Exhibit 10.16
LICENSE AND SUPPLY AGREEMENT
LICENSE AND SUPPLY AGREEMENT (this "Agreement") by and between
PHARMACIA AB, a Delaware corporation ("Pharmacia"), and INSMED INCORPORATED, a
Virginia corporation ("Insmed"), dated as of August 28, 2002 (the "Effective
Date").
Recitals
WHEREAS, since 1995, Pharmacia and its Affiliates (defined below) have
been engaged in the business of providing the compound known as IGF-1 for the
treatment of the short stature of Growth Hormone Insensitivity Syndrome (also
known as Xxxxx Dwarfism) to doctors treating the Patients (defined below);
WHEREAS, in connection with the provision of IGF-1 to the Patients,
Pharmacia obtained certain rights from [REDACTED] ("[REDACTED]") and Pharmacia
and its Affiliates have obtained certain regulatory approvals for IGF-1 and
related information as part of Pharmacia's regulatory dossier;
WHEREAS, Insmed has the expertise, through its relationship with a
third party contract manufacturer, to manufacture IGF-1 and SomatoKine; and
WHEREAS, Pharmacia desires that Insmed assume the responsibility for
providing IGF-1 to the Patients, and Insmed is willing to assume such
responsibility in exchange for an exclusive license to Pharmacia's IGF-1
regulatory dossier and an exclusive sublicense under the [REDACTED] Rights
(defined below), subject to the terms and conditions of this Agreement.
NOW THEREFORE, in consideration of the premises and the mutual promises
of the parties set forth herein, and intending to be legally bound, the parties
agree as follows:
1. Certain Definitions.
(a) "Affiliate" means, with respect to any party, its respective
direct or indirect parent company, if any, and any company, firm or other entity
which is owned or controlled, directly or indirectly, by said party or by its
parent company, but only for so long as said ownership or control shall
continue. The term "control" means the possession, directly or indirectly, of
the power to direct or cause the direction of the management and policies of a
company, firm, or other entity, whether through the ownership of at least fifty
percent (50%) of voting securities or at least fifty percent (50%) of the equity
interest of non-corporate entities, by contract or otherwise.
(b) "[REDACTED] Agreement" means the License and Development
Agreement, dated [REDACTED], between Pharmacia (formerly Kabivitrum AB) and
[REDACTED] (formerly [REDACTED]). A copy of the [REDACTED] Agreement is
attached hereto as Appendix III.
(c) "[REDACTED] Rights" means the rights under the Patents, the
Organism and the Technical Information (as such terms are defined in the
[REDACTED] Agreement) granted by [REDACTED] to Pharmacia pursuant to the
[REDACTED] Agreement.
(d) "[REDACTED] Agreement" means the Assignment Agreement, dated
as of [REDACTED], between Pharmacia and [REDACTED] pursuant to which Pharmacia
assigned certain rights relating to IGF-1 to [REDACTED]. A copy of the
[REDACTED] Agreement is attached hereto as Appendix IV.
(e) "Confidentiality Agreement" shall mean the confidentiality
agreement between the parties dated February 4, 2002.
(f) "License" shall mean the license granted by Pharmacia to
Insmed under Section 2(a) below.
(g) "Losses" shall mean losses, damages, costs and expense,
including without limitation reasonable attorneys' fees.
(h) "Other Indications" means applications for IGF-1, SomatoKine
and/or other compounds developed by or on behalf of Insmed from the use of the
Proprietary Information other than the treatment of Growth Hormone Insensitivity
Syndrome.
(i) "Patients" mean those patients that have been receiving IGF-1
from Pharmacia listed on Appendix I to this Agreement.
(j) "Product" means IGF-1 and/or SomatoKine (defined as the
complex of IGF-1 with IGFBP-3).
(k) "Proprietary Information" means all regulatory submissions
made and regulatory approvals obtained by Pharmacia and its Affiliates with
respect to IGF-1 and all data and other information relevant to such regulatory
approvals, including but not limited to records of communications with and
submissions to regulatory agencies, all as more fully described in Appendix II
to this Agreement. For clarity, the parties acknowledge and agree that all of
the Proprietary Information is derived from IGF-1 manufactured using the yeast
process and not the E-coli process.
(l) "Request For Approval" means a written request submitted by
Insmed to Pharmacia for the approval to use the Proprietary Information to seek
regulatory approval for Other Indications.
(m) "Sufficient Quantities" means therapeutic dosages and dose
regimens of the Product required by each Patient as determined in conjunction
with each Patient's doctor.
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2. License.
