1
Certain confidential portions of this Exhibit were omitted by means of blackout
of the text (the "Xxxx"). This Exhibit has been filed separately with the
Secretary of the Commission without the Xxxx pursuant to the Company's
Application Requesting Confidential Treatment under Rule
406 under the Securities Act.
EXHIBIT 10.9
EXCLUSIVE LICENSE AGREEMENT
by and between
ANTHRA PHARMACEUTICALS, INC.
and
PRODESFARMA, S.A.
Dated as of April 17, 1997
2
TABLE OF CONTENTS
Page
----
ARTICLE I
DEFINITIONS............................................................. 2
ARTICLE II
PRODUCT DEVELOPMENT..................................................... 6
2.1 Clinical Studies............................................. 6
2.2 Registrations and Approvals.................................. 7
2.3 Pricing and Reimbursement.................................... 7
ARTICLE III
SUPPLY OF THE PRODUCT................................................... 8
3.1 Anthra Obligation............................................ 8
3.2 Good Faith Forecasts......................................... 8
3.3 Firm Forecasts............................................... 9
3.4 Purchase Orders.............................................. 9
3.5 Delivery..................................................... 10
3.6 Inability to Supply.......................................... 10
3.7 Warranty..................................................... 11
3.8 Price........................................................ 11
3.9 Specifications Amendments.................................... 12
3.10 Records...................................................... 12
ARTICLE IV
MARKETING AND SALE OF THE PRODUCT....................................... 12
4.1 Prodesfarma Obligation....................................... 12
4.2 Compliance................................................... 13
4.3 Trademarks................................................... 13
4.4 Price of the Product......................................... 13
4.5 Marketing Materials.......................................... 14
4.6 Product Liability Insurance.................................. 14
4.7 Competition.................................................. 14
ARTICLE V
LICENSE GRANTS.......................................................... 15
5.1 Grants....................................................... 15
5.2 Sublicenses.................................................. 15
ARTICLE VI
LICENSE FEES............................................................ 16
6.1 License Fees................................................. 16
6.2 Payment of License Fees...................................... 16
6.3 Royalties.................................................... 17
6.4 Withholding Taxes............................................ 17
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Page
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ARTICLE VII
EXECUTIVE MANAGEMENT COMMITTEE.......................................... 17
7.1 Formation of the EMC......................................... 17
7.2 Authority of the EMC......................................... 18
7.3 Procedural Rules of the EMC.................................. 19
ARTICLE VIII
REPORTING............................................................... 20
8.1 Reporting by Parties......................................... 20
8.2 Record Keeping............................................... 20
8.3 Audit of Records............................................. 20
ARTICLE IX
ADVERSE EVENT AND OTHER INFORMATION EXCHANGE............................ 21
9.1 Notification................................................. 21
9.2 Material Communications...................................... 21
ARTICLE X
PRODUCT RECALL.......................................................... 22
10.1 Notification and Recall...................................... 22
10.2 Recall Expenses.............................................. 23
ARTICLE XI
INTELLECTUAL PROPERTY RIGHTS............................................ 23
11.1 Ownership of Licensed Know-how............................... 23
11.2 Ownership of Filings and Approvals........................... 24
11.3 Ownership of Data............................................ 24
11.4 Enforcement of Intellectual Property Rights.................. 24
11.5 Cooperation.................................................. 25
ARTICLE XII
CONFIDENTIALITY......................................................... 25
12.1 Confidential Information..................................... 25
12.2 Disclosure of Confidential Information....................... 26
12.3 Use of Names................................................. 27
ARTICLE XIII
WARRANTIES; INDEMNITIES................................................. 27
13.1 Representations and Warranties............................... 27
13.2 Warranties of Anthra......................................... 28
13.3 Indemnification of Prodesfarma............................... 29
13.4 Indemnification of Anthra.................................... 29
13.5 Indemnification Procedure.................................... 29
2
4
ARTICLE XIV
TERM AND TERMINATION.................................................... 31
14.1 Term........................................................ 31
14.2 Termination for Material Breach............................. 32
14.3 Termination for Breach of Investment Agreement.............. 32
14.4 Unilateral Termination by Prodesfarma or Anthra............. 33
14.5 Termination for Other Events................................ 33
14.6 Effect of Expiration or Termination......................... 34
14.7 Survival of Licenses and Royalty Obligations;
Assignment of Registrations and Trademarks.................. 35
ARTICLE XV
GENERAL PROVISIONS...................................................... 36
15.1 Force Majeure............................................... 36
15.2 Notice...................................................... 36
15.3 Further Assurances.......................................... 37
15.4 Successors and Assigns...................................... 38
15.5 Governing Law............................................... 38
15.6 Arbitration................................................. 38
15.7 Severability................................................ 39
15.8 Counterparts................................................ 40
15.9 Captions.................................................... 40
15.10 Independent Contractors..................................... 40
15.11 Entire Agreement............................................ 41
ANNEX A................................................................. 42
ANNEX B................................................................. 44
ANNEX C................................................................. 45
3
5
THIS EXCLUSIVE LICENSE AGREEMENT (this "Agreement"), is made as of
April 17, 1997, by and between Anthra Pharmaceuticals, Inc., a corporation
organized under the laws of the State of Delaware, U.S.A, having its principal
business office at 00 Xxxxxx Xxxx, Xxxxxxxxx, X.X. 00000, X.X.X. ("Anthra"), and
Prodesfarma, S.A., a corporation organized under the laws of Spain, having its
principal business office at Xxxxx xxx Xxxx Xxxxxx 0, 00000 Xxxx Xxxx Xxxxxxx,
Xxxxxxxxx, Xxxxx ("Prodesfarma"),
WITNESSETH:
WHEREAS, Anthra has developed certain proprietary know-how and data
with respect to N-Trifluoroacetyladriamycin-14 valerate, a doxorubicin
derivative ("AD 32"),
WHEREAS, Anthra intends to secure the regulatory approvals required
in order to promote, market and sell AD 32 in Spain and Portugal (collectively,
the "Territory"),
WHEREAS, Prodesfarma has considerable experience in the promotion,
marketing and sale of pharmaceutical products in the Territory, and has in place
a large and experienced marketing staff that can expedite the distribution of AD
32 in the Territory, and
WHEREAS, Prodesfarma desires to obtain an exclusive license from
Anthra to promote, market and sell AD 32 in the
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Territory, and Anthra desires to grant such a license, on the terms set forth
herein;
WHEREAS, as an inducement to Anthra to enter into this Agreement,
Prodesfarma has entered into that certain Series D Convertible Preferred Stock
Purchase Agreement of even date herewith;
NOW, THEREFORE, the parties agree as follows:
ARTICLE I
DEFINITIONS
1.1 "AD 32" shall have the meaning set forth in the preamble hereto.
