MASTER CLINICAL DEVELOPMENT AGREEMENT

Exhibit 10.21

 

MASTER

 

CLINICAL DEVELOPMENT AGREEMENT

 

between

 

NEUROBIOLOGICAL TECHNOLOGIES, INC.

Mahwah, NJ 07495

 

and

 

SCIREX CORPORATION

Horsham, PA 19044

MASTER CLINICAL DEVELOPMENT AGREEMENT

 

THIS MASTER CLINICAL DEVELOPMENT AGREEMENT (“Agreement”), made as of the date last signed below is by and between Neurobiological Technologies, Inc., a company having its principal place of business at Crossroads Corporate Center, One International Boulevard, Suite 400, Mahwah, NJ 07495 (“NTI”), 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, NTI 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) or biological product(s) (collectively, “Drug” or “Drugs” as the context requires); and

 

WHEREAS, SCIREX is in the business of providing services for the development of investigational new Drugs and marketed Drugs; and

 

WHEREAS, NTI desires to contract with SCIREX from time to time, and SCIREX desires to be contracted by NTI, for the purposes of providing such services to assist NTI 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

 

1.1 SCIREX hereby agrees to conduct the Projects with all due diligence in accordance with NTI’s instructions. The details, specifications and obligations of each Project will be included as an Exhibit to this Agreement. SCIREX will conduct the Projects in accordance with agreed upon Protocols and as outlined in the Exhibits.

 

1.2 No Project Exhibit shall be made or incorporated as a part of this Agreement without first being executed by the authorized representatives of the parties hereto.

 

1.3 To the extent any terms set forth in a Project Exhibit conflict with the terms of this Agreement, the terms of this Agreement shall control unless otherwise expressly set forth by the parties in the Project Exhibit.

 

1.4 Projects will be conducted in accordance with all applicable federal, state and local laws, statutes, ordinances and regulations, including without limitation the Federal Food, Drug and Cosmetic Act, Public Health Service Act, and Good Clinical Practices guidances as they may be amended from time to time.

 

1.5 If SCIREX is required to execute or obtain the execution of any agreements with a site to conduct a clinical trial or study (“Site Agreements”), such Site Agreements shall contain all provisions as specified by NTI in the applicable Project Exhibit or as otherwise approved in advance by NTI in writing, and shall include binding budgets approved in advance by NTI.

 

1.6 SCIREX shall not subcontract or assign any of its obligations unless otherwise expressly set forth by the parties in the Project Exhibit.

 

1.7 SCIREX will immediately notify NTI of any reasonable suspicion of fraud it has by any party.

 

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2. TRANSFER OF RESPONSIBILITIES

 

2.1 For compliance under 21 C.F.R. 312.52, NTI must identify all Investigational New Drug (IND) Exemption responsibilities that will be transferred to SCIREX. Each Exhibit will contain a description of transferred obligations. NTI agrees that the same description 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.

 

3. CLINICAL SUPPLIES

 

3.1 Unless otherwise specified in an Exhibit, NTI will supply the clinical investigators with the Drugs and other clinical drug supplies as are agreed upon by SCIREX and NTI 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

 

4.1 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. RECORDS

 

5.1 SCIREX shall maintain all materials, information, source documents, source code used to generate output, correspondence, and data obtained or generated by SCIREX or its employees, agents, consultants, or contractors, in the course of providing services hereunder, including all electronic media, computerized records and files (collectively “Records”) in accordance with this Agreement, the Project Exhibit(s), Good Clinical Practice, and all applicable laws and requirements and will use its best efforts to ensure that they are maintained in a safe and secure manner protected from fire, theft, disclosure and destruction.

 

5.2 SCIREX shall cooperate with any internal review or audit by NTI or NTI’s authorized representative and make any and all Records available for examination and duplication, during normal business hours and at mutually agreeable times. SCIREX will cooperate with NTI in accommodating any unannounced visits, investigations, or inspections by regulatory authorities including without limitation FDA, and will provide documents, information, and access properly requested. SCIREX will promptly notify NTI of any regulatory inquiries, proposed regulatory actions, investigations, site visits (whether announced or unannounced), correspondence, or communications that relate to a Project.

 

5.3 At any time NTI may request in writing that all Records be (i) delivered to NTI to a location designated in NTI’s written request in such form as is then currently in the possess of SCIREX; (ii) retained by SCIREX for NTI in a safe and secure manner as described in Paragraph 5.1 and for a period to be defined by NTI’s written request at NTI’s expense; or (iii) disposed of, at the direction and written request of NTI, unless such materials are otherwise required to be stored or maintained by SCIREX as a matter of law or regulation. In no event shall SCIREX dispose of any Records without first giving NTI sixty (60) days prior written notice of its intent to do so.

 

5.4 SCIREX will permit NTI representatives to examine or audit, with reasonable notice, the work performed under this Agreement, the facilities, systems, and equipment at or with which the services hereunder are performed, and the personnel, procedures, programming, and records related to such services.

 

5.5 SCIREX represents and warrants that all computer systems and electronic records used by SCIREX comply with all applicable laws and requirements, including without limitation the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule, and to its knowledge are free of any unintended programming problems, viruses, locks, or access controls that will impair NTI’s use of such records, recognizing that NTI must have access from SCIREX to use such Records.

