EXHIBIT 10.11
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 Supply Agreement (this "Agreement") is entered into this 11th day of
February, 1998 by and between ▇▇▇▇ Imaging Corporation ("▇▇▇▇"), an Indiana
corporation having a principal place of business at ▇▇▇ ▇▇▇▇▇ ▇▇▇▇▇ ▇▇▇▇,
▇▇▇▇▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇ ▇▇▇▇▇, and PRAECIS PHARMACEUTICALS INCORPORATED, a Delaware
corporation having a principal place of business at ▇▇▇ ▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇,
▇▇▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇▇▇▇▇ ("PRAECIS").
RECITALS
1. PRAECIS is engaged in the development, sale and distribution of
pharmaceuticals products;
2. ▇▇▇▇ is engaged in the filling and labeling of certain pharmaceutical
products;
3. PRAECIS and ▇▇▇▇ desire to have ▇▇▇▇ fill, bulk package, and ship to PRAECIS
or its designee pharmaceutical products for development, distribution and sale
by PRAECIS.
NOW, THEREFORE, in consideration of the mutual covenants and agreements
contained herein, the parties agree as follows:
DEFINITIONS
As used in this Agreement, the following words and phrases shall have the
following meanings:
1.1 "Affiliate" of a party hereto shall mean any entity which controls, is
controlled by, or is under common control with such party. For purposes of this
definition, a party shall be deemed to control another entity if it owns or
controls, directly or indirectly, at least fifty percent (50%) of the voting
equity of another entity (or other comparable ownership interest for an entity
other than a corporation). For
CONFIDENTIAL INFORMATION OMITTED AND FILED SEPARATELY
WITH THE SECURITIES AND EXCHANGE COMMISSION.
ASTERISKS (*) DENOTE SUCH OMISSIONS.
purposes of this agreement, "Affiliate" shall also include development and or
marketing partners.
1.2 "Drug Product Intermediate" shall mean the PPI-149-*** in powder form.
1.3 "Effective Date" shall mean the date on which both parties have executed
this Agreement.
1.4 "Confidential Information" shall mean all information and data provided by
the parties to each other hereunder except any portion thereof which:
(i) is known to the recipient as evidenced by its written records before receipt
thereof under this Agreement;
(ii) is disclosed to the recipient after acceptance of this Agreement by a third
person who has the right to make such disclosure;
(iii) is or becomes part of the public domain through no fault of the recipient;
(iv) which the recipient can reasonably establish is independently developed by
recipient without access to the information disclosed hereunder; or
(v) is required to be disclosed by governmental or judicial order, rule, law or
regulation; provided in such case the recipient shall provide the disclosing
party a notice of such required disclosure and an opportunity to contest such
disclosure.
1.5 "Contract Requirements" shall mean PRAECIS' requirements for the
development, and launch of Product in the United States and all other parts of
the world during the term.
1.6 "Environmental Laws" shall mean all applicable federal, state and local
laws, ordinances and regulations relating to environmental protection or control
and handling of hazardous materials, including, but not limited to, the Federal
Water Pollution Control Act, the Resource Conservation & Recovery Act, the Safe
Drinking Water Act, the Toxic Substance Control Act, the Clean Air Act, the
Comprehen-
2
sive Environmental Response Compensation and Liability Act, the Occupational
Safety and Health Act, all as amended, and other comparable local, state and
federal laws.
1.7 "Manufacture" shall mean the filling, bulk packaging, bulk labeling, and
associated QC release of Product by ▇▇▇▇.
1.8 "Presentation" shall mean the treated Type I glass tubing vial with rubber
stopper and aluminum seal in which the Product is packaged.
1.9 "Product shall mean "PPI-149-Depot" in final packaged and labeled form.
1.10 "Product Specifications" shall mean the specifications for Product that are
set forth in the Provisional Product Specification Sheet. (Schedule 2)
1.11 "Project Plan" shall mean the manual containing the parameters for the
Manufacture of Product as set forth in Schedule I attached hereto and by
reference made a part hereof.
1.12 "Provisional Product Specification Sheet" shall mean a listing of the
Product Specifications and the testing to be performed on the Drug Product
Intermediate, the in-process Product, the Product, and the stability program.
The stability program shall be mutually agreed upon using protocols consistent
with ICH guidelines by the Parties as soon as practical.
1.13 "PRAECIS Trademarks and Tradenames" shall mean the proprietary name for
Product owned or licensed by PRAECIS.
QUANTITY AND MANUFACTURE OF PRODUCT
2.1 Pursuant to the terms and conditions of this Agreement, PRAECIS shall
purchase from ▇▇▇▇ the Contract Requirements of Product, and ▇▇▇▇ shall
Manufacture and deliver to PRAECIS the Contract Requirements of Product in
accordance with the Project Plan.
2.2. Both Parties shall collaborate to develop and file rework procedures. If
during the Manufacture of any lot of Product, any rework or remanufacture is
required in order to meet the Product Specifications, ▇▇▇▇ shall conduct such
rework or remanufacture at Cooks expense. Product Specifications may be modified
from
3
CONFIDENTIAL INFORMATION OMITTED AND FILED SEPARATELY
WITH THE SECURITIES AND EXCHANGE COMMISSION.
