2.1 “Software” means the V5 Traceability software, including updates, upgrades, and documentation provided by Provider under this MSA. This Agreement applies to Version 5.9 during the applicable term unless otherwise agreed in writing.
2.2 “Hosted Services” means the hosting, maintenance, and support of the Software on a third-party cloud hosting provider’s infrastructure, managed by Provider and accessible by Customer via the internet.
2.3 “On-Premise Installation” means the installation and operation of the Software on Customer’s own hardware and / or infrastructure at Customer’s designated location.
2.3.1 “Default Deployment Architecture” means unless otherwise specified in the Order Form / Signed Proposal, the Software shall be deployed on-premises at Customer’s designated location. If Customer elects a hosted (cloud) deployment, this must be clearly indicated on the Order Form / Signed Proposal at the time of order placement.
2.4 “Services” means Hosted Services (if elected), implementation / onboarding services (if purchased), support, maintenance, training assistance, validation assistance, installation services, and related professional services provided by Provider.
2.4.1 “Presales Services” means limited-scope paid or complimentary commercial services offered before full subscription go-live or expansion, including ERP Gap Analysis, Proof of Concept (POC), discovery, and similar evaluation services described in the applicable commercial record.
2.5 “Order Form / Signed Proposal” means a document, proposal, quote, renewal, invoice, accepted Stripe checkout, accepted Stripe Customer Portal change, or other record provided by Provider and accepted by Customer specifying the Software level, deployment election (Hosted vs On-Premise), applicable license model, Services, onboarding / implementation items (if any), fees, and other details of Customer’s engagement.
2.6 “Onboarding / Implementation Services” means one-time professional services purchased by Customer for initial setup, configuration, project management, custom API integration, training sessions, UAT facilitation (if included), validation support (if included), and related rollout activities, as described in the applicable Order Form / Signed Proposal. For clarity, ERP Gap Analysis and Proof of Concept engagements may be purchased either as Presales Services or as part of a broader onboarding scope, depending on the applicable commercial record.
2.7 “Onboarding Fees” means one-time fees for Onboarding / Implementation Services, billed upfront as stated in the applicable Order Form / Signed Proposal.
2.8 “ERP Gap Analysis” means a structured analysis of Customer’s ERP data model, workflows, and integration requirements to identify gaps, required mappings, and integration approach, which may be purchased in advance of implementation as a Presales Service or as part of an implementation engagement.
2.9 “Custom API Integration” means API integration work that is specific to Customer’s environment and requirements, including any custom mappings, transforms, or connectors beyond standard configuration, when purchased.
2.10 “Critical Issues” means severe Software malfunctions that prevent Customer from performing essential business operations reliant on the Software.
2.11 “Security Incident” means any unauthorized access, use, disclosure, alteration, or destruction of Customer Data, or a confirmed compromise of the confidentiality, integrity, or availability of Hosted Services.
2.12 “Sandbox Environment” means a separate, isolated testing environment provided by Provider for deploying Software upgrades prior to production use (or, for On-Premise Installations, an environment designated by Customer for testing).
2.13 “Customer Data” means all data uploaded to or generated by the Software by or on behalf of Customer (including regulated records), excluding Usage Data as defined in §2.19.
2.14 “Service Level Agreement (SLA)” means the performance guarantees and commitments outlined in Section 11 of this Agreement, including uptime, response times, and resolution targets for Hosted Services.
2.15 “Renewal Term” means each additional one-year period automatically commenced under Section 5.2.
2.16 “Invoice” means Provider’s written request for payment issued under Section 5.5 and / or Section 6.
2.17 “Device” means a dedicated human-machine interface (HMI) such as a PC or tablet computer used to access the Software, identified by a unique network interface (e.g., MAC address). For clarity, a “Device” does not include passive peripherals such as scales, scanners, printers, or similar equipment—even if such peripherals have IP or MAC addresses—unless expressly listed as licensed HMIs on a historical Order Form / Signed Proposal.
2.18 “Legacy User License” means a historical named-user license quantity reflected in a prior Order Form / Signed Proposal or renewal arrangement. Legacy User Licenses are no longer Provider’s current standard commercial model for new customers, but may continue to be recognized solely as part of a Customer’s grandfathered subscription arrangement under this Agreement.
