Exhibit 10.3
CONFIDENTIAL TREATMENT REQUEST
[ * ] INDICATES INFORMATION THAT HAS BEEN OMITTED PURSUANT TO A
CONFIDENTIAL TREATMENT REQUEST AND THIS INFORMATION HAS BEEN FILED UNDER
SEPARATE COVER WITH THE COMMISSION.
SECOND SUPPLY AGREEMENT
THIS SUPPLY AGREEMENT ("Agreement") made as of the 1st day of February
2008, between ANDAPHARM LLC, a Florida limited liability company having its
principal place of business at 0000 XX 00xx Xxxxxxx, Xxxx Xxxxxxxxxx, Xxxxxxx
00000 ("ANDAPHARM") and Breckenridge Pharmaceutical, Inc. having its principal
place of business at 0000 X. Xxxxxx Xxxxxx, Xxxx Xxxxx, XX 00000
("BRECKENRIDGE").
RECITALS
A. WHEREAS, ANDAPHARM is engaged in the business of developing,
manufacturing, and selling pharmaceutical products;
B. WHEREAS, BRECKENRIDGE is engaged in the business of developing,
marketing and distributing pharmaceutical products;
C. WHEREAS ANDAPHARM agrees to supply commercial quantities of the
designated products exclusively to and on behalf of BRECKENRIDGE,
subject to other terms herein.
X. XXXXXXXXXXXX agrees to purchase from ANDAPHARM commercial supplies
of the designated products.
E. WHEREAS ANDAPHARM and BRECKENRIDGE entered into a Supply Agreement
on March 13, 2007, pursuant to which ANDAPHARM agreed to supply
[ * * ] to BRECKENRIDGE (the "Original Supply Agreement");
F. WHEREAS, ANDAPHARM and BRECKENRIDGE desire to agree upon new terms,
whereby ANDAPHARM will supply [ * ] to Breckenridge as set forth
herein, and which shall supercede the Original Supply Agreement; and
NOW, THEREFORE, in consideration of the mutual covenants set forth herein,
the receipt and sufficiency of which are hereby acknowledged, the parties
hereto, each intending to be legally bound, hereby agree as follows:
ARTICLE 1 - DEFINITIONS
1.1 "AFFILIATE" of a party means any Person directly or indirectly controlled
by, controlling or under common control with such party. "CONTROL" means
the legal power to direct or cause the direction of the general management
or policies of a Person through more than fifty percent (50%) of the
ownership of voting securities, by contract or by other means.
1.2 THE PRODUCT(S). The "Product(s)" shall mean the Product(s) listed in
EXHIBIT A. Products(s) may be added to EXHIBIT A by written agreement of
the parties.
1.3 THE FDA. The "FDA" shall mean the United States Food and Drug
Administration.
* PORTIONS OF THIS EXHIBIT HAVE BEEN OMITTED AND FILED SEPARATELY PURSUANT TO AN
APPLICATION FOR CONFIDENTIAL TREATMENT FILED WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 24b-2 UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS
AMENDED.
1.4 PURCHASE TERM. The "Purchase Term" shall mean the [ * ] period that begins
on the date this agreement is signed. In the event that neither party
gives the other written notice [ * ] months prior to the end of the
initial [ * ] Purchase Term, the Agreement shall automatically be extended
for successive [ * ] terms.
1.5 PURCHASE PRICE. The "Purchase Price" shall mean the price per unit as
specified in EXHIBIT A hereof and subject to adjustment in accordance with
Paragraph 2.2.
ARTICLE 2 - SUPPLY & PURCHASE
2.1 MANUFACTURE AND SUPPLY OF PRODUCT. Subject to the terms of this Agreement,
ANDAPHARM shall [ * ] to manufacture, package, and supply the Product
to BRECKENRIDGE, subject to other terms herein. All Products shall be
supplied by ANDAPHARM in accordance with accepted purchase orders received
from BRECKENRIDGE. In consideration of ANDAPHARM's commitments in this
Agreement, BRECKENRIDGE shall purchase from ANDAPHARM the minimum annual
requirement listed on EXHIBIT A, as provided herein. The minimum annual
requirement period shall commence [ * ] [ * ]. In its sole
discretion, BRECKENRIDGE shall be permitted to have the Product
manufactured for and supplied to its Affiliate, who is qualified to
receive the Product and [ * ].
