EXHIBIT 10.4
NONEXCLUSIVE SUBLICENSE AGREEMENT
This Agreement is effective on September 8, 1999 (the "Effective Date"), and is
by and among Seragen, Inc. (hereinafter "Seragen"), a Delaware corporation
having a place of business at 00 Xxxxx Xxxxxx, Xxxxxxxxx, Xxxxxxxxxxxxx 00000 on
the one hand, and Xxxxxxxx-Xx Xxxxx Inc., a New Jersey corporation having
offices at 000 Xxxxxxxxx Xxxxxx, Xxxxxx, Xxx Xxxxxx 00000 (hereinafter
"Xxxxx-Xxxxxx") and X.Xxxxxxxx-Xx Xxxxx Ltd, a corporation organized under the
laws of Switzerland, having offices at Xxxxxxxxxxxxxxxxx 000, XX-0000 Xxxxx,
Xxxxxxxxxxx (hereinafter "Roche-Basel") (hereinafter Xxxxx-Xxxxxx and
Xxxxx-Xxxxx are individually and collectively, "Roche") on the other hand.
WITNESSETH
WHEREAS, Roche is engaged in the commercialization and development of the
active ingredient daclizumab under the trademark Zenapax(R); and
WHEREAS, Seragen has entered into a License and Royalty Agreement dated
June 1, 1990 (the "Xxxx Israel License", a copy of which is attached hereto as
Exhibit B with financial terms redacted) with The Xxxx Israel Hospital
Association, now known as Xxxx Israel Deaconess Medical Center ("Xxxx Israel")
under which Seragen has exclusive license rights to certain patents and patent
applications which name Xx. Xxxxx X. Xxxxx as the inventor ( the "Xxxxx Patents"
as defined below), including the right to grant sublicenses to the Xxxxx
Patents;
WHEREAS, a dispute has arisen between Seragen and Roche concerning the
Xxxxx Patents and daclizumab; and
WHEREAS, Roche and Seragen wish to settle all outstanding patent issues
regarding daclizumab and the Xxxxx Patents;
NOW, THEREFORE, in consideration of the premises and the mutual covenants
contained herein and in Roche's reliance on the statements made by Xxxx Israel
in the document attached hereto as Exhibit C, the parties hereto agree as
follows:
ARTICLE I - DEFINITIONS
For the purpose of this Agreement, the following words and phrases shall
have the following meanings:
"Adjusted Gross Sales" means the gross sales amount, on a
country-by-country basis, in the Territory invoiced for Licensed Product by the
Roche Group to third parties, less
(a) amounts actually allowed as volume or quantity discounts, rebates (
price reductions, including Medicaid or performance based and similar
types of rebates,
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e.g., chargebacks or retroactive price reductions), returns
(including withdrawals and recalls); and
(b) sales, excise and turnover taxes imposed directly upon and actually
paid by the Roche Group.
"Affiliate" means (i) an entity which owns, directly or indirectly, a
controlling interest in Roche or Seragen, by stock ownership or otherwise; or
(ii) an entity which is owned by Roche or Seragen, either directly or
indirectly, by stock ownership or otherwise; or (iii) an entity, the majority
ownership of which is directly or indirectly common to the majority ownership of
Roche or Seragen. Anything to the contrary in this paragraph notwithstanding,
Genentech, Inc., a Delaware corporation, shall not be deemed an Affiliate of
Roche unless Roche notifies Seragen that Roche wishes for Genentech, Inc. to be
deemed an Affiliate of Roche.
"BLA" means a Biologics License Application filed pursuant to the
requirements of the FDA.
"FDA" means the United States Food and Drug Administration.
"Large Market Autoimmune Indication" means any of the following therapeutic
indications: *** ***
"Licensed Product" means any product (1) that contains daclizumab, an
immunosuppressive, humanized IgG1 monoclonal antibody that binds specifically to
the alpha subunit of the human high-affinity interleukin-2 (IL-2) receptor that
is expressed on the surface of activated lymphocytes and is currently sold under
the trademark Zenapax(R), and (2) the making, having made, using, selling,
offering for sale or importing of which, but for this Agreement, would infringe
a Valid Claim.
