Terms of Service

1. Acceptance of Terms

These Terms of Service (“Terms”) constitute a legally binding agreement between the entity or individual (“Customer,” “you,” or “your”) accessing or using the Simrogate platform and Aurigate Technologies (“Simrogate,” “we,” “us,” or “our”), a company organized under the laws of the Province of Ontario, Canada.

By accessing, browsing, or using the Service, creating an account, or clicking “I Agree” (or similar affirmation), you acknowledge that you have read, understood, and agree to be bound by these Terms and our Privacy Policy, which is incorporated herein by reference. If you are entering into these Terms on behalf of a company or other legal entity, you represent that you have the authority to bind such entity to these Terms. If you do not agree to these Terms, you must not access or use the Service.

2. Definitions

In these Terms, the following definitions apply:

2.1 “Service” means the Simrogate cloud-based software platform, including all features, functionalities, APIs, integrations, AI/ML-powered tools, mobile applications, and related services provided by Simrogate, as described in the applicable Documentation and Order Form.

2.2 “Customer” means the entity or individual that has entered into a subscription agreement with Simrogate to access and use the Service.

2.3 “Customer Data” means all data, files, documents, records, information, and materials that Customer or its Authorized Users upload, submit, store, transmit, or otherwise make available through the Service, including but not limited to lot release records, quality data, compliance documentation, certificate of analysis data, and regulatory submissions.

2.4 “Authorized Users” means individuals who are authorized by Customer to access and use the Service under Customer’s account, subject to the user limits specified in the applicable subscription plan.

2.5 “Subscription Term” means the period during which Customer has paid for and is authorized to access the Service, as specified in the applicable Order Form.

2.6 “Documentation” means the user guides, online help, release notes, training materials, and other technical and operational documentation for the Service made available by Simrogate.

2.7 “Confidential Information” means any non-public information disclosed by either party to the other, whether orally, in writing, or electronically, that is designated as confidential or that reasonably should be understood to be confidential given the nature of the information and circumstances of disclosure. Confidential Information includes, without limitation, business plans, product roadmaps, technical data, Customer Data, pricing, financial information, and trade secrets.

2.8 “Order Form” means any ordering document, statement of work, or online subscription page that references these Terms and specifies the Service plan, fees, Subscription Term, and other applicable details.

2.9 “Data Processing Agreement” or “DPA” means the data processing agreement between the parties governing the processing of personal data in connection with the Service.

2.10 “Applicable Law” means all laws, regulations, rules, and governmental requirements applicable to either party’s performance under these Terms, including but not limited to FDA regulations (21 CFR Parts 11, 210, 211, 600, 610, and 820), Health Canada regulations, EU GMP Annex 11, and any other applicable regulatory requirements.

3. Account Registration and Access

3.1 Eligibility

The Service is intended for use by businesses and organizations operating in FDA-regulated and other regulated industries. By registering for an account, you represent and warrant that: (a) you are at least 18 years of age; (b) you have the legal capacity and authority to enter into these Terms; and (c) all registration information you submit is truthful, accurate, and complete.

3.2 Account Security

Customer is responsible for maintaining the confidentiality of all account credentials, including usernames and passwords. Customer shall: (a) implement appropriate access controls for all Authorized Users; (b) promptly notify Simrogate of any unauthorized access to or use of the account; (c) ensure that account credentials are not shared among multiple individuals; and (d) be responsible for all activities that occur under Customer’s account.

3.3 Authorized Users

Customer may permit Authorized Users to access the Service in accordance with the user limits specified in the applicable subscription plan. Customer is responsible for ensuring that all Authorized Users comply with these Terms and shall be liable for any breach of these Terms by its Authorized Users.

4. Subscription and Fees

4.1 Subscription Plans

Simrogate offers the following subscription tiers, subject to change:

• Starter: $3,500 USD per month
• Professional: $8,000 USD per month
• Enterprise: Custom pricing, available upon request

Specific features, user limits, storage allocations, and service levels for each tier are described on the Simrogate pricing page and in the applicable Order Form.

4.2 Annual Billing

Customers who elect annual billing shall receive a twenty percent (20%) discount on the applicable monthly rate. Annual subscriptions are billed in advance for the full Subscription Term.

4.3 Payment Terms

All fees are due and payable within thirty (30) days of the invoice date unless otherwise specified in the Order Form. Fees are stated in United States Dollars (USD) and are exclusive of all applicable taxes, levies, and duties, which shall be Customer’s responsibility.

