EXHIBIT 10.12
CONFIDENTIAL INFORMATION OMITTED AND FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION
PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT
ASTERISKS (*) DENOTE SUCH OMISSIONS.
SUPPLY AGREEMENT
THIS AGREEMENT (the "Agreement") dated as of this twenty-third (23) day of
July, 1998, by and between PRAECIS PHARMACEUTICALS INCORPORATED, a Delaware
corporation, of 0 Xxxxxxxxx Xxxxxx, Xxxxxxxxx, XX 00000-0000 ("PRAECIS") and
Xxxxxxxx Chemicals, Inc., an Iowa corporation of 0000 Xxxxxxxx Xxxxxx, Xxxxxxx
Xxxx, Xxxx 00000-0000 ("XXXXXXXX").
WITNESSETH:
WHEREAS, PRAECIS is in the business of developing and commercializing
pharmaceutical chemicals and has submitted information regarding PPI-149 peptide
(the "Peptide") in a PPI-149-*** formulation ("***") *** to the Federal Food and
Drug Administration ("FDA") for testing and approval; and
WHEREAS, PRAECIS and XXXXXXXX have entered into a letter agreement dated
November 28, 1997 (the "Letter Agreement") which provides, among other things,
for XXXXXXXX to manufacture and supply PRAECIS, and for PRAECIS to purchase from
XXXXXXXX, certain qualification batches of *** using the Peptide supplied by
PRAECIS as a raw ingredient, and for the parties to negotiate and execute a
mutually agreeable Supply Agreement with respect to ***; and
WHEREAS, XXXXXXXX owns and operates a pilot plant pharmaceutical
manufacturing facility (the "Facility") in Xxxxxxx City, Iowa, meeting cGMP
requirements. XXXXXXXX will be required to design, engineer, install and qualify
additional equipment and facility which will enable XXXXXXXX to produce
commercial quantities of ***; and
WHEREAS, the parties have reached agreement as set forth herein with
respect to the terms of the Supply Agreement contemplated by the Letter
Agreement.
CONFIDENTIAL INFORMATION OMITTED AND FILED SEPARATELY
WITH THE SECURITIES AND EXCHANGE COMMISSION.
ASTERISKS (*) DENOTE SUCH OMISSIONS.
NOW THEREFORE, in consideration of the mutual covenants contained herein,
the parties hereby agree as follows:
1. MANUFACTURE
A. Subject to the terms and conditions set forth herein, during the Term (as
hereinafter defined), XXXXXXXX shall manufacture for and supply to PRAECIS, and
PRAECIS shall purchase from XXXXXXXX, PRAECIS's requirements of ***.
B. Not withstanding Section 1A. above, PRAECIS retains the right, at its sole
option, to qualify one or more alternative suppliers at any time during the
Term. Upon completion of such qualification, PRAECIS may order up to *** (***%)
of its annual requirements for *** from such alternative suppliers; provided
that, without limitation of its other remedies, PRAECIS may order a greater
percent (up to 100%) of such requirements from such alternative suppliers if
XXXXXXXX is unable to meet is supply obligations hereunder.
2. TERM
Subject to earlier termination as provided in Section 20 below or extension as
provided in this Section 2, this Agreement shall commence on the date hereof and
shall continue for a period of *** (the "Original Term"); provided that
commencing with the *** anniversary of the date hereof and on each subsequent
anniversary, the term of this Agreement shall automatically be extended for an
additional *** from the then current expiration date, unless either party
provides written notice to the other party electing not to extend the term of
this Agreement, such notice to be provided at least twelve (12) months prior to
the applicable anniversary date (the term of this Agreement, as so extended or
earlier terminated, being referred so as the "Term").
3. CONFIDENTIALITY
The parties hereto have entered into a Non-Disclosure Agreement dated as of
September 2, 1997 (the "Non-Disclosure Agreement") relating to the Technical
Information (as hereinafter defined) and such agreement is attached hereto as
Exhibit A and is incorporated herein and made part hereof. The parties agree
that all Technical or
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CONFIDENTIAL INFORMATION OMITTED AND FILED SEPARATELY
WITH THE SECURITIES AND EXCHANGE COMMISSION.
ASTERISKS (*) DENOTE SUCH OMISSIONS.
Confidential Information disclosed by either party to the other shall be
covered under the terms of the Non-Disclosure Agreement and, notwithstanding any
provision of the Non-Disclosure Agreement, shall be held confidential as
provided in the Non-Disclosure Agreement from time of disclosure until ten (10)
years after the end of the Term.
4. PRODUCTION UNIT AND EQUIPMENT
A. The parties recognize that additional equipment must be installed at the
Facility to permit XXXXXXXX to produce *** in the required commercial
quantities. XXXXXXXX shall be responsible for the design, engineering,
installation and qualification of the additional equipment and facility for the
*** Production Facility (the "Production Facility"), and PRAECIS shall be
responsible for the capital and other costs incurred by XXXXXXXX associated with
constructing and completing the Production Facility (the "Costs"). The costs
shall be recovered by XXXXXXXX in monthly payments by PRAECIS (on an invoice
pass through basis) over the length of the engineering, construction and
commission phase of the project. XXXXXXXX shall provide the project management
team and the Costs shall be capped at *** ($***). The Production Facility shall
be dedicated to PRAECIS over the Original Term of this Agreement. XXXXXXXX shall
make best efforts to commission the Production Facility in ***. Although the
Costs shall be paid for by PRAECIS, XXXXXXXX shall own the Production Facility
and all installed equipment and PRAECIS shall have no claim thereon whatsoever.
