Proposal For Clinical Research Services

Exhibit 10.2

CONFIDENTIAL TREATMENT REQUESTED

WITH RESPECT TO CERTAIN PORTIONS HEREOF

DENOTED WITH " ***"


A Proposal to Provide Clinical Research Services for:


Protocol: BUP-201

*** Evaluation of the Efficacy, Safety, and Tolerability of BEMA99 Buprenorphine in the Treatment of Pain Associated with ***


Prepared for:

David Blum, MD

Vice President, Clinical Research and Medical Affairs

BioDelivery Sciences International

801 Corporate Center Drive, Suite 210

Raleigh, NC 27607

Tel: 919.582.9050

Fax: 919.582.9051

Email: dblum@bdsinternational.com

Project No. ***

09 February 2009

Previous: ***

Prepared by:

Pam Myrick Senior Associate II, Proposal Development BRUCE M. WAKEMAN Vice President U.S., Business Development

Premier Research Group TEL: 727.865.0803 322 Monte Cristo Blvd MOBILE: 727.244.9809 Tierra Verde, FL 33715 EMAIL: bruce.wakeman@premier-research.com


CONFIDENTIAL TREATMENT REQUESTED WITH RESPECT TO CERTAIN PORTIONS HEREOF

DENOTED WITH " ***"


Table of Contents

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EXECUTIVE SUMMARY 1

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PROJECT CONSIDERATIONS 3

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PROJECT RESPONSIBILITIES 4

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PROJECT OUTLINE 5

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PROJECT TIMELINE 6

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PROJECT TEAM DESIGN 7

BDSI/Premier Research Project Team Organizational Chart 8

Project Team Leadership 9

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PROJECT IMPLEMENTATION PLAN 12

Project Plan Development 12

Parallel Processing Approach99 12

Start-up Activities 12

Enrollment Plan 13

Communication 13

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PRICE SUMMARY 15

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DETAILED COST ESTIMATE 16

Notes on Pass-through Estimates 19

I.

Travel Costs 22

II.

Institutional Review Board (IRB) Fees 22

III.

Shipping 22

IV.

Miscellaneous 22

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CLINICAL RESEARCH CENTER INVESTIGATOR GRANT SUMMARY 20

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SERVICE DESCRIPTIONS 21

2. Project Management 26

3. Clinical Monitoring and Site Management 27

4. Biostatistics 31

5. Quality Assurance 33

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PAYMENT SCHEDULE 39


CONFIDENTIAL

This document is provided with the understanding that the copyright and the information contained herein remains the

property of Premier Research Group Limited. It shall be kept confidential and used only by the company or person to whom

it is addressed, for no purpose other than assessing the merits of Premier Research Group Limited.

CONFIDENTIAL TREATMENT REQUESTED WITH RESPECT TO CERTAIN PORTIONS HEREOF

DENOTED WITH " ***"


Executive Summary

Premier Research Group Limited (" Premier Research" ) is pleased to present this revised proposal in support of the BEMA99 Buprenorphine program in patients with *** . In response to your request, we have prepared the following proposal outlining our strategy to successfully conduct this study. We look forward to this opportunity to collaborate with the BDSI team and appreciate the study information you have provided. We have attempted to accurately respond to your needs in the proposal text and cost estimate, and trust that the information in this document will be informative and valuable as you determine your outsourcing needs. Where there are outstanding issues or answers yet unknown, Premier Research has made related assumptions.

In the pages that follow, we present compelling reasons why Premier Research is the best choice for this project. Those reasons include:

Premier Research is recognized as an industry leader in clinical research for acute and chronic pain, having managed more than 350 analgesia trials treating more than 90,000 patients. We have conducted some of the largest and most important drug trials in pain in multi-center trials around the world and at our Research Centers in the United States.

