Exhibit 10.1
[ ] Paclitaxel Supply Agreement
THIS SUPPLY AGREEMENT ("Agreement"), dated February 3, 1999,
is entered into by and between [ ], a [ ] corporation
("[ ]"), and XXXXXX, INC., a Colorado corporation
("Supplier").
WHEREAS, Supplier is a manufacturer of paclitaxel bulk drug
substance, has determined to exit such manufacturing business,
has in stock a quantity of the raw material used to make
paclitaxel bulk drug substance, and desires to use some of
such stock to manufacture and supply to [ ] paclitaxel
bulk drug substance; and
WHEREAS, [ ] desires to have Supplier manufacture and
supply paclitaxel bulk drug substance on and subject to the
terms and conditions set forth herein;
NOW, THEREFORE, in consideration of the premises and the
mutual covenants and conditions set forth in this Agreement,
and other good and valuable consideration the receipt and
sufficiency of which are hereby acknowledged, the parties
agree as follows:
1. Definitions
1.1 Definitions. In addition to terms defined elsewhere in
this Agreement, the terms set forth below have the meanings
indicated for the purposes of this Agreement.
"Affiliate" means any Person which controls, is controlled by
or is under common control with [ ] or Supplier, as the
case may be. The term "control" means the ownership, directly
or indirectly, of 50 percent or more of the voting stock or
equity interest of the subject Person.
"Designated Period" means the period commencing with the date
of this Agreement and ending on the third anniversary of the
Manufacture Date of the last lot of substance delivered by
Supplier to [ ] under this Agreement.
"DMF" means a Drug Master File for the Substance maintained by
Supplier on file with a Regulatory Authority.
"FDA" means the Food and Drug Administration or any successor
agency of the United States government.
"FDCA" means the United States Food, Drug and Cosmetic Act of
1938, as amended from time to time, and the regulations and
guidelines promulgated pursuant thereto.
"GMP" means "good manufacturing practices," as that term is
defined under the FDCA.
"Manufacture Date" means, with respect to any lot of
Substance, the date of manufacture of such lot as coded in the
label for that lot in accordance with Supplier?s normal
labeling practices.
"Person" means any natural person, corporation, unincorporated
organization, partnership, association, joint stock company,
joint venture, trust or government, or any agency or political
subdivision of any government, or any other entity.
"Product" means a finished dosage form pharmaceutical product
for human consumption containing the Substance as an active
ingredient.
"Protocols" means the analytical methods and procedures
referred to in Schedule 1 and Supplier Protocol [ ], as
such analytical methods and procedures have been provided to [
] in writing prior to the execution of this Agreement.
"Regulatory Authorities" means the FDA and its foreign
equivalents, as applicable.
"Specifications" means the specifications for Substance
attached as Schedule 1 attached hereto and incorporated
herein, as the same may be amended from time to time by mutual
agreement of the parties.
"Substance" means paclitaxel bulk drug substance manufactured
and released by Supplier in accordance with GMP which
satisfies the Specifications.
2. Supply
2.1 Agreement to Supply. On and subject to the terms and
conditions of this Agreement, Supplier shall manufacture and
sell to [ ], and [ ] shall purchase from Supplier, an
aggregate of [ ] kilograms of Substance in such quantities
and at such times as are specified in Schedule 2 hereto.
2.2 Purchase Price; Escrow.
(a) The purchase price to be paid by [ ] to Supplier
for the Substance conforming to this Agreement shall be US$[
] per kilogram delivered. The purchase price shall be paid
as provided in Section 2.4(b), provided that a portion of the
purchase price shall be paid pursuant to escrow as provided in
Section 2.2(b).
