1. Introduction to Kindeva
Kindeva Drug Delivery is a global contract development and manufacturing organization (CDMO) focused on drug delivery products and services to pharmaceutical and biopharmaceutical customers. Our capabilities span the development and manufacture of complex drug and combination products, including sterile injectables, inhalation and transdermal drug delivery, supporting customers from early-stage development through clinical and commercial-scale manufacturing.
With more than 2,000 employees across 10 locations in the United States and the United Kingdom, Kindeva operates within a highly regulated industry where quality, reliability, integrity and responsible business practices are fundamental to our work and to the patients ultimately served by the products we help develop and manufacture.
2. Our KIND Values
Our KIND values guide how we work and the standards we set for ourselves. We expect our suppliers to understand these values and demonstrate the same underlying principles in how they work with Kindeva:
Kinetic – energy and momentum drive us forward. We value suppliers who are responsive, proactive and focused on achieving the best possible outcomes.
Innovation – challenging, simplifying and improving. We expect suppliers to look for opportunities to improve, solve problems and bring forward better ways of working.
Now – urgency and execution matter. We expect suppliers to take ownership, respond with appropriate urgency and follow through on commitments.
Delivery – focus on the important and achieve results. We expect suppliers to deliver what has been agreed, to the required quality and standards, and within agreed timelines.
These principles underpin the relationships we want to build with our suppliers: accountable, collaborative and focused on consistently delivering high standards. Our suppliers are an important part of our extended value chain and play a critical role in our ability to meet our commitments to customers and, ultimately, the patients who rely on the medicines we help manufacture.
We believe a robust, ethical, responsible and sustainable supply chain is fundamental to our success. We therefore seek to work with suppliers who share our commitment to quality, integrity, compliance, responsible business practices and continuous improvement.
These Supplier Guidelines set out the minimum standards and expectations for organizations supplying goods or services to Kindeva and form the foundation of how we expect our suppliers to work with us.
3. Questions, Reporting Concerns & Violations
Kindeva’s objective is to maintain honest, transparent and responsible business practices. Kindeva complies with all applicable laws, regulations and standards. Contractors, sub-contractors, consultants and suppliers (referred to as Suppliers), are expected to conduct themselves in line with the Supplier Code of Conduct (also referred to as the “Code”) and to uphold the Kindeva “Values”. The Supplier Code of Conduct sets out the requirements and expectations for Suppliers when engaged with works either directly or indirectly on behalf of Kindeva.
Suppliers are expected to:
- have read and understood this Code;
- act in accordance with this Code across all its operations and interactions with Kindeva;
- abide by all applicable laws, regulations and standards;
- take all reasonable steps to notify Kindeva if they are unable to abide by this Code (or any part of this Code), or applicable laws, regulations and standards;
- take reasonable steps to ensure their own contractors, subcontractors, consultants and suppliers (“Sub-Suppliers”) also act in accordance with this Code when engaged to perform
- services or work (including the supply of goods) for Kindeva;
- communicate to their own Sub-Suppliers the expectations set out by this Code; and,
- comply with all obligations and terms in any agreement that it enters into with Kindeva (and where such terms are more onerous than the requirements of this Code, comply with the terms of such agreements).
Kindeva expects that all Suppliers will actively self-assess their compliance with this Code, as well as assessing compliance of its subsidiaries or supply chain, including all Sub-Suppliers. Suppliers are expected to take timely steps to report and remedy any breaches or potential breaches of this Code. If a Supplier considers or suspects that another party engaged by Kindeva (or a Kindeva employee) has breached its obligations under this Code, the Supplier is encouraged to report its concerns to Kindeva. Kindeva will treat reports confidentiality to the extent practicably and permitted by law and will protect retaliation against individuals who raise concerns in good faith. To raise a concern in respect of any issue relating to any breach or potential breach of this Code of Conduct, please email Kindeva at https://secure.ethicspoint.com/domain/media/en/gui/74459/index.html
Kindeva reserves the right, subject to applicable contractual rights, to assess Supplier compliance with this Code through questionnaires, documentation reviews, audits, site inspections, or other reasonable means.
4. Supplier Selection
Suppliers’ conduct and compliance with the Code are key factors in the evaluation, selection and retention of our Suppliers. In the event that Kindeva becomes aware of any actions or conditions not in compliance with the Code, we will request corrective actions and if not remediated within a reasonable time period determined by Kindeva based on the nature and severity of the issue, may exercise any right to terminate an agreement with any Supplier.
