1
Confidential Materials omitted and filed separately with the
Securities and Exchange Commission. Asterisks denote omissions.
EXHIBIT 10.6
LICENSE AGREEMENT
-----------------
This Agreement, made and entered into this 6th day of June 1990, by and
between Biogen, Inc. a Massachusetts corporation, of 00 Xxxxxxxxx Xxxxxx,
Xxxxxxxxx, XX 00000 ("BIOGEN") and Health Research, Inc., a not-for-profit
corporation of 0000 Xxxxxx Xxxxx Xxxxx, Xxxxxx, Xxx Xxxx 00000 ("HRI").
WHEREAS, HRI is a co-owner with BIOGEN of the Licensed Patent Rights (as
herein defined); and
WHEREAS, BIOGEN desires to become exclusively licensed to HRI's rights in
the Licensed Patent Rights.
NOW, THEREFORE, for good and valuable consideration and upon the mutual
covenants and promises hereinafter set forth, the parties agree as follows:
1. DEFINITIONS
-----------
1.1 "Affiliates" shall mean any corporation, partnership, or other business
organization which directly or indirectly controls, is controlled by, or is
under common control with BIOGEN. For purposes of this Agreement, "control"
shall mean the holding directly or indirectly of fifty percent (50%) or more of
the voting stock or other ownership interest of the corporation or business
entity involved.
1.2 "Licensed Patent Rights" shall mean the co-owned BIOGEN and HRI patent
application listed in Exhibit A, attached hereto, and any foreign counterpart
patent applications and any patents which issue therefrom, together with any
extensions, reissues, renewals, divisions, continuations or
continuations-in-part thereof, and any other co-owned BIOGEN and HRI patent
applications or patents describing or arising out of the inventions covered by
the patent application listed in Exhibit A.
1.3 "Licensed Product(s)" shall mean any product which falls within the
scope of a claim of the Licensed Patent Rights or is made in whole or in part in
accordance with a process which falls within the scope of a claim of the
Licensed Patent Rights.
1.4 "Net Sales" shall mean the gross invoice price of Licensed Product(s)
sold in any country by BIOGEN or its Affiliates to any party other than
sublicensees, less deductions for (i) any sales taxes, excise taxes and duties,
(ii) packaging, shipping, handling and insurance charges, (iii) allowances and
adjustments for spoiled, damages, outdated or returned Licensed Product(s), and
(iv) trade discounts, to the extent such deductions are actually billed or
credited to the customer. Sales or transfers of Licensed Product(s) between
BIOGEN and its Affiliates shall not be deemed Net Sales unless BIOGEN or its
Affiliates are the end users of the Licensed Product(s).
1.5 "Sublicense Income" shall mean the royalty income actually received by
BIOGEN or its Affiliates from the sale of Licensed Product(s) by BIOGEN's
sublicensees, less deductions for any withholding or other taxes. It is agreed
that royalty income shall not include payments BIOGEN or its Affiliates receive
from the supply of material, equipment, know-how,
2
Confidential Materials omitted and filed separately with the
Securities and Exchange Commission. Asterisks denote omissions.
technical information and the like to BIOGEN's sublicensees, and shall not
include the sales or transfers of Licensed Product(s) between BIOGEN or its
Affiliates and the sublicensees unless the sublicensees are the end users of the
Licensed Product(s).
2. LICENSE GRANT
-------------
2.1 Subject to the terms and conditions hereinafter set forth, HRI hereby
grants to BIOGEN and its Affiliates a worldwide license, with the right to grant
sublicenses, under the Licensed Patent Rights to make, have made, use, sell, and
have sold Licensed Product(s). Such license shall be exclusive except that HRI
reserves the right to use the Licensed Patent Rights for noncommercial research
and educational purposes.
3. PAYMENTS
--------
3.1 In consideration for the contribution to the scientific and technical
developments relating to Licensed Products by the HRI, BIOGEN shall pay the
following non-refundable fees to HRI:
(a) [**] U.S. Dollars [**] within thirty (30) days of execution of this
Agreement.
(b) [**] U.S. dollars [**] within thirty (30) days of BIOGEN's submission
of the first Investigational New Drug application to the United States
Food and Drug Administration ("FDA") for a Licensed Product.