4.4 Late Payment

Any amounts not paid when due shall accrue interest at the rate of one and one-half percent (1.5%) per month, or the maximum rate permitted by applicable law, whichever is less. Simrogate reserves the right to suspend access to the Service upon fifteen (15) days’ written notice of non-payment.

4.5 Price Changes

Simrogate may modify subscription fees upon at least thirty (30) days’ prior written notice to Customer. Price changes shall take effect at the start of the next Subscription Term following the notice period. Customer’s continued use of the Service after a price change constitutes acceptance of the new pricing.

5. Permitted Use and Restrictions

5.1 License Grant

Subject to Customer’s compliance with these Terms and payment of all applicable fees, Simrogate hereby grants Customer a limited, non-exclusive, non-transferable, non-sublicensable, revocable right to access and use the Service during the Subscription Term solely for Customer’s internal business purposes in accordance with the Documentation and applicable Order Form.

5.2 Acceptable Use

Customer shall use the Service only for lawful purposes and in compliance with all Applicable Laws. Customer shall not use the Service in any manner that could damage, disable, overburden, or impair the Service or interfere with any other party’s use of the Service.

5.3 Restrictions

Customer shall not, and shall not permit any third party to:

• Copy, modify, adapt, translate, or create derivative works of the Service or any component thereof;
• Reverse engineer, disassemble, decompile, or otherwise attempt to derive the source code, algorithms, or underlying structure of the Service;
• Rent, lease, lend, sell, resell, sublicense, distribute, or otherwise make the Service available to any third party, except as expressly permitted herein;
• Circumvent, disable, or otherwise interfere with any security-related features of the Service, including audit trail mechanisms, access controls, and electronic signature controls;
• Use the Service to develop a competing product or service;
• Use automated means (including bots, scrapers, or crawlers) to access the Service except through Simrogate-provided APIs;
• Upload, transmit, or store any malicious code, viruses, or harmful components through the Service;
• Use the Service to store or process data in violation of any applicable privacy, data protection, or regulatory requirements;
• Remove, alter, or obscure any proprietary notices, labels, or marks on the Service.

6. Customer Responsibilities

6.1 Accuracy of Data

Customer is solely responsible for the accuracy, quality, integrity, legality, reliability, and appropriateness of all Customer Data submitted to the Service. Simrogate shall not be responsible or liable for any errors, omissions, or inaccuracies in Customer Data or any decisions made based on such data.

6.2 User Training

Customer is responsible for ensuring that all Authorized Users are adequately trained on the proper use of the Service, including but not limited to features related to electronic signatures, audit trails, and regulatory compliance workflows. Simrogate shall make training materials and Documentation available to assist with this obligation.

6.3 Regulatory Compliance

Customer acknowledges and agrees that regulatory compliance with all Applicable Laws, including FDA regulations, Health Canada regulations, EU GMP requirements, and any other applicable regulatory frameworks, is solely Customer’s responsibility. While the Service provides tools and features designed to assist with compliance activities, the use of the Service does not guarantee regulatory compliance. Customer shall independently validate that its use of the Service meets all applicable regulatory requirements.

6.4 System Validation

Where required by Applicable Law or industry practice, Customer is responsible for performing and documenting validation of the Service within Customer’s regulated environment. Simrogate shall provide reasonable cooperation and validation support documentation upon request.

6.5 Maintaining Backups

While Simrogate maintains backups of Customer Data as described in the Documentation, Customer is responsible for maintaining its own independent backups of Customer Data. Simrogate shall not be liable for any loss or corruption of Customer Data to the extent that Customer has failed to maintain adequate backups.

7. Intellectual Property

7.1 Simrogate’s Intellectual Property

The Service, including all software, algorithms, machine learning models, user interfaces, designs, documentation, and all related intellectual property rights, are and shall remain the exclusive property of Simrogate and its licensors. These Terms do not convey to Customer any rights of ownership in or to the Service, but only a limited right of use as expressly set forth herein. All rights not expressly granted are reserved by Simrogate.

7.2 Customer Data Ownership

As between the parties, Customer retains all right, title, and interest in and to Customer Data. Customer hereby grants Simrogate a limited, non-exclusive, worldwide license to access, use, process, and display Customer Data solely as necessary to provide, maintain, and improve the Service and to comply with applicable legal obligations.

7.3 Aggregated and De-Identified Data

Simrogate may use aggregated and de-identified data derived from Customer’s use of the Service for purposes of improving the Service, developing new features, conducting research, and generating industry benchmarks, provided that such data does not identify Customer or any individual. Customer acknowledges that such aggregated data shall be owned by Simrogate.