Mr. Michael Kuss, Vice President, Clinical Research Centers, in particular, is an expert in the field of analgesia research and as part of Premier Research' s commitment to quality assurance, is offered in a supervisory capacity at no charge to BDSI throughout the course of the study. Mr. Kuss is familiar with many of the aspects involved in conducting successful pain studies and will offer his scientific guidance and therapeutic expertise on critical success factors crucial to the conduct of this program.

Together with our operational experts, the senior leadership at Premier Research understands the challenges and nuances involved in pain studies and will be available to support the project team as needed. Our experienced study team will provide more efficient program execution, including the ability to predict and overcome complex study issues in an expeditious manner and complete this study within the timeline BDSI has requested.

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Experienced Staff Available to Meet Your Timelines

Our experienced study team will provide more efficient study execution, including the ability to predict and overcome complex study issues in an expeditious manner. We can provide a detailed staffing plan, including team member credentials, which are unrivaled in the industry.

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Top-Down Commitment to Customer Satisfaction

We are small enough to provide appropriate levels of oversight to ensure that projects are conducted in a timely and efficient manner, but large enough to provide Sponsor with staffing and pricing considerations appropriate to a long term relationship.


Confidential

4395 BioDelivery Sciences International Proposal v3

Protocol: BUP-201

CONFIDENTIAL TREATMENT REQUESTED WITH RESPECT TO CERTAIN PORTIONS HEREOF

DENOTED WITH " ***"

Sponsor: BioDelivery Sciences International Study Medication: BEMA99 Buprenorphine Protocol Number: BUP-201 Protocol Title: *** Evaluation of the Efficacy, Safety, and Tolerability of BEMA99 Buprenorphine in the Treatment of Pain Associated with *** Clinical Phase: II Indication: *** Participating Regions: North America Number of Subjects Enrolled/Complete: *** Number of Sites Participating: *** Premier Research Services Requested: Clinical Trial Management, Biostatistics, Quality Assurance Total Estimated Investigator Grant: $ *** Duration of CRO Services: *** Total Estimated Premier Research Fees: $***

We hope that the information in this document demonstrates our capabilities in this indication and conveys Premier Research' s commitment to becoming a true partner with you in reaching and exceeding study goals. We enthusiastically anticipate the prospect of conducting this important program for BDSI and look forward to further discussions with you regarding the information we have provided.


Confidential

4395 BioDelivery Sciences International Proposal v3

Protocol: BUP-201

CONFIDENTIAL TREATMENT REQUESTED WITH RESPECT TO CERTAIN PORTIONS HEREOF

DENOTED WITH " ***"


Project Considerations

Premier Research understands the important role that we will play in the conduct of this study and looks forward to collaborating with BDSI to assure the study' s success. In preparing this proposal, we have sought input from our in-house operations and medical specialists on the design, study timeline and other factors related to enrollment and investigator site selection. The following are issues that Premier Research has identified for your consideration and that we feel are important to the successful completion of the program. The below comments are based on the original study synopsis date *** provided by BDSI to Premier Research. ullet

Premier Research would like to recommend a *** .

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We would also like to suggest the use of *** . If no *** are to be evaluated, we would recommend that *** also be used as the *** .

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Premier Research would like to suggest the use of the *** .

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Premier Research would recommend the use of a modified BOCF imputation procedure instead of the currently proposed *** for the primary analysis.

We welcome the opportunity to discuss further the issues associated with this trial and present our capabilities in person upon BDSI' s request. Please see the following project responsibilities, outline, timeline, and budget summary for a complete list of assumptions and specifications that factored into our proposal.

