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Privacy Policy

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PURPOSE

This Privacy Policy ("Policy") describes how KeyMay LifeSciences Pvt Ltd ("KeyMay", "we", "us", or "our") collects, uses, protects, and discloses Personal Information. This Policy is designed to comply with applicable privacy laws, including the Health Insurance Portability and Accountability Act (HIPAA), the California Consumer Privacy Act (CCPA), and FDA regulations (21 CFR Part 11) where applicable to our operations in the United States and globally.

SCOPE AND APPLICABILITY

This Policy applies to Personal Information we collect when we provide Clinical Research Organization (CRO) services to Clients, engage with prospective Clients, employees, investigators, and website visitors. It applies to data collected via our website (www.keymaylife.com) and through our clinical data management systems.

WHAT PERSONAL INFORMATION DO WE COLLECT?

As a full-service CRO, we collect Personal Information to facilitate clinical trials and business operations. Categories of data subjects include:

• Employees & Candidates: Name, contact details, SSN/Tax ID, background checks, and professional qualifications for employment purposes.
• Clinical Site Staff & Investigators: Name, CVs, medical licenses, financial disclosures (for FDA 1572 forms), and contact information to assess suitability for clinical trials.
• Trial Participants: KeyMay primarily processes De-Identified or Pseudonymized health data (Key-Coded) in accordance with HIPAA Privacy Rule and Good Clinical Practice (GCP). We generally do not hold direct identifiers of trial subjects unless required for specific pharmacovigilance or safety reporting.
• Website Visitors: IP address, browser type, and contact details voluntarily submitted via forms for marketing or inquiry purposes.

LEGAL BASIS FOR PROCESSING (US & GLOBAL CONTEXT)

We process Personal Information based on the following grounds:

• Contractual Performance: To fulfill our obligations under Master Services Agreements (MSAs) with Sponsors.
• Legal Obligation: To comply with FDA, EMA, and other regulatory authority requirements for clinical trial data integrity and safety reporting.
• Legitimate Business Interests: For fraud prevention, network security, and improving our services.
• Consent: Where required (e.g., for CCPA consumer requests or direct marketing), we obtain explicit consent.

HIPAA & PROTECTED HEALTH INFORMATION (PHI)

When acting as a Business Associate to covered entities (e.g., hospitals, clinics), KeyMay complies with the HIPAA Security and Privacy Rules. We implement administrative, physical, and technical safeguards to ensure the confidentiality, integrity, and availability of Electronic Protected Health Information (ePHI). We do not sell PHI or use it for marketing purposes.

CALIFORNIA RESIDENTS (CCPA RIGHTS)

Under the CCPA, California residents have specific rights regarding their Personal Information:

• Right to Know: You may request details about the categories and specific pieces of Personal Information we have collected.
• Right to Delete: You may request the deletion of your Personal Information, subject to certain exceptions (e.g., legal retention requirements for clinical data).
• Right to Opt-Out: We do not sell your personal data. However, you have the right to opt-out of the sale of personal information if our practices change.
• Non-Discrimination: We will not discriminate against you for exercising your CCPA rights.

To exercise these rights, please contact us at info@keymaylife.com.

DATA RETENTION

We retain Personal Information only as long as necessary. For clinical trial data, retention periods are dictated by regulatory requirements (e.g., 21 CFR Part 11 requires retention for specific periods after marketing approval). Non-clinical data is retained according to our corporate records management policy.

INTERNATIONAL DATA TRANSFERS

KeyMay operates globally. Personal Information may be transferred to our headquarters in India or other locations. We ensure appropriate safeguards are in place, such as Standard Contractual Clauses (SCCs) or adherence to Data Privacy Frameworks, to protect data transferred across borders.

SECURITY MEASURES

We utilize enterprise-grade security including AES-256 encryption for data at rest and TLS 1.3 for data in transit. Access to personal data is restricted based on the principle of least privilege and is protected by Multi-Factor Authentication (MFA).

CONTACT US

If you have questions about this Policy or wish to exercise your data privacy rights, please contact our Privacy Officer:

KeyMay LifeSciences Pvt Ltd
Crystal Corner, 150 Feet Ring Road
Rajkot, Gujarat 360006, India
Email: info@keymaylife.com

Last Updated: 2025

Terms of Use

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Last Updated: January 2025

Welcome to the website of KeyMay LifeSciences Pvt Ltd ("KeyMay", "we", "us", or "our"). By accessing or using our website (www.keymaylife.com), you agree to comply with and be bound by the following Terms of Use. Please read them carefully. If you do not agree to these terms, you should not use or access this website.

1. ACCEPTANCE OF TERMS

By using this site, you acknowledge that you have read, understood, and agree to be bound by these Terms of Use and our Privacy Policy. These terms apply to all visitors, users, and others who access or use the Service.

2. NO MEDICAL ADVICE

The content provided on this website, including text, graphics, images, and other material, is for informational purposes only. Nothing on this website constitutes medical advice, diagnosis, or treatment. KeyMay is a Clinical Research Organization (CRO) providing B2B services to pharmaceutical and biotechnology companies. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition.

3. INTELLECTUAL PROPERTY RIGHTS

All content, features, and functionality on this website (including but not limited to software, code, algorithms, designs, text, and graphics) are the exclusive property of KeyMay LifeSciences Pvt Ltd and its licensors. They are protected by copyright, trademark, and other intellectual property laws of India, the United States, and foreign countries. You may not reproduce, distribute, modify, create derivative works of, publicly display, publicly perform, republish, download, store, or transmit any of the material on our website without our prior written consent.

