Exhibit 10.1
*Certain confidential information contained in this document, marked by
brackets, has been omitted and filed with the Securities and Exchange Commission
pursuant to Rule 406 of the Securities Act of 1933, as amended.
SUPPLY TRANSFER AGREEMENT
THIS SUPPLY TRANSFER AGREEMENT ("Agreement") is made effective as of March 21,
2001, by and between IMMUNEX CORPORATION, a Washington corporation having its
principal place of business at 00 Xxxxxxxxxx Xxxxxx, Xxxxxxx, Xxxxxxxxxx 00000
("Immunex"), and MEDIMMUNE, INC., a Delaware corporation, having its principal
place of business at 00 Xxxx Xxxxxxx Xxxx Xxxx, Xxxxxxxxxxxx, Xxxxxxxx 00000
("MedImmune").
WHEREAS, Immunex sells and distributes commercially the biopharmaceutical
product Enbrel(R) (etanercept) in the United States, pursuant to its approved
Biologics License Application ("BLA") for the product;
WHEREAS, MedImmune sells and distributes commercially the biopharmaceutical
product Synagis(R) (palivizumab) throughout the world, pursuant to its approved
product registrations therefor;
WHEREAS, Enbrel and Synagis are both currently manufactured by Boehringer
Ingelheim Pharma KG, a German corporation with a manufacturing operation located
in Biberach an der Riss, Federal Republic of Germany ("BIP"), pursuant to
separate supply agreements that BIP has entered into with Immunex and MedImmune,
respectively;
WHEREAS, Immunex is seeking to obtain additional manufacturing capacity for
Enbrel from BIP beyond the manufacturing capacity currently reserved for Enbrel
in the supply agreement between Immunex and BIP;
WHEREAS, MedImmune may, as a result of additional manufacturing capacity
obtained for Synagis elsewhere, be in a position to relinquish some of the
manufacturing capacity that it has reserved for Synagis at BIP [*]; and
WHEREAS, Immunex desires to obtain, and MedImmune desires to transfer to
Immunex, any such manufacturing capacity at BIP that MedImmune is able to
relinquish, all on the terms and conditions set forth in this Agreement.
NOW THEREFORE, in consideration of the mutual covenants contained herein, and
for other good and valuable consideration, the receipt and sufficiency of which
are hereby acknowledged, the Parties (as defined herein) hereto, intending to be
legally bound, do hereby agree as follows:
Article 1. Definitions
-----------------------
1.1 "Affiliate" shall mean any corporation or business entity of which a Party
owns directly or indirectly, fifty percent (50%) or more of the assets or
outstanding stock, or any corporation which a Party directly or indirectly
controls, or any parent corporation that owns, directly or indirectly,
fifty percent (50%) or more of the assets or outstanding stock of a Party
or directly or indirectly controls a Party. For purposes of this
Agreement, American Home Products Corporation shall be deemed an Affiliate
of Immunex.
--------------------------------
* Confidential Treatment Request
1
1.2 "BIP Facility" shall mean BIP's manufacturing campus located at
Xxxxxxxxxxxx Xxxxxx 00, 00000 Xxxxxxxx an der Riss, Federal Republic of
Germany, at which Enbrel (as defined herein) and Synagis (as defined
herein) are manufactured.
1.3 "Enbrel" shall mean the pharmaceutical product etanercept, in any form.
1.4 "Enbrel Bulk Drug Substance" shall mean etanercept in bulk drug substance
form.
1.5 "Enbrel Bulk Drug Substance Lot" shall mean a single [*] L fermentation
scale lot of purified etanercept, processed to result in bulk drug
substance.
1.6 "Enbrel Finished Product" shall mean Enbrel Bulk Drug Substance that has
been formulated, compounded, filled into vials and lyophilized by BIP, and
then labeled by a third party for commercial distribution, in accordance
with the terms of the Enbrel Supply Agreement (as defined herein) and a
third party supply agreement for the labeling and packaging operations for
Enbrel.
