PORTIONS OF THIS EXHIBIT IDENTIFIED BY "***" HAVE BEEN DELETED PURSUANT
TO A REQUEST FOR CONFIDENTIAL TREATMENT FILED WITH THE SECURITIES AND
EXCHANGE COMMISSION UNDER RULE 406 OF THE SECURITIES ACT OF 1933, AS
AMENDED, AND THE FREEDOM OF INFORMATION ACT.
EXHIBIT 10(H)(i)
AGREEMENT FOR COLLABORATIVE PROGRAM 1996-1997.
The basis of our further cooperation are included in the summary letter of
January 25, 1996 (Dr., Xxxxxx - Dr. Le Bars,) and in the letter of August
19, 1996 (Xx. X.X. Xxxxxxx - Dr. T.M. Itil).
The main activity for further cooperation between Dr. Le Bars and Xxxxxxx
Company is the monitoring and the completion of the
*******************-Study according to rules and regulations for a Good
Clinical Practice. In order to avoid any problems to achieve the goal, we
decided to take into account the previous; contracts and agreement related
to the study (Contractual Agreement for Therapy Resistant Depression
Program of June 22th 92, including respect of the study protocol and
addendum, data analysis, reporting; and sponsor ownership).
The remaining financial figures related to these agreements are as follow:
Fourth and final payment, ****************** Study ********** U$
letters Jan. 25th and Aug. 19th 1996 ********** U$
********** U$
There are at this time no further financial commitments between Xxxxxxx
and HZI Therefore it was decided to use the above mentioned Budget for
the following activities in 1996 and 1997:
1. Study ******
1.1) Preparing for further publications 1996-1997 deeding with:
- Definition of clinical responders
- Correlation of clinical data with ***** and ****
- special statistical analyses for trend or estimated outcome
1.2) A final report of the study supporting the publication and
approved by Dr Le Bars will be submitted to Xxxxxxx.
2. **************-Program
2.1) Preparation of an addendum to specify or update outcome
measures and statistical analyses of the study.
2.2) Monitoring the data entered in the CRF and update of the
computerized data if necessary.
2.3) Visit of centers, consolidation of different data and close out.
2.4) Analyses and Preparation of the final report.
2.5) submission and approval by WHO and investigators of final
report and agreement that all results belong to Xxxxxxx in
accordance within HZI- XXXXXXX Xxxx 22th 92 contract .
3. The discussions on future projects with **** could not provide
definite decisions on study to be performed particularly because
**** is still ongoing, at least as analysis, reporting and
publication are concerned, and because the **** program is not yet
completed at the date of this agreement. However, in order to
maintain opportunities for further collaboration, the following has
been agreed upon:
Within the frame of the future **** program ( with ****), Dr. Le
Bars will be a member of the advisory board. He will present, if
necessary in December, the Xxxxxxx data to interested parties. In
addition Dr Le Bars will help Xxxxxxx to take care of the
progression of the **** study.
Financial support will be allocated within the current 96-97 budget
to Dr. Le Bars shall be included in the future **** study as an
investigator center, as already mentioned in the August letter. The
amount of patients and the total cost of this participation will be
independent if the current budget and may follow the future study
figure and requirement.
The issues developed in the above chapter 3 will only come in force
when the study will be initiated and in this case, an extra contractual
agreement will be finalized (most likely within second semester of 97).
Budget for 1996/1997
Dr. Le Bars Involvement
********** U$ (no later than end of Oct. 1996)
Monitoring of ***** and *****
(2.1, 2.2, 2.3 and 1.1)
********* U$ after finishing ***** publication (1.1) and
submission of supportive data set as reported in (1.2).
********* U$ after completion of the ***** study enrollment and
If the monitoring of the data, respecting all points of
chapter 2, is satisfactory for Xxxxxxx advisory
committee. If the clause is no longer applicable the
unused funds will be reallocated to future
collaborative work.
********** U$ at the submission to Xxxxxxx of the **** deposition data
set, analysis and report of the study (2.4, 2.5)
HZI and Dr. Itil agreement
An advanced payment of ***** U$ will Immediately be paid to complete the
**** study enrollment and finalize the data collection.
In addition, ***** U$ will immediately be paid to cover the cost of the
addendum of the ***** study protocol and to initiate the conceptualization
and the drafting of a future ***** protocol. However these funds will be
paid at the one condition that the whole current agreement is approved,
dated and signed by Dr. Itil.
By signing and dating the current document all parties, represented by Dr.
T.M. Itil, Dr. P. Le Bars and Dr. H. Slumpf agree that any relevant
conditions specified in this document, come in modification of the
original contractual agreements, or projects included in previous letters
of intent.
Xx. X. Xxxxx, date and signature: s/Xx. X.Xxxxxx October 23, 1996
Dr. P. Le Bars, date and signature: s/Xx. X. XxXxxx, October 23, 1996
Dr. T.M. Itil, date and signature: __________________________________
PORTIONS OF THIS EXHIBIT IDENTIFIED BY "***" HAVE BEEN DELETED PURSUANT
TO A REQUEST FOR CONFIDENTIAL TREATMENT FILED WITH THE SECURITIES AND
EXCHANGE COMMISSION UNDER RULE 406 OF THE SECURITIES ACT OF 1933, AS
AMENDED, AND THE FREEDOM OF INFORMATION ACT.
EXHIBIT 10(H)(ii)
Xxxxxxx-Xxxxxxx Pharmaceuticals Inc.
Route 202-206 ~ X.X. Xxx 0000 x Xxxxxxxxxx, XX 00000-0000
-----------------------------------------------------------------------------------------------------
AGREEMENT FOR GRANT ASSISTANCE FOR CLINICAL INVESTIGATION PAGE 1 OF 2
-----------------------------------------------------------------------------------------------------
NAME OR CODE NUMBER OF DRUG PROTOCOL NUMBER
******* ***
-----------------------------------------------------------------------------------------------------
***********************************************************************************************
**************
-----------------------------------------------------------------------------------------------------
SPONSOR PRINCIPAL INVESTIGATOR(S) MAKE CHECKS PAYABLE TO:
-----------------------------------------------------------------------------------------------------
Clinical Research Department NAME AND ADDRESS: NAME AND ADDRESS:
Xxxxxxx-Xxxxxxx Pharmaceuticals Inc.
Xxxxx 000-000, X.X. Xxx 0000 Turan Itil, M.D. HZI Research Center Inc.
Xxxxxxxxxxx, New Jersey 2HZI Research Center Inc. 000 Xxxxx Xxxxxx Xxxx
08876-1258 000 Xxxxx Xxxxxx Xxxx Xxxxxxxxx, XX 00000
By: F. Xxxxx Xxxx, M.D. Xxxxxxxxx, XX 00000
Medical Director
Clinical Neuroscince INVESTIGATOR NUMBER: 117 SOCIAL SECURITY OR FEDERAL
ID NUMBER: 00-0000000
--------------------------------------------------------------- -------------------------------------
The undersigned submits this state- Principal Investigator(s) also
ment as a condition for receiving agrees that he/she and appropriate
grant assistance for the study of ancillary staff will be available
the above named drug: for and assist with any and all
sponsor monitoring visits and spon-
1.A If payment is to be made to the sor or regulatory agency audits of
Principal Investigator(s) directly. investigator's study records and
The study will be conducted by the procedures, as part of the Agreement
undersigned in accordance with the for Grant Assistance for Clinical
plan of investigator described in Investigation.
the above-referenced protocol and
Detailed Cost Breakdown Per Subject. 5. Grant checks are to be made
No changes shall be made in the pro- payable by the Sponsor to the Prin-
tocol or Detailed Cost Breakdown cipal Investigator(s) or additional
except by mutual agreement in writ- Authorized Payee(s) and sent to the
ing between the Sponsor and Princi- addressee(s) listed above. The total
pal Investigator(s). grant may be paid by pre-determined
installments agreed to by both the
1.B If payment is to be made to an Sponsor and Principal Investiga-
Authorized Payee acting as an agent tor(s)
of Principal Investigator(s). The
undersigned Principal Investiga- 6. The Sponsor is required to file
tor(s) by executing page 1 of the an IRS From 1099 with the U.S. In-
Agreement for Grant Assistance for ternal Revenue Service for all pay-
Clinical Investigation agrees to ees. The Principal Investigator(s)
conduct the study in accordance with is, therefore, required to furnish
the plan of investigation and the the Sponsor with the Social Security
terms of the Detailed Cost Breakdown or Federal Identification Number for
Per Subject and authorizes the Spon- all payees.
sor to pay the Authorized Payee di-
rectly ail monies which are the sub- 7. Because of governmental regula-
ject of grant assistance. The Autho- tions concerning freedom of informa-
rized Payee, as agent of the Princi- tion, the following has been added
pal Investigator(s) by executing the to this agreement:
Detailed Cost Breakdown Per Subject
form agrees to disburse all monies Expect to the extent of prior public
received from the Sponsor,, in ac- disclosure by the Sponsor the Spon-
cordance therewith. The Principal sor regards the following matters
Investigator(s) and the Authorized pertaining to the study to be confi-
Payee. dential information: the nature of
the compound under investigation,
2. The Principal Investigator(s) the protocol, and all raw data with
is responsible for ensuring the respect to the safety and efficacy,
scheduled enrollment of subjects and of the compound. The Principal In-
for the recording of all observa- vestigator(s) agrees that such in-
tions and other pertinent data on formation will not be disclosed to
the case report forms to be supplied third parties except where autho-
by the Sponsor. All data relevant to rized by the Sponsor or where re-
the investigational plan shall be quired by law. Further, the Princi-
made available b the Sponsor on re- pal Investigator(s) agrees not to
quest. publish the results of the study
until the Sponsor has reviewed the
3. Both Sponsor and Principal In- Principal Investigator(s) s proposed
vestigator(s) agree to comply with publication manuscript.
all applicable government regula-
tions. 8. The Sponsor shall have the
right to terminate this study at any
4. The Principal Investigator(s) time effective upon written notifi-
understands that the results of the cation to the Principal Investiga-
study may be used by the Sponsor in tor(s). The Principal Investiga-
support of an application for new tor(s) agrees to return a prorated
drug approval. Therefore, upon com- portion of the grant based on the
pletion of the study, the Principal percent of the total patient popula-
Investigator(s) agrees to cooperate tion in the attached protocol not
with the Sponsor, upon request, in enrolled by reason of such termina-
the preparation and review of any tion. Sponsor agrees to reimburse
reports, including a final study the Principal Investigator(s) for
report of the results of the study reasonable costs incurred pursuant
and agrees to acknowledge same by to this agreement which have not
written signature. otherwise been reimbursed by the
Sponsor, provided that this xxxx-
bursement shall not be made if ter-
mination is based upon failure of
the Principal Investigator(s) to
adhere to the attached protocol or
to any other provisions of this
agreement.
