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PRODUCT DEVELOPMENT AND LICENSE AGREEMENT

Technology License Assignment Agreement

PRODUCT DEVELOPMENT AND LICENSE AGREEMENT | Document Parties: DYAX CORP | CMIC Co Ltd You are currently viewing:
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DYAX CORP | CMIC Co Ltd

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Title: PRODUCT DEVELOPMENT AND LICENSE AGREEMENT
Governing Law: Massachusetts     Date: 11/2/2010
Industry: Biotechnology and Drugs     Sector: Healthcare

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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-


 

 

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.

 

 

-2-


 

 

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:

 

 

(a)

Manufacturing Costs for obtaining the Drug Substance and/or Drug Product to be used for the Development of Product;

 

 

(b)

costs of the studies on the preclinical, toxicological, pharmacokinetic, metabolic, clinical and/or stability aspects of Compound or Product;

 

 

(c)

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;

 

 

(d)

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

 

 

(e)

the fully allocated costs of internal clinical, regulatory, scientific, or technical personnel engaged in such Development.

 

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.

 

 

-3-


 

 

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:

 

 

(a)

[******]; and

 

 

(b)

[******].

 

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:

 

 

(i)

[******];

 

 

(ii)

[******]; and

 

 

(iii)

[******].

 

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.

 

 

-4-


 

 

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.

 

 

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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:

 

 

(a)

the costs for [******]; and

 

 

(b)

[******].

 

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.

 

 

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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.

 

1.87         [******]

 

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.

 

 

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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.

 

 

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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 .

 

 

(a)

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.

 

 

(b)

Specific Responsibilities .  In addition to its overall responsibility for such oversight, the JSC shall in particular:

 

 

(i)

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;

 

 

(ii)

review and approve the updates by CMIC to each Development Plan not less than annually;

 

 

(iii)

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;

 

 

(iv)

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;

 

 

(v)

review, discuss and agree on the Trademarks that shall be used in connection with the Commercialization of Products in Field in CMIC Territory;

 

Confidential materials omitted and filed separately with the Securities and Exchange Commission.  Asterisks denote such omission.

 

 

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(vi)

review, discuss and comment on the Commercialization plans and strategies for Product in Field in CMIC Territory;

 

 

(vii)

review, discuss and comment on CMIC's order forecasts and commercial supply requirements for Product;

 

 

(viii)

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

 

 

(ix)

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.

 

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:

 

 

(a)

any use of such Third Party that is Product Competitor shall be subject to Dyax's prior written approval;

 

Confidential materials omitted and filed separately with the Securities and Exchange Commission.  Asterisks denote such omission.

 

 

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(b)

CMIC shall remain at all times fully liable for its responsibilities under this Agreement;

 

 

(c)

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

 

 

(d)

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.

 

ARTICLE III

LICENSE GRANTS; TRANSFERS AND ASSIGNMENTS

 

3.1          Dyax Grants .

 

 

(a)

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.

 

 

(b)

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 .

 

 

(c)

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.

 

 

(d)

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:

 

 

(i)

[******];

 

 

(ii)

CMIC may only grant a sublicense [******]:

 

 

(A)

[******]; or

 

 

(B)

[******].

 

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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(iii)

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;

 

 

(iv)

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

 

 

(v)

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).

 

3.2          Grant Back License .

 

 

(a)

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.

 

 

(b)

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:

 

 

(i)

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;

 

 

(ii)

Dyax may only grant a sublicense to [******]:

 

 

(A)

[******]; or

 

 

(B)

[******].

 

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;

 

 

(iii)

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

 

 

(iv)

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).

 

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.

 

 

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3.4         [******].

 

3.5          Scope of Agreement; Activities in the Dyax Territory .  The Parties acknowledge and agree that, unless otherwise expressly stated herein:

 

 

(a)

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

 

 

(b)

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.

