Master Service Agreement

1. Definitions

• “Platform” means the BatchCortex AI batch monitoring software-as-a-service, including the web dashboard, API, edge agent software, and all associated documentation.
• “Customer” means the pharmaceutical manufacturing organization executing this Agreement.
• “Authorized Users” means Customer's employees and contractors authorized to access the Platform.
• “Batch Data” means all sensor readings, process parameters, audit trail entries, and manufacturing data processed by the Platform on behalf of Customer.
• “GMP Records” means any Platform outputs that form part of Customer's Good Manufacturing Practice documentation, including deviation reports, audit trails, and electronic signatures.
• “Subscription Term” means the period specified in the applicable Order Form.
• “Order Form” means the document specifying services, pricing, and term executed by both parties.

2. Services

2.1. BatchCortex grants Customer a non-exclusive, non-transferable right to access and use the Platform during the Subscription Term, subject to the terms of this Agreement and the applicable Order Form.

2.2. The Platform is a decision-support tool. All critical manufacturing decisions, including batch release, deviation classification, and corrective actions, remain the sole responsibility of Customer's Qualified Person(s) and authorized personnel.

2.3. BatchCortex does not make GMP decisions. The Platform provides anomaly detection, trend analysis, and report generation to assist Customer's quality decision-making processes.

3. Customer Obligations

3.1. Customer shall ensure all Authorized Users are appropriately trained on Platform use within their GMP responsibilities.

3.2. Customer shall maintain its own validated quality management system. The Platform supplements but does not replace Customer's existing GMP infrastructure.

3.3. Customer is responsible for the accuracy and completeness of configuration data (process parameters, specification limits, escalation contacts) provided to BatchCortex.

3.4. Customer shall promptly notify BatchCortex of any suspected data integrity issues, security incidents, or regulatory actions related to Platform use.

4. Data Ownership and Processing

4.1. Customer owns all Batch Data.BatchCortex processes Batch Data solely to provide the Services. BatchCortex does not acquire any ownership interest in Customer's data.

4.2. Data processing is governed by the Data Processing Agreement (DPA), attached as Schedule A, which forms part of this Agreement.

4.3. All Batch Data is stored and processed within the European Union. See the DPA for sub-processor details and data residency commitments.

4.4. Upon termination, BatchCortex will provide Customer with a complete export of all Batch Data in standard formats (CSV, JSON) within 30 days. Following export confirmation, BatchCortex will delete all Customer data within 90 days, with certification of destruction provided upon request.

5. Intellectual Property

5.1. BatchCortex retains all intellectual property rights in the Platform, including algorithms, models, user interface, and documentation.

5.2. Customer retains all intellectual property rights in its Batch Data, process configurations, and manufacturing know-how.

5.3. BatchCortex may use anonymized, aggregated operational metrics (e.g., system performance, feature usage patterns) to improve the Platform. No Customer-identifiable or Batch-identifiable data will be used for this purpose without explicit written consent.

6. Audit Rights

6.1. Customer may audit BatchCortex's compliance with this Agreement, the DPA, and applicable GMP requirements upon 30 days' written notice, during normal business hours, no more than once per calendar year.

6.2. BatchCortex will cooperate with Customer's supplier qualification processes, including providing completed supplier quality questionnaires, system architecture documentation, and validation evidence as reasonably requested.

6.3. If Customer's regulatory authority requires an audit of BatchCortex as a GMP-critical supplier, BatchCortex will cooperate fully with such regulatory audit.

7. Service Levels

7.1. BatchCortex targets 99.5% monthly Platform availability, excluding scheduled maintenance windows communicated at least 48 hours in advance.

7.2. Service level credits are detailed in Schedule B (SLA). Credits are Customer's sole and exclusive remedy for downtime.

7.3. BatchCortex will notify Customer within 1 hour of any unplanned outage affecting data collection or audit trail integrity.

8. Limitation of Liability

8.1. BatchCortex is a decision-support tool, not a safety-critical control system. The Platform does not directly control manufacturing equipment or make autonomous batch release decisions.

8.2. To the maximum extent permitted by Swedish law, BatchCortex's aggregate liability under this Agreement shall not exceed the total fees paid by Customer in the 12 months preceding the event giving rise to the claim.

8.3. Neither party shall be liable for indirect, incidental, consequential, special, or punitive damages, including lost profits, lost production, or regulatory penalties, regardless of the theory of liability.

8.4. The limitations in Sections 8.2 and 8.3 shall not apply to: (a) breaches of confidentiality obligations; (b) data protection breaches caused by gross negligence or willful misconduct; or (c) indemnification obligations under Section 9.

8.5. Nothing in this Agreement excludes or limits liability that cannot be excluded or limited under applicable Swedish law, including liability for gross negligence (grov oaktsamhet) or willful misconduct.

9. Indemnification

9.1. BatchCortex shall indemnify Customer against third-party claims arising from: (a) infringement of intellectual property rights by the Platform; (b) BatchCortex's breach of its data protection obligations.

9.2. Customer shall indemnify BatchCortex against third-party claims arising from: (a) Customer's use of the Platform in violation of this Agreement; (b) Customer's GMP decisions made using Platform outputs.

10. Regulatory Compliance

10.1. BatchCortex represents that the Platform is designed in accordance with: EU GMP Annex 11 (Computerised Systems), EU GMP Annex 22 (AI/ML in GMP), GAMP 5 Second Edition guidance, and applicable provisions of the EU AI Act.

10.2. BatchCortex will maintain validation documentation suitable for Customer's supplier qualification requirements, including Installation Qualification (IQ) and Operational Qualification (OQ) evidence.

10.3. BatchCortex will notify Customer within 30 days of any material change to Platform architecture, sub-processors, or data processing locations that could affect Customer's validated state.

11. Confidentiality

11.1. Each party shall maintain the confidentiality of the other's Confidential Information using at least the same degree of care it uses for its own confidential information, but no less than reasonable care.

11.2. Confidential Information does not include information that: (a) is or becomes publicly available; (b) was known prior to disclosure; (c) is independently developed; or (d) is required to be disclosed by law or regulation.

12. Term and Termination

12.1. This Agreement commences on the Effective Date and continues for the Subscription Term specified in the applicable Order Form. It automatically renews for successive 12-month periods unless either party provides 90 days' written notice of non-renewal.

12.2. Either party may terminate for material breach if the breach is not cured within 30 days of written notice.

12.3. Either party may terminate immediately if the other party: (a) becomes insolvent; (b) ceases operations; or (c) fails to maintain required regulatory compliance.

12.4. Upon termination, the data export and deletion provisions of Section 4.4 apply.

13. Governing Law and Dispute Resolution

13.1. This Agreement is governed by the laws of Sweden, without regard to conflict of law principles.

13.2. Disputes shall be resolved by the Stockholm Chamber of Commerce Arbitration Institute (SCC) under its Rules for Expedited Arbitrations. The seat of arbitration shall be Stockholm, Sweden. The language of arbitration shall be English.

14. General

14.1. This Agreement, together with all Schedules and Order Forms, constitutes the entire agreement between the parties.

14.2. No amendment shall be effective unless in writing and signed by both parties.

14.3. Neither party may assign this Agreement without the other's prior written consent, except in connection with a merger, acquisition, or sale of substantially all assets.

Schedules

• Schedule A: Data Processing Agreement (DPA)
• Schedule B: Service Level Agreement (SLA)
• Schedule C: Order Form Template