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`
end
</PDF>Prepared by MERRILL CORPORATION

QuickLinks
 -- Click here to rapidly navigate through this document

 
 

Exhibit 10.16    
  

DATA MANAGEMENT AND REPORTING

SERVICES AGREEMENT
  By and Between
  CLINFO SYSTEMS, LLC

and

AXONYX INCORPORATED
  Effective Dates: October 2, 2000 through September 30, 2001 

CLINFO SYSTEMS, LLC

400 White Oakshade Road

New Canaan, CT 06840  

 Phone: (203) 762-9656  •  FAX: (203) 761-8681  •  Email:
info@clinfosys.com  

 
DATA MANAGEMENT SERVICES AGREEMENT  

	Name and address of CLINFO SYSTEMS, LLC contact;
	

Principal:	
 	

Heidi M. Patzelt
	

Title:	
 	

Managing Director
	

Address:	
 	

400 White Oakshade Road

New Canaan, Connecticut 06840
	

Telephone:	
 	

(203) 762-9656
	

FAX:	
 	

(203) 761-8981
	

Email:	
 	

hpatzelt@clinfosys.com
	

 Name and address of AXONYX INC. Contact:
	

Principal:	
 	

Robert G. Burford, Ph.D., F.A.C.A.
	

Title:	
 	

Vice President of Product Development
	

Address:	
 	

AXONYX Incorporated

825 Third Avenue, 40th Floor

New York, NY 10022
	

Telephone:	
 	

(212) 688-4770
	

FAX:	
 	

(212) 688-4843
	

Email:	
 	

rburford@home.com

2

   AXONYX INC. and CLINFO SYSTEMS, LLC hereby agree as follows:  

1.  Term  

    The term of this Agreement shall be for the period beginning on October 2, 2000 and ending on or before September 30, 2001, unless terminated
sooner as provided for herein. 

2.  Scope of Work  

    CLINFO SYSTEMS, LLC shall perform the Data Management and Reporting services for AXONYX INC., as described in Exhibit 1 (the "SERVICES"),
attached hereto and made fully a part hereof. 

3.  Compensation  

    In consideration for the SERVICES, AXONYX INC. shall pay CLINFO SYSTEMS, LLC a professional fee in the amount and on the terms specified in
Exhibit 2 (the "FEE") attached hereto and made fully a part hereof. The total amount payable pursuant to this Agreement (including any reimbursable expenses allowable under this Agreement) may
not exceed $360,000.00 without the prior written consent of AXONYX INC. 

4.  Representations of CLINFO SYSTEMS, LLC  

    CLINFO SYSTEMS, LLC represents that CLINFO SYSTEMS, LLC has the requisite education, expertise, experience and skill, to render the desired SERVICES and CLINFO
SYSTEMS, LLC shall perform the SERVICES in a competent and efficient manner. CLINFO SYSTEMS, LLC further represents that CLINFO SYSTEMS, LLC shall abide by all laws, rules and regulations that apply
to the performance of the SERVICES, including applicable requirements regarding equal employment
opportunity and the provisions of Executive Order 11246 and related rules and, when on AXONYX INC. premises, CLINFO SYSTEMS, LLC shall comply with AXONYX INC. policies with respect to
conduct of visitors. 

5.  Confidentiality  

    During the performance of the SERVICES contemplated by this Agreement, CLINFO SYSTEMS, LLC may acquire certain Confidential, Proprietary, and/or Trade Secret
information of AXONYX INC. ("CONFIDENTIAL INFORMATION"). CLINFO SYSTEMS, LLC shall neither use nor disclose such CONFIDENTIAL INFORMATION for any purpose other than as is specifically allowed
by this Agreement. 

    CLINFO
SYSTEMS, LLC shall disclose such CONFIDENTIAL INFORMATION only to such of its employees as may reasonably be required to assist CLINFO SYSTEMS, LLC in the performance of this
AGREEMENT. In the event of such disclosure, CLINFO SYSTEMS, LLC shall advise its employees of the confidential nature of the information and shall instruct them to take all necessary and reasonable
precautions to prevent the unauthorized use or disclosure thereof. Each of CLINFO SYSTEMS, LLC's employees, consultants, and contractors execute a CLINFO SYSTEMS, LLC Confidentiality Agreement binding
them to uphold any Confidentiality Agreement entered into by CLINFO SYSTEMS, LLC. 

