Exhibit 10.1
PORTIONS OF THIS EXHIBIT WERE
OMITTED AND HAVE BEEN FILED SEPARATELY WITH THE SECRETARY OF THE
COMMISSION PURSUANT TO AN APPLICATION FOR CONFIDENTIAL TREATMENT
UNDER RULE 24b-2 OF THE EXCHANGE ACT; [***] DENOTES
OMISSIONS.
SETTLEMENT, LICENSE AND
DEVELOPMENT AGREEMENT
T HIS S ETTLEMENT , L ICENSE AND D EVELOPMENT A GREEMENT (the “ Agreement ”), is
entered into as of March 5, 2007 (the “Execution
Date” ) by and between Tercica, Inc., a company
incorporated under the laws of Delaware with offices at 2000 Sierra
Point Parkway, Suite 400, Brisbane, CA 94005, United States of
America (“ Tercica ”), Insmed Incorporated, a
company incorporated under the laws of Virginia with offices at
8720 Stony Point Parkway, Suite 200, Richmond, VA 23235, Insmed
Therapeutic Proteins, Inc., a company incorporated under the laws
of Colorado with offices at 2590 Central Avenue, Boulder, CO 80301,
and Celtrix Pharmaceuticals, Inc., a company incorporated under the
laws of Delaware with offices at 8720 Stony Point Parkway, Suite
200, Richmond, VA 23235 (collectively, “ Insmed
”) and Genentech, Inc., a company incorporated under the laws
of Delaware with offices at 1 DNA Way, South San Francisco,
California 94080 (“ GNE ”). Tercica, GNE and
Insmed are sometimes referred to herein individually as a “
Party ” and collectively as the “ Parties
.”
RECITALS
Whereas , Tercica and GNE have entered into that certain
License and Collaboration Agreement dated April 15, 2002, as
amended on July 25, 2003 and November 25, 2003 (the
“ GNE US License ”); and Tercica and GNE have
also entered into that certain International License and
Collaboration Agreement dated July 25, 2003 (the “
GNE Ex-US License ”); whereby, inter alia, GNE has
granted to Tercica a license under the GNE Patents (as defined
below), including U.S. Patent No. 5,258,287; U.S. Patent No.
5,187,151; and U.S. Patent No. 6,331,414;
Whereas , certain disputes and controversies have arisen
between the Parties relating to the claims, counter-claims,
cross-claims, and demands set forth in the following civil action
filed on December 23, 2004: Genentech Inc., et al. v.
Insmed Incorporated, et al ., United States District Court for
the Northern District of California (the “ Court
”), Case No. 04-CV-05429-CW (EMC) (the “
Lawsuit ”). Tercica and GNE alleged that
Insmed’s making, using, selling, offering to sell, importing
or exporting of the product known as IPLEX™, infringed or
will infringe under 35 U.S.C. § 271(a) – (c) and
(g), certain asserted claims of United States Patent Nos. 5,187,151
(the “ ‘151 Patent ”), 5,258,287 (the
“ ‘287 Patent ”) and 6,331,414 (the
“ ‘414 Patent ”) (collectively, the
“ Asserted Patents ”);
Whereas , Insmed denied such allegations and further
alleged, among other defenses, that the asserted claims of the
Asserted Patents were invalid under various theories, including
those arising under 35 U.S.C. § 102, 103, 112 and 135. Insmed
further asserted that the ‘151 Patent was unenforceable for
alleged inequitable conduct;
Whereas , the Parties had a full and fair opportunity to
litigate the case fully, including asserting motions for summary
judgment and jury trial;
Whereas , the Court adjudicated as a matter of law on
June 30, 2006 that Insmed’s method of making the rhIGF-I
component of IPLEX™ literally infringed Claims 1 and 9 of the
‘414 Patent (Docket No. 510), and Insmed subsequently
stipulated that its methodology literally infringed Claims 2, 3, 4
and 10 of the ‘414 Patent;
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PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE
BEEN FILED SEPARATELY WITH THE SECRETARY OF THE COMMISSION PURSUANT
TO AN APPLICATION FOR CONFIDENTIAL TREATMENT UNDER RULE 24b-2 OF
THE EXCHANGE ACT; [***] DENOTES OMISSIONS.
Whereas , a jury trial that commenced on
November 6, 2006, resulted in the Verdict Form (Docket # 1006)
filed December 6, 2006. The Jury further awarded damages to
Tercica and GNE of $7.5 million and a royalty of 15% of
IPLEX™ sales through December 6, 2006 (the “
Damages ”);
Whereas , legal proceedings among the Parties (and also
Avecia Limited, a company incorporated under the laws of England
and Wales, whose registered office is at PO Box 42, Hexagon Tower,
Blackley, Manchester M9 8ZS, United Kingdom (“ Avecia
”)) and relating to European Patent (UK) No. 0 571 417 have
been commenced in the United Kingdom in the High Court of Justice
under action numbers HC 04 C 03940 and HC 05 C 00415 (the “
UK Proceedings ”);
Whereas , the Parties have determined that it is in
their mutual interest to avoid the expense, distraction, and
uncertainty of further litigation and have therefore agreed to
conclude and resolve all of their disputes under the Lawsuit and UK
Proceedings and settle and consent to judgment of such Lawsuit and
UK Proceedings pursuant to the terms and conditions of this
Agreement, the Consent Judgment and Permanent Injunction, and the
UK Proceedings Settlement Agreement; and
Whereas , the Parties and Avecia have agreed, as of the
date hereof, to enter into that certain Settlement Agreement (the
“ UK Proceedings Settlement Agreement ”) which
sets forth the terms and conditions by which the Parties and Avecia
have agreed to settle the UK Proceedings.
Now, therefore
, in consideration of the releases
and mutual promises, covenants and conditions contained herein, and
other good and valuable consideration, including this Agreement,
the Consent Judgment and Permanent Injunction, and the UK
Proceedings Settlement Agreement, the Parties agree as
follows:
ARTICLE 1
DEFINITIONS
1.1 “ Adult Primary IGF-1 Deficiency
” means abnormally low concentrations of IGF-1 in adults that
are: (a) not secondary to growth hormone deficiency; and
(b) not secondary to specific pathophysiological states
outside the GH/IGF-1 system.
1.2 “ Affiliate ” means any
corporation, company, partnership, joint venture and/or firm which
controls, is controlled by, or is under common control with a
Party; provided that F. Hoffman-la Roche AG (including its
subsidiaries) shall be considered a Third Party for purposes of
this Agreement, rather than as an Affiliate of GNE. For purposes of
the foregoing sentence, “control” and, with correlative
meanings, the terms “controlled by” and “under
common control with”, mean (a) in the case of corporate
entities, direct or indirect ownership of at least fifty percent
(50%) of the stock or shares having the right to vote for the
election of directors and (b) in the case of non-corporate
entities, direct or indirect ownership of at least fifty percent
(50%) of the equity interest with the power to direct the
management and policies of such non-corporate entities.
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PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE
BEEN FILED SEPARATELY WITH THE SECRETARY OF THE COMMISSION PURSUANT
TO AN APPLICATION FOR CONFIDENTIAL TREATMENT UNDER RULE 24b-2 OF
THE EXCHANGE ACT; [***] DENOTES OMISSIONS.
1.3 “ Agreement ” has the meaning
assigned to it in the preamble above.
1.4 “ Aggregated Named Patient and
Off-Label Sales ” has the meaning assigned to it in
Section 7.1(a)(iv)(3).
1.5 “ ALS ” means Lou
Gehrig’s disease.
1.6 “ ALS Portion ” has the
meaning assigned to it in Section 7.1(a)(iii).
1.7 “ ALS Royalty ” has the
meaning assigned to it in Section 7.1(a)(iii).
1.8 “ Avecia ” has the meaning
assigned to it in the Recitals of this Agreement.
1.9 “ Booking Party ” means the
Party responsible for booking sales of a Product for an Opt-In
Indication after Tercica or GNE has exercised its Opt-In
right.
1.10 “ Claims ” has the meaning
assigned to it in Section 11.1.
1.11 “ Commercialization Plan ”
means, in the event Tercica or GNE exercises its Co-Promotion
Option for a particular Permitted Indication, the plan prepared by
the JCC that would govern the Parties’ co-promotion and
related commercialization activities for a Product with respect to
such Permitted Indication in accordance with
Section 5.3(c).
1.12 “ Committee ” means the Joint
Development Committee or Joint Commercialization Committee, as
applicable.
1.13
“Completion” means, with respect to a given clinical trial,
the completion of all data analysis to be conducted in connection
with such clinical trial.
1.14 “ Confidential Information ”
has the meaning assigned to it in Section 9.1.
1.15 “ Control ” with the
correlative meaning “Controlled by” means, with respect
to intellectual property, possession of the right to grant a
license or sublicense as provided for herein without violating
(a) any law or governmental regulation applicable to such
license or sublicense; or (b) the terms of any agreement or
other arrangement with any Third Party that exists as of the
Effective Date, or, if the applicable intellectual property is
acquired or the right to such intellectual property is to be
granted after the Effective Date, the date of such acquisition or
proposed grant, whichever is later.
1.16 “ Co-Promotion Agreement ”
has the meaning assigned to it in Section 5.3(b).
1.17 “ Co-Promotion Option ” has
the meaning assigned to it in Section 5.2.
1.18 “ Co-Promotion Term ” has the
meaning assigned to it in Section 5.3(b).
1.19 “ Court ” has the meaning
assigned to it in the Recitals of this Agreement.
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PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE
BEEN FILED SEPARATELY WITH THE SECRETARY OF THE COMMISSION PURSUANT
TO AN APPLICATION FOR CONFIDENTIAL TREATMENT UNDER RULE 24b-2 OF
THE EXCHANGE ACT; [***] DENOTES OMISSIONS.
1.20 “ Damages ” has the meaning
assigned to it in the Recitals of this Agreement.
1.21 “ Data Services ” has the
meaning assigned to it in Section 5.5(a)(i).
1.22 “ Development Costs ” has the
meaning assigned to it in Exhibit A .
1.23 “ Diabetes ” means a
progressive disease of carbohydrate metabolism involving inadequate
production or utilization of insulin that is characterized by
hyperglycemia and glycosuria. The term shall apply to any form of
diabetes, including without limitation, Type 1 and Type 2 diabetes,
as well as other hyperglycemic disorders, such as hyperinsulinemia,
hyperlipidemia, insulin-resistant diabetes such as
Mendenhall’s Syndrome, Werner Syndrome, leprechaunism,
lipoatrophic diabetes.
1.24 “ Diabetes Orphan Indication
” means any Diabetes indication that is also an Orphan
Indication.
1.25 “ Disclosing Party ” has the
meaning assigned to it in Section 9.1.
1.26 “ Dispute ” has the meaning
assigned to it in Section 13.1.
1.27 “ Effective Date ” has the
meaning assigned to it in Section 2.1.