ASTERISKS (*) DENOTE SUCH OMISSIONS.
time to time by prior written agreement signed by an authorized representative
of each party without the necessity of amending this Agreement.
FORECASTS AND ORDER
3.1 Upon the Effective Date of this Agreement and on or before the first day of
each calendar quarter thereafter, PRAECIS will provide to ▇▇▇▇ PRAECIS' good
faith estimate of PRAECIS' Contract Requirements for that quarter and the
succeeding three quarters. PRAECIS shall not submit unit forecasts for any
quarter in an amount greater than *** units. ▇▇▇▇ specifically agrees that such
forecasts submitted by PRAECIS will be for general planning purposes only, and
shall not be binding on PRAECIS nor affect PRAECIS' right to submit orders under
Section 3.2 of this Agreement. During each calendar quarter, ▇▇▇▇ shall supply
PRAECIS with quantity of Product ordered by PRAECIS unless the quantity for any
quarter exceeds *** percent (***%) of PRAECIS' estimated quantity for such
calendar quarter in accordance with this Section 3.1, in which case ▇▇▇▇ shall
supply PRAECIS with at least ***% of PRAECIS' estimated quantity.
3.2 PRAECIS shall submit its purchase orders from time to time to ▇▇▇▇ covering
PRAECIS' purchases of Product pursuant to this Agreement. Each purchase order
shall designate the quantity of Product covered by the order, shipping
instructions, and appropriate delivery addresses and shall specify the delivery
date, of no earlier than thirty (30) days from the date PRAECIS submits the
purchase order. Except as provided herein, such purchase order shall be binding
to PRAECIS and to ▇▇▇▇. ▇▇▇▇ shall provide a confirmation of receipt of the
purchase order. If ▇▇▇▇ is unable to meet the specified delivery date, ("Failure
to Supply"), ▇▇▇▇ shall promptly notify PRAECIS and provide to PRAECIS an
alternative delivery date within 30 days of the originally specified delivery
date, in which case the ▇▇▇▇ shall not be deemed to be in breach of its supply
obligations. To the extent of any conflict between purchase orders submitted by
PRAECIS and this Agreement, this Agreement shall control.
3.3 Immediately upon ▇▇▇▇'▇ confirmation of a PRAECIS purchase order, PRAECIS
shall ship to ▇▇▇▇, F.O.B. ▇▇▇▇ in Bloomington, Indiana, without cost to ▇▇▇▇, a
quantity of Drug Product Intermediate necessary for Manufacture of the
4
Product ordered pursuant to such purchase order. ▇▇▇▇ shall have no
responsibility for delays in delivery of Product caused by delays in receipt of
Drug Product Intermediate from PRAECIS.
PRICE
4.1 The price and payment schedule to be paid by PRAECIS for Product ("Purchase
Price") shall be set forth in Annex A - Pricing Schedule.
4.2 If ▇▇▇▇ is unable to fulfill the orders placed by PRAECIS, the price to be
paid by PRAECIS shall be calculated on quantities ordered by PRAECIS and for
which ▇▇▇▇ is responsible to supply per 3.1.
SHIPMENT AND INVOICING
5.1 Product shall be delivered to PRAECIS, or its designate, F.O.B. ▇▇▇▇'▇
facility in Bloomington, Indiana freight collect, by a common carrier designated
by PRAECIS. Title and risk of loss, delay or damage in transmit shall pass to
PRAECIS upon delivery by ▇▇▇▇ of Product to common carrier at ▇▇▇▇'▇ facility.
5.2 ▇▇▇▇ shall invoice PRAECIS for Products as of the date shipped by ▇▇▇▇. Each
such invoice shall be payable by PRAECIS net thirty (30) days from date of
receipt by PRAECIS of the invoice. Payments not received within thirty (30) days
from the date of receipt by PRAECIS of the invoice shall bear interest at 1 1/2%
per month. PRAECIS shall be responsible for all taxes, fees, and other expenses
incurred in connection with the distribution and sale of Product. Any claims
arising from alleged Product shortages, or failures in shipment or delivery
shall be waived and released by Buyer unless made in writing to ▇▇▇▇ within
twenty (20) business days from the date of delivery.
