EXHIBIT 10.12
DATED JUNE 21, 2002
XXX PHARMACEUTICAL PRODUCTS LTD. A/S
(XXX PHARMA A/S)
- and -
PHARMION CORPORATION
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LICENSE AND DISTRIBUTION AGREEMENT
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TABLE OF CONTENTS
1. Definitions and Interpretation..................................................................... 2
2. Appointment of Pharmion; License Grant............................................................. 8
3. Existing NDA and Existing IND...................................................................... 9
4. Commercialization Efforts in the Territory......................................................... 10
5. Coordination of Development Efforts; Development for Additional Indications........................ 13
6. Consideration...................................................................................... 18
7. Manufacture and Supply of Product.................................................................. 21
8. Product Returns.................................................................................... 24
9. Monthly Reporting, Forecasting and Ordering........................................................ 24
10. Packaging and Labeling; Use of Name................................................................ 25
11. Quality of Product................................................................................. 26
12. Delivery........................................................................................... 28
13. Supply Price; Payment for Product Supply........................................................... 30
14. Adverse Drug Experiences; Complaints............................................................... 31
15. Undertakings and Warranties of Pharmion............................................................ 32
16. Undertakings and Warranties of XXX................................................................. 34
17. Confidentiality.................................................................................... 35
18. Indemnities........................................................................................ 36
19. Duration and Termination........................................................................... 37
20. Consequences of Termination........................................................................ 39
21. Rights and Remedies................................................................................ 40
22. Force Majeure...................................................................................... 40
23. Gross Inequities................................................................................... 41
24. Notice............................................................................................. 41
25. Entire Agreement/Variations........................................................................ 42
26. Counterparts; English Language..................................................................... 42
27. Severance of Terms................................................................................. 42
28. Publication/Presentation/Press Release............................................................. 43
29. Partnership/Agency; Third Parties.................................................................. 43
30. Assignment......................................................................................... 43
License and Distribution Agreement Page i
31. Audit Rights....................................................................................... 43
32. Governing Law and Jurisdiction..................................................................... 44
Schedules:
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Schedule 1 XXX Logo Guidelines
Schedule 2 Minimum Payments
Schedule 3 Trade Xxxx
Schedule 4 Transition Coordination Procedures
Schedule 5 Form of Technical Assistance Agreement
Schedule 6 Finished Goods Packaging Specifications
Schedule 7 Location of Initial Inventory
License and Distribution Agreement Page ii
LICENSE AND DISTRIBUTION AGREEMENT
THIS AGREEMENT is made the 21st day of June 2002
BETWEEN:
(1) XXX PHARMACEUTICAL PRODUCTS LTD. A/S (XXX PHARMA A/S), a company
organized under the laws of Denmark and having its principal place of
business at Xxxxxxxxxxxxxx 00, XX-0000 Xxxxxxxx, Xxxxxxx ("XXX") and
(2) PHARMION CORPORATION, a company organized under the laws of the State
of Delaware, USA and having its principal place of business at 0000
Xxxxxxxxx Xxxx, Xxxxxxx, Xxxxxxxx 00000 ("Pharmion")
RECITALS:
(A) XXX is the owner of trade marks and owns or controls Data (as
hereinafter defined) relating to the Product (as hereinafter defined),
and is currently marketing and selling the Product in various global
markets including the United States.
(B) XXX is the holder of an Existing NDA and an Existing IND (each as
hereinafter defined) for the Product in the United States, and is in a
position to supply Product to Pharmion for distribution in the United
States on the terms hereinafter described.
(C) Pharmion's personnel have expertise and experience in the development,
registration, marketing and distribution of pharmaceutical products in
the United States.
(D) Pharmion wishes to become the sponsor of the Existing NDA and to
distribute the Product under the Trade Xxxx (as hereinafter defined)
for the Initial Indication (as hereinafter defined), and to become the
sponsor of the Existing IND (as hereinafter defined) and to develop,
obtain supplemental NDAs for and distribute the Product using the Data
for Additional Indications and New Presentations (both as hereinafter
defined) in the United States, and XXX is willing to grant such rights
to Pharmion and to supply Pharmion's requirements of the Product, all
on the terms and conditions set out in this Agreement.
NOW, THEREFORE, THE PARTIES HEREBY AGREE AS FOLLOWS:
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1. DEFINITIONS AND INTERPRETATION
1.1. In this Agreement, the following terms shall have the following
meanings unless the context requires otherwise:
"ADDITIONAL INDICATION" means any indication other than the Initial
Indication.
"ADDITIONAL NDA" means any supplemental NDA or any additional NDA
"AFFILIATE" means any corporation, firm, partnership, organization or
entity that directly or indirectly controls, is controlled by or is
under common control with such entity. For the purpose of this
definition the term "control" means direct or indirect ownership of at
least fifty percent (50%) of the outstanding equity voting stock (or
such lesser percentage which is the maximum allowed to be owned by a
foreign corporation in a particular jurisdiction) of an entity.
"AGENCY" means any governmental authority in the XXX Territory
responsible for granting approvals and clearance for marketing and sale
of the Product.
"BUSINESS DAY" means every day except a Saturday, Sunday or a day which
is a statutory holiday in Denmark or in the United States.
"CASH DISCOUNT" means a discount for prompt payment given by Pharmion
to its customers in the ordinary course of business, not to exceed two
percent (2%) of the amount invoiced to such customers.
"cGMP" means current good manufacturing practices as established, from
time to time, by the FDA.
"COMMERCIALLY REASONABLE EFFORTS" means efforts by a Party consistent
with the prudent exercise of business judgments which shall not be less
than for the development, manufacturing, registration or
commercialization (as the case may be) of such Party's own
pharmaceutical products of similar commercial potential.
"CONTROL" OR"CONTROLLED" means possession of the ability to grant a
license or sublicense of Data or other intangible rights as provided
for herein without violating the terms of any agreement or other
arrangement with any third party.
"CURRENT DISTRIBUTOR" means UPS Supply Chain Solutions, Inc, 000
Xxxxxxx Xxxxx, Xxxxx 000, Xxxxxxx Xxxxxxx 00000.
"DANISH INDEX" means the Summarisk loenindeks for den private sektor -
Industri (the Danish Pay Index for Industry) published by Statistics
Denmark and currently posted on the internet at xxx.xxx.xx.
"DATA" means information in the possession or Control of XXX relating
to the Product and the Existing NDA and the Existing IND and Marketing
Authorizations and necessary or desirable for the marketing and sale of
the
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Product in the Territory or the XXX Territory or for the clinical
development of the Product for Additional Indications or New
Presentations in the Territory including, without limitation,
confidential know how, technical information, technology and trade
secrets relating to the Product, information relating to the
pre-clinical and clinical testing and approval of the Product,
information relating to any suspected adverse drug experiences with the
Product and any toxicological, pharmacological or pharmacokinetic
studies relating to the Product.
"DEVELOPMENT AND MARKETING COMMITTEE" means the Development and
Marketing Committee described in Section 5.3 and 5.4
"DEVELOPMENT PLAN" means an outline proposal for the development of the
Product for an Additional Indication or a New Presentation, to be
submitted to the Development and Marketing Committee in accordance with
Section 5.5.
"EFFECTIVE DATE" means July 12, 2002, provided, that neither Pharmion
nor XXX shall have delivered the notice described in Section 1.3.
"EXISTING IND" means the Investigational New Drug Application number
59,764 currently held by XXX
"EXISTING NDA" means the NDA as in effect on the Effective Date, NDA
number 20-484.
"FDA" means the United States Food and Drug Administration.
"FINISHED GOODS" means Product Packed and ready for sale to the
ultimate customer.
"FIRM ORDER" shall have the meaning set forth in Section 9.3.
"IMPROVEMENTS" means all improvements, modifications or adaptations to
any part of the Data or the Product made or acquired by either Party
during the term of this Agreement.
"INITIAL INDICATION" means the treatment of acute symptomatic deep vein
thrombosis, with or without pulmonary embolism, when administered in
conjunction with warfarin sodium.
"INITIAL INVENTORY" means Product labeled for the Territory that is
available and in stock with the Current Distributor on the Effective
Date.
"INITIAL INVENTORY VALUE" means the value of the Initial Inventory
based upon the application of the Price Per Vial to the total count of
Initial Inventory as determined in accordance with Section 7.9.
"XXX LOGO GUIDELINES" means the guidelines for use of the XXX name and
the Assyrian Lion logo attached to this Agreement as Schedule 1.
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"XXX PRODUCT BRANDING" means collectively: the Trade Xxxx, the XXX
name, the Assyrian Lion, the XXX Product Design Concept, the XXX Logo
Guidelines and any domain names or websites related to the Product in
the USA.
"XXX PRODUCT DESIGN CONCEPT" means the global design concept for
packaging and promotional materials related to the Product developed by
XXX and previously delivered to Pharmion.
"XXX TERRITORY" means all countries of the world except the United
States of America and its present possessions and territories.
"LONG-RANGE FORECAST" has the meaning set out in Section 9.2 herein.
"MANUFACTURE" OR"MANUFACTURING" means all the operations required to
manufacture, test, release, handle, store, ship and destroy the
Product, or any step thereof, as the case may be.
"MANUFACTURER" means (i) XXX and (ii) any successor entity chosen by
XXX for Manufacturing and Packing the Product for supply in the
Territory in accordance with the procedures contemplated by Section 7.8
hereof.
"MARKETING AUTHORIZATIONS" means any approvals, product and/or
establishment licenses, marketing authorizations or registrations of
any federal, state or local Agency necessary for the commercial
manufacture, use, storage, import, export, transport, marketing or sale
of the Product in any country or regulatory jurisdiction of the XXX
Territory.
"MARKETING PLAN" means the annual marketing plan developed by Pharmion
for the Product as described in Section 4.3.
"MINIMUM PAYMENTS" means the amounts specified in Schedule 2 hereof.
"NDA" means a New Drug Application with the FDA necessary for the
commercial manufacture, use, storage, import, export, transport,
marketing or sale of the Product in the Territory.
"NEW PRESENTATIONS" means presentations for parenteral administration
of the Product in addition to the presentation in vials described in
the Existing NDA.
"NET SALES" means the amount invoiced by Pharmion for sales of Product
to a third party less deductions for: (i) shipping, freight charges or
insurance paid to the extent separately set forth in the amount
invoiced to Pharmion's customer; (ii) sales and excise taxes and any
other direct taxes paid by Pharmion; (iii) retroactive price
reductions; (iv) rebates, non-cash rebates or allowances actually
incurred; (v) quantity discounts, Cash Discounts or chargebacks
actually incurred in the ordinary course of business in connection with
the sale of such Product; and (vi) allowances or credits actually
granted to customers, not in excess of the selling price of such
Product on account of governmental laws, written regulations
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or code, price differences, rejection, outdating, spoiled, damaged,
recalls or returns of such Product, with all such items in (i) through
(vi) being incurred or accrued in accordance with U.S. generally
accepted accounting principles. There shall be no deduction from the
invoiced sales price for sales commissions paid to independent sales
representatives or employees of Pharmion. To the extent that the
Product is sold by Pharmion in combination with other products, then
the Net Sales for such combined sales shall be calculated as follows:
Net Sales = C * [P / (P+O) ],
where "C" are the net revenues from the combined sale, "P" is the price
of the Product which is part of such combined sale, when the Product is
separately sold, and "O" is the price of the other components of the
combined sale when separately sold, provided that if the fraction
resulting from such calculation is less than 0.70, then the result
shall be deemed for purposes of this Agreement to be 0.70.
For the purpose of calculating Net Sales, the Parties recognize that
(a) Pharmion's customers may include persons in the chain of commerce
who enter into agreements with Pharmion as to price even though title
to the Product does not pass directly from Pharmion to such customers,
and even though payment for such Product is not made by such customers
directly to Pharmion, and (b) in such cases, chargebacks paid by
Pharmion to or through a third party (such as a wholesaler) can be
deducted by Pharmion from gross revenue in order to calculate Net
Sales. Any deductions listed above that involve a payment by Pharmion
shall be taken as a deduction against aggregate sales for the period in
which the payment is made.
"PACK", "PACKED" OR "PACKING" means the operations which comprise the
labeling and packaging of the Product or any step thereof, as the case
may be.
"PACKAGING" means the packaging in which the Product is supplied by XXX
to Pharmion.
"PARTIES" means XXX and Pharmion and "PARTY" means either of them as
the context indicates.
