AGREEMENT
This Agreement made and effective this 7th day of December 1996, (the
"Effective Date"), by and between ALTANA INC., a New York corporation having
offices at 00 Xxxxxx Xxxx, Xxxxxxxx, Xxx Xxxx 00000, hereinafter referred to as
"Altana") and FLEMINGTON PHARMACEUTICAL CORP., a corporation with offices at 00
Xxxxx Xxxxxx, Xxxxxxxxxx, Xxx Xxxxxx 00000 (hereinafter referred to as
"Flemington").
WHEREAS, Flemington is a pharmaceutical company engaged in the
development of various products, including a nitroglycerin lingual spray; and
WHEREAS, Altana is a pharmaceutical company which markets a
nitroglycerin topical ointment under the name Nitrol; and Altana desires to
obtain the exclusive rights to market Flemington's nitroglycerin lingual spray
product in the United States; and
WHEREAS, Flemington desires to grant such exclusive rights to Altana;
NOW, THEREFORE, in consideration of the mutual covenants herein
contained, Flemington and Altana agree as follows:
1. Definitions.
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(a) Product means Nitroglycerin in a glass spray
canister, which is in compliance with the specifications to be set forth by
mutual agreement of the parties in an ANDA, defined below, and for which the
approval of the United States Food and Drug Administration (FDA) ultimately
grants approval.
(b) ANDA means an Abbreviated New Drug Application for
the Product, to be prepared by Flemington and delivered by it to Altana for
filing in Altana's name with FDA.
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(c) Acceptance For Filing means that FDA has accepted the
ANDA for the Product and an application number has been assigned by FDA to the
ANDA.
(d) FDA Approval means approval by FDA of the ANDA for
the Product, authorizing the manufacture of the Product by Flemington's contract
manufacturer and its marketing and sale within the Territory by Altana.
(e) Territory means the United States of America,
including the Commonwealth of Puerto Rico and the Territory of the Virgin
Islands.
(f) CGMP means current Good Manufacturing Practices, as
promulgated and enforced by FDA pursuant to regulations adopted from time to
time under authority of the Food, Drug and Cosmetics Act (the Act), detailing
requirements for licensed manufacturing facilities.
2. Grant.
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(a) During the Term of this Agreement, subject to the
terms and conditions set forth herein, Altana shall have exclusive rights to
sell and distribute the Product within the Territory.
(b) The ANDA shall be filed showing Altana as the sole
applicant, and it is the Parties' intent that the approved ANDA shall continue
throughout the Term of the Agreement to be in the sole name of Altana.
(c) Nothing in this Agreement shall be construed to grant
any license to Altana to manufacture the Product under any inventions, secret
formula(e), secret process(es) or other confidential or secret information owned
or controlled by Flemington or Rapid Spray, whether or not patented, relating to
the Product or its manufacture.
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3. Registration.
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(a) Promptly following execution of this Agreement by the
Parties, shall proceed diligently to prepare an ANDA for the Product in a
canister containing approximately 200 doses (spray activations) of the active
ingredient and deliver the same to Altana for filing by it with FDA.
(b) Altana shall be kept fully informed by Flemington of
the progress of the preparation of the ANDA, and Altana's regulatory affairs
personnel shall have full opportunity for review of and input on the form and
contents of the ANDA.
(c) Following acceptance of the filing of the ANDA by
FDA, and the completion of development, including necessary stability testing,
of a second size of canister to contain approximately 300 doses, Flemington
shall prepare and submit to Altana for filing with FDA an Amendment to the ANDA
also seeking approval for the second size canister.
(d) Following filing, Flemington shall provide Altana
with all necessary support in responding to any requests from FDA for additional
information or data.
(e) The Parties agree that their mutual intent is that no
in vivo bioequivalency study for the Product is to be carried out or included in
the ANDA. Rather, it is their intent that the ANDA will contain a request,
pursuant to 21 CFR 320.22(a) and 21 CFR 320.22(b)(5) for a waiver of the
requirement of an in vivo bioequivalence study on the grounds that the Product
for which approval is being sought is (a) an oral solution; (b) its active drug
ingredient is in the same concentration as the FDA-approved nitroglycerin spray
product being marketed by Xxxxx-Xxxxxxx Xxxxxx; and (c) it contains no inactive
ingredient known to significantly affect absorption of the active drug
ingredient.