6.1. PRAECIS shall have a period of sixty (60) days from the date of receipt of
Product at PRAECIS or other facility designated in the purchase order to inspect
any shipment of Product to determine whether that shipment conforms to the
Product Specifications except as specifically provided for in 6.2. If PRAECIS
believes that any shipment of Product does not conform to the Product
Specifications, PRAECIS shall, within five (5) days of when such non-conformity
of the Product to the Specifications is or reasonably should have been
discovered, but in no case more than sixty (60) days from the receipt of
product, except as specifically provided in 6.2, so notify ▇▇▇▇ by telephone
including a detailed explanation of the non-confor-
5
mity and shall confirm such notice with a written confirmation by overnight
delivery. If ▇▇▇▇ agrees that the Product does not conform to the Product
Specifications, it shall notify PRAECIS by telephone and shall confirm such
notice with a written confirmation. If ▇▇▇▇ agrees that the Product does not
conform to the Product Specifications, PRAECIS shall return the non-conforming
Product to ▇▇▇▇, at ▇▇▇▇'▇ expense, for disposal or rework at PRAECIS'
discretion, by ▇▇▇▇ at ▇▇▇▇'▇ expense. If ▇▇▇▇ does not agree with PRAECIS'
determination that the Product does not conform to the Product Specifications,
▇▇▇▇ shall notify PRAECIS by telephone and shall confirm such notice with a
written confirmation. In the event of a dispute as to whether or not Product is
non-conforming, PRAECIS and ▇▇▇▇ shall use good faith efforts to resolve the
issues as to whether the Product conforms to Product Specifications. In case
▇▇▇▇ and PRAECIS cannot resolve the issue as to the conformity or non-conformity
of Product, the subject will be submitted to a mutually acceptable lab for
determination. The determination of such mutually acceptable lab shall be
binding on the parties. The non-prevailing party shall bear the cost of testing
at the mutually acceptable lab. In the event PRAECIS fails to notify ▇▇▇▇ of
non-conforming Product with the sixty (60) day period, PRAECIS shall be deemed
to have accepted such Product. ▇▇▇▇, at its expense, shall use its commercial
good faith to replace any confirmed, non-conforming Product, including
nonrecoverable Drug Product Intermediate, within the shortest reasonable time.
6.2. Product will be tested routinely by ▇▇▇▇ for stability in accordance with
mutually agreed upon protocols consistent with ICH guidelines. In the event a
lot of Product is shown to be significantly less stable than NDA registration
stability lots, and upon investigation the decreased stability is attributable
solely to Manufacture, ▇▇▇▇ will recover and resupply at its expense.
TERM AND TERMINATION
7.1 This Agreement shall be effective on the Effective Date and shall continue
until NDA Approval of the Product (the "Term" unless earlier terminated in
accordance with the terms of this Agreement.
7.2 Either party may terminate this Agreement upon the breach of any material
provision of this Agreement by the other party, including Failure to Supply, if
such breach is not cured within thirty (30) days after written notice thereof to
the breaching party.
6
7.3 In the event of the termination or cancellation of this Agreement, with the
exception of termination by PRAECIS for breach by ▇▇▇▇, PRAECIS shall reimburse
▇▇▇▇ for all raw materials and components ordered prior to termination and not
cancellable at no cost to ▇▇▇▇. PRAECIS shall pay prices described in Annex A
for (a) all work-in-process commenced by ▇▇▇▇ and (b) all finished goods of
▇▇▇▇. ▇▇▇▇ shall ship such materials to PRAECIS at PRAECIS' cost and per
PRAECIS' instructions. PRAECIS shall make payment for all expenses described in
this Section 7.3 net thirty (30) days from the invoice date.
7.4 Termination, expiration, cancellation or abandonment of this Agreement
through any means or for any reason shall not relieve the parties of any
obligation accruing prior thereto and shall be without prejudice to the rights
and remedies of either party with respect to any antecedent breach of any of the
provisions of this Agreement and the provisions of Section 11, 13, 15 and 16
hereof shall survive.
7.5 The Parties agree to discuss in good faith an extension of this Agreement
upon expiration, it being understood that the terms of an extended agreement
would be substantially equivalent to the terms of this Agreement.
MANUFACTURE OF PRODUCT
8.1 Product shall be Manufactured in accordance with current Good Manufacturing
Practices promulgated by the United States Food and Drug Administration (the
"FDA") and the applicable New Drug Application (NDA) filed with the FDA. If
applicable, Product shall be manufactured in accordance with foreign (i.e.,
outside of the United States) current Good manufacturing Practices and
applicable laws and regulations, pursuant to submissions filed. PRAECIS shall be
responsible for keeping ▇▇▇▇ apprised of any foreign submissions and providing
▇▇▇▇ copies of said submissions.
8.2 PRAECIS, and its Affiliates, shall have the right to inspect ▇▇▇▇'▇
facilities solely as they relate to the Manufacture of the Product, to determine
compliance with (i) current Good Manufacturing Practices and (ii) applicable
federal, state and local laws, regulations and rules. Such inspections shall not
occur more than twice per year with a greater frequency only upon approval by
▇▇▇▇. Such inspections shall be scheduled at mutually agreeable times upon
reasonable advance written notice to ▇▇▇▇, shall be at PRAECIS' or its
Affiliates' expense, and shall be conducted in a manner that in no way
interrupts or impairs, in any significant manner, the manufacturing operations,
at such facilities in which ▇▇▇▇ manufactures, tests, sources
7
materials and/or stores Product. These facilities are specified in Schedule I.
The location of manufacturing operations shall not be changed without
appropriate change of control procedures. ▇▇▇▇ shall use good faith efforts to
enable PRAECIS to inspect and sample materials from all ▇▇▇▇ suppliers as they
relate to the Manufacture of Product. All information disclosed or reviewed in
such inspections shall be deemed to be Confidential Information.
8.3 ▇▇▇▇ agrees to collaborate with PRAECIS and its Affiliates before, during
and after any regulatory inspection which is relevant to the Manufacture of the
Product. Any observations from any inspection of ▇▇▇▇ will be discussed and an
action plan for prompt resolution of any identified issue will be agreed to by
both Parties and implemented by ▇▇▇▇.