 

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 (the “Second Offer”).  The Original Terms shall set forth [******].  Within [******] following its receipt of the Second Offer, CMIC shall notify Dyax in writing of whether it wishes to obtain such license on the Original Terms.  If CMIC does wish to obtain such license on the Original Terms, the Parties shall negotiate in good faith for a period of [******] regarding any additional terms and conditions (other than those set forth herein) applicable to such license.  If CMIC does not wish to obtain such license on the Original Terms or if the Parties fail to execute a final and definite agreement on the full terms and conditions of such license within such [******] period, Dyax shall be free to offer such license to any other Person, provided, however, that the terms and conditions so offered to such other Person should not be more favorable to such other Person than the Original Terms.  If CMIC does wish to obtain such license on the Original Terms and the Parties has executed a final and definite agreement on the full terms and conditions of such license within such [******] period, then all the terms and conditions of such license shall be deemed to be part of this Agreement.  Furthermore, CMIC Territory shall thereafter include the People's Republic of China.

 

Confidential materials omitted and filed separately with the Securities and Exchange Commission.  Asterisks denote such omission.

 

 

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ARTICLE IV

DEVELOPMENT AND REGULATORY MATTERS

 

4.1          HAE Development Plan . As soon as practicable after [******], the JSC shall convene to review and discuss the activities that are necessary to obtain Regulatory Approval of Product for the treatment of HAE in CMIC Territory.  Following this process, but in any event no later than [******] after the first day of the first JSC meeting for the HAE Indication, CMIC and Dyax shall jointly complete, and the JSC shall approve, a formal plan to obtain Regulatory Approval for Product in CMIC Territory for the HAE Indication (the " HAE Development Plan ").  The HAE Development Plan shall set forth all the activities that are necessary to obtain Regulatory Approval of Product for the treatment of HAE in CMIC Territory as well as the strategies and timelines for completing such activities.

 

4.2          Development Plan for Other Angioedema Indications . As soon as practicable after [******], the JSC shall convene to review and discuss the activities that are necessary to Develop and obtain Regulatory Approval of Product for the treatment of such Other Angioedema in CMIC Territory.  Following this process, as soon as it is practicable after the first JSC meeting for such Other Angioedema Indication, CMIC and Dyax shall jointly complete, and the JSC shall approve, a formal plan to Develop and obtain Regulatory Approval for Product in CMIC Territory for such Other Angioedema Indication (each, an " Other Angioedema Development Plan ").  Each Other Angioedema Development Plan shall set forth all the activities that are necessary to obtain Regulatory Approval of Product for the treatment of such Other Angioedema in CMIC Territory as well as the strategies and timelines for completing such activities.

 

4.3          Roles and Responsibilities .

 

 

(a)

Development Activities . CMIC shall assume all the authority and responsibility for all the activities conducted relating to the Development of Product for any Indication in Field in CMIC Territory; provided that the JSC shall review and monitor such activities in accordance with Section 2.1(b) and the following process:

 

 

(i)

CMIC shall review and update each Development Plan from time to time (but not less frequently than annually) to include therein any additional activities required by any Regulatory Authority in CMIC Territory, up until filing of the application for Regulatory Approval of Product for the applicable Indication in CMIC Territory or the completion of the activities covered thereunder;

 

 

(ii)

CMIC shall submit all such proposed updates to the JSC for review and approval at the first JSC meeting after such proposal; and

 

 

(iii)

the JSC shall review such proposed updates and may approve such proposed updates and, upon such approval by the JSC, the HAE Development Plan shall be amended accordingly.

 

 

(b)

Regulatory Activities . CMIC shall assume all the authority and responsibility for all Regulatory Activities relating to Product for any Indication in Field in CMIC Territory; provided that the JSC shall review and monitor such activities in accordance with Section 2.1(b).   In connection with any such Regulatory Activities, Dyax shall, upon CMIC's request, promptly provide CMIC with any Dyax Development Data that is reasonably deemed to be necessary or useful for Regulatory Approval of Product in Field in CMIC Territory.  For the avoidance of doubt, CMIC shall be the holder of all the Marketing Authorization Applications filed in CMIC Territory. CMIC may have its Affiliate hold the Marketing Authorization Application and Regulatory Approval of Product in Field in CMIC Territory.