(b) (i) Concurrently with the execution of this
Agreement, the parties shall execute and deliver an Escrow
Agreement substantially in the form of Exhibit A hereto, with
[ ], or such other financial institution as the parties
may agree, as the Escrow Agent; and [ ] shall deposit the
sum of US$[ ] (representing the purchase price for the
last US$[ ] of Substance to be delivered by Supplier to [
] pursuant to this Agreement) with the Escrow Agent to hold
as the "Escrowed Funds" in accordance with the Escrow
Agreement. The Escrow Agreement provides that the Escrow
Agent shall make certain releases and deliveries on the tenth
banking day following receipt from Supplier (as "Seller") of a
"Delivery Notice" as prescribed in the Escrow Agreement
unless, prior to that day, the Escrow Agent has received a
"Claim Notice" from [ ] (as "Buyer") as prescribed in the
Escrow Agreement.
(ii) Supplier hereby agrees with [ ] that Supplier will
not deliver a Delivery Notice to the Escrow Agent under the
Escrow Agreement prior to the earliest of the following
events?
(A) Supplier has delivered to [ ] all of the Substance
required to be delivered by Supplier under, and in accordance
with, this Agreement, and at least 30 days have elapsed after
the last such delivery, and either (1) [ ] has not given
Supplier notice of nonconformity as to any of such Substance
pursuant to Section 2.4(a) or (2) all of such Substance as to
which [ ] has given such notice of nonconformity has been
determined to be conforming pursuant to Section 2.4(a); or
(B) Supplier has tendered for delivery to [ ] all of
the Substance required to be tendered by Supplier under this
Agreement (all of which Substance is in conformance with the
requirements therefor under this Agreement) to a date upon
which [ ] repudiates its obligations under this Agreement
or otherwise by action or omission legally excuses Supplier
from further performance under this Agreement, and such
repudiation or legal excuse, as the case may be, remains in
effect and does not arise out of any breach by Supplier.
Credits and refunds given by Supplier as contemplated in this
Agreement shall be included in determining the quantities of
Substance that Supplier is required to deliver or tender for
delivery under this Agreement. Seller agrees to give to [
] a copy of any Delivery Notice that it gives to the Escrow
Agent, no later than the time the Delivery Notice is given to
the Escrow Agent.
(iii) [ ] hereby agrees with Supplier that it will not
deliver a Claim Notice to the Escrow Agent under the Escrow
Agreement unless, to the time the Claim Notice is delivered to
the Escrow Agent, neither of the following has occurred?
(A) Supplier has delivered to [ ] all of the Substance
required to be delivered by Supplier under, and in accordance
with, this Agreement, and at least 30 days have elapsed after
the last such delivery, and either (1) [ ] has not given
Supplier notice of nonconformity as to any of such Substance
pursuant to Section 2.4(a) or (2) all of such Substance as to
which [ ] has given such notice of nonconformity has been
determined to be conforming pursuant to Section 2.4(a);
(B) Supplier has tendered for delivery to [ ] all of
the Substance required to be tendered by Supplier under this
Agreement (all of which Substance is in conformance with the
requirements therefor under this Agreement) to a date upon
which [ ] repudiates its obligations under this Agreement
or otherwise by action or omission legally excuses Supplier
from further performance under this Agreement, and such
repudiation or legal excuse, as the case may be, remains in
effect and does not arise out of any breach by Supplier.
The parties agree that any dispute as to either party's rights
to any portion of the Escrowed Funds may be resolved by
arbitration pursuant to Section 8.14, and each party shall
participate in providing such instructions to the Escrow
Agent, with respect to the Escrowed Funds, as may be required
by award in such arbitration. Upon delivery of any portion of
the Escrowed Funds to Supplier, such delivered portion shall
be credited toward [ ]'s obligations to pay the purchase
price.
2.3 Shipment. Sales of the Substance shall be F.O.B. [
]'s [ ] plant or such other location within the United
States of America as may be designated by [ ]. Supplier
will bear all risk of loss, delay or damage in transit until
the Substance is actually received by [ ]. Supplier shall
pay all costs related to the delivery of the Substance to [
], including, without limitation, all freight, insurance and
handling charges. Title and risk of loss to the Substance
shall pass to [ ] upon [ ]?s receipt of the Substance
at its designated delivery destination.