"PATENTS" means patents covering inventions that may be developed by
either Party during the term of this Agreement and that relate
specifically to the Product, any Improvements or any New Presentations
and any continuations, continuations-in-part, divisions, provisionals
or any substitute applications, any patent issued with respect to any
such patent applications, any reissue, reexamination, renewal or
extension (including any supplemental patent certificate) of any such
patent, and any confirmation patent or patent of addition based on any
such patent, and all foreign counterparts of any of the foregoing.
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"PRICE PER NEW PRESENTATION" means, as to each New Presentation, the
price per unit of Product in such New Presentation determined in
accordance with Section 13.3.
"PRICE PER VIAL" means U.S. $12.50 for each 2 xx xxxx containing
twenty-thousand (20,000) anti-Xa International Units/ml, as such price
shall be adjusted for changes in the Danish Index as called for by
Section 13.2.
"PRODUCT" means pharmaceutical products containing tinzaparin sodium
for parenteral use known as INNOHEP sold under the Trade Xxxx and more
particularly identified in the Existing NDA, as such product
description may be expanded by an Additional NDA .
"PRODUCT MARKETING MATERIALS" means all marketing materials used with
respect to the Product in the Territory that are in existence as of the
Effective Date, in any form, to the extent such materials are in the
possession and Control of XXX and are legally permitted to be
transferred to Pharmion including, without limitation, all advertising
materials, product data, price lists, mailing lists, customer lists,
sales materials, marketing information, promotional materials,
scientific and commercial publications, market research, artwork for
the production of packaging components, television masters, web sites,
domain names and other materials associated with the Product in the
Territory. Product Marketing Materials shall also include marketing
materials developed by XXX during the term of the Agreement for use in
connection with the sale of the Product in the XXX Territory or
developed by Pharmion for use in connection with the sale of the
Product in the Territory. Product Marketing Materials shall not,
however, include databases of internal XXX communications regarding the
Product.
"SALES INCEPTION DATE" means the later of (i) July 15, 2002 or (ii) the
date on which the count of the Initial Inventory shall have been
completed in accordance with Section 7.9.3(a) of this Agreement.
"SHARING PERCENTAGE" means, as to each Party, the percentage of total
worldwide sales of the Product that was represented by the Net Sales of
the Product in its respective territory (with the definition of Net
Sales to be deemed appropriately modified in the case of XXX to cover
sales of XXX in the XXX Territory) during the immediately preceding
calendar year, provided, that in the case of the first 16 months
following the Effective Date, the Sharing Percentage shall be 30 % in
the case of Pharmion and 70 % in the case of XXX.
"SHORT-DATED" means, with respect to the Initial Inventory, inventory
having a remaining shelf life as of the Effective Date of less than
twelve months.
"SKU" means stock keeping unit, the unit of finished packs as prepared
for distribution to the market.
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"SPECIFICATIONS" means all Manufacturing, Packing, quality assurance
and quality release specifications, standard test methods and sampling
plans as approved by the FDA.
"TECHNICAL ASSISTANCE AGREEMENT" means the technical assistance
agreement to be entered into by XXX and Pharmion as described in
Section 7.7.
"TERRITORY" means the United States of America, including its current
possessions and territories.
"TRADE XXXX" means the trade xxxx owned by XXX, including registrations
and applications for registration thereof (and all renewals,
modifications and extensions thereof), listed on Schedule 3 attached
hereto, and used in connection with the Product in the Territory.
1.2. Construction and Interpretation
In the interpretation of this Agreement:
1.2.1 the headings are for convenience only and shall not affect the
interpretation hereof;
1.2.2 references in this Agreement to Sections, Schedules and
Exhibits are to the sections of, and schedules and exhibits
to, this Agreement;
1.2.3 unless the context otherwise requires the singular shall
include the plural and vice versa, reference to any gender
shall include reference to the other gender, and references to
persons shall include bodies corporate, unincorporated
associations and partnerships; and
1.2.4 this Agreement includes the Schedules and Exhibits hereto.
1.3. Effectiveness of Agreement.
Prior to the date of this Agreement, the Parties have agreed upon a
protocol for the due diligence that each will conduct regarding the
other subsequent to the date of execution of this Agreement, including
the names of the individuals from each of the Parties that will be
involved, a schedule of their meetings, the location of the meetings or
facilities to be inspected, the documents to be examined and the
subject matters to be discussed (the "Agreed Diligence Protocol")
During the two week period immediately following the execution of this
Agreement by both Parties, each Party will grant access to its
personnel involved with the production, marketing and development of
the Product and the facilities in which the Product is produced in
order to enable the other Party and its personnel to conduct their
final due diligence in accordance with the Agreed Diligence Protocol.
It shall be a condition to the effectiveness of this Agreement that
each Party shall be satisfied, in its sole discretion, with the
information
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gathered during such due diligence process. Such condition shall be
deemed to have been met unless, on or prior to July 12, 2002, either
Party delivers written notice to the other Party that it has decided
not to proceed with the transactions contemplated by this Agreement. If
no such notice is issued, then this Agreement shall become effective on
the Effective Date. If either Party delivers such a notice, then this
Agreement shall never come into effect and neither Party shall have any
rights or obligations under this Agreement.
2. APPOINTMENT OF PHARMION; LICENSE GRANT
2.1. Subject to the terms and conditions of this Agreement, with effect from
the Effective Date, XXX hereby appoints Pharmion as its exclusive
distributor for the Product in the Territory and hereby grants to
Pharmion the exclusive right and license:
2.1.1 to purchase the Product from XXX for resale in the Territory;
2.1.2 to advertise, market, promote, distribute, use and sell the
Product, using the Data and under and by reference to the
Trade Xxxx and the other XXX Product Branding, in the
Territory (i) for the Initial Indication and (ii) for any
Additional Indications or New Presentations that are approved
by the Development and Marketing Committee and covered by an
appropriate Additional NDA;
2.1.3 to become the sponsor of the Existing NDA for the Product from
XXX as contemplated by Section 3, and to use the Data to
maintain the Existing NDA for the Product in the Initial
Indication;
2.1.4 to develop the Product using the Data and Improvements for any
Additional Indications or New Presentations approved by the
Development and Marketing Committee, and in connection with
such development to become the sponsor of the Existing IND for
the Product and to apply for additional INDs for the Product
and obtain Additional NDAs for the sale of the Product for
such Additional Indications or New Presentations;
2.1.5 to use the Product Marketing Materials and the XXX Product
Branding in connection with the advertising, marketing,
promotion and distribution of the Product in the Territory;
2.1.6 to develop patient and medical personnel educational programs
as may be required by the FDA or deemed appropriate by
Pharmion for the promotion and development of the Product
2.2. During the term of this Agreement and subject to any contrary legal
requirement that may be imposed upon it, Pharmion will not: (i) seek
customers or establish any branch or distribution depot for the Product
in any country which is outside
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the Territory, or (ii) actively export the Product to any customer
outside the Territory or to any customer within the Territory for
resale outside the Territory.
2.3. During the term of this Agreement and subject to any contrary legal
requirement that may be imposed upon it, XXX will not: (i) seek
customers or establish any branch or distribution depot for the Product
in the Territory, or (ii) actively export the Product outside the
Territory for use or resale in the Territory to any person other than
Pharmion.
2.4. From and after the Effective Date, XXX will to the extent XXX is
legally permitted to do so transfer or procure the transfer to Pharmion
of such elements of the Data, as well as the then current Product
Marketing Materials, which Pharmion may request from time to time and
that are not otherwise contained in the materials transferred as part
of the Existing NDA transferred in accordance with Section 3.1. During
the term of this Agreement, each Party shall, upon the reasonable
request of the other, transfer such data developed by such Party as
comprise Improvements, as well as such new Product Marketing Materials
as have been developed by such Party. All such transfers shall be
coordinated through the Development and Marketing Committee, and each
Party shall have the right, consistent with Agency regulations in the
Territory or the countries within the XXX Territory, to use the Product
Marketing Materials developed by the other to aid in developing its own
Product Marketing Materials for use within its own territory.
3. EXISTING NDA AND EXISTING IND
3.1. XXX will promptly transfer sponsorship of the Existing NDA naming
Pharmion as the NDA holder in place of XXX. XXX will transfer or
procure the transfer to Pharmion of a complete copy of the approved
application relating to the Product for the Territory, including
supplements and records that are required to be kept under 21 CFR
314.81, such documentation to include paper files and, if available,
electronic versions to enable Pharmion to maintain the Existing NDA and
apply for Additional NDAs in the Territory. The Parties hereby agree to
use Commercially Reasonable Efforts to complete the filing of the
transfer of the Existing NDA within four (4) weeks of the Effective
Date. XXX, in collaboration, with Pharmion, will establish a mutually
acceptable communication and interaction process to facilitate a smooth
transfer of the Existing NDA.
3.2. Until such time as each of the foregoing changes of holder is effected,
XXX will maintain the Existing NDA, and XXX shall bear all costs and
expenses incurred in connection with such maintenance.
3.3. Following the transfer of sponsorship, Pharmion shall keep XXX informed
of any changes to the Existing NDA and any Additional NDA which
Pharmion wishes to make or is required to make by the FDA. Changes
relating to the Product, Specifications, Manufacturing or Packaging
shall be dealt with between the parties as specified in Section 11.2.
Changes relating to Additional Indications or
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New Presentations shall be dealt with between the parties as specified
in Section 5.
3.4. Pharmion will not use the Data or the NDA which it obtains except as
required for the purposes of this Agreement and within the Territory.
Pharmion will not grant access to the Data to any third party (other
than a medical professional or an investigator or another consultant
who has entered into confidentiality obligations equivalent to those
set out in this Agreement and who requires access to such Data in
connection with the development or distribution of the Product) or
refer, or authorize reference, to the NDA dossier to enable it or any
such third party to obtain a product license for any products
whatsoever.
3.5. XXX will promptly apply for a transfer of sponsorship of the Existing
IND, naming Pharmion as the IND holder in place of XXX. XXX will
transfer or procure the transfer to Pharmion a complete copy of all
available regulatory documentation relating to the Existing IND, such
documentation to include paper files and, if available, electronic
versions to enable Pharmion to maintain the Existing IND and carry
forward the research contemplated by the Existing IND. XXX, in
collaboration, with Pharmion, will establish a mutually acceptable
communication and interaction process to facilitate a smooth transfer
of the Existing IND.
4. COMMERCIALIZATION EFFORTS IN THE TERRITORY
4.1. Pharmion's Authority/Responsibility. During the term of this Agreement,
Pharmion shall use Commercially Reasonable Efforts to promptly
re-launch and to promote the Product in the Territory, and, except as
otherwise expressly herein provided, Pharmion shall have the right and
responsibility to take such actions with respect to the Product as
would normally be done in accordance with accepted business practices
in the marketing of pharmaceutical products and legal requirements to
obtain and maintain the authorization and/or ability to market a
pharmaceutical product in the the Territory and to market the Product,
including, without limitation, the following:
4.1.1 conducting human clinical trials of the Product as Pharmion
determines are reasonable, necessary or desirable, subject to
the approval of the Development and Marketing Committee, as
contemplated by Section 5;
4.1.2 making appropriate filings, as contemplated by Section 5, for
the registration of one or more Additional Indications for the
therapeutic use of the Product;
4.1.3 marketing the Product at such prices and on such other terms
and conditions as Pharmion determines are reasonable,
necessary or desirable;
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4.1.4 developing patient and medical personnel educational programs
as may be required by the FDA or deemed appropriate by
Pharmion for the promotion and development of the Product;
4.1.5 responding to product and medical complaints relating to the
Product (as called for by Section 14 hereof, Pharmion shall
promptly advise XXX of any such complaints which it receives
from regulators, customers or patients);
4.1.6 except as otherwise provided in Section 8, handling all
returns of the Product;
4.1.7 handling, in accordance with Section 14.4 hereof and with the
cooperation of XXX, all recalls of the Product;
4.1.8 communicating with the FDA and any state or local governmental
agencies and satisfying their requirements regarding the
authorization and/or continued authorization to market the
Product in the Territory; and
4.1.9 handling Product distribution, inventory and receivables.
Pharmion's exercise of the rights and license granted hereunder shall
be subject to Pharmion's continuing obligation to adhere to the XXX
Product Branding in its promotion and marketing of the Product.