1.28 “ EMEA ” means the European
Medicines Agency, a decentralized body of the European
Union.
1.29 “ European Union ” or “
EU ” means all of the European Union member states as
of the applicable time during the Term.
1.30 “ Excluded Indications ”
means (a) Excluded Indications as such term is defined in
Section 1.21 of the GNE US License, and (b) Excluded
Indications as such term is defined in Section 1.19 of the GNE
Ex-US License.
1.31 “Execution
Date” has the
meaning assigned to it in the preamble of this
Agreement.
1.32 “ Existing Insmed Indications
” means myotonic muscular dystrophy, HIV related Adipose
Redistribution Syndrome (HARS), retinopathy of prematurity,
recovery from burns and trauma, and recovery from hip
fracture.
1.33 “ Existing Patient ” has the
meaning assigned to it in Section 3.1(a).
1.34 “ FDA ” means the United
States Food and Drug Administration or its successor.
1.35 “ Fully Burdened Manufacturing
Costs ” has the meaning assigned to it in Exhibit
A .
1.36 “ GNE Licenses ” means both
the GNE US License and the GNE Ex-US License, as each is defined in
the Recitals of this Agreement.
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PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE
BEEN FILED SEPARATELY WITH THE SECRETARY OF THE COMMISSION PURSUANT
TO AN APPLICATION FOR CONFIDENTIAL TREATMENT UNDER RULE 24b-2 OF
THE EXCHANGE ACT; [***] DENOTES OMISSIONS.
1.37 “ GNE Patents ” means
(a) GNE Patents as such term is defined in Section 1.35
of the GNE US License, and (b) GNE Patents as such term is
defined in Section 1.33 of the GNE Ex-US License.
1.38 “ IGF-1 ” means
native-sequence insulin-like growth factor-1 from any species with
or without an N-terminal methionine, allelic variants thereof, and
sequence variants thereof wherein substitutions and/deletions are
made in the region from 1 to 5 amino acids from the N-terminus of
the mature native-sequence IGF-1 of any species, including
des-IGF-1 and variants wherein at least the glutamic acid residue
is absent at position 3 from the N-terminus of native-sequence
human IGF-1.
1.39 “ IGFBP-3 ” means
native-sequence, insulin-like growth factor binding protein-3 as
described in WO 89/09268 published October 5, 1989, that binds
IGF-1, including allelic variants of, and animal equivalents to,
human BP3 as well as human BP3, for example, the bovine, ovine,
porcine and equine species, and may be from any source, whether
natural, synthetic, or recombinant, provided that it will bind to
the appropriate binding domain of IGF-1.
1.40 “ IND ” means an
investigational new drug application as defined under United States
law and foreign equivalents.
1.41 “ Indemnified Party ” has the
meaning assigned to it in Section 11.4.
1.42 “ Indemnifying Party ” has
the meaning assigned to it in Section 11.4.
1.43 “ Infringing Activity ” means
any manufacture, use, sale, offer for sale, or importation of a
Product, either by Insmed or through an Affiliate or Sublicensee or
subcontractor, that would infringe any unexpired GNE Patents in the
Other Territory.
1.44 “ Insmed Patents ” means all
patents and patent applications Controlled by Insmed as of the
Effective Date (if any) or during the Term, in any country of the
Territory, that claim the manufacture, use, sale, offer for sale,
or importation of Product or IGF-1.
1.45 “ Ipsen ” means
Tercica’s sublicensee of certain of the Licensed Patents,
Beaufour Ipsen Pharma or its Affiliates, in the Other Territory,
pursuant to that certain Increlex™ License and Collaboration
Agreement between Tercica and Ipsen dated October 13,
2006.
1.46 “ Joint Commercialization Committee
” or “ JCC ” means the committee formed by
the Parties as described in Section 6.3(a).
1.47 “ Joint Development Committee
” or “ JDC ” means the committee formed by
the Parties as described in Section 6.2(a).
1.48 “ Launch Date ” has the
meaning assigned to it in Section 5.3(b).
1.49 “ Lawsuit ” has the meaning
assigned to it in the Recitals of this Agreement.
1.50 “ Licensed Patents ” means
(a) the GNE Patents and (b) all patents and patent
applications Controlled by Tercica as of the Effective Date or
during the Term that claim the manufacture, use, sale or
importation of Product and/or that claim the
manufacture,
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PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE
BEEN FILED SEPARATELY WITH THE SECRETARY OF THE COMMISSION PURSUANT
TO AN APPLICATION FOR CONFIDENTIAL TREATMENT UNDER RULE 24b-2 OF
THE EXCHANGE ACT; [***] DENOTES OMISSIONS.
use, sale, or importation of any product or
process used in Insmed’s production of Product, including,
but not limited to recombinant production of IGF-1 or any IGF-1
binding protein, and purification of IGF-1 or any IGF-1 binding
protein.
1.51 “ Marketing Authorization ”
means an approval necessary for the manufacture, marketing,
importation and sale of a Product for one or more indications in a
country or regulatory jurisdiction, which may include, without
limitation, the approval of an NDA or MAA, satisfaction of all
applicable regulatory and notification requirements, and Pricing
Approval (if required). For purposes of this definition,
“Pricing Approval” means such approval, agreement,
determination or governmental decision establishing prices for a
Product that can be charged to consumers and will be reimbursed by
governmental authorities in countries, territories or possessions
where governmental authorities or Regulatory Authorities of such
country, territory or possession approve or determine pricing of
pharmaceutical products for reimbursement or otherwise.
1.52 “ Material Breach ” has the
meaning assigned to it in Section 12.2.
1.53 “ Named Patient Basis ” means
the supply of a Product for a particular individual for the
treatment of an indication for which such Product does not yet have
Marketing Authorization in the country in which it is prescribed,
in response to a specific request of a prescribing physician for
such individual patient, where permitted by and in accordance with
the laws of the EU member state(s) concerned and in accordance with
Directive 2001/83/EC (and in particular Article 5 thereof), as
amended by Directive 2004/27/EC, and Regulation (EC)
No. 726/2004.
1.54 “ Named Patient Indications ”
means myotonic muscular dystrophy, HIV related Adipose
Redistribution Syndrome (HARS), retinopathy of prematurity,
recovery from burns and trauma, and recovery from hip
fracture.
1.55 “ Net Sales ” has the meaning
assigned to it in Exhibit A .
1.56 “ New Sales Tracking Data ”
has the meaning assigned to it in
Section 5.5(a)(ii).
1.57 “ Non-ALS Portion ” has the
meaning assigned to it in Section 7.1(a)(iv)(3)
1.58 “ Non - Booking Party
” means the Party that is not responsible for booking sales
of a Product for an Opt-In Indication after Tercica or GNE has
exercised its Opt-In right.
1.59 “ Non-Orphan Indication ”
means any Permitted Indication which is not an Orphan
Indication.
1.60 “ Non-Permitted Indications ”
means (a) primary IGFD, (b) severe primary IGFD,
(c) Noonan’s syndrome, (d) growth hormone
deficiency, (e) adult growth hormone deficiency (as approved
by the FDA and consisting of two subgroups: adult and child onset),
(f) Adult Primary IGF-1 Deficiency, (g) idiopathic short
stature, (h) any other short stature indications,
(i) Laron’s Syndrome, (j) growth hormone
insensitivity (GHIS), (k) any diseases or conditions which are
approved for sale by Tercica or GNE, as of the Effective Date, for
the treatment by growth hormone, and (l) all Excluded
Indications, which, for the purpose of this Agreement
and
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PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE
BEEN FILED SEPARATELY WITH THE SECRETARY OF THE COMMISSION PURSUANT
TO AN APPLICATION FOR CONFIDENTIAL TREATMENT UNDER RULE 24b-2 OF
THE EXCHANGE ACT; [***] DENOTES OMISSIONS.
with respect to Insmed, includes ALS, but which
inclusion for purposes of this definition of Non-Permitted
Indications shall in no event be interpreted as a concession on the
part of either Tercica or GNE as to whether ALS is or is not
included within the Excluded Indications with respect to
Tercica’s license from GNE under the GNE Licenses.
1.61 “ Non-Permitted Product ”
means (a) any product containing IGF-1 without any other
bioactive agent, in any dosage or formulation, including without
limitation the product known as INCRELEX (mecasermin) that is sold
by Tercica as of the Effective Date, or (b) any product
containing a combination of IGF-1 and any other active
ingredient(s) (excluding IGFBP-3 unless and only as permitted in
Section 3.2(b) below).
1.62 “North American
Territory” means
the United States and Canada.
1.63 “ Off-Label Sales ” has the
meaning assigned to it in Section 7.1(a)(iv)(2).
1.64 “ Operating Profit (Loss) ”
has the meaning assigned to it in Exhibit A .
1.65 “ Opt-In ” has the meaning
assigned to it in Section 4.2(a).
1.66 “ Opt-In Diabetes Orphan Indication
” has the meaning assigned to it in
Section 4.3(d).
1.67 “Opt-In Effective
Date” has the
meaning assigned to it in Section 4.2(b).
1.68 “ Opt-In Exercise Notice ”
has the meaning assigned to it in Section 4.2(b).
1.69 “ Opt-In Indication ” has the
meaning assigned to it in Section 4.2(b).
1.70 “ Opt-In Information ” means
any and all information that is reasonably available to Insmed and
which would be reasonably material for Tercica and/or GNE to make a
decision regarding the exercise of its Opt-In right at such stage
of development and may include, without limitation, any of the
following information to the extent generated: a copy of
formulation, stability, toxicology, pharmacokinetic, preclinical
and clinical development plans and data; complete analysis,
results, reports, and interpretations of the foregoing; an
accounting of all Development Costs; any pertinent manufacturing
information; and any related FDA documentation (including the IND,
clinical protocol, investigator’s brochure, FDA minutes and
correspondence).
1.71 “ Opt-In Party ” has the
meaning assigned to it in Section 4.2(b).
1.72 “ Opt-In Payment ” has the
meaning assigned to it in Section 4.2(e).
1.73 “ Opt-In Period ” has the
meaning assigned to it in Section 4.2(b).
1.74 “ Opt-Out ” has the meaning
assigned to it in Section 4.4.
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PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE
BEEN FILED SEPARATELY WITH THE SECRETARY OF THE COMMISSION PURSUANT
TO AN APPLICATION FOR CONFIDENTIAL TREATMENT UNDER RULE 24b-2 OF
THE EXCHANGE ACT; [***] DENOTES OMISSIONS.
1.75 “ Orphan Indication ” means
an indication for which the FDA has granted orphan status as
defined in 21 C.F.R. Pt. 316, as may be amended from time to time.
As of the Execution Date, such term is defined in 21 C.F.R. Pt. 316
as a rare disease or condition within the Permitted Indications
which: (a) affects less than 200,000 persons in the U.S. or
(b) affects more than 200,000 persons in the U.S. but for
which there is no reasonable expectation that the cost of
developing and making available in the U.S. a drug for such disease
or condition will be recovered from sales in the United States of
such drug, as further defined in and for which Orphan Drug
designation may be sought under the Orphan Drug Act of
1983.
