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.
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.)
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)
- 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
Ready to streamline your life science contract process?
Biotech’s like AN2 have small legal teams, often one or two full time lawyers. To keep pace with the business, we must find ways to increase bandwidth—and we have to do so within budget and without sacrificing services levels. The lawyers at Lovell are seasoned practitioners who combine the focused expertise of outside counsel with the soft skills needed to build relationships and support in-house clients. I trust them to operate directly at all levels of our organization. My business colleagues appreciate the practical lawyering and efficient processing times. I appreciate that my team then has time and space to focus on more strategic and consequential matters.”
Chief Legal Officer @ AN2 Therapeutics
As the former Chief Legal Officer at Eisai, Actelion, and GW Pharmaceuticals, I have had the pleasure of working with Lovell since their inception in 2010. Their team of attorneys with diverse practice areas offers exceptional and creative contract support that is both friendly and knowledgeable. Lovell’s cost-effective approach to everyday contract needs is unparalleled, making them an indispensable partner for global pharmaceutical companies. I wholeheartedly recommend Lovell for their extraordinary work.”
Former Chief Legal Officer @ GW Pharmaceuticals / Actelion / Eisai
Having worked with many premiere law firms, it’s difficult for me to think of a better value than what Lovell delivers. Within 30 days of onboarding, the Lovell team seamlessly integrated themselves into my Legal department and absorbed much of the day-to-day operational contracting and related client counseling so that my team and I could focus on other strategic priorities for the Company. I’m continually impressed with the Lovell team’s breadth of experience and ability to practically advise on contracting matters ranging from pre-clinical research and clinical development through commercialization. Coupled with the firm’s responsiveness and professionalism, this has given me the confidence to leverage them as my go-to “outside-in-house counsel.”
General Counsel @ Frontier Medicines
I have worked with Lovell for almost 10 years and across 4 different biotech companies with good reason: Ken, Caroline, Nirali and the rest of Lovell team provide timely, professional and cost-effective routine contract review. What’s more, they can help establish contracting systems and processes from scratch, and then grow with your company as it makes its way through all stages of drug product lifecycle, including discovery, development, manufacturing and commercialization.”
VP, Legal @ Nuvation Bio
I am very pleased to share my experience working with Lovell. As an early-stage company, we lack in-house legal support, but Lovell has proven to be a game-changer for us. Their team effortlessly integrated with our business and provided us with invaluable templates and streamlined our operations. Lovell implemented a system for managing contracts that has made it easier for our executive leadership, finance, and business personnel to stay informed on the status of each agreement. I would highly recommend Lovell to anyone seeking exceptional contract support."
Nishan de Sliva
CEO @ Radionetics Oncology
I feel very fortunate to have found Lovell as a partner to serve our growing company’s legal needs. Above all, we are struck by Lovell’s attentiveness to our key projects, including our efforts to serve customers, build documentation for our software’s users, and tackle ongoing contractual discussions. Their partnership is clear, and we look forward to working together in the future.”
Founder and CEO @ Storyboard Technology
Your partner for the entire contract lifecycle
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