(c) [**] U.S. dollars [**] within thirty (30) days of Biogen's submission
of the first New Drug Application to the FDA for a Licensed Product.
(d) [**] U.S. dollars [**] within thirty (30) days of the FDA's approval of
Biogen's first New Drug Application for a Licensed Product.
3.2 In consideration for the rights granted by HRI to BIOGEN hereunder,
BIOGEN shall pay to HRI:
(a) A minimum annual royalty of [**] U.S. dollars [**] beginning with the
calendar year following the first sale of Licensed Product.
(b) A royalty on the cumulative annual Net Sales of Licensed Product
according to the following schedule:
Cumulative Annual Net Sales Royalty Percentage
--------------------------- ------------------
[**] Million U.S. Dollars [**]
[**] Million U.S. Dollars [**]
[**] Million U.S. Dollars [**]
[**] Million U.S. Dollars & Greater [**]
2
3
Confidential Materials omitted and filed separately with the
Securities and Exchange Commission. Asterisks denote omissions.
(c) A royalty of [**] of the Sublicense Income received by BIOGEN and its
Affiliates.
3.3 BIOGEN shall be entitled to credit any minimum annual royalty paid to
HRI in a calendar year pursuant to Section 3.2(a) against any royalties earned
in that same calendar year and due to HRI pursuant to Section 3.2(b).
3.4 Unless this Agreement is terminated pursuant to Article 9, BIOGEN
shall, within sixty (60) days after the last days of June and December in each
year during the term of this Agreement, provide HRI with an accounting of Net
Sales and/or Sublicense Income for the immediately preceding six (6) month
period (the Royalty Period). Further, BIOGEN shall provide HRI with an
accounting of the royalties due with respect to the preceding six (6) month
period and shall, at the time when it delivers such account, make payment of the
amount of royalty payment due under this Article 3.
3.5 BIOGEN shall keep (or cause to be kept) and maintain complete and
accurate records of its Net Sales and Sublicense Income in accordance with
generally accepted accounting procedures. Such records shall be accessible for
review by HRI or by an independent certified public accountant selected and paid
for by HRI and acceptable to BIOGEN (which acceptance shall not be unreasonably
withheld), not more than once a year at any reasonable time during business
hours within one (1) year after the end of the royalty period to which such
records relate, for the purpose of verifying any royalty due thereon. The
individual conducting such review shall disclose to HRI only information
relating to the accuracy of the records kept and the payments made, shall be
under a duty to keep confidential any other information gleaned from such
records.
3.6 All monies to be paid to HRI shall be made and computed in United
States Dollars, and BIOGEN shall use its reasonable efforts to convert royalty
payments payable on Net Sales and Sublicense income in any country foreign to
United States Dollars; provided, however, that if conversion to and transfer of
Dollars cannot be made by BIOGEN in any country for any reason, BIOGEN may pay
such sums in the currency of the country in which such sales are made, deposited
in HRI's name in a bank designated by HRI in any such country. The rate of
exchange of local currencies to United States Dollars shall be at the rate of
exchange in force on the last business day of the Royalty Period as reported by
The Wall Street Journal.
3.7 If BIOGEN or its Affiliates or their sublicensees, in order to operate
under or exploit the licenses granted under Article 2 of this Agreement in any
country, is required to make any payment (including, but not limited to,
royalties, up-front payments, option fees or license fees) to one or more third
parties to obtain a license or similar right in the absence of which the
Licensed Products could not be used, manufactured or sold in such country
without violating the property, patent or other right of a third party, BIOGEN
may deduct from royalties otherwise payable to HRI an amount equal to such
payments made during the same Royalty Period to such third party, provided that
(a) the royalties paid to HRI for such Royalty Period shall not be reduced on
any payment date by more than [**] and (b) BIOGEN provides HRI with evidence,
reasonably satisfactory to HRI, of such third-party payments.
3
4
4. COMMERCIALIZATION
-----------------
4.1 BIOGEN agrees to use reasonable commercial efforts to research and
develop, obtain regulatory approval and commercialize Licensed Product(s) in the
United States and agrees to provide HRI with written annual reports on such
efforts.
4.2 BIOGEN shall not use the name of HRI, the New York State Department of
Health or New York State in any advertising or promotional sales literature
without the prior written consent of HRI, except that BIOGEN may state that it
is licensed by HRI under the Licensed Patents Rights.