"Net Sales" means the amount calculated by subtracting a lump sum deduction
of *** from the Adjusted Gross Sales to cover all other expenses or discounts,
including but not limited to cash discounts, outward freights, postage charges,
packaging materials, custom duties, transportation and insurance charges,
discounts granted later than at the time of invoicing, and other direct
expenses.
"Roche Group" means, individually and collectively, Roche, its Affiliates
and sublicensees.
"Small Market Autoimmune Indication" means all autoimmune indications ***
*** *** *** that are not Large Market Autoimmune Indications.
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"Royalty Term" means the period of time commencing on January 1, 2001 and
ending on a country by country basis upon the last date on which the making,
having made, using, selling, offering for sale or importing of Licensed Product
in the Territory by the Roche Group would, but for this Agreement, infringe a
Valid Claim in such country.
"Xxxxx Patents" means all patents and patent applications throughout the
world claiming priority of U.S. Serial No. 772,893, filed September 5, 1985, and
any, renewals, reexaminations, continuations, continuations-in-part, divisions,
patents of addition, extensions, and/or reissues of any of these patents and
patent applications, except that Xxxxx Patents shall not include US Patent Nos.
5,336,489 issued August 9, 1994, 5,510,105 issued April 23, 1996, 5,587,162
issued December 24, 1996 or 5,607,675 issued March 4, 1997. Xxxxx Patents shall
include without limitation those patents and patent applications listed on the
attached Exhibit A.
"Term of this Agreement" has the meaning set forth in Section 7.1.
"Territory" means the United States of America ("U.S"), Australia, New
Zealand and Canada.
"Valid Claim" means a claim in any unexpired and issued Xxxxx Patent that
has not been disclaimed, revoked or held invalid by a final unappealable
decision of a court or governmental agency of competent jurisdiction, and which
claim is otherwise enforceable.
ARTICLE II - GRANT
2.1 License Grant. Seragen grants to Roche a non-exclusive sublicense with
the right to grant further sublicenses, under the Xxxxx Patents to make, use,
have made, sell, offer for sale and import the Licensed Product in the
Territory.
2.2 Covenant. Seragen shall not undertake any act or enter into any
amendment of the Xxxx Israel License that would adversely affect the rights or
obligations of Roche under this Agreement without the prior written consent of
Roche.
ARTICLE III - SUBLICENSE PAYMENTS
3.1 Initial Royalty. For Net Sales of Licensed Product occurring before the
Effective Date, ROCHE shall pay to Seragen a one-time royalty of Two Million
Five Hundred Thousand ($2,500,000) dollars within seven (7) business days after
the date all parties become signatory to this Agreement and receipt by
Xxxxx-Xxxxxx of an invoice.
3.2 Milestones. Within thirty (30) days after achievement of each of the
milestones set forth below, Roche shall pay to Seragen the nonrefundable
milestone payment set forth below:
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(a) *** upon the first BLA approved in the US for use of the Licensed
Product to treat a Small Market Autoimmune Indication; and
(b) *** upon the first BLA approved in the US for use of the Licensed
Product to treat a Large Market Autoimmune Indication.
3.3 Royalties. During the Royalty Term, Roche shall pay to Seragen the
following royalty, , on Net Sales of the Licensed Product in the Territory:
(a) ***% of annual Net Sales up to $*** million;
(b) ***% of annual Net Sales between $*** million and $*** million;
and
(c) ***% of annual Net Sales exceeding $*** million.
ARTICLE IV - PAYMENTS; RECORDS; AUDITS
4.1 Payment; Reports. Within ninety (90) days after the end of each
calendar half year during the Royalty Term, Roche shall (i) provide Seragen with
a report of Net Sales for that calendar half year by the Roche Group and as
reported by any sublicensees in such calendar half year, and (ii) pay royalties
to Seragen under this Agreement for Net Sales in that calendar half year. Roche
shall provide the reports due to Seragen at the address listed below:
Ligand Pharmaceuticals Incorporated
00000 Xxxxxxx Xxxxxx Xxxxx
Xxx Xxxxx, XX 00000
Roche shall pay the royalties due to Seragen under this Agreement by wire
transfer to:
Imperial Bank
San Diego Regional Xxxxxx
000X Xxxxxx
Xxx Xxxxx, XX 00000
ABA#: 000000000
Account #: 00-000-000
Account Name: Seragen General Account
4.2 Currency Roche shall make all payments due under this Agreement in US
Dollars. For purposes of computing royalties, when calculating Adjusted Gross
Sales, the amount of sales in currencies other than US Dollars shall be
converted into Swiss Francs for the countries concerned, using the average
monthly rate of exchange at the time for the such currencies calculated on the
basis of the daily rate of exchange as retrieved from the Reuters System during
such month. When calculating Net Sales, such conversion shall be at the average
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rate of Swiss Francs to the US Dollar calculated on the basis of the daily rate
of exchange as retrieved from the Reuters System for the applicable reporting
period.
