Terms and Conditions

Last updated: January 28, 2026

Please read these terms and conditions carefully before using our services or website.

Interpretation and Definitions

Interpretation

The words of which the initial letter is capitalized have meanings defined under the following conditions. The following definitions shall have the same meaning regardless of whether they appear in singular or in plural.

Definitions

For the purposes of these Terms and Conditions:

  • Affiliate means an entity that controls, is controlled by or is under common control with a party, where “control” means ownership of 50% or more of the shares, equity interest or other securities entitled to vote for election of directors or other managing authority.

  • Client means the individual, company, or legal entity that engages Axeleros for consulting services or uses the Website.

  • Company (referred to as either “the Company”, “We”, “Us”, “Our” or “Axeleros” in this Agreement) refers to Axeleros, a global consulting firm specializing in preclinical development and regulatory strategy.

  • Confidential Information means all non-public information disclosed by either party, including but not limited to research data, regulatory strategies, study designs, business plans, and proprietary methodologies.

  • Consulting Services refers to the professional advisory services provided by Axeleros, including but not limited to regulatory strategy consulting, preclinical development planning, non-clinical study oversight, and related professional services.

  • Deliverables means any reports, strategies, recommendations, documentation, or other work product created by Axeleros for the Client as part of the Consulting Services.

  • Device means any device that can access the Website such as a computer, a cellphone, or a digital tablet.

  • Regulatory Authorities means governmental agencies responsible for regulating pharmaceutical, biotechnology, and medical device products, including but not limited to FDA (United States), EMA (European Union), PMDA (Japan), NMPA (China), and similar bodies worldwide.

  • Service or Services refers to the Consulting Services and the Website collectively.

  • Terms and Conditions (also referred to as “Terms”) mean these Terms and Conditions that form the entire agreement between You and the Company regarding the use of the Services.

  • Third-party Service Provider means any Contract Research Organization (CRO), laboratory, testing facility, or other service provider engaged in connection with the Consulting Services.

  • Website refers to Axeleros’ website, accessible from https://axeleros.com

  • You means the individual accessing or using the Services, or the company, or other legal entity on behalf of which such individual is accessing or using the Services, as applicable.

Acknowledgment

These are the Terms and Conditions governing the use of our Services and the agreement that operates between You and Axeleros. These Terms and Conditions set out the rights and obligations of all users and clients regarding the use of our Services.

Your access to and use of the Services is conditioned on Your acceptance of and compliance with these Terms and Conditions. These Terms and Conditions apply to all visitors, users, and clients who access or use our Services.

By accessing or using the Services, or by engaging Axeleros for Consulting Services, You agree to be bound by these Terms and Conditions. If You disagree with any part of these Terms and Conditions then You may not access or use our Services.

You represent that you are over the age of 18 and have the legal authority to enter into binding agreements. If You are entering into this agreement on behalf of a company or other legal entity, You represent that You have the authority to bind such entity to these Terms.

Your access to and use of the Services is also conditioned on Your acceptance of and compliance with our Privacy Policy. Our Privacy Policy describes our policies and procedures on the collection, use, and disclosure of Your personal information and tells You about Your privacy rights. Please read our Privacy Policy carefully before using our Services.

Nature of Consulting Services

Professional Advisory Services

Axeleros provides professional consulting services in the field of preclinical development and regulatory strategy. Our services are advisory in nature and are designed to support Your decision-making process. All recommendations, strategies, and advice provided by Axeleros are based on our professional expertise and knowledge as of the date provided.

No Guarantee of Regulatory Approval

You acknowledge and agree that:

  • Axeleros does not guarantee regulatory approval from any Regulatory Authority
  • Regulatory decisions are made solely by the relevant Regulatory Authorities
  • Outcomes may vary based on factors outside Axeleros’ control
  • Our recommendations are based on current regulations and guidance, which may change
  • Each regulatory submission is evaluated independently by Regulatory Authorities

Client Responsibilities

When engaging our Consulting Services, You agree to:

  • Provide complete, accurate, and timely information necessary for our work
  • Disclose all material facts relevant to the engagement
  • Respond promptly to requests for information or clarification
  • Make final decisions regarding Your regulatory and development strategies
  • Ensure compliance with all applicable laws and regulations
  • Implement our recommendations at Your own discretion and risk