Confidential

4395 BioDelivery Sciences International Proposal v3

Protocol: BUP-201

CONFIDENTIAL TREATMENT REQUESTED WITH RESPECT TO CERTAIN PORTIONS HEREOF

DENOTED WITH " ***"


Project Responsibilities

***


Confidential

4395 BioDelivery Sciences International Proposal v3

Protocol: BUP-201

CONFIDENTIAL TREATMENT REQUESTED WITH RESPECT TO CERTAIN PORTIONS HEREOF

DENOTED WITH " ***"


Project Outline

***


Confidential

4395 BioDelivery Sciences International Proposal v3

Protocol: BUP-201

CONFIDENTIAL TREATMENT REQUESTED WITH RESPECT TO CERTAIN PORTIONS HEREOF

DENOTED WITH " ***"


Project Timeline


Activity

Timeframe

Projected Dates

***


Confidential

4395 BioDelivery Sciences International Proposal v3

Protocol: BUP-201

CONFIDENTIAL TREATMENT REQUESTED WITH RESPECT TO CERTAIN PORTIONS HEREOF

DENOTED WITH " ***"


Project Team Design

Premier Research will draw from our collection of qualified individuals to provide BDSI with a team that has the skills, knowledge, and relevant experience to successfully manage your clinical trial. We are organized into several separate operational units; skill centers that perform the majority of the day-to-day client services: Clinical Trial Management, Medical Management, Data Operations, Biostatistics, Medical Writing, Regulatory Affairs, Quality Assurance and Information Technology Client Services (our Interactive Voice Response systems). Each skill center provides the resources for the services required in drug development for their respective areas.

Project teams are the primary functional unit at Premier Research. A Project Manager, Clinical Manager, and Biometrics Project Manager generally comprise the leadership of the project team. With scientific guidance provided by our therapeutic experts in Medical Affairs and senior level management and oversight provided on every project, we offer a strong focus on your needs leading to a project team that is proactive, highly skilled and responsive.

The Project Manager is ultimately responsible for overall strategy, planning and execution of the project, from start to finish. Experienced in the indication and/or therapeutic area required, these team members provide the necessary scientific and operational oversight to ensure that our programs and projects stay on the critical path and that our clients receive timely and high quality deliverables.

Another element that contributes to the success of the project team is the Biometrics Project Manager (BPM). Because study start up is a very busy time with the initiation of activities in all disciplines, the benefits of a BPM joining the team maximize the attention to all details at the launch of a trial. The management responsibility of the study is then shared between the project manager and the BPM. The Project Manager focuses on clinical, medical, safety, and regulatory activities while the BPM focuses on the IVRS, data management, biostatistics, and medical writing activities. This allows the Project Manager to spend more time on external critical relationships and increase the time dedicated to the sites and the site staff allowing our team to build long term networks. The Project Manager remains responsible for the clinical study from beginning to end but has the added resource of a BPM to assist in the management of the back end services.

Premier Research' s Parallel Processing Approach, combined with our focused management strategy, ensures our clients the most efficient and cost-effective clinical trial. In addition, one key team member is assigned from each skill center and is responsible for the major set of tasks and deliverables provided by his or her skill center. Each project team is completed by a number of contributors; individuals with backgrounds and expertise from their skill centers that are needed to satisfactorily execute the requirements of a given project. The project team will exist for the duration of the project. However, the amount and continuity of time spent on the project will vary depending on the role of the individual assigned to the project. The project team will receive support from the heads and line managers within the skill centers, along with senior management when needed.


Confidential

4395 BioDelivery Sciences International Proposal v3

Protocol: BUP-201

CONFIDENTIAL TREATMENT REQUESTED WITH RESPECT TO CERTAIN PORTIONS HEREOF

DENOTED WITH " ***"


Premier Research believes that this team structure: ullet

Ensures the efficient use of each team member' s knowledge and experience, ullet

Ensures the focused management of each individual study,

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And provides overall guidance for all projects and programs, ensuring comprehensive project operations, team integration and seamless execution of the program.

We have provided an organizational chart displaying the structure of this team, and we have also included biographical sketches of our team leaders to demonstrate why BDSI can be assured that it will be working with a skilled and knowledgeable team.

