Exhibit 10.1
Dyax Corp. has requested that the
highlighted portions of this document be accorded confidential
treatment pursuant to Rule 24b-2 promulgated under the Securities
Exchange Act of 1934, as amended.
CONFIDENTIAL
DOCUMENT
EXECUTION COPY
PRODUCT DEVELOPMENT AND LICENSE
AGREEMENT
BY AND BETWEEN
DYAX CORP.
AND
CMIC CO. LTD.
DATED AS OF SEPTEMBER 28,
2010
Confidential materials omitted
and filed separately with the Securities and Exchange
Commission. Asterisks denote such omission.
PRODUCT DEVELOPMENT AND LICENSE
AGREEMENT
This Product Development and License Agreement
(this " Agreement ") is made effective as of September 28,
2010 (the " Effective Date ") by and between Dyax Corp.,
with offices at 300 Technology Square, Cambridge, Massachusetts
02139, U.S.A. (" Dyax "), and CMIC Co. Ltd., with offices at
Kongo Bldg, 7-10-4 Nishigotanda, Shinagawa-ku, Tokyo 141-0031 ("
CMIC ").
INTRODUCTION
WHEREAS, Dyax owns or controls certain patents,
know-how and other rights related to its proprietary novel plasma
kallikrein inhibitor known as DX-88 (ecallantide);
WHEREAS, CMIC is engaged in the development and
commercialization of pharmaceutical products in Japan;
WHEREAS, CMIC desires to obtain a license from
Dyax to develop products incorporating DX-88 for the treatment of
angioedemas in the CMIC Territory (as such term is defined herein);
and
WHEREAS, Dyax is willing to grant CMIC such a
license on the terms and conditions set forth herein;
NOW, THEREFORE, for and in consideration of the
mutual covenants contained herein, Dyax and CMIC hereby agree as
follows:
ARTICLE I
DEFINITIONS
As used in this Agreement, the following terms
shall have the meanings set forth below:
1.1 "
Affiliate ". Affiliate shall mean with respect to
any Person, any Person controlling, controlled by or under common
control with the former Person. For the purposes of this
Section 1.1, "control" shall mean (a) in the case of a Person that
is a corporate entity, the direct or indirect ownership of more
than fifty percent (50%) of the stock, shares or ownership interest
having the right to vote for the election of directors of such
Person and (b) in the case of a Person that is an entity, but is
not a corporate entity, the direct or indirect possession of the
power to direct, or cause the direction of, the management or
policies of such Person, whether through the ownership of voting
securities, by contract or otherwise.
1.2 "
Alliance Manager ". Alliance Manager shall have
the meaning given to that term under Section 2.6.
1.3 "
Bankruptcy Code ". The Bankruptcy Code shall mean
Title 11 of the United States Code.
1.4 "
Batch ". Batch shall mean a quantity of Drug
Substance manufactured by Dyax (or its CMO) that (a) is expected to
have a uniform character and quality within specified limits, and
(b) is produced according to a single manufacturing run during the
same cycle.
1.5 "
Blocking Third Party Patent Rights ". Blocking
Third Party Patent Rights shall mean, with respect to any country
in the CMIC Territory, on a country-by-country basis, the Patent
Rights in such country owned or controlled by a Third Party that
would Cover Product or its Manufacture or Commercialization in the
Field. Notwithstanding the foregoing, the
[******].
1.6 "
Breaching Party ". Breaching Party shall have the
meaning given to that term under Section 12.2(b).
1.7 "
Business Day ". Business Day shall mean a day
that is not a Saturday, Sunday or a day on which banking
institutions in Cambridge, Massachusetts, USA or Tokyo, Japan
remain closed.
1.8 "
Calendar Quarter ". Calendar Quarter shall mean
each of the periods ending on March 31, June 30, September 30 and
December 31 of any year.
Confidential materials omitted
and filed separately with the Securities and Exchange
Commission. Asterisks denote such omission.
1.9 "
Challenging Party ". Challenging Party shall have
the meaning given to that term under Section 12.2(d).
1.10 "
CMIC Development Data ". CMIC Development Data shall mean,
as it pertains to Product or its use, all pharmacology and
toxicology data and information, pre-clinical study data, clinical
trial data, protocols, safety data, quality data and other
regulatory information and reports, whether in written or
electronic form, generated or developed by CMIC or any of its
Affiliates in the course of performing the activities under this
Agreement during the Term.
1.11 "
CMIC Intellectual Property ". CMIC Intellectual
Property shall mean CMIC Know-How and CMIC Patent Rights,
collectively.
1.12 "
CMIC Know-How ". CMIC Know-How shall mean any
Know-How that (a) [******], and (b) is useful for the Development,
Manufacture and/or Commercialization of Compound or Product as
contemplated by this Agreement.
1.13 "
CMIC Patent Rights ". CMIC Patent Rights shall
mean any Patent Rights that (a) claim CMIC Know-How, and (b)
[******]. CMIC Patent Rights shall include CMIC's rights
in Joint Patent Rights as well as any Patent Rights covering CMIC
Sole Inventions.
1.14 "
CMIC Product Trademarks ". CMIC Product
Trademarks shall have the meaning given to that term under Section
8.8(d)
1.15 "
CMIC Promotional Materials ". CMIC Promotional
Materials shall have the meaning given to that term in Section
5.2.
