Use of a Master Service Agreement Standardized Template to Expedite Contracting in Cell Therapies Product Onboarding

In the rapidly evolving field of cell therapies, Providers face the challenge of contracting individually with each Manufacturer to onboard new products. This process is complicated by the lack of standardization, as Manufacturer contracts vary widely in content, structure, and requirements. To address these challenges, we developed a Provider-drafted Master Service Agreement (MSA) standard template. A significant portion of the content commonly found in Manufacturers contracts can be standardized across products to align with Provider policies and operations. Our goal is to ensure consistency across agreements and reduce negotiation timelines, which in current state takes an average of 9 months. We hope this proactive strategy will alleviate the burden on both Providers and Manufacturers, while fostering more efficient and balanced partnerships during product onboarding. 1. Methods: Analyzed contracts in cell therapy portfolio so far negotiated to identify common concepts for standardization 2. Tested a preliminary “terms sheet” with one manufacturer in advance of their Master Service Agreement, with favorable Results: Reorganized concepts to follow intuitive order, reflective of Provider processes and allow for easy reference 3. Commenced review by operations and legal teams to align content 4. Identified contract content that contains organization specific language (proprietary), such as insurance, IP, etc. 5. Prepared a standardized MSA template to support negotiations with Manufacturer Identification of inconsistencies and gaps in contract standards between Manufacturer and Provider (Figure 1) ○ Reciprocal terms needed in contracts to support Provider policies ○ Organization of contracts need to reflect the intuitive order of operations ○ Redundancies throughout contracts prolong negotiations ○ Inconsistencies in content across supplemental documents, including quality agreement and trade policies ○ Variation in naming of contract by type (i.e. MSA, Trade Agreement, Terms broader adoption should shorten the nine-month negotiation cycle and refine the template while still accommodating proprietary provisions. In parallel, an initiative will standardize the Quality Agreement and require it for Manufacturers. Together, these actions will accelerate contracting and improve consistency across engagements.