1.2 "Affiliate" of a person shall mean any corporation, partnership
or other entity that directly, or indirectly through one or more intermediaries,
controls, is controlled by or is under common control with such person.
"Control" and, with correlative meanings, the terms "controlled by" and "under
common control with" shall mean the power to direct or cause the direction of
the management or policies of a person, whether through the ownership of voting
securities, by contract, resolution, regulation or otherwise.
1.3 "Anthra" shall mean Anthra Pharmaceuticals, Inc. and its
Affiliates.
1.4 "Approval" shall mean any approval, including
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price and reimbursement approvals, granted by the appropriate regulatory
authority in (or valid with respect to) any country in the Territory for the
lawful Marketing of the Product.
1.5 "Disclosing Party" shall have the meaning set forth in Section
12.1.
1.6 "EMC" shall mean the Executive Management Committee established
pursuant to Article VII.
1.7 "EU" shall mean the European Union, as constituted from time to
time.
1.8 "FDA" shall mean the United States Food and Drug Administration.
1.9 "FDA Approval" shall have the meaning set forth in Section
6.1(b).
1.10 "Indications" shall mean all indications for human use.
1.11 "Investment Agreement" shall have the meaning set forth in
Section 14.3.
1.12 "Licensed Know-how" shall mean all technical knowledge,
expertise, skill, practice, proprietary rights, inventions, formulae, trade
secrets, analytical methodology, processes, preclinical, clinical, stability and
other data, toxicological information and all other experience in tangible or
intangible form relating to AD 32 or the Product in which Anthra
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has an ownership or licensable interest and which is in the possession or under
the control of Anthra as of the date of this Agreement or which Anthra may
develop or acquire hereafter pursuant to this Agreement. "Licensed Know-how"
shall be deemed to include any and all improvements to AD 32, the Product or the
Licensed Know-how that Anthra may develop during the term of this Agreement.
1.13 "Losses" shall have the meaning set forth in Section 13.3.
1.14 "Market" or "Marketing" shall mean all programs and activities
relating to the promotion and sale of the Product in the Territory including but
not limited to labeling, advertising, studies, seminars, symposia, training and
education, detailing, selling, contracting for sale of and distributing the
Product.
1.15 "Net Sales" shall mean, ***
1.16 "Notice" shall have the meaning set forth in Section 15.2.
1.17 "Pricing" shall have the meaning set forth in Section 2.3.
1.18 "Prodesfarma" shall mean Prodesfarma, S.A. and its Affiliates.
1.19 "Product" shall mean AD 32, in finished dosage
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form, including all forms of application and administration and for all
Indications, whether or not in combination with any other pharmacologically
active ingredient.
1.20 "Product Specifications" shall mean the specifications and
quality control testing procedures for the Product set forth in Annex A hereto,
as amended from time to time in the sole discretion of Anthra.
1.21 "Receiving Party" shall have the meaning set forth in Section
12.1.
1.22 "Registration" shall mean a filing with an appropriate
authority within any country in the Territory for the purpose of obtaining legal
and regulatory approval for the Marketing of the Product in such country.
1.23 "Remedies" shall have the meaning set forth in Section 11.4.
1.24 "Sublicensee" shall have the meaning set forth in Section 5.2.
1.25 "Territory" shall mean, collectively, Spain and Portugal.
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ARTICLE II
PRODUCT DEVELOPMENT
2.1 Clinical Studies. Anthra shall perform, directly or indirectly,
all clinical studies required in connection with the submission of Registrations
as to at least two Indications for the Product in the Territory, as listed in
the clinical plan set forth in Annex B hereto. Anthra shall be responsible for
all communications, both before and after Approval of each such Registration,
with regulatory authorities inside and outside the Territory in connection with
such studies, documents, filings and approvals as may be required in such
Territory.
2.2 Registrations and Approvals. Anthra agrees to file the
Registrations and, subject to Section 2.3, to use commercially reasonable
efforts to obtain the Approvals for the Territory. All such Registrations and
Approvals shall be filed in the name of Anthra; provided, however, that Anthra
shall take all necessary steps, pursuant to applicable Spanish, Portuguese
and/or EU law or regulation, to cause Prodesfarma to be recorded as the
distributor of the Product in the Territory, either by means of the initial
Registration or a supplemental application that cross-references the
Registration and identifies Prodesfarma as the distributor of the Product in the
Territory, subject to Prodesfarma's timely provision to Anthra of such
information
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(including, without limitation, trademarks) of Prodesfarma as Anthra may
reasonably require in connection with such recordation.
2.3 Pricing and Reimbursement. Upon the grant of the Registration
with respect to a country in the Territory, Prodesfarma shall have sole
responsibility and authority to communicate with the appropriate regulatory
authorities for the purpose of securing any necessary approvals with respect to
the commercial pricing of the Product, subject to Section 4.4, and determining
the reimbursement pricing of the Product in connection with any
government-sponsored or government-funded health insurance program available in
such country (the "Pricing").
ARTICLE III
SUPPLY OF THE PRODUCT
3.1 Anthra Obligation. Subject to the terms and conditions of this
Agreement, Anthra agrees to use its commercially reasonable efforts to supply
Prodesfarma with its requirements of the Product, and Prodesfarma agrees to
purchase its requirements of the Product, for resale in the Territory pursuant
to this Agreement.
3.2 Good Faith Forecasts. No later than *** after Anthra files its
initial Registration for the Product in the EU,
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Prodesfarma shall provide Anthra with a forecast estimating Prodesfarma's ***
requirements of the Product (and the desired delivery dates therefor) for the
succeeding *** period. Thereafter, on or before the first day of *** of each
year during the term hereof, Prodesfarma shall provide Anthra with an updated
forecast estimating Prodesfarma's *** requirements of the Product (and the
desired delivery dates therefor) for the succeeding *** period. Prodesfarma
shall prepare such estimates in good faith; provided, however, that, subject to
Section 3.3, such estimates shall not be binding on either party.
