Bracketed information omitted and filed separately with the Securities and
Exchange Commission
Confidential Treatment Requested Under 17 C.F.R. Sections 200.80 (b)(4), 200.83
and 240.24b-2
EXHIBIT 10.5
CORNING BIO INC.
MANUFACTURING SERVICES AGREEMENT
This manufacturing services agreement dated this 17th of September,
1996 (the "Agreement") between Sensus Corporation, a Delaware corporation
("Sponsor") having its principal place of business at 98 San Jacinto Boulevard.
Suite 430, Austin, TX 78701 and Corning Bio Inc., a Delaware Corporation
("CBI"), having its principal place of business at 6051 George Watts Hill,
Research Triangle Park, NC, 27709.
WITNESSETH
WHEREAS, CBI provides a full range of bioprocessing services to the
biopharmaceutical industry, including process development, fermentation, cell
culture, separation/purification, bioanalytical chemistry, quality control,
quality assurance, fill/finish, and regulatory affairs.
WHEREAS, sponsor desires CBI to perform services in accordance with the terms of
this Agreement and the Scope of work (as hereinafter defined) related to the
development of a process for production and the production of the material known
as Somavert/TM/ (the "Product" and also referred to as rh Growth Hormone
Antagonist) and CBI desires to perform such services.
NOW, THEREFORE, in consideration of the above statements and other good and
valuable consideration, the sufficiency and receipt of which are hereby
acknowledged, the parties hereto agree as follows:
Section 1.
SCOPE OF WORK
a) Upon CBI's written acceptance of a detailed scope of work document ("Scope")
to be provided by Sponsor or prepared by CBI under Sponsor's direction and
approved by Sponsor, CBI will perform the service or services ("Program")
for Sponsor in accordance with the Scope. The Scope will specify the program
design, information desired, estimated duration of the Program, and all
other matters pertinent to completion of the Program, and will be deemed a
part of this Agreement and is attached hereto as Attachment A and is
incorporated herein by reference.
b) CBI will, at Sponsor's request, consult with Sponsor in developing the
Program design in a manner consistent with current regulatory guidelines.
However, CBI does not warrant that the Program and/or the Program results
will satisfy the requirements of any regulatory agencies at the time of
submission of Program results to such agencies.
1.
Section 2.
PROGRAM PERFORMANCE
CBI shall use its best efforts to provide facilities, supplies, and staff
necessary to complete the Program as provided in the Scope, as it may be
modified as provided herein, and in accordance with the terms of this Agreement.
In the event of any conflict, the terms of this Agreement shall control.
Section 3
PROGRAM MATERIALS
a) Sponsor will provide CBI with sufficient amounts of all raw materials, or
other substances with which to perform the Program (the "Materials"), as
well as all documentation and such other data as may be necessary, to
apprise CBI of the stability of the Materials, process characteristics,
proper storage, manufacturing and safety requirements. Sponsor will also
provide CBI with all necessary information to effect the reliable transfer
of the process from the Sponsor to CBI.
b) Upon completion of the Program, any remaining samples of the Materials or
other substances provided to CBI will be returned to Sponsor or retained by
CBI in compliance with regulatory requirements. CBI will appoint a CBI
representative (the "Program Director") to be responsible for the completion
of the Program by CBI. The Program Director will coordinate performance of
the Program with a representative designated by Sponsor (the "Sponsor
Representative"), which representative shall have responsibility over all
matters relating to performance of the Program on behalf of Sponsor. Unless
otherwise agreed in the Scope, all communications between CBI and the
Sponsor regarding the conduct of the Program pursuant to the Scope shall be
addressed to or routed through the Program Director and Sponsor
Representative, directly. CBI may, under notification and approval by the
Sponsor, substitute the Program Director during the course of the program.
Section 4.
COMPLIANCE WITH GOVERNMENT REGULATIONS
a) CBI will perform the Program in accordance with the Scope and in accordance
with the current state of the Food and Drug Administration's Good
Manufacturing Practices. Subject to paragraph b. of Section 4 below, CBI
will also comply in all material respects with all applicable government
regulatory requirements concerning current Good Manufacturing Practices
appropriate to the Program.
b) Should such government regulatory requirements be changed, CBI will make
every reasonable effort to satisfy the new requirements. In the event that
2.
compliance with such new regulatory requirements necessitates a change in
the Scope for the Program, CBI will submit to Sponsor a revised technical
and cost proposal for Sponsor's acceptance prior to making any changes in
the Scope or the Program.
c) In the event of a conflict in government regulations, Sponsor will
designate, in writing, which regulations shall be followed by CBI in its
performance of the Program.
Section 5.
FACILITY VISITS
a) Sponsor's representatives may visit CBI's facility at reasonable times and
with reasonable frequency during normal operation of the Program to observe
the progress of the Program. CBI will assist Sponsor in scheduling such
visits which will be in compliance with CBI's internal policies and standard
operating procedures covering such activities.
Section 6.
COMPENSATION
Estimates for manpower, facility utilization and level of effort for the Program
are outlined in the Scope. Sponsor shall pay CBI the initial payment and will be
invoiced monthly for work performed under the Scope in accordance with the
Payment Schedule attached hereto as Attachment B and in accordance with the
hourly personnel and weekly facility billing rates listed below:
Personnel Hourly Rates
----------------------
1996 1997
----- -----
Vice President $ [*] $ [*]
Process Development Scientist [*] [*]
Manager/Engineer [*] [*]
Supervisor [*] [*]
QA Professional [*] [*]
Operator [*] [*]
QA Technician [*] [*]
Clerical [*] [*]
Facility Weekly Rates
---------------------
1996 1997
----- -----
Process Development Area* $[*] $[*]
Fermentation Area, Main Plant $[*] $[*]
*Assumes using approx. one-fourth of the total process development facility.
[*] = CERTAIN INFORMATION ON THIS PAGE HAS BEEN OMITTED AND FILED SEPARATELY
WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO
THE OMITTED PORTIONS.
3.
b) Payment for laboratory consumables and other materials used in and for the
Program will be in accordance with the terms and conditions of this
paragraph (b). General laboratory consumables will be billed as used and an
estimate of consumable costs for the program is attached hereto as
Attachment C.
Both parties recognize that CBI will be starting-up a new laboratory to
perform the Program. The consumable fee is meant to cover items actually
used in the performance of the Program. The Sponsor will not be responsible
for stocking general lab supplies as part of the laboratory start-up.
The consumables billing and usage will be reviewed quarterly with the
Sponsor.
'Capital' purchases greater than $[*] that are required for performing the
Program will be approved by the Sponsor prior to purchase. Such purchases
will be invoiced to the Sponsor as part of the normal monthly invoice and
contain a [*] handling fee.
c) Payment is due 30 days after Sponsor's receipt of the invoice. Late payments
are subject to an interest charge of one and one-half percent (1 1/2%) per
month. Any payments that are greater than 90 days past due constitute a
breach of this Agreement. See Section 13 for procedure for resolution of
payment dispute.
Section 7.
CONFIDENTIAL INFORMATION/LEGAL PROCEEDINGS
a) CBI will not disclose, without Sponsor's written permission, any information
pertaining to Sponsor's Program unless such disclosure: 1) is to an
affiliate of CBI who is under a similar obligation to keep such information
confidential; 2) is or becomes publicly available through no fault of CBI;
3) is disclosed by a third party entitled to disclose it; 4) is already
known to CBI as shown by its prior written records; or 5) is required by any
law, rule, regulation, order decision, decree, subpoena or other legal
process to be disclosed. If such disclosure is requested by legal process,
CBI will make all reasonable efforts to notify Sponsor of this request
promptly prior to any disclosure to permit Sponsor to oppose such disclosure
by appropriate legal action.
b) If CBI shall be obliged to provide testimony or records regarding any
Sponsor Program in any legal or administrative proceeding, then Sponsor
shall reimburse CBI its out-of-pocket costs therefore plus an hourly fee for
its employees or representatives equal to the internal fully burdened costs
to CBI of such employee or representative.