4.2. Transition Coordination. Prior to the date of this Agreement, the
Parties have developed a proposed set of procedures for the orderly
transition of the marketing, distribution, order processing, billing
and collection relating to the Product in the Territory from LEO's
Canadian Affiliate and the Current Distributor to Pharmion and such new
wholesaling or distribution organization as Pharmion shall select. Such
procedures are set forth in Schedule 4 to this Agreement. XXX shall be
responsible for all costs and expenses associated with the termination
of agreements relating to such services that XXX or its Affiliate may
have entered into prior to the date of this Agreement.
4.3. Annual Marketing Plan.
4.3.1 Pharmion shall annually prepare a marketing plan for the
forthcoming calendar year describing the then current
marketing environment for the Product, including market share
data relating to the Product and other products in its
therapeutic class, and the proposed marketing programs, Other
Clinical Studies (as defined in Section 5.6) and medical
education programs which it intends to undertake in the
forthcoming year, as well as forecasts of the sales of the
Product for such year (each a "Marketing Plan"). Included in
each Marketing Plan shall be (a) Pharmion's proposed sampling
strategy for the forthcoming year including the estimated
number of units of Product
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that Pharmion proposes to deliver as samples in such year and
(b) Pharmion's estimate of Product that it may need to
contribute to compassionate use programs. The Marketing Plan
shall also contain a five year sales forecast, broken down on
a monthly basis for the first two years and on an annual basis
for the remaining three years. Each such Marketing Plan shall
be treated by both Parties as a good faith statement of
Pharmion's intentions for the forthcoming year and estimate
for subsequent year, but such Marketing Plan shall not be
deemed to be a contractual commitment by Pharmion to undertake
all of the efforts described in such Plan or to achieve the
goals or sales levels contained in such Plan.
4.3.2 Pharmion shall deliver the Marketing Plan for the calendar
year 2003 on or before October 1, 2002 and thereafter shall
deliver a new draft Marketing Plan by September 1 and a final
plan by October 1 of each successive calendar year.
4.3.3 The Development and Marketing Committee shall discuss each
such Marketing Plan at a meeting to be held no later than
September 15 of each year, and Pharmion shall in good faith
take into account changes to such Marketing Plan recommended
by the representatives of XXX on the Development and Marketing
Committee; provided, that for the calendar years 2007 and
onward, the Parties shall agree in good faith to each year's
annual Net Sales forecast.
4.4. Pharmion Commercial Organization. Pharmion shall use Commercially
Reasonable Efforts to establish:
4.4.1 a sales force of not less than twenty-five full-time
equivalent representatives that actively promote the Product
with high priority;
4.4.2 an appropriate supporting organizational structure for the
Product, comprised of either Pharmion employees or individuals
under third party contracts with Pharmion, consisting of at
least two regional directors, three medical liaisons, two
national account managers, one product manager and one
customer service manager
4.5. Maintenance of Inventory. Within two full fiscal quarters following the
Effective Date, Pharmion shall establish and thereafter use
Commercially Reasonable Efforts to maintain an inventory of Product
representing at least three months of supply, based upon the then most
current Long-Range Forecast.
4.6. Maintenance of NDA and IND. Pharmion shall bear all costs of
maintaining the Existing NDA, Additional NDAs, if any, and the Existing
IND for the Product in the Territory.
4.7. XXX Cooperation. XXX shall provide such assistance and cooperation as
Pharmion may reasonably request to re-launch the Product in the
Territory and,
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more generally, to promote the Product in the Territory, including
collaborating with Pharmion on developing transatlantic
sales/marketing/scientific events and inviting Pharmion to participate
in LEO's "international experience exchange" activities regarding the
Product.
4.8. Communications with Agencies. XXX shall be notified in advance of any
meeting related to the Product between Pharmion and the FDA. Pharmion
shall be notified in advance of any meeting related to the Product
between XXX and any Agencies in the XXX Territory where, in the
reasonable judgment of XXX, any such meeting could have an adverse
effect on the development or sale by Pharmion of the Product in the
Territory or the Manufacture and supply of the Product. Pharmion and
XXX shall, in addition, cooperate with one another to keep the other
Party informed of any other significant interface or communication with
the FDA or the Agencies which might adversely affect LEO's or
Pharmion's activities under this Agreement.
4.9. New XXX Products. In the event that XXX develops one or more new
products within the same therapeutic class as the Product, XXX will
keep Pharmion informed regarding the development of such products and
provide Pharmion with an opportunity to compete with third parties to
obtain the rights to market such product or products in the Territory.
5. COORDINATION OF DEVELOPMENT EFFORTS; DEVELOPMENT FOR ADDITIONAL
INDICATIONS
5.1. Pharmion's Development Efforts. Pharmion shall use Commercially
Reasonable Efforts to develop the Product for any Additional
Indications or New Presentations approved by the Development and
Marketing Committee.
5.1.1 Annual Development Plan. Pharmion shall annually prepare a
development plan for the forthcoming calendar year describing
the steps which Pharmion desires to take for the development
of Additional Indications or New Presentations for the Product
during the forthcoming calendar year (each a "Development
Plan"). Each such Development Plan shall be treated by both
Parties as a good faith statement of Pharmion's intentions for
the forthcoming year, but such Development Plan shall not be
deemed to be a contractual commitment by Pharmion to undertake
all of the efforts described in such Plan or to achieve the
goals contained in such Plan. Each such Development Plan shall
be presented for approval to the Development and Marketing
Committee as contemplated by Section 5.5 below.
5.1.2 Pharmion shall deliver the Development Plan for the calendar
year 2003 on or before October 1, 2002 and thereafter shall
deliver a new draft Development Plan by September 1, and a
final Development Plan by October 1 of each successive
calendar year.
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5.1.3 The Development and Marketing Committee shall discuss each
such Development Plan at a meeting to be held no later than 15
September of each year, and Pharmion shall in good faith take
into account changes to such Development Plan recommended by
the representatives of XXX on the Development and Marketing
Committee. Final approval of any such Development Plan shall
be determined as provided in Section 5.5 below.
5.2. Coordinators. Within thirty (30) days of the Effective Date, the
Parties will each appoint one individual (each a "Coordinator ") who
shall be the principal representative of such Party with respect to all
matters arising under this Agreement and who shall be responsible to
coordinate communications from the other Party to and within his or her
respective organization. Each Party will notify the other as to the
name of the individual so appointed. Each Party may replace its
Coordinator at any time, upon notice to the other Party.
5.3. Development and Marketing Committee.
5.3.1 Composition of the Committee. Within thirty (30) days of the
Effective Date, XXX and Pharmion will establish a Development
and Marketing Committee. The Development and Marketing
Committee will be composed of the Coordinator from each Party
and such additional representatives from each Party as the
respective Coordinators shall select, it being the intention
of the Parties that, when required by the subject matter of
the meeting, each Party shall have participating in the
meeting of the Committee representatives with the relevant
expertise in areas such as clinical development,
manufacturing, marketing and regulatory affairs. Either Party
may replace any or all of its representatives at any time upon
written notice to the other Party. The Development and
Marketing Committee will meet (in person, telephonically or
via videoconference) at least quarterly or more frequently if
reasonably requested by either Party.
5.3.2 Committee Procedures. Meetings of the Development and
Marketing Committee may be convened by either Party with
notice to the other Party, and both Parties shall use
Commercially Reasonable Efforts to have a representative in
attendance at meetings of the Committee within two (2) weeks
of the delivery of such notice. No meeting of the Development
and Marketing Committee shall, for purposes of this Agreement,
be validly constituted unless at least one (1) member
representing each Party shall be in attendance (a quorum of
the Committee), and no action shall be taken or deemed validly
taken by the Committee unless such action shall have been
approved by unanimous vote of the members of the Committee
participating at a meeting at which a quorum is present. All
actions validly taken by the Committee shall be duly recorded
in minutes of the Committee prepared by a member of the
Committee selected for that purpose at
14
any given meeting, with the responsibility for the preparation
of such minutes to alternate between the Parties at each
meeting. Such minutes shall be furnished to each Party within
two (2) weeks of any given meeting by the designated recorder
of the minutes and shall be retained by each Party as part of
its records of actions taken with respect to this Agreement.
Each party shall bear its own cost incurred in participation
in the Development and Marketing Committee.
5.4. Functions of Development and Marketing Committee. The Development and
Marketing Committee shall: (a) exchange information on the development
of the Product in the XXX Territory and the Territory, including the
exchange of information regarding ongoing and new clinical studies,
regulatory strategy and commercial development, Improvements and new
Product Marketing Materials; (b) discuss the need, desirability of,
structure and/or allocation of costs of any clinical studies or other
development efforts relating to the Product to be carried out in the
XXX Territory or the Territory; (c) discuss actions planned by either
Party with respect to the Product where such actions could reasonably
be expected to have a material impact on the Product in the Territory
or the XXX Territory; (d) discuss collaboration in the development of
the Product in the Territory for indications other than the Initial
Indication; (e) review and discuss each Marketing Plan as contemplated
by Section 4.3.3; (f) review and discuss each Development Plan as
contemplated by Section 5.1.3; and (g) discuss in good faith other
issues relating to the marketing or development of the Product in the
Territory.
5.5. Development of Product for Additional Indications or New Presentations.
Pharmion shall not proceed with the development of the Product for an
Additional Indication or a New Presentation without first submitting a
Development Plan to the Development and Marketing Committee. If a
Development Plan submitted by Pharmion is not unanimously approved by
the members of the Development and Marketing Committee, then the
dispute shall be referred to the CEO of Pharmion and the CEO of XXX for
resolution. In the event that the dispute is not resolved by these
individuals, XXX shall have the final right to decide whether Pharmion
may proceed with such Development Plan. Where the development of a
Product for an Additional Indication or New Presentation being sought
by Pharmion and approved by the Development and Marketing Committee
requires process development or manufacturing changes, Pharmion will
reimburse XXX for all reasonable costs incurred by XXX in making such
changes unless the Parties have agreed to share the costs of such
development pursuant to Section 5.6 below, in which case LEO's process
development and manufacturing costs will be included in the costs to be
divided between the Parties.
5.6. Clinical Studies.
5.6.1 Categorization of Studies. For purposes of this Agreement,
clinical studies relating to the Product shall be categorized
either (i) as "Registration Studies" which shall be studies
conducted with the
15
intention of being filed with the FDA or an Agency for the
purpose of obtaining an Additional Indication or (ii) as
"Other Studies". Such categorization shall be determined by
action of the Development and Marketing Committee at the time
that either Party proposes to conduct a clinical study
relating to the Product.
5.6.2 Sharing of Data. Data from all clinical studies conducted by
or on behalf of either Party shall be made available to the
other Party for all purposes of safety reporting or other
compliance with compulsory regulatory reporting requirements
in its respective territory. Data resulting from Other
Clinical Studies, and Data resulting from the publication of
results of Registration Studies, may also be used by either
Party for medical marketing purposes regardless of which Party
funds such studies.
5.6.3 Shared Costs. Where XXX and Pharmion agree, prior to the
commencement of any Registration Study related to the Product
proposed either by Pharmion or XXX, that the results of such
study may be used for the purpose of obtaining approval for a
New Indication in both the XXX Territory and the Territory,
the costs of the study shall be shared by the Parties and the
cost allocation, structure, timelines and other details of the
study shall be agreed between the Parties in good faith taking
account of the relative importance and value to each Party of
the study in question. The results of and data generated by
any study jointly funded by the Parties will be owned by XXX
but XXX hereby grants Pharmion an exclusive license to use
such results and Data for the purpose of obtaining an
Additional NDA for the Product in an Additional Indication in
the Territory or for such other uses in connection with the
sale of the Product for the Initial Indication and the
Additional Indication in the Territory as are permitted under
the laws of the Territory for the term of and subject to the
conditions of this Agreement.