B. Upon signing of this Agreement, PRAECIS shall execute a binding Purchase
Order for *** of *** at a price of ***, F.O.B. Xxxxxxx City, Iowa, for delivery
as soon as practical after completion and commissioning of the Production
Facility. XXXXXXXX'x obligation to complete the Production Facility shall be
subject to PRAECIS's execution, not later than October 1, 1998, of a binding
Purchase Order for at least an additional *** of *** at a price of ***, for
delivery in calendar year 1999.
C. In the event that PRAECIS does not proceed with the commercialization of ***,
either because of its inability to obtain the requisite regulatory approvals or
for any other reason including its inability to provide XXXXXXXX with Peptide
and other raw materials necessary to fill such order, PRAECIS may instead pay to
XXXXXXXX
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CONFIDENTIAL INFORMATION OMITTED AND FILED SEPARATELY
WITH THE SECURITIES AND EXCHANGE COMMISSION.
ASTERISKS (*) DENOTE SUCH OMISSIONS.
the amount which it would have been required to pay (at time it would have been
required to make such payment) under Section 4(B) above had PRAECIS actually
received both shipments of ***.
D. All *** will be billed at the time the product successfully passes Quality
Control and Quality Assurance. Payment is required 30 days from invoice date.
Ownership and risk of loss passes to PRAECIS at the time of invoicing.
5. FORECASTING
A. Thirty (30) days prior to the start of each calendar quarter during the Term,
PRAECIS will provide XXXXXXXX with a written non-binding four quarter rolling
forecast estimating PRAECIS's *** requirements for the next four quarters or for
each remaining quarter if the remainder of the Term is less than four quarters
and, without limitation of XXXXXXXX'x supply obligations under Section 1 hereof,
XXXXXXXX may use such orders as the basis to schedule production.
B. At least thirty (30) days prior to the start of each month during the Term
PRAECIS shall give XXXXXXXX firm purchase orders for its *** requirements during
the next month. XXXXXXXX shall deliver *** to PRAECIS not later than
thirty-seven (37) days from the date of XXXXXXXX'x receipt of a firm Purchase
Order, the Peptide and other raw materials.
C. If PRAECIS's actual requirements in any calendar quarter exceed the most
recent forecast for that quarter by more than ***, without limitation of
XXXXXXXX'x supply obligations under Section 1 with respect to an amount of ***
equal to *** of such forecasted amount (the "*** Amount"), XXXXXXXX shall only
be required to use best efforts to meet PRAECIS' requirements in excess of the
*** Amount.
6. PRICE
A. Following FDA (or equivalent foreign regulatory) approval of the Peptide in a
*** formulation, the base price per kilogram for quantities up to *** per
calendar year shall be ***, and *** for any quantities in excess of *** in any
calendar year. All prices are F.O.B. Xxxxxxx City, Iowa. *** will be billed at
the time the ***
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CONFIDENTIAL INFORMATION OMITTED AND FILED SEPARATELY
WITH THE SECURITIES AND EXCHANGE COMMISSION.
ASTERISKS (*) DENOTE SUCH OMISSIONS.
successfully passes Quality Control and Quality Assurance. Payment is required
thirty (30) days from invoice date. Ownership and risk of loss passes to PRAECIS
at the time of invoicing.
B. Following FDA (or equivalent foreign regulatory) approval of the Peptide in a
*** formulation, the base price will be adjusted annually by XXXXXXXX by an
amount not to exceed the change in the published Produce Price Index for
Chemicals and Allied Products (PPI), as published by the Bureau of Labor
Statistics of the U.S. Department of Labor. The parties agree that the PPI
factor adjustment will begin at the average for June 1998 at 144.9.
X. XXXXXXXX shall use best efforts to maximize the concentration of active
Peptide in *** and to maximize the conversion of Peptide to ***, consistent with
the In-Process Limits (as defined herein).
D. The parties shall seek to establish a mutually agreed program to reduce
manufacturing costs and improvement yields in the *** process (the "Program").
Any cost savings or yield improvements resulting from the Program shall be ***
by the parties and will be reflected in annual price adjustments. For yield
improvements, if Yield is defined as the mole of *** produce per mole of peptide
reacted, and if Yield becomes higher, the sales price of *** is adjusted upward
as follows:
Adjusted Price = ***
Yield #1 is the Average Yield of the 3-kilogram validation lots
Yield #2 is a future Yield
E. Each party shall bear its own costs in the Program, provided that PRAECIS
shall bear the costs of any raw material losses in the Program with the
exception of raw material losses due to negligence or willful misconduct by
XXXXXXXX which shall be borne entirely by XXXXXXXX. In the event new capital is
required to implement a cost savings program both parties will share the cost
equally.
7. RAW MATERIALS, SHIPPING AND WAREHOUSING
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CONFIDENTIAL INFORMATION OMITTED AND FILED SEPARATELY
WITH THE SECURITIES AND EXCHANGE COMMISSION.