(a) LABELING AND PACKAGING. With the exception of label artwork,
which shall be provided by BRECKENRIDGE, ANDAPHARM shall be solely
responsible for the procuring of materials and API, packaging,
labeling, performing all applicable analytical release testing, and
otherwise preparing for delivery of the Product in accordance with
the specifications agreed upon by the parties, as well as applicable
federal and state regulations, including, without limitation, cGMP's
relating to the FDA. ANDAPHARM shall perform all of the above
services for product samples except for labels, labeling, and
packaging. API shall be ordered from a supplier providing a suitable
Certificate of Analysis demonstrating compliance with the required
Specifications. Andapharm shall be responsible for all costs
relating to [ * ]; however, in the event that Breckenridge requests
more than [ * ], it shall be charged [ * ];
i) [ * ]
ii) [ * ]
(b) DATING. All Product shipped on behalf of BRECKENRIDGE, on the
date of shipment by ANDAPHARM, shall have a shelf-life of at least
[ * ] months, but
* PORTIONS OF THIS EXHIBIT HAVE BEEN OMITTED AND FILED SEPARATELY PURSUANT TO AN
APPLICATION FOR CONFIDENTIAL TREATMENT FILED WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 24b-2 UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS
AMENDED.
2
only if the stability testing results support a minimum of a [ * ]
month shelf-life.
(c) LIMITED EXCLUSIVITY. ANDAPHARM shall not be obligated to, and
will not, manufacture and supply the Product to any third party
during the Term, except to [ * ].
2.2 PURCHASE ORDERS AND PRICE. $ [ * ] of [ * ] as described in Exhibit X.
Xxxxxxxxxxxx shall make all purchases hereunder by submitting to Andapharm
written purchase orders. Each Purchase Order shall be in batch-size
multiples of [ * ] bottles with a minimum [ * ] day delivery date.
Andapharm shall notify Breckenridge within [ * ] days of receipt of
Purchase Order if it cannot fulfill Breckenridge's requirements contained
therein.
The initial purchase prices for the Products purchased under this
Agreement shall be those set forth on EXHIBIT A. The parties agree to
cooperate in adjusting prices due to [ * ]
ANDAPHARM agrees to provide documentation for such costs, if requested by
Breckenridge. [ * ], price increase for the finished-good Product
shall not exceed [ * ]. Any change contemplated herein shall be
mutually agreed upon by the parties hereto and memorialized in a writing
signed by both ANDAPHARM and BRECKENRIDGE. After [ * ] of the Purchase
Term, this Agreement may be terminated by either party with [ * ] days
written notice if a price adjustment cannot be mutually agreed upon and
assuming any such proposed adjustments are commercially reasonable.
2.3 DELIVERY. Delivery shall be [ * ], or to any other location in
[ * * ], no later than the delivery date specified by
BRECKENRIDGE, but, in no event, later than [ * ] days from the date of
manufacture.
2.4 BILLING AND PAYMENT. ANDAPHARM shall invoice BRECKENRIDGE the Purchase
Price for all units in each shipment of Products delivered to
BRECKENRIDGE. Payment terms shall be as per section 2.5.
2.5 PREPAYMENT OF API. Breckenridge agrees to prepay, subject to pricing
fluctuations, the cost of API at [ * ] per [ * ].
ARTICLE 3 - QUALITY AND REGULATORY COMPLIANCE
3.1 QUALITY CONTROL. Each shipment of the Product to BRECKENRIDGE shall be
accompanied by a Certificate of Analysis prepared by an authorized
representative of ANDAPHARM certifying that the Product in the shipment
has been tested in accordance with the specifications for the Product and
was manufactured in compliance with cGMP. ANDAPHARM will send a copy of
the Certificate of Analysis with each shipment to BRECKENRIDGE, and the
original will be filed at ANDAPHARM, but shall be made
* PORTIONS OF THIS EXHIBIT HAVE BEEN OMITTED AND FILED SEPARATELY PURSUANT TO AN
APPLICATION FOR CONFIDENTIAL TREATMENT FILED WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 24b-2 UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS
AMENDED.
3
available to BRECKENRIDGE upon request.
(a) Each lot of the Product shall be manufactured according the
specifications mutually agreed upon between the parties. ANDAPHARM
shall promptly notify BRECKENRIDGE in writing prior to instituting
any changes to the specifications for the Product;
(b) ANDAPHARM shall be permitted to subcontract some portions of the
work contemplated by this Agreement to a third party upon first
obtaining prior written consent from BRECKENRIDGE, which shall not
be unreasonably withheld. Notwithstanding the preceding sentence,
ANDAPHARM shall remain solely responsible for executing and
monitoring the work performed by such subcontractors, including cGMP
compliance of such subcontractor(s), pursuant to the terms of this
Agreement. In addition, ANDAPHARM may subcontract packaging to Xxxx
Pharmaceuticals without the consent of BRECKENRIDGE.
3.2 REJECTION. Provided BRECKENRIDGE provides valid testing methods and
protocols to ANDAPHARM, BRECKENRIDGE may examine and test Products as it
sees fit. If BRECKENRIDGE finds that any lot of the Product, or part
thereof, fails to conform to agreed specifications or other
representations and warranties given by ANDAPHARM herein, then
BRECKENRIDGE will notify ANDAPHARM within [ * ] days of receipt of the
Product, specifying the manner in which all or part of such shipment fails
to meet the required specifications. If BRECKENRIDGE rejects a shipment
before payment is due, [ * ]. If BRECKENRIDGE rejects a shipment after
payment has been made, [ * ].