3.3 Firm Forecasts. Prodesfarma shall provide Anthra with a firm
forecast of Prodesfarma's requirements of the Product (and the desired delivery
dates therefor) (i) for the *** period beginning on ***, not later than *** of
the preceding year, and (ii) for the *** period beginning on ***, not later than
*** of such year. Prodesfarma may amend any firm forecast (i) ***, upon written
notice to Anthra, if the net change in the quantity of the forecasted
requirements of the Product is *** or less, or (ii) upon *** prior written
notice to Anthra, if such change exceeds ***. Except as provided in the
preceding sentence, Prodesfarma shall be obligated to purchase, and Anthra shall
be obligated to sell, such quantities of the Product as are set forth in the
firm forecast, on the delivery schedule set forth
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therein.
3.4 Purchase Orders. Prodesfarma shall issue to Anthra firm purchase
orders for each delivery, not later than *** prior to the forecasted delivery
date. The quantities ordered shall be consistent with the firm forecast for the
relevant period given by Prodesfarma pursuant to Section 3.3 (and, if
applicable, as amended pursuant to Section 3.3). In the event that the terms of
any such purchase order are not consistent with this Agreement, the terms of
this Agreement shall prevail.
3.5 Delivery. Delivery of each order of Product shall be made *** at
a facility to be designated by Anthra. Anthra shall arrange for *** of the
Product to a destination designated by Prodesfarma and by a common carrier
designated by Prodesfarma. Prodesfarma shall carry out all customs formalities
necessary for the import clearance of the shipment and obtain, at its own risk
and expense, any import license or other governmental authorization required in
connection with its importation. *** Anthra shall promptly invoice Prodesfarma
for all Product shipped. Invoices shall be accompanied by a *** and a *** for
each invoiced lot of Product.
3.6 Inability to Supply. In the event that Anthra shall have reason
to believe that it will be unable to supply Prodesfarma with the full quantity
of the Product forecasted to
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be ordered or actually ordered by Prodesfarma in a timely manner, Anthra shall
promptly notify Prodesfarma thereof. Prodesfarma and Anthra shall promptly meet
to discuss how to supply Prodesfarma's requirements in a timely manner.
Following such discussions, Prodesfarma may enter ***.
3.7 Warranty. Anthra warrants that, at the time of delivery of the
Product to Prodesfarma, the Product will (i) have been manufactured, stored and
shipped in accordance with applicable GMPs and all other applicable laws, rules,
regulations or requirements of regulatory authorities relating to the Territory,
(ii) have been manufactured in accordance with the Product Specifications, and
(iii) not be adulterated or misbranded under the Federal Food, Drug, and
Cosmetic Act, as amended, and or under any other applicable laws, rules,
regulations or requirements of regulatory authorities in or relating to the
Territory.
3.8 Price. The parties hereby agree that the supply price for the
Product, ***. Payment shall be made in United States dollars. Terms of payment
shall be net *** from the later of date of receipt of invoice and date of
delivery of the invoiced Product.
3.9 Specifications Amendments. Anthra reserves the right to amend
and/or supplement the Product Specifications
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unilaterally for the purpose of complying with GMPs or applicable Registrations,
incorporating improvements, or for any other reasonable business purpose,
subject to the grant of any Approvals required by applicable law in the
Territory in connection with any such changes.
3.10 Records. Anthra shall maintain all records necessary to comply
with all applicable laws, rules and regulations in the Territory relating to the
manufacturing of the Product. All such records shall be maintained for such
period as may be required by law, rule or regulation; provided, however, that
all records relating to the manufacture, stability and quality control of each
batch of the Product shall be retained at least until the first anniversary of
the end of the approved shelf life for all Product from such batch.
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ARTICLE IV
MARKETING AND SALE OF THE PRODUCT
4.1 Prodesfarma Obligation. Prodesfarma shall use commercially
reasonable efforts to Market and sell the Product in the Territory and shall in
any event commence Marketing of the Product as soon as practicable in each
country in the Territory as to which an Approval has been granted and, where
applicable, Pricing of the Product has been granted by the appropriate
governmental authority. Prodesfarma shall bear all costs and expenses arising
out of or relating to the Marketing, distribution and sale of the Product. All
Product sales in the Territory shall be made by, and for the account of,
Prodesfarma or its Affiliates or Sublicensees, as the case may be.
4.2 Compliance. Prodesfarma shall comply with all applicable laws,
regulations and Approvals in conducting the Marketing and sale of the Product in
the Territory, including without limitation all requirements as to pre-Marketing
approval of Product labelling.
4.3 Trademarks. Prodesfarma shall be responsible for the selection,
registration and maintenance of all trademarks that it or its agents employ in
connection with the Marketing of the Product. Except as provided in Section
14.7, Anthra shall not acquire or assert any right, title, and interest in and
to
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any such trademark.
4.4 Price of the Product. Subject to applicable governmental
regulations, Prodesfarma shall use commercially reasonable efforts to obtain the
best in-market price for the Product in each country in the Territory under the
prevailing marketing conditions; provided, however, that nothing in this Section
4.4 shall be deemed to restrict the freedom of Prodesfarma to determine prices
for the Product in the Territory. Prodesfarma shall keep Anthra informed of its
efforts in this regard in response to Anthra's written requests from time to
time.
4.5 Marketing Materials. Prodesfarma shall develop, at its sole
expense, appropriate Marketing and promotional materials for the Product in the
Territory for its use and for use by its Sublicensees. Prodesfarma agrees to
provide Anthra with a sample copy of each such item, together with an English
translation thereof, before making use thereof, and agrees to use such item only
after receiving the prior written approval of Anthra. Prodesfarma shall not, and
shall its Sublicensees not to, use any materials not approved by Anthra, for the
purpose of Marketing the Product.
4.6 Product Liability Insurance. Prodesfarma shall maintain, with an
insurance carrier reasonably acceptable to
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Anthra, at the sole expense of Prodesfarma, product liability insurance relating
to the Product that is comparable in type and amount to the insurance it
maintains with respect to its most similar other pharmaceutical products that
are Marketed, distributed and sold in the Territory.
4.7 Competition. Prodesfarma agrees that, during the term of this
Agreement, it shall not, and shall not permit any of its Affiliates or
Sublicensees to, develop, Market or sell in the Territory any anthracycline
(other than AD32) for intracavitary use that competes with the Product, for any
Indication for which the Product shall have received labelling approval in the
Territory. The parties acknowledge that all restrictions contained in this
Section 4.7 are reasonable, valid and necessary for the adequate protection of
the Product business.