ASTERISKS (*) DENOTE SUCH OMISSIONS.
A. PRAECIS will provide, at PRAECIS's sole risk and expense, all Peptide and
other raw materials (except WFI water which will be supplied by XXXXXXXX),
freight prepaid, to the Production Facility, in such amounts and at such times
as shall be jointly determined by XXXXXXXX and PRAECIS to be required for
manufacture of *** ordered by PRAECIS; provided that with respect to any
purchase order, PRAECIS shall not be required to supply XXXXXXXX with Peptide
and other raw materials required to fill such order more than fifteen (15) days
prior to submission to XXXXXXXX of such purchase order. Risk of loss of Peptide
and the other raw materials delivered by PRAECIS shall pass to XXXXXXXX when
safely delivered at the Production Facility.
B. PRAECIS will provide a Certificate of Analysis ("CA") for each lot of Peptide
delivered to XXXXXXXX for use in producing *** XXXXXXXX will perform a cGMP
identity test upon receipt of Peptide. Any cost of loss resulting from
XXXXXXXX'x use of off-spec material in reliance on PRAECIS's CA shall be
PRAECIS's sole responsibility unless such off-spec condition shall be the fault
of XXXXXXXX who shall then bear such risk. XXXXXXXX shall be responsible for any
rework or loss rising from actions or omissions of XXXXXXXX, including any costs
to rework or replace PRAECIS-supplied materials.
C. Upon completion of manufacture, XXXXXXXX will arrange for shipment of *** to
PRAECIS designated locations, F.O.B. the Facility. *** will be billed at the
time the product successfully passes Quality Control and Quality Assurance as
evidenced by receipt of a CA. Payment is required 30 days from invoice date.
Ownership and risk of loss passes to PRAECIS at the time of invoicing.
8. ANALYTICAL SERVICES
A. PRAECIS desires to have XXXXXXXX provided a CA for each lot of ***
manufactured at XXXXXXXX'x facility according to the in-process limits attached
hereto as Exhibit B (the "In-Process Limits"). A CA will accompany each lot of
*** shipped.
X. XXXXXXXX and PRAECIS agree to jointly establish a release procedure for ***
manufactured by XXXXXXXX. XXXXXXXX shall obtain prior written approval
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CONFIDENTIAL INFORMATION OMITTED AND FILED SEPARATELY
WITH THE SECURITIES AND EXCHANGE COMMISSION.
ASTERISKS (*) DENOTE SUCH OMISSIONS.
from PRAECIS for any exemption in the In-Process Limits. If, at any time, ***
produced for PRAECIS fails to meet the In-Process Limits, PRAECIS and XXXXXXXX
agree to work together in good faith to attempt to resolve any such problem
through rework of the ***, as appropriate, and XXXXXXXX will perform a failure
investigation and report results to PRAECIS.
C. Any changes to the In-Process Limits must be approved and signed by
authorized representatives of both parties as may be designated from time to
time.
X. XXXXXXXX will maintain retention samples no greater than 0.5 gram of each lot
of *** produced for a period of (1) year from the date of shipment. Such samples
will be returned to PRAECIS or it's designate upon request by PRAECIS.
E. Analytical methods will be validated and reports will be provided to PRAECIS.
As necessary, cross-validation will be performed with other parties.
9. INVOICING AND INVENTORIES
XXXXXXXX shall invoice PRAECIS immediately following completion of ***
manufacture, packaging and Quality Control and Quality Assurance approval.
Payment shall be due from PRAECIS within thirty (30) days of date of XXXXXXXX'x
invoice. Ownership and risk of loss passes to PRAECIS as the time of invoicing.
Xxxx of Lading for each shipment will accompany the shipment. Within ten (10)
days following the end of each month during the Term, XXXXXXXX shall submit the
following to PRAECIS.
A. Inventory of *** at the end of each calendar month and a listing of each
shipment of *** made during such calendar month showing truck or car numbers,
date, weight and number of containers; and
B. Inventory of Peptide supplied by PRAECIS at the end of each calendar month;
and
C. Total amount of Peptide used in the processing of *** during such calendar
month.
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CONFIDENTIAL INFORMATION OMITTED AND FILED SEPARATELY
WITH THE SECURITIES AND EXCHANGE COMMISSION.
ASTERISKS (*) DENOTE SUCH OMISSIONS.
10. CHANGE IN MATERIAL, PROCESS OR PROCEDURE.
XXXXXXXX shall obtain prior written approval of PRAECIS for any change in
materials or methods of manufacture or analysis employed in producing ***
hereunder, and XXXXXXXX shall promptly notify PRAECIS of and implement any
changes advised by any appropriate regulatory agency or other authority.
11. FACILITY INSPECTION
A. Upon reasonable prior notice, PRAECIS and its Licensees who agree to be bound
by the terms of Non-Disclosure Agreement shall have the right to inspect and
audit the Production Facility, provided that if PRAECIS requests an inspection
at a time when such inspection would not present a significant risk of
disclosure of confidential information of XXXXXXXX or a customer of XXXXXXXX
other than PRAECIS. XXXXXXXX will, if practical, arrange for the inspection to
take place within five (5) working days from the date of said request.