1.76 “Other
Territory” means
all countries of the Territory other than the United
States.
1.77 “ Percentage Interest ” has
the meaning assigned to it in Section 4.2(a).
1.78 “Permanent
Injunction” has the
meaning assigned to in Section 2.1.
1.79 “ Permitted Indications ”
means all indications except the Non-Permitted Indications. For the
avoidance of doubt, Permitted Indications includes (a) the
treatment by growth hormone of HIV patients with wasting or
cachexia; and (b) all Existing Insmed Indications.
1.80 “ Phase III Enabling Trial ”
means, with respect to any given Permitted Indication, a human
clinical trial on a sufficient number of subjects (who are patients
with the condition being addressed), with clinically meaningful,
regulatorily recognized efficacy endpoints which generates
statistically significant efficacy and establishes a safe and
effective dose and is designed such that, if successful, Insmed
would be allowed by the FDA and/or EMEA to proceed with a pivotal
clinical trial that would support the filing of an application for
marketing approval for such Permitted Indication. As further
discussed in Section 6.2, the Joint Development Committee is
responsible for determining whether a given proposed trial by
Insmed meets the foregoing definition for a Phase III Enabling
Trial prior to the conduct of such trial.
1.81 “ Product ” means any product
containing IGF-1 and IGFBP-3, in any dosage, formulation or method
of administration, or any co-administration of IGF-1 and IGFBP-3,
including without limitation the product known as IPLEX (mecasermin
rinfabate) that is sold by Insmed as of the Execution Date. Product
does not include any combination product containing IGF-1 and
IGFBP-3 and any other active ingredient(s). For purposes of this
definition, the term “active ingredient(s)” does not
include drug delivery vehicles, adjuvants, and excipients except
for those that are recognized by the FDA as active
ingredients.
1.82 “ Product Labeling ” means
(a) the full prescribing information for a Product approved by
the applicable Regulatory Authority, and (b) all labels and
other written, printed or graphic information (including without
limitation any Product trademarks) included in or placed upon any
container, wrapper or package insert used with or for a
Product.
1.83 “ Promotional Materials ”
means all sales representative training materials and all written,
printed, graphic, electronic, audio or video matter, including,
without limitation, journal advertisements, sales visual aids,
leave items, formulary binders, reprints, direct mail,
direct-to-consumer advertising, internet postings, broadcast
advertisements and sales reminder aides (for example,
note
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PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE
BEEN FILED SEPARATELY WITH THE SECRETARY OF THE COMMISSION PURSUANT
TO AN APPLICATION FOR CONFIDENTIAL TREATMENT UNDER RULE 24b-2 OF
THE EXCHANGE ACT; [***] DENOTES OMISSIONS.
pads, pens and other such items) intended for
use or used by a Party or its Affiliates, sublicensees or licensees
in connection with any promotion of a Product for such Permitted
Indication, but excluding Product Labeling.
1.84 “ Receiving Party ” has the
meaning assigned to it in Section 9.1.
1.85 “ Regulatory Authority ”
means any government agency having the responsibility for granting
Marketing Authorizations and any other government entities with
authority over the manufacturing and the marketing of a
Product.
1.86 “ ROW Territory ” means all
countries and territories in the Territory other than the countries
in the North American Territory.
1.87 “ Sale Country ” means a
country in which a Product is used, sold, offered for sale, or
imported.
1.88 “ Sales Tracking Dispute ”
has the meaning assigned to it in Section 7.1(f).
1.89 “ Sales Tracking Methodology
” has the meaning assigned to it in
Section 5.5(a)(i).
1.90 “ Sales Tracking Panel ” has
the meaning assigned to it in Section 5.5(d).
1.91 “ Sole Promotion Option ” has
the meaning assigned to it in Section 5.2.
1.92 “ Sublicensee ” means a Third
Party to whom Insmed or its Affiliates sublicenses its rights and
obligations under Section 3.1 of this Agreement. Sublicensee
shall also include any Third Party who purchases its supply of
Product, in finished form from Insmed, its Affiliates or
Sublicensee for resale into the market, where, as a partial or full
consideration for such purchase, such Third Party has a payment
obligation to Insmed, its Affiliates or Sublicensee that is a
percentage of its net sales, including without limitation a royalty
obligation.
1.93 “ Supply Agreement ” has the
meaning assigned to it in Section 5.4(b).
1.94 “ Term ” has the meaning
assigned to it in Section 12.1(a).
1.95 “ Territory ” means all
countries of the world.
1.96 “ Third Party ” means a
person or entity other than Tercica, GNE, Insmed, or any of their
Affiliates.
1.97 “ Trademark ” means
IPLEX™ and all other trademarks used or intended for use by
Insmed or its Affiliates on the Effective Date or during the Term
in connection with the marketing or sale of a Product, other than
the corporate names of Insmed and its Affiliates, their trade
names, service marks, domain names, and associated logos and
designs.
1.98 “ Triggering Delivery ” has
the meaning assigned to it in Section 4.2(c).
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PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE
BEEN FILED SEPARATELY WITH THE SECRETARY OF THE COMMISSION PURSUANT
TO AN APPLICATION FOR CONFIDENTIAL TREATMENT UNDER RULE 24b-2 OF
THE EXCHANGE ACT; [***] DENOTES OMISSIONS.
1.99 “ UK Proceedings ” has the
meaning assigned to it in the Recitals of this
Agreement.
1.100 “ UK Proceedings Settlement
Agreement ” has the meaning assigned to it in the
Recitals of this Agreement.
ARTICLE 2
CONSENT JUDGMENT AND PERMANENT
INJUNCTION;
RELEASES AND
WAIVER
2.1 Entry of Consent Judgment and
Permanent Injunction. A
Consent Judgment and Permanent Injunction in the form of Exhibit
B will be executed herewith (the “Permanent
Injunction” ), and the Parties agree to take all steps
necessary to have the Permanent Injunction executed by the Court
and filed with the Court and hereby authorize and instruct their
respective counsel to take those steps. This Agreement shall only
become effective upon the execution of the Permanent Injunction by
or on behalf of the Parties to the action and the Court, the entry
and filing of the Permanent Injunction, and the execution of the UK
Proceedings Settlement Agreement in the form of Exhibit C
(the date by which the last of such events has occurred, the
“Effective Date” ).
2.2 Waiver of Damages
. Tercica waives all rights to any
Damages awarded in the Lawsuit upon execution and entry by the
Court of the Permanent Injunction and the execution of the UK
Proceedings Settlement Agreement.
2.3 Release by
Tercica. Tercica, by and
for itself and on behalf of its employees, agents, other
representatives, sublicensees, officers, directors, stockholders,
partners, members, subsidiaries, predecessors, successors, and
assigns, irrevocably, perpetually and fully releases and discharges
Insmed as well as Insmed’s employees, agents, fill-finishers,
customers, downstream sellers and users of a Product, and
Insmed’s other representatives, officers, directors,
stockholders, partners, members, subsidiaries, predecessors,
successors, licensees, distributors, and assigns, from any and all
claims, rights, demands, liabilities, obligations, damages,
actions, and causes of action, of every kind and nature, in law,
equity, or otherwise, known and unknown, suspected and unsuspected,
disclosed and undisclosed, arising out of any act, omission, event,
transaction or occurrence on or before the Effective Date solely to
the extent relating to both (a) a Product and (b) the
Licensed Patents; provided that this release shall not extend to
and affect the rights and obligations under the Permanent
Injunction.
2.4 Release by GNE.
GNE, by and for itself and on behalf
of its employees, agents, other representatives, sublicensees,
officers, directors, stockholders, partners, members, subsidiaries,
predecessors, successors, and assigns, irrevocably, perpetually and
fully releases and discharges Insmed as well as Insmed’s
employees, agents, fill-finishers, customers, downstream sellers
and users of a Product, and Insmed’s other representatives,
officers, directors, stockholders, partners, members, subsidiaries,
predecessors, successors, licensees, distributors, and assigns,
from any and all claims, rights, demands, liabilities, obligations,
damages, actions, and causes of action, of every kind and nature,
in law, equity, or otherwise, known and unknown, suspected and
unsuspected, disclosed and undisclosed, arising out of any act,
omission, event, transaction or occurrence on or before the
Effective Date solely to the extent relating to both (a) a
Product and (b) the GNE Patents; provided that this release
shall not extend to and affect the rights and obligations under the
Permanent Injunction.
10
PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE
BEEN FILED SEPARATELY WITH THE SECRETARY OF THE COMMISSION PURSUANT
TO AN APPLICATION FOR CONFIDENTIAL TREATMENT UNDER RULE 24b-2 OF
THE EXCHANGE ACT; [***] DENOTES OMISSIONS.
2.5 Release by Insmed.
Insmed, by and for itself and on
behalf of its employees, agents, other representatives,
sublicensees, officers, directors, stockholders, partners, members,
subsidiaries, predecessors, successors, and assigns, irrevocably,
perpetually and fully releases and discharges Tercica and GNE as
well as each of Tercica’s and GNE’s respective
employees, agents, fill-finishers, customers, downstream sellers
and users of Increlex, and Tercica’s and GNE’s other
representatives, officers, directors, stockholders, partners,
members, subsidiaries, predecessors, successors, licensees,
distributors, and assigns, from any and all claims, rights,
demands, liabilities, obligations, damages, actions, and causes of
action, of every kind and nature, in law, equity, or otherwise,
known and unknown, suspected and unsuspected, disclosed and
undisclosed, arising out of any act, omission, event, transaction
or occurrence on or before the Effective Date solely to the extent
relating to both (a) the Insmed Patents and (b) any
Non-Permitted Products; provided that this release shall not affect
the rights and obligations under the Permanent
Injunction.
2.6 Waiver of Section 1542
of California Civil Code. Each of Tercica, GNE and Insmed hereby declares
and acknowledges the contents of Section 1542 of the
California Civil Code, and that section and the benefits thereof
are hereby expressly waived. Section 1542 provides as follows:
“A general release does not extend to claims which the
creditor does not know or suspect to exist in his favor at the time
of executing the release, which if known by him must have
materially affected his settlement with the
debtor.”
2.7 Other Waivers and
Stipulations. The Parties
hereby incorporate by reference the conclusions of law, the
findings of fact, waivers and stipulations set forth in the
Permanent Injunction.
2.8 Discontinuance of UK
Proceedings. The Parties
shall promptly and permanently discontinue the claims and
counterclaims in the UK Proceedings, on the basis that each Party
shall be responsible for the costs incurred by it in connection
with those proceedings (other than costs which have already been
paid by one Party to another pursuant to an order of the United
Kingdom Court made prior to the Effective Date). The Parties
shall accordingly enter into and perform the UK Proceedings
Settlement Agreement relating to the UK Proceedings in the form of
Exhibit C forthwith following the execution of this
Agreement. Insmed shall ensure that Avecia shall, and shall
cause Avecia to, execute such settlement agreement and do all such
acts and execute all such documents as may be necessary or
desirable to give effect to the provisions of such settlement
agreement, including the discontinuance of the claims brought by
Avecia against Tercica and GNE in the course of the UK Proceedings.