1.7 "Enbrel Four-Pack" shall mean a unit that includes four (4) vials of
Enbrel Finished Product and that has been labeled, packaged, and is
commercially saleable as a unit.
1.8 "Enbrel Run" shall mean a single [*] fermentation scale run of the process
for manufacturing Enbrel in bulk form.
1.9 "Enbrel Supply Agreement" shall mean the November 5, 1998 agreement among
Immunex, BIP, and American Home Products Corporation for the manufacture
of Enbrel at the BIP Facility, as amended by the parties thereto.
1.10 "Enhanced Yield Process" or "EYP" shall mean certain process steps and
materials that MedImmune anticipates using at its Frederick, Maryland
facility to manufacture Synagis, upon receiving approval from the U.S.
Food and Drug Administration ("FDA") therefor.
1.11 "Party" or "Parties" shall mean Immunex and/or MedImmune, as the context
requires.
1.12 "Successful Enbrel Run" shall mean an Enbrel Run that has resulted in any
quantity of Enbrel Four-Packs that have been released for commercial sale
according to the terms in the Enbrel Supply Agreement.
1.13 "Synagis" shall mean the pharmaceutical product palivizumab, in any form.
1.14 "Synagis Contract Runs" shall mean the production runs scheduled for the
manufacture of Synagis at the BIP Facility under the Synagis Supply
Agreement (as defined herein), [*].
1.15 "Synagis Supply Agreement" shall mean the agreement dated November 21,
1997 between MedImmune and BIP for the manufacture of Synagis at the BIP
Facility.
1.16 "Transferred Run(s)" means the Unused Synagis Run(s) as to which MedImmune
provides written notice to Immunex under Section 2.1.
--------------------------------
* Confidential Treatment Request
2
1.17 "Unused Synagis Runs" shall mean, [*], that number of Synagis Contract
Runs remaining in the particular calendar year that MedImmune releases to
BIP.
Article 2. Transfer of Synagis Runs
------------------------------------
2.1 Production Runs
---------------
(a) Immunex and MedImmune understand and agree that, within the sole
discretion of MedImmune, MedImmune may release Synagis Contract Runs to
BIP but that MedImmune is under no obligation to release any Synagis
Contract Runs to BIP unless MedImmune has obtained approval from the FDA
to implement the EYP at MedImmune's Frederick, Maryland manufacturing
facility, and MedImmune, within its sole discretion, has determined that
certain Synagis Contract Runs are not needed for MedImmune's commercial
needs for Synagis. In such event, the obligation to release Synagis
Contract Runs to Immunex shall only extend to those Synagis Contract Runs
as to which MedImmune within its sole discretion has determined are not
needed by MedImmune for MedImmune's commercial needs for Synagis.
(b) MedImmune and Immunex agree that it is an important aspect of this
Agreement that Immunex and BIP be made aware of potential Unused Synagis
Runs as soon as possible. MedImmune agrees to notify Immunex of the
scheduling of Synagis Contract Runs and to promptly notify Immunex when
MedImmune decides to release or is obligated to release Synagis Contract
Runs. Immunex and MedImmune each agree to use reasonable efforts to
communicate with and work with each other and BIP in order to avoid any
unnecessary delay in allowing Immunex to start an Enbrel Run as a result
of the transfer of any Unused Synagis Run hereunder.
(c) The parties understand and agree that MedImmune is under no obligation to
ensure that BIP will allot Transferred Synagis Runs to Immunex and
MedImmune has no liability to Immunex in the event that Transferred
Synagis Runs are not alloted to Immunex.
2.2 Transfer. Immunex shall become legally and financially responsible to BIP
for any Transferred Run that is allotted to Immunex by BIP under the terms
of the Enbrel Supply Agreement.
Article 3. Compensation
------------------------
3.1 Payment for Enbrel Run Starts. Immunex shall pay MedImmune [*] for each
Enbrel Run made available to Immunex by BIP as a result of a Transferred
Run, which amount shall become due and payable within sixty (60) days
after production [*] for each such Enbrel Run [*]. Immunex shall notify
MedImmune when an Enbrel Run satisfies the criteria in this Section 3.1
within [*] after such criteria are satisfied, and if so requested by
MedImmune, Immunex shall instruct BIP to confirm same.