 

 

(c)

Reformulation .  Notwithstanding anything to the contrary contained herein, any Development or other activities relating to the reformulation of Product (including the activities conducted under any Development Plan) shall be conducted by Dyax.

 

Confidential materials omitted and filed separately with the Securities and Exchange Commission.  Asterisks denote such omission.

 

 

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4.4          Diligent Development Efforts

 

 

(a)

CMIC shall use [******] to Develop and obtain Regulatory Approval for Product in the HAE Indication according to the HAE Development Plan and in any Other Angioedema Indication according to the Other Angioedema Development Plan approved by the JSC for such Indication in CMIC Territory. For the purpose of this Section 4.4(a), CMIC’s [******] shall be deemed satisfied by the performance of at least one of the following events in each Calendar Year during the Term with respect to each such Indication: [******].

 

 

(b)

Without limiting the generality of Section 4.4(a), CMIC (directly or through its Related Parties) shall, subject to the provisions of Section 4.4(c) and Section 4.4(d), achieve the following specific development milestones for Product in the HAE Indication in CMIC Territory.

 

Milestone Event

 

Deadline

 

 

 

[******]

 

[******]

 

 

 

[******]

 

[******]

 

Each date indicated in this Section 4.4(b) (and any subsequent dates reflecting an extension permitted hereunder) shall be extended automatically to reflect any delay in the achievement of the applicable milestone attributable to External Factors.  For the purposes of this Section 4.4(b), an “External Factor” shall mean that one or more of the following events or circumstances, which has delayed the Development of Product in the HAE Indication in CMIC Territory, has occurred in the Development, Manufacturing or regulatory conditions relating to Product; provided that such events or circumstances were not caused by the negligent act or omission of CMIC or any of its Related Parties:  [******].  The relevant date(s) in this Section 4.4(b) (and any subsequent dates reflecting an extension permitted hereunder) shall be extended by the number of days to be agreed upon by the Parties reasonably based upon the JSC’s reasonable assessment of the period of time required to reach the applicable milestone event in light of the relevant External Factors.

 

 

(c)

In addition to the foregoing, CMIC may extend the period for completion of any milestone event described in Section 4.4(b) above by up to [******], upon prior written notice to Dyax and the payment to Dyax of a monthly extension fee of [******] for each such [******] extension.

 

 

(d)

If CMIC fails to meet its obligations under Section 4.4(b) in any material respect, then Dyax shall have, as its sole and exclusive remedy for such failure by CMIC, the right to terminate this Agreement pursuant to Section 12.2(a).

 

4.5          Manner of Performance; Reports .

 

 

(a)

CMIC shall perform, or cause to be performed, all of the Development activities for which it is responsible under this Agreement, in good scientific manner and in compliance with all the applicable laws and regulations and good clinical and laboratory practices.

 

 

(b)

CMIC agrees to keep Dyax fully informed of its progress in, results (including the development of any technology or inventions) of, status on and plans for developing Product in Field in CMIC Territory.

 

 

(c)

Within [******] after the end of each Calendar Quarter in which the Development activities are performed by CMIC and at least [******] prior to the quarterly meeting of the JSC, CMIC shall provide to the JSC a written progress report, which shall describe the Development activities that CMIC has performed or caused to be performed during such Calendar Quarter, shall evaluate the works performed in relation to the goals and timelines established under the applicable Development Plan, and shall provide such other information as may be reasonably requested by the JSC with respect to such Development activities.

 

Confidential materials omitted and filed separately with the Securities and Exchange Commission.  Asterisks denote such omission.