Notwithstanding anything to the contrary in this Section 2.8,
as between Tercica and GNE, Tercica shall absorb and bear sole
responsibility for payment of any fees, costs, and expenses
incurred by GNE relating to the prosecution and/or defense of the
Lawsuit and/or the UK Proceedings (with the exception of the time
and expenses of any GNE employee(s) allocated or attributed to such
prosecution and/or defense, which costs shall be borne by
GNE).
11
PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE
BEEN FILED SEPARATELY WITH THE SECRETARY OF THE COMMISSION PURSUANT
TO AN APPLICATION FOR CONFIDENTIAL TREATMENT UNDER RULE 24b-2 OF
THE EXCHANGE ACT; [***] DENOTES OMISSIONS.
2.9 Survival of this Article
2. The Parties hereby
agree and acknowledge that the releases, waivers, and covenants
made in this Article 2 shall survive the expiration or any
termination of this Agreement, including any termination based on a
claim by a Party that another Party has breached this Agreement,
the Permanent Injunction or the UK Proceedings Settlement Agreement
and any such breach shall not be construed as evidence of a failure
of consideration for the granting of the releases, waivers and
covenants set forth in this Article 2.
ARTICLE 3
LICENSE GRANTS
3.1 Licenses to
Insmed.
(a) Limited License for
Non-Permitted Indications in the United States.
Subject to the terms and conditions
of this Agreement, including without limitation Insmed’s
fulfillment of its royalty obligations under Section 7.1 below
and Insmed’s continued compliance with its covenants in
Section 3.5 and the Permanent Injunction and the UK
Proceedings Settlement Agreement, Tercica hereby grants Insmed a
non-exclusive, non-sublicenseable license or sublicense, as
applicable, under Tercica’s entire right, title and interest
in and to the Licensed Patents to make, have made, use, sell, offer
for sale, and import Product for sale in the United States for any
Non-Permitted Indication solely for the continuing treatment of any
Existing Patient, for a period of twelve (12) months from the
Effective Date. “ Existing Patient ” means no
more than one hundred ten (110) patients for whom a Product is
prescribed for a Non-Permitted Indication as of the Effective Date.
The Parties agree to send to prescribing physicians a joint letter
in the form attached hereto as Exhibit D . The license
granted under this Section 3.1(a) shall be royalty-free with
respect to Net Sales arising from sales to the Existing Patients
during the first three (3) months after the Effective Date. If
any such sales to Existing Patients occur after such three
(3)-month period, such sales shall be royalty-bearing pursuant to
Section 7.1(a)(i), but only until the date which is twelve
(12) months after the Effective Date. Any sales of a Product
by Insmed to such Existing Patients after such twelve (12)-month
period, or any sales of a Product by Insmed to any patient who is
not an Existing Patient for the treatment of any Non-Permitted
Indication at any time after the Effective Date, shall be evidence
of Material Breach by Insmed of this Section 3.1(a) and/or a
violation of the Permanent Injunction, and Tercica may take any
action and/or seek any remedy in law or equity for such breach or
violation.
(b) License for Named Patient
Indications in the European Union on Named Patient
Basis. Subject to the
terms and conditions of this Agreement, including without
limitation Insmed’s fulfillment of its royalty obligations
under Section 7.1 below, and Insmed’s continued
compliance with its covenants in Section 3.5 and the Permanent
Injunction and UK Proceedings Settlement Agreement, Tercica hereby
grants Insmed a limited, non-exclusive, non-sublicenseable,
royalty-bearing license, or sublicense, as applicable, under
Tercica’s entire right, title and interest in and to the
Licensed Patents to make, have made, use, sell, offer for sale, and
import Product for sale in any country in the European Union solely
for the treatment of one or more of the Named Patient Indications,
on a Named Patient Basis only; provided that Tercica and GNE each
shall have the right to perform audits, either by itself or through
its designee, on Insmed’s compliance with any laws,
regulations and guidelines applicable to conducting such activities
on a Named Patient Basis in addition to, and pursuant to the
procedures described in, Section 7.8.
12
PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE
BEEN FILED SEPARATELY WITH THE SECRETARY OF THE COMMISSION PURSUANT
TO AN APPLICATION FOR CONFIDENTIAL TREATMENT UNDER RULE 24b-2 OF
THE EXCHANGE ACT; [***] DENOTES OMISSIONS.
(c) License for Permitted
Indications in the Territory. Subject to the terms and conditions of this
Agreement, including without limitation the exclusion of rights and
restrictive covenants set forth in Section 3.1(e),
Tercica’s and GNE’s Opt-In rights described in
Section 4.2, Insmed’s royalty obligations under
Section 7.1 below, and Insmed’s continued compliance
with its covenants in Section 3.5 and the Permanent Injunction
and UK Proceedings Settlement Agreement, Tercica hereby grants
Insmed a non-exclusive, royalty-bearing license, or sublicense, as
applicable, with the right to sublicense solely as permitted under
this Section 3.1(c), under Tercica’s entire right, title
and interest in and to the Licensed Patents to make, have made,
use, sell, offer for sale, and import Product for sale in all
countries in the Territory, solely for use in the treatment of any
of the Permitted Indications. Subject to Tercica’s and
GNE’s Opt-In rights under Section 4.2, the license
granted in this Section 3.1(c) may be sublicensed by Insmed to
Third Parties with the prior written consent of Tercica and GNE,
such consent not to be unreasonably withheld or delayed.
(d) Limited Covenant-Not-To-Sue
for ALS Indication on Named Patient Basis in Italy.
Subject to the terms and conditions
of this Agreement, including without limitation Insmed’s
fulfillment of its royalty obligations to GNE under
Section 7.1 below, and Insmed’s continued compliance
with its covenants in Section 3.5 and the Permanent Injunction
and UK Proceedings Settlement Agreement, each of GNE and Tercica
hereby covenants that it shall not, to the extent it has the right
to do so, enforce, or permit or encourage the enforcement of,
against Insmed or its Affiliates any Licensed Patents in connection
with the making, having made and using of a Product for the limited
purpose of: (i) using, selling, offering for sale, and
importing Product for sale in Italy solely for the treatment of ALS
on a Named Patient Basis only; provided that each of Tercica and
GNE shall have the right to perform audits, either by itself or
through its designee, on Insmed’s compliance with any laws,
regulations and guidelines applicable to conducting such activities
on a Named Patient Basis in addition to, and pursuant to the
procedures described in, Section 7.8, and (ii) conducting
a single non-pivotal clinical trial (i.e., such clinical trial
cannot and shall not be used to support regulatory filing or
application for Marketing Authorizations anywhere in the
Territory), for the ALS indication in Italy, in connection with
Insmed’s treating patients in Italy for the ALS indication on
a Named Patient Basis. For the avoidance of doubt, and
notwithstanding the payment of royalties solely to GNE pursuant to
Section 7.1(a)(iii) based upon Insmed’s sales under this
Section 3.1(d) and Tercica’s audit rights set forth in
this Section 7.1(d), each of Tercica and GNE reserves the
right to its respective interpretation of the GNE Licenses as to
whether the scope of the GNE Licenses includes a grant of rights to
the ALS indication by GNE to Tercica.
(e) Diabetes Restriction in the
Other Territory. Insmed
hereby covenants that, notwithstanding the license grant in
Section 3.1(c), it will not market, sell, offer for sale or
have sold a Product for Diabetes in the Other Territory to the
extent the manufacture, use or sale of such Product would infringe,
in the Other Territory and if not for the licenses granted under
this Agreement, the patent rights licensed to Tercica and
sublicensed to Insmed under the GNE Licenses.
13
PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE
BEEN FILED SEPARATELY WITH THE SECRETARY OF THE COMMISSION PURSUANT
TO AN APPLICATION FOR CONFIDENTIAL TREATMENT UNDER RULE 24b-2 OF
THE EXCHANGE ACT; [***] DENOTES OMISSIONS.
(f) Included Subsidiary
Rights. For avoidance of
doubt, the above licenses and limited covenant-not-to-sue granted
in Sections 3.1(a) through (d) relating to a Product include
the right to make (and have made) IGF-1 and IGFBP-3, solely for use
in the manufacture of Product, but such licenses do not include the
right to use, sell, offer for sale or import either IGF-1 or
IGFBP-3 separately.
3.2 Rights Granted to Tercica and
GNE.
(a) Covenant not to
Sue. Insmed hereby
covenants that it shall not enforce, or permit or encourage the
enforcement of, against Tercica, GNE or Ipsen, or any of their
respective Affiliates, sublicensees, successors or assigns any
Insmed Patents in connection with the development or
commercialization of any Non-Permitted Product in the Territory,
and in the event Insmed transfers any right under such Insmed
Patents to a Third Party, Insmed shall ensure that such covenant
not to sue is binding upon such Third Party in writing.
(b) License in the Event of an
Opt-In. In the event
Tercica and/or GNE exercises its Opt-In right with respect to a
given Permitted Indication pursuant to Section 4.2 below,
Insmed hereby grants such Opt-In Party a non-exclusive, worldwide
license, with the right to grant sublicenses as provided in this
Section 3.2(b), under the Insmed Patents to make, have made,
use, sell, offer for sale and import Product for the Opt-In
Indication as and to the extent permitted under this Agreement. Any
sublicense by Tercica or GNE (or their assignees as permitted under
Section 4.2(a)) under the rights granted in this
Section 3.2(b) to a sublicensee other than a distributor,
subcontractor or consultant in the normal course of business shall
be made by Tercica or GNE only with the consent of Insmed, such
consent not to be unreasonably withheld, provided however that
sublicenses to Ipsen shall not require the consent of Insmed. In
addition, Insmed agrees to execute all documents as may be
reasonably required by Tercica or GNE or Ipsen or their authorized
sublicensees for the purpose of recording any such sublicense(s)
with any relevant regulatory or administrative authorities and in
the event Insmed transfers any right in the affected Insmed Patents
to a Third Party, Insmed shall ensure that such Third Party is
bound, in writing, by the obligation set forth in this
sentence.
3.3 GNE Licenses.
The Parties acknowledge that the
license granted to Insmed under Section 3.1 above constitutes
a sublicense with respect to the GNE Patents under the licenses
granted to Tercica by GNE under the GNE Licenses. As a result, the
licenses granted under Section 3.1 above, and the terms and
conditions of this Agreement, shall be subject to the terms and
conditions of the GNE Licenses. GNE hereby agrees to the granting
of such sublicense to Insmed by Tercica as set forth in
Section 3.1. Nothing in this Agreement shall be construed as:
(a) the expansion or reduction of the scope of licenses
Tercica received from GNE under the GNE Licenses; or
(b) implying whether or not the license granted to Tercica
under the GNE Agreements includes the ALS indication.