8.4. ▇▇▇▇ shall test, or cause to be tested, in accordance with the
Specifications, each batch of Product Manufactured pursuant to this Agreement
before delivery to PRAECIS. A certificate of analysis for each released batch of
Product delivered to PRAECIS shall set forth the items tested by ▇▇▇▇,
specifications, and test results. ▇▇▇▇ shall send, or cause to be sent, such
certificates to PRAECIS prior to or at the same time of shipment of Product to
PRAECIS. ▇▇▇▇ shall also send as soon as possible, but in no case later than one
week later, additional documentation, consisting of batch records and a
statement of GMP compliance, and such other documents to be agreed upon by ▇▇▇▇
and PRAECIS.
8.5. At PRAECIS' option, ▇▇▇▇ shall perform all stability testing required to be
performed on production batches of Product as per 1.12.
8.6. PRAECIS shall provide ▇▇▇▇ a Material Safety Data Sheet for Product. ▇▇▇▇
shall immediately notify PRAECIS of any unusual health or environmental
occurrence relating to the Product, including, but not limited to any claim or
complaint by any ▇▇▇▇ employee or third party that the operations of ▇▇▇▇
pursuant to this Agreement have resulted in any adverse health or safety effect
on an employee or third party. ▇▇▇▇ agrees to advise PRAECIS immediately of any
safety or toxicity problems of which it becomes aware regarding the Product.
PURCHASE OF MATERIALS
9.1. ▇▇▇▇ shall purchase at ▇▇▇▇'▇ expense all packaging materials listed in
Schedule I, primary container components and secondary packaging materials
required to supply Product. ▇▇▇▇ will be responsible for any and all
subcontractor
8
expenses, including but not limited to sterilization testing, incurred to
Manufacture Product.
TRADEMARKS AND TRADENAMES
10.1. PRAECIS hereby licenses ▇▇▇▇ to use the PRAECIS Trademarks and Tradenames
for the sole purpose of allowing ▇▇▇▇ to fulfill its responsibilities under this
Agreement.
10.2. PRAECIS shall be solely responsible for selecting, registering and
enforcing the PRAECIS Trademarks and Tradenames used to identify the Product and
shall have sole and exclusive rights in such PRAECIS Trademarks and Tradenames.
WARRANTY AND LIMITATION OF DAMAGES
11.1. ▇▇▇▇ warrants that Product shall conform with the Product Specifications
at the time of Manufacture, and shall be Manufactured in accordance with GMP.
The Parties agree that a system of mutual change control shall be established.
▇▇▇▇ will inform PRAECIS of any implemented change.
11.2. EXCEPT FOR THOSE WARRANTIES SET FORTH IN THIS SECTION 11, SECTION 12 AND
SECTION 13, ▇▇▇▇ MAKES NO OTHER WARRANTIES, WRITTEN, ORAL, EXPRESS OR IMPLIED,
WITH RESPECT TO PRODUCT. ALL OTHER WARRANTIES, EXPRESS OR IMPLIED, INCLUDING,
WITHOUT LIMITATION, THE IMPLIED WARRANTIES OR MERCHANTABILITY AND FITNESS FOR A
PARTICULAR PURPOSE AND NONINFRINGEMENT HEREBY ARE DISCLAIMED BY ▇▇▇▇. NO
WARRANTIES OF ▇▇▇▇ MAY BE CHANGED BY ANY REPRESENTATIVES OF ▇▇▇▇. PRAECIS
ACCEPTS PRODUCT SUBJECT TO THE TERMS HEREOF.
11.3. PRAECIS' sole and exclusive remedy for breach of this Agreement, with the
exception of willful misconduct and willful disregard, is limited to, at PRAECIS
discretion, replacement by ▇▇▇▇ at the non-conforming Product, including
nonrecoverable Drug Product Intermediate, or reimbursement by ▇▇▇▇ of the
Purchase Price for the non-conforming Product, including nonrecoverable Drug
Product Intermediate, except to the extent provided above in this Section 11.3,
▇▇▇▇ shall not be liable for loss of use or profits or other collateral,
special, consequential or other damages, losses, or expenses, including but not
limited to the cost of cover or a recall, except as specified in 14.1, in
connection with or by reason of the
9
Manufacture and delivery of Product under this Agreement whether such claims are
founded in tort or contract. The foregoing constitutes the sole and exclusive
remedy of PRAECIS and the exclusive liability of ▇▇▇▇. All claims by PRAECIS for
breach or default under this Agreement shall be brought within one (1) year
after the cause of action accrued or shall be deemed waived.
REPRESENTATION AND WARRANTY REGARDING COMPLIANCE WITH LAWS
12.1. ▇▇▇▇ represents and warrants that it has obtained (or will obtain prior to
Manufacturing Product), and will remain in compliance with during the term of
this Agreement, all permits, licenses and other authorizations (the "Permits")
which are required under federal, state and local laws, rules and regulations
applicable to the Manufacture only of Product; provided, however, ▇▇▇▇ shall
have no obligation to obtain Permits relating to the sale, marketing,
distribution or use of Drug Product Intermediate or Product or with respect to
the labeling of Product. ▇▇▇▇ makes no representation or warranty with respect
to the sale, marketing, distribution or use of Drug Product Intermediate or
Product or as to printed materials supplied by PRAECIS or its designate.