    CLINFO
SYSTEMS, LLC shall not disclose to others, without AXONYX INC. consent, the fact that CLINFO SYSTEMS, LLC is acting on behalf of AXONYX INC. and CLINFO SYSTEMS,
LLC shall not publish on the subject of this relationship without first providing AXONYX INC. with the opportunity to review and offer reasonable objection to the contemplated publication. 

3

 

    Upon the expiration or termination of this Agreement, CLINFO SYSTEMS, LLC shall return to AXONYX INC. all tangible forms of CONFIDENTIAL INFORMATION, including any and all
copies and/or derivatives of CONFIDENTIAL INFORMATION made by CLINFO SYSTEMS, LLC (or CLINFO SYSTEMS, LLC's employees), as well as any writings, drawings, specifications, manuals or other printed
material made by CLINFO SYSTEMS, LLC (or CLINFO SYSTEMS, LLC's employees) and based on, or derived from, CONFIDENTIAL INFORMATION. 

    The
obligations set forth in this Article 5, including the obligations of confidentiality and non-use, shall be continuing and shall survive the expiration or
termination of this Agreement. 

6.  Conflicts of Interest  

    CLINFO SYSTEMS, LLC hereby warrants and affirms that it has advised AXONYX INC. in writing prior to the date of signing this Agreement, of any
relationship with any third parties, including competitors of AXONYX INC., which would present a conflict of interest with the SERVICES or which would prevent CLINFO SYSTEMS, LLC from
performing the SERVICES contemplated by this Agreement. CLINFO SYSTEMS, LLC further warrants and affirms that CLINFO SYSTEMS, LLC shall advise AXONYX INC. of any such relationships that might
arise during the term of this Agreement. In such event, AXONYX INC. shall have the option to terminate this Agreement without further liability to CLINFO SYSTEMS, LLC other than the obligations
to pay for SERVICES actually rendered as of the date of such termination. 

7.  Independent Contractor  

    The parties hereto agree that CLINFO SYSTEMS, LLC is being retained and shall perform as an "Independent Contractor" and CLINFO SYSTEMS, LLC and any employees
of CLINFO SYSTEMS, LLC performing SERVICES shall not be employees of AXONYX INC. The means, methods and manner in which SERVICES are rendered by CLINFO SYSTEMS, LLC shall be within CLINFO
SYSTEMS, LLC's sole control and discretion. 

    Nothing
contained in this Agreement shall be construed as making the parties joint ventures or as granting to either party the authority to bind or contract any obligations in the
name of or on the account of the other party or to make any representations, guarantees or warranties on behalf of the other party. 

    AXONYX INC.
shall not be responsible for CLINFO SYSTEMS, LLC's acts or the acts of its employees while performing the SERVICES whether on AXONYX INC. premises or
elsewhere. 

8.  Tax Reporting and Payment  

    CLINFO SYSTEMS, LLC further acknowledges and agrees that they shall be solely responsible for paying the appropriate amount of all federal, state and local
taxes with respect to all compensation paid to CLINFO SYSTEMS, LLC pursuant to this Agreement, and that AXONYX INC. shall have no responsibility whatsoever for withholding or paying any such
taxes for or on behalf of CLINFO SYSTEMS, LLC. CLINFO SYSTEMS, LLC further agrees to indemnify and hold AXONYX INC. harmless from and against any and all damages, losses, expenses, or penalties
arising from or in connection with any claim brought by a federal, state or local taxing authority with regard to CLINFO SYSTEMS, LLC's failure to pay required taxes or failure to file required forms
with regard to compensation paid to CLINFO SYSTEMS, LLC by AXONYX INC. pursuant to this Agreement. 

4

 

9.  Insurance  

    CLINFO SYSTEMS, LLC acknowledges and agrees that AXONYX INC. does not and will not maintain or procure any worker's compensation insurance for or on
behalf of CLINFO SYSTEMS, LLC or CLINFO SYSTEMS, LLC's employees. 