5.6.4 Funded Registration Studies. In the event that either Party (a
"Non Funding Party") is unwilling to share in the cost of any
Registration Study to be carried out by the other Party (the
"Funding Party") and approved by the Development and Marketing
Committee with respect to the Product, and such study
generates data which the Funding Party reasonably believes may
be used by the Non Funding Party to obtain Marketing
Authorization or an Additional NDA for the Product in an
Additional Indication in any country(ies) of the XXX Territory
or in the Territory, as the case may be, then the following
provisions shall apply:
The Funding Party shall, by notice, require the Non Funding
Party to decide within ninety (90) days of receipt of a data
package containing a summary of the clinical data for such
Additional Indication whether
16
the Non Funding Party elects to use such data for the purpose
of obtaining Marketing Authorization or an Additional NDA for
the Product in an Additional Indication in any country(ies) of
the XXX Territory or in the Territory, as the case may be. If
the Non Funding Party so elects, then:
(a) the Parties shall agree upon a development program
for such purpose and the Non Funding Party shall
undertake to perform the necessary work at its own
cost and to reimburse the Funding Party, by means of
a royalty of 5% on Net Sales of the Product (with
such definition to be deemed appropriately modified
to cover sales of XXX if XXX is the Non Funding
Party), up to an amount equal to 50% of the
reasonable costs, incurred by the funding Party in
conducting the Registration Study from the date of
enrollment of the first patient, plus interest from
such date through the date on which such amount shall
have been reimbursed at LIBOR, as in effect from time
to time during such period; and
(b) the results of and data generated by any study funded
by the Funding Party will be owned by the Funding
Party but such Party shall grant to the Non-Funding
Party an exclusive license during the term of this
Agreement to use such results and data for the
purpose of obtaining Marketing Authorization or an
Additional NDA for the Product in an Additional
Indication in the XXX Territory or the Territory, as
the case may be; provided, that if Pharmion is the
Funding Party, ownership of the results and data from
such study shall be transferred to XXX promptly
following termination of this Agreement.
If the Non Funding Party shall not elect to so share in the
costs of such Registration Study, then during the term of this
Agreement, such Non Funding Party shall not have the right to
utilize the Data resulting from such Registration Study to
apply for or obtain an Additional NDA or Marketing
Authorization for an Additional Indication utilizing such
Data; provided, that if Pharmion is the Funding Party,
ownership of the results and data from such study shall be
transferred to XXX promptly following termination of this
Agreement.
5.6.5 Clinical Trial Agreements. In connection with Registration
Studies or Other Clinical Studies sponsored by Pharmion,
Pharmion will use Commercially Reasonable Efforts to ensure
that all clinical trial agreements with third parties,
including principal investigators and CROs, will be assignable
to XXX and that such agreements may be terminated, on no more
than 90 days' notice by the payment of no more than the costs
incurred by the third party through the date of termination.
17
6. CONSIDERATION
6.1. Purchase Price Payable on Execution. Pharmion shall pay to XXX the sum
of seven million five hundred thousand dollars (U.S. $7,500,000) as
payment of purchase price for the rights granted under this Agreement,
via wire transfer within five (5) Business Days of the Effective Date,
less the amount of two hundred thousand dollars (U.S. $ 200,000) which
was previously paid by Pharmion to XXX in connection with a letter
agreement dated May 23, 2002, and which XXX hereby acknowledges shall
be fully credited against such purchase price . All of such payment
shall be non-refundable, but a portion thereof may be creditable
against royalties as provided in Section 6.3 below.
6.2. Royalty. Commencing at the end of the first calendar quarter in which
the Sales Inception Date occurs, Pharmion will pay XXX during the
remaining term of this Agreement a royalty, payable on a quarterly
basis, equal to (a) the Specified Percentage (as defined below) of Net
Sales of Product in the Territory during such calendar quarter, less
(b) Pharmion's purchase price of the units of Product sold during such
calendar quarter (as charged to Pharmion by XXX in accordance with
Section 13 for purposes other than clinical trials, sampling or
compassionate use) based upon a "first-in/first-out" accounting of
Pharmion's Product inventory, subject always to LEO's right to receive
Minimum Payments as provided in Section 6.8. For purposes of this
Section 6.2, the term "Specified Percentage" shall mean:
6.2.1 thirty percent (30%) of all Net Sales up to and including $20
million per calendar year; and
6.2.2 thirty-five percent (35%) of all Net Sales above $20 million
per calendar year.
6.3. Royalty Credits. Two million five hundred thousand dollars ($2,500,000)
of the amount paid under Section 6.1 shall be creditable against the
royalties payable under Section 6.2. with respect to Net Sales recorded
during the thirty (30) month period commencing on September 1, 2002,
provided, however, that if Pharmion shall not have relaunched the
Product before December 31, 2002 for reasons unrelated to the transfer
of the Existing NDA or manufacturing or supply issues, such credit
shall be limited to One Million Five Hundred Thousand Dollars
($1,500,000). In addition, if Net Sales for the calendar year 2003
exceed sixteen million dollars (U.S. $ 16,000,000), then an additional
one million dollars (U.S. $1,000,000) shall be creditable against the
royalties payable under Section 6.2. with respect to Net Sales recorded
during the twenty-four (24) month period commencing January 1, 2004.
6.4. Withholding Tax. Any tax which Pharmion is required to pay or withhold
from royalty payments to be made to XXX under this Agreement shall be
deducted from the amount otherwise due, provided that, in regard to any
such deduction, Pharmion shall give XXX such assistance as may be
reasonably necessary to
18
enable or assist XXX to claim exemption therefrom or a reduction
thereof and shall provide XXX with an official tax certificate as soon
as possible.
6.5. Invoices for Royalties. If required by Pharmion, XXX shall submit a
written invoice addressed to Pharmion for each royalty payment to be
made by Pharmion under this Agreement. XXX shall submit these written
invoices to Pharmion within a reasonable period following the request
from Pharmion and based upon the last quarterly royalty report from
Pharmion provided to XXX in accordance with Section 6.7.
6.6. Royalty Calculation and Payment.
6.6.1 Timing. Royalties shall be calculated and paid to XXX
quarterly, and shall be due forty-five (45) days following the
end of each calendar quarter.
6.6.2 Currency of Payment. Royalties shall be payable in U.S.
Dollars.
6.7. Royalty Reports. Commencing at the end of the first calendar quarter in
which the Sales Inception Date occurs, Pharmion shall submit quarterly
payment reports to XXX within (45) days following the end of each
calendar quarter. Such reports shall include, but not be limited to:
6.7.1 An accounting of Net Sales within the Territory during such
quarter;
6.7.2 An accounting of the aggregate purchase price paid by Pharmion
to XXX for the units of Products sold during such quarter; and
6.7.3 the calculation of the royalty amounts owing to XXX pursuant
to this Section 6, including, if applicable, the use of
payments creditable under either Section 6.3 or 6.8.
6.8. Minimum Payments.
6.8.1 For each calendar year commencing with the year ending
December 31, 2003, if the sum of (x) the amounts paid (or
credited as paid) to XXX pursuant to Section 6.2 and 6.3, and
(y) the amounts referred to in Section 13 (paid by Pharmion as
the purchase price for the relevant purchased units) shall be
less than the Minimum Payment for such calendar year set forth
in Schedule 2, then Pharmion shall make a lump sum payment to
XXX in the amount equal to such shortfall, with such lump sum
payment to be made simultaneously with the payments due to XXX
under Section 6.2 in respect of the fourth quarter of such
calendar year. All such payments shall be non-refundable.
6.8.2 Any amounts paid under this Section 6.8 shall be creditable
against the amounts, if any, by which
19
(a) the sum of (x) the amounts paid (or credited as paid)
to XXX pursuant to Section 6.2 and 6.3, and (y) the
amounts referred to in Section 13 (paid by Pharmion
as the purchase price for the relevant purchased
units) in any of the three (3) following calendar
years
shall exceed
(b) the Minimum Payment applicable to such subsequent
year;
with any such credit to be applied against royalties payable
during the fourth quarter of such calendar year (and to the
extent not fully applied, the quarterly payments of the next
succeeding calendar year).
6.8.3 The Minimum Payments for the years 2003 through 2006 are set
forth on Schedule 2. For each subsequent calendar year such
Minimum Payments shall be an amount equal to the royalty
payments (including the purchase price of the units sold)
called for by Section 6.2 applied to twenty-five percent (25%)
of the budgeted Net Sales for such year as determined by
reference to the final Marketing Plan delivered by Pharmion to
XXX as called for by Section 4.3 hereof, provided that the
annual Net Sales for any such calendar year shall be not less
than the Net Sales of the immediately prior calendar year plus
the average growth of the fractionated heparin market (ATC B1
+B2, latest available MAT figures) for the then most recently
available twelve month period, as measured by the data
published by a mutually acceptable third party market data
collection organization.
6.9. Minimum Sales.
If Net Sales for any two consecutive calendar years are less than fifty
percent (50%) of the Net Sales forecasts for such years, either as set
forth in Schedule 2 or as provided in Sections 4.3.3 and 6.8.3, then
(a) Pharmion shall have the right to pay XXX an amount equal to the
difference between (i) the payments that would have been due to XXX
under Section 6.2 had Pharmion achieved fifty percent of such Net Sales
for such calendar years, and (ii) the amounts paid by Pharmion to XXX
under Section 6.8 with respect to such calendar years, with such
payment to be made simultaneously with the payments due to XXX under
Section 6.2 in respect of the fourth quarter of the second of such
calendar years, and (b) if Pharmion does not make such payment, XXX
shall have the right, for the thirty (30) day period following the date
on which such payment would otherwise be due to terminate this
Agreement by notice to Pharmion.
6.10. No Other Royalties. The royalties set out in this Section 6 are the
only royalties payable by Pharmion to XXX or to any third party in
connection with the exclusive distributor and purchase arrangements and
licenses granted herein.
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7. MANUFACTURE AND SUPPLY OF PRODUCT
7.1. Exclusive Supply; Requirements. XXX will sell to Pharmion and Pharmion
will purchase from XXX all of Pharmion's requirements of the Product
for sale in the Territory and for conducting clinical trials, sampling,
participation in compassionate use programs, and for such other
purposes as Pharmion shall require.
7.2. Supply Efforts. XXX shall use Commercially Reasonable Efforts to
manufacture or otherwise supply sufficient quantities of the Product to
Pharmion to satisfy Pharmion's purchase requirements. XXX will
manufacture the Product at the facility specified in the Existing NDA
or, after compliance with Section 11.2, such newer facility as XXX may
establish, provided that such newer facility shall have regulatory
compliance characteristics at least as favorable as the current
facility and is otherwise reasonably acceptable to Pharmion. XXX will
provide the Product to Pharmion as Finished Goods and Packed in
accordance with the specifications as described in Section 10 and
Schedule 6 (Finished Goods Packaging Specification).
7.3. Inspection. Upon reasonable notice to XXX, during normal business hours
and in a manner calculated not to unreasonably interfere with LEO's
conduct of business, XXX shall allow Pharmion's employees or
representatives to inspect the Manufacturing, Packaging, testing,
storing, stability and quality control facilities and/or programs of
XXX which relate to the Product and which Pharmion reasonably needs to
inspect in order to discharge its obligations as the holder of the NDA
in the Territory. To the extent Pharmion wishes to use the services of
a consultant in connection with any such inspection, it shall (a)
identify such consultant to XXX for its prior approval, such approval
not to be unreasonably withheld or delayed, (b) obtain a
confidentiality undertaking from such consultant consistent with the
provisions of Section 17, (c) cause a Pharmion employee to accompany
such consultant on any such inspection, and (d) use Commercially
Reasonable Efforts to utilize the same consultant for any subsequent
inspection of the same facility.
7.4. Allocation of Supply. In the event that XXX anticipates a shortage of
supply of Product for sale in the Territory and the XXX Territory, XXX
shall notify Pharmion of such shortage as soon as possible, and XXX
shall in good faith allocate Product between the Territory and various
countries within the XXX Territory in a fair and equitable manner,
taking into account: the historic sales of the Product in the various
markets, the then current demand for the Product in the various markets
as evidenced by customer purchase orders and levels of back-orders, and
the relative inventory levels available in the various markets.
7.5. Interruption of Supply. In case of any interruption of supply by XXX,
whether as a result of force majeure events or failure of XXX for any
reason to meet Pharmion's supply requirements, the Parties will
cooperate to seek to provide Pharmion with an alternate source of
supply (including seeking to validate an
21
alternative manufacturing source) for the period in which (or for the
amount of Product that) XXX is unable to supply Pharmion.
7.6. Safety Stock. In order to reduce the risk of any gap in supply, XXX
will produce and maintain a sufficient inventory of active drug
substance to permit XXX to produce at least 6 months supply of Product
for the Territory, based on Pharmion's then current Long-Range
Forecast.
7.7. Technical Assistance Agreement. Within 6 weeks, following the Effective
Date of this Agreement, the Parties will enter into a technical
assistance agreement substantially in the form of Schedule 5. To the
extent of any conflict or inconsistency between this Agreement and such
Technical Assistance Agreement, the terms and conditions of this
Agreement shall control, unless otherwise agreed to in writing by the
Parties.