4. USE OF THE SITE

You agree to use the site only for lawful purposes. You are prohibited from:

• Using the site in any way that violates any applicable federal, state, local, or international law or regulation.
• Attempting to gain unauthorized access to, interfere with, damage, or disrupt any parts of the website, the server on which the website is stored, or any server, computer, or database connected to the website.
• Introducing any viruses, trojan horses, worms, logic bombs, or other material that is malicious or technologically harmful.

5. DISCLAIMER OF WARRANTIES

Your use of the website is at your own risk. The website is provided on an "AS IS" and "AS AVAILABLE" basis, without any warranties of any kind, either express or implied. KeyMay makes no warranty or representation with respect to the completeness, security, reliability, quality, accuracy, or availability of the website.

6. LIMITATION OF LIABILITY

To the fullest extent provided by law, in no event will KeyMay LifeSciences Pvt Ltd, its affiliates, or their licensors, service providers, employees, agents, officers, or directors be liable for damages of any kind, under any legal theory, arising out of or in connection with your use, or inability to use, the website, any websites linked to it, or any content on the website.

7. THIRD-PARTY LINKS

Our website may contain links to third-party websites or services that are not owned or controlled by KeyMay. KeyMay has no control over, and assumes no responsibility for, the content, privacy policies, or practices of any third-party websites or services.

8. GOVERNING LAW AND JURISDICTION

All matters relating to the website and these Terms of Use shall be governed by and construed in accordance with the laws of India. Any legal suit, action, or proceeding arising out of, or related to, these Terms of Use or the website shall be instituted exclusively in the courts of Rajkot, Gujarat, India.

9. CHANGES TO TERMS

We reserve the right to withdraw or amend this website, and any service or material we provide on the website, in our sole discretion without notice. We may revise and update these Terms of Use from time to time. All changes are effective immediately when we post them.

10. CONTACT INFORMATION

To ask questions or comment about these Terms of Use, contact us at:

KeyMay LifeSciences Pvt Ltd
Crystal Corner, 150 Feet Ring Road
Rajkot, Gujarat 360006, India
Email: info@keymaylife.com

Code of Conduct

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1. A MESSAGE FROM LEADERSHIP

At KeyMay LifeSciences, our mission is to advance healthcare through rigorous, ethical, and innovative clinical research. This Code of Conduct outlines the principles that guide our decisions and actions. Every employee, contractor, and partner is expected to uphold these standards to ensure we maintain the trust of patients, clients, and regulators.

2. OUR CORE VALUES

• Integrity: We do the right thing, even when no one is watching.
• Patient Safety: The well-being of clinical trial participants is our primary concern.
• Quality: We are committed to excellence and accuracy in data generation.
• Innovation: We embrace technology to solve complex clinical challenges.

3. PATIENT SAFETY & ETHICAL RESEARCH

Our work directly impacts human lives. KeyMay is dedicated to protecting the rights, safety, and well-being of trial subjects.

• Good Clinical Practice (GCP): We strictly adhere to ICH-GCP guidelines, the Declaration of Helsinki, and local regulations (e.g., US FDA 21 CFR, EMA).
• Informed Consent: We ensure that the informed consent process is transparent, voluntary, and documented.
• Data Integrity: We follow the ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate) to ensure data reliability. Falsification or fabrication of data is strictly prohibited and grounds for immediate termination.

4. ANTI-BRIBERY & CORRUPTION

KeyMay has a zero-tolerance policy towards bribery and corruption.

• Kickbacks: We do not offer, promise, or accept anything of value to influence a business decision or government action.
• Healthcare Professionals (HCPs): Interactions with HCPs must be professional, legitimate, and transparent. Gifts or entertainment that could be perceived as an inducement are prohibited.
• Compliance: We comply with the US Foreign Corrupt Practices Act (FCPA), UK Bribery Act, and other applicable anti-corruption laws.

5. CONFLICTS OF INTEREST

Employees must avoid situations where personal interests conflict, or appear to conflict, with the interests of KeyMay or our clients. Any potential conflict must be disclosed immediately to the Compliance Officer.

6. CONFIDENTIALITY & DATA PRIVACY

We are guardians of sensitive information.

• Proprietary Information: Employees must protect KeyMay’s and our clients' intellectual property and trade secrets.
• Personal Data: We treat personal data, especially Protected Health Information (PHI), with the highest level of security in compliance with HIPAA, GDPR, and other privacy laws.

7. WORKPLACE ENVIRONMENT

KeyMay provides a safe, inclusive, and respectful workplace.

• Non-Discrimination: We do not tolerate discrimination based on race, color, religion, gender, age, national origin, disability, or sexual orientation.
• Harassment-Free: Sexual or physical harassment, bullying, and intimidation are strictly prohibited.
• Health & Safety: We are committed to providing a healthy and safe work environment for all employees and visitors.

8. REPORTING VIOLATIONS (WHISTLEBLOWING)

Employees are encouraged to report any suspected violations of this Code, the law, or company policies. KeyMay prohibits retaliation against anyone who reports a concern in good faith.

Reports can be made anonymously to the Compliance Officer or via our ethics hotline.

9. CONTACT INFORMATION

For questions regarding this Code of Conduct, please contact:

Compliance Department
KeyMay LifeSciences Pvt Ltd
Email: info@keymaylife.com