10. Ownership of Developments  

    All written materials and other works which are directly related to the current project and which may be subject to patent or copyright that are made,
conceived or written by CLINFO SYSTEMS, LLC or CLINFO SYSTEMS, LLC's employees during the term of this Agreement, and for ninety (90) days after it expires, and which are based upon the
SERVICES performed by CLINFO SYSTEMS, LLC for AXONYX INC. ("DEVELOPMENTS") shall become AXONYX INC. property. CLINFO SYSTEMS, LLC agrees to hold all DEVELOPMENTS confidential in
accordance with Article 4 of this Agreement. 

11. Disclosure and Transfer of DEVELOPMENTS  

    CLINFO SYSTEMS, LLC shall disclose promptly to AXONYX INC. each DEVELOPMENT and, upon AXONYX INC. request and at AXONYX INC. expense,
CLINFO SYSTEMS, LLC shall assist AXONYX INC., or anyone AXONYX INC. designates, in filing patent or copyright applications in any country in the world. Each copyrightable work, to the
extent permitted by law, shall be considered a work made for hire and the authorship and copyright of the work shall be in AXONYX INC.'s name. CLINFO SYSTEMS, LLC shall execute all papers and
do all things which may be necessary or advisable, in the opinion of AXONYX INC., to prosecute such patent or copyright applications and to vest in AXONYX INC., or its designee, all the
right, title and interest in and to the DEVELOPMENTS. 

12. Disclosures to AXONYX INC.  

    If during the term of this Agreement, CLINFO SYSTEMS, LLC discloses any copyrightable works, to AXONYX INC. which were conceived or written prior to
this Agreement or which are not based upon the SERVICES performed by CLINFO SYSTEMS, LLC for AXONYX INC. under this Agreement,
AXONYX INC. shall have no liability to CLINFO SYSTEMS, LLC because of its use of such works, except liability for infringement of any valid copyright now or hereafter issued thereon. 

13. Liability  

    In the event of an actual breach by CLINFO SYSTEMS, LLC of any of the terms of this Agreement, with the exception of Articles 5, 10 and 11, AXONYX INC.
and its successors, officers, directors, agents and employees agree to indemnify, defend, and hold harmless from any and all actions, causes of action, claims, demand, cost, liabilities, expenses and
damages in excess of the fees paid to CLINFOSYS, LLC by AXONYX INC. Furthermore, CLINFO SYSTEMS, LLC shall have no liability to AXONYX INC. for consequential, punitive, and speculative
damages or lost profits resulting because of such a breach. 

14. Termination  

    In the event that a party hereto shall commit a material breach of this Agreement, the other party hereto shall have the right to terminate this Agreement
immediately. 

    AXONYX INC.
may terminate this Agreement at any time by giving CLINFO SYSTEMS, LLC thirty (30) days written notice of such termination. In such event, AXONYX INC.
shall pay CLINFO SYSTEMS, LLC for SERVICES performed by CLINFO SYSTEMS, LLC pursuant to this Agreement 

5

 

as of the effective date of such notice. CLINFO SYSTEMS, LLC shall reimburse AXONYX INC. any and all moneys received by CLINFO SYSTEMS, LLC from AXONYX INC. which are in excess of the
money earned by CLINFO SYSTEMS, LLC as of the effective date of such notice. 

15. Miscellaneous Provisions  

 15.1 Assignability  

     No assignment by CLINFO SYSTEMS, LLC of this Agreement or any of its rights, duties or obligations hereunder, shall be binding on AXONYX INC. without
AXONYX INC.'s prior written consent. 

 15.2 Complete Agreement  

     This Agreement supersedes all prior Agreements and understandings between the parties related to the subject matter of this Agreement. 

 15.3 Amendment  

     This Agreement may not be altered, changed or amended except when written and signed by each of the parties hereto. 

 15.4 Survival  

     The provisions of Articles 5, 10 and 11 of this Agreement shall survive the termination of this Agreement. 

 15.5 Severability  

     In the event that any provision of this Agreement is held illegal or invalid for any reason, such provision shall not affect the remaining parts of this
Agreement, but this Agreement shall be construed and enforced as if that illegal and invalid provision had never been inserted herein. 

