by the communities we serve and the wellbeing of both our patients and our environment. As Quality is the foundation of everything we do and everyone is responsible for upholding it, Gilead is committed to:

• Bringing safe and effective medicinal products and cell therapies to patients.
• Fostering a proactive risk management culture that safeguards data integrity, security, and compliance at every level of the organization.
• Maintaining an effective Quality Management System and ensuring it is suitable and adequate.
• Proactively complying with internal and applicable external requirements, including regulatory requirements, to ensure product quality, safety and effectiveness.
• Striving for continual improvement in our resources, processes, infrastructure, and work environment throughout the organization.
• Developing and engaging our people, partners, and suppliers to uphold our quality standards.

We believe that quality not only builds patient trust but is imperative to Gilead’s vision of creating a healthier world for all people.