3.4 No Implied
Licenses. Except as
explicitly set forth in this Agreement, no Party grants any
license, express or implied, under its intellectual property rights
to any other Party. Each Party covenants that it will not use or
practice any other Party’s intellectual property rights
licensed to it under this Agreement except for the purposes
expressly permitted in the applicable license grant.
14
PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE
BEEN FILED SEPARATELY WITH THE SECRETARY OF THE COMMISSION PURSUANT
TO AN APPLICATION FOR CONFIDENTIAL TREATMENT UNDER RULE 24b-2 OF
THE EXCHANGE ACT; [***] DENOTES OMISSIONS.
3.5 Insmed Covenants.
In light of the Lawsuit and the
Damages awarded therein, and in consideration of the licenses
granted by Tercica and GNE to Insmed in Section 3.1, Insmed
hereby covenants the following (which covenants shall be in
addition to those set forth in the Permanent
Injunction):
(a) Insmed shall not, and shall cause its Affiliates
and Sublicensees to not, directly or indirectly: (i) conduct
clinical trials for or otherwise seek any Marketing Authorization
for, promote, market, or knowingly sell or offer for sale a Product
for the treatment of any Non-Permitted Indication in any country in
the Other Territory except as expressly permitted under
Section 3.1(b) above with respect to the Named Patient
Indications on a Named Patient Basis and Section 3.1(d) above
with respect to the ALS indication on a Named Patient Basis, for so
long as (A) any such clinical trial or Marketing Authorization
uses or depends on the supply of such Product manufactured in a
country in which such manufacture is covered by any unexpired
Licensed Patents in such country, (B) any such promotion,
marketing, sale or offer for sale of such Product depends on the
supply of such Product manufactured in a country in which such
manufacture is covered by any unexpired Licensed Patents in such
country, or (C) any such promotion, marketing, sale or offer
for sale of such Product arises from or depends on the use, sale,
offer for sale, or importation of such Product in a country in
which such use, sale, offer for sale, or importation is covered by
any unexpired Licensed Patents in such country. For purposes of
determining the duration of such covenant in countries in the Other
Territory where a Product is sold which is manufactured in the
United States, the last to expire Licensed Patents with respect to
such countries shall include U.S. Patent No. 6,331,414 to the
extent such patent covers the manufacture of the Product sold (or
any components thereof).
(b) Within fifteen (15) business days after the
Effective Date, Insmed shall withdraw, or cause to be withdrawn,
all currently pending applications for Marketing Authorization in
the Other Territory, including specifically its currently pending
application for Marketing Authorization with the EMEA for a Product
for the treatment of primary IGF-1 deficiency and patients with
growth hormone gene deletion.
(c) Insmed shall not apply for or submit an
application with the EMEA or any other governmental authority
within the European Union or anywhere else in the Other Territory
for Marketing Authorization of a Product for any of the
Non-Permitted Indications; provided, however, that for any such
Marketing Authorization the foregoing covenant shall terminate upon
the expiration of the last to expire Licensed Patents (i) that
exists in a country in the European Union or the Other Territory
and that covers the manufacture, use, sale, offer for sale, or
importation of such Product to be performed under the license of
the Marketing Authorization, or (ii) that exists in a country
in the Territory and that covers the process by which such Product
is manufactured in such country for subsequent use, sale, offer for
sale, or importation in the European Union or other country in the
Other Territory under the license of the Marketing
Authorization.
(d) If Insmed or its Affiliates or Sublicensees
challenge(s) the validity or enforceability of the Licensed Patents
anywhere in the Territory, then either Tercica or GNE shall have
the right to terminate the licenses granted to Insmed under
Section 3.1 of this Agreement pursuant to
Section 12.3(a)(i) below.
15
PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE
BEEN FILED SEPARATELY WITH THE SECRETARY OF THE COMMISSION PURSUANT
TO AN APPLICATION FOR CONFIDENTIAL TREATMENT UNDER RULE 24b-2 OF
THE EXCHANGE ACT; [***] DENOTES OMISSIONS.
3.6 Non-Disparagement.
Insmed, Tercica and GNE each shall
not defame, libel, slander or otherwise disparage in any manner, or
tortiously interfere with the business, contracts, relationships or
prospective economic advantage appurtenant to: (a) the market
opportunity for any product (e.g., the size of the market for
severe Primary IGFD); or (b) any product of the other
Parties.
ARTICLE 4
DEVELOPMENT AND OPT-IN
RIGHTS
4.1 Development of Product Prior
to Opt-In. Unless and
until Tercica or GNE exercises its Opt-In right under
Section 4.2 below, Insmed shall have the sole responsibility
for the development of a Product for use in a given Permitted
Indication. As between the Parties to this Agreement, Insmed shall
bear all Development Costs incurred with respect to a Product for
all Permitted Indications prior to the Opt-in Effective Date,
subject to the Opt-In Party’s reimbursement of a portion of
such Development Costs pursuant to Section 4.2(e)
below.
4.2 GNE and Tercica’s
Opt-In Right for Permitted Indications.
(a) General.
Tercica and GNE shall each have the
option to co-develop a Product for any particular Permitted
Indication at any time during the period when such Product is being
developed clinically for such Permitted Indication, until the end
of the Opt-In Period for such Permitted Indication. Such
co-development right, once exercised, allows Tercica or GNE as the
Opt-In Party to fund 50% (such percentage, the “
Percentage Interest ”) of the Development Costs for a
Product for such Permitted Indication and participate in a
corresponding 50% portion of the Operating Profit (Loss) resulting
from the commercialization of such Product for such Permitted
Indication, participate in development decision-making, and
participate in commercialization, all as and to the extent set
forth below and in Article 5 (the “ Opt-In ”).
It is understood and agreed that Insmed shall not enter into any
agreement with a Third Party to develop or commercialize a Product
for any Permitted Indication prior to the expiration of the Opt-In
Period for such Permitted Indication. It is further understood and
agreed that Tercica shall have the right to assign to Ipsen its
Opt-In rights and obligations with respect to the ROW Territory or
certain country(ies) within such ROW Territory, as well as its
Co-Promotion Option and Sole Promotion Option, on a Permitted
Indication-by-Permitted Indication basis, in which case reference
to “Tercica” as used in this Section 4.2 and in
Sections 4.3 and 4.4, and in Article 5, shall also include Ipsen.
It is also further understood and agreed that GNE shall have the
right to assign to a Third Party designee its Opt-In rights and
obligations with respect to the ROW Territory or certain
country(ies) within such ROW Territory, as well as its Co-Promotion
Option and Sole Promotion Option, on a Permitted
Indication-by-Permitted Indication basis, subject to Insmed’s
consent, not to be unreasonably withheld, in which case reference
to “GNE” as used in this Section 4.2 and in
Sections 4.3 and 4.4, and in Article 5, shall also include such
Third Party designee.
(b) Opt-In Period;
Effectiveness. Tercica’s and GNE’s Opt-In rights
shall commence, on a Permitted Indication by Permitted Indication
basis, at the commencement of the first human clinical trials of a
Product for such Permitted Indication, and shall terminate on the
earlier of: (i) exercise by Tercica or GNE of such Opt-In, or
(ii) 91 days after the Triggering Delivery for such
16
PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE
BEEN FILED SEPARATELY WITH THE SECRETARY OF THE COMMISSION PURSUANT
TO AN APPLICATION FOR CONFIDENTIAL TREATMENT UNDER RULE 24b-2 OF
THE EXCHANGE ACT; [***] DENOTES OMISSIONS.
Permitted Indication without exercise by either
GNE or Tercica of its Opt-In rights (the “ Opt-In
Period ” for such Permitted Indication), as described in
more detail in this Section 4.2. For the avoidance of doubt,
Tercica and GNE may exercise their respective Opt-In rights at any
time during the Opt-In Period in accordance with this
Section 4.2 by providing written notice to Insmed of the same
(such notice, the “ Opt-In Exercise Notice ”).
Insmed shall promptly submit a written confirmation to the Party
whose Opt-In Exercise Notice has been received (unless otherwise
properly rejected as not being properly submitted by the potential
Opt-In Party pursuant to this Section 4.2), along with an
invoice detailing the amount of the Opt-In Payment due Insmed. Such
Opt-In shall become effective upon receipt by Insmed of such Opt-In
Payment (the “Opt-In Effective Date” ). At the
Opt-In Effective Date, the Party having submitted such Opt-In
Exercise Notice shall thereupon become an “ Opt-In
Party ” and such Permitted Indication shall become an
“ Opt-In Indication .”
(c) Opt-In Information;
Triggering Delivery. On a
regular basis but no less frequently than once per calendar
quarter, Insmed shall provide to Tercica and GNE a written progress
report setting forth, for each Permitted Indication then undergoing
development and as to which the Opt-In rights have not been
exercised or lapsed: (i) a summary of all clinical trials
planned and actually conducted, as well as all results thereof, for
a Product for treatment of each such Permitted Indication;
(ii) all Opt-In Information that has not been previously
disclosed to either Tercica or GNE as of such time; and
(iii) a summary of all Development Costs incurred as of such
time with respect to such Permitted Indication. In particular, and
notwithstanding such quarterly reporting obligation, Insmed shall,
within sixty (60) days after the Completion of the first Phase
III Enabling Trial for a Product for such Permitted Indication,
deliver to Tercica and GNE all Opt-In Information relating to such
trial and any other Opt-In Information that has not been previously
disclosed to either Tercica or GNE, as well as a summary of all
Development Costs incurred as of such time with respect to such
Permitted Indication (this delivery of such Opt-in Information and
Development Cost information is the “Triggering
Delivery”). Tercica and GNE shall use the Opt-In Information
solely for the purpose of evaluating the Opt-In opportunity and
such Opt-In Information and shall not disclose any non-public
portion of such Opt-In Information to any Third Party without the
prior written consent of Insmed. Following delivery of any such
Opt-in Information and Development Cost information, Insmed shall
promptly supply any additional information or respond to any
questions as requested by GNE or Tercica based upon its review of
such information. Upon the expiration of the Opt-In Period, each of
GNE and Tercica shall return such Opt-In Information to Insmed if
such Party has not exercised its Opt-In right under this Section
4.2.
(d) Opt-In Rights and
Procedures.
(i) During the Opt-In Period, Tercica shall have the
first right to exercise the Opt-In right throughout the Territory
with respect to any Orphan Indication that is not a Diabetes Orphan
Indication. In the event Tercica does not so exercise such right
within sixty (60) days of the Triggering Delivery, it shall
notify Insmed and GNE in writing. Upon receipt of such written
notice, GNE shall have an additional period of thirty
(30) days following the date of such notice by Tercica to
elect to exercise the Opt-In right with respect to such Orphan
Indication. For avoidance of doubt, this Opt-In right shall expire
upon the first to occur of the exercise of the Opt-In Right, or
ninety one (91) days after the Triggering Delivery.
