1
Certain confidential portions of this Exhibit were omitted by means of blackout
of the text (the "▇▇▇▇"). This Exhibit has been filed separately with the
Secretary of the Commission without the ▇▇▇▇ pursuant to the Company's
Application Requesting Confidential Treatment under Rule 406 under the
Securities Act.
EXHIBIT 10.14
EXCLUSIVE LICENSE, SALE AND DISTRIBUTION AGREEMENT
by and between
ANTHRA PHARMACEUTICALS, INC.
and
NYCOMED PHARMA AS
Dated as of October 14, 1997
2
TABLE OF CONTENTS
Page
----
ARTICLE I
DEFINITIONS.................................................................. 2
ARTICLE II
PRODUCT DEVELOPMENT.......................................................... 10
2.1 Clinical Studies for Technical Approvals....................... 10
2.2 Registrations and Technical Approvals.......................... 12
2.3 Maintenance of Technical Approvals............................. 12
2.4 Pricing Approvals.............................................. 12
2.5 Expenses....................................................... 14
ARTICLE III
SUPPLY OF THE PRODUCT........................................................ 14
3.1 Obligations.................................................... 14
3.2 Delivery Terms................................................. 15
3.3 Warranty....................................................... 15
3.4 Defective Products............................................. 15
3.5 Delayed Delivery............................................... 17
3.6 Price.......................................................... 18
3.7 Payment........................................................ 19
3.8 Specifications Amendments...................................... 20
3.9 Records........................................................ 21
3.10 Manufacturing Agreement........................................ 21
3.11 Inspection Reports............................................. 21
ARTICLE IV
MARKETING AND SALE OF THE PRODUCT............................................ 22
4.1 Nycomed Obligation............................................. 22
4.2 Clinical Studies in Support of Marketing....................... 23
4.3 Compliance..................................................... 23
4.4 Use of Trademarks.............................................. 24
4.5 Resale Price of the Product.................................... 24
4.6 Marketing Materials............................................ 24
4.7 Technical and Marketing Support................................ 25
4.8 Product Liability Insurance.................................... 25
4.9 Covenant....................................................... 25
ARTICLE V
LICENSE GRANTS............................................................... 26
5.1 Grants......................................................... 26
5.2 Sublicenses.................................................... 27
5.3 China.......................................................... 27
5.4 Other Countries Outside the Territory.......................... 28
5.5 Activities Outside the Territory............................... 29
5.6 Nycomed Trademark Grant to Anthra.............................. 29
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ARTICLE VI
LICENSE FEES AND OPTIONS..................................................... 30
6.1 License Fees................................................... 30
6.2 Payment of License Fees........................................ 31
6.3 Royalties...................................................... 32
6.4 Withholding Taxes.............................................. 32
6.5 Options........................................................ 32
ARTICLE VII
JOINT CONSULTATION COMMITTEE................................................. 34
7.1 Formation of the JCC........................................... 34
7.2 Authority of the JCC........................................... 35
7.3 Procedural Rules of the JCC.................................... 36
ARTICLE VIII
REPORTING.................................................................... 37
8.1 Reporting by Parties........................................... 37
8.2 Record Keeping................................................. 37
8.3 Audit of Records............................................... 38
ARTICLE IX
ADVERSE EVENT AND OTHER INFORMATION EXCHANGE................................. 38
9.1 Notification................................................... 38
9.2 Material Communications........................................ 39
ARTICLE X
PRODUCT RECALL............................................................... 39
10.1 Notification and Recall........................................ 39
10.2 Recall Expenses................................................ 40
ARTICLE XI
INTELLECTUAL PROPERTY RIGHTS................................................. 40
11.1 Ownership of Licensed Know-how................................. 40
11.2 Ownership of Product Improvements.............................. 41
11.3 Additional Developments........................................ 41
11.4 Ownership of Filings and Approvals............................. 42
11.5 Ownership of Data.............................................. 42
11.6 Enforcement of Intellectual Property Rights.................... 43
11.7 Cooperation.................................................... 43
ARTICLE XII
CONFIDENTIALITY.............................................................. 44
12.1 Confidential Information....................................... 44
12.2 Disclosure of Confidential Information......................... 45
12.3 Use of Names................................................... 46
12.4 Publications................................................... 46
ARTICLE XIII
WARRANTIES; INDEMNITIES...................................................... 46
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13.1 Representations and Warranties................................. 46
13.2 Warranties of Anthra........................................... 47
13.3 Indemnification of Nycomed..................................... 48
13.4 Indemnification of Anthra...................................... 48
13.5 Indemnification Procedure...................................... 49
13.6 Limitation of Liability........................................ 50
ARTICLE XIV
TERM AND TERMINATION......................................................... 51
14.1 Term........................................................... 51
14.2 Termination for Material Breach................................ 51
14.3 Unilateral Termination by Anthra............................... 51
14.4 Termination for Other Events................................... 52
14.5 Effect of Expiration or Termination............................ 53
14.6 No Compensation................................................ 54
14.7 Survival....................................................... 54
ARTICLE XV
GENERAL PROVISIONS........................................................... 56
15.1 Force Majeure.................................................. 56
15.2 Notice......................................................... 57
15.3 Further Assurances............................................. 58
15.4 Successors and Assigns......................................... 58
15.5 Governing Law.................................................. 60
15.6 Arbitration.................................................... 60
15.7 Severability................................................... 61
15.8 Counterparts................................................... 61
15.9 Captions....................................................... 61
15.10 Independent Contractors........................................ 62
15.11 Entire Agreement............................................... 62
ANNEX A ..................................................................... 64
ANNEX B ..................................................................... 65
ANNEX C ..................................................................... 66
ANNEX D ..................................................................... 67
ANNEX E ..................................................................... 68
ANNEX F ..................................................................... 69
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THIS EXCLUSIVE LICENSE, SALE AND DISTRIBUTION AGREEMENT (this
"Agreement"), made as of October 14, 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 ▇▇ ▇▇▇▇▇▇ ▇▇▇▇,
▇▇▇▇▇▇▇▇▇, ▇.▇. ▇▇▇▇▇, ▇.▇.▇. ("Anthra"), and Nycomed Pharma AS, a corporation
organized under the laws of Norway, having its principal business office at
Sandakerveien 78, ▇.▇. ▇▇▇ ▇▇▇▇ - ▇▇▇▇▇▇▇, ▇-▇▇▇▇, ▇▇▇▇, ▇▇▇▇▇▇ ("Nycomed"),
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 the Product (as defined below) in the
Territory (as defined below),
WHEREAS, Nycomed has specialized experience in the promotion,
marketing and sale of pharmaceutical products to hospitals in the Territory, and
has in place an experienced marketing and sales staff that can expedite the
distribution of the Product in the Territory,
WHEREAS, Nycomed desires to obtain an exclusive license from Anthra
to promote, market and sell the Product in the Territory, and Anthra desires to
grant such a license, on
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the terms set forth herein,
WHEREAS, Anthra and Nycomed intend to negotiate a Manufacturing
Agreement pursuant to which Nycomed would manufacture Product using AD 32
supplied by Anthra, and
WHEREAS, as an inducement to Anthra to enter into this Agreement,
Nycomed has entered into an Investment 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 "Additional Development" shall mean any dosage form or means of
delivery of the Product other than those set forth in Section 1.31, or any
indication for the Product other than the Indications.
1.3 "Affiliate" shall mean, with respect to a Person, 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.
1.4 "Anthra" shall mean Anthra Pharmaceuticals, Inc. and its
Affiliates.
1.5 "Anthra Trademark" shall mean any Trademark owned by Anthra or
in which Anthra has a license (with right
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to sublicense) from time to time during the term hereof.
1.6 "Approvals" shall mean, collectively, the Pricing Approvals and
Technical Approvals.
1.7 "Change of Control" shall mean, with respect to a Person, the
transfer of Control of such Person from one third party to another third party.
1.8 "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.
1.9 "Disclosing Party" shall have the meaning set forth in Section
12.1.
1.10 "EU" shall mean the European Union, as constituted from time to
time.
1.11 "Exchange Rate" shall mean, with respect to a currency other
than United States Dollars, the currency exchange rate between such currency and
United States Dollars as set forth in the Eastern edition of the Wall Street
Journal on a designated reference date.