 

 

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4.6            Exchange of Development Information .  In accordance with and subject to the terms of Article IX, on an ongoing basis during the Term:

 

 

(a)

Dyax shall, [******], disclose and transfer to CMIC an electronic copy of the Common Technical Document for Product in the HAE Indication.  Furthermore, within [******], Dyax shall disclose and transfer to CMIC all other Dyax Development Data necessary or useful to the Development of Compound or Product for use in Field in CMIC Territory and shall update such Dyax Development Data and disclose and transfer such updated Dyax Development Data to CMIC at least once semi-annually.  Dyax acknowledges and agrees that all the data generated in connection with the Development activities conducted by Dyax and/or its Related Parties with respect to Compound or Product in Field may be used by CMIC to obtain the Regulatory Approval for Product in Field in CMIC Territory.

 

 

(b)

CMIC shall [******] disclose and transfer to Dyax all the CMIC Development Data necessary or useful to the Development of Compound or Product for use in Field in  Dyax Territory or outside Field in any country in the world and shall update such CMIC Development Data and disclose and transfer such updated CMIC Development Data to Dyax at least [******].  CMIC acknowledges and agrees that all such data may be used by Dyax to obtain the Regulatory Approval for Product in Field in Dyax Territory or outside Field in any country of the world.

 

 

(c)

Upon reasonable notice during normal business hours as coordinated through the Alliance Managers and the JSC, each Party shall provide the other Party with such assistance and access to its employees, consultants and subcontractors as may be reasonably necessary for such other Party to exercise its rights and perform its obligations with respect to the Development, Regulatory Activities, Manufacture and/or Commercialization of Product under this Agreement.

 

4.7            Regulatory Submissions and Regulatory Approvals .

 

 

(a)

CMIC shall own, and may have its Affiliate own, all the Regulatory Filings and Regulatory Approvals for Product in Field in CMIC Territory, and shall be responsible for the Regulatory Activities for Product in Field in CMIC Territory; provided that, unless Dyax otherwise agrees in good faith, any Regulatory Filings for Product in the HAE Indication in CMIC Territory shall be consistent (to the extent permitted by the applicable law) with the Regulatory Filings for Product in the HAE Indication in the United States. If permitted under the Japanese laws, Dyax and its Related Parties shall have the right to access all the data contained or referenced in such Regulatory Filings, including all reports, correspondence and conversation logs (“Access and Reference Rights”), and CMIC shall provide appropriate notification of Dyax's and its Related Parties' Access and Reference Rights to the related Regulatory Authorities. Again, if permitted under the Japanese laws, CMIC hereby grants, and shall ensure that its Related Parties grant, to Dyax a "Right of Reference or Use," as that term is defined in 21 C.F.R. §314.3(b) as amended from time to time, and any foreign equivalents thereto, to any and all the data contained or referenced in any such Regulatory Filing, including all reports, correspondence and conversation logs, and CMIC shall provide appropriate notification of Dyax's and its Related Parties' Access and Reference Rights to the related Regulatory Authorities.   Notwithstanding the foregoing, CMIC agrees that Dyax shall have the right to access all the data contained or referenced in such Regulatory Filings, through CMIC, to the same extent that CMIC or its Related Parties is granted such access.

 

 

(b)

Dyax shall own all the Regulatory Filings and Regulatory Approvals for Compound and for Product (i) in Field in Dyax Territory and (ii) outside Field in any country of the world, and shall be responsible for all the Regulatory Activities (i) in Field in Dyax Territory and (ii) outside Field in any country of the world.  CMIC and its Related Parties shall have the right to access all the data contained or referenced in such Regulatory Filings, including all reports, correspondence and conversation logs, to the extent applicable to use of Product in Field in CMIC Territory, and Dyax shall provide appropriate notification of CMIC's and its Related Parties’ Access and Reference Rights to the related Regulatory Authorities.  Dyax hereby grants, and shall ensure that its Related Parties grant, to CMIC a "Right of Reference or Use," as that term is defined in 21 C.F.R. §314.3(b) as amended from time to time, and any foreign equivalents thereto, to any and all data contained or referenced in any such Regulatory Filings, including all reports, correspondence and conversation logs, and Dyax shall provide appropriate notification of CMIC's and its Related Parties' Access and Reference Rights to the related Regulatory Authorities.