ARTICLE V
LICENSE GRANTS
5.1 Grants. Subject to the terms and conditions of this Agreement,
including without limitation Section 6.1, Anthra hereby grants to Prodesfarma an
exclusive license in the Territory under the Licensed Know-how to Market, sell,
distribute, and have Marketed, sold, and distributed the Product for all
Indications; provided, however, that if Net Sales of the Product in the
Territory fail in any two consecutive years to
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meet the minimum annual sales level for such year specified in Annex C hereto
(collectively, the "Minimums") (or a pro rata portion thereof in the event of a
partial year), then such license shall automatically become non-exclusive; and
provided, further, that if (i) a third party shall lawfully commence Marketing a
generic version of the Product in the Territory or (ii) the Approval for the
peri-TURB and ovarian indications of the Product shall not have been granted in
the Territory by December 31, 2001, then the parties agree to review and make
appropriate revisions to the Minimums.
5.2 Sublicenses. Prodesfarma shall have the right to grant to third
parties (each, a "Sublicensee") sublicenses under the licenses granted in
Section 5.1, subject to the prior written consent of Anthra, which shall not be
unreasonably withheld.
ARTICLE VI
LICENSE FEES
6.1 License Fees. In consideration of the licenses granted in
Article V, Prodesfarma shall pay Anthra license fees as follows:
(a) a single payment of Two Hundred Thousand U.S. Dollars
(U.S. $200,000) upon the signing of this Agreement;
(b) ***
6.2 Payment of License Fees. All license fees due from Prodesfarma
under this Agreement shall be paid in U.S. Dollars by wire transfer of
immediately available funds to an account at a commercial bank designated by
Anthra at least five business days before payment is due.
6.3 Royalties.***.
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6.4 Withholding Taxes. Prodesfarma shall pay any and all withholding
taxes or similar charges imposed by any government in the Territory on any
amounts due to Anthra from Prodesfarma pursuant to this Article VI to the proper
taxing authority, and proof of payment of such taxes or charges will be secured
and sent to Anthra as evidence of such payment. All amounts paid by Prodesfarma
pursuant to this Section 6.4 shall be paid for the account of Anthra and
deducted from the amounts due from Prodesfarma to Anthra pursuant to Section
6.1.
ARTICLE VII
EXECUTIVE MANAGEMENT COMMITTEE
7.1 Formation of the EMC. In order to facilitate the exchange of
information between the parties relating to their activities pursuant to this
Agreement, the parties hereby establish an executive management committee (the
"EMC") comprised of four individuals. Prodesfarma and Anthra shall each appoint
two members of the EMC. Each member of the EMC shall be an employee or member of
the Board of Directors of the party that appointed such member. Initial
appointments shall be made within fourteen (14) days of the date of this
Agreement. A member of the EMC may be removed at any time, with or without
cause, by the party that originally appointed such member. A member of the EMC
shall serve until a successor is named by the party that
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appointed such member.
7.2 Authority of the EMC. The EMC shall (a) monitor and review the
progress of Product development activities conducted by Anthra pursuant to this
Agreement (including, but not limited to, all clinical studies and Registrations
related thereto), (b) monitor and review the progress of all Product Marketing
and sales activities conducted by Prodesfarma pursuant to this Agreement, and
(c) take such other actions as the parties may mutually agree, except that the
EMC may not take any action that would conflict with any provision of this
Agreement. It is not intended that the EMC have any power or authority to direct
the conduct of the affairs or the decision-making of either party hereto. Each
party to this Agreement shall retain the rights, powers, and discretion granted
to it under this Agreement, and no such rights, powers, or discretion shall be
delegated to or vested in the EMC unless such delegation or vesting of rights is
expressly provided for in this Agreement or the parties expressly so agree in
writing. The EMC shall not have the power to amend or modify this Agreement,
which may only be amended or modified as provided in Section 15.11.
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7.3 Procedural Rules of the EMC.
(a) The EMC shall adopt such standing rules as shall be
necessary for its work.
(b) A quorum of the EMC shall consist of two members, provided
that at least one member appointed by each party is present. Members of the EMC
may attend a meeting either in person or by telephone conference call.
Representation by proxy shall not be allowed.
(c) The EMC may take action (1) by consensus of the members
present at a meeting at which a quorum exists, or (2) by written resolutions
approved in writing by all of the members.
(d) The EMC shall have a chairperson and a secretary. The
first chairperson shall be a member of the EMC designated by Anthra. Each
chairperson shall serve a one-year term, and the office shall alternate between
members appointed by Anthra and members appointed by Prodesfarma. The first
secretary shall be a member of the EMC designated by Prodesfarma. Each secretary
shall serve a one-year term, and the office shall alternate between members
appointed by Prodesfarma and members appointed by Anthra.
(e) The EMC shall meet semi-annually or more frequently as
mutually agreed upon by the members, at times and
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places mutually agreed upon. Thirty calendar days' prior written Notice of any
such meeting shall be provided to the members, unless such Notice is waived in
writing by the members.
ARTICLE VIII
REPORTING
8.1 Reporting by Parties. The parties hereto shall use their
commercially reasonable efforts to keep each other informed of their activities
pursuant to this Agreement, including without limitation material developments
relating to the performance of their respective obligations under this
Agreement.
8.2 Record Keeping. Prodesfarma shall, and shall cause its
Sublicensees to, keep complete and accurate books and records pertaining to the
use and sale of the Product, including the names and addresses and purchase
order details for each customer to which it sells the Product. Such books and
records shall be retained by for at least five (5) years after the expiration or
termination of this Agreement, or for such longer period if and as required by
applicable law.
8.3 Audit of Records. At the request of Anthra, Prodesfarma shall,
and shall cause its Sublicensees to, permit Anthra and its representatives, at
reasonable times and upon reasonable notice, to examine the books and records
maintained
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pursuant to Section 8.2.