1.12 "Indemnifiable Losses" shall have the meaning set forth in
Section 13.3(a).
1.13 "Indications" shall mean, collectively, the
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Refractory TCC Indication, the Peri-TUR Indication, and the Ovarian Indication.
1.14 "Initial Term" shall have the meaning set forth in Section
14.1.
1.15 "Investment Agreement" shall mean that Investment Agreement
between Nycomed and Anthra of even date herewith.
1.16 "JCC" shall mean the Joint Consultation Committee established
pursuant to Article VII.
1.17 "Launch" shall mean the first commercial sale of the Product in
the Territory.
1.18 "Licensed Know-how" shall mean all information and materials,
including without limitation, products, devices, apparatus, 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 and know-how in
tangible or intangible form as well as proprietary rights, whether patented,
patentable or otherwise, relating to AD 32 or the Product, (i) which are in the
possession or under the control of Anthra as of the date of this Agreement and
in which Anthra has an ownership or licensable interest, and (ii) which are
necessary to Nycomed in the exercise of its rights under the license grants in
Section 5.1.
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1.19 "Manufacture" shall mean the manufacturing, formulating,
packaging, labeling, warehousing and quality control testing of the Product.
1.20 "Manufacturing Agreement" shall have the meaning set forth in
Section 3.10.
1.21 "Major EU Member State" shall mean one of the United Kingdom,
France, Italy, or Germany.
1.22 "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 advertising, studies, seminars, symposia, training and education,
detailing, selling, submission of tender bids, contracting for sale of and
distributing the Product.
1.23 "Minimum Purchase Requirement" shall mean***
1.24 "Net Sales" shall mean***
1.25 "Notice" shall have the meaning set forth in Section 15.2.
1.26 "Nycomed" shall mean Nycomed Pharma AS and its Affiliates.
1.27 "Ovarian Indication" shall mean the intraperitoneal treatment
of refractory small volume ovarian cancer in humans.
1.28 "Peri-TUR Indication" shall mean the adjunctive intravesical
treatment of superficial bladder cancer after transurethral resection of the
bladder in humans.
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1.29 "Person" shall mean an individual, partnership, corporation,
business trust, joint stock company, limited liability company, trust,
unincorporated association, joint venture, government (or agency there), or
other entity of similar nature.
1.30 "Pricing Approval" shall mean any and all licenses,
registrations, authorizations and/or approvals relating to the commercial
pricing of the Product, or the reimbursement pricing of the Product for any
government-sponsored or government-funded health insurance program in any
country in the Territory, that are required by any national, supra-national,
regional, state or local regulatory agency, department, bureau or other
governmental entity in the Territory, in connection with the distribution, use
or sale of the Product in any country in the Territory, as amended or
supplemented from time to time.
1.31 "Product" shall mean AD 32, in finished dosage form in 200 mg
and 800 mg vials, for administration intravesically and intraperitoneally.
1.32 "Product Improvements" shall mean all discoveries, processes,
formulae, data, improvements, know-how, trade secrets, procedures, Regulatory
Documentation, marketing studies, and inventions, patentable or otherwise, that
both (i) relate directly to AD 32 in finished dosage form and (ii) are created,
developed, or arise as a result of, or
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in connection with the performance of activities pursuant to this Agreement,
other than any Additional Developments.
1.33 "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 pursuant to Section 3.8.
1.34 "Product Trademark(s)" shall mean the Trademark(s) selected by
the parties pursuant to Section 4.4, for use in the Marketing of the Product in
the Territory.
1.35 "Receiving Party" shall have the meaning set forth in Section
12.1.
1.36 "Refractory TCC Indication" shall mean the intravesical
treatment of refractory superficial transition cell carcinoma in humans.
1.37 "Registration" shall mean a filing with a Regulatory Authority
in (or with respect to) any country in the Territory for the purpose of
obtaining an Approval.
1.38 "Regulatory Authority" shall mean the government regulatory
authority or authorities responsible for granting the Approvals in (or with
respect to) each country in the Territory.
1.39 "Remedies" shall have the meaning set forth in Section 11.6.
1.40 "Sublicensee" shall have the meaning set forth in Section 5.2.
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1.41 "Technical Approval" shall mean any and all technical, medical
and scientific licenses, registrations, authorizations and/or approvals of the
Product (including manufacturing approvals and authorizations, marketing
authorizations and labeling approvals related thereto) that are required by any
national, supra-national, regional, state or local regulatory agency,
department, bureau or other governmental entity in the Territory, for the
distribution, use or sale of the Product in any country in the Territory, as
amended or supplemented from time to time. The Technical Approvals shall not
include any Pricing Approval.
1.42 "Territory" shall mean the countries listed in Annex E hereto.
1.43 "Trademark" shall mean any trademark, trade dress, brand ▇▇▇▇,
trade name, brand name, logo or business symbol.
ARTICLE II
PRODUCT DEVELOPMENT
2.1 Clinical Studies for Technical Approvals.
(a) Anthra shall perform, directly or indirectly, all clinical
studies required in connection with the submission of Registrations for
Technical Approvals for the Product and the Indications, as listed in the
clinical plan set forth in Annex B hereto; provided, however, that if the
parties shall mutually agree that the size of the relevant
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market in a country in the Territory does not justify incurring the cost of
conducting any such study or studies required for such country, or if the
parties reach the spending caps set forth in Section 2.1(c) and fail to decide
to fund, on a mutually agreed basis, the completion of any Section 2.1(c) study
or studies with respect to any country in the Territory, then Anthra shall not
be required to conduct (or complete) such study or studies, and Anthra and
Nycomed shall be relieved of their respective obligations pursuant to Sections
2.2, 2.3 and 2.4 with respect to such country. Anthra shall be responsible for
all communications, both before and after grant of the Technical Approvals, with
Regulatory Authorities in connection with such studies, Registrations, and
Technical Approvals.
(b) Anthra shall bear the expense of all clinical studies that
it shall perform pursuant to Section 2.1(a) in connection with the submission of
Registrations for Technical Approvals in each country in the Territory, prior to
the grant of all Technical Approvals with respect to such country.
(c) With respect to any clinical studies that (i) the
Regulatory Authorities permit to be conducted after the grant of the Technical
Approvals with respect to such country and (ii) are required to be conducted as
a condition of such grant of the Technical Approvals, Nycomed agrees to
reimburse Anthra, within thirty (30) days after receipt of an invoice therefor,
for fifty percent (50%) of the aggregate direct costs and expenses of Anthra
attributable to such studies; provided, however, that the protocols for each
such clinical study shall be subject to the mutual agreement of the parties; and
provided, further, that the obligation of Nycomed to reimburse Anthra pursuant
to this Section 2.1(c) and Section 2.4(c) shall be capped at Six Hundred
Thousand U.S. Dollars (U.S. $600,000) in the aggregate; and provided, further,
that Anthra shall not have any obligation to conduct or complete any such study
or studies after it has incurred aggregate direct costs and expenses pursuant to
this Section 2.1(c) and/or Section 2.4(c) equal to One Million Two Hundred
Thousand U.S. Dollars (U.S. $1,200,000) (including amounts to be reimbursed by
Nycomed pursuant to this Section 2.1(c) and Section 2.4(c)).
2.2 Registrations and Technical Approvals. Subject to Section
2.1(a), Anthra shall file the Registrations for Technical Approvals for each
country in the Territory and shall use its commercially reasonable efforts to
obtain the
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Technical Approvals. All such Registrations and Approvals shall be filed in the
name of Anthra or in the name of Anthra's designee; provided, however, that
Anthra shall take all necessary steps, to the extent permitted by applicable law
in countries comprising the Territory, and/or EU law or regulation, to cause
Nycomed 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 Nycomed as the distributor of
the Product in the Territory, subject to Nycomed's timely provision to Anthra of
such information as Anthra may reasonably require in connection with such
recordation.
2.3 Maintenance of Technical Approvals. Except as otherwise provided
in Section 2.1(a) and 2.4, Anthra agrees to use its commercially reasonable
efforts to maintain the Technical Approvals obtained pursuant to Section 2.2,
throughout the term of this Agreement.
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2.4 Pricing Approvals.