BDSI/Premier Research Project Team Organizational Chart


Confidential

4395 BioDelivery Sciences International Proposal v3

Protocol: BUP-201

CONFIDENTIAL TREATMENT REQUESTED WITH RESPECT TO CERTAIN PORTIONS HEREOF

DENOTED WITH " ***"


Project Team Leadership

Michael Kuss, BS

Vice President, Clinical Research Center Administration Mr. Michael Kuss has worked for Premier Research Group since 2001. He currently is the Vice President of the Clinical Research Centers. He previously served as the Vice President of Medical Affairs in Analgesia and as the Executive Director, Clinical Trials Management for three years and worked as a Senior Director, Analgesia and Rheumatology, (SCIREX Corporation). From 1986 to 2001 he worked for Pharmacia (formerly G.D. Searle) in various positions with the last being Director of Research and Development. Prior to G.D. Searle, Mr. Kuss worked as a Clinical Research Associate, (Abbott Laboratories), and as an Infectious Diseases Research Technologist, (Good Samaritan Hospital and Wright State University SOM).

While at Premier Research Group, Mr. Kuss has worked primarily on projects in the Analgesia and Rheumatology area. He is responsible for working with clients to help develop clinical development plans, write protocols, manage Premier study teams to conduct clinical trials and participate in the preparation of clinical study reports. At Pharmacia, Mr. Kuss was responsible for clinical development of several COX-2 inhibitors (celecoxib, valdecoxib and parecoxib) and NSAIDs (oxaprozin, oxaprozin potassium and diclofenac/misoprostol) as part of the Arthritis and Inflammation team. He also played an integral part in the development of lomefloxacin, a quinolone anti-infective. He is an author on many publications and posters in the areas of analgesia, rheumatology and infectious diseases. Mr. Kuss graduated from Wright State University in Dayton, Ohio with a BS in Medical Technology. He received a certification in Medical Technology from the American Society of Clinical Pathology.

Mr. Kuss is a member of the American Pain Society and Drug Information Association. He is a frequent presenter at annual meetings of the American Pain Society and American College of Rheumatology annual meetings. He has presented at the DIA annual meeting and at several DIA sponsored symposia.

Clinical Executive Leadership

Stephen Daniels, DO Executive Medical Director, Clinical Research Center Administration

Dr. Stephen Daniels is the Executive Director of the Research Centers, a position he has held for over five years. Dr. Daniels has served as principal investigator on numerous acute pain trials, including many in dental, bunionectomy, knee arthroscopy and dysmenorrhea which involved oral, parenteral, and intranasal analgesics.

Prior to joining Premier Research, Dr. Daniels spent two years as the Medical Director at Research for Health in Houston, TX and prior to that was Medical Director as RLC Healthcare. Dr. Daniels is a graduate of Texas Wesleyan College and Texas College of Osteopathic Medicine where he received his D.O.

Over the past 5 years Dr. Daniels has authored or co-authored 12 publications in peer-reviewed medical journals and provided medical oversight on all acute pain analgesic trials conducted within the Clinical Research Centers.


Confidential

4395 BioDelivery Sciences International Proposal v3

Protocol: BUP-201

CONFIDENTIAL TREATMENT REQUESTED WITH RESPECT TO CERTAIN PORTIONS HEREOF

DENOTED WITH " ***"


Craig Dale, BBA

Executive Director, Clinical Trial Management

Mr. Dale has worked for Premier Research Group since 1998. He currently works as Executive Director, Clinical Trial Management. Previous to that, he worked as a Senior Director, Clinical Trials Management (2005 - 2007), as a Project Director, General Medicine, (2001 - 2005) and as Senior Project Manager, General Medicine, (1998-2001). He will be available to consult with the project team during these studies and will act as a liaison with BDSI as needed. Mr. Dale' s supervision is part of Premier Research' s commitment to quality assurance and is offered at no charge to BDSI.