(a) Terms of License. Pharmacia hereby grants to Insmed or
Insmed's designee(s) an exclusive (except as to Pharmacia's retained rights set
forth below), worldwide, royalty-free, fully paid up license, with the right to
grant sublicenses, under the Proprietary Information to (i) seek and maintain
regulatory approvals in jurisdictions designated by Insmed from time to time for
the use of the Product in the treatment of Growth Hormone Insensitivity Syndrome
(including Xxxxx Dwarfism), and (ii) develop, make, have made, use, sell, offer
for sale and import commercial products incorporating the Product for the
treatment of Growth Hormone Insensitivity Syndrome (including Xxxxx Dwarfism).
Pharmacia hereby grants to Insmed an exclusive royalty bearing sublicense under
the [REDACTED] Rights and to the extent the Proprietary Information contains the
[REDACTED] Rights, the License shall be subject to the terms and conditions of
the [REDACTED] Agreement. The License is subject to Pharmacia's and its
Affiliates' nonexclusive license under the Proprietary Information to develop,
make, have made, use, sell, offer for sale or import any pharmaceutical product
or device; provided, however, Pharmacia and its Affiliates' may not grant
licenses or sublicenses to the Proprietary Information or the [REDACTED] Rights
to any third party, and will terminate any such rights granted by it to any of
its Affiliates that ceases to be an Affiliate.
(b) Other Indications. If Insmed desires to use the Proprietary
Information to pursue regulatory approval for Other Indications, it will submit
to Pharmacia a Request For Approval containing in reasonable detail information
regarding the Other Indications, and will provide such additional information
regarding the Other Indications as Pharmacia may reasonably request. Pharmacia
must respond to a Request For Approval in writing within forty-five (45) days
after its receipt thereof; provided, Pharmacia may reject such Request for
Approval in its sole discretion. Pharmacia's response to a Request For Approval
may contain terms, including without limitation royalties, under which Pharmacia
may be willing to grant the licenses specified in such Request For Approval. If
Pharmacia does not deliver a written response to Insmed within such forty-five
(45) day period, Insmed shall deliver another copy of such Request For Approval
containing the information required in this Section 2(b) (the "Second Request")
and Pharmacia shall have fifteen (15) days to respond in writing to the Second
Request. If Pharmacia does not deliver a written response to the Second Request
within such fifteen (15) day period, it will be deemed to have given its
approval for the Other Indications described in the Request For Approval on the
same terms as the License. Pharmacia shall treat the information contained in a
Request For Approval and all supplementary information provided by Insmed in
response to a request from Pharmacia as strictly confidential, and will not make
any use of such information other than for the purpose of evaluating the Request
For Approval. Pharmacia shall limit access to the Request For Approval to those
of its employees and consultants who reasonably require access in order for
Pharmacia to evaluate the Request For Approval, and will be responsible for the
compliance by all such employees and consultants with Pharmacia's obligations
hereunder.
(c) Costs. Insmed will be responsible for all costs and expenses
incurred by it in connection with its use of the Proprietary Information,
including without limitation its submission of the Proprietary Information as
part of its regulatory filings for the Product.
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Insmed will have no responsibility for costs incurred by Pharmacia with respect
to the Proprietary Information prior to the date hereof.
(d) [REDACTED] Agreement. To the extent the Proprietary
Information contains the [REDACTED] Rights, Insmed shall comply with the
[REDACTED] Agreement. However, Pharmacia understands that Insmed desires to
renegotiate the terms of the [REDACTED] Agreement, including without limitation
the royalties. Promptly after the Effective Date, Insmed shall contact
[REDACTED] and use its commercially reasonable efforts to obtain a license under
the [REDACTED] Rights on terms acceptable to Insmed (the "Amended [REDACTED]
Agreement"). The Amended [REDACTED] Agreement shall provide that the [REDACTED]
Agreement has been terminated and Pharmacia shall have no further obligations to
[REDACTED]. Pharmacia shall reasonably cooperate with Insmed in connection with
the termination of the [REDACTED] Agreement. Insmed shall promptly provide a
copy of the Amended [REDACTED] Agreement to Pharmacia. In the event Insmed and
[REDACTED] do not execute the Amended [REDACTED] Agreement, Insmed shall have
the right, in its sole discretion, to return the Proprietary Information to
Pharmacia and the terms of this Agreement relating to Insmed's rights under the
Proprietary Information shall terminate upon Insmed's written notice to
Pharmacia; provided, however, Insmed shall continue to be responsible for supply
of IGF-1 or SomatoKine in accordance with this Agreement.