------------------------------------------------------------------------------
SIGNATURE(S) OF PRINCIPAL INVESTIGATOR(S) DATE April 12,1995
s/Turan Itil, M.D.
------------------------------------------------------------------------------
SIGNATURE OF VICE PRESIDENT OF GROUP
BUSINESS DEVELOPMENT AND ADMINISTRATION DATE
Xxxxxx X. Xxxxxxxx
------------------------------------------------------------------------------
XXXXXXX-XXXXXXX PHARMACEUTICALS INC.
Route 202-206 ~ X.X. Xxx 0000 x Xxxxxxxxxx, XX 00000-0000
----------------------------------------------------------------------------------------------
DETAILED COST BREAKDOWN PER SUBJECT PAGE 2 OF 2
----------------------------------------------------------------------------------------------
NAME OR CODE NUMBER OF DRUG PROTOCOL NUMBER PRINCIPAL INVESTIGATOR(S) DATE OF REQUEST
******* *** Turan Itil, M.D.
---------------------------- ------------------ ------------------------------ ---------------
STUDY START DATE STUDY COMPLETION DATE NO. OF SUBJECTS (ACCORDING TO PROTOCOL)
MARCH 1995 MAY 1997 at least ** completed
------------------------- ------------------------- ------------------------------------------
----------------------------------------------------------------------------------------------
1. CLINICAL COSTS - FEES FOR SERVICES (PER SUBJECT) $ ********
SPECIFY IN DETAIL
*********************************, **********************, ***************
----------------------------------------------------------------------------------------------
************ Exam (**************), *********** (*********) $ ******
----------------------------------------------------------------------------------------------
**************, **************, *************, ************** $ ******
----------------------------------------------------------------------------------------------
****************, **********************, *************, ************* $ ********
----------------------------------------------------------------------------------------------
2. LABORATORY TEST COSTS (PER SUBJECT)
SPECIFY IN DETAIL
************, **********, ************************************************* $ ******
----------------------------------------------------------------------------------------------
*************************** $ ******
----------------------------------------------------------------------------------------------
----------------------------------------------------------------------------------------------
----------------------------------------------------------------------------------------------
----------------------------------------------------------------------------------------------
3. ******************************** $ ******
----------------------------------------------------------------------------------------------
4. *********** (PER SUBJECT)
SPECIFY IN DETAIL
************** - if required $ *****
************** - if required $ ******
----------------------------------------------------------------------------------------------
5. *********** AND *********** COSTS (PER SUBJECT) $ ******
----------------------------------------------------------------------------------------------
6. OTHER COSTS (PER SUBJECT)
SPECIFY IN DETAIL
Recruitment, Screening/Attrition, Other Records Administration, Patient and $ ********
Caregiver Lunches, Patient Transport and Administrative Fee
----------------------------------------------------------------------------------------------
*** Processing $ *****
----------------------------------------------------------------------------------------------
******/******* ****** $ ********
----------------------------------------------------------------------------------------------
TOTAL COSTS PER SUBJECT $ *********
----------------------------------------------------------------------------------------------
TOTAL GRANT REQUEST (Total Cost Per Subject x Number of Subjects) $ **********
------------------------------------------------------------------------------ ---------------
SUBMITTED: MEDICAL DIRECTOR DATE SIGNATURE OF PRINCIPAL INVESTIGATOR(S) DATE
CLINICAL NEUROSCIENCE
s/F. Xxxxx Xxxx, M.D. March 11, 1995 s/Turan Itil, M.D. April 12, 1995
----------------------------------------------------------------------------------------------
APPROVED: VICE PRESIDENT GROUP BUSINESS
DEVELOPMENT AND ADMINISTRATION DATE
Xxxxxx X. Xxxxxxxx
---------------------------------------------- ---------------------------------------------
COPIES TO: CRD CENTRAL FILES o FINANCE AND ACCOUNTING o SPONSOR o INVESTIGATOR
HOECHST XXXXXX XXXXXXX, INC.
Route 202-206 . X.X. Xxx 0000 . Xxxxxxxxxxx, XX 00000-0000
Telephone (000) 000-0000
-------------------------------------------------------------------------
Direct Dial (000) 000-0000
Fax: (000) 000-0000
June 14, 1996
Turan Itil, M.D.
HZI Research Center, Inc.
000 Xxxxx Xxxxxx Xxxx
Xxxxxxxxx, XX 00000
RE: ******************** AMENDMENT 5 - AGREEMENT FOR METHOD OF PAYMENT
Dear Dr. Itil:
By signing this letter and the attached schedule you agree to the method
of payment described below for this ******* study amendment for an
open-label extension of treatment.
Payments will be issued for work done on the basis of the number of
visits completed in the treatment extension period by each subject during
the interval following the previous payment. The table attached provides
the amount payable for each completed visit. Costs for prematurely
terminated patients will be paid on the basis of work done referring to
the unit costs in the attached table.
As indicated in the protocol, HMR reserves the option to discontinue the
study at your site at any time following initiation. In this event, HMR
would reimburse your site only for expenses incurred to that point.
We look forward to hearing from you.
With best regards,
s/Xx. Xxxxx X. Xxxx
Xx. Xxxxx X. Xxxx
Associate Director
Clinical Neuroscience
I accept the conditions of payment specified in this letter and the
attached table.
s/Xx. Xxxxx Itil
Investigator's Signature Date
Note: Also sign attached table
******************* AMENDMENT 5 METHOD OF PAYMENT SCHEDULE 6/13/96
-------------------------------------------------------------------------------------------------------------
VISIT 20 21 22 23 24 25 26 27 28 29 30
PROCEDURE TOTAL
**** ** ** ** ** ** ***
*** ** **
*** ** **
**** ** **
*** ** **
**** *** ***
********** *** ***
**************** ** ** ** ** ** ** ** ***
******************* ** **
**************** ** ** ** ** ** ** ** **
*** ** ** ** ***
*********** ** ** ** ** ** ** ** ** ** ** ** ***
************** *** *** *** *** ***
********** *** *** *** *** ***
******************** ** ** ** ** ** ** ** ** ** ** ***
***** ** ** ** ** ** ** ** ** ** ** ** ****
************** ** **
******************** ** ** ** ** ** ** ** ** ** ** ** ***
TOTALS *** *** *** *** *** *** *** *** *** *** *** ****
----------------------- ----- ------ ------ ------ ------ ------ ----- ------ ------ ----- ------ -------
I ACCEPT THE METHOD OF PAYMENT DESCRIBED ABOVE. ___________________________________
SIGNATURE DATE
PORTIONS OF THIS EXHIBIT IDENTIFIED BY "***" HAVE BEEN DELETED PURSUANT
TO A REQUEST FOR CONFIDENTIAL TREATMENT FILED WITH THE SECURITIES AND
EXCHANGE COMMISSION UNDER RULE 406 OF THE SECURITIES ACT OF 1933, AS
AMENDED, AND THE FREEDOM OF INFORMATION ACT.
EXHIBIT 10(H)(iii)
XXXXXXX-XXXXXXX PHARMACEUTICALS INC.
Route 202-206 ~ X.X. Xxx 0000 x Xxxxxxxxxx, XX 00000-0000
--------------------------------------------------------------------------------------------
AGREEMENT FOR GRANT ASSISTANCE FOR CLINICAL INVESTIGATION PAGE 1 OF 2
---------------------------------------------------------------------------------------------
NAME OR CODE NUMBER OF DRUG PROTOCOL NUMBER
******* ***
---------------------------------------------- ----------------------------------------------
PROTOCOL TITLE
*********************************************************************** *********************
---------------------------------------------------------------------------------------------
SPONSOR PRINCIPAL INVESTIGATOR(S) MAKE CHECKS PAYABLE TO:
Clinical Research Department NAME AND ADDRESS: NAME AND ADDRESS:
Xxxxxxx-Xxxxxxx Pharmaceuticals Inc.
Xxxxx 000-000, X.X. Xxx 0000 Turan Itil, M.D. HZI Research Center Inc.
Xxxxxxxxxxx, New Jersey 08876-1258 HZI Research Center Inc. 000 Xxxxx Xxxxxx Xxxx
000 Xxxxx Xxxxxx Xxxx Xxxxxxxxx, XX 00000
By: F. Xxxxx Xxxx, M.D. Xxxxxxxxx, XX 00000
Medical Director
Clinical Neuroscince INVESTIGATOR NUMBER: 117 SOCIAL SECURITY OR FEDERAL
ID NUMBER: 00-0000000
------------------------------- ------------------------------- -----------------------------
The undersigned submits this state- Principal Investigator(s) also
ment as a condition for receiving agrees that he/she and appropriate
grant assistance for the study of ancillary staff will be available
the above named drug: for and assist with any and all
sponsor monitoring visits and spon-
1.A If payment is to be made to the sor or regulatory agency audits of
Principal Investigator(s) directly. investigator's study records and
The study will be conducted by the procedures, as part of the Agreement
undersigned in accordance with the for Grant Assistance for Clinical
plan of investigator described in Investigation.
the above-referenced protocol and
Detailed Cost Breakdown Per Subject. 5. Grant checks are to be made
No changes shall be made in the pro- payable by the Sponsor to the Prin-
tocol or Detailed Cost Breakdown cipal Investigator(s) or additional
except by mutual agreement in writ- Authorized Payee(s) and sent to the
ing between the Sponsor and Princi- addressee(s) listed above. The to-
pal Investigator(s). xxx xxxxx may be paid by pre-deter-
mined installments agreed to by both
1.B If payment is to be made to an the Sponsor and Principal Investiga-
Authorized Payee acting as an agent tor(s)
of Principal Investigator(s). The
undersigned Principal Investiga- 6. The Sponsor is required to file
tor(s) by executing page 1 of the an IRS Form 1099 with the U.S. In-
Agreement for Grant Assistance for ternal Revenue Service for all pay-
Clinical Investigation agrees to ees. The Principal Investigator(s)
conduct the study h accordance with is, therefore, required to furnish
the plan of investigation and the the Sponsor with the Social Security
terms of the Detailed Cost Breakdown or Federal Identification Number for
Per Subject and authorizes the Spon- all payees.