 

Confidential materials omitted and filed separately with the Securities and Exchange Commission.  Asterisks denote such omission

 

 

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4.8            Complaints; Adverse Event Reporting Procedures; Notice of Adverse Events Affecting Compound .

 

 

(a)

Each Party may and shall have access to all the Complaints and Safety Data generated by the other Party and/or its Related Parties and contractors in connection with the Development, Regulatory Activities, Manufacture and Commercialization of Product, subject to and to the extent provided for in this Agreement.

 

 

(b)

Each Party shall maintain a record of any and all the Complaints and Safety Data it receives with respect to Product.  Each Party shall notify the other Party in reasonable detail of any Complaint or Safety Data received by such Party with respect to Product within sufficient time to allow such other Party and/or its Related Parties to comply with any and all regulatory and other requirements imposed upon them in any jurisdiction in which or for which such Product is being Developed in clinical studies or Commercialized.

 

 

(c)

Each Party shall require its Related Parties to provide it with all the Complaints and Safety Data relating to Product which they receive. Each Party shall provide the other Party with all the Complaints and Safety Data which it receives relating to Product and which is necessary or desirable for the other Party to comply with all the applicable laws, rules and regulations with respect to Product.  Each Party shall provide such information to the other Party within [******] after its first receipt; provided that any information relating to a serious adverse experience (SAE), as that term is defined at 21 C.F.R. §600.80, in the ICH Guidelines and/or in the Directive 2001/83/EC, shall be provided to the other Party by such party within [******] after such party initially receives it.  The Party providing Complaints or Safety Data shall make all reasonable efforts to assist the receiving Party with any follow-up investigation necessary to comply with applicable laws, rules and regulations with respect to Product.

 

 

(d)

Dyax shall maintain, or Dyax shall enter into an Agreement with a Third Party to maintain, a global adverse event database for Product (the " AE Database ") and shall record any and all Complaints and Safety Data, which Dyax  receives in relation to Product, in the AE Database for CMIC's use in CMIC Territory. CMIC shall have access to all data in the AE Database.

 

 

(e)

With respect to Product in Field in CMIC Territory, CMIC shall be responsible for submitting adverse event reports to the applicable Regulatory Authorities.  With respect to Product in Field in Dyax Territory and outside Field in all countries of the world, Dyax shall be responsible for submitting adverse event reports to the applicable Regulatory Authorities.

 

 

(f)

Within [******], the Parties shall develop and agree in writing upon the safety data exchange procedures governing the coordination of collection, investigation, reporting, and exchange of the information concerning any adverse experiences, and any product quality and product complaints involving adverse experiences, and any other Complaints and Safety Data, related to Product, sufficient to enable each Party to comply with its legal and regulatory obligations (the " Pharmacovigilance Agreement "). Dyax shall execute pharmacovigilance agreements with any of CMIC’s future Related Parties involved in the Development, Manufacture or Commercialization of Product.  Such pharmacovigilance agreements shall conform in all material respects with the Pharmacovigilance Agreement to be executed by and between Dyax and CMIC.

 

 

(g)

The Parties acknowledge and agree that all the safety data maintained in the AE Database for Product may be used by both Parties and their respective Related Parties (i) to obtain all the applicable Regulatory Approvals in accordance with the terms of this Agreement and (ii) in connection with any litigation relating to Product.