(e) [REDACTED] Agreement. [REDACTED] pursuant to the [REDACTED]
Agreement. The parties further acknowledge that after each party's review of the
[REDACTED] Agreement no rights to the Proprietary Information have been granted
to [REDACTED]. In order to induce Pharmacia to enter into this Agreement, Insmed
shall be fully responsible for any and all claims by or on behalf of [REDACTED]
arising out of the License.
3. Supply to Patients.
(a) Supply Commitment. Insmed agrees that with respect to each
Patient, Insmed will supply each Patient's physician with Sufficient Quantities
of IGF-1 or SomatoKine as soon as practicable but not later than ninety (90)
days after receiving regulatory approval from the specific regulatory authority
to treat patients with the Product and continuing for a period of five years
from such date, or such earlier time as the Patient's physician determines to
discontinue the Patient's use of IGF-1 or SomatoKine. Product will be supplied
by Insmed in a timely manner as determined by Insmed in coordination with the
Patient's physician. Notwithstanding the foregoing, Insmed may provide
SomatoKine to the Patients' physicians in lieu of IGF-1 only in the event that
it is determined that SomatoKine is substantially equivalent to IGF-1 with
respect to safety and efficacy in the treatment of Growth Hormone Insensitivity
Syndrome (including Xxxxx Dwarfism). [REDACTED]. Insmed shall bear the cost of
manufacturing and distributing the Product to the Patients' physicians for
administration to the Patients.
(b) Compliance. Insmed will carry out its obligations under
Section 3(a) in accordance with all applicable laws and regulations, including
without limitation cGMPs.
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(c) Reporting. Insmed will provide Pharmacia with quarterly
written updates specifying the quantities of Product supplied to each Patient
and the timing of such deliveries, provided that Pharmacia is required to keep
all confidential medical information regarding Patients strictly confidential.
(d) Supply Default. In the event Insmed fails to (or reasonably
anticipates that it will fail to) materially comply with its obligations under
Section 3(a), Insmed will deliver prompt written notice to Pharmacia, and if
Insmed is unable to cure such failure within ninety (90) days after delivery of
such notice, Pharmacia will have the right, in its sole discretion, to either
(i) terminate the License, (ii) require Insmed to enter into a supply
arrangement with Pharmacia under which Insmed would be required to supply
Sufficient Quantities of the Product for the Patients at Insmed's cost of
manufacture, or (iii) require Insmed to arrange for a third party to supply
Sufficient Quantities of the Product to the Patients' physicians in accordance
with the terms of this Agreement. If Pharmacia elects to terminate the License,
Insmed must return all Proprietary Information (and all notes, documents and
other materials containing Proprietary Information) in its possession, to
Pharmacia, provided that Insmed's counsel may retain one copy of the Proprietary
Information to be used solely for the purpose of enabling Insmed to defend
itself in or pursue any litigation or other legal proceeding that may arise from
or relate to this Agreement or its use of the Proprietary Information. Insmed
acknowledges and agrees that money damages may not be a sufficient remedy for
any breach of its obligations under Section 3(a) and that, in addition to any
and all other remedies available at law or in equity, Pharmacia will be entitled
to seek equitable relief, including injunctions and specific performance, as a
remedy for any refusal by Insmed to supply Product to the Patients' physicians
as contemplated herein.
4. Delivery of Proprietary Information. Upon the execution of this
Agreement, Pharmacia will endeavor to reasonably cooperate with Insmed in its
pursuit of regulatory approval for the Products and will deliver to Insmed
copies of the Proprietary Information in written and (where available)
machine-readable format. In addition, Pharmacia will promptly notify Insmed in
writing of any and all material developments affecting the Proprietary
Information and information which may be otherwise useful in obtaining
regulatory approvals for the Product that it or its Affilates develop, if any.
Such additional information will be treated as Proprietary Information for all
purposes of this Agreement. Notwithstanding anything to the contrary set forth
herein, Insmed agrees that Pharmacia's obligations to deliver the Proprietary
Information shall be limited to those documents and materials containing
Proprietary Information that are available to Pharmacia as of the date of this
Agreement, and Pharmacia or its Affiliates shall have no obligation to develop
any new data pertaining to the Proprietary Information. Pharmacia represents and
warrants that, to its knowledge, the Proprietary Information will, upon delivery
to Insmed, be true, accurate and complete with respect to the Proprietary
Information available to Pharmacia as of the date of this Agreement.