sor to pay the Authorized Payee di-
rectly ail monies which are the sub- 7. Because of governmental regula-
ject of grant assistance. The Au- tions concerning freedom of informa-
thorized Payee, as agent of the tion, the following has been added
Principal Investigator(s) by execut- to this agreement:
ing the Detailed Cost Breakdown Per
SubJect form agrees to disburse all Expect to the extent of prior public
monies received from the Sponsor,, disclosure by the Sponsor the Spon-
in accordance therewith. The Prin- sor regards the following matters
cipal Investigator(s) and the Autho- pertaining to the study to be confi-
rized Payee. dential information: the nature of
the compound under investigation,
2. The Principal Investigator(s) the protocol, and all raw data with
is responsible for ensuring the respect to the safety and efficacy,
scheduled enrollment of subjects and of the compound. The Principal In-
for the recording of all observa- vestigator(s) agrees that such in-
tions and other pertinent data on formation will not be disclosed to
the case report forms to be supplied third parties except where autho-
by the Sponsor. All data relevant to rized by the Sponsor or where re-
the investigational plan shall be quired by law. Further, the Princi-
made available b the Sponsor on re- pal Investigator(s) agrees not to
quest. publish the results of the study
until the Sponsor has reviewed the
3. Both Sponsor and Principal In- Principal Investigator(s) s proposed
vestigator(s) agree to comply with publication manuscript.
all applicable government regula-
tions. 8. The Sponsor shall have the
right to terminate this study at any
4. The Principal Investigator(s) time effective upon written notifi-
understands that the results of the cation to the Principal Investiga-
study may be used by the Sponsor in tor(s). The Principal Investiga-
support of an application for new tor(s) agrees to return a prorated
drug approval. Therefore, upon com- portion of the grant based on the
pletion of the study, the Principal percent of the total patient popula-
Investigator(s) agrees to cooperate tion in the attached protocol not
with the Sponsor, upon request, in enrolled by reason of such termina-
the preparation and review of any tion. Sponsor agrees to reimburse
reports, including a final study the Principal Investigator(s) for
report of the results of the study reasonable costs incurred pursuant
and agrees to acknowledge same by to this agreement which have not
written signature. otherwise been reimbursed by the
Sponsor, provided that this xxxx-
bursement shall not be made if ter-
mination is based upon failure of
the Principal Investigator(s) to
adhere to the attached protocol or
to any other provisions of this
agreement.
------------------------------------------------------------------------------
SIGNATURE(S) OF PRINCIPAL INVESTIGATOR(S) DATE
Turan Itil, M.D.
------------------------------------------------------------------------------
SIGNATURE OF XXXXXXX-XXXXXXX PHARMACEUTICALS INC. DATE
Xxxxxxx X. Xxxx, Business Director Neuroscience
------------------------------------------------------------------------------
XXXXXXX-XXXXXXX PHARMACEUTICALS INC.
Route 202-206 ~ X.X. Xxx 0000 x Xxxxxxxxxx, XX 00000-0000
-----------------------------------------------------------------------------------------------
DETAILED COST BREAKDOWN PER SUBJECT
PAGE 2 OF 2
-----------------------------------------------------------------------------------------------
NAME OR CODE NUMBER OF DRUG PROTOCOL NUMBER PRINCIPAL INVESTIGATOR(S) DATE OF REQUEST
******* *** Turan Itil, M.D.
-----------------------------------------------------------------------------------------------
-----------------------------------------------------------------------------------------------
STUDY START DATE STUDY COMPLETION DATE NO. OF SUBJECTS (ACCORDING TO PROTOCOL)
MARCH 1995 MAY 1997 at least ** completed
------------------------- ------------------------- ------------------------------------------
1. CLINICAL COSTS - FEES FOR SERVICES (PER SUBJECT)
SPECIFY IN DETAIL
*****************************, *******************, ********************** $ ********
----------------------------------------------------------------------------------------------
****************************, ***************** $ ******
----------------------------------------------------------------------------------------------
******************************, *************, ************** $ ******
----------------------------------------------------------------------------------------------
***************, *********************, *************, ************* $ ********
----------------------------------------------------------------------------------------------
2. LABORATORY TEST COSTS (PER SUBJECT)
SPECIFY IN DETAIL
************, **********, ************************************************ $ ******
----------------------------------------------------------------------------------------------
*************************** $ ******
----------------------------------------------------------------------------------------------
----------------------------------------------------------------------------------------------
----------------------------------------------------------------------------------------------
----------------------------------------------------------------------------------------------
3. ********* (PER SUBJECT) ********* $ ******
----------------------------------------------------------------------------------------------
4. *********** (PER SUBJECT)
SPECIFY IN DETAIL
************** - if required $ *****
----------------------------------------------------------------------------------------------
************** - if required $ ******
----------------------------------------------------------------------------------------------
5. *********** AND ************ COSTS (PER SUBJECT) $ ******
----------------------------------------------------------------------------------------------
6. OTHER COSTS (PER SUBJECT)
SPECIFY IN DETAIL
Recruitment, Screening/Attrition, Other Records Administration, Patient $ ********
and Caregiver Lunches, Patient Transport and Administrative Fee
----------------------------------------------------------------------------------------------
*** Processing $ *****
----------------------------------------------------------------------------------------------
****************************** $ ******
----------------------------------------------------------------------------------------------
TOTAL COSTS PER SUBJECT $ ********
----------------------------------------------------------------------------------------------
TOTAL GRANT REQUEST (Total Cost
Per Subject x Number of Subjects) $ *********
------------------------------------------------------------------------------- ==============
SUBMITTED: MEDICAL DIRECTOR DATE SIGNATURE OF PRINCIPAL INVESTIGATOR(S) DATE
CLINICAL NEUROSCIENCE
F. Xxxxx Xxxx, M.D. Turan Itil, M.D.
----------------------------------------------------------------------------------------------
APPROVED: DATE
XXXXXXX-XXXXXXX PHARMACEUTICALS INC. Xxxxxxx X. Xxxx
Business Director Neuroscience
---------------------------------------------- ---------------------------------------------
COPIES TO: CRD CENTRAL FILES o FINANCE AND ACCOUNTING o SPONSOR o INVESTIGATOR
HOECHST XXXXXX XXXXXXX, INC.
Route 202-206 . X.X. Xxx 0000 . Xxxxxxxxxxx, XX 00000-0000
Telephone (000) 000-0000
----------------------------------------------------------------------
Direct Dial (000) 000-0000
Fax: (000) 000-0000
June 14, 1996
Turan Itil, M.D.
HZI Research Center, Inc.
000 Xxxxx Xxxxxx Xxxx
Xxxxxxxxx, XX 00000
RE: ********************* AMENDMENT 6 - AGREEMENT FOR METHOD OF PAYMENT
Dear Dr. Itil:
By signing this letter and the attached schedule you agree to the method
of payment described below for this ****** study amendment for an
open-label extension of treatment.
Payments will be issued for work done on the basis of the number of
visits completed in the treatment extension period by each subject during
the interval following the previous payment. The table attached provides
the amount payable for each completed visit. Costs for prematurely
terminated payments will be paid on the basis of work done referring to
the unit costs in the attached table.
As indicated in the protocol, HMR reserves the option to discontinue the
study at your site at any time following initiation. In this event, HMR
would reimburse your site only for expenses incurred to that point.
We look forward to hearing from you.
With best regards,
Xx. Xxxxx X. Xxxx
Associate Director
Clinical Neuroscience
I accept the conditions of payment specified in this letter and the
attached table.
------------------------------------ -------------
Investigator's Signature Date
Note: Also sign attached table
******************* AMENDMENT 6 METHOD OF PAYMENT SCHEDULE
---------------------------------------------------------------------------------------------------------------
VISIT 14 15 16 17 18 19 20 21 22 23 24
PROCEDURE TOTAL
**** ** ** ** ** ** ***
*** ** **
*** ** **
**** ** **
*** ** **
**** *** ***
********** *** ***
****************** ** ** ** ** ** ** ** ***
****************** ** **
****************** ** ** ** ** ** ** ** **
*** ** ** ** ***
*********** ** ** ** ** ** ** ** ** ** ** ** ***
************** *** *** *** *** ***
********** *** *** *** *** ***
****************** ** ** ** ** ** ** ** ** ** ** ***
***** ** ** ** ** ** ** ** ** ** ** ** ****
************** ** **
****************** ** ** ** ** ** ** ** ** ** ** ** ***
TOTALS *** *** *** *** *** *** *** *** *** *** *** ****
---------------------- ------ ------ ------ ------ ------ ------ ------ ------ ------ ------ ------ -------
I ACCEPT THE METHOD OF PAYMENT DESCRIBED ABOVE. ___________________________________
SIGNATURE DATE
PORTIONS OF THIS EXHIBIT IDENTIFIED BY "***" HAVE BEEN DELETED PURSUANT
TO A REQUEST FOR CONFIDENTIAL TREATMENT FILED WITH THE SECURITIES AND
EXCHANGE COMMISSION UNDER RULE 406 OF THE SECURITIES ACT OF 1933, AS
AMENDED, AND THE FREEDOM OF INFORMATION ACT.
EXHIBIT 10(H)(v)
Unimed Pharmaceuticals, Inc.
Research Agreement
Study No.: **********
Agreement made this 6th day of December, 1996, by and between the New
York Institute for Medical Research, a private no
t-for-profit corporation
in the public service, organized and existing under the laws of the State
of New York and having its offices 000 Xxxxx Xxxxxx Xxxx, Xxxxxxxxx, XX
00000 (hereafter called "the Institute"), and Unimed Pharmaceuticals,
Inc., organized and existing under the laws of the State of Delaware and
having its offices at 0000 X. Xxxx Xxxx Xxxx, Xxxxxxx Xxxxx, XX
00000-0000 (hereinafter called "the Sponsor").
1. The Institute will undertake the project entitled ******************
************************************************************************
***********************************************************************
***********************************************************************
********************************************************************
******. (Sponsor Study **************; hereinafter called "the Study".
2. The Scope of Work. The work to be performed is as described in the
attached protocol labeled Exhibit "A".
3. Principal Investigator. The project will be under the supervision of
Turan M. Itil, MD, Chairman of the Institute. The Principal Investigator
will be responsible for the direction of the Study in accordance with all
applicable Institute policies and all applicable laws and regulations,
including but not limited to Federal Food, Drug and Cosmetic Act
regulations and guidelines. If during the performance period (as
hereafter defined) the Principal Investigator shall cease to supervise
the Study, then the Institute shall so notify the Sponsor and shall
endeavor to find a Principal Investigator or Principal Investigators
acceptable to the Sponsor to continue the supervision of the Study in
place of the Principal Investigator. If the Institute Is unable to find
such a Principal Investigator acceptable to the Sponsor, which acceptance
shall not unreasonably be withheld, within two months after such notice
to the Sponsor, this Agreement may be terminated by either party upon
written notice to the other party.
4. Period. The period of performance will be December 6, 1996, to
December 2, 1997.