4.3 Records and Audits. Roche shall keep, and shall cause its Affiliates
and sublicensees to keep, complete and accurate records of Licensed Products
sold in sufficient detail to permit Ligand to determine the amount of royalties
due and confirm the accuracy of all payments due hereunder. The Roche Group, as
appropriate, shall be obligated to retain such records for no more than three
(3) years following the end of the reporting period to which such records
pertain.
At Seragen's request, Roche will cause its independent certified public
accountants to prepare, preferably during Roche's annual audit, an abstract of
Roche's books and records for review by Seragen's independent certified public
accountants. If, based on a review of such abstracts, Seragen reasonably
believes that a full audit of said books and records would be necessary for the
confirmation of the accuracy of all royalties due hereunder, Seragen's
independent certified public accountants shall have full access to review all
work papers and supporting documents pertinent to such abstracts, and shall have
the right to discuss such documentation with Roche's independent certified
public accountants. After such review and discussion, if Seragen still
reasonably believes that a full audit of said books and records would be
necessary for the confirmation of all payments due hereunder, Seragen shall have
the right to cause its independent certified public accountants to which Roche
has no reasonable objection (meaning, e.g., that such accountants have
broad-based worldwide contacts and experience) to audit such records to confirm
the Net Sales of Licensed Product and the accuracy of royalty calculations. If
the independent certified public accountants selected by Seragen are not the
independent certified public accountants used by Roche to prepare such
abstracts, Roche shall have the right to have its independent certified public
accountants and financial personnel present at all times during such audit.
The audit rights under this Section 4.3 may be exercised by Seragen no more
often than once per year, within three (3) years after the reporting period to
which such records relate, upon no less than thirty (30) days prior written
notice to Roche, and during Roche's normal business hours. Seragen will bear the
full cost of any such audit unless such audit discloses an underpayment of more
than *** from the amount of royalties due. In such case, Roche shall promptly
pay Seragen any underpayment and shall bear the full cost of such audit.
4.4 Taxes. Roche may deduct, from consideration due Seragen hereunder, any
and all withholding taxes levied on account of payments and/or royalties paid to
Seragen hereunder. Roche shall pay the withholding tax to the proper taxing
authority and, upon request of Seragen, shall obtain and send to Seragen proof
of such tax payment as evidence of such tax payment.
ARTICLE V - REPRESENTATIONS AND WARRANTIES
5.1 Corporate Power. Each party hereby represents and warrants that such
party is duly organized and validly existing under the laws of the state of its
incorporation and has full
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corporate power and authority to enter into this Agreement and to carry out
the provisions hereof.
5.2 Due Authorization. Each party hereby represents and warrants that such
party is duly authorized to execute and deliver this Agreement and to perform
its obligations hereunder.
5.3 Binding Agreement. Each party hereby represents and warrants that this
Agreement is a legal and valid obligation binding upon it and is enforceable in
accordance with its terms. The execution, delivery and performance of this
Agreement by such party does not conflict with any agreement, instrument or
understanding, oral or written, to which it is a party or by which it may be
bound, nor violate any law or regulation of any court, governmental body or
administrative or other agency having authority over it.
5.4 Seragen Representations. Seragen represents and warrants that, as of
the Effective Date:
(a) the Xxxxx Patents are not subject to any pending interference,
opposition, cancellation or other protest proceeding;
(b) it is not aware of any information that it reasonably believes renders
invalid and/or unenforceable any claims of the Xxxxx Patents;
(c) under the Xxxx Israel License, Seragen has the full and exclusive
right to grant all rights and licenses granted hereunder to Roche; and
(d) there are no patent or patent applications throughout the world other
than the Xxxxx Patents owned or controlled by Seragen or its
Affiliates which could be asserted to prevent the Roche Group from
making, having made, using, offering for sale, selling or importing
Licensed Product in any country.