3.2 Payment for Successful Enbrel Runs. In addition to the amount set forth
in Section 3.1 above, Immunex shall pay MedImmune, for each Successful
Enbrel Run, an amount based on the following formula:
--------------------------------
* Confidential Treatment Request
3
(a) A fraction shall be calculated as follows:
(i) the numerator shall be the number of Enbrel Four-Packs obtained from the
Successful Enbrel Run; and
(ii) the denominator shall be the average number of Enbrel Four-Packs obtained
from a Successful Enbrel Run during the year 2000.
(b) The fraction calculated in Section 3.2(a) above shall be multiplied by [*]
to determine the additional payment owed by Immunex for such Successful
Enbrel Run.
Notwithstanding the foregoing, Immunex shall not be obligated to pay MedImmune
more than [*], pursuant to this Section 3.2, for each Successful Enbrel Run.
3.3 Additional MedImmune Costs and Expenses. For [*]. Within [*] after
incurring any such costs, MedImmune shall provide Immunex with a written
statement of such costs, along with reasonable documentation therefor. [*]
after receiving such properly prepared statement and documentation,
Immunex shall pay to MedImmune any such amounts as provided in Section
3.4.
3.4 Payment Method. Within [*] after the last day of each calendar quarter
during the term hereof during which Immunex incurs amounts that it owes
MedImmune under Section 3.2, Immunex shall deliver to MedImmune a report
setting forth the amounts owed hereunder incurred during such calendar
quarter, along with payment of such amount. Such reports shall be
considered Confidential Information of Immunex subject to the terms of
Article 5 hereof.
3.5 Inspection of Books and Records. Immunex shall maintain accurate books
and records, which enable the calculation of amounts payable hereunder to
be verified, and shall retain such books and records for each quarterly
period for two (2) years after submission of the payment and corresponding
report under Section 3.4 above. Upon at least thirty (30) days' prior
written notice to Immunex, independent public accountants selected by
MedImmune and reasonably acceptable to Immunex may have access to the
books and records of Immunex during normal business hours to conduct a
review or audit of such books and records, solely and to the extent
necessary to confirm the accuracy of Immunex's calculation and payment of
amounts due in accordance with the terms hereof. All information obtained
during any such review or audit shall be Confidential Information of
Immunex subject to the terms of Article 5 hereof, including information
related to the number of Enbrel Four-Packs obtained during any Successful
Enbrel Run and the average number of Enbrel Four Packs obtained from a
Successful Enbrel Run during the year 2000. Any such review or audit shall
be at the expense of MedImmune; provided, however, that if such
accountants reasonably determine that such amounts have been, for any
calendar quarter, understated by an amount equal to or greater than [*],
Immunex shall, in addition, to remitting the additional amount determined
to be due, pay all reasonable fees and expenses incurred by such
accountants in making such determination.
--------------------------------
* Confidential Treatment Request
4
Article 4. Term; Termination
-----------------------------
4.1 Term. This Agreement shall take effect as of the date set forth above
and, unless earlier terminated as set forth in Section 4.2 below, shall
expire on [*].
4.2 Termination for Breach. Either Party may terminate this Agreement for
material breach of the other terms hereof by the other Party, after
providing at least [*] prior written notice to the other Party specifying
the precise nature of the breach. In the event that the Party receiving
such notice has not cured the breach within such [*] period (or within a
longer reasonable period of time if the breaching Party delivers a written
certification that such material breach is not reasonably capable of being
cured within [*] and that such Party is working diligently to cure such
breach), this Agreement shall be terminable immediately upon written
notice by the non-breaching Party.
4.3 Amounts Due. Expiration or termination of this Agreement for any reason
shall not exempt either Party from paying to the other Party any amounts
due to such Party and outstanding at the time of such expiration or
termination.