7.4 Feedback

If Customer provides any suggestions, ideas, enhancement requests, feedback, recommendations, or other information regarding the Service (“Feedback”), Customer hereby assigns to Simrogate all right, title, and interest in such Feedback. Simrogate shall be free to use, incorporate, disclose, and exploit such Feedback without restriction or obligation of any kind to Customer.

7.5 Improvements

Any improvements, modifications, enhancements, or derivative works to the Service, whether or not incorporating Customer Feedback, shall be the sole and exclusive property of Simrogate.

8. Confidentiality

8.1 Mutual Obligations

Each party (as “Receiving Party”) agrees that it shall: (a) hold the Confidential Information of the other party (as “Disclosing Party”) in strict confidence; (b) not disclose such Confidential Information to any third party except as expressly permitted herein; and (c) use such Confidential Information only for the purposes of performing its obligations or exercising its rights under these Terms. The Receiving Party shall protect the Disclosing Party’s Confidential Information using at least the same degree of care it uses to protect its own confidential information, but in no event less than reasonable care.

8.2 Exceptions

Confidential Information shall not include information that: (a) is or becomes publicly available through no fault of the Receiving Party; (b) was rightfully in the Receiving Party’s possession before receipt from the Disclosing Party; (c) is rightfully obtained by the Receiving Party from a third party without breach of any obligation of confidentiality; or (d) is independently developed by the Receiving Party without use of or reference to the Disclosing Party’s Confidential Information.

8.3 Required Disclosures

The Receiving Party may disclose Confidential Information to the extent required by applicable law, regulation, or court order, provided that the Receiving Party shall: (a) give the Disclosing Party prompt written notice of such requirement (to the extent legally permitted); (b) cooperate with the Disclosing Party in seeking a protective order or other appropriate remedy; and (c) disclose only that portion of the Confidential Information that is legally required to be disclosed.

8.4 Duration

The obligations of confidentiality set forth in this Section shall survive the termination or expiration of these Terms for a period of five (5) years, except with respect to trade secrets, which shall be protected for so long as they remain trade secrets under applicable law.

9. Data Protection and Security

9.1 Privacy Policy and DPA

Simrogate’s collection, use, and processing of personal data in connection with the Service are governed by our Privacy Policy and, where applicable, the Data Processing Agreement entered into between the parties. Both documents are incorporated by reference into these Terms.

9.2 Regulatory Compliance Features

The Service is designed to provide features that support compliance with 21 CFR Part 11 and equivalent regulations, including but not limited to: (a) complete audit trails with tamper-evident logging of all system activities; (b) electronic signature capabilities with appropriate authentication controls; (c) data integrity controls including checksums and versioning; (d) role-based access controls with configurable permission levels; and (e) system validation support documentation. Customer acknowledges that the availability and configuration of these features may vary by subscription tier.

9.3 Security Standards

Simrogate maintains administrative, technical, and physical safeguards designed to protect Customer Data, including: (a) SOC 2 Type II compliance; (b) encryption of data in transit (TLS 1.2 or higher) and at rest (AES-256); (c) regular security assessments and penetration testing; (d) access controls and authentication mechanisms; and (e) business continuity and disaster recovery procedures.

9.4 Breach Notification

In the event of a confirmed security breach that results in unauthorized access to, or disclosure of, Customer Data, Simrogate shall notify Customer without undue delay and in any event within seventy-two (72) hours of becoming aware of the breach. Notification shall include: (a) the nature of the breach; (b) the categories and approximate number of data records affected; (c) the likely consequences of the breach; and (d) the measures taken or proposed to address the breach and mitigate its effects.

9.5 Shared Responsibility Model

Security of the Service is a shared responsibility. Simrogate is responsible for the security of the underlying infrastructure, application, and platform. Customer is responsible for: (a) managing user access and authentication; (b) configuring security settings within the Service; (c) protecting account credentials; (d) ensuring the security of Customer’s own networks, devices, and systems used to access the Service; and (e) promptly reporting any suspected security incidents.

10. Regulatory Disclaimer

11. Warranty Disclaimers

11.1 Limited Warranty

Simrogate warrants that during the Subscription Term, the Service will perform materially in accordance with the applicable Documentation. Customer’s sole and exclusive remedy for breach of this warranty shall be, at Simrogate’s option: (a) correction of the non-conforming Service; or (b) termination of the affected subscription and a pro-rata refund of prepaid fees for the remainder of the Subscription Term.