B. PRAECIS employees and Licensees who are present at the Production Facility
shall comply with all XXXXXXXX'x rules, regulations and instructions from
XXXXXXXX'x employees, and PRAECIS assumes all liability, costs and loss of
whatever kind directly resulting from the presence of PRAECIS's employees at the
Production Facility, provided that XXXXXXXX shall be responsible for its
negligence, recklessness or willful misconduct.
12. PACKAGING
The *** supplied by XXXXXXXX hereunder shall be packaged in containers specified
by PRAECIS (but supplied by XXXXXXXX) and shall bear labels supplied by XXXXXXXX
using label copy supplied by PRAECIS. PRAECIS shall be solely responsible for
complying with any applicable laws, regulations, rules or ordinances (federal,
state or local) relating to the container and the contents of the labels. In
addition to the container specifications and labels, PRAECIS shall also provide
XXXXXXXX with all the packaging component specifications necessary to package
the ***.
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CONFIDENTIAL INFORMATION OMITTED AND FILED SEPARATELY
WITH THE SECURITIES AND EXCHANGE COMMISSION.
ASTERISKS (*) DENOTE SUCH OMISSIONS.
13. WASTE DISPOSAL
XXXXXXXX is responsible for all costs and liabilities associated with the
transport and approved disposal of waste streams generated by the manufacture of
*** at the Facility. Upon request, XXXXXXXX will provide to PRAECIS copies of
all manifests for shipping *** waste streams from the Production Facility. At
PRAECIS option and PRAECIS' expense, all waste will be shipped to PRAECIS or
it's designate.
14. SAFETY INFORMATION
PRAECIS will supply Material Safety Data Sheets ("MSDS") for Peptide and ***.
XXXXXXXX will obtain from their raw material suppliers all other raw material
MSDS's utilized in the manufacture of the *** before said manufacture will
begin.
15. REGULATORY APPROVALS
XXXXXXXX is responsible for securing and complying with the necessary worldwide
regulatory approvals for the manufacture and supply of *** and any substitute
*** at the Facility, in the case where modifications to the manufacture and
supply of *** are not required by regulatory agencies and PRAECIS requests
modifications to the manufacture and supply of ***, PRAECIS shall reimburse
XXXXXXXX promptly for all increased approval and compliance costs. If PRAECIS
offers and XXXXXXXX accepts substitute or additional ***'s, PRAECIS shall be
responsible for all costs of regulatory compliance, and shall reimburse XXXXXXXX
promptly for all such approval and compliance costs. PRAECIS shall be solely
responsible for obtaining all regulatory approvals required for the sale of ***
to PRAECIS's customers.
16. TECHNICAL INFORMATION
A. PRAECIS has developed and is the owner of certain technical information
required to produce ***(the "Technical Information"), and except to the extent
provided in this Section 16A, XXXXXXXX shall have no rights of any kind with
respect to any Technical Information. PRAECIS hereby licenses the Technical
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CONFIDENTIAL INFORMATION OMITTED AND FILED SEPARATELY
WITH THE SECURITIES AND EXCHANGE COMMISSION.
ASTERISKS (*) DENOTE SUCH OMISSIONS.
Information to XXXXXXXX on non-exclusive, royalty-free basis for the sole
purpose of producing *** for PRAECIS during the Term.
B. Any and all improvements, discoveries and/or inventions, whether or not
patentable, which may be made or conceived by XXXXXXXX during the Term which is
based on or incorporates or uses any Technical Information, or otherwise arises
out of XXXXXXXX'x performance of its obligations hereunder shall be the sole and
exclusive property of PRAECIS. Process or equipment information or
recommendations provided by PRAECIS and/or inventions relating to such process
and/or equipment information or recommendations, which arise in whole or in part
out of such information shall also be the sole and exclusive property of
PRAECIS. XXXXXXXX shall provide full disclosure to PRAECIS of all such
improvements, discoveries, and/or inventions described above, and shall execute
or cause to be executed any and all applications, assignments, or other
instruments which PRAECIS shall deem necessary or useful in order to apply for,
obtain and protect Patents of the United States and all foreign countries with
respect to any and all such discoveries, improvements and/or inventions and
shall, and hereby does, assign and convey to PRAECIS the sole and exclusive
right, title, and interest in and to any and all such discoveries, improvements
and/or inventions and to all patent applications and patents thereon. PRAECIS
will bear the cost of preparation of all such patent applications and patents.
PRAECIS shall xxxxx XXXXXXXX a royalty-free, perpetual, worldwide license under
any patent so obtained and agrees that XXXXXXXX can utilize any operational
knowledge in other areas of its business; provided that such license shall not
extend to, and XXXXXXXX shall not utilize any operational knowledge to provide,
products, services or processes which are competitive with the business of
PRAECIS.
17. WARRANTIES
X. XXXXXXXX warrants and represents:
(i) that all *** manufactured by XXXXXXXX hereunder will meet the
In-Process Limits and will be made in accordance with worldwide cGMP;
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CONFIDENTIAL INFORMATION OMITTED AND FILED SEPARATELY
WITH THE SECURITIES AND EXCHANGE COMMISSION.
ASTERISKS (*) DENOTE SUCH OMISSIONS.
(ii) that the Production Facility (and the operations thereof) is, and
shall remain during the term hereof, in substantial compliance with all
applicable laws, statutes, rules, regulations or ordinances (federal, state or
local) including but not limited to those enforced by the U.S. Environmental
Protection Agency and the Occupational Safety and Health Administration.