ARTICLE IX
ADVERSE EVENT AND OTHER INFORMATION EXCHANGE
9.1 Notification. Each party shall provide prompt Notice to the
other party of information in or coming into its possession or control
concerning side effects, injury, toxicity or sensitivity reaction associated
with commercial and clinical uses, studies, investigations or tests of the
Product (animal or human), whether or not determined to be attributable to the
Product, and whether arising out of clinical studies or Marketing and sale of
the Product. Further, each party shall notify the other's responsible drug
safety department by telephone or facsimile within three (3) business days, to
be followed by a written confirmation within ten (10) business days, after such
party first becomes aware of a circumstance that might necessitate a recall,
expedited notification of relevant regulatory authorities or significant change
in the label of the Product. Information concerning other complaints and other
adverse reactions regarding the Product shall be exchanged between the parties
in writing promptly, but in any event not less frequently than semi-annually.
Each party shall make such reports as are necessary to comply with laws and
regulations applicable to it, at its sole expense.
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9.2 Material Communications. Each party shall, within five (5)
business days, provide Notice to the other party of any material communications
with any governmental agency concerning the Product that occurs after the filing
of the Registration for the Product in the Territory, including, without
limitation, adverse drug reaction reports. Copies of all such material
communications shall be attached to the Notice sent pursuant to this Section
9.2. A translation of the material communication into English shall be sent
within ten (10) business days after the original Notice. Notwithstanding the
foregoing, in the event of a communication or directive from a regulatory
authority commencing or threatening seizure of Product or other removal from the
market of an approved Product, the party receiving such information shall
transmit such information to the other party within one business day.
ARTICLE X
PRODUCT RECALL
10.1 Notification and Recall. In the event that any governmental
agency or authority issues or requests a recall or takes similar action in
connection with the Product, or in the event either party determines that an
event, incident or circumstance has occurred which may result in the need for a
recall or market withdrawal, the party notified of or wishing to
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call such recall or similar action shall, within twenty-four (24) hours, advise
the other party thereof by telephone or facsimile, after which the parties shall
promptly discuss an appropriate course of action; provided, however, that either
party may initiate a recall or market withdrawal thereafter if it deems such
action necessary or appropriate.
10.2 Recall Expenses. Each of the parties hereto shall bear the
expenses of any recall resulting from breach of its respective obligations
hereunder. Such expenses of recall shall include, without limitation, the
expenses of notification and destruction or return of the recalled Product and
the sum paid for the recalled Product.
ARTICLE XI
INTELLECTUAL PROPERTY RIGHTS
11.1 Ownership of Licensed Know-how. Except as otherwise expressly
provided in Section 5.1, all right, title to, and interest in the Licensed
Know-how shall remain in Anthra. Anthra shall have the sole right to file for,
obtain, maintain, register and extend patent protection for the Licensed
Know-how, and to control the prosecution of applications therefor. If, after a
written request from Prodesfarma, Anthra decides not to file for, obtain,
maintain, register or extend patent protection for the Licensed Know-how,
Prodesfarma shall have the right, at
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its own expense, to take any such action in the name of Anthra. For the
avoidance of doubt, nothing in this Section 11.1 shall be construed to require
Prodesfarma to assign to Anthra the rights to any improvements to the Licensed
Know-How that Prodesfarma may develop in the Territory; provided, however, that
if, during the term of this Agreement, Prodesfarma or any of its Affiliates or
Sublicensees develops any such improvements, Prodesfarma shall so notify Anthra
and shall grant, or shall cause such Affiliate or Sublicensee, as the case may
be, to grant to Anthra a royalty-free, world-wide, perpetual, non-exclusive
license to use such improvements.
11.2 Ownership of Filings and Approvals. Anthra shall own all
rights, title and interest in (a) all Registrations and other submissions to
governmental authorities made pursuant to this Agreement, and (b) all Approvals
made or granted with respect to the Product in the Territory.
11.3 Ownership of Data. Anthra shall own all rights, title and
interest to the preclinical and clinical data arising out of its activities
pursuant to this Agreement.
11.4 Enforcement of Intellectual Property Rights. In the event of
any infringement by a third party of any intellectual property rights relating
to the Product in the Territory, Anthra shall have the first right (but not the
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obligation) to pursue any and all injunctive, compensatory and other remedies
and reliefs (collectively, "Remedies") against such third party. Should Anthra
determine not to pursue Remedies within 180 days after Notice from Prodesfarma
requesting Anthra to do so, then Prodesfarma shall have the right (but not the
obligation) to pursue Remedies against such third party. The party pursuing
Remedies shall bear its own costs and expenses relating to such pursuit. Any
damages or other amounts collected shall be distributed, first, to the party
that pursued Remedies to cover its costs and expenses and, second, to the other
party to cover its costs and expenses, if any, relating to the pursuit of such
Remedies; any remaining amount shall be distributed to the party that pursued
the Remedies.
11.5 Cooperation. In the event of any infringement by a third party
of any intellectual property right owned by a party hereto, each party shall, at
its own cost and expense, use all reasonable efforts to assist and cooperate
with the other party in connection with the latter's pursuit of Remedies against
the infringing party.
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ARTICLE XII
CONFIDENTIALITY
12.1 Confidential Information. Except to the extent permitted by
this Agreement or as otherwise agreed by the parties in writing, the parties
agree that, at all times during the term of this Agreement and for a five (5)
year period following termination or expiration hereof, the party receiving
information (the "Receiving Party") shall keep completely confidential, shall
not publish or otherwise disclose and shall not use directly or indirectly for
any purpose any information furnished to it by the other party (the "Disclosing
Party") pursuant to this Agreement or otherwise relating to any transaction
contemplated hereby, including information heretofore furnished to it, except to
the extent that the Receiving Party can establish by competent proof that such
information:
(a) was already known to the Receiving Party, other than under
an obligation of confidentiality, at the time of disclosure by the Disclosing
Party;
(b) was part of the public domain at the time of its
disclosure by the Disclosing Party;
(c) became part of the public domain after its disclosure by
the Disclosing Party, other than through any act or omission of the Receiving
Party in breach of this Agreement; or
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(d) was disclosed to the Receiving Party by a third party who
had no obligation not to disclose such information to others.
12.2 Disclosure of Confidential Information. Each party may disclose
the other's information to the extent that such disclosure is reasonably
necessary in filing or prosecuting patent applications, pursuing or defending
litigation, or complying with applicable governmental regulations, provided that
if a Receiving Party intends to make any such disclosure, it shall give
reasonable advance written Notice to the Disclosing Party of such intention.