5. Payments. In full compensation for the performance of the Study by the
Institute, the Sponsor shall pay the amount of $*******. The mutually
agreed upon budget is attached here to as "Exhibit B.. Payment of the
$******* shall be made in accordance with the mutually agreed open
payment schedule attached hereto as "Exhibit "C". No payment will be made
for ineligible subjects enrolled into the Study. Checks will be made
payable to "HZI Research Center Inc., 000 Xxxxx Xxxxxx Xx., Xxxxxxxxx,
XX, 00000. Payments will be sent c/o Dr. Itil who will be responsible for
ensuring deposit in the proper study account.
6. Inventions and Patents. All results, discoveries, and inventions
developed as a direct result of Unimed- Sponsored Study ********** by the
Institute, its agents, employees, or any other person Involved In the
Study, including the Principal Investigator, shall be the exclusive
property of the Sponsor, but the Institute may have access to the data
for internal purposes.
7. Confidential Information. (a) Confidential Information as used herein
shall mean compounds or substances and information or data in written or
tangible form delivered by or on behalf of the Sponsor hereunder for the
performance of the Study and which is clearly labeled as confidential by
the Sponsor. Oral discussions between the Sponsor and the Institute shall
be deemed confidential unless otherwise stipulated by the Sponsor.
Confidential Information will not include any information that: (i) was
known by the Institute prior to its receipt from the Sponsor; (ii) is
generally publicly known or becomes publicly known subsequent to its
receipt from the Sponsor through no fault of the Institute; (iii) Is
hereafter developed by the Institute Independent of any disclosure by the
Sponsor hereunder; or, (iv) is received by the Institute from another
party not under an obligation of confidentiality to the Sponsor. (b) Both
parties recognize that the industrial standards for handling Confidential
Information may not be appropriate in academic settings. However, the
Institute agrees to retain Confidential Information In such confidence as
the Institute retains its own Confidential Information, not to reveal
such Confidential Information to third parties, except, as required, to
the Food and Drug Administration (FDA), without the prior written
permission of the Sponsor, and to use such Confidential Information only
for the purpose of conducting the research or work hereunder. At the
termination of this agreement, all Confidential Information (including
copies and unused substances) will be returned to the Sponsor, except
that the Institute may retain one copy of such Confidential Information
for archival purposes only. (c) The results of the Study shall be treated
in confidence by the Institute, except that the Institute retains the
right to publish any and all of its Study results, subject to the terms
of Section 10 below. (d) The Sponsor shall have the right to use, copy
and distribute as it sees fit any of the published results of the Study
and to use and copy unpublished research results, provided that the
Sponsor may not use the name of the Institute and its officers, agents or
employees for any public or commercial purpose, including advertising,
promotional or sales literature or product labeling without the prior
written consent of the Institute. (e) The Institute and the Sponsor shall
hold the business terms of this Agreement in confidence and shall not
disclose them or any of them to any third party except with prior written
consent of the other party or as otherwise required by law or regulation.
8. Termination. (a) This project may be terminated by the Sponsor upon
thirty (30) days written notice. In the event of termination by the
Sponsor, the Institute will be reimbursed for all costs incurred and all
non-cancelable commitments under Section 5. In the event of termination
by the Institute pursuant to Section 3 above, any unexpended or
unobligated balance of funds advanced by the Sponsor shall be refunded to
the Sponsor. Except in accordance with Section 3, the Institute may not
terminate the Study prior to completion of all pending assignments. (b)
sections 6, 7, 9, 10, 11 and 14 of this Agreement shall survive
termination or expiration of this Agreement.
9. Use of the Name of the Institute. The Sponsor shall not make use of
the Institute's name or the name(s) of any member of its staff for
publicity or advertising purposes, except with the consent of, and to the
extent approved by, the Institute.
10. Publications and Copyrights. (a) It is understood that the Institute
is involved in medical research and education. As such, it retains the
exclusive right of first publication of the results of this research in
peer- reviewed technical Journals and the like. The subject matter of such
publication shall not contain information about the processes or methods
of the Sponsor, and shall be confined to a statement of new discoveries
and interpretations of scientific fact. The Sponsor shall have the right
to review any proposed publication before submission to technical journals
and the like. Prior to submission for publication of a manuscript
describing the results of any aspect of the Study, the Institute shall
send the Sponsor a copy of the manuscript to be submitted, and shall allow
the Sponsor thirty (30) days from the date of receipt to review the
manuscript. The purposes for such review are: 0) to provide the Sponsor
with the opportunity to review and comment on the contents of the proposed
publication; (ii) to Identify any Confidential Information belonging to
the Sponsor to be deleted from the proposed publication; and, (iii) to
allow the Sponsor to determine whether the manuscript contains subject
matter for which patent protection should be sought prior to publication
of such manuscript. Should the Sponsor believe the manuscript contains
Confidential Information belonging to the Sponsor or that the subject
matter of the manuscript contains a patentable Invention, then prior to
the expiration of thirty (30) days from the date of receipt of such
manuscript to the Sponsor by the Institute, the Sponsor shall give written
notification of such determination to the Institute. (b) The Institute
agrees that no data will be disclosed to any outside persons until the
tests are complete, codes have been broken, and statistical analysis
completed. (c) The to, and the right to determine the disposition of, any
copyrights, or copyrightable material, first produced or composed in the
performance of this research, shall remain with the Institute, provided
that the Institute shall grant to the Sponsor an irrevocable royalty free,
non-exclusive right to reproduce, translate, and use all such copyrighted
material for its own purposes.
11. Records and Reports. (a) A final report of the progress of the work
shall be made to the Sponsor by the Principal Investigator within 45 days
of completion. For projects lasting more than six months, Interim reports
may be requested by the Sponsor at no more than four-month Intervals. (b)
Progress reports and data are to be maintained on a current basis by the
Institute and made available to authorized representatives of the FDA or
the Sponsor. Any FDA or Sponsor request for a follow-up report of the
study will be expedited. In the event of a request for an audit or report
by the FDA, the Institute shall notify the Sponsor immediately and prior
to any response. Study records include laboratory data and analyses based
on that data. The Principal Investigator shall be responsible for the
accuracy and completeness of the data for each patient. The Institute
shall retain records for a period of two (2) years after the NDA approval
or discontinuation of the IND. If the Principal Investigator moves during
this time, the Institute shall notify the Sponsor concerning the location
of the records of the Study. The Institute must contact the Sponsor prior
to disposing of any records related to the Study.
12. Changes. The Sponsor or the Institute may, at any time, in writing to
each other, suggest and by mutual agreement make changes within the
general scope of the work, including but not limited to: (a) revising or
adding to the work or deleting portions thereof, (b) revising the period
or schedule of performance, or (c) increasing or decreasing the total
cost. Upon receipt of such notice of change and their mutual agreement
thereto, the parties shall immediately use their best efforts to take all
necessary steps to comply therewith.
13. Use of Drugs and/or Chemicals. If drugs and/or chemicals are supplied
by the Sponsor, and if requested by the Institute, the Sponsor agrees to
accept unused portions of drugs and/or chemicals supplied by the Sponsor
under this Agreement, including the containers in which the drugs and/or
chemicals are shipped, provided that said drugs and/or chemicals and
containers are properly labeled by the Institute, upon the return to the
Sponsor. Further, for each drug and/or chemical supplied under this
Agreement, the Sponsor agrees to furnish the Institute with sufficient
information to permit reasonable interpretation of the results obtained
in the investigations described herein, and to identify precautions
needed to help protect the health and safety of personnel using the drugs
and/or chemicals.
14. Indemnification. (a) The Sponsor agrees to indemnify and hold
harmless the Principal Investigator, the Institute, its agents, officers,
and employees against any and all losses, expenses, claims, actions,
lawsuits and Judgments thereon (including reasonable attorney fees
through the appellate levels), which may be brought against the Institute
and Hs agents, officers, and employees by reason of personal injury,
illness or death to any person as a result of administration of the
medication provided that any loss, liability or damage resulting from:
(i) failure to adhere to the terms of the Protocol or the Sponsor's
written instruction relative to the use of the investigational drug; (ii)
failure to comply with generally accepted medical standards or any
applicable FDA, NIH or other governmental requirements; or, (iii) acts of
negligence or willful malfeasance by the Principal Investigator, the
Institute, Hs agents of any of these or any other person associated with
the Institute who participates in any professional or technical
activities of the study is excluded from this agreement to indemnify,
defend and hold harmless. Administration of medication or placebo, or
other treatment pursuant to the Protocol shall not be considered
negligence by the Institute. In the event any such claim is made or
lawsuit is initiated, the Institute shall notify the Sponsor within ten
(10) days of receipt of notice of claim in writing and shall cooperate
fully In the defense of such lawsuit and permit the Sponsor or it
insurance carrier to defend such a claim or lawsuit. The provisions of
this paragraph shall continue after the termination of this agreement.
(b) The institute and the Principal Investigator agree to notify the
Sponsor as soon as they become aware of a claim or action and to
cooperate with and to authorize the Sponsor to carry out sole management
and defense of such claim or action. (c) Neither the Principal
Investigator, the Institute, nor its officers, agents or employees shall
compromise or settle any claim or action without the prior written
approval of the Sponsor. (d) The Institute agrees to indemnify the
Sponsor, its employees and agents for the cost of defense and damages
awarded, if any, arising out of any claim or lawsuit brought by a subject
who has become 111 or physically Injured or has suffered complications of
any underlying injury as a result of the negligence or willful
malfeasance of the Principal Investigator, or the Institute's employees
or agents, or the failure of the Principal Investigator, or the
Institute's employees or agents to conduct the Study In accordance with
the Protocol, directions, instructions and precautions communicated by
the Sponsor, or generally accepted medical standards, or to comply with
any applicable FDA, NIH or other governmental requirements.
15. Insurance. Within thirty (30) days after the effective date of this
Agreement, the Sponsor shall furnish evidence to the Institute that the
Sponsor has sufficient financial protection to satisfy the
indemnification obligations set forth in this Agreement. Such evidence
shall be in the form of a letter accompanying the Sponsor's audited
financial statements in which an authorized official of the Sponsor
indicates that the Sponsor has sufficient assets to cover potential
losses which might arise in connection with the Sponsor's indemnification
obligations. The Institute will inform the Sponsor if such protection is
not acceptable.
16. Notices. All communications, reports, and notices required or
permitted hereunder shall be deemed sufficiently given if in writing and
personally delivered or sent by facsimile or registered mail, postage
prepaid, return receipt requested, addressee to the parties as follows or
at such other address as a party shall have given notice Of pursuant
hereto:
If to the Sponsor:
Xxxxxx X. Xxxxxx, Ph.D.
Vice President, Clinical & Regulatory Affairs
Unimed Pharmaceuticals, Inc.