1.16 "
CMIC Sole Inventions ". CMIC Sole Inventions
shall have the meaning given to that term under Section
8.1(b).
1.17 "
CMIC Territory ". CMIC Territory shall mean
Japan. Furthermore, if, pursuant to the Right of Second
Offer described in Section 3.6, Dyax and CMIC reach a full
agreement on the terms and conditions of a license to develop,
manufacture and/or commercialize Product in the People's Republic
of China, then, subject to such terms and conditions, CMIC
Territory shall thereafter include the People's Republic of
China.
1.18 "
CMO ". CMO shall mean a contract manufacturing
organization contracting with Dyax to supply Dyax or CMIC with Drug
Substance or Drug Product pursuant to Article VI.
1.19 "
Commercialization " or " Commercialize
". Commercialization or Commercialize shall mean the
activities to market, promote, store, import, export, offer to sell
and sell Product, including conducting any Post-Approval Studies to
support Commercialization. Commercialization shall not
include any activities that are covered by the definitions of
"Development", "Manufacturing" or "Post-Filing
Activities".
1.20 "
Commercially Reasonable Efforts ". Commercially
Reasonable Efforts shall mean the conduct and completion of an
activity by a Party in a diligent and commercially reasonable
manner, using efforts not less than the efforts the Party uses to
other similar activities, based on conditions then prevailing and
any other technical, legal, scientific, medical or commercial
factors that the Party deems in good faith to be
relevant.
1.21 "
Competitive Infringement ". Competitive
Infringement shall have the meaning given to that term under
Section 8.3(a).
1.22 "
Competitive Product ". Competitive Product shall
mean [******].
1.23 "
Complaint ". Complaint shall mean any information
concerning any side effect, injury, toxicity or sensitivity
reaction, or any unexpected incident, adverse drug experience (as
that term is defined in Section 505-1 of the FDCA) or adverse event
(as that term is defined under the ICH Guidelines) in or involving
a subject or, in the case of pre-clinical studies, an animal in a
toxicology study, and the seriousness thereof, whether or not
determined to be attributable to Compound or Product, including any
such information received by either Party from its Related Parties
or other Third Parties.
Confidential materials omitted
and filed separately with the Securities and Exchange
Commission. Asterisks denote such omission.
1.24 "
Compound ". Compound shall mean the compound
known as DX-88 (ecallantide) with the amino acid sequence described
in Exhibit A .
1.25 "
Confidential Information ". Confidential
Information shall have the meaning given to that term under Section
9.1.
1.26 "
Confidentiality Agreement ". Confidentiality
Agreement shall mean the Confidentiality Agreement executed by and
between the parties hereto as of June 2, 2009.
1.27 "
Control " or " Controlled ". Control or
Controlled shall mean, with respect to any intellectual property
right or other intangible property, or Know-How, the possession
(whether by license granted to or ownership vested in a Party or
its Affiliate, other than pursuant to this Agreement) by the Party
of the ability to grant to the other Party access, ownership and/or
a license or sublicense as provided for herein without violating
the terms and conditions of any agreement with any Third Party
[******].
For clarity,
this proviso shall not apply to any In-License of Blocking Third
Party Patent Rights.
1.28 "
Cover ", " Covering " or " Covered
". Cover, Covering or Covered shall mean, with respect
to Compound, Product and/or technology, that (a) in the absence of
a license granted under a Valid Claim of an issued patent, the
making, use, offering for sale, sale, or importation of Compound or
Product, or the practice of such technology would infringe such
Valid Claim, and (b) in the absence of a license granted under a
Valid Claim of a patent application, the making, use, offering for
sale, sale, or importation of Compound or Product, or the practice
of such technology would infringe such Valid Claim if it were to
issue in a patent.
1.29 "
Development " or " Develop ". Development
or Develop shall mean, in respect of Compound or Product,
pre-clinical and clinical research and drug development activities,
including toxicology, test method development and stability testing
and studies, process development, formulation development, delivery
system development, quality assurance and quality control
development, statistical analysis, clinical studies (other than
post-approval studies), regulatory affairs, and product approval
and regulatory activities (excluding regulatory activities directed
to obtaining pricing and reimbursement approvals).
1.30 "
Development Costs ". Development Costs shall
mean, with respect to Compound or Product, all of the out-of-pocket
and internal costs and expenses incurred by or on behalf of the
Parties after the Effective Date in connection with the Development
of Compound or Product for use in the Field. Development
Costs shall consist of:
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Manufacturing
Costs for obtaining the Drug Substance and/or Drug Product to be
used for the Development of Product;
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costs of the
studies on the preclinical, toxicological, pharmacokinetic,
metabolic, clinical and/or stability aspects of Compound or
Product;
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costs of
conducting the clinical studies for Product (other than
Post-Approval Studies), including the costs of clinical supplies,
and all of the internal and external costs incurred in purchasing
and/or packaging comparator drugs, disposal of clinical samples,
related regulatory compliance, quality control, medical affairs,
clinical operations, study subject recruitment and the preparation,
collation and/or validation of data from such clinical
studies;
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costs of
preparing, submitting, reviewing or developing data or information,
and preparing medical writing, for the purpose of submission to a
Regulatory Authority to obtain approval to commence clinical
studies (other than Post-Approval Studies) or to obtain Regulatory
Approval for Product and the costs associated with submitting for,
amending or maintaining such approval(s); and
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the fully
allocated costs of internal clinical, regulatory, scientific, or
technical personnel engaged in such Development.