2.4 Product Inspection; Payment.
(a) All Substance received by [ ] shall be subject to
inspection and testing by [ ] within 30 days following [
]?s receipt thereof. When the results of any testing
conducted within such period indicate that a lot of delivered
Substance does not meet the Specifications or any other
provisions of this Agreement, [ ] will give Supplier
notice thereof, identifying with particularity the claims of
nonconformance, within the applicable 30-day period. Supplier
shall have 30 days after receipt of [ ]?s notice within
which to give notice to [ ] whether Supplier accepts or
rejects [ ]?s claims of nonconformance. Any dispute
arising under this Section 2.4(a) shall be resolved by
re-testing by a qualified testing laboratory acceptable to
both parties. The cost of the re-testing shall be borne by [
] if the lot is shown to be conforming, and by Supplier if
the lot is shown to be nonconforming. Substance which is
determined to be nonconforming pursuant to the foregoing
provisions may be rejected and returned to Supplier at
Supplier's expense including transportation and handling
costs, provided that [ ] returns the nonconforming
Substance to Supplier in accordance with Supplier's
instructions; provided, however, that, if Supplier does not
provide such instructions within 30 days after [ ]'s
notice of rejection, or the testing laboratory's determination
of nonconformity, as the case may be, then [ ] may dispose
of the nonconforming substance in such manner as it
determines, at Supplier's expense. Within 60 days after
rejection of Substance by [ ], or determination of
nonconformity by the testing laboratory, as the case may be,
Supplier shall, at its option, either (i) make replacement
delivery of conforming Substance at no cost or charge to [
] or (ii) issue full refund or credit to [ ] for the
amount paid or invoiced for the nonconforming Substance.
Supplier shall have no further obligation to deliver
replacement quantities of Substance as to which it has issued
refund or credit, and the total quantity purchasable by [
] under this Agreement shall be reduced accordingly. Payment
for Substance shall not be deemed acceptance of such
Substance.
(b) [ ] shall pay Supplier the purchase price for
conforming or otherwise accepted Substance delivered to [
] no later than 30 days after the later of (i) [ ]'s
receipt of the Substance or (ii) determination of conformity
by the testing laboratory as contemplated in Section 2.4(a),
as the case may be. Notwithstanding the foregoing, the
purchase price for the last US$[ ] of Substance to be
delivered by Supplier to [ ] shall be deposited in escrow
by [ ] as contemplated in Section 2.2(b) and, upon
delivery of any portion of the Escrowed Funds to or for the
benefit of Supplier as contemplated in Section 2.2(b), such
delivered portion shall be credited toward [ ]'s
obligations to pay the purchase price.
3. Regulatory Matters and Manufacturing Standards
3.1 Maintenance of Drug Master File.
(a) During the Designated Period, Supplier shall, at
Supplier's expense, (i) [ ].
(b) Supplier shall not make any change to any DMF without
the prior written approval of [ ], which approval shall
not be unreasonably withheld. Supplier shall provide [ ]
with one copy of the non-proprietary portion of each DMF and
any non-proprietary updates and amendments thereto promptly
upon completion thereof. Promptly upon [ ]'s request,
Supplier agrees to provide [ ] with any required
authorization to allow all applicable Regulatory Authorities
to access, review and refer to the DMFs in connection with any
regulatory submissions or product applications by [ ] and
its designees. At the request of [ ] or any Regulatory
Authority, Supplier shall execute and deliver to [ ], or
to the Regulatory Authority with a copy to [ ], as
applicable, any further documents that [ ] or the
Regulatory Authority may request to evidence the rights of [
] hereunder.
(c) After Supplier has delivered [ ] kilograms of
conforming Substance to [ ] and has fully performed and
completed its obligations under 3.1(a)(iii) above, Supplier,
at its option, may assign and transfer any or all of the DMFs
to [ ] (or its designee), provided that such assignment
and transfer can be made without any material adverse effect
on [ ], the Product, approval of the Product, the DMFs or
[ ]?s marketing, sale or use of the Substance or Product,
and [ ] will cooperate to accomplish such assignment and
transfer.
