Life Sciences
Contracts
Lovell provides contract support to life sciences companies in five primary areas: Commercial, R&D/Preclinical, Clinical Trials, Manufacturing, and Health Care Providers (HCPs). We offer our clients industry-proven templates, as well as drafting and negotiating contracts on behalf of our clients. We collaborate with business personnel and legal departments (if present) to ensure a harmonious balance between our clients' commercial objectives and legal and regulatory necessities.
R&D / Preclinical
Developing a drug for the market takes many years of research and development, often lasting over a decade, and this process involves significant R&D expenditures. Contracts are used to manage the terms of these expenses. Lovell has ample experience with R&D and preclinical contracts, and can offer industry-tested, ready-to-use templates to make the contracting process easier and more efficient.
Clinical Trials
Life sciences companies face significant pressure to get the contracts
right for clinical trials. Lovell balances its clients’ needs to quickly activate sites and begin enrollment, while negotiating agreements pragmatically that manage risk, protect intellectual property rights, and ensure compliance with applicable data privacy laws and regulatory requirements.
Lovell attorneys have helped launch hundreds of clinical trials with thousands of sites, both in the United States and abroad.
- Site Feasibility
- Lovell provides quick and efficient negotiation of confidentiality agreements with potential clinical trial sites
- Negotiate contract research organizations (CRO) agreements
- Provide industry-tested and ready to use clinical trial agreement (CTA) templates for U.S. sites
- Strengthen and tailor CRO-provided CTAs
- Playbooks for CTAs
- Lovell offers a playbook for its template CTA
- We also review and improve playbooks provided by CRO
- Negotiate CTAs with sites
- Review informed consent form
- Negotiate all clinical trial related agreements (i.e., consulting, lab support, testing, etc.)
Manufacturing (CMC)
For all life sciences companies, establishing a dependable and adaptable supply chain is a crucial task. Lovell facilitates the negotiation of agreements pertaining to pre-clinical laboratory services, formulation and development, and cGMP manufacturing for both clinical and commercial use.
Health Care Providers (HCPs)
Developing and marketing new medicines with the aim of helping patients requires relationships with health care professionals (HCPs) that are crucial to the mission. Life sciences companies are held to the most stringent ethical standards and legal requirements when it comes to interacting with HCPs. Lovell assists clients in navigating the constantly evolving landscape of legal, compliance, and regulatory matters related to HCP engagements, which are subject to unprecedented levels of scrutiny.
Lovell offers its clients numerous industry-tested and ready-to-use templates.
Life science contract templates:
- Clinical Trial Agreement
- Playbook for Clinical Trial Agreement
- Investigator Initiated Study Agreement
- Master Services Agreement (Contract Research Organization)
- Amendments
- Authorization and Release for Photos/Videos/Recordings
- CDAs (Mutual, One-Way, Three-Way, Business Development)
- Consulting Agreements
- Grant Agreement
- Master Services Agreement
- Statements of Work / Work Orders / Task Orders
- Services Agreement (one-time use)
- Settlement Agreement and Release
- Sponsorship Agreement
- Advisory Board Agreement
- Consulting Agreements (U.S. and Ex-U.S.)
- For HCPs, HCP Entities and Healthcare Organizations
- Educational Program Agreement
- Poster Presentation Agreement
- Speakers’ Bureau Agreement
- Sponsored Research Agreement
- Master Services Agreement (Chemistry, Manufacturing, and Controls)
- Ambassador Agreement
- Authorization and Release for Protected Health Information
- Consulting Agreement
- Master Services Agreements (R&D) Materials Transfer Agreements
*Looking for Industry-neutral contract templates? Click Here
Ready to streamline your life science contract process?