5. Management Systems and Oversight
Legal Requirements:-
Vendors shall maintain documentation necessary to demonstrate conformance with this Code and compliance with all applicable laws, regulations, rules, ordinances, permits, licenses, approvals, orders, standards and relevant requirements expressly communicated by Kindeva or incorporated into applicable agreements.
Training and Competency:-
Suppliers shall have a training program that achieves an appropriate level of knowledge, skills, and abilities in management and workers in accordance with their industry’s best practices to provide the quality of goods and services required by Kindeva. Suppliers are encouraged to maintain succession and contingency plans for critical roles that support products or services provided to Kindeva.
Continuous Improvement:-
Suppliers are expected to continually improve their business offering to Kindeva through improving operational performance, quality, reliability, sustainability and risk management.
Communication:-
Suppliers shall maintain open and direct communication with appropriate business functions, including Kindeva Procurement, and provide information in a timely way as required to maintain compliance with regulations and laws.
U.S. Government Contracts and Subcontracts:-
The products purchased from our Suppliers may be used in Kindeva’s performance of U.S. Government contracts. Kindeva is committed to the highest standards of business conduct and ethics in obtaining and performing U.S. Government contracts. We expect the same from our Suppliers when providing us with products and services that may be used in the performance of U.S. Government contracts.
Debarment and Suspension
Absent an extraordinary circumstance approved by cognizant U.S. Government officials, Kindeva will not engage in business activities with individuals or companies that are debarred, suspended, or proposed for debarment or suspension, or otherwise, excluded from award of U.S. Government contracts. Any Supplier must promptly notify us in writing if it is or subsequently becomes debarred, suspended, or proposed for debarment or suspension.
Flow Down
When applicable, the Government Contracts Addendum including the Federal Acquisition Regulation (“FAR”), or applicable FAR supplement clauses set forth therein, will be incorporated by reference into any agreement with our Suppliers or any purchase order that we issue for the acquisition of products and services.
6. Labor and Human Rights
Suppliers must support and respect the protection of internationally proclaimed human rights and treat workers with dignity and respect, free of discrimination and harassment. Suppliers shall comply with all applicable labor laws, rules, and regulations, including but not limited to, all laws forbidding the solicitation, facilitation, or any other use of slavery, servitude, forced or compulsory labor or human trafficking, or sex trafficking, as described in the U.S. laws, California Transparency in Supply Chains Act of 2010, California Civil Code, section 1714.43, the UK Modern Slavery Act 2015, and FAR 52.222-50, Combating Trafficking in Persons. Suppliers shall provide a workplace free of harsh and inhumane treatment, including any sexual harassment, sexual abuse, corporal punishment, mental or physical coercion or verbal abuse and not threaten any such treatment. Kindeva reserves the right to conduct “spot checks” at a Supplier in respect of compliance with Human Rights.
Under the U.S. Federal Acquisition Regulations (“FAR”), Suppliers are prohibited from engaging in any of the following practices:
- Any form of trafficking in persons during the period of performance of a government contract;
- Procurement of commercial sex acts during the period of performance of a government contract;
- Use of forced labor in the performance of a government contract;
- Destroying, concealing, confiscating, or otherwise denying access by an employee to the employee’s identification or immigration documents;
- Using misleading or fraudulent practices during the recruitment of employees or offering of employment;
- Using recruiters that do not comply with local labor laws of the country in which the recruitment takes place;
- Charging employees recruitment fees;
- Failing to provide return transportation or require payment for the cost of return transportation for employees who are not nationals of the country in which the work is taking place and who were brought into that country for the purpose of working on a government contract or subcontract;
- Providing or arranging housing that fails to meet the host country housing and safety standards;
- If required by law or contract, failing to provide an employment contract, recruitment agreement, or other required work document in writing in a language the employee understands.
Non-Discrimination, Diversity, and Inclusion:-
The Supplier shall maintain a policy that conforms to applicable law prohibiting discrimination in hiring and employment practices on the grounds of race, color, religion, sex, age, physical ability, national origin, or any other protected status.
Kindeva is an equal opportunity employer and a federal contractor or subcontractor. Consequently, Suppliers agree that, as applicable, they will abide by all applicable laws prohibiting discrimination in hiring and employment practices. Supplier shall comply with the requirements of 41 CFR 60-300.5(a), and 41 CFR 60-741.5(a), as applicable. These regulations prohibit discrimination against qualified protected veterans and qualified individuals with disabilities and require covered federal contractors and subcontractors to take affirmative action to employ and advance in employment such individuals. Suppliers shall also maintain employment practices that comply with all applicable equal employment opportunity and anti-discrimination laws.