(a) Subject to this Section 2.4, upon the grant of the
Technical Approvals with respect to a country in the Territory, Nycomed shall
prepare and file Registrations for all Pricing Approvals, if any, relating to
such country. Nycomed shall use its commercially reasonable efforts to obtain
and to maintain all Pricing Approvals throughout the term of this Agreement, and
shall have sole responsibility and authority to communicate with the Regulatory
Authorities with respect to the Pricing Approvals.
(b) Anthra shall conduct (or cause to be conducted) any
clinical studies which are required by the Regulatory Authorities in connection
with a Pricing Approval (or a Registration for such an Approval) for a country
in the Territory, subject to Section 2.4(c); provided, however, that the
parties shall mutually agree on the protocols for each such study; and
provided, further, that in the event that the parties shall mutually agree that
the size of the market for the Product for the Indications in such country does
not justify incurring the cost of such study or studies, then Anthra shall not
be required to conduct any studies with respect to such country pursuant to
this Section 2.4(b), and Anthra and Nycomed shall be relieved of their
respective obligations with respect to such country under Section 2.3 and
2.4(a).
(c) Nycomed agrees to reimburse Anthra, within thirty (30)
days after receipt of an invoice therefor, for fifty percent (50%) of the
aggregate direct costs and expenses of Anthra attributable to any clinical
studies conducted by Anthra pursuant to Section 2.4(b); provided, however, that
the obligation of Nycomed to reimburse Anthra pursuant to Section 2.1(c) and
this Section 2.4(c) shall be capped at Six Hundred Thousand U.S. Dollars (U.S.
$600,000) in the aggregate; and provided, further, that Anthra shall not have
any obligation to conduct or complete any such study or studies pursuant to
Section 2.4(b), and Anthra and Nycomed shall be relieved of their respective
obligations with respect to such country under Sections 2.3 and 2.4(a), after
Anthra has incurred aggregate direct costs and expenses pursuant to Section
2.1(c) and/or this Section 2.4(c) equal to One Million Two Hundred Thousand
U.S. Dollars (U.S. $1,200,000) (including amounts to be reimbursed by Nycomed
pursuant to Section 2.1(c) and this Section 2.4(c)).
2.5 Expenses. Except as otherwise expressly provided in Sections
2.1(c) and 2.4(c), each party shall be responsible for its own costs incurred in
carrying out its duties related to the development activities set forth in this
Article II.
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ARTICLE III
SUPPLY OF THE PRODUCT
3.1 Obligations. Subject to the terms and conditions of this
Agreement, Anthra agrees to use its commercially reasonable efforts to supply
Nycomed with its requirements of the Product, and Nycomed agrees to purchase its
requirements of the Product, for clinical studies and for commercial sale in the
Territory pursuant to this Agreement; provided, however, that Nycomed may
purchase supplies of the Product from, or cause the Product to be manufactured
by, one or more third parties in the event that Anthra shall fail to perform its
supply obligations under this Article III as a result of the filing by Anthra of
a petition in bankruptcy , or the filing of an involuntary petition against
Anthra, which petition shall not be dismissed within sixty (60) days after the
filing thereof.
3.2 Delivery Terms. The obligations of the parties with respect to
forecasting, orders and delivery of the Product are set forth in Annex F hereto.
3.3 Warranty. Anthra warrants that, at the time of delivery of the
Product to Nycomed, 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 in or relating to the
Territory, (ii) have been manufactured and delivered in accordance with the
Product Specifications, (iii)
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not be adulterated or misbranded under any applicable laws, rules, regulations
or requirements of Regulatory Authorities in or relating to the Territory, and
(iv) have expiration dating, at the time of delivery, equal to at least
seventy-five percent (75%) of the shelf-life approved by the relevant Regulatory
Authority, except as otherwise provided in Section 3.5.
3.4 Defective Products.
(a) In the event that Nycomed determines that any shipment of
Product, at the time of delivery, (i) does not conform to the Product
Specifications, (ii) contains misprinted or non-conforming labelling or
packaging, or (iii) has been damaged in transit (collectively, "Defective
Products"), then Nycomed shall give Anthra notice thereof (including a sample
from such shipment) within fifteen days after receipt thereof, if such defects
may be ascertained by the exercise of reasonable diligence (which shall include
laboratory testing or other chemical analysis as necessary) upon receipt
thereof, and otherwise within fifteen days after discovery thereof. If Anthra
confirms such defect, it shall promptly so notify Nycomed. If Anthra does not
confirm such defect, it shall promptly so notify Nycomed, and the parties shall
submit the disputed shipment for testing to an independent testing laboratory
that is mutually acceptable to the parties. The findings of the testing
laboratory shall be
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binding on the parties. The expenses of such testing shall be borne by Anthra if
the testing confirms the defect, and otherwise by Nycomed.
(b) If any shipment contains Defective Product, for any reason
other than the willful or negligent acts or omissions of Nycomed or its
customers or agents, Anthra shall credit Nycomed with the costs incurred by
Nycomed with respect to all such Defective Product that has not been sold (or
has been sold and returned), which costs shall be deemed equal to the sum of any
amounts paid on account of such Defective Product pursuant to Section 3.7 and
any and all transportation and storage charges incurred by Nycomed in connection
with such Defective Product. In addition, at Nycomed's option, (i) Anthra shall
be relieved of any obligation to deliver any Product in replacement of such
Defective Product, or (ii) Anthra shall replace such Defective Product as soon
as possible after Nycomed notifies Anthra of its election of option (ii) of this
Section 3.4, in which case Nycomed shall pay to Anthra any unpaid amounts in
respect of the replacement Product in accordance with Section 3.7 following
delivery of the replacement Product.
3.5 Delayed Delivery. In the event that Anthra shall fail to
deliver to Nycomed the full quantity of Product specified in a purchase order
issued by Nycomed and confirmed by Anthra pursuant to Annex F hereto, by ***
(the "Trigger Date") after the delivery date specified in such purchase order,
then the supply price (as calculated pursuant to Section 3.6 (the "Price"))
applicable to any quantities of Product delivered to Nycomed after the Trigger
Date under such purchase order shall be reduced, *** provided, further, that no
such reduction shall be made with respect to any purchase order (i) that is
confirmed by Anthra prior to January 1, 2002, or (ii) if the delay in delivery
of the Product to Nycomed shall be caused by, or result from, a delay in the
supply to Anthra of such quantities of AD 32 as Anthra shall require for use in
the Manufacture of such Product. The parties agree that Anthra, in order to
avoid incurring penalties pursuant to this Section 3.5 with respect to a
delayed shipment, may deliver to Nycomed, and Nycomed agrees to accept, ***.
3.6 Price.
(a) Subject to Sections 3.6(b) and 3.6(c), the parties hereby
agree that the supply price for the Product, per 200 mg vial, shall be the
greater of ***. The supply price for the Product, per 800 mg vial, shall be four
times the supply price per 200 mg vial, as calculated in accordance with this
Section 3.6(a).
(b) The parties agree to consult about appropriate adjustments
to the supply price for the Product with respect to a country in the Territory
in the event of significant movements in the exchange rate between such
country's local currency and U.S. Dollars during any calendar quarter.
(c) By mutual agreement of the parties, upon or after execution
of the Manufacturing Agreement, the supply price of the Product under this
Agreement may be adjusted to reflect ***.
3.7 Payment. Terms of payment by Nycomed for shipments of the
Product shall be net ***. Within ***, Nycomed shall determine the supply price
for the Product delivered during such calendar quarter, on a country-by-country
basis, using the formula set forth in the first sentence of Section 3.6. In the
event that the total amount payable to Anthra for Product delivered to Nycomed
in such quarter, calculated on the basis of such supply price and adjusted as
appropriate pursuant to Section 3.5, shall be less than sum of the payments
that Nycomed has made to Anthra for supply of the Product during such calendar
quarter, then Anthra shall credit such excess against future invoices issued to
Nycomed. In the event that such aggregate supply price shall exceed Nycomed's
payments for the Product for such calendar quarter, then Nycomed shall pay
Anthra such shortfall within forty-five (45) days after the end of such
calendar quarter.