Furthermore, nothing in this Article XII shall be construed to preclude either
party from disclosing such information to such third parties as may be necessary
in connection with the development and commercialization of the Product as
contemplated by this Agreement, including, without limitation, subcontracting
and sublicensing transactions in connection therewith, provided that the
Receiving Party in question shall in each case obtain from the proposed third
party recipient a written confidentiality undertaking containing confidentiality
obligations no less onerous than those set forth in this Article XII.
Notwithstanding anything in this Article XII to the contrary, Prodesfarma shall
have the right to disclose preclinical and clinical data and results relating to
the Product
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to qualified medical professionals for the limited purposes of advertising and
promoting the Product and conducting medical education initiatives reasonably
designed to increase Net Sales.
12.3 Use of Names. Neither party to this Agreement shall use the
name of the other in any public announcement, press release or other public
document without the written consent of such other party.
ARTICLE XIII
WARRANTIES; INDEMNITIES
13.1 Representations and Warranties. Each party represents and
warrants to the other party as follows: (i) it has full corporate power and
authority and has taken all corporate action necessary to enter into and perform
this Agreement; (ii) the execution and performance by it of its obligations
hereunder will not constitute a breach of, or conflict with, any other agreement
or arrangement, whether written or oral, by which it is bound; and (iii) this
Agreement is its legal, valid and binding obligation, enforceable in accordance
with the terms and conditions hereof.
13.2 Warranties of Anthra. Anthra warrants to Prodesfarma that (i)
Anthra has the right, power and authority to grant the license set forth in
Section 5.1, (ii) Anthra has informed Prodesfarma of all information in Anthra's
possession or
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control as of the date hereof concerning the side effects, injury, toxicity, and
sensitivity reaction and incidents or severity thereof, associated with any
clinical use, studies, investigations or tests conducted with the Product, (iii)
Anthra has conducted or has caused its contractors or consultants to conduct,
and will in the future conduct, the preclinical and clinical studies of the
Product in accordance with known or published standards of the FDA, (iv) Anthra
has employed and will in the future employ individuals of appropriate education,
knowledge, and experience to conduct or oversee the conduct of the clinical and
preclinical studies of the Product, (v) the Product as delivered to Prodesfarma
will meet the Specifications and will be in good, usable and merchantable
condition, and (vi) the exercise by Prodesfarma of its rights under this
Agreement will not infringe any intellectual property rights of any third party,
including without limitation any patent right. EXCEPT AS SET FORTH IN THE
PRECEDING SENTENCE AND IN SECTION 3.7, ANTHRA HEREBY DISCLAIMS ANY AND ALL
WARRANTIES WITH RESPECT TO THE LICENSED KNOW-HOW OR THE PRODUCT, INCLUDING
WITHOUT LIMITATION ANY IMPLIED WARRANTY OF MERCHANTABILITY OR FITNESS FOR A
PARTICULAR PURPOSE.
13.3 Indemnification of Prodesfarma. Anthra shall indemnify
Prodesfarma, its Affiliates and their respective
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directors, officers, employees and agents, and defend and save each of them
harmless, from and against any and all suits, investigations, claims, damages,
liabilities, costs and expenses (including, without limitation, reasonable
attorneys' fees and expenses) (collectively, "Losses") arising from or occurring
as a result of (i) any defect of the Product (including without limitation any
claim for inherent defects), except to the extent that such Losses result from
the storage or handling of the Product by Prodesfarma, or (ii) the breach by
Anthra of its warranty in Section 13.2(vi).
13.4 Indemnification of Anthra. Prodesfarma shall indemnify Anthra,
its Affiliates and their respective directors, officers, employees and agents,
and defend and save each of them harmless, from and against any and all Losses
arising from or occurring as a result of the storage, handling or promotion of
the Product by Prodesfarma.
13.5 Indemnification Procedure. (a) Each indemnified party agrees to
give the indemnifying party prompt written Notice of any Losses or discovery of
fact upon which such indemnified party intends to base a request for
indemnification under Section 13.3 or 13.4.
(b) Each party shall furnish promptly to the other copies of
all papers and official documents received in
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respect of any Losses. The indemnified party shall cooperate with the
indemnifying party in providing witnesses and records necessary in the defense
against any Losses.
(c) With respect to any Losses relating solely to the payment
of money damages and which will not result in the indemnified party's becoming
subject to injunctive or other relief or otherwise adversely affecting the
business of the indemnified party in any manner, and as to which the
indemnifying party shall have acknowledged in writing the obligation to
indemnify the indemnified party hereunder, the indemnifying party shall have the
sole right to defend, settle or otherwise dispose of such claim, on such terms
as the indemnifying party, in its sole discretion, shall deem appropriate.
(d) The indemnifying party shall obtain the written consent of
the indemnified party, which shall not be unreasonably withheld, prior to
ceasing to defend, settling or otherwise disposing of any Losses if as a result
thereof the indemnified party would become subject to injunctive or other
equitable relief or any remedy other than the payment of money by the
indemnifying party.
(e) The indemnifying party shall not be liable for any
settlement or other disposition of a Loss by the indemnified party which is
reached without the written consent of
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the indemnifying party.
(f) Except as provided above, the costs and expenses,
including fees and disbursements of counsel, incurred by any indemnified party
in connection with any claim shall be reimbursed on a calendar quarter basis by
the indemnifying party, without prejudice to the indemnifying party's right to
contest the indemnified party's right to indemnification and subject to refund
in the event the indemnifying party is ultimately held not to be obligated to
indemnify the indemnified party.
(g) The obligations of the parties pursuant to this Article
XIII shall survive the expiration or termination of this Agreement.
ARTICLE XIV
TERM AND TERMINATION
14.1 Term. The term of this Agreement shall commence as of the date
hereof and shall have an initial term of ten years from the date of the first
commercial sale of the product in Spain (the "Initial Term"). Thereafter this
Agreement shall be automatically extended for successive two-year terms, unless
Prodesfarma shall give Anthra written Notice at least six months prior to the
end of the then-current term that Prodesfarma objects to further extension
hereof. At the end of the Initial Term, the parties agree to discuss changes to
the supply price set forth in Section 3.8 in light of then-prevailing
competitive conditions. If the parties shall be unable to reach mutual
agreement within ninety (90) days after the end of the Initial Term as to
whether the price should be changed and, if so, what it should be, then (i)
Article III shall be of no further force and effect, (ii) Prodesfarma may
purchase its requirements of the Product from a third party, and (iii)
Prodesfarma shall pay Anthra a royalty of ***
14.2 Termination for Material Breach. This Agreement shall be
subject to early termination by either party in the event of a material breach
hereof by the other party with respect to its obligations, which breach is not
cured within sixty (60) days (or, in the case of a payment default, ten (10)
business days) following written Notice thereof by the non-breaching party.