11.2 Disclaimer

12. Limitation of Liability

13. Indemnification

13.1 Indemnification by Simrogate

Simrogate shall defend, indemnify, and hold harmless Customer and its officers, directors, employees, and agents from and against any third-party claims, damages, losses, liabilities, costs, and expenses (including reasonable attorneys’ fees) arising from allegations that Customer’s authorized use of the Service infringes or misappropriates any third party’s intellectual property rights. Simrogate’s obligations under this Section shall not apply to the extent the claim arises from: (a) Customer’s modification of the Service; (b) Customer’s combination of the Service with third-party products or services not approved by Simrogate; (c) Customer’s continued use of a version of the Service after Simrogate has provided a non-infringing replacement; or (d) Customer Data.

13.2 Indemnification by Customer

Customer shall defend, indemnify, and hold harmless Simrogate and its officers, directors, employees, and agents from and against any third-party claims, damages, losses, liabilities, costs, and expenses (including reasonable attorneys’ fees) arising from or related to: (a) Customer’s use of the Service in breach of these Terms; (b) Customer’s failure to comply with Applicable Laws, including regulatory requirements; (c) Customer Data or Customer’s collection, processing, or use of data in connection with the Service; (d) Customer’s breach of the acceptable use restrictions set forth in Section 5; (e) Customer’s regulatory non-compliance, including any fines, penalties, or sanctions imposed by any regulatory authority; and (f) any claim by a third party arising from the acts or omissions of Customer’s Authorized Users.

13.3 Indemnification Procedure

The indemnified party shall: (a) promptly notify the indemnifying party in writing of any claim for which indemnification is sought (provided that failure to provide prompt notice shall not relieve the indemnifying party of its obligations except to the extent it is materially prejudiced by such failure); (b) grant the indemnifying party sole control of the defense and settlement of such claim; and (c) provide the indemnifying party with all reasonable cooperation and assistance at the indemnifying party’s expense. The indemnifying party shall not settle any claim in a manner that imposes obligations on the indemnified party without the indemnified party’s prior written consent.

14. Term and Termination

14.1 Subscription Term

The initial Subscription Term shall be as specified in the applicable Order Form. Unless otherwise stated, subscriptions are for an annual term. The Subscription Term shall automatically renew for successive periods of equal duration unless either party provides written notice of non-renewal at least thirty (30) days before the end of the then-current term.

14.2 Termination for Cause

Either party may terminate these Terms upon written notice if the other party: (a) materially breaches these Terms and fails to cure such breach within thirty (30) days after receiving written notice specifying the breach; or (b) becomes the subject of any proceeding relating to bankruptcy, insolvency, receivership, liquidation, or assignment for the benefit of creditors.

14.3 Termination for Convenience

Customer may terminate these Terms for convenience by providing at least thirty (30) days’ written notice before the end of the then-current Subscription Term. Termination for convenience shall be effective at the end of the then-current Subscription Term. No refund shall be provided for termination for convenience during an active Subscription Term.

14.4 Effect of Termination

Upon termination or expiration of these Terms: (a) Customer’s right to access and use the Service shall immediately cease; (b) Customer shall pay all outstanding fees due and payable as of the effective date of termination; (c) Customer Data shall be available for export by Customer for a period of ninety (90) days following the effective date of termination, after which Simrogate shall have no obligation to maintain or provide any Customer Data and may delete all Customer Data in its systems unless retention is required by applicable law; and (d) each party shall return or destroy the other party’s Confidential Information in its possession.

14.5 Survival

Sections 2, 6.3, 7, 8, 10, 11, 12, 13, 14.4, 14.5, 15, and 16 through 23 shall survive any termination or expiration of these Terms.

15. Governing Law and Dispute Resolution

15.1 Governing Law

These Terms shall be governed by and construed in accordance with the laws of the Province of Ontario and the federal laws of Canada applicable therein, without regard to conflict of law principles. The United Nations Convention on Contracts for the International Sale of Goods shall not apply to these Terms.

15.2 Informal Resolution

Before initiating any formal dispute resolution proceedings, the parties shall attempt to resolve any dispute, controversy, or claim arising out of or in connection with these Terms through good-faith negotiations for a period of thirty (30) days following written notice of the dispute from one party to the other.

15.3 Binding Arbitration

If a dispute cannot be resolved through informal negotiations within the thirty (30) day period set forth in Section 15.2, such dispute shall be finally resolved by binding arbitration administered by the ADR Institute of Canada in accordance with its Arbitration Rules then in effect. The arbitration shall be conducted in Toronto, Ontario, Canada, before a single arbitrator. The language of the arbitration shall be English. The arbitrator’s decision shall be final and binding upon the parties and may be enforced in any court of competent jurisdiction.