(d) During the Designated Period, Supplier shall monitor
the stability of the Substance and comply with the DMF as on
file with the FDA in accordance with its regulatory
obligations under the FDCA and in accordance with Schedule 1.
Without limiting the generality of the foregoing, during the
Designated Period and thereafter for the period ending with
the fifth anniversary of the Manufacture Date of the last lot
of Substance delivered by Supplier to [ ] under this
Agreement (the period beginning with the end of the Designated
Period and ending on such fifth anniversary being the
?Extended Period?), Supplier shall sample the paclitaxel bulk
drug substance that it manufactures in compliance with
Supplier Protocol [ ], will monitor stability of such
samples in accordance with Supplier Protocol [ ], and
will notify [ ] promptly if, during the Designated Period
or the Extended Period, any of such samples fails to meet the
stability parameters of Supplier Protocol [ ]; provided,
however, that Supplier may, at any time following the
expiration of the Designated Period but before the expiration
of the Extended Period, transfer all of such samples and
stability data to [ ], so that [ ] may continue to so
monitor the stability of such samples. Supplier represents to
[ ] that Supplier Protocol [ ] is in conformity with
the requirements of the International Conference on
Harmonization guidelines with respect to stability testing for
active drug substances. Nothing in this Section 3.1(d) shall
be deemed to constitute a representation or warranty by
Supplier as to the stability or any other characteristic of
the Substance, the only such warranties being made as provided
in Section 4.1.
3.2 Lot Certifications. Supplier shall perform full
release testing for each lot of Substance delivered to [ ]
and shall obtain and retain a representative sample from each
such lot. Supplier shall assay and analyze each such lot in
strict accordance with the Protocols. Supplier shall provide
to [ ], with each delivery of Substance, a copy of the
certificate of analysis for each lot included in the delivery,
together with such other information as [ ] shall
reasonably request in connection therewith.
3.3 Notification of Adverse Events. During the Designated
Period, Supplier shall, immediately upon becoming aware
thereof, inform [ ] of (a) any pending or threatened
litigation, governmental investigation, proceeding or action
involving the Substance or Supplier's manufacturing facilities
for the Substance, (b) any defective, adulterated or
misbranded Substance, (c) any information suggesting that the
Substance is defective or fails to meet the Specifications.
4. Warranties and Indemnity
4.1 Representations, Warranties and Covenants. Supplier
makes to [ ] the representations, warranties and covenants
set forth in Schedule 3 and also represents, warrants and
covenants to [ ] that: (a) Supplier shall obtain and
maintain all necessary permits, registrations and licenses
required to manufacture and supply the Substance under this
Agreement, including without limitation registration of the
establishment where the Substance is manufactured and stored;
(b) Supplier will comply with all laws, rules and regulations,
including all GMP, applicable to the manufacture, labeling,
packaging, storage and shipment of the Substance in effect
from time to time; (c) the Substance supplied pursuant to this
Agreement shall fully conform with the quality and other
requirements of the Specifications; (d) the Substance shall
not be adulterated or misbranded within the meaning of the
FD&C Act, and shall not be a product that would violate any
section of the FD&C Act if introduced into interstate
commerce; (e) during the Designated Period, the Substance
shall be stable as contemplated in Supplier Protocol [ ],
with delivery to by Supplier to [ ] at ambient
temperature, provided that it is continuously stored,
following such delivery to [ ], in accordance with the
recommended storage conditions specified in Supplier Label [
] (as such label has been provided to [ ] in writing
prior to the execution of this Agreement) at temperatures
within the range of [ ]; (f) the Substance and the sale or
use of the Substance by [ ] or its Affiliates will not
infringe any patent, trademark, copyright or other rights of
third parties; and (g) Supplier has full right and authority
to enter into this Agreement without the consent or approval
of any third party.