12.2. In the event of any violation or alleged violation by ▇▇▇▇ of any of the
foregoing laws, rules or regulations which renders ▇▇▇▇ unable to perform the
obligations imposed on ▇▇▇▇ pursuant to this Agreement, PRAECIS shall have the
right to terminate this Agreement, in whole or in part, upon fifteen (15) days
prior written notice to ▇▇▇▇ and the failure of ▇▇▇▇ to cure within the fifteen
(15) day period.
12.3. ▇▇▇▇ represents and warrants that its execution, delivery and performance
of this Agreement will not constitute or result in a breach of or default under
any agreement or instrument binding on ▇▇▇▇, and ▇▇▇▇ will not enter into any
agreement which would prohibit or impair the performance by ▇▇▇▇ of its
obligations hereunder.
INDEMNIFICATION
13.1. PRAECIS shall indemnify and hold harmless ▇▇▇▇ and its employees,
subcontractors and agents from and against any and all liabilities, claims,
demands, actions, suits, losses, damages, costs and expenses (including
reasonable attorney's fees) arising out of or in connection with PRAECIS'
storage, promotion, labeling,
10
marketing, distribution, use or sale of Drug Product Intermediate or Product or
which otherwise results from PRAECIS' negligence or willful misconduct or its
breach of this Agreement, except to the extent caused solely by the negligence
or willful misconduct of ▇▇▇▇ or its employees, subcontractors or agents or
solely by the breach by ▇▇▇▇ of its warranties hereunder. ▇▇▇▇ shall use its all
reasonable efforts to establish supply contracts, that will contain change
control provisions consistent with those established between PRAECIS and ▇▇▇▇,
with any subcontractors involved in the Manufacture of Product.
13.2. ▇▇▇▇ shall indemnify and hold harmless PRAECIS and its employees and
agents from and against any and all liabilities, claims, demands, actions,
suits, losses, damages, costs and expenses (including reasonable attorney's
fees) resulting from ▇▇▇▇'▇ negligence or willful misconduct or from ▇▇▇▇'▇
breach of its warranties hereunder.
13.3. Each of the parties shall promptly notify the other of any such claim or
potential claim covered by any of the above subsections of this Section 13 and
shall include sufficient information to enable the other party to assess the
facts. Each of the parties shall cooperate fully with the other party in the
defense of all such claims. No settlement or compromise shall be binding on a
party hereto without its prior written consent.
RECALL OF PRODUCT
14.1. In the event PRAECIS shall be required to recall any Product because such
Product may violate local, state or federal laws or regulations, the laws or
regulations of any applicable foreign government or agency or the Product
Specifications, PRAECIS shall be responsible for coordinating such recall. ▇▇▇▇
shall cooperate with PRAECIS in connection with any recall, at PRAECIS' expense.
If a recall is due solely to ▇▇▇▇'▇ breach of its warranties under this
Agreement, ▇▇▇▇ shall reimburse PRAECIS for the Purchase Price, including
nonrecoverable Drug Product Intermediate, paid by PRAECIS for such recalled
Product and any reasonable, out of pocket expenses associated with such recall.
Except as specifically set forth above, PRAECIS shall be responsible for all of
the costs and expenses of such recall.
INTELLECTUAL PROPERTY
15.1. PRAECIS will indemnify and hold ▇▇▇▇ harmless from all liabilities,
claims, demands, actions, suits, losses, costs, damages and expenses (including
reasonable
11
attorney's fees) arising out of or in connection with any claim that the sale,
manufacture, marketing or distribution of Drug Product Intermediate or Product
by ▇▇▇▇ or PRAECIS violates the proprietary rights of any third party.
15.2. ▇▇▇▇ will cooperate with PRAECIS in defending or otherwise resolving any
changes of such infringement. PRAECIS will have full control of the defense of
any litigation brought against ▇▇▇▇ for actual or alleged infringement; however,
▇▇▇▇, at its expense, shall be entitled to be represented by its own counsel in
any such litigation. Except as provided in the preceding sentence, PRAECIS shall
bear all other costs and expenses of litigation, including its own attorneys'
fees, in connection with such alleged infringement, and PRAECIS will reimburse
▇▇▇▇ for any disbursement made by ▇▇▇▇ in satisfaction of any final judgment
issued in any such litigation. In the event that the sale of Product is enjoined
due to an alleged infringement by either party, PRAECIS shall refund to ▇▇▇▇ the
costs incurred by ▇▇▇▇ relating to any Product or other materials used in
connection with the Manufacture remaining in ▇▇▇▇'▇ possession.
CONFIDENTIAL INFORMATION AND NONDISCLOSURE
16.1 It is contemplated that in the course of the performance of this Agreement
each party may, from time to time, disclose Confidential Information to the
other. Each party agrees to take all reasonable steps to prevent disclosure of
Confidential Information to third parties. No provision of this Agreement shall
be construed so as to preclude disclosure of Confidential Information as may be
reasonably necessary to secure from any governmental agency necessary approvals
or licenses or to obtain patents with respect to the Product. Such obligations
of the parties relating to Confidential Information shall expire ten (10) years
after expiration or termination of this Agreement.