B. PRAECIS warrants and represents:
(i) that all Peptide and other raw materials delivered to XXXXXXXX for use
in the manufacture of *** hereunder shall meet the In-Process Limits shall be
suitable for use in the ***;
(ii) that it has the right to use the Technical Information and to grant
to XXXXXXXX the license granted pursuant to Section 18A. hereof;
18. INDEMNIFICATION
X. XXXXXXXX shall protect, defend, indemnify and hold harmless PRAECIS and its
affiliates, and their respective directors, officers, employees and agents, from
and against any and all actions, liability, loss, damage, cost or expense
(including reasonable attorney's fees) arising out of, incident to, or in any
way connected with, any breach by XXXXXXXX of this Agreement, including without
limitation any representations or warranties of XXXXXXXX set forth herein.
PRAECIS shall give XXXXXXXX prompt notice of any claim on which PRAECIS seeks
indemnification from XXXXXXXX under this Section.
B. (i) PRAECIS shall protect, defend, indemnify and hold harmless XXXXXXXX and
its affiliates, and their respective directors, officers, employees and agents,
from and against any and all actions, liability, loss, damage, cost or expense
(including reasonable attorney's fees) arising out of, incident to, or in any
way connected with, any breach by PRAECIS of this Agreement, including without
limitation any representations or warranties of PRAECIS set forth herein.
XXXXXXXX shall give PRAECIS prompt notice of any claim on which XXXXXXXX seeks
indemnification from PRAECIS under this Section.
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CONFIDENTIAL INFORMATION OMITTED AND FILED SEPARATELY
WITH THE SECURITIES AND EXCHANGE COMMISSION.
ASTERISKS (*) DENOTE SUCH OMISSIONS.
(ii) it is understood that XXXXXXXX has no control over the ultimate use
of the *** once the *** leaves the Facility, and XXXXXXXX shall have no
liability in connection with any use made of the ***, except to the extent
attributable to XXXXXXXX'x gross negligence, willful misconduct or breach of
this Agreement, including without limitation any breach of any representations
or warranties of XXXXXXXX set forth herein. PRAECIS shall protect, defend,
indemnify and hold harmless XXXXXXXX and its affiliates, and their respective
directors, officers, employees and agents, from and against any and all actions,
liability, loss, damage, cost or expense (including reasonable attorney's fees):
(a) arising out of or in connection with the sale or use of the ***; or
(b) arising out of any claim that the ***, the Technology or the
manufacturing process furnished by PRAECIS infringes any patent or
other intellectual property right of any third party or that the
labels of the *** infringe any patent, copyright or trademark of any
third party; or
(c) otherwise arising out of the labeling or packaging of the ***.
Prompt notice of any such claim asserted against XXXXXXXX shall be
given by XXXXXXXX to PRAECIS.
(d) notwithstanding the foregoing provisions of this paragraph (ii),
PRAECIS shall have no indemnify obligation under this paragraph (ii)
to the extent any action, liability, loss, damage, cost or expense
(including reasonable attorney's fees) referred to in this paragraph
(ii) is attributable to XXXXXXXX'x xxxxx negligence, willful
misconduct or breach of this Agreement, including without limitation
any breach of any representations or warranties of XXXXXXXX set
forth herein.
19. INSURANCE
XXXXXXXX shall furnish to PRAECIS, at PRAECIS request, but not later than the
date of the commencement of manufacture of *** hereunder by XXXXXXXX, adequate
evidence of the fact (including amounts of coverage) of insurance coverage, more
particularly, worker's compensation, employer's liability and comprehensive
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ASTERISKS (*) DENOTE SUCH OMISSIONS.
general liability insurance, provided that self-insurance shall be permitted.
XXXXXXXX shall carry (and provide evidence to PRAECIS of) appropriate insurance
to cover loss or damage to in-process *** and in-process Peptide.
20. TERMINATION FOR CAUSE
Either party may terminate this Agreement (and upon any such termination the
Term shall automatically end), by giving the other party ninety (90) days
written notice thereof, in any of the following events:
A. the cessation of business activities by the other party, except as the
result of the merger or consolidation referred to in Section 26 hereof;
B. (i) the admission by the other party of its inability to pay its debts as
they mature;
(ii) the filing of a petition for bankruptcy or similar proceedings by the
other party, but excluding a proceeding for reorganization pursuant to Chapter
11 of the Federal Bankruptcy Code by the other party providing that the party
continues in the operation of its business and further provided that the party
shall otherwise continue to perform its obligations under this Agreement; or
(iii) a general assignment for the benefit of creditors or similar acts by
the other party.
C. In the event this Agreement is terminated during the Production Facility
construction phase, PRAECIS shall pay XXXXXXXX the Costs incurred or irrevocably
committed to through the date of termination.
D. In the event that Xxxxxxxx does not perform under the terms of the Agreement,
Xxxxxxxx will nevertheless use its best efforts to continue to supply Product
until PRAECIS has an alternate validated replacement reproduction facility on
line. Xxxxxxxx will assist PRAECIS with the Technology transfer. In no case will
Xxxxxxxx'x best efforts obligation extend beyond the Original Term
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E. Any act of material dishonesty or violation of laws or regulations by the
other party in relation to this Agreement which could affect that party's
ability to perform hereunder.