4.2 Indemnity by Supplier. Supplier shall indemnify and
hold [ ] and its Affiliates and their respective officers,
directors and employees harmless from and against any and all
liability, damage, loss, cost or expense (including attorney's
fees and expenses) arising out of or resulting from any third
party claims made or suits brought against any of such parties
which arise or result from the breach by Supplier of any of
Supplier?s representations, warranties, covenants and
agreements under this Agreement, except to the extent such
liability, damage, loss, cost or expense arises out of or
results from the breach by [ ] of any of [ ]'s
representations, warranties, covenants and agreements under
this Agreement, or from the negligence or willful misconduct
of [ ].
4.3 Indemnity by [ ]. [ ] shall indemnify and hold
Supplier and its Affiliates and their respective officers,
directors and employees harmless from and against any and all
liability, damage, loss, cost or expense (including attorney's
fees and expenses) arising out of or resulting from any third
party claims made or suits brought against any of such parties
which arise or result (a) from [ ]'s use or sale of
Product or (b) from the breach by [ ] of any of [ ]?s
representations, warranties, covenants and agreements under
this Agreement, except to the extent such liability, damage,
loss, cost or expense arises out of or results from the breach
by Supplier of any of Supplier?s representations, warranties,
covenants and agreements under this Agreement, or from the
negligence or willful misconduct of Supplier.
5. Confidentiality
5.1 Confidential Information. During the period from the
date hereof through the tenth anniversary of the date hereof,
each party shall keep confidential and not disclose to others
or use for any purpose, other than as authorized by this
Agreement, all confidential information which was provided to
it by the other party or its Affiliates or their respective
employees or representatives ("Confidential Information"). The
restrictions of this Section 5 shall not apply to any
Confidential Information which (a) is already known to the
recipient at the time of disclosure; (b) is or becomes public
knowledge through no fault of the recipient; (c) is received
from a third party having the lawful right to disclose the
information; (d) subject to Section 5.2, is required by law to
be disclosed; (e) is required to be disclosed in order to
exercise rights granted or retained pursuant to this
Agreement; or (f) is required to be disclosed by [ ] in
connection with any applications filed with Regulatory
Authorities or in connection with its marketing and sale of
the Product.
5.2 Required Disclosure. If either party is required under
applicable law to disclose Confidential Information by any
court or to any governmental authority, the party required to
disclose the Confidential Information shall, prior to such
disclosure, notify the other party of such requirement and all
particulars related to such requirement. The notified party
shall have the right, at its expense, to object to such
disclosure and to seek confidential treatment of any
Confidential Information to be so disclosed on such terms as
it shall determine, and the other party shall fully cooperate
with the notified party in this regard.
5.3 Return of Confidential Information. This Agreement
does not constitute the conveyance of ownership with respect
to or a license to any Confidential Information. Upon the
expiration or termination of this Agreement for any reason,
each party agrees to return to the other party all
documentation or other tangible evidence or embodiment of
Confidential Information belonging to the other party.
6. Inspections
6.1 Regulatory Inspections. Supplier agrees to promptly
notify [ ] of any inspections by any Regulatory Authority
which pertain to the Substance or the premises where the
Substance is manufactured, and shall promptly provide to [
] copies of all correspondence, reports, notices, findings and
other material pertinent to such inspections, as they are
received or produced by Supplier.
6.2 Access. [ ] shall have the right, upon notice to
Supplier and during normal business hours, not more than once
during any calendar year, to inspect and audit Supplier's
facilities at which the Substance is manufactured, packaged or
stored, in order to ensure that the Substance is being
manufactured, packaged and stored in compliance with the
Specifications, current GMP and all applicable laws and
regulations. During such inspections, Supplier shall permit [
] to contact and question the appropriate knowledgeable
personnel of Supplier responsible for manufacturing, packaging
and storing the Substance. Supplier shall make available to [
] and its duly authorized representatives and agents all
books, records and documents which in any way pertain to the
manufacture of the Substance or quality control testing and
compliance procedures.