16.2. This Agreement, by reference, incorporates the Confidentiality Agreement
signed by PRAECIS and ▇▇▇▇ on January 5, 1996, and is made a part hereof as
through fully set forth herein.
16.3. Neither party shall disclose any information about this Agreement,
including its existence, without the prior written consent of the other party.
16.4. ▇▇▇▇ shall not during the term of the Agreement Manufacture or develop
compounds for themselves or for a party other than PRAECIS that exhibit
Lutenizing Hormone Releasing Hormone (LHRH) antagonist activity, other than
under this
12
Agreement. Upon Termination of the Agreement, ▇▇▇▇ shall not Manufacture or
develop a generic version of the Product.
16.5. Notwithstanding anything to the contrary in this Agreement either party
shall be permitted to disclose the terms of this Agreement to applicable
governmental tax authorities if requested by such authorities.
FORCE MAJEURE
17.1. Any delay in the performance of any of the duties or obligations of either
party hereto (except the payment of money) caused by an event outside the
affected party's reasonable control which affects the Product shall not be
considered a breach of this Agreement, and unless provided to the contrary
herein, the time required for performance shall be extended for a period equal
to the period of such delay. Such events shall include without limitation, acts
of God; acts of public enemies; insurrections; riots, injunctions; embargoes;
labor disputes, including strikes, lockouts, job actions, or boycotts; fires;
explosions; floods; shortages of energy or materials; acts or orders of any
government or agency thereof or other unforeseeable causes beyond the reasonable
control and without the fault or negligence of the party so affected. The party
so affected shall give prompt notice to the other party of such cause and a good
faith estimate of the continuing effect of the force majeure condition and the
duration of the affected party's nonperformance, and shall take whatever
reasonable steps are appropriate to relieve the effect of such causes as rapidly
as possible. If the period of nonperformance of ▇▇▇▇ because of ▇▇▇▇ force
majeure conditions exceeds sixty (60) days, PRAECIS may terminate this Agreement
by written notice to ▇▇▇▇. If the period of nonperformance of PRAECIS because of
PRAECIS force majeure conditions exceeds sixty (60) days, ▇▇▇▇ may terminate
this Agreement by written notice to PRAECIS.
COMPLIANCE WITH LAWS
18.1 Each party shall comply with all applicable federal, state and local
governmental laws, regulations and rules relating to its performance under this
Agreement.
NOTICES
19.1 All notices hereunder shall be delivered personally or by registered or
certified mail, postage prepaid, or by facsimile (confirmed by overnight
delivery), or by overnight delivery, to the following addresses of the
respective parties:
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If to ▇▇▇▇: ▇▇▇▇ Imaging Corporation
▇▇▇ ▇▇▇▇▇ ▇▇▇▇▇ ▇▇▇▇
▇▇▇▇▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇ ▇▇▇▇▇
Attn: ▇▇▇▇▇▇ ▇. ▇▇▇▇, Project Coordinator
Telefax No. ▇▇▇-▇▇▇-▇▇▇▇
Telephone No. ▇▇▇-▇▇▇-▇▇▇▇
If to PRAECIS: PRAECIS Pharmaceuticals Inc.
▇▇▇ ▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇
▇▇▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇-▇▇▇▇
Attn: VP Corporate Development
Telefax No. ▇▇▇-▇▇▇-▇▇▇▇
Telephone No. ▇▇▇-▇▇▇-▇▇▇▇
Notices shall be effective upon receipt if personally delivered, on the third
business day following the date of mailing if sent by registered or certified
mail, and on the second business day following the date of transmission or
delivery to the overnight delivery if sent by facsimile or overnight delivery. A
party may change its address listed above by notice to the other party.
APPLICABLE LAW
20.1. This Agreement is being delivered and executed in the State of Indiana.
"Venue shall be proper only in a court of competent jurisdiction located in the
State of Indiana. In any action brought regarding the validity, construction and
enforcement of this Agreement, it shall be governed in all respects by the laws
of the State of Indiana, without regard to the principals of conflicts of laws.
The parties shall be subject to personal jurisdiction in and consent to service
of process issued by such court.
ASSIGNMENT
21.1. Neither party shall assign this Agreement or any part hereof or any
interest herein to any third party, (or use any subcontractor) without the
written approval of the other party. However, PRAECIS may, without such consent,
assign or sell this Agreement to an Affiliate of PRAECIS. ▇▇▇▇ may, without such
consent, assign this Agreement to an Affiliate of ▇▇▇▇. Any permitted assignee
shall assume all obligations of its assignor under this Agreement. No assignment
shall relieve any
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party of responsibility for the performance of any accrued obligation which such
party then has hereunder.
21.2. PRAECIS shall have the right, transferable to its marketing and
development partner, ▇▇▇▇▇▇▇ ▇▇-▇▇▇▇▇, to buy the remainder of the term of the
contract ("Buy-out") subject to payment of a fee to ▇▇▇▇, to be negotiated and
agreed upon by PRAECIS and ▇▇▇▇ in good faith. Such a fee will consider the
remaining term of the contract, the PRAECIS' forecasted unit volume requirements
for the remainder of the term of the contract, the profit margin forecasted to
be received by ▇▇▇▇ from Manufacture of the Product and the reasonable
probability that ▇▇▇▇ shall recover a portion of the profits during the
remainder of the term through alternate commercial use of the facility. The
Buy-out will occur upon six months prior written notice to ▇▇▇▇.