14.3 Termination for Breach of Investment Agreement.
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This Agreement shall be subject to early termination (a) by Anthra, in the event
of a material breach by Prodesfarma of that certain Series D Convertible
Preferred Stock Purchase Agreement by and between Anthra and Prodesfarma
executed of even date herewith (the "Investment Agreement"), or (b) by
Prodesfarma, in the event of a material breach of the Investment Agreement by
Anthra, provided such breach has not been cured within sixty (60) days (or, in
the case of a payment default, ten (10) days) following written Notice thereof
by Anthra (in the case of Section 14.3(a)), or by Prodesfarma (in the case of
Section 14.3(b)).
14.4 Unilateral Termination by Prodesfarma or Anthra.
(a) Prodesfarma shall have the right to terminate this
Agreement in its entirety, upon thirty days' prior written Notice to Anthra, if
Anthra shall not have completed the analysis and reporting of the data from
studies A9301, A9302, and A9304 to the extent required for inclusion in the New
Drug Application for the Product in the United States and in the Registration
for the Product in the Territory, by December 31, 1997.
(b) Anthra shall have the right to terminate this Agreement
with respect to any country if, on the second anniversary of the grant of
Approval in such country, Prodesfarma shall have failed to launch the Product in
such country.
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14.5 Termination for Other Events. Either party may terminate this
Agreement if, at any time, the other party shall file in any court or agency
pursuant to any statute or regulation of any state or country, a petition in
bankruptcy or insolvency or for reorganization or for an arrangement or for the
appointment of a receiver or trustee of that party or of its assets, or if the
other party proposes a written agreement of composition or extension of its
debts, or if the other party shall be served with an involuntary petition
against it, filed in any insolvency proceeding, and such petition shall not be
dismissed within sixty (60) days after the filing thereof, or if the other party
shall propose or be a party to any dissolution or liquidation, or if the other
party shall make an assignment for the benefit of its creditors.
14.6 Effect of Expiration or Termination. The expiration of the term
hereof, or any early termination of this Agreement, in either case whether as a
whole or as to a single country, shall be without prejudice to any rights or
obligations of the parties that may have accrued prior to such expiration or
termination. Termination of this Agreement in accordance with the provisions
hereof shall not limit remedies which may otherwise be available in law or
equity.
Prodesfarma agrees to cooperate with Anthra in
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transferring to Anthra or a third party, as Anthra may direct, within thirty
(30) days of the expiration or termination hereof, all data, files and other
materials in the possession or under the control of Prodesfarma, relating to the
Product, except to the extent that Prodesfarma requires such data, files and
materials for the purpose of exercising any rights under this Agreement that may
survive such termination or expiration. The rights and obligations of the
parties under this Article XIV shall survive expiration or termination of this
Agreement.
14.7 Survival of Licenses and Royalty Obligations; Assignment of
Registrations and Trademarks. In the event of the termination of this Agreement
by Prodesfarma pursuant to Sections 14.2, 14.3, or 14.5, the license granted to
Prodesfarma in Section 5.1 shall remain in full force and effect through the
tenth anniversary of the first commercial sale of the Product in Spain.
In the event of the termination of this Agreement by Anthra pursuant
to this Article XIV, or the complete or partial termination of this Agreement by
Prodesfarma pursuant to Section 14.4, no license granted to Prodesfarma in
Section 5.1 shall survive such termination; provided, however, that in the event
of the termination of this Agreement by Prodesfarma pursuant to Section
14.4(a)(ii), Anthra shall promptly repay to Prodesfarma
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any payment made by Prodesfarma pursuant to Section 6.1(a).
In the event of the complete or partial termination of this
Agreement by Anthra pursuant to Section 14.2, 14.3, 14.4, or 14.5, Prodesfarma
shall promptly, but not later than thirty (30) days after such termination, at
its own expense assign and transfer to Anthra, or any third party designated by
Anthra, any trademarks then or previously used by Prodesfarma or any of its
Affiliates or agents in Marketing, distributing or selling the Product in the
Territory or the relevant country, as the case may be.
ARTICLE XV
GENERAL PROVISIONS
15.1 Force Majeure. If the performance of this Agreement or of any
obligation hereunder, except for the payment of any amounts hereunder, is
prevented, restricted or interfered with by reason of any cause beyond the
reasonable control of the affected party, such party, upon prompt written Notice
to the other party, shall be excused from such performance to the extent of the
aforementioned prevention, restriction or interference, provided that the party
so affected shall use its best efforts to avoid or remove such causes of
nonperformance and shall continue performance hereunder with the utmost dispatch
whenever such causes are removed.
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15.2 Notice. All notices, requests, reports, statements and other
communications to either party (each a "Notice") shall be in writing, in the
English language, shall refer specifically to this Agreement and shall be hand
delivered or sent by express courier service, carriage costs prepaid, or by
facsimile to the respective addresses specified below (or to such other address
as may be specified by Notice to the other party):
If to Anthra:
Anthra Pharmaceuticals, Inc.
00 Xxxxxx Xxxx
Xxxxxxxxx, X.X. 00000 XXX
Fax: (000) 000-0000
Attention: Xxxxxxx X. Xxxxxx
If to Prodesfarma:
Prodesfarma, X.X.
Xxxxx xxx Xxxx Xxxxxx 0,
00000 Xxxx Xxxx Xxxxxxx,
Xxxxxxxxx, Xxxxx
Fax: ______________
Attention: _______
Any Notice delivered by facsimile or similar means shall be
confirmed by a hard copy delivered as soon as practicable. The effective date of
any Notice shall be: (a) the date of the addressee's receipt, if delivered by
hand or express courier; (b) the date of receipt if received by 5:00 p.m. local
time on a business day or, if not, the first business day after receipt, if sent
by facsimile.
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15.3 Further Assurances. Each party shall duly execute and deliver,
or cause to be duly executed and delivered, such further instruments and do and
cause to be done such further acts and things, including, without limitation,
the filing of such assignments, agreements, documents and instruments, as may be
necessary or as the other party may reasonably request in connection with this
Agreement or to carry out more effectively the provisions and purposes hereof,
or to better assure and confirm unto such other party its rights and remedies
under, this Agreement.