17
PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE
BEEN FILED SEPARATELY WITH THE SECRETARY OF THE COMMISSION PURSUANT
TO AN APPLICATION FOR CONFIDENTIAL TREATMENT UNDER RULE 24b-2 OF
THE EXCHANGE ACT; [***] DENOTES OMISSIONS.
(ii) During the Opt-In Period, GNE shall have the
first right to exercise the Opt-In right with respect to
(1) any Non-Orphan Indications throughout the Territory and
(2) any Diabetes Orphan Indication in the United States. In
the event GNE does not so exercise such right within sixty
(60) days of the Triggering Delivery, it shall notify Insmed
and Tercica in writing. Whereupon Tercica shall have an additional
period of thirty (30) days following the date of such notice
by GNE to elect to exercise the Opt-In right with respect to such
Non-Orphan Indication or such Diabetes Orphan Indication. For
avoidance of doubt, this Opt-In right shall expire upon the first
to occur of the exercise of the Opt-In Right, or ninety one
(91) days after the Triggering Delivery.
(iii) If either Tercica or GNE provides Insmed with
the Opt-In Exercise Notice within the Opt-In Period, then Insmed
shall enter into a co-development and, where such Opt-in Party so
elects under Section 5.2, co-commercialization relationship
with the Party providing Insmed with such notice, on the terms set
forth in this Article 4 and in Article 5.
(e) Opt-In Payment; Accounting of
Development Costs. The
“ Opt-In Payment ” for a Product for a
particular Permitted Indication shall be an amount equal to fifty
percent (50%) of the total Development Costs allocable to the
development of such Product for such Permitted Indication, and
incurred as of the date of receipt of the Opt-In Exercise Notice
for such Permitted Indication. Such Opt-In Payment shall be paid to
Insmed in accordance with Section 4.2(b). All Development
Costs incurred and allocable to any Permitted Indication as of the
Effective Date will be provided, in writing, on a Permitted
Indication-by-Permitted Indication basis, by Insmed to Tercica and
GNE within thirty (30) days following the Effective Date.
During the Term and prior to the expiration of the Opt-In Period,
Insmed shall be responsible for maintaining a detailed account of
all Development Costs expended for each Permitted
Indication.
4.3 Consequences of Tercica or
GNE’s Exercise of Opt-In. If Tercica or GNE exercises the Opt-In in
accordance with Section 4.2, the following shall
apply:
(a) Collaborative
Development. Insmed and
the Opt-In Party shall discuss, via the JDC, what if any
operational matters in the development of a Product for such Opt-In
Indication shall be the responsibility of the Opt-In
Party.
(b) Ongoing Co-Funding of
Development Costs. The
Opt-In Party shall bear fifty percent (50%) of the total
Development Costs incurred from the day after the date of receipt
of the Opt-In Exercise Notice for such Permitted Indication and
allocable to the development of a Product for such Opt-In
Indication. The process for reconciling payment of such Development
Costs in order to give effect to each Opt-In Party’s
Percentage Interest shall be in accordance with Article 7 and
Exhibit A .
(c) Decision-Making
Control. The Opt-In Party
may have the deciding vote with respect to decisions in the JDC
regarding such Opt-In Indication, as provided in
Section 6.2(d)(ii).
(d) Right for GNE to Develop and
Commercialize Diabetes. In the event that GNE is the Opt-In Party and
the Opt-In Indication is a Diabetes Orphan Indication (an “
Opt-In Diabetes Orphan Indication ”), at such time, if
any, as GNE and Insmed using their respective scientific and
business judgment disagree over whether the continued development
of a Product for the Opt-In
18
PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE
BEEN FILED SEPARATELY WITH THE SECRETARY OF THE COMMISSION PURSUANT
TO AN APPLICATION FOR CONFIDENTIAL TREATMENT UNDER RULE 24b-2 OF
THE EXCHANGE ACT; [***] DENOTES OMISSIONS.
Diabetes Orphan Indication is desirable (such
that Insmed does not wish to continue development of such Product
for the Opt-In Diabetes Orphan Indication), GNE may elect to take
over the development of such Product for the Opt-In Diabetes Orphan
Indication at the sole expense of GNE and, upon notice to Insmed of
such election, the Permitted Indications shall be amended to
exclude such Opt-In Diabetes Orphan Indication solely for the
purposes of the rights granted to Insmed under Section 3.1(c),
provided that:
(i) for all other purposes of this Agreement,
including without limitation the licenses granted by Insmed to GNE
as the Opt-In Party under Section 3.2(b), the Permitted
Indications shall be deemed to include such Opt-In Diabetes Orphan
Indication;
(ii) GNE shall become, if not already, the Booking
Party for such Opt-In Diabetes Orphan Indication and shall have
final decision making authority in the commercialization of such
Product for such Opt-In Diabetes Orphan Indication in the United
States; and
(iii) the profit-sharing arrangement applicable to
such Opt-In Diabetes Orphan Indication shall continue only until
the payments so received by Insmed from GNE equals the Development
Costs incurred by Insmed for such Product for such Opt-In Diabetes
Orphan Indication, and thereafter the profit share arrangement for
such Opt-In Diabetes Orphan Indication shall terminate and GNE
shall pay to Insmed royalties on the Net Sales for such Opt-In
Diabetes Orphan Indication in the United States at a rate of [***];
provided that, such royalty payment obligation shall apply only in
the event that the use, sale, offer for sale, or importation of
such Product for use in the Opt-In Diabetes Orphan Indication would
infringe the Insmed Patents, and such royalty payment obligation
shall thereafter expire upon the later of (y) the expiration
of the last to expire Insmed Patents existing in the United States
that would be infringed by the use, sale, offer for sale, or
importation of such Product for use in such Opt-In Diabetes Orphan
Indication in the United States but for the license grant in
Section 3.2(b), and (z) the expiration of the last to
expire Insmed Patents existing in a country and that covers the
actual method of manufacture or use of such Product (or component
thereof) as practiced by Insmed in the manufacture of such Product
in such country that is subsequently sold for use in such Opt-In
Diabetes Orphan Indication in the United States.
(e) Ongoing Sharing of Profits
and Losses. As further
described in Section 7.2, Insmed and the Opt-In Party shall
share Operating Profit (Loss) with respect to a given Opt-In
Indication, based on the applicable Percentage Interest for such
Opt-In Indication.
(f) Opt-In Party’s Product
Commercialization Rights for Opt-In Indication.
If either Tercica or GNE exercises
the Opt-In right under this Section 4.2, such Party shall have
the right, at its discretion, to exercise the Sole Promotion Option
or the Co-Promotion Option for the respective Opt-In Indication
pursuant to Section 5.2. In addition, following such exercise
of the Opt-In right, Insmed shall have no right to seek, negotiate
or enter into an agreement with, a Third Party partner for the
co-development and/or co-commercialization of a Product.
19
PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE
BEEN FILED SEPARATELY WITH THE SECRETARY OF THE COMMISSION PURSUANT
TO AN APPLICATION FOR CONFIDENTIAL TREATMENT UNDER RULE 24b-2 OF
THE EXCHANGE ACT; [***] DENOTES OMISSIONS.
4.4 Opt-Out Rights.
An Opt-In Party for a particular
Opt-In Indication shall have the right to discontinue its ongoing
funding obligations for such Opt-In Indication either in total or
on a region-by-region or country-by-country basis in the Territory
(the term “region” means and includes each of the
following: the North American Territory, the EU, and Japan) for
such Opt-In Indication, for any or no reason, for a period of ten
(10) business days after the completion of an ongoing clinical
trial and the reporting of results from such clinical trial for a
Product for the treatment of such Opt-In Indication (the “
Opt-Out ”). An Opt-In Party may exercise such Opt-Out
right by providing written notice to Insmed stating the same.
Effective thirty (30) days following notice of such Opt-Out:
(a) such Party shall cease to be an Opt-In Party and the
license granted under Section 3.2(b) for such Permitted
Indication shall terminate, (b) such Party shall have no
further obligation to co-fund the ongoing Development Costs of such
Product for such Permitted Indication other than for non-cancelable
out-of-pocket costs incurred or committed to as of the effective
date of the Opt-Out for activities previously approved in
accordance herewith, (c) such Party shall have no right to
share in a portion of the Operating Profits (Loss) for such Product
for such Permitted Indication, (d) such Permitted Indication
shall cease to be an Opt-In Indication, (e) such Party shall
no longer have the Sole Promotion Option or Co-Promotion Option
with respect to such Permitted Indication, and (f) such Party
shall nor longer have any decision making control or input with
respect to the development or commercialization of such Product for
such Permitted Indication. If Insmed continues the development
and/or commercialization of such Product for such Permitted
Indication thereafter, then such Opt-In Party, after exercising its
Opt-Out right, shall receive a royalty on the Net Sales of a
Product for treatment of such Permitted Indication as further
described in Section 7.1(a)(ii). For clarity, if an Opt-In
Party exercises the Opt-Out right, it shall not have any right to a
refund or reimbursement of any payments it had made to co-fund the
Development Costs for a Product for such Permitted
Indication.
ARTICLE 5
COMMERCIALIZATION
5.1 Commercialization by
Insmed. Insmed shall have
the primary right and responsibility for commercializing a Product
for a given Permitted Indication; provided, however, that if the
Opt-In Party for a particular Opt-In Indication elects to exercise
its Co-Promotion Option or Sole Promotion Option for such Opt-In
Indication, then the Parties shall proceed as set forth in this
Article 5 and the terms of the Co-Promotion Agreement (as defined
in Section 5.3) or the terms of the Supply Agreement (as
defined in Section 5.4) shall apply to the commercialization
of such Product for the treatment of such Opt-In
Indication.
5.2 Commercialization by an
Opt-In Party. Subject to
the proper exercise of the Opt-In right described in
Section 4.2, Insmed hereby grants the Opt-In Party, for the
corresponding Opt-In Indication: (a) an option to co-promote,
worldwide, a Product with Insmed for the treatment of such Opt-In
Indication (the “ Co-Promotion Option ”); and
(b) an option to assume sole responsibility for the
commercialization of a Product for the treatment of such Opt-In
Indication (the “ Sole Promotion Option ”). It
is further understood and agreed that Tercica shall have the right
to assign to Ipsen such Co-Promotion Option or Sole Promotion
Option with respect to the ROW Territory or certain country(ies)
within such ROW Territory, in which case the “Opt-In
Party” as used in this Article 5 shall also include Ipsen. It
is also further understood and agreed that GNE shall have the right
to assign to a Third Party
20
PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE
BEEN FILED SEPARATELY WITH THE SECRETARY OF THE COMMISSION PURSUANT
TO AN APPLICATION FOR CONFIDENTIAL TREATMENT UNDER RULE 24b-2 OF
THE EXCHANGE ACT; [***] DENOTES OMISSIONS.
designee such Co-Promotion Option or Sole
Promotion Option with respect to the ROW Territory or certain
country(ies) within such ROW Territory, in which case the
“Opt-In Party” as used in this Article 5 shall also
include such Third Party designee.