3.3 RECALLS. If any Product is recalled [ * ], then [ * ] shall bear
all [ * ]. If the recalled Products are to be destroyed and the
recall is due to [ * ] ANDAPHARM, at BRECKENRIDGE's request, shall
[ * ]. If such a recall is due to [ * ], then BRECKENRIDGE shall
[ * ]. In no event shall [ * ] be responsible for any [ * ]
incurred by [ * ]. The parties agree to cooperate in case of a recall
of any of the Products and provide such information as may be necessary to
effectuate the recall and to satisfy any
* PORTIONS OF THIS EXHIBIT HAVE BEEN OMITTED AND FILED SEPARATELY PURSUANT TO AN
APPLICATION FOR CONFIDENTIAL TREATMENT FILED WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 24b-2 UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS
AMENDED.
4
regulatory requests about the recall.
3.4 DISPUTES. If ANDAPHARM disputes BRECKENRIDGE's right to reject all or part
of any shipment of the Products as set forth in Paragraph 3.2 or
BRECKENRIDGE's decision to recall any Product pursuant to paragraph 3.3
hereof (except where requested by FDA to do so), such dispute shall be
resolved by the decision of an independent testing organization or
consultant mutually agreed upon by the parties to act as an arbitrator,
the appointment of which shall not be unreasonably withheld or delayed by
either party. The determination of such entity with respect to all or part
of any shipment of the Products shall be final and binding upon the
parties and enforceable in any court of competent jurisdiction,
[ * ]. The fees and expenses of the third party making the
determination shall be paid by the party against which the determination
is made. If the parties cannot agree to the independent testing
organization or consultant to act as arbitrator within 30 days after
notice of the dispute by either party to the other with a request to
exercise this provision, the parties may proceed with their respective
rights and remedies under Florida law.
3.5 INSPECTION. BRECKENRIDGE shall have the right, at its sole cost and
expense, to enter and inspect Andapharm's premises upon reasonable notice
during normal business hours for the purpose of inspecting the facilities,
procedures and any relevant records relating to the manufacture of Product
(including but not limited to, all batch sheets and records for all
manufacturing steps), during the Term of this Agreement. In addition,
BRECKENRIDGE shall have the right, at its sole cost and expense, to be
present during the manufacture of Product, upon reasonable advance notice
to ANDAPHARM. In the event that any of ANDAPHARM's Facilities used in the
manufacturing of Product hereunder are inspected by representatives of any
U.S. federal, state or local regulatory agency in connection with
ANDAPHARM's manufacture of the Product, ANDAPHARM shall notify
BRECKENRIDGE immediately by telephone, in advance of the inspection when
practicable but in no event later than three (3) days after inspection and
follow up in writing, upon learning of such inspection, and shall supply
BRECKENRIDGE, no later than three (3) days after receipt by ANDAPHARM,
with copies of any reports or responses including, but not limited to any
Form 483s, Establishment Inspection Reports (EIRs), or Warning Letters
prepared by the agency or ANDAPHARM relating to such inspection.
3.6 MANUFACTURING RECORDS. ANDAPHARM shall maintain adequate and accurate
books and records in accordance with FDA requirements. ANDAPHARM agrees
that its quality assurance staff shall review the manufacturing records
for all steps and all lots of Product it manufactures hereunder. Upon
discovery of any deviation from GMP or from any warranty hereunder
ANDAPHARM shall conduct promptly an appropriate investigation to determine
the cause of such deviation and take appropriate action at its expense to
avoid recurrence. ANDAPHARM shall provide a copy of any such investigation
report to BRECKENRIDGE.
* PORTIONS OF THIS EXHIBIT HAVE BEEN OMITTED AND FILED SEPARATELY PURSUANT TO AN
APPLICATION FOR CONFIDENTIAL TREATMENT FILED WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 24b-2 UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS
AMENDED.
5
3.7 REGULATORY AGENCY COMMUNICATION. Each party will promptly notify but in no
event later than [ * ] days of receipt the other party of, and provide the
other party with copies of, any correspondence and/or other documentation
received or prepared by the party in connection with (1) receipt of any
warning letter or other regulatory correspondence from the FDA or any
other regulatory authority in connection with the manufacture, packaging
and storage of the Product; or (2) any recall of the Product; provided
that a party may redact from such communications portions thereof which
the party is required to keep confidential pursuant to binding agreements
with third parties.
3.8 REGULATORY APPROVAL. In the event ANDAPHARM files an application with the
FDA seeking approval for the Product, [ * ].