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Development
Costs shall not include any costs associated with Post-Filing
Activities or Post-Approval Studies, which shall be included in
Regulatory Activities Costs.
Confidential materials omitted
and filed separately with the Securities and Exchange
Commission. Asterisks denote such omission.
1.31 "
Development Plan ". Development Plan shall mean (i) the HAE
Development Plan approved by the JSC under Section 4.1 and (ii) any
Other Angioedema Development Plan approved by the JSC under Section
4.2.
1.32 "
Drug Product ". Drug Product shall mean the
finished Product formulation containing Drug Substance filled into
unlabelled vials.
1.33 "
Drug Product Order Limit ". Drug Product Order
Limit shall mean, with respect to any order for Drug Product placed
during a Calendar Quarter, a quantity equal to [******].
1.34 "
Drug Substance ". Drug Substance shall mean
Compound in bulk form manufactured for use as an active
pharmaceutical ingredient in Drug Product.
1.35 "
Drug Substance Inventory ". Drug Substance
Inventory shall mean Drug Substance that (i) has been Manufactured
by Dyax (and for which quality release has been completed) pursuant
to an order placed by CMIC in accordance with Section 6.1(c), and
(ii) is being held by Dyax (or its contractor) on behalf of CMIC
for use in the Manufacture of Drug Product ordered by CMIC in
accordance with Section 6.1(d).
1.36 "
Drug Substance Order Limit ". Drug Substance
Order Limit shall mean, with respect to any order for Drug
Substance placed during a Calendar Quarter, a quantity equal to the
lower of:
1.37 "
Dyax Development Data ". Dyax Development Data
shall mean, as it pertains to Product or its use in Field, all
pharmacology and toxicology data and information, pre-clinical
study data, clinical trial data, protocols, safety data, quality
data and other regulatory information and reports, whether in
written or electronic form, generated or developed by Dyax or its
Affiliates in the course of developing Product in Field.
1.38 "
Dyax Intellectual Property ". Dyax Intellectual
Property shall mean Dyax Know-How and Dyax Patent
Rights.
1.39 "
Dyax Know-How ". Dyax Know-How shall mean any
Know-How that (a) either is owned or Controlled by Dyax on the
Effective Date [******] and (b) is necessary for the Development,
Manufacture and/or Commercialization of Product as contemplated by
this Agreement, including all Know-How generated or developed by or
for Dyax or its Affiliates in the course of Development of
Product. Notwithstanding the foregoing, Dyax Know-How
shall specifically exclude:
1.40 "
Dyax Patent Rights ". Dyax Patent Rights shall
mean any Patent Rights that (a) Cover Dyax Know-How and (b) are
owned or Controlled by Dyax on the Effective Date or come within
Dyax's Control during the Term, including Existing Dyax Patent
Rights, Dyax's rights in Joint Patent Rights, and any Patent Rights
applicable to Dyax Sole Inventions. Notwithstanding the
foregoing, Dyax Patent Rights shall specifically exclude
[******].
1.41 "
Dyax Product Trademarks ". Dyax Product
Trademarks shall have the meaning given to that term under Section
8.8(b).
1.42 "
Dyax Sole Inventions ". Dyax Sole Inventions
shall have the meaning given to that term under Section
8.1(b).
1.43 "
Dyax Territory ". Dyax Territory shall mean all
the countries of the world outside CMIC Territory.
Confidential materials omitted
and filed separately with the Securities and Exchange
Commission. Asterisks denote such omission.
1.44 "
Executive Officers ". Executive Officers shall mean the
Chief Executive Officer of Dyax (or a senior executive officer of
Dyax designated by Dyax's Chief Executive Officer) and the Chief
Executive Officer of CMIC (or a senior executive officer of CMIC
designated by CMIC's Chief Executive Officer).
1.45 "
Existing Dyax Patent Rights ". Existing Dyax
Patent Rights shall mean those Dyax Patent Rights specifically
listed on Exhibit B .
1.46 "
FDA ". FDA shall mean the United States Food and
Drug Administration or any successor agency thereto.
1.47 "
FDCA ". FDCA shall mean the United States Federal
Food, Drug and Cosmetic Act, as amended.
1.48 "
Field ". Field shall mean use in the HAE and
Other Angioedema Indications. Notwithstanding anything to the
contrary contained herein, in no event shall Field include any use
in any other Indications (including any Indications in Opthalmic
Field or Surgical Field, which are specifically excluded from the
rights granted to CMIC under this Agreement).
1.49 "
First Commercial Sale ". First Commercial Sale
shall mean, with respect to Product in a country, the first
commercial sale of Product in the country.
1.50 "
GAAP ". GAAP shall mean (a) with respect to Dyax,
generally accepted accounting principles in the United States as
consistently applied by Dyax in the preparation of its financial
statements and (b) with respect to CMIC, generally accepted
accounting principles in Japan as consistently applied by CMIC in
the preparation of its financial statements.
1.51 "
HAE ". HAE shall mean hereditary
angioedema.
1.52 "
HAE Development Plan ". HAE Development Plan
shall have the meaning given to that term under Section
4.1.
1.53 "
ICH Guidelines ". ICH Guidelines shall mean the
International Conference on Harmonisation guidelines, including
E2A, E2B, E2C and E2D thereof as amended and any replacement
thereof.