[*] = CERTAIN INFORMATION ON THIS PAGE HAS BEEN OMITTED AND FILED SEPARATELY
WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO
THE OMITTED PORTIONS.
4.
Section 8
WORK PRODUCT
a) All work outputs (e.g. reports) will be prepared on CBI's standard format
unless otherwise specified in the Scope.
b) Sponsor will have title to all raw data, documentation, records, protocols,
specimens and other reports generated as a result of the Program. All such
written materials will be archived by CBI for a period of five (5) years
following completion of the Program unless otherwise defined by the Program
or required by applicable laws or regulations. Five (5) years after
completion of the Program, all of the aforementioned written materials will
be sent to the Sponsor and a return fee will be charged. The Sponsor may
elect to have the materials retained in the CBI Archives for an additional
period of time at additional costs. If the Sponsor chooses to have CBI
dispose of the materials, a disposal fee will be charged. CBI will continue
to retain such documentation and materials as required by regulations and as
may be required by law, pertaining to such activities as well as for
archival purposes.
Section 9
INVENTIONS AND PATENTS
At Sponsor's request, CBI will assign to Sponsor any patentable product
improvement invention discovered by CBI employees exclusively as a result of
performing the Program under this Agreement; provided Sponsor requests such
--------
assignment, in writing, within one year of notification of such invention;
provided further that CBI shall retain all fights to any inventions relating to
- ----------------
manufacturing methods and processes discovered in connection with the Program
(Process Inventions). For Process Inventions, CBI will grant to Sponsor a
royalty-free license under terms mutually agreeable to the parties for the field
of use required for Sponsor to commercialize the Product developed or produced
under this Agreement, and for so long as CBI is producing [*] of the Sponsor's
annual requirement for Product, CBI shall not license the Process Invention to
any entity other than Sponsor. If Sponsor requests and at Sponsor's expense, CBI
will execute any and all applications, assignments or other instruments and give
testimony which shall be necessary to apply for and obtain Letters of Patent of
the US or of any foreign country and Sponsor shall compensate CBI for the time
devoted to such activities and reimburse it for expenses incurred.
Section 10.
INDEPENDENT CONTRACTOR
CBI shall perform the Program as an independent contractor of Sponsor and shall
have complete and exclusive control over its facilities, equipment, employees
and agents. Nothing in this agreement or other arrangements for which it is made
shall constitute CBI, or anyone furnished or used by CBI in the performance of
the services, as employee, joint venture, partner, or servant of Sponsor.
Section 11.
INSURANCE
[*] = CERTAIN INFORMATION ON THIS PAGE HAS BEEN OMITTED AND FILED SEPARATELY
WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO
THE OMITTED PORTIONS.
5.
CBI shall secure and maintain in full force and effect throughout the
performance of the Program policies of insurance for (a) Workmen's Compensation,
(b) General Liability, (c) Automobile Liability, and (d) Product Liability
having policy limits, deductibles and other terms appropriate to the conduct of
CBI's business in CBI's sole and exclusive judgment. Certificates evidencing
such insurance will be made available for examination upon request of the
Sponsor.
Section 12
DEFAULT
If CBI is in default of its material obligations under this Agreement, then
Sponsor shall promptly notify CBI in writing of any such default. CBI shall have
a period of 45 days from the date of receipt of such notice within which to cure
such default; provided that if such default renders the Program invalid, then
---------
CBI, shall, at its option, either ( 1 ) repeat the Program at its cost within a
time period mutually agreed to by it and Sponsor or (2) refund the contract
price paid by Sponsor. If CBI shall fail to cure such default within the
specified cure period or repeat the Program, as the case may be, then this
Agreement shall, at Sponsor's option, immediately terminate. In the event of
such termination, Sponsor's sole remedy shall be, in the case where such default
has not rendered the Program invalid, a reduction in the total contract price
for the Program in an amount equal to the difference between (1) the total
contract price for the Program and (2) the value of the work properly performed,
and, in the case where such default does render the Program invalid, a refund of
the contract price; provided however that under no circumstances shall CBI be
liable to Sponsor in an amount that, in aggregate exceeds, the contract price
paid for such Program. UNDER NO CIRCUMSTANCES SHALL SPONSOR BE ENTITLED TO
INCIDENTAL, INDIRECT, CONSEQUENTIAL OR SPECIAL DAMAGES ARISING IN CONNECTION
WITH SUCH DEFAULT OR BREACH OF CBI'S OBLIGATIONS UNDER THIS AGREEMENT, THE SCOPE
OR ANY DOCUMENTS OR ATTACHMENTS RELATED THERETO.
Section 13.
DISPUTE RESOLUTION
In the event any dispute shall arise between the Sponsor and CBI with respect to
any of the terms and conditions of this Agreement or the Protocol; then senior
executives of the Sponsor and CBI shall meet as promptly as practicable after
notice of such dispute to resolve in good faith such dispute. In the event the
parties are unable, despite their good faith efforts, to resolve such dispute
within 30 days after notice of such dispute to their mutual satisfaction, then
such dispute shall be promptly after such 30 day period submitted to non-binding
mediation. The timing, venue, and method of the non-binding mediation, and the
type and identity of the mediator shall be acceptable to both the Sponsor and
CBI. The
6.
Sponsor and CBI shall share equally the costs of the mediation. If the Sponsor
and CBI are unable, despite their good faith efforts, to agree on a mediator and
the aspects of the non-binding mediation process specified above within 45 days
after the senior executives, as applicable, have unsuccessfully terminated their
discussions or if either party disagrees with the mediator's decision, in the
case where the dispute is submitted to non-binding mediation, then the Sponsor
and CBI shall be entitled to exercise and enforce all of their rights and
remedies, both in law and in equity, with respect to such dispute.
Section 14.
INDEMNIFICATION
a) CBI shall hold harmless, defend and indemnify Sponsor and its parent
company, affiliates, subsidiaries, and their respective directors, officers,
employees, and agents from and against any and all third party claims,
proceedings, damages and losses, including reasonable attorney fees and
court costs, (collectively, "Claims") arising out of: (a) the negligence or
intentional misconduct of CBI, or, (b) any breach of this Agreement by CBI.
b) Sponsor shall hold harmless, defend and indemnify CBI and its parent
company, affiliates, subsidiaries, and their respective directors, officers,
employees, and agents from and against any and all Claims arising out of:
(a) the negligence or intentional misconduct of Sponsor, (b) any breach of
this Agreement by Sponsor, or (c) CBI's involvement with the Program, or the
harmful or otherwise unsafe effects of the Product, the intermediates in the
process, or the Materials supplied by Sponsor that are not commercially
available.
Section 15
REPRESENTATION
Sponsor hereby represents to CBI that to the best of its knowledge Sponsor has
valid licenses to the raw material, expression systems, process patents and the
Product and that CBI's performance of the Program will not violate or infringe
on the patents, trademarks, tradenames, servicemarks or copyrights of any other
party.
Section 16
FORCE MAJEURE
Either party shall be excused from performing its obligations under this
Agreement if its performance is delayed or prevented by any event beyond such
party's reasonable control, including, but not limited to, acts of God, fire,
explosion, weather, disease, war, insurrection, civil strife, riots, government
action, or power failure, provided that such performance shall be excused only
to the extent of and during such disability. Any time specified for completion
of performance in the Scope falling due during or subsequent to the occurrence
of
7.
any or such events shall be automatically extended for a period of time to
recover from such disability. CBI will promptly notify Sponsor if, by reason of
any of the events referred to herein, CBI is unable to meet any such time for
performance specified in the Scope. If any part of the Program is invalid as a
result of such disability, CBI will, upon written request from Sponsor, but at
Sponsor's sole cost and expense, repeat that part of the Program affected by the
disability.