ARTICLE 4 - REPRESENTATIONS AND WARRANTIES
4.1 JOINT REPRESENTATIONS AND WARRANTIES. Each party represents to the other
that it will not take any action, or fail to take any action, that would
cause a violation of the Federal Food Drug and Cosmetic Act, or any other
Federal, State or local law or regulation during the term of this
contract.
4.2 REPRESENTATIONS AND WARRANTIES OF BRECKENRIDGE. ANDAPHARM is entering into
this Agreement in reliance upon the following express representations and
warranties, each of which is made by BRECKENRIDGE:
(a) NO CONFLICTS. BRECKENRIDGE represents and warrants that neither this
Agreement, nor the carrying out of the terms and conditions that are
contemplated by this Agreement, will violate the rights of any other party
or result in the creation of any right or claim that may adversely affect
BRECKENRIDGE's performance of its obligations under this Agreement.
(b) AUTHORITY. BRECKENRIDGE warrants, represents and covenants that
BRECKENRIDGE has the legal right to enter into this Agreement and perform
its obligations hereunder. In addition, the undersigned signatory for
BRECKENRIDGE represents and warrants that he has been duly authorized to
sign this Agreement on behalf of BRECKENRIDGE and he further represents
that all requisite corporate and partnership action has been taken on the
part of BRECKENRIDGE to approve this Agreement.
(c) REGULATORY COMPLIANCE. BRECKENRIDGE will comply with all applicable
United States and state laws, statutes, rules, and regulations, including
applicable current FDA guidelines. Without limitation, BRECKENRIDGE shall
be responsible for obtaining all necessary permissions and licenses for
the sale and distribution of Product, in accordance with the applicable
United States and state laws, statutes, rules, and
* PORTIONS OF THIS EXHIBIT HAVE BEEN OMITTED AND FILED SEPARATELY PURSUANT TO AN
APPLICATION FOR CONFIDENTIAL TREATMENT FILED WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 24b-2 UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS
AMENDED.
6
regulations;
(d) DEBARMENT. To the best of BRECKENRIDGE's knowledge, it has not and
will not use the services of any persons debarred under 21 U.S.C. Section
335(a) or (b) in any capacity associated with or related to the
manufacture of the Product. BRECKENRIDGE also warrants that neither
BRECKENRIDGE nor any of its officers or employees has been convicted of a
felony under the U.S. federal law for conduct relating to the development
or approval, including the process for development or approval, of any
drug product, new drug application or abbreviated new drug application and
neither BRECKENRIDGE nor any of its officers or employees has been
convicted of a felony under the U.S. federal law for conduct relating to
the regulation of any product under the Federal Food, Drug and Cosmetic
Act. If required, BRECKENRIDGE shall provide for FDA submission a standard
"Debarment Certification" upon request of ANDAPHARM.
4.3 REPRESENTATIONS AND WARRANTIES BY ANDAPHARM. BRECKENRIDGE is entering into
this Agreement in reliance upon the following express representations and
warranties, each of which is made by ANDAPHARM:
(a) NO CONFLICTS. ANDAPHARM represents and warrants that neither this
Agreement, nor the carrying out of the terms and conditions that are
contemplated by this Agreement, will violate the rights of any other party
or result in the creation of any right or claim that may adversely affect
ANDAPHARM's performance of its obligations under this Agreement.
(b) AUTHORITY. ANDAPHARM warrants, represents and covenants that ANDAPHARM
has the legal right to enter into this Agreement and perform its
obligations hereunder. In addition, the undersigned signatory for
ANDAPHARM represents and warrants that he has been duly authorized to sign
this Agreement on behalf of ANDAPHARM and he/she further represents that
all requisite corporate action has been taken on the part of ANDAPHARM to
approve this Agreement.
(c) REGULATORY COMPLIANCE. ANDAPHARM will comply with all applicable
United States and state laws, statutes, rules, and regulations, including
applicable current FDA guidelines, in the performance of work under this
Agreement. Without limitation, ANDAPHARM shall be responsible for
obtaining all necessary permissions and manufacturing licenses for the
manufacture of Product, in accordance with the applicable United States
and state laws, statutes, rules, and regulations;
(d) CGMP COMPLIANCE. All manufacturing under this Agreement will be
conducted in accordance in all respects with cGMP;
(e) DISBARMENT. To the best of ANDAPHARM's knowledge, it has not and will
not use the services of any persons debarred under 21 U.S.C. Section
335(a) or (b) in any capacity associated with or related to the
manufacture of the Product. ANDAPHARM also warrants that neither ANDAPHARM
nor any of its officers or employees has been convicted of a felony under
the U.S. federal law for conduct relating to the
* PORTIONS OF THIS EXHIBIT HAVE BEEN OMITTED AND FILED SEPARATELY PURSUANT TO AN
APPLICATION FOR CONFIDENTIAL TREATMENT FILED WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 24b-2 UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS
AMENDED.