0000 X. Xxxx Xxxx Xxxx
Xxxxxxx Xxxxx, XX 00000-0000
Telephone: (000) 000-0000, Extension 3010
Facsimile: (000) 000-0000
If to the Institute:
Turan M. Itil, MD, Chairman
New York Institute for Medical Research
000 Xxxxx Xxxxxx Xxxx
Xxx Xxxx, XX 00000
Telephone: (000) 000-0000
Facsimile: (014) 631-8816
17. Laws and Regulations. This Agreement shall be governed by, and
construed and enforced in accordance with, the Laws of the State of New
York. The Sponsor and the Institute shall cooperate with the Institute In
complying with any applicable Federal, state and local laws, regulations
and policies governing research. In like manner, the Principal
Investigator and the Institute agree to conduct Study ********** in
accordance with all applicable Institute policies and all applicable laws
and regulations and other governmental requirements, including but not
limited to Federal Food, Drug and Cosmetic Act regulations.
18. No Assignment. The Institute shall not have the right to assign,
delegate or transfer at any time to any party, In whole or In part, any
or all of the rights, duties and interest herein granted without first
obtaining the written consent of the other party to such assignment.
19. Miscellaneous. (a) If any provision of this Agreement Is determined
to be Invalid or void, the remaining provisions shall remain in effect.
(b) No waiver by either party of any non-performance or violations by the
other party of any of the covenants, obligations or agreements of such
other party hereunder shall be deemed to be a waiver of any subsequent
violation or non-performance of the same or any other covenant, agreement
or obligation, nor shall forbearance by any party be deemed to be a
waiver by such party of its rights or remedies with respect to such
violation or non-performance. (c) The descriptive headings contained in
this Agreement are included for convenience and reference only and shall
not be held to expand, modify or aid in the interpretation, construction
or meaning of this Agreement. (d) It is not the intent of the parties to
create a partnership or joint venture or to assume partnership
responsibility or liability. The obligations of the parties shall be
limited to those set out herein and such obligations shall be several and
not joint.
20. Entire Agreement. This Agreement, including all Exhibits referenced
herein, shall be the complete Agreement of the parties hereto and shall
supersede all prior agreements and understandings, oral or written,
between the parties respecting the subject matter hereof.
The respective parties have executed this Agreement on the
dates indicated below.
HZI RESEARCH CENTER: SPONSOR:
-------------------------------- ----------------------------------
Institute Official Sponsor Official
Xxxx X. Itil, MD Xxxxxx X. Xxxxxx, Ph.D.
-------------------------------- ----------------------------------
Typed Name Typed Name
President VP, Clinical & Regulatory Affairs
-------------------------------- ----------------------------------
Title Title
-------------------------------- ----------------------------------
Date Date
NEW YORK INSTITUTE FOR
MEDICAL RESEARCH:
I agree to act as Principal Investigator
for the project described above:
--------------------------------
Principal Investigator
Turan Itil, MD
--------------------------------
Typed Name
Chairman
--------------------------------
Title
--------------------------------
Date
PORTIONS OF THIS EXHIBIT IDENTIFIED BY "***" HAVE BEEN DELETED PURSUANT
TO A REQUEST FOR CONFIDENTIAL TREATMENT FILED WITH THE SECURITIES AND
EXCHANGE COMMISSION UNDER RULE 406 OF THE SECURITIES ACT OF 1933, AS
AMENDED, AND THE FREEDOM OF INFORMATION ACT.
EXHIBIT 10(j)
CLINICAL TRIAL AGREEMENT
Key Principles. This Clinical Trial Agreement ("Agreement") is made
this 20th day of April, 1996 by the Pharmaceuticals Division, Ciba-Geigy
Corporation, with offices at 000 Xxxxxx Xxxxxx, Xxxxxx, Xxx Xxxxxx 00000
("Ciba") and New York Institute, with offices at 000 Xxxxx Xxxxxx Xxxx;
Xxxxxxxxx, Xxx Xxxx ("Institution"). In addition, Xxxxx Xxxxx, M.D.
("Investigator") agrees to assume certain specific responsibilities
designated herein.
1. Scope. The purpose of this Agreement is to describe the
responsibilities of the parties in the performance of a clinical trial of
************* in patients with ************** ************** ("Trial").
2. Statement of Work and Payments. The clinical research protocol
entitled "**************************************************************
************************************************************************
***********************************************************************"
("Protocol") separately provided to Institution and Investigator, and as
may be modified by protocol amendment from time to time, is made a part
hereof The 'Total Grant Cost Per Patient" to Ciba for the completion of
this Trial by Institution shall not exceed the amount so designated in the
Trial "Ciba Grant Development Worksheet" ("Budget") attached as Exhibit 1
and made a part hereof Payments shall be made on the schedule set forth in
Exhibit 1 and by check in accordance with the information set forth in
Exhibit 2, Form ******.
3. Project Timeline. This Trial will be initiated by Ciba and
Institution on or about May, 1996 and the Core Trial will be completed no
later than July 13, 1997, unless Ciba, by written notice to Institution,
extends this period. Institution/Investigator will make best efforts to
provide * patients for this trial.
The extension portion of the Trial will continue until
************* is registered and launched in the US, or US development of
this compound terminates. The number of patients in the extension is
dependent upon the number of patients completing the Core Trial and
entering the Extension Trial.
4. Advertisements. Investigator must inform the IRB should he
utilize advertisements to recruit Trial subjects/patients. Investigator
must give a copy of the proposed advertisement to Ciba and the IRB for
approval. Any promotional representation or suggestion that an
investigational drug is safe or effective for the purposes for which it
is offered under investigation, is a violation of federal regulations 21
CFR 312.7 (a).
5. Obligations. Ciba will provide all supplies of ************* and
placebo necessary to conduct the Trial. institution will provide
appropriate personnel and facilities to carry out this Trial, and further
agrees that it will carry out this Trial in compliance with this
Agreement, the Protocol, CBI directions/procedures, Good Clinical
Practice regulations and all other applicable federal, state, local,
foreign and Institution's regulations or guidelines governing the conduct
of such trials.
6. Confidentiality. All oral and written information exchanged by
the parties both prior to the initiation, and during the course of this
Trial shall be considered confidential and proprietary. This information
will not be used for any purpose other than this Trial or disclosed in
any way by Institution and Investigator or any of Institution's staff
members. This obligation will not apply to information which (a) at the
time this Agreement is signed (or thereafter) is publicly available; (b)
is possessed by Institution or Investigator at the time of disclosure by
Ciba from a source other then Ciba; (c) is acquired from a third party
who has the right to disclose such information; or (d) is required by law
to be disclosed. In the event that information is required to be
disclosed, the party required to make disclosure shall notify the other
to allow that party to assert whatever exclusions or exemptions may be
available to it under such law or regulation.
7. Property. It is understood that all rights, title and interest
to the data and results arising from this Trial are the exclusive
property of Ciba. Ciba may use this information in any way it sees fit,
including, but not limited to, regulatory filings, publication,
disclosure to affiliates and third parties.
8. Publication. Upon request, Institution and Investigator shall
provide access to Ciba (or its employees or agents) to any and all
information collected on behalf of Ciba or bearing on any work done in
connection with this Trial. Any proposed publication, lecture,
manuscript, poster presentation or other dissemination of the data and
results of this Trial ('Publication") by Institution and/or Investigator
shall be submitted to Ciba at least forty-five (45) days prior to its
submission for publication or use for Ciba's review, comment and
approval. It is mutually agreed that such approval shall relate to issues
such as ensuring accurate presentation of data and/or protection of
proprietary information, but in no case shall extend to the refusal to
approve merely because such data may have an undesired impact upon Ciba's
commercial activities. Ciba's comments shall be provided without undue
delay. Final wording and/or disposition of the Publication shall be
agreed to by the parties. Data and results from this Trial shall not be
disclosed to any third party except pursuant to the publication procedure
above.
Institution and Investigator understand and agree that the Trial is a
multicenter clinical trial of ************ and that a multicenter
publication will be prepared and published. Institution and Investigator
further understand and agree that they will not publish the results of
their participation in the Trial for a period of one ( 1) year after
completion of the Trial in its entirety, allowing for the review and
analysis of the Trial results and the preparation and publication of the
multicenter manuscript. Institution and Investigator will be acknowledged
in such multicenter publication.
9. Ownership. Neither Institution nor Investigator shall acquire
any rights of any kind in ************ or its uses as a result of
participation in this Trial. Ciba and Institution and Investigator
understand and agree that all rights, title and interest in and to
inventions arising out of this Trial, and know-how incident thereto, and
any patent applications and resultant patents derived therefrom, shall be
owned by Ciba.
10. Assignments. This Agreement, and all rights and obligations
hereunder, are personal to the parties signing it and may not be assigned
without the express written consent of the other party, except that Ciba
may assign this Agreement and all its right and obligations hereunder to a
successor or assignee of the business to which this Agreement relates.
Xxxxx Xxxxx, M.D. is considered to be essential to the work performed on
this Trial. Substitution of Xxxxx Xxxxx, M.D. or substantial changes in
his level of participation or the assignment of his rights or obligations
hereunder may not be made without the express written approval of Ciba.
11. Publicity. Neither party shall use the other party's name nor
issue any public statement about this Agreement, including its existence,
without the prior written permission of the other party, except as
required by law (and, in such case, only with prior notice to the other
party). Such prior permission shall not be unreasonably withheld. The
Parties agree that in order for Institution to satisfy its reporting
obligations, it may identify Ciba as he Trial sponsor and the amount of
funding received from Ciba for the Trial, but will not include in such
report any information which identifies the name of the Trial compound or
the therapeutic areas of the Trial.
12. Choice of Law. This Agreement shall be construed and the rights
of the parties determined in accordance with the laws of the State of New
York.
13. Indemnification. Ciba will indemnify, defend and hold harmless
Institution and Investigator (collectively "Indemnitees") from any
liability for damages imposed by law for drug- related injuries to
subjects arising out of the Trial.
Ciba shall have no obligation of indemnification hereunder for any loss
or damages arising out of the negligence or willful misconduct of
Indemnitees in connection with the conduct of the Trial. This
indemnification by Ciba is expressly conditioned upon adherence by
Indemnitees in all respects to the Protocol and compliance with the
applicable requirements of the Food and Drug Administration. Ciba
reserves the right to approve all proposed settlements for damages for
which it will be required to make payments hereunder. Additionally, Ciba
reserved the right to approve any attorney for whose fees it may be
liable and to control the defense or disposition of any claim. Under all
circumstances, Institution shall notify Ciba in writing within seven (7)
days of receipt of any claim, demand or the service of any complaint.