5.5 Disclaimer of Warranties. EXCEPT AS EXPRESSLY SET FORTH IN THIS
AGREEMENT, NEITHER PARTY MAKES ANY REPRESENTATION OR WARRANTY TO THE OTHER PARTY
OF ANY KIND, EXPRESS OR IMPLIED, INCLUDING, WITHOUT LIMITATION, ANY WARRANTY OF
VALIDITY, NONINFRINGEMENT, MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE.
5.6 Limitation of Liability. ROCHE SHALL NOT BE ENTITLED TO RECOVER FROM
SERAGEN ANY SPECIAL, INCIDENTAL, CONSEQUENTIAL OR PUNITIVE DAMAGES IN CONNECTION
WITH THE SUBLICENSE GRANTED HEREUNDER.
ARTICLE VI - ASSIGNMENT
Either Party shall have the right to assign its rights and obligations
under this Agreement, provided that any such assignee shall be bound by the
terms of this Agreement. Either Party shall notify the other Party within thirty
(30) days of any such assignment. The rights and
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obligations of the Parties under this Agreement shall be binding upon and
inure to the benefit of the successors and permitted assignees of the parties.
ARTICLE VII- TERM; TERMINATION
7.1 Term. The Term of this Agreement shall begin on the Effective Date and
shall continue until the end of the Royalty Term, unless terminated earlier in
accordance with Section 7.2.
7.2 Early Termination. (a) Either party may terminate this Agreement prior
to the expiration of the Royalty Term upon the occurrence of any of the
following:
(i) Upon or after the bankruptcy, insolvency, dissolution or winding up of
the other party (other than dissolution or winding up for the purposes of
reconstruction or amalgamation); or
(ii) Upon or after the breach of any material provision of this Agreement
by the other party if the breaching party has not cured such breach within sixty
(60) days following written notice thereof by the non-breaching party.
Nonpayment by Roche of royalties or other payment obligations due under this
Agreement shall constitute a breach of a material provision of this Agreement,
including nonpayment or escrowing on the grounds that one or more claims of the
Xxxxx Patents are invalid or unenforceable.
(b) Roche shall have the right to terminate this Agreement in its entirety,
or on a country by country basis, at any time by providing thirty (30) days
prior written notice to Seragen.
(c) All rights and licenses granted under or pursuant to this Agreement by
Seragen to Roche are, and shall be otherwise be deemed to be, for purposes of
Section 365(n) of Title 11, U.S. Code ("Bankruptcy Code"), licenses of rights to
"intellectual property" as defined under Section 101(60) of the Bankruptcy Code.
The parties agree that Roche shall retain and may fully exercise all of its
rights and elections under the Bankruptcy Code.
7.3 Effect of Termination
(a) Upon termination of this Agreement by either party pursuant to Section
7.2, all rights and licenses to the extent granted to Roche by Seragen under the
Xxxxx Patents hereunder shall revert to Seragen, and, subject to Section 7.4,
all unaccrued royalty and payment and other obligations hereunder shall
terminate.
(b) Termination of this Agreement by either party pursuant to Section 7.2
shall not relieve the parties of any obligation accruing prior to such
termination.
7.4 Survival Those terms and conditions which by their nature are intended
to survive expiration or termination of this Agreement shall survive such
expiration or termination, including without limitation Section 4.3, Section
5.5, Section 5.6, Section 7.4, and Article VIII.
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7.5 Effect of Termination of the Xxxx Israel License To Seragen In the
event that the Xxxx Israel License is terminated, this Agreement shall
immediately become a direct license to Roche from Xxxx Israel, under the same
terms and conditions hereunder, with Xxxx Israel assuming all rights and
obligations of Seragen hereunder, in accordance with article 2.3 of the Xxxx
Israel License. Seragen shall promptly notify Roche in event of such
termination.
ARTICLE VIII-MISCELLANEOUS PROVISIONS
8.1 Notices. Any payment, notice or other communication pursuant to this
Agreement shall be sufficiently made or given on the date of mailing if sent to
such party by certified first class mail, postage prepaid, addressed to it at
its address below or as it shall designate by written notice given to the other
party:
SERAGEN's Notification Address: ROCHE's Notification Addresses:
Ligand Pharmaceuticals Incorporated Xxxxxxxx-Xx Xxxxx Inc.