ALLIANCES
22.1. Nothwithstanding anything to the contrary herein, ▇▇▇▇ agrees that PRAECIS
shall have the right to enter into alliances with third parties who may engage
in joint (with PRAECIS) or unilateral marketing and promoting of the Product or
any combination of products that includes the Product.
TAXES
23.1. PRAECIS shall pay all national, state, municipal or other sales, use
excise, import, property, value added, or other similar taxes, assessments or
tariffs assessed upon or levied against the sale of Product to PRAECIS pursuant
to this Agreement (or at PRAECIS' sole expense, defend against the imposition of
such taxes). ▇▇▇▇ shall notify PRAECIS of any such taxes that any governmental
authority is seeking to collect from ▇▇▇▇, and PRAECIS may assume the defense
thereof in ▇▇▇▇'▇ name, if necessary, and ▇▇▇▇ agrees to fully cooperate in such
defense to the extent of the capacity of ▇▇▇▇, at PRAECIS' expense. ▇▇▇▇ shall
pay all national, state, municipal or other taxes on the income resulting from
the sale by ▇▇▇▇ of the Product to PRAECIS under this Agreement, including but
not limited to gross income, adjusted gross income, supplemental net income,
gross receipts, excess profits taxes, or other similar taxes.
SUCCESSORS AND ASSIGNS
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24.1. This Agreement shall be binding upon and shall inure to the benefit of the
parties hereto, their affiliates, successors and permitted assigns.
ENTIRE AGREEMENT
25.1.1 This Agreement constitutes the entire agreement between the parties
concerning the subject matter hereof and supersedes all written or oral prior
agreements or understandings with respect thereto.
SEVERABILITY
26.1. If any term or provision of this Agreement shall for any reason be held
invalid, illegal or unenforceable in any respect, such invalidity, illegality or
shall not affect any other term or provision hereof, and this Agreement shall be
interpreted and construed as if such term or provision, to the extent the same
shall have been held to be invalid, illegal or unenforceable, had never been
contained herein.
WAIVER-MODIFICATION OF AGREEMENT
27.1 No waiver or modification of any of the terms of this Agreement shall be
valid unless in writing and signed by authorized representatives of both parties
hereto. Failure by either party to enforce any rights under this Agreement shall
not be construed as a waiver of such rights nor shall a waiver by either party
in one or more instances be construed as constituting a continuing waiver or as
a waiver in other instances.
INDEPENDENT CONTRACTOR and USE OF MACHINE
28.1 ▇▇▇▇ shall act as an independent contractor for PRAECIS in providing the
services required hereunder and shall not be considered an agent for joint
venture with PRAECIS. Unless otherwise provided herein to the contrary, ▇▇▇▇
shall furnish all expertise, labor, supervision, machining and equipment
necessary for performance hereunder and shall obtain and maintain all building
and other permits and licenses required by public authorities.
29.1 PRAECIS will purchase at its own expense a Perry Acco filling machine to
install at ▇▇▇▇ for Manufacture of NDA validation and subsequent commercial
lots. Prior to NDA validation, the machine shall be fully dedicated to
Manufacture of Product. This machine will be returned to PRAECIS, at PRAECIS'
request upon
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Termination of this Agreement. ▇▇▇▇ will provide to PRAECIS a certificate of
insurance on the aforementioned PRAECIS purchased equipment.
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IN WITNESS WHEREOF, the parties have caused this Agreement to be signed by their
duly authorized representatives as of the later date written below.
▇▇▇▇ IMAGING CORPORATION PRAECIS PHARMACEUTICALS INC.
By: /s/ ▇▇▇▇▇ ▇. ▇▇▇▇▇▇ By: /s/ ▇▇▇▇ ▇. Silver
-------------------------- ------------------------------------------
Title: President Title: Vice President - Corporate Development
---------------------- --------------------------------------
Date: March 16, 1998 Date: February 10, 1998
---------------------- --------------------------------------
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CONFIDENTIAL INFORMATION OMITTED AND FILED SEPARATELY
WITH THE SECURITIES AND EXCHANGE COMMISSION.
ASTERISKS (*) DENOTE SUCH OMISSIONS.
Annex A Project Price/Unit
Based on *** units being generated *** (includes filling, labeling, packaging,
and analytical support; all as described above)
*** Pricing Information Omitted ***
--------------------------------------------------------------------------------
For purposes of example:
*** Pricing Example Omitted ***
Price/unit in a given calendar year will be based on the total unit quantity
actually purchased for that calendar year. Over the calendar year, units will be
purchased at the unit price indicated in the schedule above. A reconciliation
will take place within thirty (30) days after the end of the calendar year.
For example:
Where,
Calendar Year Unit Purchases = ***
*** Pricing Example Omitted ***
In the case the an amount is due PRAECIS, PRAECIS shall receive a credit
immediately applicable to new orders for the then current year. In the event
that an amount is due ▇▇▇▇. PRAECIS shall submit payment in full within 60 days
of year end.