14. Termination. Either party may terminate this Agreement upon
thirty (30) days prior written notice to the other party. In the event
that Ciba exercises this right, Ciba will reimburse Institution for costs
and non-cancelable commitments incurred prior to the giving of such
notice, and shall not be responsible, after such termination, for any
other amounts set forth in this Agreement. Ciba may, in its sole
discretion, terminate this Trial if it determines that an emergency or
other condition requires this Trial to be terminated.
15. Understanding. This Agreement (including exhibits and the
Protocol) constitutes the entire understanding between the parties with
respect to the subject matter hereof and supersedes all prior or
contemporaneous agreements or understandings, oral or written. In case of
any conflict between the body of this Agreement and any of he exhibits
hereto or the Protocol, the body of this Agreement shall prevail. This
Agreement may be modified only by a document signed by all parties
hereto.
Agreement and Authorization. The parties have caused this Agreement
to be executed by their duly authorized representatives as of the day and
year first above written.
Pharmaceuticals Division New York Institute
Ciba-Geigy Corporation
By:---------------------------- By:-----------------------------------
Xxx X. Xxxxxxxxxxx
Title:Medical Research Associate Title:--------------------------------
Clinical Operations
I have read this Agreement and
understand and accept my obligations
hereunder.
By:-----------------------------------
Xxxxx Xxxxx, M.D.
Clinical Research Agreement
PORTIONS OF THIS EXHIBIT IDENTIFIED BY "***" HAVE BEEN DELETED PURSUANT
TO A REQUEST FOR CONFIDENTIAL TREATMENT FILED WITH THE SECURITIES AND
EXCHANGE COMMISSION UNDER RULE 406 OF THE SECURITIES ACT OF 1933, AS
AMENDED, AND THE FREEDOM OF INFORMATION ACT.
EXHIBIT 10(H)(iv)
Boehringer
Ingelheim
CLINICAL RESEARCH AGREEMENT
This is an Agreement made by and between Boehringer Ingelheim
Pharmaceuticals, Inc., having its principal office at 000 Xxxxxxxxx Xxxx,
Xxxxxxxxxx, Xxxxxxxxxxx 00000 (hereinafter called "BIPI") and HZI
Research Center, Inc. having its principal office at 000 Xxxxx Xxxxxx
Xxxx, Xxxxxxxxx, Xxx Xxxx 00000 (hereinafter called "HZI").
BACKGROUND OF THE AGREEMENT
Under this Agreement, BIPI will sponsor and HZI will conduct a clinical
study to establish the effects of **************************** on
*****************************
*********************************************, according to BIPI's
clinical study *******. Turan M. Itil, M.D., a staff member of HZI, shall
act as Principal Investigator.
1. DESCRIPTION OF WORK TO BE PERFORMED
HZI acting through Turan M. Itil M.D., as Principal Investigator
(hereinafter referred to as "INVESTIGATOR"), shall carry out a
clinical study of *********** according to the Protocol
*******************************************************
*********************************************************
***************************************************************
************************attached hereto as Exhibit I and
incorporated herein by reference (hereinafter referred to
as the "STUDY"). The protocol for the STUDY may be amended from
time to time by the parties hereto.
In addition, HZI, acting through its Principal Investigator Dr.
Itil, will gather data from ************* (******), perform a
database comparison, analysis and statistical strategies as
outlined in Appendix 11.11 of the attached Exhibit I.
2. REIMBURSEMENT OF COST
A. In support of the STUDY, BIPI shall pay HZI according to the
itemized grant request and payment schedule attached hereto as
Exhibit II and Exhibit IIa. In support of the services to be
performed in accordance with Appendix 11.11 ***********
(******) in Exhibit I, BIPI shall pay HZI as outlined in the
itemized request, attached hereto as Exhibit III. In the event
the protocol is amended, the money may be adjusted.
B. Payments shall be by company checks made payable to HZI
Research Center, Inc. and mailed to: Attn.: Xxxx Itil, Ph.D.,
000 Xxxxx Xxxxx Xxxx, Xxxxxxxxx, XX 00000, Tax I.D. No.
00-0000000. The Internal Revenue Service requires us to have
one record, either a Social Security number or Tax I.D.
Number for each payee. Please be sure the payee and the
number you provide are an exact match with that which is
listed with the IRS or SSA.
3. PERSONNEL
The STUDY shall be performed by personnel assigned thereto by HZI,
who shall work under the supervision and direction of Turan M.
Itil, M.D., who shall be designated the Principal Investigator. HZI
shall promptly notify BIPI should Dr. Itil no longer be able to
function as Principal Investigator. In such event, BIPI may, at its
discretion, terminate this Agreement, such termination being BIPI's
sole remedy against HZI.
This Agreement is not to be construed as creating any employment or
agency relationship between INVESTIGATOR and BIPI. It is understood
and agreed that INVESTIGATOR and HZI will be acting as independent
contractors and not as employees or agents of BIPI during the term
of this Agreement.
4. PROPRIETARY INFORMATION
All information of BIPI (including, but not limited to,
information, data, know-how or chemical or biological samples)
which is disclosed or given by BIPI to HZI in connection with the
STUDY to be performed hereunder and which is identified in writing
by BIPI as being proprietary shall be referred to for the purpose
of this Agreement as Proprietary Information. HZI receiving
Proprietary Information shall, throughout the original or extended
term hereof, and for five years thereafter, treat the same as
confidential; that is, HZI shall refrain from using such
Proprietary Information for any purpose except the conduct of the
STUDY and shall further refrain from disclosing the Proprietary
Information to any third party, absent the prior written permission
of BIPI. HZI shall make those staff members who are assigned to the
STUDY aware that they, too, are to treat the Proprietary
Information as confidential. These obligations of confidentiality
shall not apply to information which:
A. was known to HZI party prior to disclosure;
B. at the time of disclosure was generally available to the
public, or which after disclosure becomes generally available
to the public through no fault of HZI;
C. is hereinafter made available to HZI by a third party having
the apparent right to do so; or,
D. is developed independently by HZI..
5. STUDY RESULTS
HZI agrees that any or all information resulting from, or generated
or developed by the STUDY is the property of BIPI and may be used
by BIPI in connection with any of its research, development,
marketing, or promotional activities, and may be disclosed by BIPI
to third parties, including without limitation, other clinical
INVESTIGATOR, consultants, the Food and Drug Administration (herein
"FDA"), and other federal, state, and/or local regulatory agencies.
6. The parties shall indemnify each other as provided below:
A. BIPI Indemnity
(1) BIPI undertakes to indemnify and hold harmless; HZI,
Principal Investigator, HZI's trustees, officers,
agents, employees, students, persons holding academic
appointments within HZI, and affiliated hospitals, from
any and all liability, loss or damage they may suffer
as the result of claims, demands, costs, including
reasonable attorneys' fees, or judgments against them
arising out of activities to be carried out in
performance of the STUDY and the Statement of
Investigator FDA Form 1572; provided however, that BIPI
will not be responsible for any losses or claims,
including attorneys' fees and court costs, arising from
any injuries or damages that are a result of:
a) the sole negligence or intentional misconduct of HZI,
the Principal Investigator, or HZI employees;
b) research activities conducted contrary to the
provisions of theProtocol or outside the scope of
the Protocol;
c) actions by HZI in violation of applicable laws or
regulations, xxxx violation of any written
instructions from BIPI;
d) unauthorized warranties by HZI relating to the
Product.
(2) BIPI agrees to provide a diligent defense against any
claims brought against HZI, Principal Investigator,
trustees, officers, agents, employees, students,
persons holding academic appointments within HZI and
affiliated hospitals with respect to the subject of the
indemnity contained in this section, whether such
claims or actions are rightfully or wrongfully brought
or filed.
B. HZI Indemnity
(1) HZI undertakes to indemnify and hold harmless BIPI, its
officers, agents and employees, from any and all liability,
loss or damage they may suffer as a result of claims,
demands, costs, including reasonable attorneys' fees, or
judgments against them arising out of activities to be
carried out in performance of the STUDY and the Statement of
Investigator FDA Form 1572 for the STUDY, where such injury
results from a failure to adhere to the terms of the
applicable protocol(s) or negligence in attending to a
research subject.
(2) HZI agrees to provide a diligent defense against any claims
brought or actions filed against BIPI, its officers, agents,
and employees, with respect to the subject of the indemnity
contained in this section, whether such claims or actions are
rightfully or wrongfully brought or filed.
C. Conditions of Indemnity
Any party (hereinafter referred to as the "Indemnified Party")
wishing to be indemnified hereunder shall:
(1) promptly after receipt of notice of any complaint or the
commencement of any action, suit or proceeding giving rise to
the right or indemnification, notify the other party thereof
in writing of all particulars known to the Indemnified Party
and enclose a copy of all papers served;
(2) permit the other party to retain counsel of that party's
choosing to represent the Indemnified Party (but in the event
that the other party does not choose counsel to represent the
Indemnified Party, the Indemnified Party may select its own
counsel, the fee and costs of which counsel will be borne by
the other party); and
(3) allow the other party to retain exclusive control of any such
action, suit or proceeding including the right to make any
settlement provided that the other party will not make any
settlement which could reasonably be expected to have a
negative effect on the reputation of the Indemnified Party,
without the prior written consent of the Indemnified Party.
7. TIME FOR COMPLETION OF STUDY
A. HZI shall use reasonable efforts to complete the STUDY by January 31, 1998
B. Notwithstanding the foregoing, the STUDY may be terminated by BIPI
at any time upon 30 days advance written notice to the HZI. Upon
receipt of notice of early termination, HZI shall use its best
efforts promptly to limit or terminate any outstanding commitments
and to conclude the work. All costs incurred by HZI as a result of
such termination shall be reimbursable including, without
limitation, all non- reimbursed costs and non-cancelable
commitments incurred prior to the receipt of the notice of
termination.
8. FORCE MAJEURE
HZI shall not be liable for any failure to perform as required by
this Agreement, to the extent such failure to perform is caused by
any reason beyond HZI control, or by reason of any of the
following: labor disturbances or disputes of any kind, accidents,
failure of any required governmental approval, civil disorders,
acts of aggression, acts of God, energy or other conservation
measures, failure of utilities, mechanical breakdowns, material
shortages, disease, or similar occurrences.
9. SERENDIPITOUS INVENTION
HZI shall retain exclusive ownership of any serendipitous invention
conceived and first reduced to practice in the course of, and as
part of or under the STUDY solely by an employee of HZI
(hereinafter referred to as the INVENTION"). In consideration of
BIPI's support of the STUDY as provided herein, HZI hereby grants
to BIPI an option to obtain an exclusive, worldwide license (with
right to grant sublicenses) under any patent claiming an INVENTION.
In the event that BIPI elects to exercise its license option, HZI
shall enter into negotiations in good faith as to the terms and
conditions of the licensing agreement based on usual and customary
commercial standards, but in no event shall HZI and BIPI be
obligated to negotiate for more than six (6) months from the date
of BIPI's exercise of its option hereunder.