Third-Party Service Providers

Axeleros may recommend or facilitate engagement with Third-party Service Providers (such as CROs and testing facilities). You acknowledge that:

  • Axeleros is not responsible for the performance or deliverables of Third-party Service Providers
  • Separate agreements may be required with Third-party Service Providers
  • You are responsible for evaluating and selecting Third-party Service Providers
  • Axeleros’ role is limited to advisory and oversight services unless otherwise specified in writing

Confidentiality

Mutual Obligations

Both parties agree to maintain the confidentiality of all Confidential Information received from the other party. Confidential Information shall not be disclosed to third parties without prior written consent, except as required by law or to professional advisors bound by confidentiality obligations.

Exceptions

Confidential Information does not include information that:

  • Is or becomes publicly available through no breach of this agreement
  • Was rightfully in the receiving party’s possession prior to disclosure
  • Is independently developed without use of the Confidential Information
  • Is rightfully received from a third party without breach of any confidentiality obligation

Duration

The confidentiality obligations shall survive for five (5) years from the date of disclosure or termination of the engagement, whichever is later.

Intellectual Property

Deliverables

Upon full payment of all fees, Axeleros grants You a non-exclusive, non-transferable license to use the Deliverables for Your internal business purposes related to the specific engagement.

Axeleros Methodologies

All methodologies, frameworks, tools, templates, and know-how used by Axeleros remain the exclusive property of Axeleros. No license or right to these materials is granted except as explicitly stated in the Deliverables.

Client Materials

You retain all rights to Your pre-existing materials, data, and information provided to Axeleros. You grant Axeleros a limited license to use such materials solely for the purpose of providing the Consulting Services.

Payment Terms

Fees

Fees for Consulting Services will be specified in separate engagement letters or statements of work. Unless otherwise agreed in writing:

  • Fees are due within thirty (30) days of invoice date
  • Late payments may incur interest charges at the rate of 1.5% per month or the maximum rate permitted by law, whichever is less
  • Axeleros reserves the right to suspend services for non-payment

Expenses

You agree to reimburse Axeleros for reasonable out-of-pocket expenses incurred in connection with the Consulting Services, subject to Your prior approval for expenses exceeding amounts specified in the engagement letter.

Our Website may contain links to third-party websites, including Regulatory Authorities, Third-party Service Providers, scientific databases, or other resources not owned or controlled by Axeleros.

Axeleros has no control over, and assumes no responsibility for, the content, privacy policies, or practices of any third-party websites or services. You further acknowledge and agree that Axeleros shall not be responsible or liable, directly or indirectly, for any damage or loss caused or alleged to be caused by or in connection with the use of or reliance on any such content, goods, or services available on or through any such websites or services.

We strongly advise You to read the terms and conditions and privacy policies of any third-party websites or services that You visit.

Term and Termination

Website Access

Axeleros may terminate or suspend Your access to the Website immediately, without prior notice or liability, for any reason whatsoever, including without limitation if You breach these Terms and Conditions.

Consulting Engagements

For Consulting Services engagements:

  • Either party may terminate the engagement with thirty (30) days’ written notice
  • You remain responsible for payment of all fees for services rendered prior to termination
  • Axeleros may terminate immediately for non-payment or material breach by Client
  • Upon termination, Axeleros will deliver all completed Deliverables upon receipt of payment

Survival

The following provisions shall survive termination: Confidentiality, Intellectual Property, Payment Terms, Limitation of Liability, and Governing Law.

Limitation of Liability

General Limitation

TO THE MAXIMUM EXTENT PERMITTED BY APPLICABLE LAW, THE ENTIRE LIABILITY OF AXELEROS UNDER ANY PROVISION OF THESE TERMS, AND YOUR EXCLUSIVE REMEDY, SHALL BE LIMITED TO THE FEES ACTUALLY PAID BY YOU TO AXELEROS FOR THE SPECIFIC ENGAGEMENT GIVING RISE TO THE CLAIM DURING THE TWELVE (12) MONTHS PRECEDING THE EVENT GIVING RISE TO LIABILITY, OR ONE THOUSAND DOLLARS (USD $1,000), WHICHEVER IS GREATER.