7.8. Change of Manufacturer. If at any time during the term of this
Agreement, XXX decides to outsource the Manufacture of the Product, XXX
will notify Pharmion promptly and in any event at least twelve (12)
months before such transfer of Manufacture is expected to be completed,
and the Parties will negotiate in good faith any necessary changes to
Sections 9 and 12 of this Agreement, and any procedures developed
thereunder. XXX shall only select a Manufacturer that holds cGMP
certification from the FDA. XXX will use Commercially Reasonable
Efforts to ensure that the change of Manufacturer will not affect the
safety or efficacy of the Product. The necessary steps for the change
of the Manufacturer will be handled within the scope of an NDA
supplement submitted to the FDA. XXX will cooperate with Pharmion by
providing the available Manufacturing and other data required to
support any required supplement to the NDA. Any such change of
Manufacturer may also require changes to the forecasting and ordering
procedures set forth in this Agreement, and the Parties agree to make
any reasonable changes to such procedures resulting from any such
change of Manufacturer. Costs associated with any such change of
Manufacturer will be borne by XXX except where such costs are
associated with changes requested by Pharmion or where additional work
is required only in order to comply with new regulatory or other
requirements in the Territory, in which case such costs will be
reimbursed by Pharmion.
7.9. Purchase of Initial Inventory
7.9.1 Halt of Shipments. As of the close of business on the
Effective Date, XXX will instruct the Current Distributor to
halt temporarily all shipments of Product in the Territory for
a period of up to five (5) Business Days pending the stock
taking described below.
7.9.2 Purchase of Initial Inventory. Pharmion shall purchase, and
take title to, the Initial Inventory effective as of the Sales
Inception Date. The purchase price for the Initial Inventory
shall be the Initial Inventory Value which shall be determined
and paid for as described below.
22
7.9.3 Stock Taking.
(a) As soon as practicable after the Effective Date, XXX
shall conduct a count at those principal locations of
the Current Distributor at which the Initial
Inventory is located (as specified in Schedule 7 to
this Agreement) to determine the quantities of
Initial Inventory outstanding at such locations as of
the Effective Date that are neither damaged or Short
Dated. Pharmion and one or more of its agents or
representatives shall have the right to observe the
count and determination of the Initial Inventory.
Based upon such count and the Price Per Xxxx, XXX
shall prepare and deliver a statement of Initial
Inventory Value (the "Statement of Inventory Value")
to Pharmion. If Pharmion agrees with the Statement of
Inventory Value, it shall promptly so notify XXX,
whereupon the Statement of Inventory Value delivered
by XXX to Pharmion shall be final, binding and
conclusive on the parties hereto.
(b) Pharmion may dispute any amounts reflected on the
Statement of Inventory Value, but only on the basis
that the Initial Inventory was not correctly counted
or is otherwise damaged or Short-Dated; provided,
however, that Pharmion shall have notified XXX in
writing of each disputed item, specifying the amount
thereof in dispute and setting forth, in reasonable
detail, the basis for such dispute, within five (5)
Business Days of LEO's delivery of the Statement of
Inventory Value to Pharmion. In the event of such a
dispute, XXX and Pharmion shall attempt to reconcile
their differences, and any resolution by them as to
any disputed amounts shall be final, binding and
conclusive on the parties hereto. If XXX and Pharmion
are unable to resolve any such dispute within five
(5) Business Days after Pharmion's delivery of its
notice of dispute to XXX, XXX and Pharmion shall
submit the items remaining in dispute for resolution
to a mutually acceptable independent accounting firm
of international reputation (the "Independent
Accounting Firm"), in accordance with the provisions
of Section 31.
(c) The Statement of Inventory Value shall be deemed
final for the purposes of this Section 7.9.3 upon the
earlier of (i) Pharmion's notice to XXX that it
accepts the Statement of Inventory Value, (ii) the
failure of Pharmion to notify XXX of a dispute within
five (5) Business Days after LEO's delivery of the
Statement of Inventory Value to Pharmion or (iii) the
resolution of all disputes pursuant to Section 31.
Within five (5) Business Days of the Statement of
Inventory Value being deemed final, Pharmion shall
pay to XXX by wire transfer the full amount of the
Initial Inventory Value.
23
7.9.4 Resumption of Shipments. Promptly following the completion of
the count of the Initial Inventory as described in Section
7.9.3 above, XXX will instruct the Current Distributor to
resume shipments of Product in the Territory, with all such
shipments to be for the account of Pharmion. In addition, XXX
shall advise the Current Distributor that from and after the
Sales Inception Date title in and to the Initial Inventory
shall vest in Pharmion.
7.9.5 Further Assurances. To the extent deemed necessary or
appropriate by either Party and at its request, XXX shall
execute such bills of sale or other transfer documents as may
be so requested to evidence the transfer of title in and to
the Initial Inventory to Pharmion.
8. PRODUCT RETURNS
8.1. Returns. XXX will be fully responsible for the processing of all
Product returns of Product previously sold in XXX or XxXxxx trade
dress, and any costs or expenses associated with such returns, and XXX
shall keep Pharmion informed, on a regular basis, of both the volume of
such returns and the customers from whom such returned Product was
obtained. To the extent that customers deliver such returns to
Pharmion, and Pharmion issues credits to such customers, Pharmion shall
notify XXX regarding such transactions and XXX shall reimburse Pharmion
for the costs of such credits.
9. MONTHLY REPORTING, FORECASTING AND ORDERING
9.1. Monthly Reporting. Within five Business Days after the end of each
calendar month during the term of this Agreement, Pharmion shall
deliver to XXX, in written form or in such electronic form as the
Parties shall mutually agree upon, a report of (i) the gross sales of
Product during the such month, in both U.S. dollars and in units per
SKU, (ii) the current level of inventory of Product held by Pharmion as
of the end of such month in units per SKU, and (iii) the number of
units of Product distributed by Pharmion during such month as samples,
clinical trial supplies, or for compassionate use (each a "Monthly
Report").
9.2. Long-Range Forecast. On the Effective Date, and on a monthly basis
thereafter, delivered simultaneously with its Monthly Report, Pharmion
shall xxxxxxx XXX with a rolling monthly forecast (in a mutually
acceptable format) of the quantities of Product by SKU that Pharmion
intends to order during the succeeding eighteen (18) month period (the
"Long-Range Forecast"). All monthly amounts specified in such forecasts
shall be for quantities of Product in integral multiples of 12,000
vials or such other batch size as XXX may, from time to time, specify
to Pharmion in compliance with the provisions of Section 11.2.1. Each
Long-Range Forecast shall represent Pharmion's most current estimates
for planning purposes but, except as provided in Section 9.3 below,
shall not be deemed to be purchase commitments.
24
9.3. Firm Orders. To the extent consistent with the volume limitations set
forth in Section 9.4 below, the first four (4) months of the Long-Range
Forecast (consisting of the then current month and the following three
months), as updated monthly, shall be non-cancelable legally binding
commitments on the part of XXX to supply and on the part of Pharmion to
purchase, the quantity of Product by SKU as set forth in the Long-Range
Forecast (each such first 4 month commitment, a "Firm Order"). Pharmion
shall confirm monthly each Firm Order for the next four month period in
writing to XXX; provided, however, that Pharmion's failure to deliver
such confirmation shall not impact Pharmion's obligation to purchase
such quantities.
9.4. Variations of Long-Range Forecasts. With every monthly update of the
Long-Range Forecast, each of months five through seven can be increased
or decreased without regard to SKU by twenty percent (20%) of the
quantity forecast in the Long-Range Forecast of the previous month.
Each of months eight through twelve can be increased or decreased
without regard to SKU by fifty percent (50%) of the quantity forecasted
in the Long-Range Forecast of the previous month. Unless consented to
in writing by the Parties, each Firm Order must be for that quantity of
Product that is consistent with the variations permitted in the
Long-Range Forecasts under this Section 9.4.
9.5. Terms of Firm Orders. Any Firm Orders, or related purchase orders,
purchase order releases, confirmations, acceptances, advices and
similar documents submitted by either Party in conducting the
activities contemplated under this Agreement are for administration
purposes only and shall not add to or modify the terms of this
Agreement. To the extent of any conflict or inconsistency between this
Agreement and any such document, the terms and conditions of this
Agreement shall control as to a particular order, unless otherwise
agreed to in writing by the Parties.
10. PACKAGING AND LABELING; USE OF NAME
10.1. Packaging and Labeling.
10.1.1 Pharmion shall be responsible for all costs of developing new
Packaging and labeling for the Product, and shall provide XXX
all art work for Packing components and wording to be applied
to the Product, which shall be consistent with FDA approved
labeling for the Product in the Territory. All such artwork
shall be consistent with the XXX Product Design Concept
wherever and whenever legally possible.
10.1.2 Pharmion shall be responsible for ensuring that all Packaging
and labeling, including, but not limited to, the package
make-up, package inserts and other elements relating to
Packaging, as well as all promotional material, complies with
all laws, regulations and codes of practice applicable to such
Packaging and labeling in the Territory.
25
10.1.3 Pharmion shall provide the information required under this
Section 10 to XXX at least four (4) months prior to the
requested delivery of Product reflecting such information. If
Pharmion requests a change in any of the Packing components,
Pharmion shall reimburse XXX for the cost of any existing and
unused inventory of such materials which do not reflect such
change, up to a maximum of six (6) month's supply of such
components, upon presentation by XXX to Pharmion of a
statement, in reasonable detail, of the amounts of such unused
inventory and the cost of manufacture of such inventory.
10.1.4 XXX shall manufacture, or contract with third parties for the
manufacture, of all Packing components and cause such
components to be so manufactured consistent with the
information provided to XXX by Pharmion.
10.1.5 In case XXX requires changes to the Packaging for technical
reasons (e.g. changes to Packaging technology or equipment),
XXX shall bear all costs of such changes and the obsolete
inventory of Packaging and label materials, if any, resulting
therefrom.
10.1.6 Promptly after each change of Packaging material, twenty-five
(25) samples of each new Packaging material shall be provided
to Pharmion, along with the date of first use of such
materials.
10.2. Name and Logo Use. For the term of this Agreement, XXX grants Pharmion
a non-exclusive limited right to use the "XXX" name and the Assyrian
Lion, and Pharmion shall use the "XXX" name and the Assyrian Lion only
in accordance with the XXX Logo Guidelines, for the purpose of
identifying XXX as the originator and manufacturer on all Packaging
materials, labels, inserts and any other printed matter included in the
Product to the extent required by law, regulations and codes of
practice in the Territory. Pharmion shall always use the XXX Device
Xxxx and the XXX Word Xxxx, as identified on Schedule 1, on all
relevant Packaging components.
11. QUALITY OF PRODUCT
11.1. Manufacturing Warranty. XXX warrants that (i) the Product shall be
produced in accordance with cGMP, (ii) when shipped to Pharmion the
Product shall not be adulterated or misbranded and (iii) the Product
shall be otherwise manufactured in accordance with the Specifications
and with such written manufacturing procedures and finished product
specifications (including packaging specifications) as are contained in
the Existing NDA, in any NDA annual reports, and in any Additional NDA
which may be issued during the term of this Agreement. To the extent
permitted by law, XXX HEREBY DISCLAIMS ALL OTHER WARRANTIES REGARDING
THE PRODUCT, EXPRESS OR IMPLIED, INCLUDING WARRANTIES OF
MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE.
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11.2. Manufacturing and Product Changes
11.2.1 PRODUCT CHANGES. Except for the Required Changes defined in
Section 11.2.2 below, XXX shall not make or allow to be made
any changes to the Product, Specifications, Manufacturing or
Packaging that would require supplements to the NDA or
notification to the FDA, without the prior written consent of
Pharmion, such consent not to be unreasonably withheld or
delayed. XXX will keep Pharmion informed of Manufacturing or
other changes to the Product reportable to an Agency which may
have an impact on the NDA, and Pharmion shall be responsible
for making any necessary regulatory filings and obtaining any
necessary approvals of the resulting supplements to the NDA
from the FDA. XXX will use Commercially Reasonable Efforts to
ensure that the timing of LEO's notice to Pharmion of any such
change shall permit adequate time for Pharmion to make any
necessary regulatory filings and obtain any necessary approval
of the corresponding supplements to the NDA from the FDA prior
to the change being implemented.
11.2.2 REQUIRED CHANGES. The following changes shall constitute
Required Changes: (i) changes to the Specifications or
Manufacturing or Packaging processes that are required by laws
or regulations (including, without limitation, cGMP), or by
medical or scientific concerns as to the quality, safety
and/or efficacy of the Product (collectively "Required
Changes"); (ii) changes to the Specifications or Manufacturing
or Packaging processes which arise out of the change of
Manufacturer from XXX to a third party as provided in Section
7.8; and (iii) changes which XXX reasonably considers
necessary or desirable and which do not change the character
or identity of the Product in such a way as to have an adverse
effect on Pharmion's interest in the Product in the Territory.