2.19 “Legacy Device License” means a historical device-based license quantity reflected in a prior Order Form / Signed Proposal or renewal arrangement. Legacy Device Licenses are no longer Provider’s current standard commercial model for new customers, but may continue to be recognized solely as part of a Customer’s grandfathered subscription arrangement under this Agreement.
2.20 “Usage Data” means event-level data and metadata generated by Customer’s and Users’ interaction with the Software or Hosted Services, such as login timestamps, user / account identifiers, device or browser type, session duration, feature interactions, performance metrics, and application / error logs. “Usage Data” excludes the business content of Customer’s regulated records except to the extent incidentally captured in error logs.
2.21 “Aggregated / De-identified Data” means data that does not identify—and cannot reasonably be used to identify—any natural person or Customer.
2.22 “User” means an individual authorized by Customer to access the Software.
2.23 “Seat License” or “Seat” means a license entitling Customer to permit concurrent access to the Software by up to the number of simultaneously active Users purchased by Customer. A Seat is measured by concurrent use rather than total headcount. Customer may authorize more named Users than the number of Seats purchased, provided the number of simultaneously active Users does not exceed the licensed Seat count at any time. Provider may use session controls, authentication controls, audit logs, and other reasonable technical measures to enforce Seat limits and prevent circumvention.
2.24 “Grandfathered Subscription Terms” means subscription pricing, license quantities, commercial treatment, and related renewal rights that Provider has agreed to continue honoring for a specific Customer even though such pricing or structure originated under an older pricing model, historical named-user model, historical device model, or older converted service arrangement. For clarity, Grandfathered Subscription Terms are part of a current subscription relationship, not a perpetual license grant.
2.25 “Converted Legacy Customer” means a Customer whose older perpetual-license, support, service, named-user, or device-based commercial arrangement has already been converted to a subscription relationship, but whose pricing and/or commercial treatment may continue under Grandfathered Subscription Terms.
2.26 “Timely Payment” means Provider’s receipt in full of all undisputed invoiced amounts on or before the applicable due date stated on the Invoice or Order Form / Signed Proposal, without extension, carry-forward, or partial payment unless expressly agreed by Provider in writing.
2.27 “Documentation” means Provider’s then-current user guides, admin guides, release notes, and training materials made available to Customer.
2.28 “Confidential Information” means non-public information disclosed by a Party that is designated as confidential or that a reasonable person would understand to be confidential, including business, technical, pricing, security, product information, and Customer Data.
2.29 “DPA” means Provider’s Data Processing Addendum (if applicable), incorporated by reference where required by law and made available upon request.
2.30 “Assessment Documentation” means the independent assessment documentation made available by Provider regarding the Software’s alignment with technical controls commonly associated with 21 CFR Part 11, EU Annex 11, and GMP expectations (e.g., assessment report and supporting artifacts provided by Provider, if any).
2.31 “IQ / OQ” means installation qualification and operational qualification activities performed as part of Customer’s validation program in Customer’s environment.
2.32 “UAT” or “User Acceptance Testing” means the pre-go-live testing performed to confirm configured workflows and system behavior meet Customer’s intended use and acceptance criteria.
2.33 “POC” or “Proof of Concept” means a paid, limited-scope Services engagement intended to confirm fit quickly. POCs are intentionally constrained unless otherwise stated in the applicable Order Form / Signed Proposal and commonly exclude integrations, multi-site rollout, mass data migration, and validation services (IQ / OQ / UAT).
2.34 “Stripe Customer Portal” means Provider’s third-party billing portal used for subscription billing, payment method management, seat changes, billing-frequency changes where offered, renewals, and other commercial self-service actions.
2.35 “Account Manager” means Provider personnel authorized to quote, scope, approve, or coordinate additional Services, expansions, and development requests.
2.36 “Configurable Software Classification” means Provider’s classification of V5 as highly configurable standard software. Where useful for Customer validation planning, Provider may describe V5 using legacy GAMP 4-style terminology for configurable standard software; however, Customer remains responsible for validation of the actual configured intended use in Customer’s environment.
2.37 “Separate Branch Development” means software development, whether paid or complimentary, performed in a controlled source-code branch distinct from the main production branch until reviewed, tested, approved, and merged under Provider’s change control process.