3.8 Specifications Amendments. Anthra reserves the
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right to amend and/or supplement the Product Specifications unilaterally for the
purpose of complying with GMPs or applicable Approvals, 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; provided, however, that Anthra may not amend the Product
Specifications so as to incorporate any Additional Development therein, without
the prior written consent of Nycomed, which shall not be unreasonably withheld;
provided, however, that withholding such consent because of a disagreement
between the parties as to the appropriate rate of royalty to be paid by Nycomed
with respect to such Additional Development shall not be deemed unreasonable for
purposes of this Section 3.8.
3.9 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.
3.10 Manufacturing Agreement. Anthra and Nycomed
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shall make a good faith effort, within one hundred eighty (180) days after the
date hereof, to negotiate and enter into a manufacturing agreement (the
"Manufacturing Agreement"), pursuant to which Nycomed will Manufacture Product
using AD 32 supplied to Nycomed by Anthra.
3.11 Inspection Reports. Anthra agrees to advise Nycomed, promptly
after Anthra becomes aware thereof, of any proposed or announced visit or
inspection, or any unannounced visit or inspection, by any governmental or
regulatory agent, of any Anthra facilities used in the performance of its
obligations hereunder. Further, Anthra agrees to advise Nycomed, promptly after
receipt by Anthra of notice thereof, of any proposed or announced visit or
inspection or any unannounced visit or inspection by any such agent of any third
party facility used in the manufacturing of the Product supplied to Nycomed
hereunder. Anthra shall provide Nycomed with a reasonable description of each
such visit or inspection, promptly after such visit or inspection (or promptly
after receipt of such description, in the case of third party facilities) and
with copies of any letters, reports or other documents (including 483's) issued
by any such agents that relate to the Product, promptly after receipt thereof.
ARTICLE IV
MARKETING AND SALE OF THE PRODUCT
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4.1 Nycomed Obligation. Nycomed shall use its commercially
reasonable efforts to Market and sell the Product in the Territory and shall
commence Marketing of the Product as soon as practicable in each country in the
Territory as to which Technical Approvals have been granted and, where
applicable, where Pricing Approval has also been granted; provided, however,
that in any event, Nycomed shall commence active Marketing of the Product and
shall launch the Product in each country in the Territory by the later to occur
of (i) *** that such Technical Approvals (or Pricing Approval, if required),
have been granted in such country and (ii) *** delivery by Anthra to Nycomed of
the first commercial supplies of the Product. Nycomed 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, Nycomed or its Affiliates or Sublicensees, as the case may be.
4.2 Clinical Studies in Support of Marketing. Nycomed may conduct
(or cause to be conducted), in its sole discretion and at its own expense, any
clinical studies which are specifically designed in support of the Marketing of
the Product in the Territory. Nycomed agrees to provide Anthra with a copy of
the draft protocol for each such study and shall not commence such study prior
to receiving Anthra's prior written approval of such protocol, which approval
may
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not be unreasonably withheld. *** Nycomed agrees not to invoice any third party
for such clinical supplies of the Product at a price lower than the commercial
sales price determined by Nycomed pursuant to Section 4.5.
4.3 Compliance. Nycomed 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. Further, Nycomed agrees to comply with all
written instructions from Anthra relating to the storage, handling and
transportation of the Product, and all Product Specifications relating thereto.
4.4 Use of Trademarks.
(a) The parties shall jointly select the Trademark(s) to be
used as the Product Trademark(s), not later than December 31, 1997.
(b) Neither Nycomed nor any of its Affiliates or Sublicensees
shall market or sell the Product under any Trademark other than the Product
Trademarks. Except as provided in Sections 5.6, Anthra shall not acquire or
assert any right, title, and interest in and to any Product Trademark (other
than the Anthra Trademarks).
4.5 Resale Price of the Product. Subject to applicable governmental
regulations, Nycomed shall use commercially reasonable efforts to obtain the
best in-market
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price for the Product in each country in the Territory under the prevailing
marketing conditions; provided, however, that nothing in this Section 4.5 shall
be deemed to restrict the freedom of Nycomed to determine prices for the Product
in the Territory.
4.6 Marketing Materials. Nycomed 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. Nycomed agrees to provide to Anthra
(i) a sample copy of each such item, together with an English translation
thereof, or (ii) the text (in English) of each such item and a certification of
the accuracy of the translation of such text into the language in which such
item shall appear, as Nycomed in its sole discretion shall elect, not less than
thirty (30) days prior to making any use thereof. Anthra shall approve or
disapprove each such item, in its sole discretion. In the event that Anthra
shall fail to notify Nycomed in writing of its approval or disapproval of any
such item within ten business days after receipt thereof, such item shall be
deemed to have been approved by Anthra. Nycomed agrees to use such items only
after receiving the approval of Anthra. Nycomed shall not, and shall cause its
Sublicensees not to, use any materials not approved by Anthra, for the purpose
of Marketing the Product.
4.7 Technical and Marketing Support. Anthra shall
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use commercially reasonable efforts to provide Nycomed with technical support in
connection with the training of the Nycomed sales force with regard to the
Product, and to cooperate with Nycomed in undertaking strategic marketing
activities including, without limitation, participation on speaker panels at
international symposia.
4.8 Product Liability Insurance. Nycomed shall maintain, with an
insurance carrier reasonably acceptable to Anthra, at the sole expense of
Nycomed, 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.
4.9 Covenant. As an integral part of the exclusive dealing
arrangement between the parties set forth in this Agreement, each party 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 product (other than AD 32) for intracavitary use that competes with the
Product with respect to any Indication for which the Product shall have received
labelling approval in the Territory; provided, however, that Anthra may develop,
Market or sell in the Territory anthracycline products (other than AD 32) for
intracavitary use that compete with the Product with respect to one or more
Indications for which the
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Product shall have received labelling approval in the Territory. The parties
acknowledge that the provisions of this Section 4.9 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 Nycomed (i) an
exclusive license under the Licensed Know-how to Market, sell, distribute, and
have Marketed, sold, and distributed the Product in the Territory for the
Indications, (ii) a non-exclusive license under the Licensed Know-how to develop
the Product in the Territory, solely to the extent necessary in conducting
clinical studies pursuant to Section 4.2, and (iii) subject to Section 4.4, a
non-exclusive license to use the Anthra Trademarks to Market, sell, distribute,
and have Marketed, sold and distributed the Product in the Territory for the
Indications; provided, however, that if Nycomed shall fail to purchase from
Anthra in any calendar year an aggregate quantity of Product at least equal to
the Minimum Purchase Requirement for such year, then all exclusive licenses
granted in this Section 5.1 shall automatically become non-exclusive; provided,
further, that for purposes of making the determination pursuant to the preceding
proviso, Nycomed shall be deemed to have purchased
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from Anthra in any calendar year all quantities of the Product set forth in
purchase orders confirmed by Anthra pursuant to Annex F hereof which specify
delivery dates during such calendar year, regardless of whether such deliveries
are made in a timely manner.
5.2 Sublicenses. Nycomed shall have the right to grant to third
parties sublicenses under the licenses granted in Section 5.1, subject to the
prior written consent of Anthra, which shall not be unreasonably withheld (each,
a "Sublicensee").
5.3 China. Nycomed agrees to provide to Anthra in writing, not later
than April 30, 1998, forecasts of, and proposed minimum purchase levels for, Net
Sales in the People's Republic of China (the "PRC") for a three-year period
beginning with the year of Launch in the PRC, based on the assumption that
Anthra will grant Nycomed an exclusive license to Market and sell the Product in
the PRC for the Indications. In the event that (i) Anthra shall determine, in
its sole discretion, after consultation with Nycomed and due consideration of
relevant materials provided by Nycomed, that (A) such forecasts and minimum
purchase levels, in the context of a market assessment, are acceptable, (B)
Anthra's intellectual property rights in the Product will be protected to
Anthra's reasonable satisfaction, and (C) an adequate source of Product supply
can be assured in order to meet
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demand in the PRC, and (ii) Nycomed agrees to bear a mutually agreed percentage
of the costs to be incurred by Anthra in obtaining and maintaining the necessary
marketing approvals in the PRC, then Nycomed shall have the option to enter into
a license agreement with Anthra relating to the development, Marketing and sale
of the Product in the PRC for the Indications, on the terms and conditions
relating to pricing set forth in this Agreement, and on other terms and
conditions similar to those set forth in this Agreement, modified as appropriate
to reflect the agreement of the parties with respect to the conditions set forth
in (i) and (ii) above; provided, however, that if the parties shall fail to
execute such license agreement by September 30, 1998, then Anthra shall have no
further obligations, and Nycomed shall have no further rights, with respect to
the PRC under this Agreement.