The Parties shall cooperate in making such Required Changes
promptly. If a Required Change is necessary because of laws or
regulations that apply in the Territory but not in the XXX
Territory, all costs of making such Required Change shall be
borne by Pharmion. Conversely, if a Required Change is
necessary because of laws or regulations that apply in the XXX
Territory but not in the Territory, all reasonable costs of
making such Required Change shall be borne by XXX. If a
Required Change is required by the FDA and Agencies in both
the Territory and the XXX Territory, then XXX and Pharmion
shall share the reasonable cost of such Required Change in
proportion to their respective Sharing Percentages.
If: (i) an FDA request disables the implementation of
requirements of an Agency in the XXX Territory, (ii) an Agency
request disables the implementation of requirements of the FDA
or the FDA does not approve of a change required by an Agency,
or (iii) despite the
27
exercise of Commercially Reasonable Efforts, XXX is unable to
make or have a Required Change of the FDA made without
material adverse effects on the Product in the XXX Territory,
then the Parties will negotiate in good faith to solve this
issue and make such adjustments to this Agreement as are fair
and equitable.
11.2.3 DISCRETIONARY CHANGES. Pharmion may request changes to the
Specifications or Manufacturing or Packaging process that are
not Required Changes, including, but not limited to, changes
to the existing Product, New Presentations, or changes to the
existing or additional Packaging (collectively "Discretionary
Changes"). XXX shall use Commercially Reasonable Efforts to
make or have such Discretionary Changes made unless XXX in
good faith considers that such Discretionary Changes requested
by Pharmion will have a material adverse effect on the Product
or on LEO's ability to Manufacture the Product or on LEO's
interests in the Product in the XXX Territory.
11.2.4 COSTS OF DISCRETIONARY CHANGES. Any and all costs associated
with Discretionary Changes which are not requested by XXX
(including internal administrative costs and the use of
external technical consultants by XXX with the written consent
of Pharmion, which shall not be unreasonably withheld or
delayed, in effectuating such changes) shall be borne by
Pharmion. Any and all costs associated with Discretionary
Changes initiated by XXX shall be borne by XXX.
11.3. Stability and Record-Keeping. XXX shall:
11.3.1 select and retain samples of each batch and lot of Finished
Goods and conduct an ongoing stability program in compliance
with cGMP and in accordance with the provisions of the
Existing NDA and Additional NDA on selected batches and
maintain all legally required samples, documents, and records
including, without limitation, batch and lot production,
quality control and stability records, for such period as is
required by the FDA in the Territory, and
11.3.2 make available for review by Pharmion, at any reasonable time,
all records relevant to Manufacturing and Packing hereunder
and necessary for the discharge by Pharmion of its obligations
as holder of the NDA in the Territory, including written
investigations of any deviations that may have been generated
from Manufacturing, Packaging, inspection or testing
processes.
12. DELIVERY
12.1. Delivery Dates. Unless otherwise agreed to by the Parties, deliveries
shall be made on a monthly basis. At the time Pharmion places a Firm
Order, Pharmion
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will provide XXX with specific shipping dates, allowing in each case
for a minimum of 90 day's production time. To the extent that such
shipping dates are consistent with such ninety (90) day period, XXX
shall acknowledge such shipping dates in its order confirmations,
whereupon such shipping dates shall become binding.
12.2. Timing of Delivery. XXX shall use Commercially Reasonable Efforts to
meet the shipping dates and order quantities indicated in Pharmion's
binding and accepted Firm Orders for the Product. If any circumstances
occur that could result in any delivery delay or significant variation
in quantity, XXX shall immediately inform Pharmion thereof in
sufficient detail for Pharmion to assess the likelihood that such
delivery delay or variation in quantity will adversely affect its
inventory situation. Any shipment delivered that is within plus or
minus ten percent (+/-10%) of the quantity ordered and/or plus or minus
five (+/-5) Business Days of the shipping date specified on the
relevant Firm Order will be considered as delivered on time.
12.3. Shipping Terms. Each shipment of the Product shall be delivered to
Pharmion FCA (Incoterms 2000) Ballerup, Denmark. XXX will cooperate
with Pharmion and will arrange for carriage of the Product to such
destinations as Pharmion shall direct and for insurance of the Product
(in such amounts as Pharmion shall determine) in connection therewith,
all at Pharmion's sole cost and expense.
12.4. Acceptance. Pharmion shall, within forty-five (45) days of receipt of
each shipment of Product by Pharmion or Pharmion's agent, notify XXX in
writing of any defect by reason of which Pharmion alleges that the
Product delivered fails to meet the specifications warranted by XXX as
provided in Section 11.1 hereof and which should be apparent on
reasonable inspection. If Pharmion notifies XXX of any defect in a
shipment of Product, XXX shall have the right, but not the obligation,
to send one or more quality control representatives to retest such
Product in co-operation with quality control representatives of
Pharmion. Pharmion shall store all shipments of the Product in
accordance with storage specifications established by XXX. In the event
of a disagreement between Pharmion and XXX regarding the quality of one
or more shipments of Product, the parties shall submit samples of the
shipment in question to an independent testing laboratory (selected by
mutual agreement of Pharmion and XXX) to make a determination, which
shall be binding upon the Parties, as to the compliance or lack of
compliance of such shipment with the specifications warranted by XXX.
XXX shall promptly credit Pharmion for any defective shipments. If
Pharmion fails to give such a notice under this Section 12.4 then,
except in respect of any defect which is not apparent on reasonable
inspection (a "Latent Defect"), the Product shall be conclusively
presumed to meet the specifications warranted by XXX as provided in
Section 11.1 hereof, and accordingly Pharmion shall be deemed to have
accepted the delivery of the Product in question.
12.4.1 Replacement of Defective Product. If any shipment of Product
does not comply with the Specifications, for reasons primarily
attributable
29
to XXX or the Manufacturer, XXX shall remedy or have remedied
such defect at its own cost and in agreement with Pharmion. If
this is not possible or advisable for regulatory, technical,
quality, medical or economic reasons, the shipment shall be
properly destroyed and/or disposed of at LEO's expense. XXX
shall not be entitled to any remuneration for any such
unusable shipment. XXX shall use Commercially Reasonable
Efforts to provide a replacement delivery as quickly as
possible.
12.5. Certificates of Analysis and Compliance. XXX shall deliver to Pharmion,
together with each delivery of each batch of Product, the corresponding
Certificate of Compliance and the Certificate of Analysis relating to
such batch. The Certificate of Analysis shall give full analytical
results with respect to regulatory Specifications for each batch. The
Certificate of Compliance will confirm that the Product has been made
and tested in accordance with the master batch record, the
Specifications and the test methods specified in the NDA. XXX shall
promptly inform Pharmion of significant events and/or results
including, but not limited to, quality incidents and batch deviations
which may have occurred during the Manufacturing and/or Packing and
which might affect the quality of the Product.
13. SUPPLY PRICE; PAYMENT FOR PRODUCT SUPPLY
13.1. Price.
13.1.1 Except as provided in clauses (2) and (3) below, Pharmion
shall purchase the Product from XXX at the Price Per Vial.
13.1.2 For Product purchased by Pharmion for the purpose of
conducting clinical trials, the price shall equal fifty
percent (50%) of the Price Per Vial.
13.1.3 For Product purchased by Pharmion for samples given by
Pharmion free of charge to health care professionals and
members of the trade, up to an aggregate amount proposed each
year in its Marketing Plan and approved by XXX, such approval
not to be unreasonably withheld or delayed, the price shall
equal fifty percent (50%) of the Price Per Vial.
13.1.4 For Product purchased by Pharmion for distribution in
connection with compassionate use programs, up to an aggregate
amount estimated each year in its Marketing Plan and approved
by XXX, such approval not to be unreasonably withheld or
delayed, the price shall equal fifty percent (50%) of the
Price Per Vial.
13.2. Danish Index Adjustment. On or before February 28 of each calendar year
of the term of this Agreement, XXX shall deliver to Pharmion a
statement setting forth the level of the Danish Index for the four
quarters ended November of the
30
immediately preceding calendar year and the percentage change in such
Danish Index from the comparable four quarters ended November of the
prior calendar year, and certifying that such data was the data
published by Statistics Denmark. From and after the date of delivery of
such statement to Pharmion, the Price Per Vial shall be changed, with
effect from January 1 of the then current calendar year, from that
which was applicable during the prior calendar year, either upward or
downward, by the percentage change in the Danish Index so reported.
13.3. Price for New Presentations. Prior to the submission of an Additional
NDA for the Product in a New Presentation, the Parties will negotiate
in good faith the price to be paid for each unit of Product in such New
Presentation (as to each New Presentation, its "Price Per New
Presentation"), as well as an appropriate amendment to the provisions
of Sections 13.1 and 13.2 of this Agreement to accommodate such price
in a manner consistent with the Price Per Vial.
13.4. Payment. Payment for the Product shall be made by Pharmion to XXX in
the following manner and provided that Pharmion has first received an
invoice from XXX in respect thereof:
13.4.1 payment shall be made within thirty (30) days of the end of
the calendar month in which XXX delivers the Product to
Pharmion and Pharmion accepts such Product in accordance with
Section 12.4; and
13.4.2 payment shall be made by Pharmion in U.S. Dollars to such bank
account as XXX shall from time to time in writing designate.
13.5. Payments not made on the due date shall bear interest beginning the due
date and ending the payment date at the rate of 1.5% per month,
calculated on the basis of a 365-day year, actual days elapsed.
14. ADVERSE DRUG EXPERIENCES; COMPLAINTS
14.1. Preparation of Standard Operating Procedure: Each Party will have
reporting responsibility in its own territory and for exchange of drug
related information arising out of its territory with the other Party.
Within sixty (60) days of execution of this Agreement, the Parties
agree to enter into a standard operating procedure to govern
collection, investigation and reporting to regulatory authorities and
each other of Product-related adverse drug experience reports, quality
reports, and complaint reports, such that each of the Parties can
comply with its legal obligations worldwide. The standard operating
procedure will be promptly amended as changes in legal obligations
require.
14.2. Agency Action. The Parties agree to notify each other as soon as
possible of any information received by a Party regarding any
threatened or pending action by the FDA or an Agency which may affect
the safety or efficacy claims of the Product or the continued marketing
of the Product.
31
14.3. Questions and Complaints. Each Party shall have the sole responsibility
for responding to questions and complaints from its customers and for
reporting adverse drug experiences (as defined by the applicable
regulations) to the relevant health authorities in its respective
territory, unless otherwise required by applicable laws, rules or
regulations. Each Party is responsible for providing submissions and
information to appropriate regulatory authorities and the other Party
regarding regulatory issues, including pharmacovigilance and safety
submissions concerning the Product, in their respective territories.
Each Party will cooperate with the other Party in reporting adverse
drug experiences as provided in this Article 14.
14.4. Product Recalls
If any governmental authority having jurisdiction requires or
reasonably requests either Party to recall any Product due to a defect
in the Manufacture, processing, Packaging or labeling of the Product or
for any other reason whatsoever, such Party shall immediately notify
the other Party to this Agreement. Each Party shall also have the right
to initiate a recall in its own territory in the absence of a request
from a governmental authority after consultation with the other Party.
Prior to commencing any recall, the Party commencing such recall shall
review with the other Party the proposed manner in which the recall is
to be carried out. Each Party agrees to follow any reasonable advice of
the other Party as to the manner of carrying out the recall, so long as
such advice is not contrary to any instructions of any governmental
authority involved in the recall. The Party commencing the recall shall
carry out the recall in the manner agreed upon between XXX and Pharmion
in as expeditious a manner as possible and in such a way as to cause
the least disruption to sales of the Product and to preserve the
goodwill and reputation attached to the Product and to the names of the
Parties. Without prejudice to Pharmion's rights against XXX pursuant to
this Agreement, Pharmion shall bear all costs of any product recall
carried out in the Territory; provided that XXX shall promptly
reimburse Pharmion for reasonable costs directly related to any recall
resulting from the Product having a Latent Defect.