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4. Payments.
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(a) Altana shall pay to Flemington for the Product rights
granted herein, the following amounts:
(i) upon execution of this Agreement $ 12,500.00
(ii) upon Acceptance For Filing of the ANDA
$ 12,500.00
(iii) upon FDA Approval of the ANDA $250,000.00
(b) If FDA shall refuse to file the ANDA as submitted, or
if the ANDA shall be filed but then either be disapproved by FDA or FDA should
demand submission of additional data which the parties are unable to satisfy,
Flemington shall be under no obligation to return to Altana funds paid pursuant
to Paragraphs 4(a)(i) or (ii), or both, above. Notwithstanding anything to the
contrary in this Paragraph 4(b), if FDA files the ANDA and subsequently demands
in vivo bioequivalence testing, any funds paid pursuant to 4(a)(ii) will be
refunded to Altana.
(c) Altana shall reimburse Flemington for the costs of
all stability testing for the 300-spray canister subsequently to be added to the
ANDA via Amendment.
5. Orders.
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(a) Altana shall purchase all of its requirements for
Product exclusively from Flemington.
(b) Altana shall submit to Flemington an annual forecast,
on a month-by-month basis, of its requirements of Product, commencing upon
evidence of imminent approval of the ANDA. Such forecast shall be revised on an
annual basis and shall not be binding on either Altana or Flemington.
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(c) From time to time, but at least 90 days prior to the
specified delivery date, Altana shall submit firm purchase orders setting forth
quantities, delivery dates and shipping instructions.
(d) Firm purchase orders for Product submitted by Altana
to Flemington shall automatically be deemed accepted if it is within 150% of
Altana's forecasted requirements for Product in the month of requested delivery.
Flemington shall exercise its best efforts to accommodate Altana if purchase
orders exceed the 150% of the forecasted amount.
(e) The minimum order quantity for any single order is
20,000 units.
6. Price.
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(a) The Price to be paid by Altana to Flemington shall be
$4.50 per 200 spray of Product, packaged in individual packages with a label of
Altana's design affixed to the exterior of the canister and each individual
canister in its own container with an insert or outsert.
(b) The Parties shall agree upon a reduction in price if
Altana elects to perform the final packaging.
(c) The price for the 300 spray canister shall be agreed
upon by the Parties.
(d) It is the intent of the Parties that both Flemington
and Altana be able to maintain reasonable gross margins on sales. The Parties
recognize, however, that unanticipated market, regulatory or other conditions
may adversely impact either Flemington's cost of goods or the price at which
Altana can sell the Product, and that both of the Parties may not be able to
maintain their presently anticipated respective margins. In that case, the
Parties agree to negotiate pricing with the intent of producing an outcome which
is fair and equitable to both Parties. If the Parties are unable to resolve
pricing to their mutual satisfaction, the Party raising
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the subject may submit the issue to Arbitration as elsewhere provided in this
Agreement; the arbitrators, however, shall be directed to honor the Parties'
mutual expectation of a reciprocal opportunity to earn a fair profit.
(e) Payment shall be made in United States dollars 30
days from the date of invoice.
(f) The Product will be shipped F.O.B. site of
manufacture.
7. Trademarks and Labeling.
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(a) Before initial production, Altana shall provide
Flemington with "camera-ready" artwork (which may be in agreed-upon electronic
form) for the label to be affixed to each individual canister of Product, for
the outer package, and for the package insert (or outsert).
(b) Altana and Flemington agree that trademarks used on
the Product manufactured for Altana under this Agreement are the exclusive
property of Altana and Flemington shall have no rights thereto. Upon
termination, Flemington agrees that it will not use any Altana trademark.
8. Specifications.
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(a) Product sold to Altana hereunder shall meet the
specifications set forth in Exhibit A hereto (the "Specifications"). Altana
shall examine the Product within sixty (60) days after receipt. if the Product
does not meet the Specifications, Altana shall immediately notify Flemington.