Section 17.
ALLOCATION OF RESOURCES
If delays in the agreed commencement or performance of the Program occur because
of the Sponsor's inability to supply CBI with the Materials or any information
required to begin or perform the Program within 30 days of such agreed time, CBI
may reallocate resources being held for performance of the Program without
incurring liability to Sponsor.
Section 18.
USE OF NAMES
Neither party shall use the name of the other party or the names of the
employees of the other party in any advertising or sales promotional material or
in any publication without prior written permission of such party.
Section 19.
TERMINATION BY SPONSOR
a) Sponsor may at any time terminate the Program prior to completion by giving
written notice to CBI. In such event CBI shall immediately comply with such
notice to terminate work on the Program and use its best efforts to reduce
cost to Sponsor, and Sponsor shall pay CBI upon receipt of CBI's invoice all
of its costs incurred or irrevocably obligated, plus, as liquidated damages
and not as a penalty, a pro rata portion of applicable profit for the
Program as of the date of termination. The amount of such profit and the
basis for the computation thereof shall be specified in a certificate signed
by the Chief Financial Officer of CBI.
b) The termination of this Agreement for any reason shall not relieve either
party of its obligation to the other for obligations in respect of (i)
confidentiality of information, (ii) consents for advertising purposes and
publications, (iii) indemnification and, (iv) compensation for services
performed.
Section 20.
ASSIGNMENT
a) This Agreement shall not be assigned in whole or in part by either party
without the prior written consent of the other, which consent shall not be
unreasonably withheld or delayed. Any attempt to assign this Agreement
without such consent shall be void and of no effect.
b) Notwithstanding anything in paragraph a. of this Section 20 to the contrary,
with the approval of the Sponsor, certain tasks specified in the Scope may
be subcontracted by CBI.
8.
Section 21.
NOTICE
All notices to be given as required in the Agreement shall be in writing and
shall be delivered personally, sent by telecopies, or mailed either by a
reputable overnight carrier or first class mail, postage prepaid to the parties
at the addresses set forth above or such other addresses as the parties may
designate in writing. Such notice shall be effective on the date sent, if
delivered personally or sent by telecopier, the date after delivery if sent by
overnight carrier and on the date received if mailed first class.
Section 22.
CHOICE OF LAW
This Agreement shall be construed and enforced in accordance with the laws of
the State of North Carolina.
Section 23.
WAIVER/SEVERABILITY
No waiver of any provision of this Agreement, whether by conduct or otherwise,
in any one or more instances shall be deemed to be or be construed as a further
or continuing waiver of any such provision, or of any other provision or
condition of this Agreement. If any provisions hereof shall be determined to be
invalid or unenforceable, the validity and effect of the other provisions of
this Agreement shall not be effected thereby.
Section 24.
ENTIRE AGREEMENT; MODIFICATION/COUNTERPARTS
This instrument and the Scope set forth the entire Agreement between the parties
hereto with respect to the performance of the Program by CBI for Sponsor and as
such, supersedes all prior and contemporaneous negotiations, agreements,
representations, understandings, and commitments with respect thereto and shall
take precedence over all terms, conditions and provisions on any purchase order
form or form of order acknowledgment or other document purporting to address the
same subject matter. This Agreement shall not be waived, released, discharged,
changed or modified in any manner except by an instrument signed by the duly
authorized officers of each of the partied hereto, which instrument shall make
specific reference to this Agreement and shall express the plan or intention to
modify same. This Agreement may be executed in one or more counterparts each of
which shall be deemed an original but all of which together shall constitute one
and the same instrument.
9.
This Agreement becomes effective and binding on both parties on and as of the
last date that the parties hereto have executed this Agreement. Should terms
contained herein be at variance with the terms and conditions specified in
Sponsor's written acceptance, then the terms and conditions contained herein
take precedence.
Sensus Corporation
/s/ William F. Bennett /s/ Chris Kuebler
By: _____________________________ By: _____________________________
William F. Bennett Chris Kuebler
Name: ____________________________ Name: ____________________________
Sr. VP Manufacturing Chairman
Title: _________________________ Title: _________________________
20 Sept. 96 9-19-86
Date: __________________________ Date: _________________________
10.
ATTACHMENT A
TO MANUFACTURING SERVICES AGREEMENT BETWEEN
CORNING BIO AND SENSUS DATED 17 SEPTEMBER 1996*
[*]
*Terms not defined herein shall have the meaning set forth in the Manufacturing
Services Agreement.
[*] = CERTAIN INFORMATION ON THIS PAGE HAS BEEN OMITTED AND FILED SEPARATELY
WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO
THE OMITTED PORTIONS.
1.
[*]
[*] = CERTAIN INFORMATION ON THIS PAGE HAS BEEN OMITTED AND FILED SEPARATELY
WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO
THE OMITTED PORTIONS.
2.
[*]
[*] = CERTAIN INFORMATION ON THIS PAGE HAS BEEN OMITTED AND FILED SEPARATELY
WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO
THE OMITTED PORTIONS.
3.
5) ENGINEERING
-----------
The goal of engineering is to transfer laboratory scale processes to
manufacturing in an economical and properly scaled fashion.
[*]
[*] = CERTAIN INFORMATION ON THIS PAGE HAS BEEN OMITTED AND FILED SEPARATELY
WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO
THE OMITTED PORTIONS.
4.
B. BENCHMARKS
[*]
[*] = CERTAIN INFORMATION ON THIS PAGE HAS BEEN OMITTED AND FILED SEPARATELY
WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO
THE OMITTED PORTIONS.
5.
D.) INFORMATION TRANSFER:
---------------------
It is Corning Bio's intent to update and transfer pertinent data to Sensus at
regular intervals. The intervals are to be determined by mutual agreement and
will be implemented at the commencement of the Program. Written reports will be
prepared in Corning Bio's standard format. Updates and data transfer can be
accomplished by one or more of the following methods:
Weekly phone calls
Monthly Reports
Quarterly reports
Data Transfer Meetings
E.) COMMENCEMENT OF THE PROJECT:
----------------------------
Development efforts will begin upon a mutually agreeable date. Tentatively, that
date is November 1, 1996.
16.
ATTACHMENT B
TO MANUFACTURING SERVICES AGREEMENT BETWEEN
CORNING BIO AND SENSUS DATED 17 SEPTEMBER 1996
PAYMENT SCHEDULE
----------------
PAYMENTS AND INVOICES ESTIMATED DATE PAYMENT
- --------------------- -------------- -------
[*]
*Monthly invoices will be issued on or about the first of each month and will
cover activities and purchases through the 24th of the preceding month.
[*] = CERTAIN INFORMATION ON THIS PAGE HAS BEEN OMITTED AND FILED SEPARATELY
WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO
THE OMITTED PORTIONS.
ATTACHMENT C
TO MANUFACTURING SERVICES AGREEMENT BETWEEN
CORNING BIO AND SENSUS DATED 17 SEPTEMBER 1996
ESTIMATE FOR CONSUMABLES FOR SENSUS PROGRAM
-------------------------------------------
Estimated Estimated
Area Total/month Total for 6 months
- ---- ----------- ------------------
[*]
[*] = CERTAIN INFORMATION ON THIS PAGE HAS BEEN OMITTED AND FILED SEPARATELY
WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO
THE OMITTED PORTIONS.
18.
[*] CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY
WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO
THE OMITTED PORTIONS.