00000 Xxxxxxx Xxxxxx Xxxxx 000 Xxxxxxxxx Xxxxxx
Xxx Xxxxx, XX 00000 Xxxxxx, Xxx Xxxxxx 00000
Attention: Xxxxxxx X. Xxxxxxx, Attention: Corporate Secretary
Senior Vice President,
General Counsel, Government Affairs X.Xxxxxxxx-Xx Xxxxx Ltd
Xxxxxxxxxxxxxxxxx 000
XX-0000 Xxxxx
Xxxxxxxxxxx
Attention: Corporate Law Department
8.2 Governing Law. This Agreement shall be construed, governed, interpreted
and applied in accordance with the laws of the State of New Jersey.
8.3 Integration. The parties hereto acknowledge that this Agreement sets
forth the entire Agreement and understanding of the parties hereto as to the
subject matter hereof, and shall not be subject to any change or modification
except by the execution of a written instrument subscribed to by the parties
hereto.
8.4 Severability. The provisions of this Agreement are severable, and in
the event that any provisions of this Agreement shall be determined to be
invalid or unenforceable under any controlling body of the law, such invalidity
or unenforceability shall not in any way affect the validity or enforceability
of the remaining provisions hereof.
8.5 Non-Waiver of Rights. The failure of either party to assert a right
hereunder or to insist upon compliance with any term or condition of this
Agreement shall not constitute a waiver of that right or excuse a similar
subsequent failure to perform any such term or condition by the other party.
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8.6 Publicity. Neither party will disclose the existence or terms of this
Agreement to any third party other than (1) as required by law or government
regulations, (2) to its Affiliates, assignees and sublicensees or potential
Affiliates, potential assignees and potential sublicensees (hereinafter
collectively "Receiving Party"), provided such Receiving Party is party to a
written agreement to retain such disclosure as confidential (3) to Xxxx Israel,
or (4) as agreed upon by the parties.
The parties have agreed to public disclosure of the press release set forth
in Exhibit D by Seragen or its Affiliate on or after the Effective Date, as well
as subsequent public disclosure of the information provided in Exhibit D.
Neither party will issue any press release or other public announcement relating
to this Agreement disclosing additional information not provided in Exhibit D
without first obtaining written approval from the other party, which approval
shall not be unreasonably withheld.
8.7 Counterparts. This Agreement may be executed in any number of
counterparts and each of such counterparts shall for all purposes be an original
and all such counterparts shall together constitute but one and the same
agreement.
IN WITNESS WHEREOF, the parties have hereunto set their hands and seals and
duly executed this Agreement the day and year set forth below.
SERAGEN, INC. XXXXXXXX-XX XXXXX INC.
By /s/ Xxxxx X. Xxxxx By: /s/ Xxxxxx X. Xxxxx
Xxxxx X. Xxxxx
Title: Vice President, Title: Vice President
Commercial Operations
Date: 09/08/99 Date: 09/09/99
X.XXXXXXXX-XX XXXXX LTD
By: /s/ Xxxxxx Xxxxxxx Xxxx Xxxxxxxxx
Title: Director Deputy Director
Date: 09/10/99
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EXHIBIT A
Xxxxx Patents
1. U.S. Patent No 5,011,684 issued April 30, 1991
2. U.S. Patent No. 5,674,494 issued October 7, 1997
3. U.S. Patent No. 5,916,559 issued June 29, 1999
4. *** ***
5. Canadian Patent No. 1,275,951 issued November 6, 1990
6. Australian Patent No. 575,210 issued July 21, 1988
7. New Zealand Patent No. 213,983 issued June 28, 1989
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Exhibit B
Copy of Xxxx Israel License
Filed as Exhibit 10.11 to Form 10-K filed by Seragen, Inc. on April 2,
1997, as amended.