Product which does not meet the Specifications shall be returned to Flemington
at Flemington's expense and the purchase price therefor credited to Altana's
account. Any such Product shall be replaced by Flemington as promptly as
possible.
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(b) Altana shall have the option, with respect to any lot
of Product, to rely upon a certificate of analysis issued by Flemington or its
contract manufacturer, upon the basis of testing performed by Flemington or its
contract manufacturer. Flemington shall send or cause to be sent such
certificate of analysis for each lot of Product delivered to Altana.
(c) If the alleged defect is an issue of chemistry, any
dispute between the Parties as to whether or not Product is defective shall be
referred by them to a mutually acceptable independent laboratory. If the alleged
defect is something other than chemistry, any dispute between the Parties as to
whether or not Product is defective shall be referred by them to a mutually
acceptable industry expert. The cost of the laboratory (including the cost of
assays and any other services) or the expert's fees, as applicable, shall be
borne by the Party whose position was found to be in error.
9. Warranties and Indemnification.
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(a) Flemington warrants that all Product delivered to
Altana pursuant to this Agreement will at the time of such delivery not be
adulterated or misbranded within the meaning of the Act, as amended, or within
the meaning of any applicable state or municipal law in which the definitions of
adulteration or misbranding are substantially the same as that contained in the
Act, as such Act and such laws are constituted and effective at the time of
delivery and will not be an article which may not, under the provisions of such
Act, be introduced into interstate commerce. Notwithstanding anything to the
contrary in this paragraph, Flemington's warranty hereunder does not extend to
any packaging or labeling provided by, or which is the responsibility of,
Altana.
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(b) Flemington represents and warrants to Altana that
neither the importation of Product into the Territory, nor the sale and
distribution of Product by Altana within the Territory, will infringe upon the
right of any other person, including, without limitation, any patent
infringement.
(c) Flemington hereby indemnifies Altana and undertakes
to hold it harmless against all damages, costs and expenses incurred as a result
of any claims or suits arising solely out of the sale by Altana of Product
(whether in the nature of product liability, patent infringement or otherwise)
sold by Flemington or its contract manufacturer, without any action by Altana
subsequent to delivery of Product contributing thereto; provided that prompt
notice is given to Flemington of any such claim or suit, and provided further
that Flemington shall have the option to undertake and conduct the defense of
any suit so brought, and that no settlement of any such claim or suit is made
without the advance written consent of Flemington to the fact and terms of such
settlement.
10. Term and Termination.
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(a) The term of this Agreement shall be the market life
of the Product.
(b) This Agreement, and the rights and obligations of the
Parties under it (other than those which may have become vested before
termination) may be terminated:
(1) Without action by either Party if FDA
refuses to file the ANDA without a supporting bioequivalence
study or demands such study to complete the review of the
ANDA.
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(2) Without action by either Party if FDA, in a
final agency action, denies approval and the Parties do not
elect jointly to appeal that denial.
(3) By written notice from one Party to the
other if the Party to which the notice is directed is in
material breach of its obligations under this Agreement, in
which case termination shall become effective 60 days after
the date of giving of the notice, unless the breach has been
cured within that period.
(4) By Altana if the importation, manufacture or
distribution of Product within the Territory is determined to
infringe upon the right(s) of a third party, in which case,
Flemington shall reimburse any monies paid to it by Altana
under Paragraph 4(a) of this Agreement.
(5) By Flemington if Altana shall discontinue
selling the Product within the Territory.
(c) if this Agreement shall be terminated by Flemington
pursuant to Paragraph 10(b)(3), above, Altana agrees, upon written request of
Flemington, to transfer the ANDA to Flemington, and to execute any documents
necessary to effect such transfer with FDA, at no cost to Flemington,
11. Physician or Consumer Adverse Reaction Reports Complaints and/or
Inquiries.