7. Product Recall
7.1 Product Recall. If, during the Designated Period, (a)
any Regulatory Authority shall rightfully seize any of the
Substance or Product or shall request or require the recall of
any of the Product or (b) [ ] deems it necessary to
initiate a voluntary recall of any Product, and if the cause
or reason for any such seizure or recall relates to the
Substance and (in the case of a seizure or recall by reason of
the action of a Regulatory Authority) the Regulatory Authority
has issued a warning letter to Supplier, then Supplier shall
be responsible for and shall indemnify and hold [ ] and
its Affiliates and their respective officers, directors and
employees harmless from and against any and all claims,
losses, damages and liabilities, including attorneys fees and
expenses, relating to such recall and seizure, including,
without limitation, the cost of notifying customers, the costs
associated with the shipment of recalled Product from [
]'s customers, the cost of the Substance and all credits
extended to [ ]'s customers as a result thereof, and all
other costs of effecting such seizure or recall.
8. Miscellaneous.
8.1 Notice. All notices, requests, consents and other
communications required or permitted under this Agreement
shall be in writing and shall be (as elected by the person
giving such notice) hand delivered by messenger or courier
service, telecommunicated, or mailed by registered or
certified mail (postage prepaid), return receipt requested,
addressed to:
If to [ ]: [ ]
[ ]
[ ]
[ ]
[ ]
[ ]
with a copy to: [ ]
[ ]
[ ]
[ ]
[ ]
[ ]
If to Supplier: [ ]
[ ]
[ ]
[ ]
[ ]
[ ]
Each such notice shall be deemed delivered (1) on the date
delivered if by personal delivery, (2) on the date
telecommunicated if by facsimile, and (3) on the date upon
which the return receipt is signed or delivery is refused or
the notice is designated by the postal authorities as not
deliverable, as the case may be, if mailed. By giving to the
other parties at least 15 days written notice thereof, the
parties and their respective successors and permitted assigns
shall have the right from time to time to change their
respective addresses.
8.2 Further Assurances. Each party agrees to execute and
deliver any and all such other and additional instruments and
documents and do any and all such other acts and things as
may be necessary or expedient to effectuate more fully this
Agreement and to carry out the business contemplated by this
Agreement.
8.3 Survival. The indemnification, confidentiality and
other obligations of the parties shall not be affected or
impaired by and shall survive completion of delivery of and
payment for [ ] kilograms of Substance.
8.4 Force Majeure. The inability of any party to commence
or complete its obligations hereunder by the dates herein
required resulting from delays caused by strikes,
insurrection, acts of God, war, emergencies, shortages or
unavailability of materials, or other causes beyond the
party's reasonable control which shall have been timely
communicated to the other party, shall extend the period for
the performance of the obligations for the period equal to the
period(s) of any such delays(s); provided that such party
shall continue to perform to the extent feasible in view of
such force majeure; and provided further, that if such force
majeure shall continue for a period of six months, the other
party shall have the right to terminate this Agreement upon
written notice to the party unable to perform.
8.5 Assignment; Binding Effect. This Agreement may not be
assigned by Supplier without the written consent of [ ].
Subject to the foregoing, this Agreement shall be binding upon
and inure to the benefit of the parties hereto and their
respective successors and permitted assigns.
8.6 Waiver and Amendment. Any representation, warranty,
covenant, term or condition of this Agreement which may
legally be waived, may be waived, or the time of performance
thereof extended, at any time by the party hereto entitled to
the benefit thereof, and any term, condition or covenant
(including, without limitation, the period during which any
condition is to be satisfied or any obligation performed) may
be amended by the parties hereto at any time. Any such
waiver, extension or amendment shall be evidenced by an
instrument in writing executed by an officer authorized to
execute waivers, extensions or amendments. No waiver by any
party, whether express or implied, of its rights under any
provision of this Agreement shall constitute a waiver of such
party's rights under such provisions at any other time or a
waiver of such party's rights under any other provision of
this Agreement. No failure by any party to take any action
against any breach of this Agreement or default by another
party shall constitute a waiver of the former party's right to
enforce any provision of this Agreement or to take action
against such breach or default or any subsequent breach or
default by such other party.