AMENDMENT NO. 1
TO
MANUFACTURING SERVICES AGREEMENT
Amendment No. 1 dated as of July 3, 1997 (this "Amendment No. 1") between
Covance Biotechnology Services Inc., (f/k/a Corning Bio Inc.), a Delaware
corporation having its principal place of business at 6051 George Watts Hill
Drive, P.O. Box 13865, Research Triangle Park, NC 27709-3865 ("CBSI") and Sensus
Corporation, a Delaware corporation having its principal place of business at 98
San Jacinto Boulevard, Suite 430, Austin, TX 78701 ("Sponsor").
WITNESSETH:
WHEREAS, CBSI and Sponsor have entered into that certain Manufacturing
Services Agreement dated September 17, 1996 (the "Agreement") wherein CBSI
agreed to perform certain services for Sponsor in connection with the
development of a manufacturing process for a material known as rhGHA, or B2036-
PEG ("Product") in accordance with the Scope; (terms defined in the Agreement
and not otherwise defined herein are used herein as defined therein); and
WHEREAS, CBSI has progressed the development phase of the production process
for Product as defined in the Scope and Sponsor now wishes to amend the
Agreement whereby CBSI will undertake the production phase of the Program for
Product in accordance with the terms of a new scope of work document (as defined
below) and CBSI desires to amend the Agreement to provide said manufacturing
services to Sponsor.
NOW, THEREFORE, for good and valuable consideration the sufficiency and
receipt of which are hereby acknowledged, the parties agree to as follows:
1. SCOPE OF WORK. A detailed scope of work document for the production of
Product (the "Revised Scope") prepared by the parties is attached to this
Amendment No. 1. CBSI will perform the services set forth in the Revised Scope
in accordance with the terms and conditions of the Agreement. Except as
expressly modified herein, all terms and conditions of the Agreement will remain
in full force and affect.
2. AMENDMENT TO SECTION 6 OF THE AGREEMENT. Section 6 of the Agreement is
hereby amended to append subparagraph d) to Section 6 as follows:
d) The Revised Scope attached to this Amendment No. 1 outlines the
activities that will be performed during the manufacturing phase of the
Sponsor's development program for the Product. The Revised Scope also
contains the prices and Payment Schedule associated with performing the
activities outlined in the Revised Scope. CBSI will invoice Sponsor after
achieving the milestones listed in the Payment Schedule. The amount of
the invoices will
1.
equal the payment associated with the corresponding milestone. The
estimated dates in the Payment Schedule are provided for planning
purposes; invoices will be sent after actually achieving milestones.
Payment is due 30 days after Sponsor's receipt of the invoice. Late
payments are subject to an interest charge of one and one-half percent (1
1/2%) per month. Any payments greater than 90 days past due constitute a
breach of this Agreement.
3. AMENDMENT TO SECTION 14 OF THE AGREEMENT. Section 14 of the Agreement is
hereby amended in full to read as follows:
SECTION 14.
INDEMNIFICATION
(A) CBSI shall indemnify Sponsor and its affiliates and their respective
officers, directors, agents, and employees from any loss, cost, damage or
expense (a "Loss") from any lawsuit, action, claim, demand, assessment or
proceeding (a "Claim") for personal injury to Program participants or
personal injury to any employee or agent of Sponsor or property damage
arising or occurring during the conduct of the Program as a result of
CBSI's negligence, gross negligence or intentional misconduct or
inaction; provided that if such Loss or Claim arises in whole or in part
--------
from Sponsor's negligence, gross negligence or intentional misconduct or
inaction; or CBSI's violation, noncompliance, or nonperformance of any of
the terms of this Agreement then the amount of the Loss that CBSI shall
indemnify Sponsor for pursuant to this Section 14 shall be reduced by an
amount in proportion to the percentage of Sponsor's responsibilities for
such Loss determined by a court of competent jurisdiction in a final and
non-appealable decision or in a binding settlement between the parties.
(B) Sponsor shall indemnify CBSI and its affiliates and their respective
officers, directors, employees and agents (the "CBSI Group") from any
Claim or Loss arising from or related to (i) personal injury to a
participant in the Program or personal injury to any employee of the CBSI
Group directly caused by the Material, Product, intermediates or the
Program, (ii) the harmful or otherwise unsafe effect of the Materials or
Product, including, without limitation, a Claim based upon Sponsor or any
other person's use, consumption, sale, distribution or marketing of any
substance, including the Material or the Product, (iii) the negligence,
gross negligence or intentional misconduct or inaction of Sponsor in the
performance of its obligations under this Agreement or Scope related to
the Program, or (iv) the Sponsor's violation, non-compliance or non-
performance of any of the terms of this Agreement or the Sponsor's breach
of any representation made herein, or (v) any violation or infringement
of any third party's intellectual property rights including, without
limitation, any patent, copyright, trademark, trade secret, license or
other property
2.
right; provided that if such Loss or Claim (other than a Loss or Claim
--------
described in clause (ii) hereof) arises in whole or in part from
CBSI's negligence, gross negligence or intentional misconduct or
inaction or, with respect to a Loss or Claim described in clause (v)
hereof, from any violation or infringement of any third party's
intellectual property rights arising from CBSI's use of any expression
system or process developed by CBSI under this Agreement to make,
create, or produce the Product (except to the extent that Sponsor is a
contributory infringer) or CBSI's violation, noncompliance, or
nonperformance of any of the terms of this Agreement, then the amount
of such Loss that Sponsor shall indemnify the CBSI Group for pursuant
to this Section 14 shall be reduced by an amount in proportion to the
percentage of CBSI's responsibilities for such Loss as determined by a
court of competent jurisdiction in a final and non-appealable decision
or in a binding settlement between the parties. Sponsor shall not
indemnify the CBSI Group from any Loss from any claim described in
clause (ii) hereof arising solely from the gross negligence,
recklessness, or willful misconduct or inaction of CBSI.
(C) Upon receipt of notice of any Claim which may give rise to a right
of indemnity from the other party hereto, the party seeking
indemnification (the "Indemnified Party") shall give written notice
thereof to the other party, (the "Indemnifying Party") with a Claim
for indemnity. Such Claim for indemnity shall indicate the nature of
the Claim and the basis therefore. Promptly after a claim is made for
which the Indemnified Party seeks indemnity, the Indemnified Party
shall permit the Indemnifying Party, at its option and expense, to
assume the complete defense of such Claim, provided that (i) the
--------
Indemnified Party will have the right to participate in the defense of
any such Claim at its own cost and expense, (ii) the Indemnifying
Party will conduct the defense of any such Claim with due regard for
the business interests and potential related liabilities of the
Indemnified Party and (iii) the Indemnifying Party will, prior to
making any settlement, consult with the Indemnified Party as to the
terms of such settlement. The Indemnified Party shall have the right,
at its election, to release and hold harmless the Indemnifying Party
from its obligations hereunder with respect to such Claim and assume
the complete defense of the same in return for payment by the
Indemnifying Party to the Indemnified Party of the amount of the
Indemnifying Party's settlement offer. The Indemnifying Party will
not, in defense of any such Claim, except with the consent of the
Indemnified Party, consent to the entry of any judgment or enter into
any settlement which does not include, and an unconditional term
thereof, the giving by the claimant or plaintiff to the Indemnified
Party of a release from all liability in respect thereof. After
notice to the Indemnified Party of the Indemnifying Party's election
to assume the defense of such Claim, the Indemnifying Party shall be
liable to the Indemnified Party for such legal or other expenses
subsequently
3.
incurred by the Indemnified Party in connection with the defense
thereof at the request of the Indemnifying Party. As to those Claims
with respect to which the Indemnifying Party does not elect to assume
control of the defense, the Indemnified Party will afford the
Indemnifying Party an opportunity to participate in such defense at
the Indemnifying Party's own cost and expense, and will not settle or
otherwise dispose of any of the same without the consent of the
Indemnifying Party.
4. AMENDMENT TO SECTION 15 OF THE AGREEMENT. Section 15 of the Agreement
is hereby amended in full to read as follows:
SECTION 15.
