MASTER CLINICAL DEVELOPMENT AGREEMENT

 

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                                                                    Exhibit 10.3

 

 

 

 

 

                                     MASTER

                         CLINICAL DEVELOPMENT AGREEMENT

 

 

                                    between

 

 

                             AVANIR PHARMACEUTICALS

                              San Diego, CA 92121

 

 

                                      and

 

 

                               SCIREX CORPORATION

                               Horsham, PA 19044

                                        

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                     MASTER CLINICAL DEVELOPMENT AGREEMENT

 

     THIS AGREEMENT, made as of the date last signed below is by and between

Avanir Pharmaceuticals, a company having its principal place of business at

11388 Sorrento Valley Road, Suite 200, San Diego, CA 92121 ("Avanir"), and

SCIREX Corporation a corporation of the State of Delaware having its principal

place of business at 755 Business Center Drive, Horsham, PA 19044 ("SCIREX").

 

                                  WITNESSETH:

 

     WHEREAS, Avanir is engaged in the development, manufacture, distribution

and sale of pharmaceutical products and it currently considers from time to time

the evaluation of new drug(s) ("Drug" or "Drugs" as the context requires); and

 

     WHEREAS, SCIREX is in the business of providing services for the

development of experimental new drugs and marketed drugs; and

 

     WHEREAS, Avanir desires to contract with SCIREX from time to time, and

SCIREX desires to be contracted by Avanir, for the purposes of providing such

services to assist Avanir in the execution of clinical development projects

("Project" or "Projects" as the context requires) relating to Drugs as outlined

in the project-specific exhibits to this Agreement ("Exhibit" or "Exhibits" as

the context requires).

 

     NOW, THEREFORE, the parties hereby agree as follows:

 

                            1.  OBLIGATIONS OF SCIREX

 

     SCIREX hereby agrees to conduct the Projects in accordance with Avanir's

instructions. The details, specifications and obligations of each Project will

be included as an Exhibit. SCIREX will conduct the Projects in accordance with

agreed upon protocols and as outlined in the Exhibits. Projects will be

conducted in accordance with all applicable federal, state and local laws,

statutes, ordinances and regulations.

 

                       2.   TRANSFER OF RESPONSIBILITIES

 

     For compliance under 21 CFR 312.52, Avanir must identify all

responsibilities which will be transferred to SCIREX. Each Exhibit will contain

a detailed description of transferred obligations. Avanir agrees that the same

description and extent of obligations transferred should be included in form

FDA-1571, Section #13 relating to the specific Drugs under investigation. SCIREX

agrees to carry out diligently all transferred obligations.

 

 

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                             3.   CLINICAL SUPPLIES

 

     Unless otherwise specified in an Exhibit, Avanir will supply the clinical

investigators with the Drugs and other clinical drug supplies as are agreed upon

by SCIREX and Avanir for the timely completion of the Projects, and will direct

the shipment of any such supplies to the location indicated by SCIREX, within a

reasonable time after receipt of notification from SCIREX of the need for any

such clinical supplies.

 

                             4.   STATUS REPORTING

 

     SCIREX will provide status reports on the Projects as agreed to in each

specific Exhibit. The status reports will include, but not be limited to, data

regarding the number of patients entering the Projects, as well as data

regarding the number of patients that either drop out of the Projects or

complete the Projects. Reports of monitoring visits will also be provided on a

timely basis as specified in the Exhibits.