5. Intellectual Property Rights.
(a) Ownership of Intellectual Property. As between Pharmacia and
Insmed, all clinical results and other data resulting from the application of
Product provided by Insmed to the Patients shall be the exclusive property of
Insmed. In addition, Insmed will be
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the sole owner of all patent applications, patents, continuations, divisionals
and other intellectual property rights pertaining to SomatoKine and IGF-1 and
all know-how and technology derived from Insmed's use of the Proprietary
Information. For clarity, nothing in this Agreement shall be deemed to confer
any rights in existing patents and patent applications and all patent
applications hereafter filed, including 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 supplementary protection
certificate) of any such patent, and any confirmation patent or registration
patent or patent of addition based on any such patent, and all foreign
counterparts of any of the foregoing owned or controlled by Pharmacia or its
Affiliates. However, Pharmacia represents and warrants that there are no
existing patents or patent applications owned or under the control of Pharmacia
or its Affiliates that would preclude Insmed from exercising its rights
hereunder.
(b) Infringement Claims. Each party shall promptly notify the
other party in writing if it receives or becomes aware of any claim from any
third party that the use of the Proprietary Information by Insmed in the manner
contemplated herein infringes such third party's intellectual property rights.
6. Representations and Warranties.
(a) Corporate Power and Authority. Each party represents and
warrants that is has all requisite corporate power and authority to enter into
this Agreement and to perform its obligations hereunder, including but not
limited to, in the case of Pharmacia, the power to grant the License to Insmed,
except as provided in Section 6(c) below.
(b) Due Authorization. Each party represents and warrants that
this Agreement and the performance by it of its obligations hereunder,
including, without limitation, the grant of the License, has been duly
authorized and that this Agreement is fully binding and enforceable on it in
accordance with its terms, subject to applicable laws relating to creditors'
rights generally.
(c) No Infringement. Pharmacia represents and warrants that, to
its knowledge, neither it nor any of its Affiliates is party to any other
agreement or understanding, written or verbal, which is in conflict with the
terms of this Agreement. For clarity, Pharmacia has disclosed to Insmed the
terms of the [REDACTED] Agreement and Pharmacia makes no representation or
warranties with respect to the [REDACTED] Agreement.
7. Indemnification.
(a) Indemnification of Pharmacia. Insmed will indemnify, defend
and hold harmless Pharmacia, its Affiliates, and their respective officers,
directors, employees and agents from and against all Losses arising out of (i)
Insmed's failure to comply with its obligations or Insmed's negligence or
willful misconduct in the performance of its obligations, (ii) any acts or
omissions of Insmed's sublicensees, (iii) any breach by Insmed of its
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representations and warranties set forth in this Agreement, (iv) the [REDACTED]
Agreement and the Amended [REDACTED] Agreement, if any, and (v) claims by or on
behalf of [REDACTED] relating to the License.
(b) Indemnification of Insmed. Pharmacia will indemnify, defend
and hold harmless Insmed, its Affiliates, and their respective officers,
directors, employees and agents from and against all Losses arising out of (i)
Pharmacia's failure to comply with its obligations set forth herein, and (ii)
any breach by Pharmacia of its representations and warranties set forth in this
Agreement.
(c) Indemnification Procedures. Any party seeking indemnification
pursuant to Section 7(a) or 7(b) (the "Indemnified Party") shall notify the
party providing such indemnification (the "Indemnitor") in writing promptly upon
becoming aware of any claim, threatened claim, damage, loss, suit, proceeding or
liability to which such indemnification may apply (a "Claim"). Failure to
provide such notice shall constitute a waiver of the Indemnitor's indemnity
obligations hereunder if, and only if, the Indemnitor is materially prejudiced
thereby. The Indemnitor shall assume and control the defense of the Claim at its
expense through counsel of its own choosing, such counsel to be reasonably
acceptable to the Indemnified Party. If the Indemnitor so assumes the defense of
the Claim, the Indemnified Party shall cooperate in such defense at the expense
of the Indemnitor. If the Indemnitor fails to assume the defense of a Claim,
then the Indemnified Party may defend the Claim at the expense of the
Indemnitor. The Indemnitor may not settle any Claim (other than a settlement
solely involving the payment of money which is paid by the Indemnitor and the
payment of which fully releasing the Indemnified Party) without the prior
written consent of the Indemnified Party, which consent may not be unreasonably
withheld.
(d) Survival. If the License is terminated for any reason, the
provisions of this Section 7 shall survive such termination.
8. Miscellaneous.
(a) Force Majeure. Neither party shall be liable to the other for
any delay or failure to perform hereunder, which delay or failure is due to
causes beyond the reasonable control of said party, including but not limited to
acts of God, acts of the public enemy, acts of the United States of America, any
other country, or any state, territory or political subdivision thereof or of
the District of Columbia, fires, floods, epidemics, quarantine restrictions,
strikes or freight embargoes.