REPRESENTATION
The Sponsor hereby represents and warrants that CBSI's performance of its
obligations under this Agreement, including, without limitation, the
making, production or creation of the Product or the use of the Materials
and the expression systems and processes used to make, create or produce
the Product, does not violate or infringe on the issued patents,
trademarks, tradenames, servicemarks or copyrights or other intellectual
property rights of any other party; provided that the foregoing shall not
--------
apply to the extent that any such expression systems or process used to
make, create or produce the Product were developed by CBSI.
5. AMENDMENT. No amendments or modifications to this Amendment No. 1 and
no further amendments or modifications the Agreement may be made without the
written agreement of the parties hereto.
IN WITNESS WHEREOF, the parties hereto have executed or caused this Amendment
No. 1 to be executed by their respective officers or other representatives
hereunder duly authorized as of the date first written above.
COVANCE BIOTECHNOLOGY SERVICES, INC. SENSUS CORPORATION
/s/ Christopher A Kuebler /s/ William F. Bennett
By:_______________________________ By:_______________________________
Christopher A Kuebler William F. Bennett
Name:_____________________________ Name:_____________________________
Chairman Sr. V.P.
Title:____________________________ Title:____________________________
7/3/97 3 July 97
Date:_____________________________ Date:_____________________________
4.
REVISED SCOPE OF WORK FOR
AMENDMENT NO. 1 TO
MANUFACTURING SERVICES AGREEMENT
WITH SENSUS CORPORATION
(CONTAINING PRICES AND PAYMENT SCHEDULE)
SCOPE CONTENTS
Section Page
[*]
[*] = CERTAIN INFORMATION ON THIS PAGE HAS BEEN OMITTED AND FILED SEPARATELY
WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO
THE OMITTED PORTIONS.
1.
OVERALL PROGRAM OBJECTIVES
OBJECTIVES
[*]
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WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO
THE OMITTED PORTIONS.
2.
SECTION 1.
[*]
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WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO
THE OMITTED PORTIONS.
3.
[*]
[*] = CERTAIN INFORMATION ON THIS PAGE HAS BEEN OMITTED AND FILED SEPARATELY
WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO
THE OMITTED PORTIONS.
4.
[*]
[*] = CERTAIN INFORMATION ON THIS PAGE HAS BEEN OMITTED AND FILED SEPARATELY
WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO
THE OMITTED PORTIONS.
5.
SECTION 2.
TECHNOLOGY TRANSFER/PREPRODUCTION ACTIVITIES
[*]
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WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO
THE OMITTED PORTIONS.
6.
TECHNOLOGY TRANSFER/PREPRODUCTION ACTIVITIES
[*]
[*] = CERTAIN INFORMATION ON THIS PAGE HAS BEEN OMITTED AND FILED SEPARATELY
WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO
THE OMITTED PORTIONS.
7.
SECTION 3.
[*]
[*] = CERTAIN INFORMATION ON THIS PAGE HAS BEEN OMITTED AND FILED SEPARATELY
WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO
THE OMITTED PORTIONS.
7.
[*]
[*] = CERTAIN INFORMATION ON THIS PAGE HAS BEEN OMITTED AND FILED SEPARATELY
WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO
THE OMITTED PORTIONS.
9.
[*]
[*] = CERTAIN INFORMATION ON THIS PAGE HAS BEEN OMITTED AND FILED SEPARATELY
WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO
THE OMITTED PORTIONS.
10.
SECTION 4.
CGMP PRODUCTION FOR PHASE III CLINICAL TRIALS AND
ESTABLISHMENT OF A REFERENCE STANDARD
[*]
[*] = CERTAIN INFORMATION ON THIS PAGE HAS BEEN OMITTED AND FILED SEPARATELY
WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO
THE OMITTED PORTIONS.
11.
CGMP PRODUCTION FOR PHASE III CLINICAL TRIALS AND
ESTABLISHMENT OF A REFERENCE STANDARD
[*]
[*] = CERTAIN INFORMATION ON THIS PAGE HAS BEEN OMITTED AND FILED SEPARATELY
WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO
THE OMITTED PORTIONS.
12.
SECTION 5.
FORMULATION AND FILL/FINISH ACTIVITIES
[*]
[*] = CERTAIN INFORMATION ON THIS PAGE HAS BEEN OMITTED AND FILED SEPARATELY
WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO
THE OMITTED PORTIONS.
13.
FORMULATION AND FILL/FINISH ACTIVITIES
[*]
[*] = CERTAIN INFORMATION ON THIS PAGE HAS BEEN OMITTED AND FILED SEPARATELY
WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO
THE OMITTED PORTIONS.
14.
SECTION 6.
REGULATORY SUPPORT SERVICES
[*]
[*] = CERTAIN INFORMATION ON THIS PAGE HAS BEEN OMITTED AND FILED SEPARATELY
WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO
THE OMITTED PORTIONS.
15.
REGULATORY SUPPORT
[*]
[*] = CERTAIN INFORMATION ON THIS PAGE HAS BEEN OMITTED AND FILED SEPARATELY
WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO
THE OMITTED PORTIONS.
16.
SECTION 7
[*]
[*] = CERTAIN INFORMATION ON THIS PAGE HAS BEEN OMITTED AND FILED SEPARATELY
WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO
THE OMITTED PORTIONS.
17.
[*]
[*] = CERTAIN INFORMATION ON THIS PAGE HAS BEEN OMITTED AND FILED SEPARATELY
WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO
THE OMITTED PORTIONS.
18.
SECTION 8.
[*]
[*] = CERTAIN INFORMATION ON THIS PAGE HAS BEEN OMITTED AND FILED SEPARATELY
WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO
THE OMITTED PORTIONS.
19.
[*]
[*] = CERTAIN INFORMATION ON THIS PAGE HAS BEEN OMITTED AND FILED SEPARATELY
WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO
THE OMITTED PORTIONS.
20.
STABILITY STUDIES
ESTIMATES FOR
KEY MILESTONES AND PRICE
[*]
[*] = CERTAIN INFORMATION ON THIS PAGE HAS BEEN OMITTED AND FILED SEPARATELY
WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO
THE OMITTED PORTIONS.
21.
SECTION 9.
PRICE SUMMARY
[*]
[*] = CERTAIN INFORMATION ON THIS PAGE HAS BEEN OMITTED AND FILED SEPARATELY
WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO
THE OMITTED PORTIONS.
22.
PAYMENT SCHEDULE
[*]
[*] = CERTAIN INFORMATION ON THIS PAGE HAS BEEN OMITTED AND FILED SEPARATELY
WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO
THE OMITTED PORTIONS.
23.
[*] CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY
WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO
THE OMITTED PORTIONS.
AMENDMENT NO. 2
TO
MANUFACTURING SERVICES AGREEMENT
Amendment No. 2 dated as of October 3, 1997 (this "Amendment No. 2") between
Covance Biotechnology Services Inc., (f/k/a Corning Bio Inc.), a Delaware
corporation having its principal place of business at 6051 George Watts Hill
Drive, P.O. Box 13865, Research Triangle Park, NC 27709-3865 ("CBSI") and Sensus
Corporation, a Delaware corporation having its principal place of business at 98
San Jacinto Boulevard, Suite 430, Austin, TX 78701 ("Sponsor").
WITNESSETH:
WHEREAS, CBSI and Sponsor have entered into that certain Manufacturing
Services Agreement dated September 17, 1996 (the "Agreement") wherein CBSI
agreed to perform certain services for Sponsor in connection with the
development of a process for a material known as rhGHA, or B2036-PEG ("Product")
in accordance with the Scope; (terms defined in the Agreement and not otherwise
defined herein are used herein as defined therein); and
WHEREAS, the Sponsor now wishes to amend the Agreement based upon certain
development results whereby CBSI will undertake further development and
refinement of the manufacturing process and analytical techniques related to the
Product in accordance with the terms of a new scope of work (as defined below)
and CBSI desires to amend the Agreement to provide said process development
services to Sponsor.