7
development or approval, including the process for development or
approval, of any drug product, new drug application or abbreviated new
drug application and neither ANDAPHARM nor any of its officers or
employees has been convicted of a felony under the U.S. federal law for
conduct relating to the regulation of any product under the Federal Food,
Drug and Cosmetic Act. If required, ANDAPHARM shall provide for FDA
submission a standard "Debarrment Certification" upon request of
BRECKENRIDGE.
4.4 SURVIVAL. The representations and warranties set forth in this Agreement
shall survive any termination or expiration of this Agreement for any
reason for a period of [*] years following any such termination or
expiration. Any claim based in whole or part upon any breach of
representation or warranty must be brought within such [*] period.
ARTICLE 5 - REGULATORY MATTERS
5.1 REGULATORY DOCUMENTATION. ANDAPHARM shall make available for BRECKENRIDGE
to inspect all licenses and permits necessary for BRECKENRIDGE to insure
it has met its regulatory requirements. BRECKENRIDGE may not remove any
documentation from ANDAPHARM without ANDAPHARM's knowledge, and will not
allow any documents marked as confidential to be shown to other parties
without ANDAPHARMs consent; provided such information is not already in
the public domain; known by that party prior to any review, or required to
continue compliance with any regulatory agency.
5.2 PRODUCT COMPLAINTS. Each party shall immediately inform the other in
writing of quality, health or safety related concerns or inquiries that
raise potentially serious and unexpected quality, health or safety
concerns as to any of the Products. All such other information not
involving any of the above shall be transmitted to the other party within
[*] business days following receipt. BRECKENRIDGE shall be responsible for
receiving, recording and responding to all inquiries or complaints from
customers, including alleged adverse drug events relating to the Product.
Each Party agrees to cooperate with the other Party and to provide all
information reasonably necessary to investigate and respond to any such
inquiries or complaints and each Party agrees to keep the other Party
regularly and promptly informed of any complaints it receives relating to
the Product and to notify the other Party of any adverse drug event
reports coming to its attention during the term of this Agreement.
ARTICLE 6 - INDEMNIFICATION
6.1 INDEMNIFICATION. BRECKENRIDGE shall, at its sole cost and expense, defend,
indemnify and hold ANDAPHARM and its affiliates and their respective
officers, directors, agents and employees harmless from and against any
third-party losses, claims, liabilities, obligations, expenses and/or
damages (collectively, "Claim(s)") to the extent that such Claims arise
out of or in connection with, result from, or are caused by: (i)
BRECKENRIDGE or any of BRECKENRIDGE's Personnel's gross negligence,
willful misconduct or fraud in connection with the marketing, sale, or
distribution of the Product as relating to this Agreement; (ii) any breach
by BRECKENRIDGE of any of
* PORTIONS OF THIS EXHIBIT HAVE BEEN OMITTED AND FILED SEPARATELY PURSUANT TO AN
APPLICATION FOR CONFIDENTIAL TREATMENT FILED WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 24b-2 UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS
AMENDED.
8
its representations, terms, obligations, warranties or covenants contained
in this Agreement; (iii) any allegation that any of the Products, or any
aspect thereof, infringes upon or violates any patent, copyright, trade
secret, trademark or other proprietary right of any third party relating
to the marketing, sale, or distribution of the Product as relating to this
Agreement; or (iv); PROVIDED, HOWEVER, that BRECKENRIDGE shall have no
liability or indemnification obligations hereunder to the extent any such
Claim is caused by the gross negligence, willful misconduct or fraud of
ANDAPHARM, its affiliates or their respective officers, directors, agents
and/or employees. Any and all legal-related matters and costs triggered by
this provision shall be undertaken and incurred, respectively, solely
through counsel selected and managed by BRECKENRIDGE, in its sole
discretion, who shall assume sole direction and control of such legal
matters. ANDAPHARM agrees to fully cooperate in the defense of any such
Claims. Breckenridge shall be obligated under this provision so long as
Andapharm notifies Breckenridge within ten (10) days of learning of any
Claims, or cease and desist notices related thereto, which would trigger
Breckenridge's obligations hereunder. The indemnification rights set forth
in this Section 4.4 are in addition to, and shall not limit in any way,
any rights to action or remedies that the parties may have in law or
equity.