8.7 Entire Agreement. This Agreement and the Exhibit
attached hereto contain every obligation and understanding
between the parties relating to the subject hereof and merges
all prior discussions, negotiations and agreements, if any,
between them, and none of the parties shall be bound by any
conditions, definitions, understandings, warranties or
representations other than as expressly provided or referred
to herein.
8.8 Severability. In the event that any one or more of the
provisions contained in this Agreement shall be declared
invalid, void or unenforceable, in any country, the remainder
of the provisions of this Agreement shall remain in full force
and effect, and such invalid, void or unenforceable provision
shall be interpreted in such country in a manner which
accomplishes, to the extent possible, the original purpose of
such provision.
8.9 Section Headings. The section headings in this
Agreement are for convenience of reference only and shall not
be deemed to affect the interpretation of any provision of
this Agreement.
8.10 No Third Party Rights. The provisions of this
Agreement are for the exclusive benefit of the parties to this
Agreement, and no other Person (including without limitation
any creditor of any party to this Agreement) shall have any
right or claim against any party to this Agreement by reason
of those provisions or be entitled to enforce any of those
provisions against any party to this Agreement.
8.11 Relationship of Parties. This Agreement shall not
constitute or be construed as creating a partnership or joint
venture between [ ] and Supplier, and neither party shall
be liable for any debts or obligations of the other party. [
] shall in no way be considered as being an agent or
representative of Supplier in any dealings which [ ] may
have with any third party, and [ ] may neither act for,
nor bind, Supplier in any such dealings.
8.12 Construction. The parties acknowledge that each has
been advised by counsel during the course of negotiation of
this Agreement and, therefore, that this Agreement shall be
interpreted without regard to any presumption or rule
requiring construction against the party causing this
Agreement to be drafted.
8.13 Governing Law. This Agreement has been entered into
and shall be construed and enforced in accordance with the
laws of the [ ] without reference to the choice of law
principles thereof.
8.14 Arbitration. All disputes arising out of or relating
to this Agreement or to the breach or validity thereof shall
be finally settled by an arbitration proceeding to be held at
a neutral location that is mutually agreeable to the parties
(or is determined by the American Arbitration Association if
the parties are not able to agree) under the Commercial Rules
of Arbitration of the American Arbitration Association by
three neutral arbitrators appointed in accordance with those
rules. The decision of the arbitrators shall be binding and
conclusive upon each party hereto and may be enforced in any
court of competent jurisdiction. At least one of the
arbitrators shall have substantial experience in
pharmaceutical supply agreements. The arbitrators shall be
specifically empowered to render a decree requiring specific
performance.
8.15 Equitable Remedies. Each of the parties acknowledges
and agrees that, in the event of a breach or threatened breach
of this Agreement by any party or the failure of a party to
perform in accordance with the specific terms hereof, the
other party hereto will be irreparably damaged and that
monetary damages would not provide an adequate remedy.
Accordingly, it is agreed that, in addition to any and all
other rights which may be available, at law or in equity, the
non-breaching party shall be entitled to injunctive relief
and/or specifically to enforce the terms and provisions hereof
in any court of competent jurisdiction.
8.16 Remedies Cumulative. The rights and remedies given in
this Agreement to a nondefaulting party shall be deemed
cumulative, and the exercise of one of such remedies shall not
operate to bar the exercise of any other rights and remedies
reserved to a nondefaulting party under the provisions of this
Agreement or given to a nondefaulting party at law or in
equity.
8.17 Prevailing Party. If either party commences an action
against the other to interpret or enforce any of the terms of
this Agreement or as a result of a breach by the other party
of any of its terms, the prevailing party shall be entitled to
recover from the nonprevailing party attorneys' fees, costs
and expenses incurred by the prevailing party in connection
with such action.
8.18 Counterparts. This Agreement may be executed in any
number of counterparts, each of which shall be deemed an
original but all of which together shall constitute one and
the same instrument.
8.19 English Version. In the event that this Agreement is
translated into a language other than English, the English
version of this Agreement shall control all questions of
interpretation with respect thereto.