NOW, THEREFORE, for good and valuable consideration the sufficiency and
receipt of which are hereby acknowledged, the parties hereto agree as follows:
1. SCOPE OF WORK. A detailed scope of work document for the development
activities related to the Product (the "Scope") prepared by the parties is
attached to this Amendment No. 2. CBSI will perform the services as set forth
in the Scope in accordance with the terms and conditions of the Agreement.
Except as expressly modified herein, all terms and conditions of the Agreement
will remain in full force and affect.
2. AMENDMENT TO SECTION 6 OF THE AGREEMENT. Section 6 paragraphs a) and b)
are revised as follows and now read:
Section 6.
COMPENSATION
a) CBSI will invoice Sponsor on a monthly basis. Invoices will be based
on
[*]
[*] = CERTAIN INFORMATION ON THIS PAGE HAS BEEN OMITTED AND FILED SEPARATELY
WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO
THE OMITTED PORTIONS.
1.
b) For any materials needed for the Program that [*]
3. AMENDMENT. No amendments or modifications to this Amendment No. 2 and no
further amendments or modifications to the Agreement may be made without the
written agreement of the parties hereto.
IN WITNESS WHEREOF, the parties hereto have executed or caused this Amendment
No. 2 to be executed by their respective officers or other representatives
hereunder duly authorized, as of the date first above written.
COVANCE BIOTECHNOLOGY SERVICES INC.: SENSUS CORPORATION:
By: /s/ V. Byran Lawlis By: /s/ William F. Bennett
----------------------------------- --------------------------------
Name: V. Bryan Lawlis Name: William F. Bennett
--------------------------------- ------------------------------
Title: President & CEO Title: Sr. V.P.
-------------------------------- -----------------------------
[*] = CERTAIN INFORMATION ON THIS PAGE HAS BEEN OMITTED AND FILED SEPARATELY
WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO
THE OMITTED PORTIONS.
2.
SCOPE OF WORK FOR
AMENDMENT NO. 2 TO
MANUFACTURING SERVICES AGREEMENT
WITH SENSUS CORPORATION
(CONTAINING ESTIMATED PRICING)
SCOPE CONTENTS SECTION PAGE
- -------------- ------- ----
[*]
[*] = CERTAIN INFORMATION ON THIS PAGE HAS BEEN OMITTED AND FILED SEPARATELY
WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO
THE OMITTED PORTIONS.
1.
OVERALL PROGRAM OBJECTIVES
[*]
[*] = CERTAIN INFORMATION ON THIS PAGE HAS BEEN OMITTED AND FILED SEPARATELY
WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO
THE OMITTED PORTIONS.
2.
SECTION 1
[*]
[*] = CERTAIN INFORMATION ON THIS PAGE HAS BEEN OMITTED AND FILED SEPARATELY
WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO
THE OMITTED PORTIONS.
3.
SECTION 3
[*]
[*] = CERTAIN INFORMATION ON THIS PAGE HAS BEEN OMITTED AND FILED SEPARATELY
WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO
THE OMITTED PORTIONS.
4.
SECTION 5
[*]
[*] = CERTAIN INFORMATION ON THIS PAGE HAS BEEN OMITTED AND FILED SEPARATELY
WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO
THE OMITTED PORTIONS.
5.
SECTION 7
[*]
[*] = CERTAIN INFORMATION ON THIS PAGE HAS BEEN OMITTED AND FILED SEPARATELY
WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO
THE OMITTED PORTIONS.
6.
SECTION 9
[*]
[*] = CERTAIN INFORMATION ON THIS PAGE HAS BEEN OMITTED AND FILED SEPARATELY
WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO
THE OMITTED PORTIONS.
7.
[*] CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY
WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO
THE OMITTED PORTIONS.
AMENDMENT NO. 3
TO
MANUFACTURING SERVICES AGREEMENT
Amendment No. 3 dated as of October 24, 1997 (this "Amendment No. 3") between
Covance Biotechnology Services Inc., (f/k/a Corning Bio Inc.), a Delaware
corporation having its principal place of business at 6051 George Watts Hill
Drive, P.O. Box 13865, Research Triangle Park, NC 27709-3865 ("CBSI") and Sensus
Corporation, a Delaware corporation having its principal place of business at 98
San Jacinto Boulevard, Suite 430, Austin, TX 78701 ("Sponsor").
WITNESSETH:
WHEREAS, CBSI and Sponsor have entered into that certain Manufacturing
Services Agreement dated September 17, 1996 (the "Agreement") wherein CBSI
agreed to perform certain services for Sponsor in connection with the
development of a process for a material known as rhGHA, or B2036-PEG ("Product")
in accordance with the Scope; (terms defined in the Agreement and not otherwise
defined herein are used herein as defined therein); and
WHEREAS, the Sponsor now wishes to amend the Agreement based upon certain
manufacturing results whereby CBSI will undertake two additional manufacturing
runs of the Product at the 1500-L scale in accordance with the terms of a new
scope of work (as defined below) and CBSI desires to amend the Agreement to
provide said manufacturing services to Sponsor.
NOW, THEREFORE, for good and valuable consideration the sufficiency and
receipt of which are hereby acknowledged, the parties hereto agree as follows:
1. SCOPE OF WORK. A detailed scope of work document for the manufacturing
activities related to the Product (the "Scope") prepared by the parties is
attached to this Amendment No. 3. CBSI will perform the services as set forth in
the Scope in accordance with the terms and conditions of the Agreement. Except
as expressly modified herein, all terms and conditions of the Agreement will
remain in full force and affect.
2. AMENDMENT TO SECTION 6 OF THE AGREEMENT. Section 6 paragraphs a) and b)
are revised as follows and now read:
Section 6.
COMPENSATION
e) The activities specified in the scope attached to this Amendment
No. 3 will be performed for [*]. The client will be invoiced
approximately 30 days prior to shipment of the bulk product to the
fill/finish subcontractor and payment is due prior to shipment of the
bulk from Covance facilities.
[*] = CERTAIN INFORMATION ON THIS PAGE HAS BEEN OMITTED AND FILED SEPARATELY
WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO
THE OMITTED PORTIONS.
1.
3. AMENDMENT. No amendments or modifications to this Amendment No. 3 and no
further amendments or modifications to the Agreement may be made without the
written agreement of the parties hereto.
IN WITNESS WHEREOF, the parties hereto have executed or caused this Amendment
No. 3 to be executed by their respective officers or other representatives
hereunder duly authorized, as of the date first above written.
COVANCE BIOTECHNOLOGY SENSUS CORPORATION
SERVICES INC.
By: /s/ V. Bryan Lawlis By: /s/ William Bennett
---------------------------- --------------------------------
Name: V. Bryan Lawlis Name: William Bennett
-------------------------- ------------------------------
Title: President & CEO Title: Sr. VP Mfg.
------------------------- -----------------------------
- --------------------------------------------------------------------------------
2.
SCOPE OF WORK FOR AMENDMENT NO. 3
TO MANUFACTURING SERVICES AGREEMENT
WITH SENSUS CORPORATION
[*]
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WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO
THE OMITTED PORTIONS.
CHANGE ORDER TO AMENDMENT #3 (DATED 24 OCTOBER 1997) OF THE
MANUFACTURING SERVICES AGREEMENT (DATED 17 SEPTEMBER 1996)
This Change Order to the Sensus Manufacturing Agreement will cover the
activities associated with a fifth (5th) manufacturing run (runs #3 and 4 are
covered in Amendment #3) to produce PEGylated human Growth Hormone Antagonist
(GHA). The activities are as follows:
[*]
The cost for the work described above is [*] excluding reimbursable materials
and project incidentals as defined in the Agreement and subsequent Amendments
and Scopes. This price does not include the costs for performing the fill/finish
activities at the subcontractor or final vial QA/QC release activities. This
price is based upon a significant discount of actual cost for one run.