15.4 Class Action Waiver

15.5 Injunctive Relief

Notwithstanding the foregoing, either party may seek injunctive or other equitable relief from any court of competent jurisdiction to protect its intellectual property rights or Confidential Information, or to prevent irreparable harm, without first engaging in the informal resolution or arbitration procedures described above.

16. Force Majeure

Neither party shall be liable for any delay or failure to perform its obligations under these Terms (except for payment obligations) to the extent that such delay or failure is caused by circumstances beyond the affected party’s reasonable control, including but not limited to acts of God, natural disasters, epidemics, pandemics, war, terrorism, riots, civil unrest, government actions, embargoes, sanctions, labor disputes, strikes, fire, flood, earthquake, power outages, Internet or telecommunications failures, cyberattacks, or disruptions to third-party cloud infrastructure providers. The affected party shall provide prompt written notice to the other party and shall use commercially reasonable efforts to mitigate the effects of the force majeure event.

17. Assignment

Customer may not assign or transfer these Terms, or any rights or obligations hereunder, without the prior written consent of Simrogate, and any purported assignment without such consent shall be void. Simrogate may assign these Terms, in whole or in part, without restriction, including in connection with a merger, acquisition, corporate reorganization, or sale of all or substantially all of its assets. Subject to the foregoing, these Terms shall be binding upon and inure to the benefit of the parties and their respective successors and permitted assigns.

18. Severability

If any provision of these Terms is held to be invalid, illegal, or unenforceable by a court of competent jurisdiction or an arbitrator, such provision shall be modified to the minimum extent necessary to make it valid, legal, and enforceable, or if such modification is not possible, such provision shall be severed from these Terms. The invalidity, illegality, or unenforceability of any provision shall not affect the validity or enforceability of any other provision of these Terms, and the remaining provisions shall continue in full force and effect.

19. Entire Agreement

These Terms, together with the Privacy Policy, any applicable Data Processing Agreement, Order Forms, and any other documents expressly incorporated by reference herein, constitute the entire agreement between Customer and Simrogate with respect to the subject matter hereof and supersede all prior and contemporaneous agreements, proposals, negotiations, representations, warranties, and communications, whether oral or written, relating to such subject matter. In the event of any conflict between these Terms and an Order Form, the Order Form shall prevail to the extent of the conflict.

20. Waiver

No failure or delay by either party in exercising any right, power, or privilege under these Terms shall operate as a waiver thereof, nor shall any single or partial exercise of any right, power, or privilege preclude any other or further exercise thereof or the exercise of any other right, power, or privilege. Any waiver must be in writing and signed by the waiving party to be effective.

21. Notices

All notices, requests, demands, and other communications under these Terms shall be in writing and shall be deemed duly given when: (a) delivered by hand; (b) sent by email to the registered email address on file (with confirmation of receipt); or (c) sent by internationally recognized overnight courier service. Notices to Simrogate shall be sent to: legal@simrogate.com. Notices to Customer shall be sent to the email address associated with Customer’s account. Either party may change its notice address by providing written notice to the other party in accordance with this Section.

22. Export Compliance

Customer acknowledges that the Service may be subject to export control and sanctions laws and regulations, including the Canadian Export and Import Permits Act, United States Export Administration Regulations, and other applicable trade compliance laws. Customer shall not access, use, export, re-export, or transfer the Service, directly or indirectly, in violation of any such laws or regulations. Customer represents and warrants that: (a) Customer is not located in, and will not use the Service from, any country or territory that is subject to comprehensive trade sanctions; (b) Customer is not listed on any applicable restricted or denied party list; and (c) Customer will not use the Service for any purpose prohibited by applicable export control or sanctions laws.

23. General Provisions

23.1 Independent Contractors

The relationship between Simrogate and Customer is that of independent contractors. Nothing in these Terms shall be construed to create a partnership, joint venture, agency, or employment relationship between the parties.

23.2 Third-Party Beneficiaries

These Terms do not confer any rights or remedies on any third party other than the parties hereto and their respective successors and permitted assigns.

23.3 Headings

The headings in these Terms are for convenience of reference only and shall not affect the interpretation or construction of these Terms.

23.4 Language

These Terms are drafted in the English language. If these Terms are translated into any other language, the English language version shall prevail to the extent of any inconsistency.

24. Contact Information

For questions, concerns, or notices regarding these Terms, please contact:

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