 15.6 Extraordinary Relief  

     In the event of the actual or threatened breach by CLINFO SYSTEMS, LLC of any of the terms of Articles 5, 10 and 11, AXONYX INC. shall have the right to
specific performance and injunctive relief. The rights granted by this paragraph are in addition to all other remedies and rights available at law or in equity. 

 15.7 Choice Of Law  

     This Agreement shall be construed according to the laws of Connecticut for contracts made within that state. 

 15.8 Attorney Fees Provision  

     In any litigation, arbitration, or other proceeding by which one party either seeks to enforce its rights under this Agreement (whether in contract, tort, or
both) or seeks a declaration of any rights or obligations under this Agreement, the prevailing party shall be awarded its reasonable attorney fees, and costs and expenses incurred. 

6

 

 15.9 Counterpart Originals.  

     This Agreement may be executed in any number of counterparts, each of which, when executed, shall be deemed to be an original and all of which together shall
constitute one and the same document. 

 15.10 Representation on Authority of Parties/Signatories  

     Each person signing this Agreement represents and warrants that he or she is duly authorized and has legal capacity to execute and deliver this Agreement. Each
party represents and warrants to the other that the execution and delivery of the Agreement and the performance of such party's obligations hereunder have been duly authorized and that the Agreement
is a valid and legal agreement binding on such party and enforceable in accordance with its terms. 

    IN
WITNESS WHEREOF, the parties hereto have executed, or have caused their duly authorized representatives to execute, this Agreement as of October 2, 2000. 

	CLINFO SYSTEMS, LLC	 	AXONYX INC.
	
By:	
 	

/s/ HEIDI M. PATZELT   
 Heidi M. Patzelt	
 	

By:	
 	

/s/ ROBERT G. BURFORD, PH.D.   
 Robert G. Burford, Ph.D.
	

Title:	
 	

Managing Director	
 	

Title:	
 	

Vice President Product Development
	

Date:	
 	

10/2/00	
 	

Date:	
 	

10/2/00

7

   EXHIBIT 1—SERVICES  

Preamble  

    AXONYX INC. will be conducting a multiple dose, placebo controlled clinical trial of Phenserine tartrate in sixty patients diagnosed with probable
Alzheimer's Disease, for which they require the data management and reporting services of CLINFO SYSTEMS, LLC. This study will be conducted at three US clinical trial sites from November, 2000,
through approximately April, 2001. The title of the study is 

"A double blind, randomized, placebo-controlled, oral dose study

of the efficacy and safety of Phenserine tartrate in patients

with probable Alzheimer's Disease."

Objective  

    The objective of this contract exhibit is to outline all of the CLINFO SYSTEMS, LLC's data management and reporting services required for this study. 

Assumptions  

A.  CLINFO SYSTEMS, LLC  

	1.
	This
quote is based upon a protocol by the same name dated September 22, 2000 and made a part of this agreement.

	2.
	CLINFO
SYSTEMS, LLC will have the full cooperation of AXONYX INC. in-house personnel who are, or may be involved in the successful completion of this study.

	3.
	CLINFO
SYSTEMS, LLC shall have no responsibility for recruitment or management of the investigator(s) for this study who have been selected in advance by AXONYX INC.

	4.
	CLINFO
SYSTEMS, LLC shall not be responsible for profiling the Acetycholinesterase activity and pharmacokinetics of this drug, nor the analysis of the CANTAB results.

	5.
	CLINFO
SYSTEMS, LLC shall not be responsible for the collection, maintenance, governmental filing or archival of regulatory documents associated with the clinical conduct or future
regulatory submissions of this study.

	6.
	CLINFO
SYSTEMS, LLC shall have the responsibilities detailed below which are confined to the collection, management, analysis and reporting of the data in this clinical trial.

	7.
	Any
sub-contractors selected by CLINFO SYSTEMS, LLC (with approval from AXONYX INC.) shall perform their assigned tasks in a timely manner, on budget and in full
compliance with GCP and AXONYX INC. SOP requirements.