Approved by:
/s/ Kirk Hayenga 11/14/97 /s/ William F. Bennett, Ph.D. 20 Nov 97
_______________________________ _______________________________________
Kirk Hayenga William F. Bennett, Ph.D.
Program Director - Sensus V.P. Research and Development
Covance Biotechnology Services Sensus Corporation
/s/ Charles T. White, Ph.D. 11/14/97
_______________________________________
Charles T. White, Ph.D.
V.P. Business Development
Covance Biotechnology Services
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WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO
THE OMITTED PORTIONS.
[*] CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY
WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO
THE OMITTED PORTIONS.
AMENDMENT NO. 4
TO
MANUFACTURING SERVICES AGREEMENT
Amendment No. 4 dated as of December 29, 1997 (this "Amendment No. 4")
between Covance Biotechnology Services Inc., a Delaware corporation having its
principal place of business at 6051 George Watts Hill Drive, P.O. Box 13865,
Research Triangle Park, NC 27709-3865 ("CBSI") and Sensus Corporation, a
Delaware corporation having its principal place of business at 98 San Jacinto
Boulevard, Suite 430, Austin, TX 78701 ("Sponsor").
WITNESSETH:
-----------
WHEREAS, CBSI and Sponsor have entered into that certain Manufacturing
Services Agreement dated September 17, 1996 (the "Agreement") wherein CBSI
agreed to perform certain services for Sponsor in connection with the
development of a manufacturing process for a material known as rhGHA, or B2036-
PEG ("Product") in accordance with the Scope; (terms defined in the Agreement
and not otherwise defined herein are used herein as defined therein); and
WHEREAS, CBSI has progressed the development phase of the production process
for Product as defined in the Scope and Sponsor now wishes to amend the
Agreement whereby CBSI will undertake additional manufacturing runs to generate
additional Product in accordance with the terms of a new Scope of Work document
(as defined below) and CBSI desires to amend the Agreement to provide said
manufacturing services to Sponsor.
NOW, THEREFORE, for good and valuable consideration the sufficiency and
receipt of which are hereby acknowledged, the parties agree to as follows:
1. Scope of Work. A Scope of Work document for the production of Product
--------------
(the "Scope") prepared by the parties is attached to this Amendment No. 4. CBSI
will perform the services set forth in the Scope in accordance with the terms
and conditions of the Agreement. Except as expressly modified herein, all terms
and conditions of the Agreement will remain in full force and effect.
2. Amendment to Section 6 of the Agreement. Section 6 of the Agreement is
----------------------------------------
hereby amended as follows:
1.
Section 6.
COMPENSATION
------------
f) The activities specified in the scope attached to this Amendment
No. 4 will be performed for [*]
3. Amendment. No amendments or modifications to this Amendment No. 4
----------
and no further amendments or modifications to the Agreement may be made without
the written agreement of the parties hereto.
IN WITNESS WHEREOF, the parties hereto have executed or caused this Amendment
No. 4 to be executed by their respective officers or other representatives
hereunder duly authorized as of the date first written above.
COVANCE BIOTECHNOLOGY SERVICES INC. SENSUS CORPORATION
By: /s/ Roy Dagnall By: /s/ William F. Bennett
-------------------------------- ------------------------
Name: Roy Dagnall Name: William F. Bennett
------------------------------ ----------------------
Title: COO Title: Sr. V.P.
----------------------------- ---------------------
Date: 12/30/97 Date: 31 Dec 97
------------------------------ ----------------------
- --------------------------------------------------------------------------------
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WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO
THE OMITTED PORTIONS.
2.
SCOPE OF WORK FOR AMENDMENT NO. 4 TO
------------------------------------
MANUFACTURING SERVICES AGREEMENT
--------------------------------
WITH SENSUS CORPORATION
-----------------------
BACKGROUND AND PROGRAM OBJECTIVES
- ---------------------------------
[*]
MANUFACTURING PROGRAM FOR AMENDMENT NO. 4
- -----------------------------------------
[*]
[*] = CERTAIN INFORMATION ON THIS PAGE HAS BEEN OMITTED AND FILED SEPARATELY
WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO
THE OMITTED PORTIONS.
Filling is scheduled with the subcontractor on the following dates
January 30, 1998
February 27, 1998
March 27, 1998
Additional fill dates will be scheduled as needed.
PRICE
- -----
THE PRICE FOR THIS PROGRAM IS [*] AND IS INCLUSIVE OF MATERIALS.
THE ABOVE PRICE DOES NOT INCLUDE THE FOLLOWING: PROJECT INCIDENTALS AS DEFINED
---
IN THE AGREEMENT, THE COSTS FOR PERFORMING THE FILL/FINISH ACTIVITIES AT THE
SUBCONTRACTOR OR THE COSTS FOR FINAL VIAL QA/QC RELEASE ACTIVITIES. THESE ITEMS
WILL BE INVOICED SEPARATELY.
COVANCE BIOTECHNOLOGY SERVICES SENSUS CORPORATION
Initials: [INITIALS] Initials: [INITIALS]
----------- -----------
Date: 12/30/97 Date: 31 Dec 97
--------------- ---------------
- -----------------------------------------------------------------
[*] = CERTAIN INFORMATION ON THIS PAGE HAS BEEN OMITTED AND FILED SEPARATELY
WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO
THE OMITTED PORTIONS.
CHANGE ORDER NO. 1 TO AMENDMENT NO. 4 (DATED 29 DECEMBER 1997)
OF THE MANUFACTURING SERVICES AGREEMENT (DATED 17 SEPTEMBER 1996)
[*]
Approved by:
/s/ Kirk Hayenga 2/6/98 /s/ William F. Bennett, Ph.D.
------------------------- -------------------------------
Kirk Hayenga William F. Bennett, Ph.D.
Program Director - Sensus Sr. V.P. Research and Manufacturing
Covance Biotechnology Services Sensus Corporation
/s/ V. Bryan Lawlis
------------------------
V. Bryan Lawlis
President & CEO
Covance Biotechnology Services
[*] = CERTAIN INFORMATION ON THIS PAGE HAS BEEN OMITTED AND FILED SEPARATELY
WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO
THE OMITTED PORTIONS.
5.
[*] CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY
WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO
THE OMITTED PORTIONS.
AMENDMENT NO. 5
TO
MANUFACTURING SERVICES AGREEMENT
Amendment No. 5 dated as of May 1, 1998 (this "Amendment No. 5") between
Covance Biotechnology Services Inc., a Delaware corporation having its principal
place of business at 6051 George Watts Hill Drive, P.O. Box 13865, Research
Triangle Park, NC 27709-3865 ("CBSI") and Sensus Corporation, a Delaware
corporation having its principal place of business at 98 San Jacinto Boulevard,
Suite 430, Austin, TX 78701 ("Sponsor").
WITNESSETH:
WHEREAS, CBSI and Sponsor have entered into that certain Manufacturing
Services Agreement dated September 17, 1996 (the "Agreement") wherein CBSI
agreed to perform certain services for Sponsor in connection with the
development of a manufacturing process for a material known as rhGHA, or B2036-
PEG ("Product") in accordance with the Scope; (terms defined in the Agreement
and not otherwise defined herein are used herein as defined therein); and
WHEREAS, the Agreement and the Scope were amended according to the provisions
of Amendment No. 1 dated July 3, 1997 to include initial production runs of the
Product using Process 1 and were amended according to the provisions of
Amendment No. 2 dated October 3, 1997 to provide for the development of a new
manufacturing process ("Process 2") for the manufacture of the Product and were
further amended according to Amendment No. 3 dated October 24, 1997 and
Amendment No. 4 dated December 29, 1997, to provide for and additional
production runs of the Product utilizing Process 1; and
WHEREAS, Sponsor now wishes to amend the Agreement and Scope whereby CBSI
will perform manufacturing runs to generate additional Product via Process 2 in
accordance with the terms of a new Scope of Work document (as defined below) and
CBSI and Sponsor desire to amend the Agreement to provide said manufacturing and
services.