5. WARRANTIES
----------
5.1 Each party represents and warrants that it has the full power and
authority to enter into this Agreement and that entering into this Agreement
does not breach any existing agreements already signed by that party.
5.2 Nothing herein contained shall be construed by either party hereto as a
representation or warranty that the exercise of the licensed rights will not
constitute an infringement of the intellectual property rights of third parties.
5.3 BIOGEN agrees that HRI shall have no responsibility, or liability with
respect to any Licensed Product and agrees to hold HRI, the New York State
Department of Health and New York State harmless from any and all damages,
losses, costs and expenses which they incur as a result of any action, claim or
demand as a result of activities by BIOGEN, its Affiliates and sublicensees
arising out of or relating to Licensed Product.
5.4 BIOGEN, its Affiliates and its sublicensee(s) agree to comply with all
regulations and safety standards of government agencies such as the Consumer
Product Safety Act and the Food and Drug Act.
6. PATENTS
-------
6.1 BIOGEN shall be responsible for, and bear the costs of, the filing,
prosecution, issuance, enforcement, defense and maintenance of the Licensed
Patent Rights, except as provided for in Section 6.2 below.
6.2 BIOGEN and HRI shall promptly notify the other in writing of any actual
or threatened infringement of any Licensed Patent Rights, and shall at the same
time provide the other with any available evidence of infringement. The parties
shall then discuss what action, if any, each parties believes should be taken in
the matter.
(a) In the event BIOGEN, alone or with an Affiliate or sublicensee, wishes
to take action in a suit to enforce or defend any Licensed Patent
Rights, BIOGEN may take action and, at its option, join HRI as a
plaintiff. BIOGEN, alone or with its Affiliates and sublicensees,
shall exercise control over such action and shall bear all costs
thereof, including, but not limited to attorney's fees; provided that
HRI may, if it so desires, be represented by counsel of its own
selection, the fees for which counsel shall be paid by HRI. Any
recovery from such action shall be retained by BIOGEN or shared by
BIOGEN, its Affiliates or sublicensees.
4
5
Confidential Materials omitted and filed separately with the
Securities and Exchange Commission. Asterisks denote omissions.
(b) In the event BIOGEN does not take action in a suit to enforce or defend
any Licensed Patent Rights and HRI wishes to take action, HRI may take
action and, at its option, join BIOGEN as a plaintiff. HRI shall
exercise control over such action and shall bear all costs thereof,
including, but not limited to attorney's fees; provided that BIOGEN
may, if it so desires, be represented by counsel of its own selection,
the fees for which counsel shall be paid by BIOGEN. Any recovery from
such action shall be retained by HRI.
6.3 In any suit as either party may institute or control to enforce or
defend the Licensed Patent Rights pursuant to this Agreement, the other party
hereto agrees, at the request and expense of the party initiating or controlling
the suit, to cooperate in all respects, to have its employees testify when
requested and to make available relevant records, papers, information, samples,
specimens, and the like.
6.4 Neither party may enter into a settlement or consent judgment or other
voluntary and final disposition of any suit effecting the Licensed Patent Rights
without the consent of the other party, which consent shall not be unreasonably
withheld. Notwithstanding the foregoing, the party instituting or controlling
(as the case may be) any suit referred to in this Article 6 shall have the right
to settle any claims for infringement upon such terms and conditions as it, in
its sole discretion, shall determine (including through the granting of a
sublicense by BIOGEN).
6.5 In the event an infringement or infringements by third parties of the
Licensed Patent Rights significantly affects BIOGEN's sales of Licensed
Product(s) by capturing [**] of BIOGEN's market share, and neither HRI nor
BIOGEN elect to bring an infringement suit against such infringer, the royalties
hereunder payable by BIOGEN pursuant to Article 2 shall be reduced by [**] of
the sums otherwise payable; provided, however, that BIOGEN presents information
to HRI showing the loss of market share and that such infringer has refused to
enter into a royalty bearing, sublicensing agreement with BIOGEN on terms
reasonably acceptable to BIOGEN.