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Exhibit C
September 8, 1999 Letter from Xxxx Israel to Xxxxxxxx-Xx Xxxxx
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[logo]
Xxxx Israel Deaconess
Medical Center Office of Corporate Research
Xxxx Xxxxxx 33O Brookline Avenue, Mail Stop MT-1
Xxxxxx, Xxxxxxxxxxxxx 00000 XXX
Director xxxxxxx@xxxxxxxxx.xxxxxxx.xxx
Office of Corporate Research Tel 000.000.000.0000
Fax 000.000.000.0000
September 8, 1999
Xxxxxx X. Xxxxxxxx
Vice President and Chief Patent Counsel
Xxxxxxxx-Xx Xxxxx, Inc.
000 Xxxxxxxxx Xxxxxx
Xxxxxx, Xxx Xxxxxx 00000
Dear Xxxxxx:
Xxxx Israel Deaconess Medical Center ("BIDMC") was formed by a merger between
Xxxx Israel Hospital Association ("Xxxx Israel") and the New England Deaconess
Hospital Corporation effective October 1, 1997. BIDMC has read a Nonexclusive
Sublicense Agreement ("Agreement") effective September 1, 1999, by and among
Seragen, Inc., a Delaware Corporation ("Seragen") on one hand and Xxxxxxxx
XxXxxxx Inc., a New Jersey Corporation and Xxxxxxxx-Xx Xxxxx Ltd, a corporation
organized under the laws of Switzerland (individually and collectively "Roche")
on the other hand,
BIDMC understands that Roche is entering into the Agreement in reliance on the
representations and warranties made by BIDMC to Roche set forth below.
BIDMC represents and warrants that:
1. Xxxx Israel was the assignee of the entire right, title and interest in
and to the Xxxxx Patents as that term is defined in the Agreement on
the date Seragen and Xxxx Israel entered into the Xxxx Israel License
as that term is defined in the Agreement and that BIDMC is the
successor in interest to the interests of Xxxx Israel in and to the
Xxxxx Patents and the Xxxx Israel License;
2. Seragen is empowered under the Xxxx Israel License to grant sublicenses
under the Xxxxx Patents, including to Roche as in the Agreement.
3. BIDMC and its Affiliates will not assert any patent or patent
application owned or controlled by BIDMC or its Affiliates as of
September 8, 1999 to be infringed by Roche making, having made, using,
selling, offering for sale or importing the Licensed Product in any
country throughout the world as the term "Licensed Product" is defined
in the Agreement. As used herein, the term "Affiliate" means (i) an
entity which owns, directly or indirectly, a controlling interest in
BIDMC, (ii) an entity which is owned, directly or indirectly, by BIDMC,
or (iii) an entity, the majority ownership of which is directly or
indirectly common to the majority ownership of BIDMC.
In addition, BIDMC covenants that, if the Xxxx Israel License is
terminated, BIDMC hereby agrees to Roche becoming a direct licensee of BIDMC as
provided in Section 7.5 of the Agreement.
BIDMC also hereby agrees to maintain the existence and terms of the
Agreement as confidential, except to the extent of public disclosure of the
information in Exhibit D of the Agreement in accordance with Section 8.6 of the
Agreement.
With the exception of the obligation regarding maintaining the
existence and terms of the Agreement as confidential, the provisions of this
letter will have no force and effect upon termination of the Agreement.
Agreed and accepted:
XXXX ISRAEL DEACONESS MEDICAL CENTER
/s/ Xxxx Xxxxxx
Xxxx Xxxxxx, Director
Office of Corporate Research
cc: Xxxxxxx X. Xxxxxxx (Seragen, Inc.)
Xxxxx Xxxxxxxxxx, MD (BIDMC)
Exhibit D
Press Release
Contact:
Xxxxxxxxxx X. Xxxxx
(000) 000-0000
Ligand Subsidiary Sublicenses Xxxxx Patents to Roche
-- Seragen and Xxxx Israel to receive royalties on sales of Zenapax(R) --
SAN DIEGO, CA - September 13, 1999 -- Ligand Pharmaceuticals Incorporated
(Nasdaq: LGND) announced today that its wholly-owned subsidiary, Seragen, Inc.,
has entered into a non-exclusive sublicense agreement with Basel,
Switzerland-based X. Xxxxxxxx-Xx Xxxxx Ltd. and its U.S. pharmaceutical
subsidiary Xxxxxxxx-Xx Xxxxx Inc., with respect to Seragen's rights under a
family of patents called the "Xxxxx Patents." The sublicense under the Xxxxx
Patents grants Roche the right to make, use and sell in the U.S., Canada,
Australia and New Zealand any product containing the active ingredient
daclizumab. Roche currently sells such a product under the trademark Zenapax(R)
for the treatment of acute organ rejection in patients receiving kidney
transplants.