5.4 Other Countries Outside the Territory. Anthra agrees to notify
Nycomed promptly in the event that Anthra decides to grant any licenses with
respect to the Product for the Indications covering any countries outside the
Territory, and to discuss such opportunities with Nycomed upon the request of
Nycomed.
5.5 Activities Outside the Territory. Nycomed agrees that, to the
extent permitted by applicable law, it will not (i) seek approval, directly or
indirectly, from the relevant Regulatory Authorities, to (A) qualify facilities
to
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manufacture or finish the Product outside the Territory or (B) label or relabel
the Product in a manner that would permit it to be marketed or sold outside the
Territory (other than in countries that are members of the EU), or (ii) sell or
export the Product to any third party for use or resale outside the Territory
(other than in countries that are members of the EU), or (iii) sell the Product
to any third party that it has reason to believe intends to resell or export the
Product outside the Territory (other than to countries that are members of the
EU).
5.6 Nycomed Trademark Grant to Anthra. In the event that Nycomed
shall own one or more of the Trademarks selected as Product Trademarks pursuant
to Section 4.4, then Nycomed shall promptly grant Anthra a non-exclusive,
perpetual, world-wide, royalty-free license (with the right to sublicense) to
use such Product Trademarks for Marketing and sale of the Product to the level
of distribution that, in turn, sells to patients and hospitals. Any third party
to which Anthra grants a sublicense hereunder (including without limitation
distributors and agents) to use such Product Trademarks for the purpose of
Marketing, selling and distributing the Product shall be required to pay to
Anthra, *** provided, however, that in the event of the partial or complete
termination of this Agreement, then during the period from the effective date of
such termination through the end of
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the Initial Term, (i) any sublicenses granted by Anthra to use the Product
Trademarks in the Territory shall be royalty-free, if Anthra terminated this
Agreement pursuant to Section 14.2, and (ii) any sublicenses granted by Anthra
to use the Product Trademarks in any country as to which Anthra terminated this
Agreement pursuant to Section 14.3(a) shall be royalty-free.
ARTICLE VI
LICENSE FEES AND OPTIONS
6.1 License Fees. In consideration of the licenses granted in
Article V, ***.
6.2 Payment of License Fees. All license fees due from Nycomed under
Section 6.1, and all royalties due from Anthra under Section 5.6, shall be paid
in U.S. Dollars by wire transfer of immediately available funds to an account at
a commercial bank designated by Anthra or Nycomed, as the case may be, at least
five business days before payment is due.
6.3 Royalties. ***
6.4 Withholding Taxes. Nycomed shall pay any and all withholding
taxes or similar charges imposed by any government in the Territory on any
amounts due to Anthra from Nycomed 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 Nycomed
pursuant to this Section 6.4 shall be paid for the account of Anthra and
deducted from the amounts due from Nycomed to Anthra pursuant to Section 6.1.
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6.5 Options. In consideration of the payments made by Nycomed
pursuant to this Article VI and the Investment Agreement of even date herewith,
Anthra shall grant to Nycomed options to purchase either Series D Convertible
Preferred Stock of Anthra (the "Series D Stock") or common stock of Anthra
("Common Stock", and together with the Series D Stock, the "Stock"), as
determined pursuant to Section 6.5(d), on the following terms and conditions:
(a) Upon receipt of the payment from Nycomed pursuant to Section
6.1(a), an option to purchase up to Thirty-Three Thousand Three
Hundred and Thirty-Three (33,333) shares of Stock at Fifteen
U.S. Dollars (U.S. $15) per share, such option to be exercised
not later than the earlier to occur of (i) the tenth day after
Nycomed receives notice that the first Major EU Member State has
granted the Technical Approvals for the Peri-TUR Indication and
(ii) twenty-four months after the date on which the first Major
EU Member State has granted the Technical Approvals for the
Refractory TCC Indication;
(b) Upon receipt of the payment from Nycomed pursuant to Section
6.1(b), an option to purchase up to Thirty-Three Thousand Three
Hundred and Thirty-Three (33,333) shares of Stock at Fifteen
U.S. Dollars (U.S. $15) per share, such option to be exercised
not later than the earlier to occur of (i) the tenth day after
Nycomed receives notice that the first major EU Member State has
granted the Technical Approvals for the Ovarian Indication and
(ii) twenty-four months after the date on which the first Major
EU Member State has granted the Technical Approvals for the
Peri-TUR Indication; and
(c) Upon receipt of the payment from Nycomed pursuant to Section
6.1(c), an option to purchase up to that number of shares of
Stock which can be purchased for One Million U.S. Dollars (U.S.
$1,000,000), at a price per share equal to (i) the prevailing
price of publicly-traded shares of Stock on the date of grant of
the option, or (ii) if such shares are not publicly-traded as of
such date, a price equal to the quotient of (A) the total market
valuation of Anthra, (i) as determined by Anthra in its sole
discretion and notified to Nycomed, or, in the event that
Nycomed shall notify Anthra that Nycomed does not accept such
valuation, (ii) as determined by an internationally-recognized
investment bank or accounting firm mutually acceptable to Anthra
and Nycomed, and (B) the number of shares of Stock outstanding
as of such date. The fees and expenses of such investment bank
or accounting firm in connection with such valuation shall be
for the account of Nycomed. Such option shall be exercised not
later than twenty-four months after the date on which Nycomed
receives notice that the first Major EU Member State has granted
the Technical Approvals for the Product for the Ovarian
Indication.
(d) In the event that shares of the Common Stock are not publicly-
traded on a national securities exchange at the time that any of
the foregoing options shall be exercised, then such option shall
be exercisable for Series D Stock, and in the event that shares
of the Common Stock are publicly-traded on such an exchange at
such time, then such option shall be exercisable for Common
Stock.
ARTICLE VII
JOINT CONSULTATION COMMITTEE
7.1 Formation of the JCC. In order to facilitate the exchange of
information between the parties relating to their activities pursuant to this
Agreement, the parties hereby establish a joint consultation committee (the
"JCC") comprised of four individuals. Nycomed and Anthra shall each appoint two
members of the JCC. Each member of the JCC shall be a senior 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 JCC may be removed at any time, with or without
cause, by the party that originally appointed such member. A member of the JCC
shall serve until a successor is named by the party that appointed such member.
7.2 Authority of the JCC. The JCC 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 Nycomed pursuant to this Agreement, including
without limitation, premarketing activities and clinical studies conducted
pursuant to Section 4.2, (c) discuss issues
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concerning supply of the Product, (d) discuss issues concerning the market
position and competitiveness of the Product in the Territory, (d) discuss
whether, and on what basis, the parties should continue funding any clinical
studies as to which the spending caps set forth in Sections 2.1(c) and 2.4(c)
have been reached, and (f) take such other actions as the parties may mutually
agree, except that the JCC may not take any action that would conflict with any
provision of this Agreement. It is not intended that the JCC 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 JCC unless such delegation or
vesting of rights is expressly provided for in this Agreement or the parties
expressly so agree in writing. The JCC shall not have the power to amend or
modify this Agreement, which may only be amended or modified as provided in
Section 15.11.
7.3 Procedural Rules of the JCC.
(a) The JCC shall adopt such standing rules as shall be
necessary for its work.
(b) A quorum of the JCC shall consist of two members, provided
that at least one member appointed by Nycomed and at least one member appointed
by Anthra is
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present. Members of the JCC may attend a meeting either in person or by
telephone conference call. Representation by proxy shall not be allowed.
(c) The JCC 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 JCC shall have a chairperson and a secretary. The
first chairperson shall be a member of the JCC 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 Nycomed. The first
secretary shall be a member of the JCC designated by Nycomed. Each secretary
shall serve a one-year term, and the office shall alternate between members
appointed by Nycomed and members appointed by Anthra.
(e) The JCC shall meet every six months or more frequently as
mutually agreed upon by the members, at times and 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
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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. Nycomed shall, and shall cause its Sublicensees
to, keep complete and accurate books and records pertaining to the internal
distribution and sale of the Product (and, in the case of Nycomed, pertaining to
any clinical studies conducted pursuant to Section 4.2), including the names and
addresses and purchase order details for each customer to which it sells the
Product (and in the case of Nycomed, the names and addresses of each Person to
which it distributes the clinical supplies of the Product pursuant to Section
4.2). Such books and records shall be retained by for at least six (6) 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, Nycomed 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 pursuant to Section 8.2.