	8.
	CLINFO
SYSTEMS, LLC will operate and maintain an efficient communications system with the investigator and sponsor alike, including

	a.
	A
24-hour toll-free telephone number for investigational site inquiries.

	b.
	Broadcast
FAX/E-Mail capabilities for rapid dissemination of information.

	c.
	CRF
FAX receipt from the site and processing 24 hours/day, 7 days/week 

B.  AXONYX INC.  

	1.
	AXONYX INC.
shall be responsible for conveying information to CLINFO SYSTEMS, LLC in a timely manner regarding any changes to the protocol, site conduct guidelines,
monitoring procedures, assigned study personnel, etc. 

8

 

	2.
	AXONYX INC.
shall be responsible for source document verification of the data recorded on the Case Report Forms.

	3.
	AXONYX INC.
shall be responsible for providing monitoring services by qualified clinical research associates (CRAs) as per the code of federal regulations CFR 21 governing
these activities.

	4.
	AXONYX INC.
shall be responsible for funding investigators and study personnel directly, plus in-house CRA and other clinical research personnel.

	5.
	AXONYX INC.
has the right to review the qualifications of all CLINFO SYSTEMS, LLC personnel assigned to this project and to be informed of any changes in said assignments
during the course of the project. 

C.  Patients: 60 to complete 

D.  Sites: 3 

E.  Enrollment Period: @ 4 months, commencing December 1, 2000 

F.  Treatment Duration: 16 weeks per patient, including follow-up 

G.  Case Report Forms (requiring bilingual Psychometric CRFs)

	1.
	@
29 unique Case Report Forms to be designed (@ 88 unique data collection pages)

	2.
	@
175 pages/patient to be databased

	3.
	@
10,500 total CRF pages to be processed at least once for the study

	4.
	Assume
40% require scrubbing/clarification, therefore @14,700 pages to process 

H.  Last CRF to be sent to CLINFO SYSTEMS, LLC: July 1, 2001 

Services to be provided by CLINFO SYSTEMS, LLC  

	1.
	Generation
of treatment randomization.

	2.
	Case
Report Form and database design and validation.

	3.
	Case
Report Form production and distribution.

	4.
	Development
and implementation of a Data Management Plan approved by AXONYX, INC.

	5.
	Scanning,
filing, and electronic entry of preliminary and final CRF data into both a Microsoft Access V5.0 database and a SAS V. 8 data library constructed for this study.

	6.
	Programming
and publication of daily SAS v.8 reports to a secure section of the CLINFO SYSTEMS, LLC Internet home page and management of the site to allow the sponsor and
investigators access through secure codes. Reports to include

	a.
	Patient
tracking statistics

	b.
	All
demographic tables as per DMP specifications

	c.
	Up
to 6 other reports AXONYX INC. wishes to view. 

	7.
	Performance
of CLINFO SYSTEMS, LLC Quality Assurance (QA) and Quality Control (QC) routines. QA/QC reports are to include programming validation, error estimations, and consistency
and validity error checks used to clean the data and detect the presence of fraud. 

9

 

	8.
	Unblinding
the study database after all patients' data have been verified, all quality assurance procedures have been executed, and all eligibility/evaluability determinations have
been made.

	9.
	Statistical
programming, analysis and reporting.

	10.
	Integrated
Clinical/Statistical study report writing.

	11.
	Archival
and indexing of all final CRF images onto CD-ROM. Distribution of one copy to each investigator (3) and two copies to the sponsor. CLINFO SYSTEMS, LLC
shall retain one copy for a period of five years for potential FDA inspection use.

	12.
	Archival
of the statistical report, the clinical report, all associated summary tables and data listings, the incremental and locked database (including audit trail), all SAS
programs used to analyze the data, all QA/QC reports and all general data related correspondence on CD-ROM. 

10

 

EXHIBIT 2—FEES  

A. Estimated Costs from October 2, 2000 through September 30, 2001—@ 12 mos.  

	 
	 	Service(s)
	 	Estimated

Work Units
	 	Cost Per Unit
	 	Estimated

Total Cost

	

1.	
 	

Generation and documentation of treatment randomization	
 	

4 Stat/Pgm total hours	
 	
$	

96/hour	
 	
$	

384
	

2.	
 	

Case Report Form design, production and distribution, including bilingual psychometric forms	
 	

65 Case Books (88 unique CRF pages, 175 pages/ 3-rig binder)	
 	
$	

535/book	
 	
$	

34,775
	

3.	
 	