1.54 "
IND ". IND shall mean an Investigational New Drug
Application filed with FDA or a similar application to conduct
clinical studies filed with an applicable Regulatory Authority
outside of the United States.
1.55 "
Indemnified Parties ". Indemnified Parties shall
have the meaning given to that term under Section 11.3.
1.56 "
Indemnifying Parties ". Indemnifying Parties
shall have the meaning given to that term under Section
11.3.
1.57 "
Indication ". Indication shall mean a specified
therapeutic use of a Product, which use has been approved by a
Regulatory Authority (whether through a label expansion or a
separate Regulatory Approval).
1.58 "
In-License ". In-License shall mean an agreement
between a Party or its Affiliate and a Third Party pursuant to
which the Party or its Affiliate has been granted a license to
Blocking Third Party Patent Rights for use by either Party or both
Parties in accordance with Section 3.4.
1.59 "
Invention ". Invention shall mean any Know-How or
Patent Right that is generated, conceived, reduced to practice
and/or developed during the Term in relation to Compound or Product
(or the use thereof).
1.60 "
Joint Intellectual Property ". Joint Intellectual
Property shall mean Joint Know-How and Joint Patent Rights,
collectively.
1.61 "
Joint Inventions ". Joint Inventions shall have
the meaning given to that term under Section 8.1(c).
Confidential materials omitted
and filed separately with the Securities and Exchange
Commission. Asterisks denote such omission.
1.62 "
Joint Know-How ". Joint Know-How shall mean any
Know-How that is generated, conceived, reduced to practice,
developed or acquired jointly by the Parties in the course of
performing the activities under this Agreement, including Joint
Inventions.
1.63 "
Joint Patent Rights ". Joint Patent Rights shall
mean the Patent Rights that Cover Joint Know-How.
1.64 "
Joint Steering Committee" or "JSC ". Joint
Steering Committee or JSC shall have the meaning given to that term
under Section 2.1(a).
1.65 "
Know-How ". Know-How shall mean any information,
whether proprietary or not and whether patentable or not, including
ideas, concepts, inventions, formulas, methods, protocols,
procedures, knowledge, know-how, trade secrets, processes, assays,
skills, experience, techniques, designs, compositions, plans,
documents, results of experimentation and testing, including
pharmacological, toxicological, and pre-clinical and clinical test
data and analytical and quality control data, improvements,
discoveries and works of authorship.
1.66 "
Knowledge ." Knowledge shall mean, with respect
to a Party or its Affiliates, the actual awareness of a certain
fact or information by an officer or senior manager or other
employee with a similar responsibility, regardless of title, of the
Party or its Affiliate.
1.67 "
Manufacturing " or " Manufacture
". Manufacturing or Manufacture shall mean the
activities directed to producing, manufacturing, processing,
filling and finishing (including packaging and labeling) any
Product or component thereof.
1.68 "
Manufacturing Costs ". Manufacturing Costs shall
mean with respect to Drug Substance or Drug Product, the
manufacturing Party's [******] costs, determined in accordance with
GAAP by the manufacturing Party in the ordinary course of its
business and incurred in the course of Manufacturing the Drug
Substance or Drug Product, which costs shall
include:
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the costs for
[******]; and
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1.69 "
Marketing Authorization Application ". Marketing
Authorization Application shall mean the application submitted to
the competent government agency to manufacture, market and sell
Product in Field in one or more countries within
Territory.
1.70 "
Net Sales ". Net Sales shall mean, with respect
to Product, the gross invoiced sales price of the Product
in CMIC Territory by CMIC and its Related Parties, less
the following deductions to the extent included in the gross
invoiced sales price for the Product or otherwise directly paid or
incurred by CMIC or its Related Parties with respect to the sale of
the Product:
In the case of any sale or other disposal of
Product between or among CMIC, it's Affiliates or Sublicensees for
resale to Third Party, the Net Sales of the Product shall be
calculated as above only on the value charged or invoiced on the
first arm's-length sale or other disposition of the Product to
Third Party.
Notwithstanding the foregoing, in any case where
Product is sold or otherwise disposed of in a transaction that is
not the arm's length sale of Product only in cash that is separate
from any sale or disposition of other products or of services, the
Net Sales of the Product shall mean the greatest of:
1.71 "
Non-Breaching Party ". Non-Breaching Party shall
have the meaning given to that term under Section
12.2(b).
1.72 "
Ophthalmic Field ". Ophthalmic Field shall mean
all uses in the therapeutic treatment or prevention of any
ophthalmic disease, infection or other ophthalmic
condition.
Confidential materials omitted
and filed separately with the Securities and Exchange
Commission. Asterisks denote such omission.
1.73 "
Other Angioedema ". Other Angioedema shall mean
acquired angioedema, drug-induced angioedema and idiopathic
angioedema.
1.74 "
Parties ". Parties shall mean Dyax and
CMIC.
1.75 "
Party ". Party shall mean either Dyax or
CMIC.
1.76 "
Patent Rights ". Patent Rights shall mean any and
all patents and patent applications anywhere in the world,
including provisional, utility, substitution, divisional,
continuation and continuation-in-part applications, and reissues,
reexaminations and extensions thereof, patents of addition and any
Supplementary Protection Certificates, restoration of patent term
and other similar rights.