ARTICLE IX
ADVERSE EVENT AND OTHER INFORMATION EXCHANGE
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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 Officer by telephone or facsimile within three (3) business days (or such
shorter period as may be specified by applicable law or regulations), 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, at its sole expense, shall make such reports as are necessary to
comply with laws and regulations applicable to it.
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
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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 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,
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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 (the "Responsible
Party") shall bear the expenses of any recall resulting from the breach of its
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. The Responsible
Party shall reimburse the other party for any recall expenses borne by such
other party within thirty days after receipt of an invoice therefor.
ARTICLE XI
INTELLECTUAL PROPERTY RIGHTS
11.1 Ownership of Licensed Know-how. Except as otherwise expressly
provided in Section 5.1, all right and 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 Nycomed, Anthra decides not to file for, obtain, maintain,
register or extend patent protection for the Licensed Know-how, Nycomed shall
have the right, at its own expense, to take any such action in the name of
Anthra.
11.2 Ownership of Product Improvements. Each party
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shall own all rights, title and interest in all Product Improvements that it may
develop. If Anthra or any of its Affiliates shall develop any Product
Improvements during the term of this Agreement, it shall so notify Nycomed and
shall grant, or cause such Affiliate to grant, to Nycomed a royalty-free,
exclusive license (with right to sublicense to Sublicensees) to use such Product
Improvements in the Marketing, distribution and sale of the Product in the
Territory; provided, however, that Nycomed may use such Product Improvements in
the Manufacturing of the Product in the Territory in the event that the
Manufacturing Agreement is executed. If Nycomed or any of its Affiliates or
Sublicensees shall develop any Product Improvements during the term of this
Agreement, it shall so notify Anthra and shall grant, or cause such Affiliate or
Sublicensee to grant, to Anthra a royalty-free, exclusive license (with right to
sublicense) to use such Product Improvements in the Manufacturing, Marketing,
distribution and sale of the Product outside the Territory.
11.3 Additional Developments. Each party shall own all rights, title
and interest in all Additional Developments that it may develop. The party that
develops any such Additional Development shall notify the other party thereof
and, subject to mutual agreement on an appropriate rate of royalty and other
terms and conditions, shall grant such other party a royalty-bearing license
(with a right to sublicense to
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Sublicensees) to use such Additional Development, (i) in the case of Nycomed as
licensee, in the Marketing, distribution and sale of the Product in the
Territory, provided, however, that Nycomed may use such Additional Development
in the Manufacturing of the Product in the Territory in the event that the
Manufacturing Agreement is executed; and (ii) in the case of Anthra as licensee,
in the Manufacturing, Marketing, distribution and sale of the Product outside
the Territory. In the event that an Anthra licensee other than Nycomed shall
develop an Additional Development, Anthra shall use commercially reasonable
efforts to assist Nycomed in procuring a royalty-bearing license to use such
Additional Development in the Marketing, sale or distribution of the Product in
the Territory; provided, however, that Nycomed shall bear all payment and other
obligations relating to such license.
11.4 Ownership of Filings and Approvals. As between Anthra and
Nycomed, Anthra shall own all rights, title and interest in (a) all
Registrations and other submissions to Regulatory Authorities made pursuant to
this Agreement, and (b) all Approvals made or granted with respect to the
Product in the Territory.
11.5 Ownership of Data. Except as otherwise provided in Sections
11.2 and 11.3, Anthra shall own all rights, title and interest to the
preclinical and clinical data arising out of its activities pursuant to this
Agreement
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or arising out of any clinical studies conducted pursuant to Section 4.2.
11.6 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
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 ninety (90) days after Notice from
Nycomed requesting Anthra to do so, then Nycomed 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.
11.7 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
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Remedies against the infringing party.
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 (x) that is furnished to the Receiving Party orally
and is of a nature which is typically regarded in the industry as confidential
or proprietary, or (y) that is clearly marked to indicate its confidential
nature and is furnished to the Receiving Party in writing, 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
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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
(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 laws and 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
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obligations no less onerous than those set forth in this Article XII.
Notwithstanding anything in this Article XII to the contrary, Nycomed shall have
the right to disclose preclinical and clinical data and results relating to the
Product to qualified health care professionals for the limited purposes of
advertising and promoting the Product and conducting medical education
initiatives reasonably designed to increase Net Sales in accordance with
accepted practices in the pharmaceutical industry.
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.
12.4 Publications. Anthra agrees not to publish, without the prior
written consent of Nycomed, any of the following preclinical or clinical data
relating to the Product: pivotal clinical study protocols; appointments,
qualifications and clinical duties of investigators involved in pivotal studies;
audit certificates of pivotal studies; reasons for premature withdrawal of
patients from pivotal studies; complete lists of all adverse events occurring in
pivotal studies; or toxicology studies pertaining to the intravesical or
intraperitoneal routes of administration not previously published.
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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 Nycomed that (i)
Anthra has the right, power and authority to grant the license set forth in
Section 5.1, (ii) 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 applicable known or published
standards of the U.S. Food and Drug Administration and other Regulatory
Authorities, (iii) 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, and (iv) the
exercise by Nycomed of its rights under this Agreement will not infringe any
intellectual
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property rights of any third party, including without limitation any patent
right. EXCEPT AS SET FORTH IN THE PRECEDING SENTENCE AND IN SECTION 3.3, ANTHRA
HEREBY DISCLAIMS ANY AND ALL TERMS, CONDITIONS AND WARRANTIES WITH RESPECT TO
THE LICENSED KNOW-HOW OR THE PRODUCT, INCLUDING WITHOUT LIMITATION ANY IMPLIED
TERM, CONDITION OR WARRANTY OF SATISFACTORY QUALITY OR FITNESS FOR A PARTICULAR
PURPOSE.
13.3 Indemnification of Nycomed.
(a) Anthra shall indemnify, defend and hold harmless Nycomed
and each of its subsidiaries, officers, directors, employees, shareholders and
distributors from and against any and all demands, claims, actions or causes of
action, assessments, losses, damages, liabilities, interest and penalties, costs
and expenses (including, without limitation, reasonable legal fees and
disbursements incurred in connection therewith and in successfully seeking
indemnification therefor, and any amounts or expenses required to be paid or
incurred in connection with any action, suit, proceeding, claim, appeal, demand,
assessment or judgment) (collectively, "Indemnifiable Losses") resulting from,
arising out of, imposed upon, or incurred by any person to be indemnified
hereunder by reason of any breach of representation, warranty or covenant of
Anthra under this Agreement, but in any event excluding matters for which
Nycomed is responsible under Section 13.4.
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(b) Anthra shall maintain product liability insurance or
self-insurance in such amounts as ordinary good business practice for its type
of business would make advisable and shall provide Nycomed with evidence of such
coverage.
13.4 Indemnification of Anthra. Nycomed shall indemnify, defend and
hold harmless Anthra and each of its subsidiaries, officers, directors,
employees, shareholders and distributors from and against any and all
Indemnifiable Losses resulting from, arising out of, imposed upon, or incurred
by any person to be indemnified hereunder by reason of (i) any breach of
representation, warranty or covenant of Nycomed under this Agreement or (ii) any
product claims, whether written or oral, made or alleged to be made by Nycomed
or its agents in the Marketing of the Product, but only to the extent that such
product claims were not provided to Nycomed by Anthra or approved in writing by
Anthra, but in any event excluding matters for which Anthra is responsible under
Section 13.3.
13.5 Indemnification Procedure. (a) All claims under Sections 13.3
and 13.4 shall be deemed to be waived unless made in writing to the indemnifying
Party within sixty (60) days after the indemnified Party became aware or should
have become aware of such claims.
(b) Each party shall furnish promptly to the
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other copies of all papers and official documents received in 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
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of 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 third party claim shall be reimbursed on a calendar
quarter basis by the indemnifying party, subject to mutual agreement of the
parties that such claim is within the scope of the indemnifying party's
indemnity in Section 13.3 or 13.4, as the case may be.