 

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6. CONFIDENTIAL INFORMATION

 

6.1 All information received by SCIREX concerning the implementation of the Projects is considered to be confidential information to NTI (“NTI Confidential Information”). NTI Confidential Information will be held in confidence by SCIREX and not disclosed to third parties; provided however, that NTI 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.

 

6.2 SCIREX will only use the NTI 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 NTI all written NTI Confidential Information, as well as all written material which incorporates any NTI 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 NTI Confidential Information for the purposes of demonstrating compliance with Good Clinical Practices, Standard Operating Procedures, NTI written instructions, and all federal, state and local laws and regulations.

 

6.3 SCIREX will not disclose, without the prior written consent of NTI, any NTI 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 with the Projects.

 

6.4 SCIREX will not use any NTI 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.

 

6.5 During the term of this Agreement and thereafter (including following any termination), NTI, 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), NTI may have access or use SCIREX Confidential Information only in connection with the Projects; provided, however, that NTI 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 NTI 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 NTI knowledge and requirements of law, rules and regulations corresponding to the exceptions set forth in 6.1 A-D above.

 

7. ACCEPTANCE OF WORK PRODUCT

 

7.1 NTI agrees to review all work products submitted by SCIREX and to advise SCIREX promptly of any errors or omissions of which NTI 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 NTI within ninety (90) days after submission of work product to NTI, and will make corrections to all errors or omissions after ninety (90) days for additional compensation at cost. Cost shall be defined as SCIREX’s

 

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standard hourly rates reduced appropriately to eliminate SCIREX’s corporate selling, general and administrative expenses and profit. Cost shall also include pass-through expenses.

 

8. COMPENSATION

 

8.1 NTI 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 NTI or others, events outside of SCIREX control, or mutual agreement between SCIREX and NTI.

 

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

 

8.3 SCIREX will submit invoices to NTI according to the schedule described in the Exhibits. All SCIREX invoices are payable within thirty (30) days of receipt of an itemized invoice and appropriate documentation reasonably acceptable to NTI and in accordance with this Agreement and the Project Exhibit. Payment may be withheld for only that portion of those invoice items that NTI reasonably determines does not meet the requirements of this Agreement or the Project Exhibit. NTI shall, within the thirty (30) day period, notify SCIREX of any contested amounts or questions regarding an invoice or invoice item. SCIREX agrees to respond to requests by NTI to clarify questions on any invoice or invoice item, and NTI agrees that it will use its best efforts to resolve contested invoice items in a timely and reasonable fashion. SCIREX acknowledges and agrees that NTI is not obligated to pay such contested amounts otherwise due and payable within the thirty (30) day period until such time as the contested issues are resolved to the satisfaction of NTI, and that NTI will not be subject to any penalty or finance charge for such withheld payments, provided that NTI acts in good faith.

 

8.4 The total cost of the Projects, individual budget components and time estimates are based on the specification and assumptions contained in the Exhibits, and subject to modification only as provided for in Section 9 hereof.

 

8.5 Travel, supplies, and other incidental related expenses that are required in support of a Project and that are consistent with the Project Exhibit and any applicable budgets, shall be reimbursed by NTI provided that (i) all air travel shall be at coach fare; and (ii) upon request by NTI, SCIREX shall promptly provide documentation and receipts regarding any such expenses.

 

8.6 SCIREX shall maintain complete and accurate accounting records related to Projects hereunder in accordance with Generally Accepted Accounting Principles. These records shall be available for inspection, review and audit at reasonable times by NTI, or its authorized representative, at NTI’s expense, for three (3) years following the end of the calendar year in which such costs are incurred.

 

9. CHANGE ORDERS

 

9.1 In the event of a change in the scope of a Project outside SCIREX’s control, the identifying party will promptly notify the other party of such change. Outside SCIREX’s control is defined for the purposes of this section 9 as situations limited to the following: (i) an amendment to a Project Protocol requested by NTI; (ii) a deviation from the Protocol required by generally accepted standards of clinical research and medical practice relating to the safety of research subjects; (iii) an unanticipated side effect of a Drug during the course of a Project that significantly slows subsequent subject enrollment; (iv) the occurrence of a Force Majeure; (v) a significant change in the scope or nature of the services requested of SCIREX; or (vi) a lack of reasonably timely execution of the obligations of NTI. A change in one of the assumptions set forth in a Project Exhibit (including, without limitation, those set forth in bold type) does not itself justify a change order unless such change meets one of the above four criteria. Within twenty (20) working days of SCIREX sending or receiving such a notice of change, SCIREX shall provide NTI with its proposal of a modification to the timeline and costs arising from such change (“Change Order”) whether such change results in an increase or decrease to the timeline or costs. NTI shall have fifteen (15) working days to review and respond to the Change Order. If the parties do not agree as to whether a change outside SCIREX’s control has occurred, or if NTI does not approve such Change Order and has not terminated the

 

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Project, both parties will use their best efforts to agree in writing on time and cost estimates that are mutually acceptable.

 

9.2 During the period when a Change Order is being prepared and reviewed, SCIREX shall continue to perform the Project, if possible, but will not be obligated to perform those services that have resulted from changes outside of its control until agreement has been reached on the Change Order; provided, however, that under certain emergency circumstances, including situations involving patient safety or other time-sensitive matters, SC