10. ASSIGNMENTS
Neither HZI nor BIPI shall assign this Agreement to any other
person without the prior written consent of the other, and any
purported assignment without such consent shall be void.
11. SEVERABILITY
In the event that a court of competent jurisdiction holds any
provision of this Agreement to be invalid, such holding shall have
no effect on the remaining provisions of this Agreement, and they
shall continue in full force and effect.
12. ENTIRE AGREEMENT: AMENDMENTS
This Agreement and the Appendices hereto contain the entire
Agreement between the parties. No amendments or modifications to
this Agreement shall be effective unless made in writing and signed
by authorized representatives of both parties.
13. GOVERNING LAW
This Agreement shall be governed by and construed in accordance
with the laws of the State of Connecticut.
IN WITNESS WHEREOF, the parties have executed this Agreement by
their duly authorized or representatives.
BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.
By:----------------------------------------
J. Xxxxxxx Xxxxxx, M.B., Ch.B., Ph.D.
Senior Vice President
Title:Medical & Drug Regulatory Affairs
-------------------------------------------
Date:--------------------------------------
HZI RESEARCH CENTER, INC.
By:----------------------------------------
Xxxx Itil, Ph.D.
Title:President & CEO
-------------------------------------------
Date:--------------------------------------
ACKNOWLEDGED BY:
Signature:
-------------------------------------------
Turan M. Itil, M.D.
Principal Investigator
Date:
-------------------------------------------
PORTIONS OF THIS EXHIBIT IDENTIFIED BY "***" HAVE BEEN DELETED PURSUANT
TO A REQUEST FOR CONFIDENTIAL TREATMENT FILED WITH THE SECURITIES AND
EXCHANGE COMMISSION UNDER RULE 406 OF THE SECURITIES ACT OF 1933, AS
AMENDED AND THE FREEDOM OF INFORMATION ACT.
EXHIBIT 10(i)
Boehringer Ingelheim Pharmaceuticals, Inc. Consultant Agreement
October 1, 1997
October 1, 1997
Xxxx X. Itil, Ph.D.
(President & CEO)
HZI Research Center, Inc.
000 Xxxxx Xxxxxx Xxxx
Xxxxxxxxx, XX 00000
Dear Dr. Itil:
I am pleased to offer HZI Research Center, Inc. (hereinafter "HZI"), a
consultantship with Boehringer Ingelheim Pharmaceuticals, Inc.
(hereinafter "BIPI"). We propose that the following be the terms and
conditions of HZI's consultantship.
1. HZI's field of consultation to BIPI shall be to instruct and train
****************** investigators in the operational process of
****************************************.
2. HZI agree to be available to provide up to sixteen (16) hours of
consultation to BIPI, at mutually agreeable times during the term
of HZI's consultantship. All consultation shall be rendered at
BIPI's facility located at 000 Xxxxxxxxx Xxxx, Xxxxxxxxxx, XX, or
at some other mutually agreed upon location.
3. The term of HZI's consultantship shall be for seven (7) months,
commencing on October 28, 1997 and ending on May 27, 1998, with
renewal or extension possible if agreed to in writing by BIPI and
HZI.
4. As compensation for HZI's services, BIPI shall pay HZI a consultant
fee of ************************* ($***) per hour, not to exceed a
total of ********************* ($*****). BIPI shall also reimburse
HZI for reasonable expenses for travel, accommodations and other
out-of-pocket expenses, which are incurred by HZI in connection with
the performance of HZI's consulting services. Payment of the
consultant fees and reimbursement of expenses shall be made within
thirty (30) days of HZI's presentation of a statement to BIPI
itemizing the hours of consultation provided and the expenses for
which reimbursement is sought.
5. BIPI shall have the right to terminate this Agreement at any time
by giving HZI notice of such intent. Upon receiving such notice,
HZI shall cease all further work under the Agreement. BIPI shall be
obligated to compensate HZI for all work done by HZI under the
Agreement prior to HZI's receipt of such notice.
6. HZI shall not, without the prior written consent of BIPI, disclose
to any third party, nor use for any purpose other than to provide
consultation under this agreement, any information which is made
available to HZI by BIPI, or any company which is affiliated with
BIPI, during the course of HZI's consultantship, or any information
which is derived by HZI directly from information which has been so
provided to HZI. These obligations of confidentiality shall not
apply to information which was known to HZI prior to receipt from
BIPI or its affiliate, which is or becomes generally known to the
public through no fault attributable to HZI, or which is hereafter
made available to HZI by any third party have a right to do so.
7. BIPI shall own and have the exclusive right to use, for any purpose,
all information, materials and reports which are provided by HZI and
are developed or written by HZI during the course of or as a result
of the consultation which HZI provide under this agreement, except
information, materials and reports already existing and not
developed by HZI for BIPI and HZI agree to assign to BIPI all right,
title and interest in and to all inventions which are conceived or
first reduced to practice by HZI during the course of or as a result
of the consultation which HZI will provide under this agreement. In
this regard, HZI further agree to cooperate with BIPI in the
preparation, filing and prosecution of any patent application, or in
the maintenance of any patent, claiming any such invention, and to
execute any document required to vest title to such invention to
BIPI.
8. With the exception of Paragraph 6, nothing in this agreement shall be
construed as limiting HZI's right to publish scientific article
provided that HZI supply BIPI with a copy of any draft manuscript,
concerning or related to HZI's work under this Agreement, prior to
its submission for publication, so that BIPI may evaluate such
manuscript and determine whether it contains subject matter on which
a patent application should be filed by BIPI pursuant to Paragraph
7, or information which was made available to HZI by BIPI. At BIPI's
request, HZI shall delay submission of such manuscript, for a period
not to exceed ninety days, in order to enable BIPI to prepare and
file a patent application, and shall delete from the manuscript any
information which is to be treated as confidential pursuant to
Paragraph 6.
9. It is agreed and understood that HZI's consulting services to BIPI
shall be performed as an independent contractor and not as an
employee or agent of BIPI.
10. HZI represent and warrant that HZI have the right to enter into
this Agreement, to grant any licenses or rights specified herein,
and that HZI have no preexisting obligations to other parties which
might preclude HZI from carrying out any or HZI's duties or
obligations under this Agreement. In particular, HZI represent and
warrant that (a) HZI's work as a consultant for BIPI will not
interfere in any way with HZI's responsibilities as an employee of
any other party; and (b) HZI's consultation under this Agreement
will relate only to HZI's general knowledge and expertise.
11. With the exception of Paragraph 6, above, nothing in this Agreement
shall be construed as limiting HZI's right to provide consultation
to other parties.
12. The obligations set forth in Paragraphs 6, 7, and 8 shall survive
the termination of this Agreement.
If the terms and conditions set forth herein are agreeable to HZI, please
sign and date both original copies of this Letter Agreement. One fully
executed original of this Letter Agreement should be returned to BIPI
whereupon it will become a binding Agreement between us.
Very truly yours,
BOEHRINGER INGELHEIM PHARMACEUTICALS INC.
By:------------------------------------------
J. Xxxxxxx Xxxxxx, M.B., Ch.B., Ph.D.
Senior Vice President, Medical & Drug
Regulatory Affairs
Date:----------------------------------------
HZI RESEARCH CENTER, INC.
By:------------------------------------------
Xxxx X. Itil, Ph.D.
President & CEO
Date:----------------------------------------
EXHIBIT 10(a)
NEUROCORP, LTD
1994 STOCK OPTION PLAN
1. Purpose
The purpose of the 1994 Stock Option Plan (the "Plan") is to
motivate and provide an incentive for or consultants and
consultants of Neurocorp, Ltd. (the "Company") and its subsidiaries
to exert their best efforts on behalf of the Company by enabling
and encouraging such individuals to acquire a greater stock
interest in the business, encouraging their continued service, and
promoting the interests of the Company and all its stockholders. In
addition, the Plan is intended to permit the Company to compete
with other companies offering similar plans in attracting and
retaining the services of executive personnel.
2. Types of Options
Options granted pursuant to the Plan shall be authorized by action
of the Board of Directors of the Company (or a Committee designated
by the Board of Directors) and may be either incentive stock
options ("incentive Stock Options") meeting the requirements of
Sections 422A of the Code or non-statutory options which are not
intended to meet the requirements of Section 429A of the Code.
3. Definitions
(a) "Board" - the Board of Directors of the Company.
(b) "Common Stock" - the common stock of the Company
(c) "Fair Market" - the "fact market value" per share of Common
Stock on a given date shall be determined by the Board with
full authority and discretion, taking into account all
factors customarily considered in determining fair market
value; provided, however, in the event that the shares of
Common Stock of Company are actively traded in an established
market, fair market value shall be the "bid" price at closing
on the date of the grant of the option.
(d) "Financial Statements" - the financial statements of the
Company.
(e) "Options" - grants of options to purchase shares of Common
Stock under the Plan.
(f) "Option Right" - the right to purchase a share of Common
Stock upon exercise of an Outstanding Option.
(g) "Outstanding Option" at any time, an option to purchase
Common Stock granted by the Company pursuant to the Plan,
whether or not such stock option is at such time exercisable,
to the extent that such stock option at such time has not
been exercised and has not terminated.
(h) "Participants" - or consultants or consultants to whom
Options have been granted under the Plan. When appropriate
and not otherwise indicated that the incapacity or death of a
Participant terminates or limits his right under the Plan,
the term "Participant" shall also be deemed to refer, in the
event of the death or incapacity of a Participant, to his or
her legal representative.
(i) "Employee," "outstanding," and "subsidiary corporation" have
meanings assigned them in Section 422A or 425 of the Internal
Revenue Code of 1954, amended ("Code").
(j) "Consultant" - a person or entity performifor the Company or
its subsidiaries pursuant to a consulting agreement.
4. Administration.
(a) This Plan shall be administered by the Board (or a committee
thereof) which may, from time to time, issue orders or adopt
resolutions, not inconsistent with, the provisions of this
Plan, to interpret the provisions and supervise the
administration of the Plan. All determinations shall be made
by an affirmative vote of a majority of the members of the
Board at a meeting called for such purpose, or reduced to
writing and signed by a majority of the members of the Board.
Subject to the Company By-laws, all decisions made by the
Board in selecting optionees, establishing the number of
shares and terms applicable to each option, and in construing
the provisions of this Plan shall be final, conclusive, and
binding on all persons including the Company, shareholders, or
consultants, and optionees. No option may be granted by the
Board under the Plan which is not approved by at least two
directors who are ineligible to receive options under the
Plan.