 

Confidential materials omitted and filed separately with the Securities and Exchange Commission.  Asterisks denote such omission

 

 

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4.9            Audits .  CMIC shall, and shall require its Related Parties to, keep the true and accurate records containing all CMIC Development Data.  Such records shall be kept by CMIC and its Related Parties during the periods required by the applicable laws and regulations, provided that such periods should not be shorter than [******] following the end of the calendar year to which they relate.  Upon [******] prior written notice to CMIC, Dyax and its Related Parties (or any Person contracted by Dyax) shall be permitted by CMIC, during normal business hours, to inspect such records and any facilities used by CMIC or its Related Parties in connection with the Development, Manufacture and Commercialization of Product for the purpose of ensuring that such activities are conducted in accordance with the applicable laws and regulations and in conformity with this Agreement.  The notice provided by Dyax to CMIC with respect to any such inspection shall indicate the nature and scope of any such inspection. Dyax shall be responsible for all the external costs associated with any such inspection, including the cost of translating any internal documents of CMIC or its Related Parties (if such translation is deemed to be necessary by Dyax).

 

ARTICLE V

COMMERCIALIZATION

 

5.1            Commercialization Efforts; Manner of Performance .

 

 

(a)

Following the Regulatory Approval of Product in any Indication in Field in CMIC Territory, CMIC shall use Commercially Reasonable Efforts to Commercialize Product in CMIC Territory in such Indication.

 

 

(b)

In connection with its obligation to use Commercially Reasonable Efforts to Develop, obtain the Regulatory Approval of and Commercialize Product in CMIC Territory in Field, CMIC acknowledges and agrees that it shall not engage in the clinical development, manufacture and/or commercialization of a therapeutic or prophylactic product that would compete, with Product in Field in CMIC Territory.  Notwithstanding the foregoing, the Parties understand that CMIC’s dominant business is a contracting business and that such contracting business could not affect the extent of such Commercially Reasonable Efforts regardless of any products or services which CMIC would provide as contractor on behalf of a third party. With such understanding, the Parties agree that this Agreement should not prevent CMIC from developing or manufacturing any products on behalf of a third party as CRO or CMO; although CMIC agrees that it shall not serve as a CRO with respect to Competitive Products until it completes enrollment of all subjects necessary to complete the clinical development of Product in the HAE Indication.

 

 

(c)

CMIC shall perform, or cause to be performed, all the Commercialization activities for which it is responsible under this Agreement in compliance with all the applicable laws and regulations.

 

5.2            Advertising and Promotional Materials .  CMIC shall be responsible, at its own cost and expense, for the creation, preparation, production, reproduction and filing with the applicable Regulatory Authorities, of the relevant written sales, promotion and advertising materials relating to Product (" CMIC Promotional Materials ") for Commercialization in Field in CMIC Territory.  All CMIC Promotional Materials shall be compliant in all material respects with all the applicable laws, rules and regulations and any guidelines established by the pharmaceutical industry in the applicable country in CMIC Territory.  When distributing the information related to Product or its use (including the information contained in scientific articles, reference publications and publicly available healthcare economic information), CMIC shall comply in all material respects with all the applicable laws, rules and regulations and any guidelines established by the pharmaceutical industry in the applicable country in CMIC Territory. [******].

 

Confidential materials omitted and filed separately with the Securities and Exchange Commission.  Asterisks denote such omission

 

 

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5.3            Sales and Distribution . CMIC and its Related Parties shall be responsible for booking sales of Product in Field in CMIC Territory and for all the aspects of the Product order processing, invoicing and collection, distribution, inventory and receivables, and for handling (at its own cost and expense) all returns, recalls, and other withdrawals of the Product sold for use in Field in CMIC Territory.  Dyax and its Related Parties shall be responsible for booking sales of Product in Field in Dyax Territory and outside Field in any country in the world and for all the aspects of the Product order processing, invoicing and collection, distribution, inventory and receivables, and for handling (at its own cost and expense) all returns, recalls, and other withdrawals of the Product sold for use in Field in Dyax Territory and outside Field in any country in the world.

 

5.4            Cross-Territory and Cross-Field Sales .  CMIC shall not, and shall ensure that its Related Parties agree not to, sell Product in Field in Dyax Territory or outside Field in any country in the world. If CMIC or any of its Related Parties receives any orders relating to use of Product in Field in Dyax Territory or outside Field in any country of the world, it shall refer such orders to Dyax.  Dyax shall be a third party beneficiary of the agreements between or among CMIC, its Affiliates, licensees, distributors and wholesalers with respect to such restriction, with the right to enforce such agreements. Furthermore, CMIC shall make Commercially Reasonable Efforts to restrict the ability of any Third Parties to export Product outside of CMIC Territory for sale and/or use in Field in Dyax Territory or outside Field in any country of the world.