Article 5. Confidentiality
----------------------------
5.1 Definition of Confidential Information. For the purposes of this
Agreement, "Confidential Information" shall mean any information disclosed
by one Party ("Disclosing Party") to the other Party ("Receiving Party")
and designated as "CONFIDENTIAL" in writing at the time of any written
disclosure, or, in the event of oral disclosure or disclosure by
demonstration, identified in writing as "CONFIDENTIAL" no later than
thirty (30) days after such oral disclosure or disclosure by
demonstration. Confidential Information shall also include such
information or materials that would reasonably be identified or understood
by the Receiving Party as the confidential or proprietary information of
the Disclosing Party, even if they are not so identified as described in
the previous sentence. Confidential Information shall not, however,
include:
(a) information which was already known by the Receiving Party at the time of
its disclosure hereunder, as evidenced by the Receiving Party's written
records;
(b) information disclosed to the Receiving Party by a third party lawfully in
possession of such information and not under an obligation of
nondisclosure to the Disclosing Party in respect thereof;
(c) information which at the time of disclosure is or subsequently becomes
patented, published or otherwise part of the public domain, except by
breach of this Agreement by the Receiving Party;
(d) information developed by the Receiving Party independently of information
obtained from the Disclosing Party; or
--------------------------------
* Confidential Treatment Request
5
(e) information which is required to be disclosed by law, regulation or the
order of a judicial or administrative authority; provided, however, that
the Receiving Party (1) gives the Disclosing Party sufficient advance
written notice to permit it to seek a protective order or other similar
order with respect to such Confidential Information and (2) thereafter
discloses only the minimum Confidential Information required to be
disclosed in order to comply, whether or not a protective order or other
similar order is obtained by such Disclosing Party.
5.2 Disclosure and Use of Confidential Information.
----------------------------------------------
(a) Obligations. The Receiving Party, its employees, and its agents shall not
disclose Confidential Information of the Disclosing Party to any third
party without the prior written consent of the Disclosing Party. In
addition, the Receiving Party, its employees, and its agents shall not use
Confidential Information of the Disclosing Party for any purpose other
than for purposes consistent with this Agreement.
(b) Exceptions. Notwithstanding the foregoing, the Receiving Party may
disclose Confidential Information (i) to its employees, Affiliates,
consultants, agents or contractors who have a need to know such
information for the Receiving Party to perform its obligations hereunder
or for other purposes consistent with this Agreement, and (ii) to BIP for
purposes consistent with this Agreement.
(c) Maintenance of Confidentiality. Each Party shall use reasonable and
customary precautions to safeguard the other Party's Confidential
Information, including ensuring that all employees, Affiliates,
consultants, agents, or contractors who are provided access to such
Confidential Information are informed of the confidential and proprietary
nature of such Confidential Information and are under obligations of
confidentiality with respect to such Confidential Information similar to
those set forth herein.
5.3 Return of Confidential Information. Upon expiration or termination of
this Agreement, and upon written request by the Disclosing Party, the
Receiving Party shall promptly return to the Disclosing Party all
Confidential Information that the Receiving Party has received from the
Disclosing Party hereunder. The Receiving Party may retain one copy of
each item of Confidential Information disclosed to it hereunder, provided
that such copy shall be retained and used solely for compliance purposes
and shall be held in the Receiving Party's confidential files.
5.4 Remedies. Either Party shall be entitled to seek injunctive relief to
enforce the terms of this Article 5.
5.5 Survival. The terms of this Article 5 shall survive expiration or
termination of this Agreement and continue for a period of [*] thereafter.
5.6 Nonuse Obligations. Except as expressly provided in this Agreement, no
right or license, either express or implied, under any patent, trademark
or proprietary right is granted hereunder by virtue of the execution of
this Agreement or the disclosure by either Party of its Confidential
Information to the other Party hereunder.
--------------------------------
* Confidential Treatment Request
6
Article 6. Consequential Damages
--------------------------------
6.1 Disclaimer of Consequential Damages. In no event shall either Party be
liable to the other Party hereunder for incidental or consequential
damages.