6.6 In the event that one or more patents, or particular claims therein
(which read on the Licensed Product) within the Licensed Patent Rights expire,
or are abandoned, or are declared invalid or by a court of last resort, or by
lower court from whose decree no appeal is taken, or certiorari is not granted
within the period allowed therefor, then such patents or particular claims
shall, as of the date of expiration or abandonment or final decree of invalidity
as the case may be, cease to be included within the License Patent Rights for
the purpose of this Agreement. HRI agrees to renegotiate in good faith with
BIOGEN a reasonable royalty rate under the remaining Licensed Patent Rights
which are unexpired and in effect, and under which BIOGEN desires to retain a
license if BIOGEN can demonstrate that subsequent to such expiration, invalidity
or abandonment of patents or particular claims (but not all of the Licensed
Patent Rights) BIOGEN's market share of Licensed Products has been reduced by
more than [**].
5
6
7. DURATION AND TERMINATION
------------------------
7.1 The license granted hereunder shall continue until expiration of the
last remaining patent granted from the Licensed Patent Rights, unless earlier
terminated in accordance with this Article.
7.2 The royalty obligations in each country shall end on a
country-by-country basis upon expiration of the patent granted from the Licensed
Patent Rights in such country.
7.3 BIOGEN shall have the right to terminate this Agreement upon ninety
(90) days prior written notice to HRI and upon payment of a termination fee
equal to the minimum annual royalty set forth in Section 3.2(a) of this
Agreement.
7.4 HRI shall have the right to terminate this Agreement: (a) in the event
BIOGEN materially breaches this Agreement or fails to account for or pay
royalties or minimum royalties as herein provided, provided, however, that if
BIOGEN cures the said breach or default within ninety (90) days of notice, this
license shall continue in full force and effect; and (b) immediately upon
written notice to BIOGEN in the event of bankruptcy, liquidation or insolvency
of BIOGEN.
7.5 Upon any termination of this Agreement nothing herein shall be
construed to release either party of any obligation matured prior to the
effective date of such termination, and BIOGEN may after the effective date of
such termination sell all Licensed Product(s) that it may have on hand at the
date of termination provided that it pays the royalties as provided in this
Agreement.
8. NOTICES
-------
8.1 Any notice required or permitted to be given hereunder shall be sent in
writing by registered or certified airmail, postage prepaid, return receipt
requested, or by telecopier, air courier or hand delivery, addressed to the
party to whom it is to be given as follows:
If to BIOGEN: BIOGEN, INC.
00 Xxxxxxxxx Xxxxxx
Xxxxxxxxx, XX 00000
Telecopier: 000 000 0000
Attention: Vice President -
Marketing and Business
With a copy to: BIOGEN, INC.
00 Xxxxxxxxx Xxxxxx
Xxxxxxxxx, XX 00000
Telecopier: 000 000 0000
Attention: Vice President -
General Counsel
If to HRI: HEALTH RESEARCH INC.
0000 Xxxxxx Xxxxx Xxxxx
Xxxxxx, XX 00000
6
7
Telecopier: (000) 000-0000
Attention: Director of Operations
or to such other address or addresses as may from time to time be given in
writing by either party to the other pursuant to the terms hereof.
8.2 Any notice sent pursuant to this Article shall be deemed delivered
within 5 days if sent by airmail and within 24 hours if sent by air courier or
hand delivery.
9. ARBITRATION
-----------
9.1 The parties desire to avoid and settle without litigation future
disputes which may arise between them relative to this Agreement. Accordingly,
the parties agree to engage in good faith negotiations to resolve any such
disputes. In the event they are unable to resolve any such dispute through
negotiation, then such dispute shall be submitted to arbitration in accordance
with the Rules of the American Arbitration Association (hereinafter "Rules")
then in effect and the award rendered by the arbitrators shall be binding as
between the parties and judgment on such award may be entered in any court
having jurisdiction thereof, provided, however, that with respect to any matter
in dispute concerning royalties due and payable by one party, such party shall
have previously exercised its rights to have an auditor examine the records of
the other party pursuant to Article 3 herein before proceeding, and further
provided that a dispute relating to the payments set forth in Paragraphs 3.1 and
3.2 of this Agreement which arises out of a contention regarding the
interpretation or validity of the Licensed Patent Rights shall not be submitted
to arbitration.