 

5.5            Recalls and Market Withdrawals .  If any Regulatory Authority in CMIC Territory requests a recall or takes a similar action in connection with the Product being Developed, Manufactured or Commercialized by CMIC under this Agreement, or if either Party determines that an event, incident or circumstance has occurred that may result in the need for a recall or market withdrawal of such Product, the Party notified of such recall or similar action, or the Party that determines the need for such recall or market withdrawal, shall, within [******] of such notification or determination, advise the other Party thereof by e-mail, overnight courier or facsimile.  CMIC shall, in consultation with Dyax, determine whether to conduct a recall of Product in CMIC Territory and the manner in which any such recall shall be conducted (except in the case of a government mandated recall, when CMIC may act for such recall without such advance notice but shall notify Dyax thereof as soon as possible).  In the event that CMIC is responsible for such recall, CMIC shall bear the expense of such recall conducted in CMIC Territory.  In the event that Dyax is responsible for such recall, Dyax shall reimburse CMIC for the expense of such recall conducted by CMIC in CMIC Territory and shall repay CMIC for the amount in which CMIC has paid to Dyax for such recalled Product. Each Party shall make available to the other Party all of its pertinent records that may be reasonably requested in order to effect any such recall.

 

ARTICLE VI

MANUFACTURE AND SUPPLY OF DRUG PRODUCT

 

6.1            Manufacture of Drug Substance and Drug Product .  Dyax shall Manufacture Drug Substance and Drug Product for CMIC (or its designee) in sufficient quantities to satisfy the requirements of CMIC and its Related Parties for use in Developing, obtaining Regulatory Approval of, and Commercializing Product in Field in CMIC Territory pursuant to this Agreement; provided that such Manufacture by Dyax shall not include packaging and labeling (which shall be conducted by CMIC at its cost and expense) and that the foregoing obligation of Dyax to Manufacture Drug Substance and Drug Product shall be subject to the following terms and conditions:

 

 

(a)

Exclusivity .  Dyax shall be CMIC's sole and exclusive manufacturer of all Drug Substance and Drug Product requirements of CMIC and its Related Parties, unless otherwise agreed by Dyax in writing.

 

 

(b)

Forecasts .  Within [******] following the filing of the Marketing Authorization Application for Product in the HAE Indication in CMIC Territory, and within [******]following the commencement of each Calendar Quarter occurring thereafter, CMIC shall give to Dyax a forecast of Product supply requirements for the [******], determined in good faith and based upon commercially reasonable estimates of Product sales.  Each such forecast shall summarize the projected Product demand, inventory targets, and inventory levels (including the projected Drug Substance Inventory levels) and the estimated quantities of Drug Substance and Drug Product that CMIC expects to order, in accordance with Sections 6.1(c) and (e).

 

Confidential materials omitted and filed separately with the Securities and Exchange Commission.  Asterisks denote such omission

 

 

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(c)

Orders for Drug Substance; Delivery .

 

 

(i)

For quantities of Drug Substance required by CMIC, CMIC shall provide Dyax with binding purchase orders for Drug Substance.  CMIC may place no more than [******].

 

 

(ii)

Upon CMIC's issuance of a binding order for Drug Substance:

 

 

(A)

Each such order shall be considered accepted by and binding upon Dyax, unless such order exceeds the Drug Substance Order Limit for the relevant Calendar Quarter , in which case such order shall be considered accepted by Dyax unless Dyax provides written notice objecting to such order within [******] after Dyax's receipt of such order. In case of  objection, Dyax shall provide the quantity requested up to the Drug Substance Order Limit for the relevant Calendar Quarter and shall use [******]to


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