(b) Each option shall be evidenced by an Option Agreement which
shall contain such term and conditions as may be approved by
the Board, and shall be signed by an officer of the Company
and the employee.
5. Effective Date and Duration.
The Plan shall become effective as of December 1, 1994. Unless
sooner terminated by the Board, the Plan will terminate on November
30, 2004, and no Options may be made, granted, or assigned under
the Plan after such date; however, shares issuable upon the
exercise of Options granted on or prior to such date may bc
subsequently delivered or made to Participants in accordance with
the terms and conditions applicable to their respective Options.
6. Eligibility
(a) Options shall be made and granted under the Plan only to or
consultants, including officers and directors who are or
consultants of the Company and its subsidiaries who are
responsible for the management, growth, and protection of the
business of the Company or to consultants of the Company or
its subsidiaries. The Participants shall be selected from
time to time by the Board, on the recommendation of the
Officers of the Company, from among those eligible.
(b) Options granted under the Plan which are intended to be
Incentive Stock Options shall be specifically designated as
incentive Stock Options and shall be subject to the following
additional teens and conditions:
No employee shall be granted any Option if he personally owns
voting stock having more than Ten Percent (10%) of the total
combined voting power of all classes of outstanding stock of the
Company. The aggregate fair market value (determined at the time
the Option is granted) of shares as to which an Option may be
granted under this Plan or under any similar program of the Company
intended to qualify under Section 422 of the Code to any one
employee in any calendar year shall not exceed $100,000 plus any
unused limitation carry over to such year as determined under
Section 422A of the Code.
7. Amendment and Termination of the Plan.
The Board may at any time terminate the Plan, or from time to time
make such amendments thereto, including additions or deletions, as
the Board deems advisable, except that no amendment may adversely
affect any Option, theretofore assigned, made or granted to a
Participant. No amendment shall be made, however,unless approved by
the Stockholders of the Company, which would (a) increase the
maximum number of shares as to which Options may be granted, (b)
extend the period during which Options may be granted, made, or
assigned, (c) change the purchase price per share at which Options
may be granted, (d) materially modify the requirements as to
eligibility for participation in the Plan, (e) reduce the minimum
time an Option must be outstanding before it may be exercised, (f)
increase the maximum period for exercise of any Option, or (g)
otherwise cause Rule 16b-3 of the Securities and Exchange
Commission, or the equivalent thereof from time to time in effect,
to become inapplicable.
8. Miscellaneous Provisions.
(a) Employment, No employees or consultants shall have any claim
or right to be granted an Option under the Plan. Neither the
Plan nor any action taken hereunder shall be construed as
giving any employee or consultant any right to be retained in
the employ of the Company, or to limit the right of the
Company or any subsidiary to terminate the employment of any
Participant at any time, or to change the terms of such
employment.
(b) Nonalienation of Benefits. A Participant's rights and
interests under the Plan may not be assigned or transferred
in whole or in part either directly or by operation of law or
otherwise (except as specifically provided in the Plan in the
event of a Participant's death), including, but not by way of
limitation, execution, levy, garnishments, attachment,
pledge, bankruptcy or in any other manner, and no such right
or interest of any Participant shall be subject to any
obligation or liability of such Participant.
(c) Effect Upon Other Compensation Plans. The adoption of the
Plan shall not affect any other compensation or incentive
plan in effect for the Company or any subsidiary, and the
Plan shall not preclude the Board from establishing any other
forms of incentive or compensation for employee or consultant
of the Company or any subsidiary.
9. Stock Subject to the Plan; Effect of Recapitalization, Merger, Etc.
(a) Shares which may be subject to Options Granted. Subject to
adjustments made pursuant subsection (b) of this Section 9,
the total number of shares which may be granted under the
Plan (which shares may be authorized but unissued shares or
treasury shares) is $1,500,000 shares of common stock without
par value. To the extent that any options granted under the
program shall expire or terminate, in whole or in part'
without having been exercised the number of shares subject
thereto shall again become available for the granting of Options
under the Plan and they may thus be reoptioned.
(b) Effect of Recapitalization, Merger, Etc.
(i) In the event there is a change in, reclassification,
subdivision, or combination of, stock dividend on, or
exchange of stock, or other similar event, the number
and class of shares subject to Options theretofore
granted under the Plan and the price per share payable
upon exercise of such Options shall be appropriately
adjusted by the Board whose determination shall be
conclusive.
(ii) If, prior to the expiration of any Option granted under
the Plan, there shall be a merger, consolidation, or
reorganization of the Company with another corporation
in which the Company is not the surviving corporation,
the holder of any then outstanding Option shall
thereafter be entitled to receive, upon exercise of the
unexercised portion of the Option, the same number and
laud of shares, securities, or other property (including
cash) as he would have received had be exercised the
unexercised portion of the Option immediately prior to
such merger, consolidation, or reorganization.
Notwithstanding the foregoing, any Participant may agree
to the assumption of his Option by a corporation other
than the Company, or the substitution of a stock option
of a corporation other than the Company for his Option.
10. Procedure for Granting Options and Related Matters
(a) Board to Make Determination. Subject to the terms, provisions,
and conditions of the Plan, the Board shall (i) select the
employees or consultants to whom Options shall be granted,
(ii) determine the number of shares subject to each Option
granted, (iii) determine the time or times when Options will
be granted, (iv) determine the time or times, when each Option
may be exercised within the limits' stated in the Plan, and
(v) establish the fair market value of the shares, and the
appropriate officers of the Company shall prescribe the form,
which shall be consistent with the Plan, of the instruments
evidencing any Options granted hereunder.
(b) Requisite Action by Participants, Etc. As a condition to the
granting of an Option, each Participant shall be required to
enter into an Agreement (the "Option Agreement") with the
Company which shall contain such provisions consistent with
the Option Plan as may be prescribed by the Board, including
such restrictions as to the transferability of the shares to
be issued upon the exercise of an Option as the Board may, in
its discretion, deem appropriate. Such restrictions may be
for the purpose of assuring compliance with Federal and State
securities laws (as contemplated by Section 13(d) hereof' or
for other reasons deemed advisable by the Board.
11. Option Price.
The purchase price per share of Common Stock under each Option
granted pursuant to the Option Plan shall be at least One Hundred
(100%) percent of the "fair market value" per share of Comm.on
Stock on the date such Option is granted.
12. Duration of Options
Except as provided in Section 15(c), each Option granted under the
Plan shall terminate not later than ten (10) years after the date
on which it was granted. The Board may, in its discretion, provide
a shorter period for any individual Option or Options.
13. Nontransferability of Options.
No Option granted under the Plan shall be transferable by a
Participant otherwise than by will or the Laws of Descent and
Distribution; and an Option may be exercised, during a Participants
lifetime by him or her.
14. Exercise of Options, Restrictions or, Exercise.
(a) Each Option shall be exercisable according to terms set by the
Board, at the time of the grant. The Board may direct that an
Option become exercisable in installments, which need not be
annual installments, over a period which may be less than the
term of the Option. At such time as an installment shall
become exercisable, it may be exercised at any time
thereafter, in whole or in part, until the expiration or
termination of the Option, unless otherwise provided in the
Option Agreement referred to under Section 10(b), an Option
granted under the Option Plan shall be exercisable, prior to
the expiration or termination of the Option, in whole at any
time or in part from time to time. Only full shares which a
Participant is entitled to purchase will be issued; no
fractional shares will be issued.
(b) A participant may purchase shares pursuant to an Option
granted under the Plan only by giving the Company written
notice of his election to exercise the Option, specifying the
number of shares to be purchased.
Payment for the stock shall be in cash. A Participant shall
have none of the rights of a Stockholder with respect to any
shares as to which he or she has exercised an Option until
the shares are issued to him or her.
(c) Each Option granted under the Plan shall be subject to the
condition that if, at any tune, in the opinion of counsel for
the Company, the registration, listing, or qualification of
the shares covered by any Option under the Securities Act of
1933, as amended (the "Act"), upon any securities exchange or
under any state law, or the consent or approval of any
governmental regulatory body or the updating, amendment, or
revision of any registration statement, listing application,
or similar document, is required as a condition of, or in
connection with,, the purchase of shares under such Option, no
such Option may be exercised unless and until such
registration, listing, qualification, consent, approval,
updating, amendment, or revision shall have been effected or
obtained free of any conditions not acceptable to the Board;
provided, however, that, subject to Section 15 hereof, if the
right to exercise any Option is suspended for any of the
foregoing reasons, the termination date for exercising such
Option is extended for the length of time of the suspension or
thirty (30) days after the date on which the holder of such
Option is modified that such suspension of the right to
exercise the Option has ended.
(d) The Board may, as a condition to the exercise by a Participant
of an Option, require that the Participant agree in writing
that he will not dispose of the shares to be acquired upon
such exercise in a transaction which, in the opinion of
counsel for the Company, would violate the Act and the rules
and regulations promulgated thereunder. The Board shall have
the authority to require additional agreements or impose
additional conditions which it reasonably believes are
necessary to assure compliance with Federal and State
securities and other laws.
(e) The Board may require the Participant to continue his or her
employment with the Company or the performance of services as
a consultant for the Company as a condition precedent to the
vesting of any Option granted hereunder.
15. Termination of Employment, Disability, Retirement or Death.
No option may be exercised by an employee or consultant unless, at
the time of such exercise, such optionee is, and has been
continuously since the date of the grant of his or her option,
employed by the Company or performing services pursuant to a
consulting agreement with the Company, except that if and to the
extent of the option agreement or instrument so provides:
(a) The option may be exercised by an optionee within the period
of three months after (i) the date the optionee ceases to be
an employee of the Company or (ii) the date such optionee's
consulting agreement with the Company is terminated (or
within such lesser period as may be specified in the
applicable option agreement);
(b) if an optionee dies while in the employ of the Company, or
while performing services pursuant to a consulting agreement
with the Company or within three months after such optionee
ceases to be such an employee or consultant, the option may
be exercised by the person to whom it is transferred by will
or the laws of descent and distribution within the period of
one year after the date of death (or within such lesser
period as may be specified in, the applicable option
agreement); and
(c) if an optionee becomes disabled (within the meaning of
Section 22(e)(3) of the Code or any successor provision
thereto which in the employ of the Company or while
performing services pursuant toe consulting agreement with
the Company, the option may be exercised within the period of
one year after the date the optionee ceases to be such an
employee or consultant because of such disability (or within
such lesser period as may be specified in the applicable
option agreement);
provided, however, that in no event may any option be exercised
after the expiration date of the option. For all purposes of the
Plan and any option granted hereunder "employment" shall be defined
in accordance with the provisions of Section 1.421-7(h) of the
Income Tax Regulations (or any successor regulations).
16. Effective Date of Plan
The Plan shall become effective as of December 1, 1994.