Overview
This agreement outlines the terms between Spectral Medical Inc. and Vantive Health Inc. concerning the distribution and commercialization of Spectral's medical products.
Key Provisions- Appointment and Exclusivity
- Vantive is appointed as the exclusive distributor for Spectral's PMX product in Canada and the United States.
- Vantive is also a non-exclusive distributor for Spectral's EAA product.
- A non-compete clause restricts Spectral from engaging in certain activities that could compete with Vantive's distribution efforts.
- Governance and Oversight
- A Joint Steering Committee (JSC) will be established to oversee the partnership's operations, including regular meetings and dispute resolution procedures.
- Regulatory Responsibilities
- Both parties have defined responsibilities concerning regulatory submissions, pharmacovigilance, product labeling, and the ability for Vantive to act as the marketing authorization holder for the EAA product. avantisai.com
- Commercialization and Marketing
- Vantive is responsible for the promotion, training, and commercialization of the products, adhering to agreed-upon standards of care and cost structures.
- Supply and Delivery
- The agreement details forecasting, purchase orders, minimum purchase requirements for PMX products, continuity of supply, shipment, delivery schedules, and product warranties.
- Financial Terms
- Specifics regarding product pricing, consideration, taxes, invoicing, and payment procedures are outlined to ensure clarity in financial transactions between the parties.
- Quality Assurance and Product Recall
- Both parties have obligations related to maintaining product quality and managing any potential product recalls, ensuring compliance with regulatory standards.
- Original Official Filing
Updated Spectral Medical / Vantive Distribution Agreement
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