Article 7. Press Releases; Use of Names, Disclosure of Agreement.
------------------------------------------------------------------
7.1 Press Releases. No press release, publicity or other form of public
written disclosure related to this Agreement shall be permitted by either
Party to be published or otherwise disclosed unless the other Party has
indicated its consent to the form of the release in writing.
Notwithstanding the foregoing, if a Party is required by law, in the
reasonable judgment of its counsel, to make a public disclosure regarding
this Agreement to fulfill its applicable regulatory reporting or other
legal disclosure obligations, such Party shall provide as much notice as
reasonably possible to the other Party, shall permit the other Party an
opportunity to review and comment on the disclosure to the extent
reasonably practicable, and shall give due consideration to any such
comments provided by the other Party.
7.2 Use of Names. MedImmune shall not make use of the name of Immunex or any
of its Affiliates in any advertising or promotional material, or
otherwise, without the prior written consent of the entity named. Immunex
shall not make use of the name of MedImmune or any of its Affiliates in
any advertising or promotional material, or otherwise, without the prior
written consent of the entity named.
7.3 Disclosure of Agreement. Notwithstanding anything else herein to the
contrary and except for public disclosures as provided in Section 7.1,
both parties agree not to disclose any of the terms of this Agreement or
the existence of this Agreement to any third person or entity except to
the extent that a Party receives a written opinion of counsel that
disclosure of this Agreement is required by applicable law, and in such
case, such Party shall take all reasonable steps to ensure that such
disclosure is subject to confidentiality obligations. Notwithstanding any
other provision to the contrary in this Section 7.3, Immunex and MedImmune
may disclose the existence but not the terms of this Agreement to BIP, and
Immunex may disclose the terms of this Agreement to American Home Products
Corporation and/or its Affiliates ("AHP"), provided AHP has agreed to be
bound by obligations of non-disclosure at least as restrictive as those
contained in this Agreement.
Article 8. Assignment.
-----------------------
8.1 Assignment. This Agreement shall be binding upon the successors and
assigns of the Parties and the name of a Party appearing herein shall be
deemed to include the names of its successors and assigns. Neither Party
may assign its interest under this Agreement without the prior written
consent of the other Party; provided, however, either Party may assign its
interest under this Agreement, without the prior written consent of the
other Party, (a) to an Affiliate, so long as the assigning Party
unconditionally guarantees the obligations of such Affiliate or (b) to a
successor of the assigning Party's business by reason of merger, sale of
all or substantially all of its assets or other form of acquisition,
provided that such successor agrees in writing to assume all of the
obligations of the assigning Party under this Agreement. Such consent
shall not be unreasonably withheld. Any purported assignment without a
required consent shall be void. No assignment shall relieve either Party
of responsibility for the performance of any obligation which accrued
prior to the effective date of such assignment.
7
Article 9. Dispute Resolution.
-------------------------------
9.1 Exclusions. Section 9.2 below shall not apply to any disputes arising
under Article 5 (Confidentiality).
9.2 Dispute Resolution. The Parties recognize that a bona fide dispute as to
certain matters may from time to time arise during the term of this
Agreement which relates to a Party's rights and/or obligations hereunder.
In the event of the occurrence of such a dispute, either Party may, by
notice to the other Party, have such dispute referred to their respective
officers designated herein, or their successors or designees, for
attempted resolution by good faith negotiations within thirty (30) days
after such notice is received. Such designated officers are as follows:
For Immunex - Xxxx Xxxxx, Senior Vice President and General Manager,
Enbrel Franchise
For MedImmune - Xxxxxxx Xxxxxxxx, Senior Vice President, Corporate
Development and Administration
In the event the designated officers are not able to resolve such dispute within
such thirty (30)-day period, or such other period of time as the Parties may
mutually agree in writing, each Party shall have the right to pursue any and all
remedies available at law or in equity.
Article 10. Miscellaneous.