1.77 "
PMDA ". PMDA shall mean the Pharmaceuticals and
Medical Devices Agency or any successor agency thereto responsible
for reviewing the application for Regulatory Approval in
Japan.
1.78 "
Person ". Person shall mean any natural person,
corporation, firm, business trust, limited liability company, joint
venture, association, organization, company, partnership or other
business entity, or any government, or any agency or political
subdivisions thereof.
1.79 "
Post-Approval Studies ". Post-Approval Studies
shall mean those studies and activities subsequent to the granting
of Regulatory Approval that are required or necessary for the
maintenance of the Regulatory Approval.
1.80 "
Post-Filing Activities ". Post-Filing Activities
shall mean all the studies and activities subsequent to filing an
application for Regulatory Approval in the CMIC Territory but prior
to obtaining the Regulatory Approval that are required, or are
necessary to comply with the requirements by the Regulatory
Authority for obtaining the Regulatory Approval in the CMIC
Territory.
1.81 "
Product ". Product shall mean any pharmaceutical product
containing Compound for subcutaneous administration.
1.82 "
Product Competitor ". Product Competitor shall
mean any [******]. As of the Effective Date, Product
Competitors consist of: [******].
1.83 "
Product Manufacturing Process ". Product
Manufacturing Process shall mean the processes used to complete the
Manufacture of unlabeled vials of Product for CMIC under this
Agreement, which processes shall include the Manufacture of Drug
Substance and Drug Product.
1.84 "
Product Trademark(s) ". Product Trademark(s)
shall mean the trademark(s) and service mark(s) distinguishing
Product, and used in connection with the Commercialization and/or
any other distribution, marketing, promotion and sale activities of
or for Product according to Section 8.8, and/or accompanying logos,
trade dresses and/or indicia of origin.
1.85 "
Prosecuting Party ". Prosecuting Party shall have
the meaning given to that term under Section 8.2(a).
1.86 "
Quality Agreement ". Quality Agreement shall have
the meaning given to that term under Section 6.5.
1.88 "[******]
License Agreement ". [******] License Agreement
shall mean the License Agreement effective [******] between
[******].
1.89 "
[******] Intellectual Property ". [******]
Intellectual Property shall mean the "[******] Expression System",
the "[******] Expression Technology" and the "[******] Patent
Rights" as such terms are defined in Paragraphs 1.3, 1.5 and 1.8 of
[******] License Agreement.
1.90 "
Regulatory Activities ". Regulatory Activities
shall mean all of the activities associated with the submission of
Regulatory Filings, including (i) preparing and drafting of the
reports for and the correspondence with Regulatory Authorities,
(ii), holding meetings and conversations with Regulatory
Authorities, (iii) Post-Filing Activities, (iv) the activities
relating to the maintenance of Regulatory Approval and (v) the
performance of Post-Approval Studies.
Confidential materials omitted
and filed separately with the Securities and Exchange
Commission. Asterisks denote such omission.
1.91 "
Regulatory Activities Costs ". Regulatory
Activities Costs shall mean all the costs and expenses (excluding
Development Costs) for Regulatory Activities, including (i) the
fully allocated costs of both Parties' internal clinical,
regulatory and technical personnel engaged in the Regulatory
Activities, (ii) the fees and other amounts to be paid to
Regulatory Authority in connection therewith, and (iii) the costs
associated with any Post-Filing Activities or Post-Approval
Studies.
1.92 "
Regulatory Approval ". Regulatory Approval shall
mean all the governmental and regulatory approvals required to
Commercialize Product for a particular indication in a particular
country, including any permit, authorization, license or approval
(or waiver) from any Regulatory Authority required for the
Commercialization of Product and separate pricing and/or
reimbursement approvals from Regulatory Authorities even if not
legally required for the Commercialization of Product.
1.93 "
Regulatory Authority ". Regulatory Authority shall mean any
federal, national, multinational, state, provincial or local
regulatory agency, department, bureau or other governmental entity
with authority over the clinical trial, marketing and/or sale of a
pharmaceutical product in a country, including FDA in the United
States and PMDA in Japan.
1.94 "
Regulatory Exclusivity ". Regulatory Exclusivity
shall have the meaning given to that term under Section
8.6.
1.95 "
Regulatory Filings ". Regulatory Filings shall mean all the
applications and registrations, including any INDs, submitted to
any Regulatory Authority with respect to Product to obtain the
Regulatory Approval of the Product in a country.
1.96 "
Related Party ". Related Party shall mean any of a Party's
Affiliates and Sublicensees.
1.97 "
Royalty Term ". Royalty Term shall be the
time-period during which CMIC shall pay royalties to Dyax under
Section 7.5(b).
1.98 "
Safety Data ". Safety Data shall mean adverse
event or adverse experience information, as defined under 21 C.F.R.
§600.80 or ICH Guidelines, as applicable, or their equivalent
under any other applicable law, and other information regarding
health risks posed by Product, including Complaints.
1.99 "
Sole Inventions ". Sole Inventions shall have the
meaning given to that term under Section 8.1(b).
1.100 "
Specifications ". Specifications shall mean the
specifications, including the necessary documentation, certificates
of analysis and test results, for Drug Substance and Drug Product,
as mutually agreed upon by the Parties. For the sake of
clarity, the Specifications for Drug Substance and Drug Product may
vary by country, depending on the countries in which Product is
Developed or in which Product is Commercialized.