6.2 INDEMNIFICATION. ANDAPHARM shall, at its sole cost and expense, defend,
indemnify and hold BRECKENRIDGE and its affiliates and their respective
officers, directors, agents and employees harmless from and against any
third-party losses, claims, liabilities, obligations, expenses and/or
damages (including without limitation reasonable attorneys'
fees)(collectively, "Claim(s)") to the extent that such Claims arise out
of or in connection with, result from, or are caused by: (i) ANDAPHARM or
any of ANDAPHARM's Personnel's gross negligence, willful misconduct or
fraud in connection with the execution and/or performance of this
Agreement, including, without limitation, the manufacturing, packaging,
and supply of the Product; (ii) any breach by ANDAPHARM of any of its
representations, terms, obligations, warranties or covenants contained in
this Agreement; (iii) any allegation that any of the Products, or any
aspect thereof, infringes upon or violates any patent, copyright, trade
secret, trademark or other proprietary right of any third party relating
to the manufacture, packaging, and supply of the Product; PROVIDED,
HOWEVER, that ANDAPHARM shall have no liability or indemnification
obligations hereunder to the extent any such Claim is caused by the gross
negligence, willful misconduct or fraud of BRECKENRIDGE, its affiliates or
their respective officers, directors, agents and/or employees. Any and all
legal-related matters and costs triggered by this provision shall be
undertaken and incurred, respectively, solely through counsel selected and
managed by ANDAPHARM, in its sole discretion, who shall assume sole
direction and control of such legal matters. BRECKENRIDGE agrees to fully
cooperate in the defense of any such Claims. Andapharm shall be obligated
under this provision so long as Breckenridge notifies Andapharm within ten
(10) days of learning of any Claims, or cease and desist notices related
thereto, which would trigger Andapharm's obligations hereunder. The
indemnification rights set forth in this Section 4.5 are in addition to,
and shall not limit in any way, any rights to action or remedies that the
parties may have in law or equity.
* PORTIONS OF THIS EXHIBIT HAVE BEEN OMITTED AND FILED SEPARATELY PURSUANT TO AN
APPLICATION FOR CONFIDENTIAL TREATMENT FILED WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 24b-2 UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS
AMENDED.
9
6.3 INSURANCE.
(a) ANDAPHARM represents and warrants that it has obtained and shall
at all times during the term of this Agreement maintain at its own cost
and expense, in respect to its performance hereunder: (a) [ * ];
(b) worker's compensation insurance in accordance with the statutory
requirements of Florida; and (c) [ * ].
(b) BRECKENRIDGE represents and warrants that it has obtained and
shall at all times maintain at its own cost and expense [ * ]
Breckenridge will supply ANDAPHARM with a certificate of insurance to
evidence such coverage, upon request.
6.4 LIMITATION OF LIABILITY. The liability of either party to the other for
any claim arising out of contract, negligence or strict liability in tort,
or any other claim relating to this Agreement, shall be limited to the
actual damages suffered or incurred by a party. Except for indemnification
for infringement and the cost of cover, in no event shall either party be
liable for incidental or consequential damages, loss of business or
profits, special or indirect damages of any nature whatsoever even if it
has been advised of the possibility of such damages. The limitations of
liability stated in this Agreement form an essential basis of the bargain
between the parties and apply regardless of whether any limited remedy
hereunder fails of its essential purpose. Nothing herein shall limit any
right of recovery under any policy of insurance or any bond.
ARTICLE 7 - TERMS, TERMINATION
7.1 TERM. This Agreement shall become effective as of the date first written
above and shall remain in full force and effect through the end of the
Purchase Term, or until earlier terminated as provided herein.
7.2 TERMINATION. This Agreement may be terminated at any time:
(a) by either party if the other party fails to remedy and make good any
default in the performance of any condition or obligation under this
Agreement within [ * ] days of the date a written notice of default
is sent to the defaulting party thereof, (OTHER THAN THE FAILURE TO
PAY ANY AMOUNT DUE UNDER THIS AGREEMENT, FOR WHICH [ * ] NOTICE
SHALL BE AVAILABLE EXCEPT AS PROVIDED ELSEWHERE.);
(b) by either party upon bankruptcy or insolvency of the other party or
placing of the business of such party in receivership;
* PORTIONS OF THIS EXHIBIT HAVE BEEN OMITTED AND FILED SEPARATELY PURSUANT TO AN
APPLICATION FOR CONFIDENTIAL TREATMENT FILED WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 24b-2 UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS
AMENDED.
10
(c) by BRECKENRIDGE upon providing written notice to ANDAPHARM, if
BRECKENRIDGE and/or ANDAPHARM are prohibited by Federal or State law
or order from manufacturing or distributing the Products.
(d) by ANDAPHARM in accordance with Article 3.8;
(e) by either party if a price adjustment cannot be mutually agreed upon
in accordance with Article 2.2.
7.3 WAIVER. Failure to terminate this Agreement following a breach or failure
to comply with the terms and conditions of this Agreement shall not be
deemed a waiver of the non breaching party's defenses, rights or causes of
action arising from such or any future breach or noncompliance.