F. The parties agree that assignment or transfer of this Agreement as provided
in Section 24 might be an alternative to termination under this provision.
G. The material breach by the other party of this Agreement, including without
limitation any such other party's representations or warranties set forth
herein, which, if curable, continues uncured for a period of ninety (90) days
after notice thereof is given to such other party.
21. FORCE MAJEURE
A. Neither party shall be liable for failure or delay of performance, except
with respect to PRAECIS's obligations of payment under Section 6(A). hereunder,
by reason of any Acts of God, riots, insurrections, strikes, lockouts,
governmental action or regulation or any other cause beyond the reasonable
control of such party. In the event of any such occurrence, deliveries of any
order placed and accepted under this Agreement or the appropriate portion of
such delivery shall be suspended for the duration of the period during which
such cause continues, provided that no such act or occurrence shall relieve
PRAECIS from its obligations of payment hereunder.
B. In the event of partial failure or delay of performance hereunder by reason
of cause described in Section 21(A). above, unaffected portions of the Facility
may be allocated to perform hereunder on an equivalent basis, but only if such
allocation is determined by PRAECIS, prior to manufacture, to be in accordance
with cGMP.
22. ARBITRATION
A. Any dispute, controversy or claim arising out of or relating to this
Agreement, or the breach hereof shall be settled by arbitration in New Jersey in
accordance with the Rules of the American Arbitration Association and judgment
upon the award rendered by the Arbitrator(s) may be entered in any court having
jurisdiction thereof. Written notice of demand for arbitration shall be filed
with the other party to the Agreement and with the American Arbitration
Association within a reasonable time after the dispute, controversy or claim has
arisen.
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ASTERISKS (*) DENOTE SUCH OMISSIONS.
B. In any such arbitration proceeding in which damages may be awarded to PRAECIS
based on XXXXXXXX'x inability or failure to meet its supply obligations under
this Agreement, such damages may include reasonably foreseeable losses arising
from such inability or failure, including loss of sales and costs and expenses
to obtain an alternate supply (including qualification of an alternate
supplier), provided that damages consisting of loss of sales may not be awarded
based on XXXXXXXX'x inability or failure to supply to the extent the cause of
such inability or failure is one or more force majeure events described in
Section 21A. above.
23. APPLICABLE LAW; ENTIRE AGREEMENT
This Agreement (including the Exhibits hereto), which shall be interpreted and
enforced in accordance with the laws of the State of Iowa, constitutes the
entire agreement between the parties, and it is expressly agreed that any and
all prior understandings or agreements relating to the subject matter of this
Agreement, whether oral or written, are automatically canceled by the execution
of this Agreement, except that the respective obligations of the parties set
forth in the Letter Agreement with respect to the manufacture, delivery and
payment for qualification lots of *** shall remain in full force and effect. The
terms and conditions set forth herein may only be modified in a subsequent
writing signed by both parties.
24. ASSIGNMENT
This Agreement may not be assigned or transferred by either party without the
prior written consent of the other party, which consent shall not be
unreasonably withheld, except (i) that either party may assign its rights
hereunder to a subsidiary or controlled affiliated company, provided that no
such assignment shall release the assigning party from its obligation hereunder
and (ii) for any such assignment by PRAECIS to an entity which this Agreement
relates, whether pursuant to a merger, consolidation, stock purchase,
recapitalization, asset sale or otherwise.
25. INDEPENDENT CONTRACTOR
XXXXXXXX'x status hereunder is that of an independent contractor. XXXXXXXX is
not, and shall not, represent itself to be PRAECIS's agent or representative.
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ASTERISKS (*) DENOTE SUCH OMISSIONS.
XXXXXXXX shall not contact or communicate with PRAECIS's customers for the ***
in any manner or for any reason unless PRAECIS shall have consented thereto in
advance.
26. NOTICES
A. All notices given pursuant to this Agreement shall be in writing and shall be
(i) hand delivered, or (ii) sent by (a) recognized overnight courier service,
(b) certified or registered mail, return receipt requested, or (c) facsimile,
addressed as follows:
To PRAECIS:
PRAECIS PHARMACEUTICALS Inc.
0 Xxxxxxxxx Xxxxxx
Xxxxxxxxx, XX 00000-0000
Attention: Vice President, Corporate Development
Facsimile No.: 000-000-0000
To XXXXXXXX:
Xxxxxxxx Chemicals, Inc.
0000 Xxxxxxxx Xxxxxx
Xxxxxxx Xxxx, Xxxx 00000
Attention: Vice President, Sales and Marketing
Facsimile No.: 000-000-0000
with a copy to:
Cambrex Corporation
Xxx Xxxxxxxxxxx Xxxxx
Xxxx Xxxxxxxxxx, XX 00000
Attention: Corporate Secretary
Facsimile No.: 000-000-0000
B. Notice shall be effective seven business days after the time of posting if
sent by mail (or on the date of delivery if hand delivered including by
overnight courier) and on the date sent (if sent by facsimile with receipt
confirmed), unless the notice
16
relates to changing a party's address for purposes of giving notice, in which
event the notice shall be effective as of the time received.
IN WITNESS WHEREOF, the parties have executed this Agreement as of the day
and year first above written.