15. UNDERTAKINGS AND WARRANTIES OF PHARMION
15.1. Pharmion shall:
15.1.1 obtain and maintain all necessary consents, permits and
approvals to sell the Product in the Territory, including
maintaining the Existing NDA and the Existing IND once it is
transferred to Pharmion, and comply with all relevant laws and
regulations in connection therewith;
15.1.2 recognize the exclusive ownership by XXX of the Trade Xxxx and
the other XXX Product Branding;
15.1.3 not, either while this Agreement is in effect or at any time
thereafter, register, use or challenge or assist others to
challenge the Trade Xxxx
32
or the other XXX Product Branding or attempt to obtain any
right in or to any such name, logotype or trade xxxx similar
to the XXX Product Branding;
15.1.4 not grant sublicenses or assignments to third parties under
the Trade Xxxx or the other XXX Product Branding and not
pledge the Trade Xxxx or make them the subject of any other
rights in rem;
15.1.5 not cause or permit anything which may damage or endanger the
Trade Xxxx or other intellectual property of XXX or LEO's
title to it or assist or allow others to do so;
15.1.6 notify XXX of any suspected infringement of the Trade Xxxx
and/or other intellectual property of XXX and take such
reasonable action as XXX may direct at LEO's expense in
relation to such infringement.
15.1.7 not modify or alter the Trade Xxxx and/or other intellectual
property of XXX or do anything which might reasonably be
expected to damage the Trade Xxxx and/or other intellectual
property of XXX;
15.1.8 indemnify XXX from any damage claims of third parties if
Pharmion should use the Trade Xxxx and/or other intellectual
property of XXX contrary to the provisions of this Agreement;
15.1.9 market, sell and distribute the Product only in livery and in
packaging as notified by Pharmion to XXX and agreed by XXX,
such agreement not to be unreasonably withheld or delayed.
Pharmion will be responsible for the accuracy of any
information which it supplies to XXX in connection with the
requirements for the Manufacture, packaging, labeling,
marketing and sale of the Product, to the extent that the
accuracy of such information may relate to compliance with
legal and regulatory requirements, and will indemnify XXX
against any failure on its part to fulfill its obligations
under this section;
15.1.10 following the transfer of the sponsorship of the Existing NDA,
ensure the compliance of the Product' labels and packaging
with the requirements of the NDA and notify XXX of any breach
of those requirements.
15.2. Pharmion hereby warrants that:
15.2.1 This Agreement is a legal and valid obligation binding upon
Pharmion and enforceable in accordance with its terms. The
execution, delivery and performance of the Agreement by
Pharmion does not conflict with any agreement, instrument or
understanding, oral or written, to which it is a party or by
which it is bound, nor violate any law or regulation of any
court, governmental body or administrative or other agency
having jurisdiction over it.
33
16. UNDERTAKINGS AND WARRANTIES OF XXX
16.1. XXX shall:
16.1.1 at its own expense, maintain the Trade Xxxx, including the
payment of all renewal fees, and, except as otherwise provided
in Section 30, not assign or license the Trade Xxxx to any
person without Pharmion's prior written consent, such consent
not to be unreasonably withheld;
16.1.2 at its own expense, take all such steps, including initiating
proceedings, as Pharmion may reasonably require to stop any
alleged infringement of the Trade Xxxx or other XXX Product
Branding in the Territory or to defend the Trade Xxxx or other
XXX Product Branding from any attack, including any invalidity
or revocation proceedings; at LEO's request, Pharmion shall
give XXX all reasonable assistance in respect of any such
proceedings, subject to XXX meeting all reasonable costs and
expenses incurred by Pharmion in giving such assistance. If
XXX is not willing or interested in initiating action against
an infringer, Pharmion shall be entitled, but not obligated,
to enter an action in its own name based on the infringement
of the Trade Xxxx or other XXX Product Branding subject to
LEO's consent. XXX may only refuse its consent for good cause
and will give Pharmion all assistance as Pharmion may
reasonably request in connection with any such action;
16.1.3 XXX shall have the exclusive right to enter oppositions
against the filing or registration of trade marks. The same
shall apply for petitions for cancellations and actions for
cancellations entered against the registration of the trade
marks of third parties; and
16.1.4 not cause or permit anything which may damage or endanger the
Trade Xxxx or other XXX Product Branding or other intellectual
property of XXX or LEO's title to it or assist or allow others
to do so.
16.2. XXX hereby warrants that:
16.2.1 This Agreement is a legal and valid obligation binding upon
XXX and enforceable in accordance with its terms. The
execution, delivery and performance of the Agreement by XXX
does not conflict with any agreement, instrument or
understanding, oral or written, to which it is a Party or by
which it is bound, nor violate any law or regulation of any
court, governmental body or administrative or other agency
having jurisdiction over it.
16.2.2 XXX has not, and during the term of this Agreement will not,
grant any right to any third party which would conflict with
the rights granted to Pharmion hereunder.
34
16.2.3 it is the owner of the Trade Xxxx and, to the best of the
knowledge and belief of XXX, the use of the Data, the Trade
Xxxx and other XXX Product Branding and the supply of the
Product in the Territory by Pharmion will not infringe the
intellectual property rights of any third party; and
16.2.4 it is the owner of, or it has the right to use, and is
entitled to permit Pharmion to use in accordance with the
terms of this Agreement, the Data.
17. CONFIDENTIALITY
17.1. Except to the extent expressly authorized by this Agreement or
otherwise agreed in writing, the Parties agree that, for the term of
this Agreement and for seven (7) years thereafter, the receiving Party
shall keep confidential and shall not publish or otherwise disclose or
use for any purpose other than as provided for it by this Agreement any
Data or other information and materials furnished to it by the other
Party pursuant to this Agreement (collectively "Confidential
Information"), except to the extent that it can be established by the
receiving Party that such Confidential Information:
(a) was already known to the receiving Party, other than under an
obligation of confidentiality, at the time of disclosure by
the other Party;
(b) was generally available to the public or otherwise part of the
public domain at the time of its disclosure to the receiving
Party;
(c) became generally available to the public or otherwise part of
the public domain after its disclosure and other than through
any act or omission of the receiving Party in breach of this
Agreement; or
(d) was disclosed to the receiving Party, other than under an
obligation of confidentiality, by a third party who had no
obligation to the disclosing Party not to disclose such
information to others.
17.2. Each Party may disclose Confidential Information hereunder to the
extent that such disclosure is reasonably necessary for exercising its
rights and carrying out its obligations under this Agreement and in
complying with applicable governmental regulations or conducting
clinical trials as authorized under this Agreement, provided that if a
Party is required by law or regulation to make any such disclosure of
the other Party's Confidential Information it will, except where
impracticable for necessary disclosures (for example, in the event of
medical emergency), give reasonable advance notice to the other Party
of such disclosure requirement and, except to the extent inappropriate
in the case of patent applications, will use its reasonable efforts to
secure confidential treatment of such Confidential Information required
to be disclosed.
35
17.3. This Article 17 shall survive termination or expiration of this
agreement for a period of ten (10) years, provided, however, that
following the termination of this Agreement XXX shall be free to use
all Data, Improvements or other confidential information relating to
the Product.
17.4. Publications. As to any clinical study of the Product which is
supported by either Party (a "Sponsoring Party") (whether for the
Initial Indication, any Additional Indication or any New Presentation),
such Sponsoring Party shall request that the principal investigator for
such study agrees to send to both Parties, or permit the Sponsoring
Party to send to the other Party (the "Receiving Party"), prior to
submission for publication, a copy of a manuscript describing the
results of such clinical study, and such Sponsoring Party shall use its
Commercially Reasonable Efforts to ensure compliance with such request.
The Receiving Party will promptly review such manuscript and send any
comments which it may have to the Sponsoring Party, no later than
twenty (20) days after receipt of such manuscript. Provided such
comments are given on a timely basis, the Sponsoring Party will give
due consideration to the comments of the Receiving Party and will use
Commercially Reasonable Efforts to ensure that such principal
investigator will give due consideration to the comments of the
Receiving Party and will not submit such manuscript for publication
until the Sponsoring Party has had an opportunity to consider the
comments of the Receiving Party. Nothing herein contained, however,
shall preclude the Sponsoring Party or the principal investigator from
submitting any such manuscript for publication after the procedures
described above have been followed, nor shall either the Sponsoring
Party or the principal investigator be required to accept any
amendments, additions or deletions in any such manuscript proposed by
the Receiving Party. Following publication of any such manuscript, each
Party shall be entitled to make such manuscript available to physicians
in its Territory, or the XXX Territory, as the case may be.
18. INDEMNITIES
18.1. XXX will indemnify and hold Pharmion and its Affiliates, and their
employees, officers and directors harmless against any loss, damages,
action, suit, claim, demand, liability, expense, bodily injury, death
or property damage (a "Loss"), that may be brought, instituted or arise
against or be incurred by such persons to the extent such Loss is based
on or arises out of: (a) the development or Manufacture of the Product
by XXX or its Affiliates, the Manufacturer or their representatives,
agents or subcontractors under this Agreement, or any actual or alleged
violation of law resulting therefrom; or (b) the breach by XXX of any
of its material covenants, representations or warranties set forth in
this Agreement; provided that the foregoing indemnification shall not
apply to any Loss to the extent such Loss is caused by the negligent or
willful misconduct of Pharmion or its Affiliates.
18.2. Pharmion will indemnify and hold XXX and its Affiliates, and their
employees, officers and directors harmless against any Loss that may be
brought, instituted or
36
arise against or be incurred by such persons to the extent such Loss is
based on or arises out of the development, use, sale, storage or
handling of the Product by Pharmion or its Affiliates or their
representatives, agents or subcontractors under this Agreement, or any
actual or alleged violation of law resulting therefrom; or (b) the
breach by Pharmion of any of its material covenants, representations or
warranties set forth in this Agreement; provided that the foregoing
indemnification shall not apply to any Loss to the extent such Loss is
caused by the negligent or willful misconduct of XXX or its Affiliates.
Each Party entitled to be indemnified by the other Party (an
"Indemnified Party") pursuant to Section 18.1 or 18.2 hereof shall give
notice to the other Party (an "Indemnifying Party") promptly after such
Indemnified Party has actual knowledge of any threatened or asserted
claim as to which indemnity may be sought, and shall permit the
Indemnifying Party to assume the defense of any such claim or any
litigation resulting therefrom; provided that counsel for the
Indemnifying Party, who shall conduct the defense of such claim or any
litigation resulting therefrom, shall be approved by the Indemnified
Party (whose approval shall not unreasonably be withheld) and the
Indemnified Party may participate in such defense at such Party's
expense (unless (i) the employment of counsel by such Indemnified Party
has been authorized by the Indemnifying Party; or (ii) the Indemnified
Party shall have reasonably concluded that there may be a conflict of
interest between the Indemnifying Party and the Indemnified Party in
the defense of such action, in each of which cases the Indemnifying
Party shall pay the reasonable fees and expenses of one law firm
serving as counsel for the Indemnified Party, which law firm shall be
subject to approval, not to be unreasonably withheld, by the
Indemnifying Party); and provided further, that the failure of any
Indemnified Party to give notice as provided herein shall not relieve
the Indemnifying Party of its obligations under this Agreement to the
extent that the failure to give notice did not result in harm to the
Indemnifying Party. No Indemnifying Party, in the defense of any such
claim or litigation, shall, except with the approval of each
Indemnified Party which approval shall not be unreasonably withheld,
consent to entry of any judgment or enter into any settlement which (i)
would result in injunctive or other relief being imposed against the
Indemnified Party; or (ii) does not include as an unconditional term
thereof giving by the claimant or plaintiff to such Indemnified Party
of a release from all liability in respect to such claim or litigation.
Each Indemnified Party shall furnish such information regarding itself
or the claim in question as an Indemnifying Party may reasonably
request in writing and shall be reasonably required in connection with
the defense of such claim and litigation resulting therefrom.
19. DURATION AND TERMINATION
19.1. This Agreement will come into force on the Effective Date and, subject
to the Parties' rights of termination in Sections 19.2 and 19.3
hereunder, will continue in force for a period of ten (10) years from
the Effective Date. If XXX intends to continue to supply the Product to
the Territory following such ten year term, XXX
37
shall so advise Pharmion at least twenty-four (24) months prior to the
end of the original term of this Agreement, and the Parties shall
negotiate in good faith an extension to the term of this Agreement for
a reasonable period of time, not to exceed five (5) years, on terms
substantially similar to those which applied during the original ten
year term.