Child Labor & Trafficking:-
Kindeva is committed to full compliance with government laws and regulations that strictly prohibit human trafficking, child labor and forced labor.
Supplier shall comply with child labor laws applicable to the country of employment. Suppliers shall use adequate and verifiable mechanisms for age verification as a part of their employment process.
Suppliers and their employees shall not engage or be involved, directly, or indirectly, in any form of trafficking in persons or use forced labor in the conduct of business.
Benefits, Wages and Hours Worked:-
Supplier shall pay employees according to applicable wage laws, including minimum wages, overtime hours and mandated benefits. Supplier shall communicate with the employee the basis on which they are being compensated in a timely manner, whether overtime is required and the wages to be paid for overtime as required by law. Supplier shall keep accurate written records regarding employee working hours and vacation hours as required by law.
Right to Join Union Organizations:-
Suppliers shall respect the rights of workers, as set forth in local laws, to associate freely, join or not join labor unions, seek representation, and join workers’ councils. Open communication and direct engagement with workers to resolve workplace and compensation issues is encouraged and expected. Workers shall be able to communicate openly with management regarding working conditions without threat of reprisal, intimidation, or harassment.
Health, Safety & Security:-
“Safety is Sustainability”, and Suppliers must demonstrate that health and safety is embedded in how they work, make decisions, manage risk, and comply with all applicable health and safety laws and regulations to provide a safe and healthy working environment.
Suppliers must have a health and safety organization that defines, implements, and trains their employees with regard to: (i) workers health and protection, (ii) process safety, and (iii) maintenance and emergency response. Suppliers must protect employees from over exposure to chemical, biological, physical hazards, and provide access to potable water. Supplier’s facilities must be constructed and maintained in accordance with the standards set by applicable law.
Animal Welfare:-
Suppliers shall ensure the humane and ethical treatment of animals and comply with all applicable laws, regulations, permits, and industry standards related to animal welfare. Animals shall only be used where legally permitted and scientifically justified. Suppliers are expected to implement practices that minimize pain, suffering, and distress and to support the principles of Replacement, Reduction, and Refinement (3Rs). Suppliers shall maintain appropriate oversight, training, housing, veterinary care, and recordkeeping to safeguard animal welfare. Kindeva reserves the right to conduct “spot checks” at a Supplier in respect of Animal Welfare.
7. Quality of Products/ Services
All products and services delivered by the Supplier must meet the quality and safety standards required by applicable law as well as required by any definitive agreement with Kindeva (MSA, Quality Agreement, or otherwise), as well as all specifications and scopes of work. Suppliers shall maintain appropriate quality management systems and controls reasonably designed to ensure the consistent quality, integrity, traceability, and compliance of products and services provided to Kindeva. Where applicable, Suppliers shall comply with current Good Manufacturing Practices (cGMP), Good Laboratory Practices (GLP), Good Distribution Practices (GDP), and other applicable GxP requirements. Suppliers shall promptly notify Kindeva of any quality, regulatory, compliance, supply, contamination, recall, inspection, warning letter, or product integrity issue that may materially affect products or services supplied to Kindeva.
8. Environment
Suppliers must integrate environmental stewardship into their operations and decision-making. Suppliers are expected to establish goals and continuous improvement initiatives that reduce environmental impacts, improve resource efficiency, minimize waste and emissions, and support responsible management of energy, water, and other natural resources.
Suppliers shall comply with all applicable environmental laws and regulations and obtain and maintain all required environmental permits, licenses, registrations, and authorizations.
Suppliers shall implement appropriate environmental management systems, controls, and procedures to:
- Ensure the safe handling, storage, transportation, recycling, treatment, and disposal of waste;
- Manage air emissions, wastewater discharges, and other environmental releases in accordance with applicable legal and regulatory requirements;
- Prevent, respond to, and mitigate accidental spills, releases, and other environmental incidents; and
- Monitor and improve environmental performance through operational efficiency, pollution prevention, and responsible resource management practices.
Suppliers are expected to responsibly manage greenhouse gas emissions, energy consumption, water use, waste generation, and other significant environmental impacts associated with their operations. Suppliers should seek opportunities to reduce their environmental footprint and support the sustainability objectives of Kindeva and its customers. Suppliers are encouraged to measure and, upon request, provide information regarding greenhouse gas emissions, energy consumption, water usage, and other sustainability metrics relevant to products and services provided to Kindeva.