5.3 Opt-In Party’s
Co-Promotion Option for Product for an Opt-In
Indication.
(a) Exercise of Co-Promotion
Option. The Opt-In Party
may exercise the Co-Promotion Option as to an Opt-In Indication by
providing written notice to Insmed within sixty (60) days
following the JDC’s decision (as set forth in approved
minutes of the JDC) to file the first application for Marketing
Authorization for a Product for such Opt-In Indication in a given
country. It is understood that such Co-Promotion Option shall be
triggered with respect to the North American Territory and the ROW
Territory independently, such that if, by way of example, the
Opt-In Party does not exercise its Co-Promotion Option for the
North American Territory (or part thereof), it may nonetheless
exercise its Co-Promotion Option for the ROW Territory (or part
thereof), provided such Opt-In Party has not exercised its right to
Opt-Out of co-development for any such North American Territory or
ROW Territory. If the Opt-In Party exercises the Co-Promotion
Option, the Opt-In Party shall co-promote such Product for the
treatment of such Opt-In Indication with Insmed, during the
Co-Promotion Term pursuant to the terms of a Co-Promotion
Agreement, as further described in Section 5.3(b) below.
Co-promotion of Product for the treatment of such Opt-In Indication
shall be overseen and coordinated by the JCC.
(b) Co-Promotion
Agreement. Promptly
following the Opt-In Party’s exercise of the Co-Promotion
Option with respect to a particular Opt-In Indication in a region
or country, the Opt-In Party and Insmed shall engage in good faith
negotiations to prepare and execute a definitive co-promotion
agreement describing the co-promotion activities of the Parties for
promoting a Product for the treatment of such Opt-In Indication in
such region or country (the “ Co-Promotion Agreement
”). The Co-Promotion Agreement will have the terms and
conditions set forth in this Article 5 and in the term sheet
attached to this Agreement as Exhibit E , as well as such
other terms as the Opt-In Party and Insmed may agree. The Opt-In
Party and Insmed will use reasonably diligent efforts to execute
the Co-Promotion Agreement at least twelve (12) months prior
to the anticipated receipt of Marketing Authorization for such
Product for such Opt-In Indication as determined by the JCC (such
date, the “ Launch Date ”) for the treatment of
such Permitted Indication in the relevant jurisdiction. The “
Co-Promotion Term ” will commence upon execution of
the Co-Promotion Agreement and will extend for so long as Insmed is
selling a Product or the termination of this Agreement, whichever
occurs first.
(c) Commercialization
Plan. If the Opt-In Party
exercises its Co-Promotion Option with respect to a particular
Opt-In Indication, the strategy and tactics for the commercial
launch of a Product for the Opt-In Indication shall be described in
a comprehensive plan that describes the launch and subsequent
co-promotion and related commercialization activities for such
Product by the Opt-In Party and Insmed (including advertising,
education, planning, marketing, sales force training and detail
allocation) (the “ Commercialization Plan ”).
The JCC shall prepare an initial draft of the Commercialization
Plan within one (1) month after the filing of the first
application for Marketing Authorization and shall approve a final
Commercialization Plan at least six (6) months prior to the
anticipated Launch Date for such Product for the treatment of such
Opt-In Indication. The JCC shall update such Commercialization Plan
as needed thereafter, but in any event annually.
21
PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE
BEEN FILED SEPARATELY WITH THE SECRETARY OF THE COMMISSION PURSUANT
TO AN APPLICATION FOR CONFIDENTIAL TREATMENT UNDER RULE 24b-2 OF
THE EXCHANGE ACT; [***] DENOTES OMISSIONS.
5.4 The Opt-In Party’s Sole
Promotion Option for Product for an Opt-In
Indication.
(a) Exercise of Sole Promotion
Option. The Opt-In Party
may exercise the Sole Promotion Option for each of its Opt-In
Indications by providing written notice to Insmed within sixty
(60) days following the JDC’s decision (as set forth in
approved minutes of the JDC) to file an application for Marketing
Authorization for a Product for such Opt-In Indication in a given
country. It is understood that such Sole Promotion Option shall be
triggered with respect to the North American Territory and the ROW
Territory independently, such that if, by way of example, the
Opt-In Party does not exercise its Sole Promotion Option for the
North American Territory (or part thereof), it may nonetheless
exercise its Sole Promotion Option for the ROW Territory (or part
thereof), provided such Opt-In Party has not exercised its right to
Opt-Out of co-development for any such North American Territory or
ROW Territory or part thereof. If the Opt-In Party exercises the
Sole Promotion Option, the Opt-In Party shall thereafter have the
sole right to market, promote, sell, and offer for sale such
Product for the treatment of such Opt-In Indication, in the region
or country(ies) as to which such option is exercised, including
without limitation, the sole right to book all sales of such
Product for such Opt-In Indication.
(b) Supply of Product by
Insmed. Promptly
following the Opt-In Party’s exercise of the Sole Promotion
Option, the Opt-In Party and Insmed shall engage in good faith
negotiations to prepare and execute a definitive supply agreement
describing terms and conditions by which Insmed shall supply or
cause to be supplied (by manufacturing itself or by procuring from
a Third Party) commercial quantities of finished, filled, and
packaged Product to the Opt-In Party for such Opt-In Indication, at
a price equal to Insmed’s Fully Burdened Manufacturing Cost
not to exceed $2,500/gram (such agreement, the “ Supply
Agreement ”). The Supply Agreement will set forth the
terms and conditions as the Opt-In Party and Insmed may agree and
as are customary in an agreement of that type, including without
limitation, any supply capacity constraints for a Product,
forecasting and ordering, inspection and rejection provisions, and
remedies in the event of supply default, including the ability of
the Opt-In Party to make or have made a Product itself in such
event. The Opt-In Party and Insmed will negotiate and execute the
Supply Agreement at least twelve (12) months prior to the
anticipated Launch Date of a Product for the treatment of such
Opt-In Indication
(c) Trademark License
. In the event Tercica and/or GNE
exercises its Sole Promotion Option with respect to a given Opt-In
Indication, Insmed hereby grants such Opt-In Party a non-exclusive,
worldwide license, with the right to grant sublicenses as provided
in this Section 5.4(c), to use the Trademark in connection
with the marketing, promotion and sale of a Product for use in the
Opt-In Indication. Any sublicense by Tercica or GNE under the
rights granted in this Section 5.4(c) to a sublicensee other
than Ipsen, or other than a distributor, subcontractor or
consultant in the normal course of business, shall be made by
Tercica or GNE only with the consent of Insmed, such consent not to
be unreasonably withheld. It is expressly understood that the
Opt-In Party exercising such Sole Promotion Option shall not be
required to use the Trademark in connection with the marketing or
sale of a Product for such Opt-In Indication, but shall have the
right to re-brand such Product for such Opt-In Indication under a
new trademark, in which event the Opt-In Party shall own all rights
in and to such new trademark and all associated
goodwill.
22
PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE
BEEN FILED SEPARATELY WITH THE SECRETARY OF THE COMMISSION PURSUANT
TO AN APPLICATION FOR CONFIDENTIAL TREATMENT UNDER RULE 24b-2 OF
THE EXCHANGE ACT; [***] DENOTES OMISSIONS.
5.5 Sales Tracking.
The Parties recognize that, subject
to the licenses granted in Section 3.1, and in light of the
Parties’ Opt-In rights with respect to given Permitted
Indications, and Sole Promotion Option, a Product may be sold by
Insmed for use in the treatment of one or more Permitted
Indications as to which the Opt-In Party has exercised its rights,
as well as Permitted Indications as to which no Opt-In rights have
been exercised, as well as to patients on a Named Patient Basis as
provided in Section 3.1(b), and to Existing Patients under
Section 3.1(a), and may also be sold by either GNE or Tercica
in the event of exercise of its Sole Promotion Option, for a given
Opt-In Indication. In addition, Products marketed by Insmed (or its
Sublicensee) or by GNE or Tercica (or their designee) in the future
for an approved Permitted Indication may nonetheless be prescribed
for use in the treatment of one or more indications which are other
than such approved Permitted Indication (i.e., “Off Label
Sales”). Given that different financial consideration is due
and owing depending upon which of the foregoing situations is
applicable (i.e., royalties vs. profit sharing), and in order to
detect and account for such sales of Product in a manner most
reflective of the Parties’ intent, the Parties agree as
follows:
(a) Sales Tracking
Methodology.
(i) Initial
Methodology. Within one
hundred eighty (180) days after the Effective Date, Tercica
and Insmed shall meet and agree upon a method of tracking sales of
Product for use in the treatment of each indication, in the country
sold (a “ Sales Tracking Methodology ”)
including (1) the use of data from Statements of Medical
Necessity, or the acquisition of one or more forms of prescription
data (including by way of example, IMS Xponent, NDCHealth
Information Network, or Drug Distribution Data) or other relevant
pharmaceutical sales tracking research services (including by way
of example, audits of the corresponding statements of medical
necessity, use of random sampling, use of data regarding
distribution channels as a proxy for indication-specific sales or
development of mathematical models for approximating
indication-specific sales) generally recognized in the
pharmaceutical industry as having a reasonable degree of accuracy
and reliability in the tracking of sales of pharmaceutical products
that have a similar nature as, and are prescribed by similar
physicians as, a Product for the Named Patient Indications and
Permitted Indications (the “ Data Services ”),
and (2) the methodology for applying any such resulting data
and information provided by such Data Services to determine the
extent of sales in each country which are attributable to each such
indication. It is expressly understood that sales of a Product for
any Non-Permitted Indications are not anticipated except to the
Existing Patients, and only for a period not to exceed twelve
(12) months from the Effective Date, and any sales that are
knowingly made to patients for use within a Non-Permitted
Indication by Insmed or its Affiliates or Sublicensees and that are
tracked to any Non-Permitted Indications after such twelve
(12) month period (or to any patients who are other than
Existing Patients within such twelve (12) month period) will
be evidence of Insmed’s breach of its covenant in
Section 3.5 and its license under
Section 3.1(a).