In consideration for the sublicense, Roche will pay Seragen a $2.5 million
royalty for sales of Zenapax(R) occurring before the date of this agreement
plus, commencing in January 2001, royalties on net sales of licensed products in
the U.S., Canada, Australia and New Zealand. Seragen will also receive milestone
payments in the event Roche receives U.S. regulatory approval of licensed
products containing daclizumab for use in the treatment of autoimmune
indications.
The Xxxxx Patents, licensed by Seragen from Xxxx Israel Deaconess Medical
Center, a major Harvard Medical School teaching hospital, cover the use of
antibodies that target the interleukin-2 (IL-2) receptor to treat transplant
rejection and autoimmune diseases. Previously a non-exclusive license was issued
to Novartis covering the product Simulect(R) to treat organ transplant
rejection, for which Ligand expects to receive royalty payments beginning in
January 2001. According to the terms of the Xxxx Israel agreement with Seragen,
Xxxx Israel will also share in the royalty and milestone payments.
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"We are pleased to complete this second sublicense agreement under the
Xxxxx Patents which we acquired exclusive rights to together with Ontak(R) in
the Seragen acquisition," said Xxxxx X. Xxxxxxxx, Ligand Chairman, President and
CEO. "This will allow us to realize significant additional value for our
shareholders from the assets of Seragen, now a wholly owned subsidiary of Ligand
Pharmaceuticals Incorporated."
Xxxxxxxx-Xx Xxxxx Inc. is a leading research-intensive pharmaceutical
company that discovers, develops, manufactures and markets
numerous important prescription drugs that improve, prolong
and save the lives of patients with serious illnesses.
Xxxxxxxx-Xx Xxxxx is a global leader in health care with
principal businesses in pharmaceuticals, diagnostics,
vitamins, fragrances, and flavors.
LIGAND PHARMACEUTICALS INCORPORATED
Ligand Pharmaceuticals Incorporated discovers, develops and markets new
drugs that address critical unmet medical needs of patients in the areas of
cancer, skin diseases, and men's and women's hormone-related diseases, as well
as osteoporosis, metabolic disorders and cardiovascular and inflammatory
diseases. Ligand's first two drugs -- Panretin(R) gel and ONTAK(R) -- were
approved for marketing in the U.S. in early 1999 and are being marketed through
its specialty cancer and HIV-center sales force in the U.S. Four additional
oncology-related products are in late-stage development, including Targretin(R)
capsules, Targretin(R) gel, Panretin(R) capsules, and Morphelan(TM) (licensed
from Elan). Ligand's proprietary drug discovery and development programs are
based on its leadership position in gene transcription technology, primarily
related to Intracellular Receptors (IR) and Signal Transducers and Activators of
Transcription (STATs).
This news release may contain certain forward looking statements by Ligand
and actual results could differ materially from those described as a result of
factors including, but not limited to the following. There can be no assurance
that (a) there will continue to be a market in the U.S. or elsewhere for
Zenapax(R) or any product subject to the sublicense agreement, (b) Roche will
pursue any other indications for Zenapax(R) or any product subject to the
sublicense agreement, (c) Seragen will receive any royalties or milestone
payments from Roche; (d) any product under development by Ligand or Roche will
receive approval from the U.S. Food and Drug Administration or other authorities
to market the product; (e) if successfully developed and thereafter approved,
there will be a market for the drug. Additional information concerning these
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factors can be found in press releases as well as in Ligand's public periodic
filings with the Securities and Exchange Commission. Ligand disclaims any intent
or obligation to update these forward-looking statements beyond the date of this
release.
# # #
Note: Public information on Ligand Pharmaceuticals Incorporated, including
our financial statements and other filings with the Securities and Exchange
Commission, our recent press releases and the package inserts for products
approved for sales and distribution in the United States, is available on our
web site at xxxx://xxx.xxxxxx.xxx.
# # #
Panretin(R) and Targretin(R) are registered trademarks of Ligand
Pharmaceuticals Incorporated, and ONTAK(R) is a registered trademark of Seragen,
Inc., a wholly owned subsidiary of Ligand.
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