(g) The obligations of the parties pursuant to this Article
XIII shall survive the expiration or termination of this Agreement.
13.6 Limitation of Liability. Notwithstanding any other provision of
this Agreement, neither party shall in any event be liable to the other party
for special, incidental, indirect or consequential damages, except in the case
of damages caused by a party's willful misconduct.
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 on which the
First Major EU Member State in the Territory grants the Technical Approvals for
the Product for any Indication (the "Initial Term"). Thereafter, the term hereof
shall automatically be extended for successive
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periods of one year, unless either party gives written notice to the other at
least twelve months prior to the end of the then-current term that such party
objects to a further extension of the term.
14.2 Termination for Material Breach. This Agreement shall be
subject to early termination by either party in the event of a material breach
of this Agreement or the Investment Agreement 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 Unilateral Termination by Anthra.
(a) Anthra shall have the right, at the sole discretion of
Anthra, by notice to Nycomed, with respect to any country in which Pricing
Approval is required, to (i) cause all exclusive licenses with respect to such
country granted to Nycomed in Section 5.1 to become non-exclusive or (ii)
terminate this Agreement with respect to such country, upon the satisfaction of
the following two conditions: (A) the parties do not mutually agree, pursuant to
Section 2.4(b), that the size of the market for the Product for the Indications
in such country does not justify incurring the cost of one or more clinical
studies required in connection with the Pricing Approval and (B) Nycomed shall
not have
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launched the Product in such country by the second anniversary of the grant of
the Technical Approvals in such country. If Anthra shall terminate this
Agreement with respect to a country pursuant to this Section 14.3, then Anthra
***
(b) Anthra shall have the right, by notice to Nycomed, to
terminate this Agreement pursuant to Section 15.4(c).
14.4 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.
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14.5 Effect of Expiration or Termination.
(a) 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.
(b) In the event of termination of this Agreement, Anthra, in
its sole discretion, may repurchase the inventory of the Product held by Nycomed
at the time of such termination, at the price at which Nycomed purchased such
Product from Anthra pursuant to this Agreement; provided, however, that if
Anthra shall not notify Nycomed, within fourteen days after such termination, of
its intention to repurchase such inventory, then Nycomed may sell such inventory
in the Territory for a period not to exceed one year from the date of such
termination.
(c) In the event of termination of this Agreement, Anthra may
cancel, at its option, any or all purchase orders received from Nycomed prior to
the date of such termination, that provide for delivery of the Product after
such date, except if failure to fill such purchase orders would cause Nycomed to
be in breach of its supply obligations to third parties under written
agreements; provided, however, that Anthra may cancel all such purchase orders
in the event of its termination of this Agreement
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pursuant to Section 14.2.
(d) Nycomed agrees to cooperate with Anthra in 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 Nycomed, directly relating to the Product
(and not including general market information and the like not directly relating
to the Product), except to the extent that Nycomed requires such data, files and
materials for the purpose of exercising any rights under this Agreement that may
survive such termination or expiration.
14.6 No Compensation. In the event that either party shall terminate
this Agreement for any reason in accordance with the terms hereof, the parties
agree that, subject to the provisions of this Article XIV, and without prejudice
to any other remedies that either party may have in respect of any breach of
this Agreement, neither party shall be entitled to any compensation or like
payment from the other party as a result of such termination.
14.7 Survival. The rights and obligations of the parties under
Sections 3.7 (Payment), 3.9 (Records), 5.6 (Nycomed Grant to Anthra), 6.5
(Options) (only with respect to the deadline for exercise of any options granted
to Nycomed pursuant thereto prior to the date of termination or expiration
hereof), 8.2 (Record Keeping), 8.3 (Audit of
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Records), Article IX (Adverse Event and Other Information Exchange) (only with
respect to Nycomed's obligations thereunder), Article X (Product Recall),
Sections 11.2 (Ownership of Product Improvements) (only with respect to Anthra's
rights thereunder), 11.3 (Additional Developments) (only with respect to
Anthra's rights thereunder), 12.1 (Confidential Information), 12.2 (Disclosure
of Confidential Information), 13.3 (Indemnification of Nycomed), 13.4
(Indemnification of Anthra), 13.5 (Indemnification Procedure), Article XIV (Term
and Termination), Sections 15.2 (Notice) and 15.6 (Arbitration) shall survive
the expiration or termination of this Agreement for any reason whatsoever.
In the event of the termination of this Agreement by Nycomed
pursuant to Sections 14.2 or 14.4, the licenses granted to Nycomed in Sections
5.1, 11.2 and 11.3 shall remain in full force and effect through the tenth
anniversary of the Launch of the Product. In the event of the termination of
this Agreement by Anthra pursuant to this Article XIV, no license granted to
Nycomed in this Agreement shall survive such termination.
ARTICLE XV
GENERAL PROVISIONS
15.1 Force Majeure.
(a) For purposes of this Section 15.1, "Force Majeure" shall
mean any event or condition not existing as of
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the date of this Agreement, unexpected as of such date, and not reasonably
within the control of either party, which prevents in whole or in material part
the performance by such party of its obligations hereunder, and shall include,
without limitation, any act of God; fire; casualty; flood; war; strike; lockout;
failure of public utilities; injunction or any act, exercise, assertion or
requirement of governmental authority, including any law, order or regulation
permanently or temporarily prohibiting or reducing the level of research or
development; epidemic; destruction of research facilities; riots; insurrection;
inability to procure or use materials, labor, equipment, transportation or
energy sufficient to meet experimentation or manufacturing needs.
(b) Upon giving notice to the other party, a party affected by
an event of Force Majeure shall be released without any liability on its part
from the performance of the relevant obligations hereunder, except for the
obligation to pay any amounts due and owing hereunder, but only to the extent
and only for the period that its performance of such obligations is prevented by
the event of Force Majeure.
(c) During the period that the performance by a party hereto
of its obligations under this Agreement has been suspended by reason of an event
of Force Majeure, the other party may likewise suspend the performance of all or
part of its obligations hereunder to the extent that such
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suspension is commercially reasonable in light of the suspension of the other
party's performance.
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.
▇▇ ▇▇▇▇▇▇ ▇▇▇▇
▇▇▇▇▇▇▇▇▇, ▇.▇. ▇▇▇▇▇ ▇.▇.▇.
Fax: (▇▇▇) ▇▇▇-▇▇▇▇
Attention: ▇▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇
If to Nycomed:
Nycomed Pharma AS
▇▇▇▇▇▇▇▇▇▇▇▇▇ ▇▇
▇.▇. ▇▇▇ ▇▇▇▇ - ▇▇▇▇▇▇▇
▇-▇▇▇▇ ▇▇▇▇
▇▇▇▇▇▇
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
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business day after receipt, if sent by facsimile.
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.
(a) The terms and provisions hereof shall inure to the benefit
of, and be binding upon, Anthra, Nycomed and their respective successors and
permitted assigns. Except in the case of an assignment or delegation to an
Affiliate, each party shall assign all of its rights and delegate all of its
duties hereunder in connection with any permitted assignment or delegation that
it may make. As a condition to the effectiveness of any such assignment, the
proposed assignee shall assume in writing and agree to be bound by the
provisions of this Agreement. Any attempt to assign or delegate any portion of
this Agreement in violation of this Section 15.4 shall be null and void.
(b) Without regard to transfers effected by
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the operation of law, neither party may assign any of its rights and interests,
or delegate any of its obligations hereunder, without the prior written consent
of the other party; provided, however, that either party may assign some or all
of its rights and delegate its duties hereunder to an Affiliate thereof without
obtaining such consent, provided that the assignor agrees to remain primarily
(and not secondarily or derivatively) liable for the full and timely performance
by such Affiliate of all such assigned obligations.
(c) In the event that (i) there is a Change of Control of
Nycomed Pharma AS (or any Person that Controls Nycomed Pharma AS, directly or
indirectly), and (ii) the Person that has acquired such Control, at the time of
such Change of Control, is developing, has developed, and/or is marketing and
selling, directly or indirectly, any product for intracavitary use that competes
with the Product with respect to any Indication for which labelling approval
will be sought or has been received in the Territory, then Anthra and Nycomed
shall use their good faith efforts to execute a co-promotion agreement, within
ninety (90) days after the date of such Change of Control, on terms and
conditions customary in the industry, pursuant to which Anthra shall have the
right to co-sell (or to contract with a third party to co-sell) the Product in
the Territory for the Indications, and Nycomed
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shall have the sole right to accept all purchase orders for the Product in the
Territory under such agreement, with all sales thereof for the account of
Nycomed; provided, however, that if the parties shall fail to execute such
agreement within such period, then Anthra may terminate this Agreement by
written notice to Nycomed.