Suppliers shall comply with all applicable laws and regulations regarding the prohibition, restriction, labelling, handling, recycling, and disposal of regulated substances used in products, manufacturing processes, and supply chain activities.
Conflict Minerals and Responsible Sourcing.
Supplier shall maintain reasonable policies, procedures, and due diligence measures designed to identify the source and chain of custody of tin, tungsten, tantalum, and gold (3TG) contained in products supplied to Kindeva and shall comply with all applicable conflict minerals and supply chain transparency laws and regulations. Upon Kindeva’s request, Supplier shall provide timely and accurate information regarding the origin of such minerals, including supporting due diligence documentation. Supplier shall promptly notify Kindeva if it becomes aware that products supplied to Kindeva may contain minerals that directly or indirectly finance or benefit armed groups or are otherwise sourced in a manner inconsistent with applicable law or Supplier’s due diligence obligations.
9. Ethics and Compliance
Business Integrity & Ethics:-
Supplier shall conduct business ethically and in compliance with all applicable laws and regulations, including applicable anti-corruption, anti-money laundering, import/export, sanctions, trade compliance, and customs laws in the jurisdictions in which it operates. Supplier shall maintain policies, procedures, and controls reasonably designed to promote lawful and ethical conduct. Supplier shall promptly notify Kindeva of any actual or suspected legal or regulatory violation, government investigation, sanctions restriction, or other circumstance that could materially affect Supplier’s ability to perform its obligations to Kindeva.
Corruption:-
Suppliers must conduct all business in full compliance with applicable anti-corruption laws including the U.S. Foreign Corrupt Practices Act, the UK Bribery Act and all federal, state, and local anti-corruption and ethics laws in every country in which they do business. Kindeva has a zero-tolerance approach to bribery and corruption and expects Suppliers to do the same. In all its activities, the Supplier and all its employees must never, directly or indirectly through intermediaries, offer or promise (or appear to offer or promise) any personal or improper advantage in an effort to obtain or retain a business or other advantage from a Third Party, whether public or private. The Supplier and all its employees must not accept (or appear to accept) any such advantage in return for any preferential treatment of a Third Party. This policy applies with equal force to all persons working with, for, or on behalf of Kindeva in any capacity, including employees at all levels, directors, officers, agency workers, volunteers, interns, agents, contractors, external consultants, third-party representatives, and business partners, such as distributors, material manufacturers, customs brokers, and other Suppliers.
Supplier shall not offer, provide, solicit, or accept gifts, hospitality, entertainment, or other benefits that could improperly influence, or appear to improperly influence, a business decision or create a conflict of interest.
Supplier shall promptly disclose to Kindeva any actual, potential, or perceived conflict of interest that could affect Supplier’s business relationship with Kindeva or the impartial performance of its obligations.
Billing and Payment Practices:-
Supplier shall submit complete, accurate, and timely invoices and supporting documentation in accordance with Kindeva’s purchasing and invoicing requirements. Supplier shall not submit false, duplicate, misleading, or fraudulent invoices, charges, or expenses. Supplier commits to only providing goods/ services to Kindeva after receipt of a fully authorised purchase order (failure to do so may lead to payment issues).
10. Books and Records
Supplier shall create and maintain complete, accurate, truthful, and timely books, records, accounts, and business documentation relating to its operations and its business with Kindeva. Records shall accurately reflect transactions and shall be maintained in accordance with applicable legal, regulatory, accounting, tax, and record-retention requirements. Supplier shall maintain appropriate internal controls designed to prevent fraud, falsification, concealment, material misstatements, or other improper recordkeeping practices. Supplier shall maintain records necessary to support product quality, regulatory compliance, traceability, and data integrity, where applicable.
11. Competition and Antitrust Compliance
Supplier shall comply with all applicable competition, antitrust, and fair-trade laws. Supplier shall not engage in anti-competitive conduct, including price-fixing, bid-rigging, market allocation, output restrictions, abuse of market power, unlawful exchanges of competitively sensitive information, cartel activities, or other practices that unlawfully restrict competition.
12. Intellectual Property, Confidentiality, Privacy & Data Protection
Supplier shall respect and protect intellectual property rights and shall implement appropriate measures to safeguard Kindeva’s confidential information, trade secrets, proprietary information, and intellectual property, as well as that of Kindeva’s customers, business partners, and other third parties.