(ii) Modifications to
Methodology. The JCC may
elect at any point to adopt a different or modified Sales Tracking
Methodology, upon request of either Party. If the JCC fails to
agree on a different Sales Tracking Methodology proposed by either
Tercica or Insmed, the Sales Tracking Methodology then in effect
shall continue to be used. Notwithstanding the foregoing, it
is
23
PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE
BEEN FILED SEPARATELY WITH THE SECRETARY OF THE COMMISSION PURSUANT
TO AN APPLICATION FOR CONFIDENTIAL TREATMENT UNDER RULE 24b-2 OF
THE EXCHANGE ACT; [***] DENOTES OMISSIONS.
understood and agreed by Tercica and Insmed that
each shall have the right, at its own expense, to undertake such
market research and analysis, including “probes” or
sampling of patient data, physician prescribing habits and the like
(the “ New Sales Tracking Data ”) or otherwise
propose modifications to the Sales Tracking Methodology at any time
during the Term, and to present such data or otherwise propose
modifications to the Sales Tracking Methodology to the JCC to
enhance the validity or reliability of the Sales Tracking
Methodology. It shall be the JCC’s continuing obligation to
review any such New Sales Tracking Data in good faith, with the
overriding obligation to ensure fair and accurate compensation to
the Parties (as applicable) under this Agreement by tracking as
accurately as reasonably possible, purchases of a Product for use
in specific indications. In the event that the JCC adopts a new
Sales Tracking Methodology that incorporates New Sales Tracking
Data proposed by a Party, the costs of such new Sales Tracking
Methodology shall be allocated between Tercica and Insmed as
provided in Section 5.5(c).
(b) Implementation by
Insmed. Promptly
following the selection and adoption by the JCC of the Sales
Tracking Methodology (and any new Sales Tracking Methodology as
applicable), Insmed hereby agrees to implement such Sales Tracking
Methodology with respect to Insmed’s annual worldwide sales
of Product.
(c) Costs.
Insmed and Tercica shall share
equally all costs incurred in implementing the Sales Tracking
Methodology until such time as GNE exercises its first Opt-In
right, in which event all such costs shall be shared equally
between Insmed, Tercica and GNE.
(d) Dispute Resolution with
Respect to Sales Tracking. Notwithstanding the dispute resolution mechanism
set forth in Article 13 below, the Parties agree that all disputes
relating to matters pertaining to sales tracking, including without
limitation the methodology(ies) to be used or implementation
thereof, shall be resolved as soon as practicable as follows: Any
Party shall bring such dispute to the attention of the other
Parties by providing the other Parties with a written notice
stating such dispute, and the Parties shall use good faith efforts
to resolve such dispute through the JCC within thirty
(30) days after the receipt of such notice. If the JCC cannot
reach resolution on such matter during such thirty (30)-day period,
then the matter shall be referred to the Chief Commercial Officer
or equivalent (or his/her designee who has decision-making
authority) of the Parties for resolution. If such executives cannot
reach resolution on such matter within ten (10) business days,
then the Parties shall refer the matter to the Sales Tracking Panel
(as defined below) for resolution, and the Sales Tracking
Panel’s decision (which shall require the consent and
agreement of 2 of the 3 panelists) on such matter shall be final
and binding upon all Parties. Notwithstanding the foregoing, GNE
may, at its option, recuse itself from such disputes with respect
to sales tracking at any time by providing the other Parties with
written notice stating such election. “Sales Tracking
Panel” shall mean a panel of three experts, each of whom
have experience in market research and intelligence gathering with
respect to pharmaceutical products (e.g., former employees of IMS),
and at least one of whom has experience in market research and drug
distribution and prescribing information collection involving
specialty pharmaceuticals. The Parties shall appoint such experts
serving on the Sales Tracking Panel within thirty (30) days
after the Effective Date through mutual agreement, and shall
maintain the number of experts on such Sales Tracking Panel during
the Term.
24
PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE
BEEN FILED SEPARATELY WITH THE SECRETARY OF THE COMMISSION PURSUANT
TO AN APPLICATION FOR CONFIDENTIAL TREATMENT UNDER RULE 24b-2 OF
THE EXCHANGE ACT; [***] DENOTES OMISSIONS.
ARTICLE 6
GOVERNANCE
6.1 Overview.
The Parties desire to establish
certain committees to facilitate the sharing of information between
the Parties and to coordinate the development and commercialization
of a Product for the treatment of Permitted Indications (as
applicable) and the implementation of the Sales Tracking
Methodology. It is understood and acknowledged by each Party that,
subject to Tercica’s and GNE’s opt-in rights in
Section 4.2, Insmed will be primarily responsible for the
development and commercialization of a Product strictly in
accordance with the licenses granted by Tercica under
Section 3.1.
6.2 Joint Development
Committee.
(a) Formation;
Composition. Within
thirty (30) days after the Effective Date, the Parties shall
establish a committee to oversee development of a Product and to
serve as a forum for sharing information regarding such development
between the Parties (the “ JDC ”). Tercica and
Insmed each shall initially appoint three (3) representatives
to the JDC, and GNE may initially appoint up to three
(3) representatives to the JDC. Following any exercise of its
Opt-In rights, GNE shall appoint or retain at least one
(1) representative, but no more than three
(3) representatives, to the JDC. The JDC may change its size
from time to time by mutual consent of its members, provided that
the JDC shall include at all times an equal number of
representatives of each of Tercica, Insmed, and where GNE so
elects, of GNE. Each Party may replace its JDC representatives at
any time upon written notice to the other Party(ies). The JDC may
invite non-members to participate in the discussions and meetings
of the JDC, provided that such participants shall have no voting
authority at the JDC. The JDC will be chaired by Insmed. The
chairperson shall be responsible for administering JDC meetings,
but shall have no additional powers or rights beyond those held by
the other representatives of the JDC.
(b) Specific Responsibilities of
the JDC. In addition to
its general responsibilities, the JDC shall in
particular:
(i) prior to an Opt-In Party’s exercise of the
Opt-In in accordance with Section 4.2 and throughout the
Opt-In Period, facilitate the flow of information from Insmed to
Tercica and GNE with respect to the development of, and obtaining
Marketing Authorization for, a Product for the treatment of any
Permitted Indications;
(ii) prior to an Opt-In Party’s exercise of the
Opt-In in accordance with Section 4.2 and throughout the
Opt-In Period, determine, prior to the conduct of such trial,
whether a proposed clinical trial for a Product satisfies the
criteria of a Phase III Enabling Trial for the applicable Opt-In
Indication; and
(iii) following an Opt-In Party’s exercise of
the Opt-In in accordance with Section 4.2 for a particular
Permitted Indication, coordinate and oversee the Parties’
development of a Product for the treatment of the applicable Opt-In
Indication.
(c) Meetings.
The JDC shall meet at least once per
calendar quarter after the Effective Date unless the Parties
mutually agree in writing to a different frequency. The JDC may
meet in person, by videoconference, or by teleconference. The
location of
25
PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE
BEEN FILED SEPARATELY WITH THE SECRETARY OF THE COMMISSION PURSUANT
TO AN APPLICATION FOR CONFIDENTIAL TREATMENT UNDER RULE 24b-2 OF
THE EXCHANGE ACT; [***] DENOTES OMISSIONS.
in-person JDC meetings will be held at locations
alternately selected by Tercica, Insmed, and GNE. Each Party shall
report to the JDC on all material issues relating to the
development of a Product promptly after such issues arise. Each
Party will bear the expense of its respective JDC members’
participation in JDC meetings. Meetings of the JDC shall be
effective only if at least one representative of each Party having
incumbent member(s) of the JDC is present or participating in such
meeting. The chairperson of the JDC shall be responsible for
keeping reasonably detailed written minutes of all JDC meetings
that reflect, without limitation, material decisions made at such
meetings. Meeting minutes will be sent to each member of the JDC
for review and approval within ten (10) business days after a
meeting.
(d) Decision-Making.
The JDC shall act by consensus. The
representatives from each Party will have, collectively, one
(1) vote on behalf of that Party. If the JDC cannot reach
consensus on any issue that comes before the JDC, then:
(i) prior to Tercica’s or GNE’s exercise
of the Opt-In in accordance with Section 4.2, Insmed shall
have the deciding vote for all issues to be determined by the JDC;
and
(ii) following the date when an Opt-In Party
exercises its Opt-In rights, such Opt-In Party would have the
deciding vote on all matters related to the Opt-In Indication
before the JDC.
It is expressly understood and
agreed that the control of decision-making authority by a Party so
as to resolve a disagreement or deadlock at the JDC for any matter
will not relieve such Party from any of its representations,
warranties, or covenants in this Agreement, nor will it enable such
Party to unilaterally modify or amend the terms of this
Agreement.
6.3 Joint Commercialization
Committee.
(a) Formation;
Composition. Promptly
following the Effective Date but in no event later than thirty
(30) days after the Effective Date, the Parties shall form a
committee to, in the first instance agree upon and approve the
Sales Tracking Methodology, and, following exercise by an Opt-In
Party of its Co-Promotion Option or Sole Promotion Option,
coordinate and oversee the Parties’ respective
commercialization activities with respect to a Product for the
treatment of any Permitted Indications (the “ JCC
”). Tercica and Insmed each shall initially appoint two
(2) representatives to the JCC, and GNE may initially appoint
up to two (2) representatives to the JCC. Following any
exercise of its Opt-In rights, GNE shall appoint at least one (1),
but no more than two (2), representatives to JCC. The JCC may
change its size from time to time by mutual consent of its members,
provided that the JCC shall include at all times of an equal number
of representatives of each of Tercica, Insmed, and where GNE so
elects, of GNE. Each Party may replace its JCC representatives at
any time upon written notice to the other Party(ies). The JCC may
invite non-members to participate in the discussions and meetings
of the JCC, provided that such participants shall have no voting
authority at the JCC. The JCC will be chaired initially by Insmed.
The chairperson shall be responsible for administering JCC
meetings, but shall have no additional powers or rights beyond
those held by the other representatives on the JCC.
26
PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE
BEEN FILED SEPARATELY WITH THE SECRETARY OF THE COMMISSION PURSUANT
TO AN APPLICATION FOR CONFIDENTIAL TREATMENT UNDER RULE 24b-2 OF
THE EXCHANGE ACT; [***] DENOTES OMISSIONS.
(b) Meetings.
The JCC shall meet at least twice
per year after its formation pursuant to Section 6.3(a) unless
the Parties mutually agree in writing to a different frequency. The
JCC may meet in person, by videoconference, or by teleconference.
The location of in-person JCC meetings will be held at locations
alternately selected by Tercica, Insmed and GNE. Meetings of the
JCC shall be effective only if at least one representative of each
Party is present or participating in such meeting. Each Party shall
report to the JCC on all material issues relating to the
commercialization of Products promptly after such issues arise.
Each Party will bear the expense of its respective JCC
members’ participation in JCC meetings. The chairperson will
be responsible for preparing reasonably detailed written minutes of
JCC meetings that reflect, without limitation, material decisions
made at such meetings. Such meeting minutes will be sent to each
member of the JCC for review and approval within ten
(10) business days after a meeting.
(c) Decision-Making.
The JCC shall act by consensus. The
representatives from each Party will have, collectively, one
(1) vote on behalf of that Party. If the JCC cannot reach
consensus on any issue that comes before the JCC, then:
(i) prior to the date when, and if, an Opt-In Party
exercises its Sole Promotion Rights with respect to a particular
Opt-In Indication pursuant to Section 5.4, and other than with
respect to Sales Tracking Methodology matters, Insmed shall have
the deciding vote for all issues to be determined by the JCC;
and
(ii) following the date when an Opt-In Party
exercises its Sole Promotion Rig