1.101 "
Sublicensee ". Sublicensee shall mean any Third
Party to whom a license or sublicense under any Dyax Intellectual
Property or CMIC Intellectual Property, as the case may be, has
been granted pursuant to this Agreement to Develop, Manufacture or
Commercialize products containing Compound.
1.102 "
Sublicensee Development Data ". Sublicensee Development Data
shall, as it pertains to Product or its use, mean all the
pharmacology and toxicology data and information, pre-clinical
study data, clinical trial data, protocols, safety data, quality
data and other regulatory information and reports, whether in
written or electronic form, generated or developed
by Sublicensee of either Party, in the course of
performing activities under this Agreement during the
Term.
1.103 "
Subsidiary ". Subsidiary shall mean any Person
(a) of which CMIC or Dyax (as applicable) is the direct or indirect
owner of over fifty percent (50%) of the voting share capital or
ownership interest, and/or (b) of which CMIC or Dyax (as
applicable) has the ability to control the policies (or to control
the recruitment and dismissal of the management who determine the
policies) through a voting agreement or other contract or through
the articles of association, bylaws or other internal
regulations.
1.104 " Supply
Agreement ". Supply Agreement shall have the meaning
given to that term under Section 6.5.
Confidential materials omitted
and filed separately with the Securities and Exchange
Commission. Asterisks denote such omission.
1.105 " Surgical
Field ". Surgical Field shall mean use of a product
to prevent or treat bleeding during the conduct of any procedure
involving the use of instruments (including lasers) to cut, abrade,
suture or otherwise physically change body tissues and/or
organs. Notwithstanding anything to the contrary,
Surgical Field shall specifically exclude all uses in the treatment
of HAE and/or other angioedemas (even during surgery).
1.106 " Term
". Term shall have the meaning given to that term under
Section 12.1.
1.107 "
Territory ". Territory shall mean CMIC Territory
or Dyax Territory, as the context requires.
1.108 " Third
Party ". Third Party shall mean any Person other
than Party or any of its Affiliates.
1.109 " Transfer
Price ". Transfer Price shall mean, with respect to
any amount of the Drug Substance or Drug Product delivered to CMIC
by Dyax for use in the Development, Manufacture or
Commercialization of Product, the [******].
1.110 " United
States ". The United States shall mean the United
States of America and its territories and possessions.
1.111 " Valid
Claim ". Valid Claim shall mean a claim (a) of any
issued, unexpired patent that has not been revoked or held
unenforceable or invalid by a decision of a court or governmental
agency of competent jurisdiction from which no appeal can be taken,
or with respect to which an appeal is not taken within the time
allowed for the appeal, and that has not been disclaimed or
admitted to be invalid or unenforceable through reissue, disclaimer
or otherwise or (b) of any patent application that has not been
cancelled, withdrawn or abandoned or been pending for
[******].
ARTICLE II
MANAGEMENT OF AGREEMENT
ACTIVITIES
2.1
Joint Steering Committee .
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Formation;
Purposes and Principles . As soon as practicable after the
Effective Date, Dyax and CMIC shall establish a joint steering
committee (the " JSC "), which shall have the overall
responsibility for the oversight of the Parties' activities in
Field in accordance with the terms of this Agreement.
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Specific
Responsibilities . In addition to its overall
responsibility for such oversight, the JSC shall in
particular:
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review, discuss
and agree on the Development activities of CMIC under any
Development Plan, including without limitation, the clinical study
endpoints, clinical methodology, monitoring and analysis
requirements for the clinical studies described in any Development
Plan;
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review and
approve the updates by CMIC to each Development Plan not less than
annually;
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review, discuss
and agree on the strategy to seek and obtain Regulatory Approval of
Product, as well as the related pricing and reimbursement
approvals, in Field in CMIC Territory;
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review and
monitor the progress in seeking and obtaining Regulatory Approval
of Product, as well as the related pricing and reimbursement
approvals, in Field in CMIC Territory;
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review, discuss
and agree on the Trademarks that shall be used in connection with
the Commercialization of Products in Field in CMIC
Territory;
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Confidential materials omitted
and filed separately with the Securities and Exchange
Commission. Asterisks denote such omission.
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review, discuss
and comment on the Commercialization plans and strategies for
Product in Field in CMIC Territory;
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review, discuss
and comment on CMIC's order forecasts and commercial supply
requirements for Product;
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facilitate the
exchange of data, information, materials and results that may be
required for the purposes of obtaining Regulatory Approvals for
Product in Field in CMIC Territory; and
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perform such
other functions as are expressly provided for elsewhere in this
Agreement or as are appropriate to further the purposes of this
Agreement as determined by the Parties, including the periodic
evaluations of performance against goals under this
Agreement.
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2.2
Working Groups . From time to time, the JSC may
establish working groups (each, a " Working Group ") to
oversee the particular projects or activities hereunder, and each
Working Group shall be constituted and shall operate as the JSC
determines.