From 1990 to 1998, Mr. Dale worked for Pharmaceutical Product Development (PPD) in various positions with the last being Senior Project Manager. While at Premier Research Group, Mr. Dale has worked primarily on projects in the General Medicine and Analgesia therapeutic areas including cardiovascular, gastroenterology and pain management. He is responsible for working with clients to help develop clinical development plans, provide therapeutic expertise to internal and external clients, manage Premier study teams to conduct clinical trials and participate in the preparation of clinical study reports.

Mr. Dale graduated from the University of Mississippi in Oxford, MS with a BBA in Marketing. He is a member of the American Pain Society and Drug Information Association.

Project Manager

Daniel Solorio, BS

Senior Project Manager, Clinical Research Centers

Mr. Solorio is responsible for overseeing the clinical operations of one or more multi-disciplinary project teams conducted in the clinical research centers. In this role, Mr. Solorio ensures that the project team has a common understanding of project objectives, specifications, deliverables, timelines and tasks.

Mr. Solorio began his career in 1996, and has been with Premier Research since 2000 focusing his experience in clinical site operations. Prior to becoming a Project Manager, Mr. Solorio worked two years as a Site Manager, one year as a Clinical Research Coordinator, and one year as a Supervisor for Clinical Research Coordinators at the Clinical Research Center in Salt Lake City, UT.

Mr. Solorio received his B.A. in Communications from the University of Utah.

Biometrics Project Management

Lisa Vickers, BA

Biometrics Project Manager

As a Biometrics Project Manager (BPM), Ms. Vickers is responsible for the overall project management of the data management, statistics and medical writing services. Ms. Vickers has worked on numerous Phase I to Phase IV projects in oncology, CNS, cardiovascular, endocrinology, urology, women' s health, immunology, dermatology, and respiratory.

Lisa Vickers has been in the Manager, Biometrics position with Premier Research Group since January 2006. Ms. Vickers was employed with PharmData Inc. as a Biometrics Project Manager from November 2003. Prior to that Ms. Vickers worked as both a Medical Writer and Project Assistant at PharmData and held positions of increasing responsibility at WorldCom.


Confidential

4395 BioDelivery Sciences International Proposal v3

Protocol: BUP-201

CONFIDENTIAL TREATMENT REQUESTED WITH RESPECT TO CERTAIN PORTIONS HEREOF

DENOTED WITH " ***"


Ms. Vickers obtained a Bachelor' s degree in Psychology and a Bachelor' s degree in Marketing from Miami University in Oxford, OH. Ms. Vickers is a member of DIA and was a member of the American Medical Writers Association for 3 years, serving as Membership chair from 2002-2003.

An experienced BPM will be assigned to BDSI' s program upon finalization of the protocol.

Biostatistics

James Johnson, PhD

Executive Director, Global Biostatistics

Dr. James Johnson is the Executive Director, Global Biostatistics with overall responsibility for strategic and tactical management for biostatistics, pharmacokinetics and biostatistical programming functions for the Premier Research. He is responsible for implementing best biostatistical and statistical programming practices, standard operating procedures, and a systems approach integrated clinical/statistical critical thinking toward drug development and clinical trial design and analysis.

Dr. Johnson has twenty-five years technical experience and leadership in Biostatistics, Clinical Trials Design and Analysis, Project Management, and International Regulatory Agency interaction. In addition Dr. Johnson provides biostatistical consulting services in the areas of cardiology, oncology, dermatology, and infectious diseases. Dr. Johnson serves on data monitoring committees and is a sub-principal investigator for a long term cardiac imaging study. Dr. Johnson has also been the lead biostatistician on five New Drug Applications, supported six additional ANDAs, and participated in many different international regulatory interactions (FDA, MHRA, EMEA, Health Canada, and Australian TGA) in his career. Dr. Johnson holds a PhD degree from North Carolina State University, along with a Master' s degree from the College of William and Mary. He is an author of over 30 publications, abstracts, and professional meeting presentations.

An experienced Biostatistician will be assigned to BDSI' s program upon finalization of the protocol and award of the program and will work under the direct supervision of Dr. Johnson to support this project.