15.5 Governing Law. This Agreement shall be governed and construed
by, and enforced in accordance with, the laws of England, without regard to
principles of conflicts of law thereof.
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 London, England and 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 (or, in case each party
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shall prevail partially, such fees and expenses shall be shared by the parties
in accordance with the decision of the arbitrators). All arbitration rulings and
awards shall be final and binding on the parties and shall be enforceable in
accordance with the 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.
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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 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, together with the Annexes
hereto, 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
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agreement, in writing, fully executed by each of the parties.
15.12 Null and Void. This Agreement shall automatically become null
and void and of no effect, without further action by the parties, in the event
that the Closing under the Investment Agreement shall not have occurred by
October 27, 1997 (or such later date as the parties may mutually agree in
writing).
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. NYCOMED PHARMA AS
By: /s/ ▇▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇ By: /s/ ▇▇▇▇▇ ▇▇▇▇▇▇▇▇
------------------------- -------------------------
▇▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇ ▇▇▇▇▇ ▇▇▇▇▇▇▇▇
President President
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ANNEX A
SPECIFICATIONS
***
62
ANNEX B
PIVOTAL CLINICAL PLAN - ONGOING STUDIES
AD 32 (N-TRIFLUOROACETYLADRIAMYCIN-14-VALERATE)
European
Study/Phase Route and Dose Claims Supported Status - August 1997
A9301, A9302, A9303 Intravesical; Refractory transitional cell carcinoma Accrual complete;
Phase II - US 800 mg weekly x 6 Follow-up ongoing
A9304 Intravesical; Refractory transitional cell carcinoma Accrual complete;
Phase II - Europe 800 mg weekly x 6 Follow-up ongoing
A9621 Intravesical; Refractory transitional cell carcinoma Ongoing
Phase II - Europe 800 mg weekly x 6 (supportive)
A9623 Intravesical; Refractory transitional cell carcinoma Ongoing
Phase II - Europe 800 mg weekly x 6 (supportive)
A9601 Intravesical; 800 mg immediately Adjunctive treatment of patients with Ongoing
Phase III - US post-TURB superficial TCC
A9503 Intraperitoneal; Refractory ovarian carcinoma Ongoing
Phase III - US 600 mg/m2 monthly x 6
A9622 Intraperitoneal; Refractory ovarian carcinoma Initiation 4Q97
Phase III - Europe 600 mg/m2 monthly x 6
A9701 Intravesical; 800 mg Adjunctive treatment of patients with Initiation 3Q97
Phase II - US immediately post-TURB superficial TCC
63
ANNEX C
BASIS FOR CALCULATION OF MINIMUM PURCHASE REQUIREMENTS
(STANDARD)
Calendar Year of Launch (Year 1) and
Calendar Years after Launch (Years 2 - 5)
(no. of 200 mg vials, or equivalent in volume)
Year 1 Year 2 Year 3 Year 4 Year 5
------ ------ ------ ------ ------
10,000 13,500 18,000 21,600 21,600
64
ANNEX D
BASIS FOR CALCULATION OF MINIMUM PURCHASE REQUIREMENTS
(AFTER CHANGE OF CONTROL)
Calendar Year of Launch (Year 1) and
Calendar Years after Launch (Years 2 - 5)
(no. of 200 mg vials, or equivalent in volume)
Year 1 Year 2 Year 3 Year 4 Year 5
------ ------ ------ ------ ------
13,333 18,000 24,000 28,800 28,800
▇▇
▇▇▇▇▇ ▇
▇▇▇▇▇▇▇▇▇
The following countries comprise the Territory:
United Kingdom, the Republic of Ireland, France, Italy, Germany, Austria,
Switzerland, Belgium, the Netherlands, Luxembourg, Sweden, Norway,
Finland, Denmark, Iceland, Greece, Poland, Slovakia, the Czech Republic,
Hungary, Romania, Bulgaria, Slovenia, Croatia, Bosnia-Hertzogovina,
Yugoslavia, Lithuania, Latvia, Estonia, Russia, and the Commonwealth of
Independent States.
66
ANNEX F
FORECASTING, ORDERS AND DELIVERY OF PRODUCT
A. Good Faith Forecasts. No later than thirty (30) days after
Anthra files its initial Registration for the Product in the EU, Nycomed
shall provide Anthra with a forecast estimating Nycomed's quarterly
requirements of the Product (and the desired delivery dates therefor) for
the succeeding eighteen (18) month period. Thereafter, on or before the
first day of January, April, July and October of each year during the term
hereof, Nycomed shall provide Anthra with an updated forecast estimating
Nycomed's quarterly requirements of the Product (and the desired delivery
dates therefor) for the succeeding eighteen (18) month period. Nycomed
shall prepare such estimates in good faith; provided, however, that,
subject to Paragraph (B) of this Annex F, such estimates shall not be
binding on either party.
B. Firm Forecasts. Nycomed shall provide Anthra with a firm
forecast of Nycomed's requirements of the Product (and the desired
delivery dates therefor) (i) for the sixth-month period beginning on
January 1 of each calendar year, not later than September 30 of the
preceding year, and (ii) for the six-month period beginning on July 1 of
each calendar year, not later than March 31 of such year. Nycomed may
amend any firm forecast (i) at any time prior to the issuance of the
affected purchase order(s), upon written notice to Anthra, if the net
change in the quantity of the forecasted requirements of the Product is
twenty percent (20%) or less, or (ii) upon written notice to Anthra at
least ninety days prior to the issuance of the affected purchase order(s),
if the net change in the quantity of the forecasted requirements of the
Product exceeds twenty percent (20%) but does not exceed thirty percent
(30%); provided, however, that in no event may Nycomed make net changes of
more than thirty percent (30%) in the quantity of the forecasted
requirements of the Product in any firm forecast. Except as provided in
the preceding sentence, Nycomed 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 therein.
C. Purchase Orders. Nycomed shall issue to Anthra firm
purchase orders for each delivery, not later than three (3)
67
months prior to the forecasted delivery date. The quantities ordered shall
be consistent with the firm forecast for the relevant period given by
Nycomed pursuant to Paragraph (B) of this Annex F (and, if applicable, as
amended pursuant thereto). In the event that the terms of any such
purchase order are not consistent with this Agreement, the terms of this
Agreement shall prevail. The submitted purchase orders shall be in
writing, whether by mail, telecopy, telegram, electronic data interchange,
or otherwise, and shall, at a minimum, set forth the product description,
quantities, language requirements, delivery dates, shipping instructions
and shipping addresses for all the Product ordered. Anthra shall issue and
send to Nycomed a confirmation of each purchase order, within five working
days after receipt thereof, provided that such purchase order conforms to
the requirements set forth in this Annex F. No purchase order may be
amended except by mutual agreement of the parties.
D. Delivery. Delivery of each order of Product shall be made,
at the election of Nycomed, (i) C.I.F. Roskilde, Denmark or (ii) F.O.B. at
a location to be designated by Anthra (Incoterms 1990). In the case of
delivery on an F.O.B. basis, Anthra shall arrange for insurance and
transportation of the Product to a destination designated by Nycomed and
by a common carrier designated by Nycomed, at the sole expense of Nycomed,
and title to and risk of loss of the Product shall pass to Nycomed at the
time of delivery to the carrier. Nycomed 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 Nycomed for all Product shipped. Invoices shall be
accompanied by a certificate of analysis showing the conformity of the
invoiced lot of Product with the Product Specifications, together with the
following information: Product name; batch number; manufacturing date;
expiry date; batch size; amount of delivered packs; a batch report stating
that the Product has been produced and controlled in accordance with EU
GMP rules and the requirements stipulated in the relevant Technical
Approval; and a certification that the Product has been released by a
Qualified Person, as defined under applicable EU regulations. The Product
shall be delivered in finished, packed form, with labelling in compliance
with applicable regulatory requirements.