9.2 Three neutral arbitrators shall be appointed by the American
Arbitration Association in accordance with such Rules, and at least one of such
arbitrators shall be an attorney-at-law, and all decisions and awards shall be
made by majority of them except for decisions relating to discovery and
disclosures as set forth in Paragraph 9.3 hereof.
9.3 Notice of a demand for arbitration of any dispute subject to
arbitration by one party shall be filed in writing with the other party and with
the American Arbitration Association. The parties agree that after any such
notice has been filed, they shall, before the hearing thereof, make discovery
and disclosure of all matters relevant to such dispute. Discovery and disclosure
shall be completed no later than ninety (90) days after filing of such notice of
arbitration unless extended upon a showing of good cause by either party to the
arbitration. The arbitrators may consider any material which is relevant to the
subject matter of such dispute even if such material might also be relevant to
an issue or issues not subject to arbitration hearing.
9.4 In the event a patent which is the subject matter of an award rendered
by the arbitrators is subsequently determined to be invalid or unenforceable in
a judgment rendered by a court of competent jurisdiction from which no appeal
can or has been taken, such award may be modified by a court of competent
jurisdiction upon application by any party to the arbitration. Any such
modification shall govern the rights and obligations between the parties from
the date of such modification.
7
8
10. MISCELLANEOUS PROVISIONS
------------------------
10.1 Neither party shall assign this Agreement without the written consent
of the other party which consent shall not be unreasonably withheld; provided,
however, that either party, without such consent, may assign or sell the same to
an affiliate or in connection with the transfer or sale of all or substantially
all of its business or in the event of its merger, consolidation, or joint
venture with another company. Each assignee shall assume all obligations of its
assignor under this Agreement. No assignment shall relieve either party of
responsibility for the performance of any accrued obligations which such party
then has hereunder.
10.2 This Agreement constitutes the entire understanding between the
parties and may not be varied except by a written document signed by both
parties.
10.3 This Agreement shall be construed, governed, interpreted, and applied
in accordance with the laws of the Commonwealth of Massachusetts, except that
questions affecting the validity, construction, and effect of any foreign patent
shall be determined by the laws of the country in which the patents were
granted.
10.4 The provisions of this Agreement are severable, and in the event that
any of the provisions of this Agreement are determined to be invalid or
unenforceable under any controlling body of law, such invalidity or
unenforceability shall not in any way affect the validity or enforceability of
the remaining provisions hereof.
IN WITNESS WHEREOF, the parties hereto have hereunder set their hands and
seals and duly executed this License Agreement the day and year first written
above.
BIOGEN, INC. HEALTH RESEARCH INC.
By: /s/ Xxxx Xxxx By: /s/ Xxx X. XxxXxXxxx
----------------------------- -------------------------------
Name: Xxxx Xxxx Name: Xxx X. XxxXxXxxx
Title: Vice President-Marketing & Title: Sec/Treasurer
Business
Date: 28 May 1990 Date: June 4, 1990
8
9
Confidential Materials omitted and filed separately with the
Securities and Exchange Commission. Asterisks denote omissions.
EXHIBIT A
---------
LICENSED PATENT RIGHTS
1. United States patent application Serial No. [**] filed [**], entitled [**].
9
10
AMENDMENT NO. 1 TO LICENSE AGREEMENT
This Amendment No. 1 to License Agreement is made as of this 1st day of
April, 1996 by and between Biogen, Inc., a Massachusetts corporation with its
principal offices located at 00 Xxxxxxxxx Xxxxxx, Xxxxxxxxx, Xxxxxxxxxxxxx,
00000 ("Biogen") and Health Research, Inc., a not-for-profit corporation with
offices located at 00 Xxxxxxx Xxxxxxxxx, Xxxxxx, Xxx Xxxx 00000 ("HRI").
Biogen and HRI are parties to a certain License Agreement dated as of June
4, 1990 ("License Agreement") under which HRI has granted to Biogen a license to
HRI's rights in certain jointly-owned patents. Biogen and HRI would like to
amend Section 10.1 of the License Agreement regarding assignment and
sublicensing. Therefore, they agree as follows:
SECTION 1. Section 10.1 of the License Agreement shall be amended to read
in its entirety as follows:
10.1 Neither party shall assign this Agreement without the written consent
of the other party, which consent shall not be unreasonably withheld;
provided, however, that either party without such consent, may assign or
sell the same to an affiliate or in connection with the transfer or sale of
all or substantially all of its business or in the event of its merger,
consolidation or joint venture with another company. Except as provided
below, each assignee shall assume all obligations of its assignor.