Supplemental Worksheet design, production and distribution (CGI)	
 	

65 sets (24 pages/report binder)	
 	
$	

28/book	
 	
$	

1,904
	

4.	
 	

Psychometric test kit design, assembly and distribution (ADAS-cog)	
 	

3 kits (1 kit/site)	
 	
$	

400/kit	
 	
$	

1,200
	

5.	
 	

CRF completion and Psychometric Testing Manual—generation, review/approval, distribution	
 	

5 sets (@60 pages/manual, 3 sites, Sponsor, and monitor)	
 	
 	

—	
 	
$	

3,000
	

6.	
 	

Data Management Plan development and maintenance	
 	

40 Sr. DM total hours	
 	
$	

78/hour	
 	
$	

3,120
	

7.	
 	

Database creation, validation, and maintenance	
 	

160 Sr. DM/Pgm total hours	
 	
$	

78/hour	
 	
$	

12,480
	

8.	
 	

Data acquisition, processing, cleaning (including audit trail), and finalization	
 	

10,500 CRF pages	
 	
$	

15.66/page	
 	
$	

164,430
	

9.	
 	

Management of electronic transfer and storage of non-safety laboratory results	
 	

24 Pgm total hours	
 	
$	

96/hour	
 	
$	

2,304
	

10.	
 	

Programming and validation of reports published daily via a secure Internet site	
 	

240 Sr. Pgm total hours	
 	
$	

108/hour	
 	
$	

25,920
	

11.	
 	

Statistical Analysis:

—Planning

—Programming and validation,

—Generation of tables and listings

—First draft statistical report generation

—Statistical report review, revision and approval	
 	

350 Sr. Stat/Pgm total hours	
 	
$	

180/hour	
 	
$	

63,000
	

12.	
 	

Integrated Clinical/Statistical Study Report:

—Planning

—First draft Report Generation

—Clinical Report review, revision and approval	
 	

160 Sr. Medical Writer total hours	
 	
$	

150/hour	
 	
$	

24,000
	
 	
 	

 	
 	

 	
 	
 	

 	
 	
 	

 

11

 

	

 	
 	

 	
 	

 	
 	
 	

 	
 	
 	
 
	

13.	
 	

Archival and transfer of reports, data, SAS programs, and QA/QC documentation in both hardcopy and electronic format, including but not limited to

—CRF image storage on CD-ROM

—Both incremental and locked databases, as well as audit trail records on CD-ROM

—Patient data listings

—Descriptive summary tables

—General data management and report correspondence, along with the final Data Management and Statistical Analysis Plans on CD-ROM

—Final Statistical Analysis

—Final Clinical Report	
 	

80 DC hours total plus materials	
 	
$	

40/hour	
 	
$	

3,200
	

14.	
 	

Data and Reporting Project Management	
 	

6 Sr. DM hours/month (12 months)	
 	
$	

78/hour	
 	
$	

5,616
	

 	
 	
TOTAL ESTIMATE	
 	

 	
 	
 	

 	
 	
$	

345,333

B. Payment Schedule  

    The total charges for services as defined in Exhibit 1, plus AXONYX INC pre-approved reimbursable expenses, are not to exceed $360,000.00
U.S., without the prior written consent of AXONYX INC. 

    Expenses
are to be submitted and paid to CLINFO SYSTEMS, LLC on a monthly basis. 

    Fees
for data management and reporting services are to be paid to CLINFO SYSTEMS, LLC according to the following payment schedule: 

	1.
	Within
90 days of signing this contract, a total of $120,000.00 will be due to CLINFO SYSTEMS, LLC.This amount shall cover all start-up costs, be payable in 2
equal installments of $60,000.00 each, and be non-refundable.

	2.
	Beginning
with January 31, 2001, and ending on July 31, 2001, monthly invoices of $27,257.00 for ongoing services will be submitted. Payment to CLINFO SYSTEMS, LLC is
due within 30 days of receipt of an invoice.

	3.
	The
final Payment of 10% of the contracted amount for services, i.e., $34,534.00 will be made upon satisfactory delivery to AXONYX, INC. of all items listed under
Exhibit 2—Table A—Service # 13. 

12

QuickLinks

Exhibit 10.16

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