8.20 Press Releases. Neither party shall issue any press
release or other publicity materials, or make any presentation
with respect to the existence of this Agreement or the terms
and conditions thereof without the prior written consent of
the other party. However, this restriction shall not apply to
disclosures required by law or regulation.
[Signatures follow.]
IN WITNESS WHEREOF, the parties have executed this Agreement
by their authorized representatives effective as of the date
first above written.
XXXXXX, INC.
By:
Name:
Title:
[ ]
By:
Name:
Title:
SCHEDULE 1
Specifications
Characteristic Test Method Description
Appearance Visual [ ]
Identity IR [ ] [ ]
HPLC [ ]
Specific rotation [ ] [ ]
Assay [ ] [ ]
Individual impurities [ ] [ ]
Specific Impurity Index
Maximum
Impurity Allowable Area
(%)
[ ] [ ]
[ ] [ ]
[ ] [ ]
[ ] [ ]
[ ] [ ]
[ ] [ ]
[ ] [ ]
Organic volatile impurities [ ] [ ]
[ ] [ ]
[ ] [ ]
[ ] [ ]
[ ] [ ]
[ ] [ ]
[ ] [ ]
Moisture (Xxxx Xxxxxxx) [ ] [ ]
Residue on Ignition [ ] [ ]
Heavy Metals [ ] [ ]
Bacterial Endotoxins [ ] [ ]
Total Microbial Count [ ] [ ]
SCHEDULE 2
Shipments
Shipments will begin with approximately [ ] kilograms and
will continue to be shipped as the Substance is produced, not
to exceed [ ] kilograms per month.
SCHEDULE 3
Additional Representations, Warranties and Covenants
Pursuant to Section 4.1 of the Agreement to which this
schedule is attached, Supplier makes the following
representations, warranties and covenants to [ ]:
1. Supplier has the right (to the exclusion of any third
party) to grant [ ] the right to reference the DMFs as
contemplated in the Agreement, subject to applicable law, and
Supplier owns all right, title and interest (to the exclusion
of any third party) in and to the DMFs to which [ ] is or
may be granted such right of reference.
2. The harvesting operations for all raw materials used to
manufacture Substance shall comply with all pertinent permits,
land use and environmental regulations of applicable
Regulatory Authorities. Supplier shall be responsible for
disposing in an environmentally safe manner any and all
residue resulting from manufacture of Substance. Supplier
agrees that it shall adopt and follow safe handling, storage,
transportation, use, treatment and disposal practices in
connection with Supplier's collection of raw materials and its
manufacture of Substance, including but not limited to, all
such practices required by federal, state and local government
law. Supplier shall instruct its employees, independent
contractors and agents of any precautions or safe use
practices required in the handling, manufacture, storage or
disposal of all materials required for Supplier's collection
of raw materials and its production of Substance. Supplier
possesses skill and expertise in the safe handling, storage,
manufacture and disposal of said products. All of the
Substance sold under the Agreement shall be produced from
Taxus biomass that has been gathered or cultivated in
compliance with any applicable federal, state or provincial
laws and regulations. Supplier shall provide [ ], in
writing, with all pertinent information available regarding
handling precautions and hazards associated with Substance,
including without limitation a current Material Safety Data
Sheet.
3. Supplier has good and marketable title to, and the right
to sell to [ ] in accordance with the Agreement, the
Substance and, at the time of delivery of the Substance to [
], the Substance shall be free and clear of any liens or
encumbrances other than those created or suffered by or under
[ ].
4. Supplier is not debarred under the FD&C Act and it does
not and will not use in any capacity the services of any
Person debarred under the FD&C Act. Neither Supplier, nor, to
the best of its knowledge, any of its employees, agents or
contractors has engaged in any activity that could lead to it
becoming debarred under the FD&C Act.
5. Supplier shall conduct its manufacturing operations
hereunder in a safe and prudent manner, in compliance with all
applicable laws and regulations (including, but not limited
to, those dealing with occupational safety and health, those
dealing with public safety and health, those dealing with
protecting the environment, and those dealing with disposal of
wastes), and in compliance with all applicable provisions of
this Agreement.