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Flemington and Altana agree that Altana shall be primarily responsible
for responding to all consumer and/or physician adverse reaction reports,
inquiries and/or complaints
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regarding use of the Product. Where Altana is unable to provide an adequate
response to a consumer and/or physician inquiry for any reason, Altana shall
seek the advice of Flemington. Flemington agrees to promptly respond to Altana's
request for advice so that Altana may maintain its record of prompt response to
all consumer and/or physician reports, complaints, or inquiries. In the event of
consumer and/or physician inquiries or complaints concerning the physical
attributes of the Product, Flemington agrees to provide Altana with all
necessary information to provide an appropriate response. In the event consumer
and/or physician complaints identify a troublesome trend regarding Product
quality, Altana and Flemington agree to cooperate fully in the investigation and
resolution of any problem which might be identified.
12. Recall.
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In the event (a) any government authority issues a request, directive
or order that the Product be recalled, or (b) a court of competent jurisdiction
orders such a recall, or (c) Altana reasonably determines after consultation
with Flemington that the Product should be recalled, the Parties shall take all
appropriate corrective actions. In the event that such recall results from any
cause or event arising from a failure of the Product to meet its specifications,
or a breach of Flemington's warranties set forth in this Agreement, Flemington
shall be responsible for all expenses of the recall.
13. Confidentiality.
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Any and all information, data or know-how received by one Party from
the other shall be maintained in confidence by the Party which receives it. Upon
expiration or earlier termination of this Agreement all such information
(together with any and all writings or copies which may contain it) shall be
returned to the disclosing Party upon request. Failure to request
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return of any such information shall not be construed as in any way releasing
the obligation of the recipient to maintain its confidentiality. The obligation
set forth herein shall not apply to information which: (a) the recipient can
show by clear and convincing evidence was already known to it before disclosure;
(b) is or comes into the public domain through no act or omission of the
recipient; (c) becomes known or available through a third party not under any
obligation of confidentiality to the recipient; or, (d) is required to be
disclosed pursuant to judicial process or order, or the disclosure of which is
necessary for Federal or State regulatory approval or compliance.
14. Assignment.
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This Agreement may not be assigned by Altana, except to a parent,
subsidiary or of Altana or to an entity acquiring all or substantially all of
Altana's assets, without the consent of Flemington, which consent shall not be
withheld unreasonably.
15. Miscellaneous Provisions.
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(a) The performance by either Party of any obligation
under this Agreement, other than an obligation to pay money, shall be excused
for any reason customarily regarded as constituting force majeure.
(b) Except as may otherwise be expressly authorized in
writing, neither Party shall have, hold itself out as having, any power or
authority to bind the other.
(c) This Agreement may only be amended, modified or
supplemented by a writing specifically identifying itself as such, which writing
must be executed with the same formality as this Agreement. Any party or person
asserting that this requirement of a writing for
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such a purpose was waived orally shall have the burden of proving the fact of
such a waiver by clear and convincing evidence.
(d) Any formal notice or communication from one Party to
the other pursuant to this Agreement (which is not intended by the Parties to
include ordinary day-to-day business communications) shall be sent by the giver
to the receiver in writing via fax, with confirming copies via both ordinary and
certified mail.
(e) This Agreement is to be controlled by and interpreted
in accordance with State of New Jersey.
(f) Any dispute between the Parties shall be resolved by
arbitration pursuant to the rules and under the auspices of the American
Arbitration Society. The place of arbitration shall be in the Borough of
Manhattan, New York City, New York, unless otherwise mutually agreed.
(g) This Agreement is intended by the Parties to be an
integrated document and to express their entire agreement regarding its subject
matter. Any other, earlier or inconsistent statements or expressions, written or
oral, as to the subject matter are expressly superseded.
(h) This Agreement is to be executed in multiple
counterparts. Any one of such counterparts bearing original signatures, or any
two counterparts which taken together bear the original signatures of both
Parties, shall be deemed to be an original of this Agreement.
(i) The headings used in this Agreement are for
convenience only and are not a part of the Agreement.
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IN WITNESS WHEREOF, the undersigned authorized representative of the
Parties have signed this Agreement effective the date set forth above.
FLEMINGTON PHARMACEUTICAL CORP ALTANA INC.
By: /s/ By: /s/
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