19.2. In addition to its rights of termination in accordance with Section 22,
Pharmion shall have the right at any time by giving notice in writing
to XXX to terminate this Agreement forthwith if XXX:
19.2.1 commits a material breach of this Agreement which is not
remedied within thirty (30) days of receipt of a notice from
Pharmion specifying the breach and requiring it to be remedied
(or, in the case of a breach not capable of being remedied
within such 30-day period, XXX has failed within such period
to take good faith steps to remedy such breach); or
19.2.2 enters into liquidation whether compulsorily or voluntarily
(otherwise than for the purposes of amalgamation or
reconstruction), compounds with its creditors, has a receiver
or manager appointed in respect of all or any part of its
assets, or is the subject of an application for an
administration order or undergoes any analogous or similar act
or proceeding under the laws of any other jurisdiction in
consequence of debt.
19.3. In addition to its rights of termination in accordance with Section 22,
XXX shall have the right at any time by giving notice in writing to
Pharmion to terminate this Agreement forthwith:
19.3.1 in accordance with the provisions of Section 6.9;
19.3.2 if Pharmion commits a material breach of this Agreement which
is not remedied within thirty (30) days of receipt of a notice
from XXX specifying the breach and requiring it to be remedied
(or, in the case of a breach not capable of being remedied
within such 30-day period, Pharmion has failed within such
period to take good faith steps to remedy such breach); or
19.3.3 if Pharmion enters into liquidation whether compulsorily or
voluntarily (otherwise than for the purposes of amalgamation
or reconstruction), compounds with its creditors, has a
receiver or manager appointed in respect of all or any part of
its assets, or is the subject of an application for an
administration order or undergoes any analogous or similar act
or proceeding under the laws of any other jurisdiction in
consequence of debt.
38
Without limiting the foregoing provisions, the failure by Pharmion to
pay any required Minimum Payments shall be deemed a material breach of
this Agreement.
20. CONSEQUENCES OF TERMINATION
20.1. Subject to the provisions of this Section 20, upon termination or
expiry of this Agreement:
20.1.1 Except as provided in Section 20.2 below, Pharmion shall cease
to make use of the Trade Xxxx, the other XXX Product Branding,
the Data and Improvements, and all rights in the Trade Xxxx,
the other XXX Product Branding, the Data, the Improvements and
all other information relating to the Product will promptly
revert to XXX and be transferred to XXX free of charge;
20.1.2 If Pharmion is then the owner of any Patents, Pharmion shall
transfer such ownership to XXX free of charge;
20.1.3 If Pharmion is then the owner of any Data, then Pharmion shall
transfer to XXX any Data related to any study for which it was
the Funding Party, as provided in Section 5.6.4, and all
restrictions imposed by Section 5.6.4 on the use by XXX of any
clinical data previously delivered by Pharmion to XXX shall be
released. At such time, XXX shall have the right, but not the
obligation, to have assigned to XXX any then pending third
party clinical trial agreements, and if XXX will assume such
agreements and, if XXX elects to terminate such agreements,
XXX shall bear the cost of such terminations.
20.1.4 Pharmion shall transfer the sponsorship of the Existing NDA
and any Additional NDA and any then pending IND from Pharmion
to XXX or a third party designated by XXX at the end of such
period of time as shall permit, in the reasonable judgment of
both Parties, an orderly transition of the distribution of the
Product in the Territory from Pharmion to XXX or such third
party, such period not to exceed six months from the date of
any such termination or the date of expiry. Simultaneously
with such transfer, Pharmion shall also return to XXX all Data
and other information relating to the Product provided to
Pharmion by XXX pursuant to this Agreement; and
20.1.5 If such termination results from the commission by Pharmion of
a material breach of this Agreement, then, in addition to any
amounts owed by Pharmion to XXX in respect of Firm Orders as
of the date of termination, Pharmion shall pay XXX the
reasonable costs actually incurred by XXX, if any, in
connection with the production of units of Product called for
by months five through twelve of the then most recent
Long-Range Forecast up to an amount not to exceed 50% of the
39
aggregate Price Per Vial of the units called for by months
five through seven of the then most recent Long-Range Forecast
and 20% of the aggregate Price Per Vial of the units called
for by months eight through twelve of the then most recent
Long-Range Forecast. The Parties agree that the above amounts
constitute a genuine pre-estimate of the loss that would be
incurred by Xxx in this situation and would not operate as a
penalty.
20.2. Notwithstanding the provisions of Section 20.1, upon termination or
expiry of this Agreement, Pharmion will be entitled:
20.2.1 to fulfill orders it has received for the Product in the
Territory up to and including the date of termination; and
20.2.2 to use any inventory of Product in its possession or ordered
from XXX as at the date of termination to fulfill any orders
referred to in Section 20.2.1.
Where Pharmion supplies any Product in accordance with this
Section 20.2, it shall be entitled to do so under and by
reference to the Trade Xxxx and shall supply such Product
subject to the terms and conditions of this Agreement.
20.3. Termination or expiry of this Agreement for any reason shall be without
prejudice to the accrued rights of either Party.
21. RIGHTS AND REMEDIES
21.1. The failure on the part of either Party hereto to exercise or enforce
any rights conferred upon it by this Agreement shall not be a waiver of
any such rights nor shall any single or partial exercise of any right,
power or privilege or further exercise thereof operate so as to bar the
later exercise or enforcement thereof.
21.2. The rights and remedies herein provided are cumulative and not
exclusive of any rights or remedies provided by law.
22. FORCE MAJEURE
Neither Party shall be in breach of this Agreement if there is any
total or partial failure of performance by it of its duties and
obligations under this Agreement by reason of force majeure. If either
Party is unable to perform its duties and obligations under this
Agreement as a direct result of force majeure, such Party shall give
written notice to the other of such inability stating the reason in
question. The operation of this Agreement shall be suspended during the
period in which the force majeure continues. Forthwith upon the reason
ceasing to exist, the Party relying upon it shall give notice to the
other of this fact. If the force majeure continues for a period of more
than ninety (90) days, the Party not
40
relying on force majeure shall be entitled to terminate this Agreement
forthwith by written notice to the other.
23. GROSS INEQUITIES
It is the intent of the parties hereto that they shall mutually benefit
from the terms, conditions and provisions of this Agreement, and in the
event that either party shall suffer a gross inequity resulting from
such terms, conditions or provisions, or from a substantial change in
circumstances or conditions, the parties shall negotiate in good faith
to resolve or remove such inequity. It is mutually agreed, however,
that nothing herein shall be construed to relieve either party of any
of its obligations under this Agreement.
24. NOTICE
24.1. Any notice or other document required to be given under this Agreement
shall be in writing and shall be served by:
24.1.1 delivery by hand;
24.1.2 sending the same by first class post or express or air mail or
other fast postal services or registered or recorded delivery
post, in each case with return receipt requested; or
24.1.3 facsimile transmission (together with postal confirmation);
addressed:
if to XXX: XXX Pharmaceutical Products Ltd. A/S
(XXX Pharma A/S)
Xxxxxxxxxxxxxx 00
XX-0000 Xxxxxxxx
Xxxxxxx
Attention: President
Fax: x00 00 00 00 00
if to Pharmion: Pharmion Corporation
0000 Xxxxxxxxx Xxxx
Xxxxxxx, Xxxxxxxx 00000 XXX
Attention: Chief Executive Officer
Fax: x0 000 000-0000
with a copy to:
Xxxxx X. Xxxxx, Esq.
Xxxxxxx Xxxx & Xxxxxxxxx
000 Xxxxxxx Xxxxxx
Xxx Xxxx, Xxx Xxxx 00000 XXX
Fax: x0 000 000-0000
41
or to such other address as may be designated in writing from
time to time by either Party to the other.
24.2. Any notice given under Section 24.1 shall be deemed to have been
received:
(i) in the case of delivery by hand, when delivered;
(ii) in the case of pre-paid post, on the third Business Day
following the day of posting; or
(iii) in the case of facsimile, on acknowledgement by the recipient
facsimile receiving equipment provided that the facsimile is
confirmed by post.
25. ENTIRE AGREEMENT/VARIATIONS
25.1. This Agreement constitutes the entire agreement and understanding
between the parties and supersedes all prior oral or written
understandings, arrangements, representations or agreements between
them relating to the subject matter of this Agreement. No director,
employee or agent of either of the parties is authorized to make any
representation or warranty to the other not contained in this
Agreement, and each of the parties acknowledges that it has not relied
on any such oral or written representations or warranties.
25.2. No variations, amendments, modifications or supplements to this
Agreement shall be valid unless made in writing in English and signed
by a duly authorized representative of each of the parties.
26. COUNTERPARTS; ENGLISH LANGUAGE
This Agreement may be executed in any number of counterparts, each of
which shall be deemed an original but all of which together shall
constitute one and the same instrument. This Agreement is entered into
in the English language. In the event of any dispute concerning the
construction or meaning of this Agreement, reference shall be made only
to this Agreement as written in English and not to any translation
hereof into any other language, and this English language version shall
be controlling for all purposes.
27. SEVERANCE OF TERMS
27.1. If the whole or any part of this Agreement is or shall become or be
declared illegal, invalid or unenforceable in any jurisdiction for any
reason whatsoever:
27.1.1 in the case of the illegality, invalidity or unenforceability
of the whole of this Agreement, it shall terminate in relation
to the jurisdiction in question; or
27.1.2 in the case of the illegality, invalidity or unenforceability
of part of this Agreement, such part shall be severed from
this Agreement in the jurisdiction in question, and such
illegality, invalidity or
42
unenforceability shall not in any way whatsoever prejudice or
affect the remaining parts of this Agreement, which shall
continue in full force and effect.
28. PUBLICATION/PRESENTATION/PRESS RELEASE
The text of any press release or other communication to be published by
or in the media by or on behalf of either of the parties concerning the
subject matter of this Agreement shall require the approval of both
parties, which approval shall not be unreasonably withheld or delayed.
29. PARTNERSHIP/AGENCY; THIRD PARTIES
29.1. None of the provisions of this Agreement shall be deemed to constitute
the relationship of partnership or agency between the parties, and
neither shall have any authority to bind the other in any way except as
provided in this Agreement.
29.2. The Parties agree that no person which is not a Party to this Agreement
is intended to benefit from or shall have any right to enforce any
provision of this Agreement by virtue of the Contracts (Rights of Third
Parties) Act.
30. ASSIGNMENT
Neither Party may assign the benefit or burden of this Agreement
without the prior written consent of the other Party except, in the
case of Pharmion, to a successor to all or substantially all of the
business of Pharmion, and except, in the case of XXX, to a successor to
all or substantially all of the business of XXX or all or substantially
all of the business of XXX relating to the Product. .
31. AUDIT RIGHTS
Each Party shall maintain books of account relating to its payment
obligations and reimbursement rights pursuant to this Agreement all in
accordance with International Accounting Standards with appropriate
controls to insure that transactions are properly recorded. Each Party
shall have the right, at its own expense, to have an independent
certified public accountant of its own selection, reasonably acceptable
to the other Party, examine at a time reasonably acceptable to the
other, during normal business hours but not more than once each
calendar year, the relevant books and records of account of the other,
to determine whether appropriate accounting has been made hereunder.
Such independent certified accountant shall treat as confidential and
shall not disclose to the Party engaging such accountant any
information other than that which is relevant to the rights of the
engaging Party hereunder or the performance by the other Party of its
obligations hereunder. In the event of a dispute between the
independent certified public accountants of Pharmion and XXX with
respect to any matter called for by this Agreement, the parties shall
select a third independent public accounting firm to arbitrate the
dispute, provided, that such firm shall have the authority only to
select from among the positions of the original two firms that position
which it
43
deems most accurate. The fees of such third firm shall be borne by the
Party whose position is not approved of by such arbitrator.
32. GOVERNING LAW AND JURISDICTION
The validity, interpretation and performance of this Agreement as well
as any disputes connected herewith shall be construed in accordance
with the laws of England, excluding the United Nations Convention on
Contracts for the International Sale of Goods. In relation to any
dispute or difference between the Parties arising out of or in
connection with this Agreement or any legal action or proceedings to
enforce this Agreement, each of the Parties irrevocably submits to the
exclusive jurisdiction of the English courts and waives any objection
to proceedings in such courts on the grounds of venue or on the grounds
that the proceedings have been brought in an inconvenient forum.
AS WITNESS, the hands of the parties or their duly authorized representatives
the day and year first above written.
XXX PHARMACEUTICAL PRODUCTS LTD. A/S PHARMION CORPORATION
(XXX PHARMA A/S)
By: /s/ Xxxxx Xxxxxxx By: /s/ Xxxxxxx X. Xxxxxxx
Name: Xxxxx Xxxxxxx Name: Xxxxxxx X. Xxxxxxx
Title: President & CEO Title: President & CEO