Each party shall give the other party prior written notice of any
assignment for which consent is required hereunder. If a party providing
notice of a proposed assignment has not received written objection to the
assignment from the other party within ten (10) days after receipt of the
notice, the other party shall be deemed to have consented to the assignment
for purposes of this Section.
Biogen is co-owner of the Licensed Patent Rights, and Biogen may decide to
retain its rights and obligations under Sections 6.1 through 6.4 of this
Agreement notwithstanding the assignment of its other rights and
obligations to a third party. However, whether or not Biogen decides to
retain such rights and obligations, Biogen's assignee, as a condition to
such assignment, shall be obligated to pay (1) the applicable
non-refundable fees set forth in Section 3.1 (if they have not previously
been paid by Biogen), and (2) the royalties set forth in Section 3.2 of
this Agreement.
If, in connection with an assignment, Biogen is a sublicensee of its
assignee, HRI shall be entitled to receive (i) royalties on its assignee's
Net Sales pursuant to Sections 3.2(a) and (b), and (ii) pursuant to Section
3.2(c), royalties on the Sublicense Income received by the assignee from
sales by Biogen.
Each party shall properly notify the other party in writing of any
completed assignment. Except as expressly provided above, upon assumption
by assignee of all or part of this Agreement in accordance with this
Section 10.1, the obligations assumed by the assignee shall cease in their
entirety to be obligations of the assignor, except that no assignment shall
relieve either party of its responsibility to the other party for the
performance of any obligations accrued prior to the date of the assignment.
11
SECTION 2. The reference in the sixth line of Section 6.5 of the License
Agreement to "Article 2" shall be changed to "Article 3."
IN WITNESS WHEREOF, the parties have executed this Amendment as of the date
and year first above written.
BIOGEN, INC. HEALTH RESEARCH INC.
By: /s/ Xxxxxxx X. Xxxx By: /s/ Xxx X. XxxXxXxxx
-------------------------------- -----------------------------
Name: Xxxxxxx X. Xxxx Name: Xxx X. XxxXxXxxx
Title: VP Marketing & Sales Title: Sec/Treasurer
2
12
ASSIGNMENT OF LICENSE
Agreement dated as of March 21, 1997 by and between BIOGEN, INC., a
corporation organized under the laws of the Commonwealth of Massachusetts with
its principal executive offices located at Fourteen Xxxxxxxxx Xxxxxx,
Xxxxxxxxx, XX 00000 ("Biogen"), and THE MEDICINES COMPANY, a corporation
organized under the laws of the State of Delaware with its principal executive
offices located at Suite 000, Xxx Xxxxxxxxx Xxxxxx, Xxxxxxxxx, XX 00000 (the
"TMC").
WHEREAS, Biogen has rights under a License Agreement dated as of June 6,
1990 by and between Biogen and Health Research, Inc., as amended by an
Amendment No. 1 to License Agreement dated as of April 1, 1996 (the "License");
and
WHEREAS, TMC wishes to have assigned to it, and Biogen is willing to
assign to TMC, all of Biogen's rights and obligations under the License;
NOW THEREFORE, for one dollar and other good and valuable consideration,
the receipt and sufficiency of which is hereby acknowledged, Biogen and TMC
hereby agree as follows:
1. TRANSFER OF LICENSE. Biogen assigns, transfers and conveys to TMC the
License and all of Biogen's rights and obligations under the License and TMC
accepts the same. TMC shall be responsible for, and shall pay or discharge,
any and all liabilities and obligations of Biogen under the License.
IN WITNESS WHEREOF, Biogen and TMC have caused this Agreement to be
executed as a sealed instrument as of the date first written above.
BIOGEN, INC. THE MEDICINES COMPANY
By: /s/ Xxxxx X. Xxxxx By: /s/ Xxxxx X. Xxxxxxxx
------------------------------- ------------------------------
Xxxxx X. Xxxxx Xxxxx X. Xxxxxxxx
President and Chief Executive President and Chief Executive
Officer Officer