Confidential

4395 BioDelivery Sciences International Proposal v3

Protocol: BUP-201

CONFIDENTIAL TREATMENT REQUESTED WITH RESPECT TO CERTAIN PORTIONS HEREOF

DENOTED WITH " ***"


Project Implementation Plan

Project Plan Development

Premier Research believes that establishing a clear and agreed upon project plan between BDSI and Premier Research prior to study start up activity is critical to the success of any collaboration. Working in concert, the leadership team for each study develops a study-specific project plan detailing project specific information and procedures to be used to carry out the activities of the clinical team. The plan will include a description of the project team and any metrics used to assess performance.

In addition, the project plan will determine appropriate communication channels, identify expectations, processes and responsibilities, and define study timelines, interim turnaround times, and critical path milestones for both Premier Research and BDSI.

Parallel Processing Approach99

Premier Research has developed a simple but highly effective strategy, the Parallel Processing Approach99 (PPA), to ensure quality, speed and cost-effectiveness. We have tested, refined, and perfected this approach over a twelve year period on over 400 projects. Using the Parallel Processing Approach, each biometrics discipline initiates and processes its part of the project as quickly as possible. As soon as the study protocol and CRF are finalized, the data management group begins the database design, the statistical group begins the statistical analysis plan (SAP) and identification of feasibility checks and the medical writing group begins the shell report. As data arrives, it is cleaned and entered. Edit checks are run against new data and these subsets of (blinded) data are used to test and validate the statistical analysis programs. The writers lay out the format of the report, including all tables, figures, and listings defined in the SAP, per FDA and ICH guidelines. In short, all the critical processes and procedures are conducted simultaneously so that by the time the final CRF data is entered and validated, all the SAS programming, the study report format, and table, graph, and analysis formats have been completed and agreed upon. Once the report is generated, an extensive ' end-to-end' review procedure is executed during which all data and results of the study are quality controlled. Because extensive ' pre-reviews' have already been done and incorporated for style, format and content issues, the final review is extremely efficient and ensures a high quality product is delivered quickly.

Start-up Activities

1. Team Training and Meetings

The availability of a final protocol and informed consent and assent templates at the beginning of the study will prevent unnecessary delays in supporting the sites with IRB submissions. Following the award of a project, the core project team, including the support of senior clinical trial management staff and business development, hold a ' hand-over' meeting that serves as the first step in launching a clinical trial at Premier Research. Because departments within our company work closely together, the project team is well informed and we will be prepared to act quickly to initiate the start of this study.


Confidential

4395 BioDelivery Sciences International Proposal v3

Protocol: BUP-201

CONFIDENTIAL TREATMENT REQUESTED WITH RESPECT TO CERTAIN PORTIONS HEREOF

DENOTED WITH " ***"


Premier Research generally holds a project kick-off meeting with BDSI. SOP, therapeutic and study specific training are tantamount to Premier Research' s practice of quality team performance, thus, this training is combined with the kick-off meeting and/or the Investigators' Meeting.

Prior to conducting initiation visits, CRAs are provided with a study-specific agenda and associated presentation to ensure consistent dissemination of study information. CRAs will have been trained with regard to the expectations for the following: query/issue resolution, site communication, project team communication, and routine visit report writing.

2. Collection of Essential Documents and IRB Submission

At the outset, several members of the Premier Research project team will be dedicated to the review and collection of regulatory documents from the investigative sites. The entire process will be closely managed and incorporate several means of communication between Premier Research and the sites to reduce errors and expedite the receipt of accurate critical documents.

Key to the management of regulatory submission is the tracking of IRB review meetings. This task is undertaken by the Premier Research clinical trial management team and tracked closely throughout the course of study start-up. Compared to local site IRB review periods that can take two to three months (if not more at times), central IRBs that Premier Research has working experience with have an average review period of two to four weeks. Sites that ...