2.3
Membership . Each of the JSC and any Working
Group shall be composed of an equal number of representatives
appointed by each of Dyax and CMIC. The JSC shall
initially have three (3) representatives of each Party, but the JSC
may change its size of the JSC from time to time by the mutual
consent of the members of the JSC. Each Party may
replace its JSC and Working Group representatives at any time upon
written notice to the other Party. The JSC shall be chaired by a
representative of Dyax. The JSC chairperson shall be
responsible for calling its meetings, preparing and circulating an
agenda for the JSC meeting in advance of the meeting, and preparing
and issuing the minutes of the meeting within
[******]thereafter. The JSC meetings shall be called by
its chairperson upon the request of either Party.
2.4
Decision-Making . The JSC and any Working Group
shall [******]. With respect to the decisions of the JSC
and any Working Group, the representatives of each Party shall have
collectively one vote on behalf of such Party. Should
the members of a Working Group maintain their disagreement on any
matter [******].
2.5
Meetings of the JSC and Working Groups . The JSC
and each Working Group shall hold meetings at such times as the JSC
and such Working Group may determine, but in no event shall the
meetings of the JSC be held less frequently than
[******]. The JSC and any Working Groups shall meet
alternately at Dyax's facilities in Cambridge, Massachusetts, USA
and CMIC's facilities in Tokyo, Japan or at such locations as the
Parties may otherwise agree. Other representatives of
each Party or, with approval of the JSC and subject to the
confidentiality and limited-usage obligations which are no less
stringent than those set forth in Article IX of this Agreement,
representatives of Third Parties involved in the Development,
Manufacture or Commercialization of Product (or the conduct of
Regulatory Activities relating thereto), may attend the meetings of
the JSC or such Working Group as nonvoting
observers. Meetings of the JSC and any Working Groups
may be held by audio or video teleconference with the consent of
each Party. Each Party shall be responsible for all of
its own costs and expenses of participating in the JSC and any
Working Groups. No action taken at a meeting of the JSC
or a Working Group shall be effective unless a representative of
each Party is present or participating in the meeting.
2.6
Alliance Managers . Each Party shall designate a
single alliance manager, who may be a member of the JSC and/or any
Working Group (the " Alliance Manager "), for all of the
activities contemplated under this Agreement. The
Alliance Managers shall be responsible for the day-to-day worldwide
coordination of the activities contemplated by this Agreement and
shall serve to facilitate communication between the
Parties. The Alliance Managers shall have the experience
and knowledge appropriate to manage such project management
responsibilities. Each Party may change its designated
Alliance Manager from time to time upon written notice to the other
Party.
2.7
Third Party Performance of Agreement Activities .
CMIC shall be entitled to utilize the services of
Third Parties to Develop, Manufacture (to the extent permitted
under Article VI) and Commercialize Product (and conduct Regulatory
Activities in connection therewith) under the following
conditions:
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any use of such
Third Party that is Product Competitor shall be subject to Dyax's
prior written approval;
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Confidential materials omitted
and filed separately with the Securities and Exchange
Commission. Asterisks denote such omission.
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CMIC shall
remain at all times fully liable for its responsibilities under
this Agreement;
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CMIC shall not
use any Third Party to conduct part or all of its obligations under
this Agreement unless CMIC's rights under its agreement with such
Third Party guarantee Dyax the same rights under this Agreement, as
guaranteed as if CMIC had conducted such obligations;
and
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any of
CMIC’s agreements with such Third Parties shall provide for
confidentiality and limited-usage obligations imposed on such Third
Parties, which are no less stringent than those set forth in
Article IX of this Agreement.
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ARTICLE III
LICENSE GRANTS; TRANSFERS AND
ASSIGNMENTS
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Grant of
Rights for Development. Subject to the terms and conditions of this
Agreement, Dyax hereby grants to CMIC an exclusive license under
Dyax Intellectual Property, with the right to grant sublicenses
solely as set forth in Section 3.1(d), to Develop, have Developed
and conduct Regulatory Activities for Compound and Product for use
in Field in CMIC Territory. Notwithstanding the
foregoing, the exclusive license granted by Dyax to CMIC under this
Section 3.1(a) does not exclude or limit the right of Dyax to use
and exploit itself Dyax Intellectual Property according to this
Agreement, or to license Dyax Intellectual Property to Third
Parties to Develop Compound or Product for use in Field in CMIC
Territory, in either case to the extent necessary for Dyax to
perform its obligations under this Agreement.
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Grant of
Rights for Manufacture . Subject to the terms and conditions
of this Agreement, Dyax hereby grants to CMIC an exclusive license
under Dyax Intellectual Property, with the right to grant
sublicenses solely as set forth in Section 3.1(d), to Manufacture
and have Manufactured Drug Substance and Drug Product for use by or
on behalf of CMIC, its Affiliates, Sublicensees and Third Party
contractors for the Development and Commercialization of Product in
Field in CMIC Territory; provided that, except for Manufacturing
activities to package and label Product for use in Field in CMIC
Territory (which activities shall be conducted by CMIC at its cost
and expense), CMIC shall not exercise any of the rights granted to
it under this Section 3.1(b) unless and until CMIC exercises its
step-in rights in accordance with Article VI hereof .
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Grant of
Rights for Commercialization. Subject to the terms and conditions
of this Agreement, Dyax hereby grants to CMIC an exclusive license
under Dyax Intellectual Property, with the right to grant
sublicenses solely as set forth in Section 3.1(d), to Commercialize
Product for use in Field in CMIC Territory.