ARTICLE 8 - ASSIGNMENT
8.1 ASSIGNMENT. This Agreement may not be assigned by BRECKENRIDGE or
ANDAPHARM or the obligations of BRECKENRIDGE and ANDAPHARM delegated
hereunder without the prior written consent of BRECKENRIDGE or ANDAPHARM,
which shall not be unreasonably withheld. Notwithstanding the foregoing,
BRECKENRIDGE or ANDAPHARM may assign any or all of its rights and
obligations under this Agreement, without obtaining the other's consent,
only in the event of the merger or consolidation of BRECKENRIDGE or
ANDAPHARM with another entity or the purchase by another entity of all or
substantially all of the assets of BRECKENRIDGE or ANDAPHARM.
Notwithstanding the foregoing, this Agreement shall survive the merger or
consolidation of BRECKENRIDGE or ANDAPHARM with another entity or the
purchase by another entity of all or substantially all of the assets of
BRECKENRIDGE or ANDAPHARM and BRECKENRIDGE and ANDAPHARM agrees to give
each other thirty (30) days' notice of any such merger, consolidation or
purchase, if and to the extent it may do so under applicable securities
laws.
ARTICLE 9 - FORCE MAJEURE
9.1 FORCE MAJEURE. No failure or omission by the parties in the performance of
any obligation according to this Agreement shall be deemed a breach of
this Agreement or create any liability if the same shall arise from any
cause or causes beyond the control of the party, including, but not
limited to, strikes, riots, war, acts of terrorism, acts of God, invasion,
fire, explosion, floods, delay of carrier, shortage or failure in the
supply of materials, energy shortage and acts of government or
governmental agencies or instrumentalities.
9.2 OBLIGATIONS OF THE PARTIES IN CASE OF FORCE MAJEURE. In the event that due
to force majeure either party hereto shall be delayed or hindered in or
prevented from the performance of its duties or doing acts required under
the terms of this Agreement, the performance of such act, except for the
obligation to pay amounts due under this Agreement, shall be excused for
the period of the delay but in no event longer than 6 months, at which
time any party may terminate the agreement. Notwithstanding the
aforementioned, the party subject to force majeure shall take all
reasonable steps to
* PORTIONS OF THIS EXHIBIT HAVE BEEN OMITTED AND FILED SEPARATELY PURSUANT TO AN
APPLICATION FOR CONFIDENTIAL TREATMENT FILED WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 24b-2 UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS
AMENDED.
11
resolve the condition(s) forming the basis of force majeure.
ARTICLE 10 - MISCELLANEOUS
10.1 GOVERNING LAW. This Agreement shall be governed by, and construed in
accordance with, the laws of the State of Florida (without regard for
conflict rules thereof) and the United States.
10.2 SEVERABILITY. Should any section, or portion, of this Agreement be held
invalid by reason of any law, statute or regulation existing now or in the
future in any jurisdiction by any court of competent authority or by
legally enforceable directive of any governmental body, then such section
or portion thereof shall be validly reformed so as to approximate the
intent of the parties as nearly as possible and, if unreformable, shall be
deemed divisible and deleted with respect to such jurisdiction; this
Agreement shall not otherwise be affected.
10.3 ENTIRE AGREEMENT. The terms and provisions contained in this Agreement,
including the Exhibits hereto, constitute the entire agreement between the
parties and shall supersede all previous communications, representations,
agreements or understandings, either oral or written, between the parties
with respect to the subject matter hereof, including the Original Supply
Agreement. No agreement or understanding varying or extending this
Agreement shall be binding upon either party hereto, unless set forth in a
writing which specifically refers to this Agreement, signed by duly
authorized officers or representatives of the respective parties, and the
provisions hereof not specifically amended thereby shall remain in full
force and effect. By execution of this agreement, the parties further
agree to waive and release all claims, unknown or unknown, it had or may
have had against the other party relating to the Original Supply
Agreement.
10.4 WAIVER. The rights and remedies of the parties to this Agreement are
cumulative and not alternative. Neither the failure nor any delay by any
party in exercising any right, power or privilege under this Agreement
will operate as a waiver of any such right, power or privilege, and no
single or partial exercise of any such right, power or privilege will
preclude any other or further exercise of such right, power or privilege
or the exercise of any other right, power or privilege.
10.5 NOTICES. All notices hereunder shall be deemed to have been delivered if
by certified mail, return receipt requested, or if sent by facsimile, as
follows.
If to BRECKENRIDGE:
Breckenridge Pharmaceutical, Inc.
00 Xxxxxxxx Xxxxx
Xxxxx 000
Xxxxxx, XX 00000
ATTN: General Counsel
With Copy to VP Business Development
If to ANDAPHARM:
* PORTIONS OF THIS EXHIBIT HAVE BEEN OMITTED AND FILED SEPARATELY PURSUANT TO AN
APPLICATION FOR CONFIDENTIAL TREATMENT FILED WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 24b-2 UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS
AMENDED.