Exclusion of Consequential Damages

TO THE MAXIMUM EXTENT PERMITTED BY APPLICABLE LAW, IN NO EVENT SHALL AXELEROS OR ITS AFFILIATES, EMPLOYEES, CONSULTANTS, OR PARTNERS BE LIABLE FOR ANY:

  • Special, incidental, indirect, consequential, or punitive damages
  • Loss of profits, revenue, business opportunities, or goodwill
  • Loss of data or information
  • Business interruption or delay
  • Costs of procurement of substitute services
  • Regulatory denials, delays, or rejections
  • Decisions or actions taken by Regulatory Authorities
  • Performance or non-performance of Third-party Service Providers
  • Results of clinical or non-clinical studies
  • Market outcomes or commercial success

This exclusion applies regardless of the theory of liability (contract, tort, negligence, strict liability, or otherwise) and even if Axeleros has been advised of the possibility of such damages.

Professional Services Limitation

You acknowledge that:

  • Consulting Services are advisory in nature and based on professional judgment
  • Regulatory and scientific landscapes are subject to change
  • Axeleros cannot control decisions made by Regulatory Authorities or outcomes of studies conducted by Third-party Service Providers
  • Final decisions regarding regulatory strategy and development programs remain Your responsibility
  • You assume all risks associated with implementing our recommendations

Jurisdictional Variations

Some jurisdictions do not allow the exclusion or limitation of incidental or consequential damages, or limitations on implied warranties. In such jurisdictions, the above limitations and exclusions shall apply to the maximum extent permitted by law.

Warranties and Disclaimers

Professional Standards

Axeleros warrants that:

  • Consulting Services will be performed in a professional and workmanlike manner consistent with industry standards
  • Services will be provided by qualified professionals with appropriate expertise
  • We will use reasonable efforts to ensure accuracy of information and recommendations

Disclaimer of Other Warranties

EXCEPT AS EXPRESSLY PROVIDED ABOVE, TO THE MAXIMUM EXTENT PERMITTED BY APPLICABLE LAW, THE SERVICES ARE PROVIDED “AS IS” AND “AS AVAILABLE” WITHOUT WARRANTY OF ANY KIND. AXELEROS EXPRESSLY DISCLAIMS ALL WARRANTIES, WHETHER EXPRESS, IMPLIED, STATUTORY, OR OTHERWISE, INCLUDING BUT NOT LIMITED TO:

  • Implied warranties of merchantability, fitness for a particular purpose, and non-infringement
  • Warranties that may arise from course of dealing, course of performance, or usage of trade
  • Warranties regarding regulatory approval, study outcomes, or market success
  • Warranties that the Website will operate uninterrupted or error-free

No Guarantee of Results

Axeleros makes no representation or warranty regarding:

  • Approval decisions by any Regulatory Authority
  • Outcomes of preclinical or clinical studies
  • Timeline for regulatory reviews or approvals
  • Market reception or commercial success of any product
  • Actions or decisions of Third-party Service Providers

Information Accuracy

While Axeleros strives to provide accurate and up-to-date information:

  • Regulatory requirements and guidance are subject to change
  • Information on the Website is for general informational purposes only
  • You should not rely solely on Website content for decision-making
  • Specific advice should be obtained through formal Consulting Services engagements

Jurisdictional Limitations

Some jurisdictions do not allow the exclusion of certain types of warranties or limitations on applicable statutory rights, so some or all of the above exclusions and limitations may not apply to You. In such cases, the exclusions and limitations shall be applied to the greatest extent enforceable under applicable law.

Governing Law

These Terms shall be governed by and construed in accordance with the laws of the jurisdiction where the Consulting Services are primarily performed, or as otherwise specified in the engagement letter, excluding its conflicts of law rules.

Your use of the Services may also be subject to other local, state, national, or international laws, including but not limited to regulations governing pharmaceutical development, data protection, and export controls.

Disputes Resolution

Informal Resolution

If You have any concern or dispute about the Services, You agree to first attempt to resolve the dispute informally by contacting Axeleros in writing and providing a detailed description of the dispute. We will make good faith efforts to resolve the matter within thirty (30) days of receiving such notice.

Mediation

If the dispute cannot be resolved informally, the parties agree to attempt resolution through mediation before a mutually acceptable mediator before pursuing litigation or arbitration.