 

                          5.  CONFIDENTIAL INFORMATION

 

     All information received by SCIREX concerning the implementation of the

Projects is considered to be confidential information to Avanir ("Avanir

Confidential Information"). Avanir Confidential Information will be held in

confidence by SCIREX and not disclosed to third parties; provided however, that

Avanir Confidential Information shall not include, and the obligations of

confidentiality and non-disclosure shall not apply to, disclosed information

that:

 

     A.   is or becomes publicly available through no fault of SCIREX;

 

     B.   is disclosed to SCIREX by a third party entitled to disclose such

          information;

 

     C.   is already known to SCIREX as shown by its prior written records; or

 

     D.   is required by law to be disclosed.

 

     SCIREX will only use the Avanir Confidential Information for the purpose of

its obligations under this Agreement. Upon the completion or earlier termination

of this Agreement, SCIREX will promptly return to Avanir all written Avanir

Confidential Information, as well as all written material which incorporates any

Avanir Confidential Information, other than such information that is required by

government regulations to be retained by it. Notwithstanding the foregoing,

SCIREX shall have the right to retain one copy of Avanir Confidential

Information for the purposes of demonstrating compliance with GCPs, SOPS, Avanir

written instructions, and all federal, state and local laws and regulations.

 

 

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     SCIREX will not disclose, without the prior written consent of Avanir, any

Avanir Confidential Information to any third party other than employees who have

a need to know such information, hospital authorities, institutional review

board members, clinical investigators, and others who must be involved the

Projects.

 

     SCIREX will not use any Avanir Confidential Information for its own benefit

or for the benefit of any third party, and will not furnish to any third party

any materials which incorporate any confidential information except as otherwise

provided for herein. All obligations of confidentiality and non-disclosure set

forth in this Agreement will survive, without limitation, the expiration or

earlier termination, for any reason, of this Agreement.

 

     During the term of this Agreement and thereafter (including following any

termination), Avanir, for itself and its employees, agents and independent

contractors, agrees to retain in confidence and not disclose to any third

parties any SCIREX Confidential Information (defined below) without having first

obtained SCIREX' written consent to such disclosure. During the term of this

Agreement, but not thereafter (including following any termination), Avanir may

have access or use SCIREX Confidential Information only in connection with the

Projects; provided, however, that Avanir may not run or have or have access to

SCIREX computer programs or computer code without SCIREX' permission, although

SCIREX will run its computer programs as part of the services provided hereunder

and as and when requested by Avanir during the term of this Agreement. "SCIREX

Confidential Information" shall include but not be limited to confidential and

proprietary know-how, statistical approaches, computer programs, operating

procedures, formulations, methods, processes, specifications and all other

intellectual property of SCIREX that SCIREX considers confidential; provided,

however, that such information shall be to exceptions based on public knowledge,

prior or lawfully obtained Avanir knowledge and requirements of law, rules and

regulations corresponding to the exceptions set forth in A-D above.

 

                        6.   ACCEPTANCE OF WORK PRODUCT

 

     Avanir agrees to review all work products submitted by SCIREX and to advise

SCIREX promptly of any errors or omissions of which Avanir becomes aware in the

course of its review or thereafter. SCIREX shall, at its expense, correct all

errors that it discovers or which are brought to its attention by Avanir within

ninety (90) days after submission of work product to Avanir. Notwithstanding any

other provision of this Agreement, SCIREX shall not be liable to Avanir, its

affiliates, successors or assigns for errors in work product which are not known

to SCIREX and are not brought to SCIREX attention within the above-stated notice

period. SCIREX' liability within the above-stated notice period shall be limited

to correction of the errors brought to its attention and shall not include

consequential or special damages, including, without limitation, loss of

profits. If errors or omissions are not known to SCIREX or brought to its

attention within

 

 

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the above-stated notice period, the work product to which they relate shall

be deemed accepted and approved by Avanir.

 

                               7.   COMPENSATION

 

     Avanir shall pay to SCIREX the investigator fees and other out-of-pocket

costs and fees set forth in the Exhibits. SCIREX shall complete the transferred

obligations and the Projects by the dates specified in the Exhibits except for

delays caused by Avanir or others, events outside of SCIREX control, or mutual

agreement between SCIREX and Avanir.

 

     The payment schedule for each Project will be contained in the appropriate

Exhibit.

 

     SCIREX will submit i