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Sublicense
Rights . CMIC
shall be entitled to grant sublicenses under the licenses granted
to it under Sections 3.1(a), (b) and (c) to its Affiliates and to
Third Parties under the following conditions:
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CMIC may only
grant a sublicense [******]:
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For clarity,
any Know-How and Patent Rights so assigned or licensed to CMIC by
any such Affiliate or Third Party shall be deemed to be CMIC
Intellectual Property hereunder;
Confidential materials omitted
and filed separately with the Securities and Exchange
Commission. Asterisks denote such omission.
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Each permitted
sublicense under this Section 3.1(d) shall be in writing, shall not
contravene or be inconsistent or in conflict with the terms of this
Agreement and shall include the provisions requiring the applicable
Sublicensee to acknowledge and agree that such sublicense is
subject to the applicable license(s) granted hereunder and to the
relevant terms of this Agreement;
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CMIC shall at
all times remain responsible for the performance of its
Sublicensees in relation to the sublicenses granted to the
Sublicensees under Section 3.1 (d) and
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CMIC shall
provide, or cause to be provided, to Dyax a copy of each such
sublicense agreement [******]; provided that CMIC shall have the
right to redact any terms contained in such sublicense agreement
that are not material to Dyax's assessment of whether the
sublicense agreement complies with the requirements of this Section
3.1(d).
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Subject to the
terms and conditions of this Agreement, CMIC hereby grants to Dyax
a non-exclusive, fully paid, royalty-free license, with the right
to grant sublicenses solely as set forth in Section 3.2(b), under
CMIC Intellectual Property, to Develop, conduct Regulatory
Activities for, Manufacture and Commercialize Compound or Product
(i) in Field in Dyax Territory, and (ii) outside Field in all
countries of the world.
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Dyax shall be
entitled to grant sublicenses under the non-exclusive licenses
granted to it under to Section 3.2(a) to its Affiliates and to
Third Parties under the following conditions:
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Each permitted
sublicense under this Section 3.2(b) shall be in writing, shall not
contravene or be inconsistent or in conflict with the terms of this
Agreement, and shall include the provisions requiring the
applicable Sublicensee to acknowledge and agree that such
sublicense is subject to the applicable license(s) granted
hereunder and to the relevant terms of this Agreement;
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Dyax may only
grant a sublicense to [******]:
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For clarity,
any Patent Rights or Know-How so licensed or assigned to Dyax by
any such Affiliate or Third Party shall be deemed to be Dyax
Intellectual Property hereunder;
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Dyax shall at
all times remain responsible for the performance of its
Sublicensees; in relation to the sublicenses granted to the
Sulicensees under Section 3.2 (b) (ii) and
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Dyax shall
provide, or cause to be provided, to CMIC a copy of each such
sublicense agreement promptly following its execution; provided
that Dyax shall have the right to redact any terms contained in
such sublicense agreement that are not material to CMIC's
assessment of whether the sublicense agreement complies with the
requirements of this Section 3.2(b).
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3.3
Retained Rights . Any rights of a Party that are
not expressly granted by such Party to the other Party under this
Agreement shall be retained by such Party. Furthermore, if any
right which is granted by a Party to the other Party is expressly
restricted or limited under this Agreement, then any right outside
of the scope of such restriction or limitation shall also be
retained by such Party. Without limiting the generality
of the immediately preceding sentence, Dyax shall retain the right
to (i) exploit and license Dyax Intellectual Property to Develop,
Manufacture and Commercialize Compound and Product for use in Field
in Dyax Territory, without any duty to account to CMIC or to obtain
CMIC's consent for such exploitation or license; (ii) exploit and
license Dyax Intellectual Property to Develop, Manufacture and
Commercialize Compound and Product outside Field in CMIC Territory,
without any duty to account to CMIC or obtain CMIC's consent for
such exploitation or license, (iii) exploit Dyax Intellectual
Property for the purposes unrelated to Compound or Product without
any duty to account to CMIC or obtain CMIC's consent for such
exploitation or license, and (iv) otherwise exercise Dyax's rights
and perform Dyax's obligations under this Agreement.
Confidential materials omitted
and filed separately with the Securities and Exchange
Commission. Asterisks denote such omission.
3.5
Scope of Agreement; Activities in the Dyax Territory
. The Parties acknowledge and agree that, unless
otherwise expressly stated herein:
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this Agreement
sets forth the terms and conditions pursuant to which (i) CMIC
shall Develop and seek Regulatory Approval for Product in Field in
CMIC Territory, and (ii) CMIC shall Manufacture and Commercialize
Product in Field in CMIC Territory; and
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the activities
of Dyax to Develop, seek Regulatory Approval for, Manufacture
and/or Commercialize Compound and/or Product in Field in Dyax
Territory and outside Field in all countries of the world shall be
outside the scope of this Agreement and under the sole
responsibility of Dyax at its cost and expense.
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3.6
Right of Second Offer; China . In the event that
Dyax has first offered to Defiante Farmaceutica S.A.
(“Defiante”) certain terms and conditions (the
“Original Terms”) of a license to Develop, Manufacture
and/or Commercialize Product in the People’s Republic of
China, and if the Original Terms have not been accepted by
Defiante within [******] of such offer or if the Original
Terms have been accepted by Defiante within such [******] period,
however, a final and definite agreement on the full terms and
conditions of such license have not been executed by Dyax and
Defiante within [******] of such offer, Dyax shall secondly offer
the Original Terms to CMIC (t