Arbitration

If mediation is unsuccessful, any disputes arising out of or relating to these Terms or the Services shall be resolved through binding arbitration administered by a mutually agreed arbitration service, unless otherwise specified in the engagement letter.

Exceptions

Either party may seek injunctive relief or other equitable remedies in court to protect confidential information or intellectual property rights without first pursuing mediation or arbitration.

For European Union (EU) Users

If You are a European Union consumer or business, You will benefit from any mandatory provisions of the law of the country in which You are resident. Nothing in these Terms affects Your rights as a consumer under EU regulations, including but not limited to data protection rights under the General Data Protection Regulation (GDPR).

Export Controls and Sanctions Compliance

You represent and warrant that:

  • You are not located in a country that is subject to a government embargo or that has been designated as a “terrorist supporting” country by the United States or other applicable jurisdiction
  • You are not listed on any government list of prohibited or restricted parties, including but not limited to the U.S. Treasury Department’s list of Specially Designated Nationals or the U.S. Department of Commerce Denied Persons List
  • You will comply with all applicable export control and sanctions laws and regulations

Controlled Information

You acknowledge that certain technical data and information shared during Consulting Services may be subject to export controls. You agree to comply with all applicable export control laws and obtain necessary licenses before sharing such information internationally.

Indemnification

You agree to indemnify, defend, and hold harmless Axeleros, its affiliates, officers, directors, employees, consultants, and agents from and against any claims, liabilities, damages, losses, costs, or expenses (including reasonable attorneys’ fees) arising out of or relating to:

  • Your breach of these Terms
  • Your violation of any law or regulation
  • Your violation of any rights of a third party
  • Your misuse of the Services or Deliverables
  • Your failure to provide accurate or complete information
  • Your implementation of our recommendations or advice

This indemnification obligation shall survive termination of these Terms and any engagement.

Insurance

Axeleros maintains professional liability insurance appropriate for our industry and services. Information about our insurance coverage is available upon request for clients engaging our Consulting Services.

Severability and Waiver

Severability

If any provision of these Terms is held to be unenforceable or invalid by a court of competent jurisdiction, such provision will be changed and interpreted to accomplish the objectives of such provision to the greatest extent possible under applicable law, and the remaining provisions will continue in full force and effect.

Waiver

The failure of Axeleros to exercise or enforce any right or provision of these Terms shall not constitute a waiver of such right or provision. Any waiver must be in writing and signed by an authorized representative of Axeleros. No waiver of a breach shall constitute a waiver of any subsequent breach.

Entire Agreement

These Terms, together with any engagement letter or statement of work for Consulting Services, constitute the entire agreement between You and Axeleros regarding the subject matter hereof and supersede all prior agreements, understandings, representations, and warranties, whether written or oral.

Translation Interpretation

These Terms and Conditions may be translated and made available in multiple languages. You agree that the original English text shall prevail in the case of any conflict or ambiguity between versions.

Changes to These Terms and Conditions

We reserve the right, at our sole discretion, to modify or replace these Terms at any time. If a revision is material, we will make reasonable efforts to provide at least thirty (30) days’ notice prior to any new terms taking effect. What constitutes a material change will be determined at our sole discretion.

For Consulting Services engagements, material changes to these Terms will not apply to ongoing engagements unless mutually agreed in writing. Such engagements will continue under the Terms in effect at the time of engagement.

By continuing to access or use our Services after revisions become effective, You agree to be bound by the revised Terms. If You do not agree to the new terms, You must discontinue use of the Services.

Assignment

You may not assign or transfer these Terms or any rights or obligations hereunder without the prior written consent of Axeleros. Axeleros may assign these Terms or any rights or obligations hereunder without restriction. Any attempted assignment in violation of this provision shall be null and void.

Force Majeure

Neither party shall be liable for any failure or delay in performance under these Terms (except for payment obligations) due to causes beyond its reasonable control, including but not limited to acts of God, war, terrorism, pandemic, government regulations, natural disasters, or labor disputes.

Contact Us

If you have any questions about these Terms and Conditions, You can contact us:

For matters related to specific Consulting Services engagements, please contact Your designated Axeleros project manager or consultant.

Axeleros - Accelerating from Lab to Market

Preclinical Development · Regulatory Strategy · Global Consulting