12
ANDAPHARM LLC
0000 XX 00xx Xxxxxxx
Xxxx Xxxxxxxxxx, Xxxxxxx 00000
ATTN: Xxxxxxx X. Xxxxx, III, Esquire
With a copy to Xxxxxx Xxxxxxx, CFO and Xxxx Xxxxxxx, Vice President,
Business Development
10.6 SURVIVAL. The provisions of Xxxxxxxxx 0, Xxxxxxxxx 6 & 10 of the Agreement
shall survive the termination of this Agreement.
10.7 COUNTERPARTS. This Agreement may be executed in two or more counterparts,
each of which will be deemed to be an original of this Agreement and all
of which, when taken together, shall be deemed to constitute one and the
same agreement. Any party to this Agreement may deliver an executed copy
hereof by facsimile transmission, including via PDF/email, to another
party hereto and any such delivery shall have the same force and effect as
any other delivery of a manually signed copy of this Agreement.
10.8 EXHIBITS, SCHEDULES. Any exhibits and schedules to this Agreement are
hereby incorporated by reference into and made a part of this Agreement.
10.9 SIGNATURE WARRANTY. It is understood and agreed by the Parties that each
represents and warrants to the other that the individual signing this
Agreement on behalf of the Party is their duly authorized representative
and that such individual's signature binds the Party represented to the
terms of this Agreement.
10.10 ARBITRATION. Any and all disputes or claims arising or out of this
Agreement shall be resolved by binding arbitration utilizing the American
Arbitration Association and under the American Arbitration Association's
commercial industry rules and to be held in the State of Florida. The
decision of any arbitration panel shall be binding on the parties and
enforceable in any court of competent jurisdiction
IN WITNESS WHEREOF, the parties hereto have caused this Agreement to be
executed by their duly authorized officers on the day and year first set forth
above.
ANDAPHARM LLC BRECKENRIDGE PHARMACEUITCAL, INC.
By: /s/ Xxxxxx Xxxxxxx By: /s/ Xxxxx X. Xxxxxx
------------------------------ ----------------------------
Name: Xxxxxx Xxxxxxx Name: Xxxxx X. Xxxxxx
Title: Chief Financial Officer Title: Vice President Business Development
Dated: Dated: 2/29/08
* PORTIONS OF THIS EXHIBIT HAVE BEEN OMITTED AND FILED SEPARATELY PURSUANT TO AN
APPLICATION FOR CONFIDENTIAL TREATMENT FILED WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 24b-2 UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS
AMENDED.
13
EXHIBIT A
--------------------------------------------------------------------------------
PRODUCT DESCRIPTION AND SPECIFICATION
--------------------------------------------------------------------------------
[
*
]
* PORTIONS OF THIS EXHIBIT HAVE BEEN OMITTED AND FILED SEPARATELY PURSUANT TO AN
APPLICATION FOR CONFIDENTIAL TREATMENT FILED WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 24b-2 UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS
AMENDED.
14
--------------------------------------------------------------------------------
PRICING AND MINIMUM QUANTITIES
--------------------------------------------------------------------------------
[
*
]
* PORTIONS OF THIS EXHIBIT HAVE BEEN OMITTED AND FILED SEPARATELY PURSUANT TO AN
APPLICATION FOR CONFIDENTIAL TREATMENT FILED WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 24b-2 UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS
AMENDED.
15
EXHIBIT B
------------------
------------------
PURCHASE ORDER
------------------
-----------------
P/O NUMBER PAGE
[LOGO] BRECKENRIDGE PHARMACEUTICAL, INC. -----------------
0000 Xxxxx Xxxxxx Xxxxxx, Xxxxx 0
Xxxx Xxxxx, XX 00000 ----------------------------------
000-000-0000 fax 000-000-0000 P/O DATE ORDER TYPE CHANGE/CANCEL
----------------------------------
ORDERED SHIP
FROM TO
--------------------------------------------------------------------------------
BUYER TERMS ACKNOW- CONFIRM FOB SHIP VIA COL/
LEDGE PPD
--------------------------------------------------------------------------------
--------------------------------------------------------------------------------
LINE QUANTITY
NO. ORDERED OUR ITEM NUMBER YOUR ITEM PRICE/ REQUESTED CHANGE
BLANKET TYPE U/M DESCRIPTION/COMMENTS NUMBER UNIT DATE CANCEL
--------------------------------------------------------------------------------
--------------------------------------------------------------------------------
COMMENTS
--------------------------------------------------------------
ORDERED BY -----------------------------------------
* PORTIONS OF THIS EXHIBIT HAVE BEEN OMITTED AND FILED SEPARATELY PURSUANT TO AN
APPLICATION FOR CONFIDENTIAL TREATMENT FILED WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 24b-2 UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS
AMENDED.
16