Witnesseth: PRAECIS PHARMACEUTICALS INC.
By:/s/ Xxxxx XxXxxxxxxx By:/s/ Xxxx X. Silver
---------------------- --------------------
Name:Xxxxx XxXxxxxxxx Name:Xxxx X. Silver
---------------------- --------------------
Title:Vice President
--------------------
Date: 7/23/98
---------------
Witnesseth: XXXXXXXX CHEMICALS, INC.
By:/s/ Xxxxxxxx X. Xxxxxxx By:/s/ Xxxxxx X. Xxxxx
----------------------- --------------------
Name:Xxxxxxxx X. Xxxxxxx Name:Xxxxxx X. Xxxxx
-------------------------- --------------------
Title:Vice President, Sales & Marketing
---------------------------------
Date:June 23, 1998
---------------
17
EXHIBIT A
CONFIDENTIAL DISCLOSURE AGREEMENT
AGREEMENT dated of September 2, 1997, by and between PRAECIS Pharmaceuticals,
Inc. ("PRAECIS"), a Delaware corporation, having its principal place of business
at Xxx Xxxxxxxxx Xxxxxx, Xxxxxxxxx, Xxxxxxxxxxxxx 00000, and Xxxxxxxx Chemicals,
Inc., an Iowa corporation having its principal place of business at 0000 00xx
Xxxxxx, Xxxxxxx Xxxx, Xxxx, 00000-0000 ("CONFIDANT").
1. Background
PRAECIS and CONFIDANT intend to engage in discussions in order to evaluate
a potential business relationship between the two parties. In the course
of such discussions and negotiations, it is anticipated that the CONFIDANT
may acquire PRAECIS's proprietary or confidential information
("CONFIDENTIAL INFORMATION") relating to PRAECIS's research and
development programs including its LHRH and drug formulation programs,
specifically; compound structures, compositions, formulation strategies,
compound characteristics, methods of preparation, methods of testing, uses
of, mechanisms of action, biologic activity, marketing research, clinical
development and registration strategies, research and management
personnel, technical and economic information, business concepts, proposed
corporate partnership arrangements, and other information relating to
PRAECIS business affairs and know how, for the purpose of enabling
CONFIDANT to evaluate the feasibility of such business relationship.
PRAECIS and CONFIDANT have entered into this Agreement in order to protect
their rights with respect to any such information in accordance with the
terms of this Agreement.
2. Disclosure of CONFIDENTIAL INFORMATION.
CONFIDANT shall hold in confidence and shall not disclose to any third
party any CONFIDENTIAL INFORMATION disclosed to it by PRAECIS, except as
expressly permitted under this Agreement. In order for such information to
be subject to the obligations set forth herein, it must be disclosed in
written or other tangible form, and clearly marked "confidential". If
disclosed orally, such information must be reduced to written or tangible
form within 30 days of initial disclosure, so marked and delivered to
CONFIDANT. CONFIDANT shall use such CONFIDENTIAL INFORMATION only for the
purpose for which it was disclosed and shall not exploit such CONFIDENTIAL
INFORMATION for its own benefit or the benefit of another without
18
the prior written consent of PRAECIS. CONFIDANT shall disclose
CONFIDENTIAL INFORMATION of PRAECIS only to its employees and consultants
who have need to know such CONFIDENTIAL INFORMATION in the course of the
performance of their duties and who are legally bound to protect the
confidentiality of such CONFIDENTIAL INFORMATION.
3. Protection of CONFIDENTIAL INFORMATION.
CONFIDANT shall protect PRAECIS's CONFIDENTIAL INFORMATION by using the
same degree of care, but not less than a reasonable degree of care, to
prevent the unauthorized use, dissemination, publication of, or access to,
PRAECIS's CONFIDENTIAL INFORMATION as it uses to protect its own
CONFIDENTIAL INFORMATION.
4. Property Rights in CONFIDENTIAL INFORMATION.
CONFIDENTIAL INFORMATION shall remain the property of PRAECIS
notwithstanding disclosure hereunder. Disclosure of CONFIDENTIAL
INFORMATION hereunder shall not be deemed to constitute a grant, by
implication or otherwise, of a right or license to the CONFIDENTIAL
INFORMATION or in any patents or patent applications of the PRAECIS.
5. Limitation on Obligations.
The obligations of each party specified in Section 3 above shall not apply
to any CONFIDENTIAL INFORMATION which:
(a) Is otherwise in the pubic domain at the time of disclosure, or becomes
publicly known, in each case, through no breach of this Agreement by
CONFIDANT (provided, however, that information shall not be disqualified
as CONFIDENTIAL INFORMATION (i) merely because it is embraced by more
general or generic information which is in the public domain or available
from a third party, or (ii) if it can only be reconstructed from
information taken from multiple sources, none of which individually shows
or fairly suggests the whole combination (with matching degree of
specificity), its principle of operation and/or the relevant use or method
of use, as applicable;
(b) Becomes known to CONFIDANT through disclosure by sources other than
PRAECIS having the rights to disclose such CONFIDENTIAL INFORMATION:
19
(c) Is generally disclosed to third parties by PRAECIS without similar
restriction on such third parties;
(d) Is approved for release by written authorization of an officer of PRAECIS;
or
(e) Is independently developed by employees or agents of CONFIDANT who have
not utilized CONFIDENTIAL INFORMATION of PRAECIS's in such independent
development.