---------------------------
10.1 Notices. Any notice required or permitted to be given hereunder by either
Party shall be in writing and shall be (a) delivered personally, (b) sent
by registered mail, return receipt requested, postage prepaid, (c) sent by
a nationally-recognized courier service guaranteeing next-day delivery,
charges prepaid, or (d) delivered by facsimile (with the original promptly
sent by any of the foregoing manners), to the addresses or facsimile
numbers of the other Party set forth herein, or at such other addresses as
may from time to time be furnished by similar notice by either Party. The
effective date of any notice hereunder shall be the date of receipt by the
receiving Party.
If to MedImmune: MedImmune, Inc.
00 Xxxx Xxxxxxx Xxxx Xxxx
Xxxxxxxxxxxx, XX 00000
Attention: Senior Vice President, Business Development
Fax: 000-000-0000
Phone: 000-000-0000
If to Immunex: Immunex Corporation
00 Xxxxxxxxxx Xxxxxx
Xxxxxxx, Xxxxxxxxxx 00000
Attention: Senior Vice President and General Manager
Enbrel Franchise
Fax: (000) 000-0000
Phone: (000) 000-0000
8
with a copy to: Immunex Corporation
00 Xxxxxxxxxx Xxxxxx
Xxxxxxx, Xxxxxxxxxx 00000
Attention: General Counsel
Fax: (000) 000-0000
Phone: (000) 000-0000
10.2 Applicable Law. This Agreement shall be governed by and construed in
accordance with the laws of the State of Maryland, exclusive of choice-of-
law rules.
10.3 Headings. All headings in this Agreement are for convenience of reference
only and shall not affect the interpretation of this Agreement.
10.4 Severance. If any provision of this Agreement is held to be invalid or
unenforceable by a court of competent jurisdiction, all other provisions
shall continue in full force and effect.
10.5 Independent Contractors. Each of the Parties is an independent contractor
and nothing herein contained shall be deemed to constitute the
relationship of partners, joint venturers, nor of principal and agent
between the Parties. Neither Party shall hold itself out to third parties
as purporting to act on behalf of, or serving as the agent of, the other
Party.
10.6 Waiver. No waiver of any term, provision or condition of this Agreement,
whether by conduct or otherwise in any one or more instances, shall be
deemed to be or construed as a further or continuing waiver of any such
term, provision or condition or of any other term, provision or condition
of this Agreement.
10.7 Counterparts. This Agreement and any amendment hereto may be executed in
any number of counterparts, each of which shall for all purposes be deemed
to be an original and all of which shall constitute the same instrument.
10.8 Survival. The provisions of Articles 3, 5, 6, 7, 9 and 10 and Sections
2.2, 4.3, 7.3 and 10.8 shall survive expiration or termination of this
Agreement for the period of time stated therein, or if no period of time
is stated therein, then indefinitely.
10.9 Entirety; Amendments. This Agreement constitutes the full understanding
of the Parties and a complete and exclusive statement of the terms of
their agreement with respect to the subject matter hereof, and no terms,
conditions, understandings or agreements purporting to modify or vary the
terms thereof shall be binding unless it is hereafter made in writing and
signed by both Parties. No modification to this Agreement shall be
effected by the acknowledgment or acceptance of any purchase order or
shipping instruction forms or similar documents containing terms or
conditions at variance with or in addition to those set forth herein. In
the event of a conflict between this Agreement and the exhibits hereto,
the terms of this Agreement shall control. This Agreement may be amended
and supplemented only by a written instrument signed by both Parties.
9
IN WITNESS WHEREOF, the Parties have caused this Agreement to be executed as of
the Effective Date.
IMMUNEX CORPORATION MEDIMMUNE, INC.
By: /s/ Xxxx X. Xxxxx By: /s/ Xxxxxx X. Xxxxx
---------------------------------- ---------------------------------------
Name: Xxxx X. Xxxxx Name: Xxxxxx X. Xxxxx
-------------------------------- -------------------------------------
Title: General Manager, Enbrel Title: President & Chief Operating Officer
------------------------------- ------------------------------------
Date: March 26, 2001 Date: March 21, 2001
-------------------------------- -------------------------------------
10