Supplier shall use confidential information only for authorized business purposes and shall not disclose such information except as authorized by Kindeva or otherwise permitted by applicable agreement or law. Any transfer of technology, know-how, data, materials, or intellectual property shall be conducted in a manner that protects intellectual property rights and confidential information.
Supplier shall comply with all applicable privacy, data protection, cybersecurity, and information security laws and regulations when collecting, accessing, processing, storing, transmitting, or otherwise handling Personal Information or other sensitive data. Supplier shall implement and maintain appropriate administrative, technical, and physical safeguards designed to protect such information against unauthorized access, use, disclosure, alteration, loss, destruction, or other misuse.
Supplier shall promptly notify Kindeva of any actual or suspected data breach, cybersecurity incident, unauthorized access, unauthorized disclosure, loss of confidential information, or other security event affecting Kindeva information, Personal Information, regulated data, or systems used to provide goods or services to Kindeva.
Supplier shall maintain policies, procedures, training, and controls reasonably designed to protect the confidentiality, integrity, availability, and security of information and records entrusted to it.
Supplier’s employees shall not take any photos or make any recording on any Kindeva site without the prior written permission of the relevant Kindeva Site Manager. Supplier’s employees shall not enter any Kindeva warehouse or production area without the permission of the Site Manager. Whilst on site, Supplier employees should not seek to obtain unauthorized information verbally or in writing from unauthorized sources. In the event Suppliers have access to Kindeva’s electronic environment (intranet, email, voicemail or other), Suppliers shall use such systems for Kindeva business purposes only and shall not intentionally or knowingly download, view or disseminate materials of a discriminatory, harassing, threatening, sexual, pornographic, racist, sexist, defamatory or otherwise offensive nature or must not communicate Kindeva’s protected and/or confidential information (personal or trade secret).
13. Cybersecurity
Supplier shall implement and maintain appropriate administrative, technical, physical, and organizational safeguards, consistent with good industry practice and applicable law, to protect Supplier’s systems, networks, and data, including any Kindeva data, from unauthorized access, use, disclosure, modification, destruction, loss, corruption, theft, ransomware, malware, or other security incidents.
Supplier shall maintain a written information security program and, throughout the Term, maintain cybersecurity polies, procedures and controls aligned with an industry-recognized cybersecurity framework, such as the National Institute of Standards and Technology (“NIST”) Cybersecurity Framework, ISO/IEC 27001, or an equivalent framework appropriate to Supplier’s business and risk profile.
Such safeguards shall include, at a minimum, reasonable access controls, multi-factor authentication, data protection controls, vulnerability management processes, incident response procedures, and security awareness training for relevant personnel.
Supplier shall notify Kindeva in writing within 24 hours, and in any event within any time period required by applicable law or applicable agreement with Kindeva, upon becoming aware of any actual or suspected security incident affecting Kindeva data, systems, or services and shall cooperate reasonably with Kindeva’s investigation, mitigation, and remediation efforts.
Supplier shall ensure that any subcontractor with access to Kindeva data is subject to written confidentiality, privacy, information security, and cybersecurity obligations that provide protections no less protective than those required of Supplier.
Further, Supplier shall maintain appropriate controls to protect the confidentiality, integrity, availability, traceability, and security of data and records related to products, services, manufacturing, laboratory, quality, regulatory and supply chain activities.
14. Business Continuity
Supplier is expected to maintain business continuity and resilience capabilities reasonably designed to support the uninterrupted supply of goods and services and minimize the impact of disruptions to operations.
Supplier is expected to have an active business continuity and disaster recovery plan appropriate to the nature, size, and risk profile of its business and to periodically review, test, and update such plans.
Suppliers shall assess risks within their supply chain and take appropriate steps to identify, mitigate, monitor and manage risks that may affect the continuity, quality, safety, availability or delivery of goods and services provided to Kindeva.
Suppliers are expected to maintain adequate financial and operational resources to support their obligations to Kindeva and to promptly notify Kindeva of any circumstances that could materially impair their ability to supply goods or services.
Supplier should consider industry-recognized business continuity standards, such as ISO 22301, when developing and maintaining its business continuity program. Compliance with ISO 22301 or other specific business continuity requirements may be required under applicable agreements with Kindeva. Supplier shall promptly notify Kindeva of any event or disruption that could materially impact the quality, safety, regulatory status, availability, or timely delivery of products or services supplied to Kindeva.