NOW, THEREFORE, for good and valuable consideration the sufficiency and
receipt of which are hereby acknowledged, the parties agree to as follows:
1. SCOPE OF WORK. A Scope of Work document for the manufacture of Product
(the "Scope") prepared by the parties and dated May 1, 1998 is attached to this
Amendment No. 5 and incorporated herein by reference. CBSI will perform the
services set forth in the Scope in accordance with the terms and conditions of
the Agreement. Except as expressly modified herein, all terms and conditions of
the Agreement will remain in full force and effect.
1.
2. AMENDMENT TO SECTION 6 OF THE AGREEMENT. Section 6 of the Agreement is
hereby amended to add Section 6 paragraph g) as follows:
Section 6.
COMPENSATION
g) The activities specified in the scope attached to this Amendment No. 5
will be performed for the prices detailed in each section of the Scope
and summarized in the Scope, Section 7. CBSI will invoice Sponsor upon
completion of a priced unit of activity, such as completion of a lot of
frozen cell paste or completion of a lot of prePEGylated bulk, but not
more frequently than monthly. Payments are due 30 days from the date of
invoice. [*] Subcontractor charges, such as for cell line testing, will
be invoiced in the month that CBSI is invoiced by the subcontractor.
Late payments are subject to an interest charge of one percent (1%) per
month.
3. CHANGE ORDERS. The Agreement is hereby amended to incorporate an
additional section, Section 25, as follows:
Section 25.
CHANGE ORDERS
a) The estimated budget for the Program specified in the Scope and the
individual budget components and time estimates specified in the Scope
are subject to a number of general and program specific assumptions.
The program specific assumptions relate to the Program design and
objectives, manpower requirements, timing, capital expenditure
requirements, if any, and other matters relating to the completion of
the Program as set forth in the Scope (the "Program Assumptions"). CBSI
also assumes that the Sponsor will cooperate and perform its
obligations under the Agreement and Scope in a timely manner, that no
event outside the control of CBSI will occur, including, without
limitation, the events described in Section 16, Force Majeure, and that
there are no changes to any applicable laws, rules or regulations which
effect the Program (the foregoing assumptions together with the Program
Assumptions, collectively, the "Assumptions"). In the event that any of
the Assumptions require modification or the Program objectives cannot
be achieved based on the Assumptions (each being, a "Modification")
then the Scope may be amended as provided in paragraph b) of this
Section 25.
b) In the event a Modification is identified by the Sponsor or by CBSI,
the identifying party shall notify the other party as soon as is
reasonably possible. CBSI shall provide Sponsor with a Change Order
containing an estimate of the required Modifications to the Program
budget and timeline specified in the Scope within 20 business days of
receiving such notice. Sponsor shall use best efforts to respond in
writing to such Change Order promptly. If Sponsor
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WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO
THE OMITTED PORTIONS.
2.
does not approve such Change Order and has not terminated the Program
but wants the Program to be modified to take into account the
Modification, then Sponsor and CBSI shall use best efforts to agree on
a Change Order that is mutually acceptable. If practicable, CBSI
shall continue work on the Program during any such negotiations, but
shall not commence work with respect to the Change Order unless
authorized in writing.
4. AMENDMENT. No amendments or modifications to this Amendment No. 5 and
no further amendments or modifications to the Agreement may be made without the
written agreement of the parties hereto.
IN WITNESS WHEREOF, the parties hereto have executed or caused this Amendment
No. 5 to be executed by their respective officers or other representatives
hereunder duly authorized as of the date first written above.
COVANCE BIOTECHNOLOGY SERVICES INC. SENSUS CORPORATION
By: /s/ V. Bryan Lawlis By: /s/ William F. Bennett
-------------------------------------- --------------------------------
Name: V. Bryan Lawlis Name: William F. Bennett
------------------------------------ ------------------------------
Title: President & CEO Title: Sr. VP
----------------------------------- -----------------------------
Date: 5/11/98 Date: 13 May 98
------------------------------------ ------------------------------
3.
SENSUS SCOPE
Amendment No. 5
SCOPE OF WORK FOR AMENDMENTS NO. 5
TO MANUFACTURING SERVICES AGREEMENT
WITH SENSUS CORPORATION
[*]
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WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO
THE OMITTED PORTIONS.
1.
SENSUS SCOPE
Amendment No. 5
SECTION 1: TECHNOLOGY TRANSFER
[*]
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WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO
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2.
SENSUS SCOPE
Amendment No. 5
SECTION 2: PERFORMANCE OF SHAKEDOWN RUNS
[*]
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WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO
THE OMITTED PORTIONS.
3.
SENSUS SCOPE
Amendment No. 5
SECTION 3: PROCESS 2 PRODUCTION RUNS
[*]
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WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO
THE OMITTED PORTIONS.
4.
SENSUS SCOPE
Amendment No. 5
[*]
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WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO
THE OMITTED PORTIONS.
5.
SENSUS SCOPE
Amendment No. 5
[*]
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WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO
THE OMITTED PORTIONS.
6.
SENSUS SCOPE
Amendment No. 5
SECTION 4: FILL FINISH ACTIVITIES
[*]
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WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO
THE OMITTED PORTIONS.
7.
SENSUS SCOPE
Amendment No. 5
SECTION 5: QA AND QC TESTING AND FINAL RELEASE ACTIVITIES
Covance will utilize QA and QC resources as necessary to support production and
release PEGylated rhGHA:
[*]
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WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO
THE OMITTED PORTIONS.
8.
SENSUS SCOPE
Amendment No. 5
SECTION 6: VALIDATION/QUALIFICATION ACTIVITIES
A proposal for validation activities leading to NDA filing is being prepared and
will be forwarded to Sensus, however, there is a certain amount of
validation/qualification that needs to be performed for the upcoming Process 2
campaign.
The objectives for the limited process validation/qualification for Process 2
are:
[*]
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WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO
THE OMITTED PORTIONS.
9.
SENSUS SCOPE
Amendment No. 5
SECTION 7: PRICE AND PAYMENT SCHEDULES
Overall Scope Price
[*]
[*]
[*]
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WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO
THE OMITTED PORTIONS.
10.
SENSUS SCOPE
Amendment No. 5
ANTICIPATED INVOICE SCHEDULE
----------------------------
[ * ]
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WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO
THE OMITTED PORTIONS.
11.
SENSUS SCOPE
Amendment No. 5
REPLACEMENT LOTS AND MANUFACTURING SUCCESS RATES
[*]
COVANCE BIOTECHNOLOGY SERVICES SENSUS CORPORATION
Initials: [INITIALS] Initials: [INITIALS]
----------- -----------
Date: 5-11-98 Date: 13 May 98
--------------- ---------------
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WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO
THE OMITTED PORTIONS.
12.
SENSUS SCOPE
Amendment No. 5
ATTACHMENT TO
SCOPE OF WORK FOR AMENDMENT NO. 5
TESTING SUMMARY
[*]
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WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO
THE OMITTED PORTIONS.
13.
SENSUS SCOPE
Amendment No. 5
[*]
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WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO
THE OMITTED PORTIONS.
14.
SENSUS SCOPE
Amendment No. 5
[*]
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WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO
THE OMITTED PORTIONS.
15.