6. Return of Documents.
CONFIDANT shall, upon the written request of PRAECIS, or upon termination
of this Agreement, return to PRAECIS all CONFIDENTIAL INFORMATION received
by CONFIDANT from PRAECIS pursuant to this Agreement (and all copies and
reproductions thereof), except that one (1) copy thereof may be retained
by CONFIDANT solely for the purpose of determining the extent of its
obligations hereunder. CONFIDANT will retain copies of reports, data, and
documentation, such as to remain in compliance with relevant regulatory
agencies.
7. Term
Exchange of information hereunder shall occur within one year from the
effective date of this agreement. This agreement shall remain in effect
for ten years from the date of the signing or until the signing of a
superseding agreement.
8. General.
(a) This Agreement and a party's rights, duties and obligations under this
Agreement are not transferable or assignable by that party without express
prior written consent of the other. Any attempt to transfer or assign this
Agreement or any of the rights, duties or obligations under this Agreement
without such consent is void
(b) This Agreement can only be modified by written agreement duly signed by
the persons authorized to sign agreements on behalf of the parties hereto,
and variance from the terms or conditions of this Agreement will be of no
effect.
20
(c) If any provision or provisions of this Agreement shall be held to be
invalid, illegal or unenforceable, the validity, legality and
enforceability of the remaining provisions shall not in any way be
affected or be impaired thereby.
(d) This Agreement shall be governed and constructed in accordance with the
laws of the State of Massachusetts.
(e) This Agreement is the complete and exclusive statement of the agreement
between the parties as to the subject matter hereof and supersedes all
communications between the parties related to the subject matter of this
Agreement.
(f) A waiver of a breach or default under this Agreement shall not be a waiver
of any other or subsequent breach or default. The failure or delay in
enforcing compliance with any term or condition of this Agreement shall
not constitute a waiver of such term or condition unless such term or
condition is expressly waived in writing.
(g) In the event of a breach or threatened breach by CONFIDANT of any of the
provisions of this Agreement, PRAECIS, in addition to any other remedies
available to it under law, shall be entitled to an injunction restraining
CONFIDANT from the performance of acts which constitute breach of this
Agreement.
(h) This Agreement shall be binding upon the parties hereto and inure to the
benefit of the parties hereto, their respective successors and permitted
assigns.
21
IN WITNESS WHEREOF, the parties hereto have executed this Agreement effective
the day and year first above written.
PRAECIS Pharmaceuticals, Inc. CONFIDANT - XXXXXXXX CHEMICALS, INC.
----------------------------- ---------
By:/s/ X. Xxxxxx By:/s/ Xxxx X. Xxxxxx
--------------------- -------------------
Name:X. Xxxxxx Name:Xxxx X. Xxxxxx
------------------- -----------------
Title:V. P., Development Title:President
------------------ ----------------
Date:September 9, 1997
-----------------
22
CONFIDENTIAL INFORMATION OMITTED AND FILED SEPARATELY
WITH THE SECURITIES AND EXCHANGE COMMISSION.
ASTERISKS (*) DENOTE SUCH OMISSIONS.
EXHIBIT B
XXXXXXXX CHEMICALS, INC. CPD 174
QUALITY ASSURANCE SPECIFICATIONS
CATEGORY: PRODUCT QC FLAG: QC
CODE NO: 2000300
NAME: PPI 149-***
SYNONYMS: ABARELIZ DEPOT
FORMULA: ***
MOLECULAR WEIGHT: ***
CAS NO: [183552-38-7]
DATE ISSUED: APRIL 24, 1998
REPLACES 04/09/1998
***: ***
DRUG PRODUCT INTERMEDIATE IN-PROCESS LIMITS
TEST ITEM LIMITS TEST METHOD
--------- ------ -----------
1. Description White to off-white ***
powder
2. *** Content *** ***
(spectrophotometric)
3. Moisture *** ***
4. HPLC ID (retention time) *** ***
5. Assay *** ***
6. Impurities (HPLC) *** ***
7. Particle Size *** ***
***
8. *** *** ***
9. *** *** ***
10. Microbial Limits (***) *** ***
11. Endotoxin (LAL) (per mg) *** ***
23
EXHIBIT B (cont.)
QUALITY ASSURANCE SPECIFICATION CODE NO. 2000300
PPI-149 Revision No. 9804
APPROVALS:
ORIGINATOR /s/ Xxxxxxx Tzarny Date: 4/22/98
---------------------- -------
QUALITY CONTROL /s/ Xxxxxxx Tzarny Date: 4/22/98
---------------------- -------
Supervisor
QUALITY ASSURANCE /s/ X.X. Xxxxx Date: 4/22/98
---------------------- -------
Manager
CHEMICAL DEVELOPMENT /s/ Xxxx Xxxxxxxxx Date: 4/22/98
---------------------- -------
Manager
SALES & MARKETING /s/ Xxxx Xxxxxx Date: 4/22/98
---------------------- -------
Director
OPERATIONS /s/ Xxxxxx Xxxxxxxx Date: 4/22/98
---------------------- -------
Manager
CHANGES: 1. Correct Replace date and Revision Number.
24