(b) Entire Agreement. This Agreement (together with the Appendices
hereto) constitutes the entire agreement of the parties with respect to the
subject matter hereof and supersedes all prior agreements, written and oral,
with respect to such subject matter.
(c) Amendment. This Agreement may not be amended, modified or
altered unless in a written agreement signed by Insmed and Pharmacia. Neither
the
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course of conduct between the parties nor trade practices shall act to modify
any provision of this Agreement.
(d) Waiver. No waiver of any breach of this Agreement shall be
effective unless in writing and signed by the party to be charged therewith. No
waiver of any breach hereof shall constitute a waiver of any other or subsequent
breach not expressly set forth in the written waiver.
(e) Assignment. This Agreement may be assigned by either party
without the other party's prior written consent upon delivery of written notice
to the non-assigning party; provided, that, assignee shall assume all of the
obligations under this Agreement and assignor shall continue to be responsible
for the performance of assignee under this Agreement.
(f) Independent Contractors. The relationship of Pharmacia and
Insmed is that of independent contractors and nothing herein is intended to
imply that either party may act as the agent of the other or take any action
binding upon the other party.
(g) Severance. In the event any provision of this Agreement is
determined by a court of competent jurisdiction to be unenforceable, the
remaining provisions of this Agreement shall remain in full force and effect,
and such unenforceable provision shall be deemed modified so as to comply with
law while maintaining, to the maximum extent possible, the original intent of
the provision.
(h) Notices. Any notice permitted or required to be given
hereunder, including without limitation notifications of Request For Approval
and all information related thereto, shall be in writing and delivered by
certified mail, return receipt requested, or by recognized overnight express
courier, addressed to the parties as follows:
If to Insmed, to: If to Pharmacia, to:
Insmed Incorporated Pharmacia AB
0000 Xxxx Xxxxx Xxxxx 000 Xxxxx 000 Xxxxx
Xxxx Xxxxx, XX 00000 Xxxxxxx, Xxx Xxxxxx 00000
Attn: President and CEO Attn: Senior Vice President-
Global Licensing
With a copy to:
Pharmacia AB
000 Xxxxx 000 Xxxxx
Xxxxxxx, Xxx Xxxxxx 00000
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Attn: Vice President and Associate
General Counsel
Either party may change the address to which notices shall be sent by
delivery of written notice to the other party in the manner set forth herein.
(i) Counterparts. This Agreement may be executed in two or more
counterparts, each of which shall be deemed an original, and together shall
constitute one and the same document.
(j) Headings. All section headings in this Agreement have been
included herein for reference purposes only and are not to be used in the
interpretation of this Agreement.
(k) Governing Law. This Agreement shall be governed in accordance
with the laws of the State of New York without giving effect to the principles
of conflicts of law. In the event of any dispute between the parties arising
under this Agreement, the parties shall seek to resolve the dispute through good
faith negotiations by their representatives authorized to settle the matter.
Such negotiations will be carried out over a period of thirty (30) days
commencing from the date one party notifies the other in writing that it desires
to initiate dispute resolution procedures, or such longer period as the parties
may agree upon. If such negotiations are unsuccessful, the matter shall be
referred to the Chief Executive Officer of Insmed and Vice President - Endocrine
Care of Pharmacia for resolution, who will meet within thirty (30) days after
the completion of the aforesaid negotiations for the purpose of seeking a
resolution of the dispute through good faith discussions. Neither party may
commence litigation to resolve a dispute under this Agreement unless they first
follow the foregoing procedures and the discussions fail to produce a resolution
of the dispute despite the reasonable efforts of the parties; provided, however,
that a party seeking injunctive relief for any breach of provisions dealing with
confidentiality of information need not comply with the foregoing provisions
before commencing legal proceedings.
(l) Mutual Drafting. This Agreement constitutes the joint product
of the parties hereto. Each provision has been subject to the mutual
consultation and agreement of such parties and shall not be construed for or
against either of them.
(m) Costs. Each party will bear its own costs in connection with
the preparation and negotiation of this Agreement.
(n) Confidentiality. All of the information disclosed by a party
under this Agreement, including without limitation the terms and conditions of
this Agreement, shall be subject to the Confidentiality Agreement, which shall
remain in full force and effect during the term of this Agreement and for a
period of five (5) years thereafter.
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IN WITNESS WHEREOF, the undersigned have executed this Agreement as of
the date first set forth above.
PHARMACIA AB
By:___________________________
Name:_________________________
Title:________________________
INSMED INCORPORATED
By:___________________________
Name:_________________________
Title:________________________
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