15.4 Successors and Assigns. The terms and provisions hereof shall
inure to the benefit of, and be binding upon, Anthra, Prodesfarma and their
respective successors and permitted assigns. Except as expressly provided
herein, neither party may, without the prior written consent of the other party,
assign or otherwise transfer any of its rights and interests, or delegate any of
its obligations, hereunder; provided, however, that either party may assign its
rights and delegate its duties hereunder to an Affiliate thereof without
obtaining such consent; and provided, further, that Prodesfarma may assign all
of its rights, and delegate all of its obligations, hereunder to Almirall, S.A.,
in connection with a merger between Prodesfarma and Almirall, S.A., without the
prior consent of Anthra. Any attempt to assign
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or delegate any portion of this Agreement in violation of this Section 15.4
shall be null and void.
15.5 Governing Law. This Agreement shall be governed by, construed,
and enforced in accordance with the laws of Spain, without regard to principles
of conflicts of law.
15.6 Arbitration. Any disputes arising under this Agreement shall be
resolved by arbitration in accordance with the Rules of Conciliation and
Arbitration of the International Chamber of Commerce. The proceedings shall be
held in New York, New York if the request for arbitration is submitted by
Prodesfarma and in Barcelona, Spain if submitted by Anthra. All proceedings
shall be conducted in the English language. The parties shall appoint an
arbitrator by mutual agreement. If the parties cannot agree on the appointment
of an arbitrator within thirty (30) days after receipt of a demand for
arbitration, each party shall appoint one arbitrator, and the two arbitrators
shall appoint a third arbitrator. If the party-appointed arbitrators cannot
agree on the third arbitrator, the third arbitrator shall be appointed by the
President of the International Chamber of Commerce. Any fees and expenses
payable with respect to the arbitration shall be borne by the party losing the
case. All arbitration rulings and awards shall be final and binding on the
parties and shall be enforceable in accordance with the
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Convention on the Recognition and Enforcement of Foreign Arbitral Awards.
15.7 Severability. If any provision hereof, other than the
requirements to pay license fees pursuant to Article VI, should be held invalid,
illegal or unenforceable in any respect in any jurisdiction, then, to the
fullest extent permitted by applicable law, (a) all other provisions hereof
shall remain in full force and effect in such jurisdiction and shall be
liberally construed in order to carry out the intent of the parties as nearly as
may be possible, (b) such invalidity, illegality or unenforceability shall not
affect the validity, legality or enforceability of such provision in any other
jurisdiction, and (c) the parties agree to use their best efforts to negotiate a
provision, in replacement of the provision held invalid, illegal or
unenforceable, that is consistent with applicable law and accomplishes, as
nearly as possible, the original intention of the parties with respect thereto.
To the fullest extent permitted by applicable law, each party hereby waives any
provision of law that would render any provision hereof prohibited or
unenforceable in any respect.
15.8 Counterparts. This Agreement shall be executed in two
counterparts, each of which shall be deemed to be an original, and all of which,
taken together, shall constitute one
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and the same instrument.
15.9 Captions. The captions of this Agreement are for convenience of
reference only and in no way define, describe, extend or limit the scope or
intent of this Agreement or the intent of any provision contained in this
Agreement.
15.10 Independent Contractors. The status of the parties under this
Agreement shall be that of independent contractors. No party shall have the
right to enter into any agreements on behalf of the other party, nor shall it
represent to any person that it has any such right or authority. Nothing in this
Agreement shall be construed as establishing a partnership or joint venture
relationship between the parties hereto.
15.11 Entire Agreement. This Agreement constitutes, on and as of the
date hereof, the entire agreement of the parties with respect to the subject
matter hereof, and all prior or contemporaneous understandings or agreements,
whether written or oral, between the parties with respect to such subject matter
are hereby superseded in their entireties. This Agreement shall not be amended
in any respect whatsoever except by a further agreement, in writing, fully
executed by each of the parties.
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IN WITNESS WHEREOF, the parties have caused this Agreement to be
duly executed and delivered as of the date first above written.
ANTHRA PHARMACEUTICALS, INC. PRODESFARMA, S.A.
By: /s/ Xxxxxxx X. Xxxxxx By: /s/ Antonio Vilacasas
----------------------------- -----------------------------
Name: Xxxxxxx X. Xxxxxx Name: Antonio Vilacasas
Title: President Title: President
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ANNEX A
SPECIFICATIONS
***
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SPECIFICATIONS
***
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ANNEX B
PIVOTAL CLINICAL PLAN
INTRACAVITARY AD 32: SUMMARY OF CLINICAL STUDIES
STUDY ROUTE INDICATION STATUS
A9301/A9302: Phase II/III IVe Refractory CIS Closed to accrual for
Safety & Efficacy NDA, complete follow-up
4Q96
A9303: Phase II/III Safety & IVe CIS, BCG-intolerant/ Closed to accrual for
Efficacy contraindicated NDA, complete follow-up
4Q96
A9601: Phase III Randomized IVe Multiple papillary tumors Initiating 3Q96,
Peri-TURB expected to close 4Q98
A9304: Phase II Safety & IVe Residual papillary bladder cancer Ongoing, will close
Efficacy (Europe) 2Q97
A9261: Phase II Safety & IVe Residual papillary bladder cancer Initiating 3Q96
Efficacy (Europe)
A9623: Phase II/III Safety & IVe Multiple papillary tumors Initiating 1Q97,
49
Efficacy (Europe) expected to close 1Q98
A9503: Phase III randomized IP Advanced refractory ovarian cancer Ongoing, expected to
AD 32 vs. Altretamine close 3Q98
A622: Phase III Randomized IP Platinum refractory ovarian cancer Initiating 0X00,
(Xxxxxx) AD 32 vs. Standard expected to close 2Q99
Treatment
50
ANNEX C
Minimum Annual Sales in the Territory
Calendar Year After Launch (U.S. $)
Year 1 Year 2 Year 3 Year 4 Year 5
------ ------ ------ ------ ------
250,000 500,000 1,000,000 1,500,000 1,800,000
Year 6 Year 7 Year 8 Year 9 Year 10
------ ------ ------ ------ -------
2,100,000 2,400,000 2,400,000 2,400,000 2,400,000