19
CONFIDENTIAL INFORMATION OMITTED AND FILED SEPARATELY
WITH THE SECURITIES AND EXCHANGE COMMISSION.
ASTERISKS (*) DENOTE SUCH OMISSIONS.
[▇▇▇▇ LETTERHEAD]
SCHEDULE I FOR PPI
(Project code 110-02)
Primary Contact - - ▇▇▇▇ ▇▇▇▇▇▇ & ▇▇▇▇ ▇▇▇▇▇▇▇, Ph.D. ph: ▇▇▇-▇▇▇-▇▇▇▇
Praecis Pharmaceuticals Inc. fax: ▇▇▇-▇▇▇-▇▇▇▇
▇ ▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇
▇▇▇▇▇▇▇▇▇, ▇▇ ▇▇▇▇▇-▇▇▇▇
Product Description -- PPI-149 Depot powder filled in a vial; used to treat
prostate cancer.
Safety - - Respirators must be worn by all personnel entering
the weighing and filling area.
Storage - - Store the bulk drug substance and finished product at
controlled room temperature. NOTE: The finished
product will be stored for 60 days free of charge
from date of ▇▇▇▇ release, after which PPI will
accrue a storage fee of $125/month/pallet (or any
quantity thereunder).
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Raw Material & Components
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Item Test Storage Supplied by ▇▇▇▇ P/N
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▇▇▇-▇▇▇-*** ▇ ▇▇ ▇▇▇▇▇▇ ▇▇▇▇-▇▇▇
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SGD molded 3 mL x 20 mm Type I vial ▇▇▇▇ 2249-928
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West 20 mm 4432/50 stopper ▇▇▇▇ 2134-321
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West 20 mm aluminum tear-off seal ▇▇▇▇ 2197-321
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NOTE: ▇▇▇▇ will store any remaining bulk drug substance for 30 days after the
fill date (unless other runs are scheduled) at which time all the inventory will
be sent back to CLIENT, F.O.B. Bloomington
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1
CONFIDENTIAL INFORMATION OMITTED AND FILED SEPARATELY
WITH THE SECURITIES AND EXCHANGE COMMISSION.
ASTERISKS (*) DENOTE SUCH OMISSIONS.
Filling -
*** Approximately 5 lines omitted ***
Chemistry/Microbiology ***
NOTE: ***
*** Approximately 23 lines omitted ***
Inspection - - ***
Labeling - - *** Approximately 4 lines omitted ***
Packaging - - *** Approximately 4 lines omitted ***
Shipping- - Shipments are F.O.B. Bloomington.
Disposal - - ***
Contacts at CPS -
Scientific Affairs Manager ▇▇▇▇ ▇▇▇▇▇▇▇▇▇▇
Materials Manager ▇▇▇▇▇▇ ▇▇▇▇▇▇
Quality Assurance Manager ▇▇▇▇▇▇▇▇ ▇▇▇▇▇
Documentation provided by CPS -
1. Master batch record for review and approval by CPS and PPI.
2. Product specific validation summaries.
3. Executed batch records (includes C of A)
2
CONFIDENTIAL INFORMATION OMITTED AND FILED SEPARATELY
WITH THE SECURITIES AND EXCHANGE COMMISSION.
ASTERISKS (*) DENOTE SUCH OMISSIONS.
-------------------------------------------------------------------------------
Project Price
-------------------------------------------------------------------------------
Based on *** units being generated *** (includes filling, labeling, packaging,
and analytical support; all as described above)
-------------------------------------------------------------------------------
*** Pricing Information Omitted ***
-------------------------------------------------------------------------------
3
CONFIDENTIAL INFORMATION OMITTED AND FILED SEPARATELY
WITH THE SECURITIES AND EXCHANGE COMMISSION.
ASTERISKS (*) DENOTE SUCH OMISSIONS.
SCHEDULE 2: Provisional Product Specification Sheet
Praecis Pharmaceuticals Inc./
▇▇▇▇ Imaging Corporation
PPI-149-Depot Drug Product Tentative Specifications
---------------------------------------------------
The following tentative specifications have been established for PPI-149-Depot.
It is understood that these specifications will be reviewed on an ongoing basis
and amended as appropriate. Regulatory agency feedback may also necessitate
specification review.
Before Reconstitution
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Test Tentative Specification
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Appearance before reconstitution White to off-white powder in a
sealed vial
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Identification ***
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***content ***
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Uniformity of vial content ***
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Peptide assay (based on uniformity of ***
content)
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Impurities ***
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Moisture content ***
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Particle size ***
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Sterility USP D71E ***
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Bacterial Endotoxin Test USP D85E ***
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Dissolution* ***
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------------
* PRAECIS is currently investigating a discriminating dissolution test
method and accordingly will implement a drug product dissolution
specification in the future.
1
CONFIDENTIAL INFORMATION OMITTED AND FILED SEPARATELY
WITH THE SECURITIES AND EXCHANGE COMMISSION.
ASTERISKS (*) DENOTE SUCH OMISSIONS.
After Reconstitution ***:
-------------------------------------------------------------------------------
Test Tentative Specifications
-------------------------------------------------------------------------------
Appearance after reconstitution White to off-white suspension
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pH after reconstitution ***
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Dose delivery after reconstitution ***
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2
