Form 10-Q/A MOMENTA PHARMACEUTICALS For: Mar 31

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, DC 20549

FORM 10-Q/A

Amendment No. 1

(MARK ONE)

x      QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the quarterly period ended March 31, 2016

or

o         TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the Transition Period from              to            

Commission File Number 000-50797

Momenta Pharmaceuticals, Inc.

(Exact name of registrant as specified in its charter)

(617) 491-9700

(Registrant’s telephone number, including area code)

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.  Yes x  No o

Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files).  Yes x   No o

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company. See definitions of “large accelerated filer,” “accelerated filer,” and “smaller reporting company” in Rule 12b-2 of the Exchange Act. (Check one):

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).  Yes o  No x

As of August 31, 2016, there were 70,983,760 shares of the registrant’s common stock, par value $0.0001 per share, outstanding.

EXPLANATORY NOTE

Momenta Pharmaceuticals, Inc. (the “Company”) is filing this Amendment No. 1 (this “Amendment”) to its Quarterly Report on Form 10-Q for the quarterly period ended March 31, 2016 (the “Original Form 10-Q”) as an exhibit-only filing in response to a comment letter received from the Securities and Exchange Commission regarding a request for confidential treatment of certain portions of Exhibit 10.2 to the Original Form 10-Q. This Amendment is being filed solely to re-file Exhibit 10.2 to remove the redaction of certain information. In addition, as required by Rule 12b-15 under the Securities Exchange Act of 1934, as amended, new certifications by our principal executive officer and principal financial officer are filed as exhibits to this Amendment.

This Amendment is limited in scope to the items identified above and should be read in conjunction with the Original Form 10-Q. This Amendment does not reflect events occurring after the filing of the Original Form 10-Q and no revisions are being made to the Company’s financial statements pursuant to this Amendment. Other than the filing of the information identified above, this Amendment does not modify or update the disclosure in the Original Form 10-Q in any way.

Item 6.    EXHIBITS

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*                                    Filed herewith.

**                             Furnished herewith.

***                      Previously filed or furnished with, or incorporated by reference in, the Original Form 10-Q.

+                                    Confidential treatment has been requested as to certain portions, which portions have been omitted and filed separately with the Securities and Exchange Commission.

The following materials filed with the Original Form 10-Q for the period ended March 31, 2016, formatted in XBRL (Extensible Business Reporting Language): (i) the Condensed Consolidated Balance Sheets at March 31, 2016 and December 31, 2015, (ii) the Condensed Consolidated Statements of Operations and Comprehensive Loss for the three months ended March 31, 2016 and 2015, (iii) the Condensed Consolidated Statements of Cash Flows for the three months ended March 31, 2016 and 2015, and (iv) Notes to Unaudited, Condensed Consolidated Financial Statements.

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SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.

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Exhibit 10.2

Confidential Treatment Requested by Momenta Pharmaceuticals, Inc.

Execution Copy

COLLABORATION AGREEMENT

BY AND BETWEEN

MOMENTA PHARMACEUTICALS, INC.

AND

MYLAN IRELAND LIMITED,

DATED AS

OF JANUARY 8, 2016

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for confidential treatment and have been filed separately with the Securities and Exchange Commission.

Confidential Treatment Requested by Momenta Pharmaceuticals, Inc.

TABLE OF CONTENTS

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for confidential treatment and have been filed separately with the Securities and Exchange Commission.

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COLLABORATION AGREEMENT

This Collaboration Agreement (the “Agreement”), executed as of January 8, 2016 (the “Execution Date”), is made by and between Momenta Pharmaceuticals, Inc., a Delaware corporation (“Momenta”), with a principal place of business at 675 West Kendall Street, Cambridge, Massachusetts 02142, and Mylan Ireland Limited, a limited company organized under the laws of Ireland (“Mylan”), with a principal place of business at South Bank House, Barrow Street, 6th Floor, Dublin 4, Ireland.  Momenta and Mylan may each be referred to individually as a “Party” or, collectively, the “Parties”.

RECITALS

The Parties desire to collaborate with respect to the development, manufacture and commercialization of a portfolio of biosimilar versions of certain reference brand biologic products, as described below.

In consideration of the premises set forth above and the mutual covenants contained herein, and other good and valuable consideration, the receipt and sufficiency of which is hereby acknowledged, Momenta and Mylan agree as follows:

ARTICLE 1.
DEFINITIONS

The capitalized terms used in this Agreement (other than the headings of the Sections or Articles) have the following meanings set forth in this Article 1, or, if not listed in this Article 1, the meanings as designated in the text of this Agreement.

1.1                               “Abatacept Innovator” means Bristol-Myers Squibb Company and its Affiliates, or any successor in interest thereto with respect to Orencia®, and Persons acting under authority thereof or in collaboration therewith, whether by contract, pursuant to a joint venture or otherwise.

1.2                               “Accounting Standards” means GAAP, consistently applied by the applicable Party.

1.3                               “Additional Clinical Trial” means a controlled clinical trial of a Product in human patients to generate safety, efficacy or clinical immunogenicity data to demonstrate that such Product is highly similar to its Reference Product and to demonstrate safety, purity, and potency of such Product, in the proposed therapeutic indication, which information is sufficient to support the filing for Regulatory Approval under Section 351(k) of the PHS Act, or corresponding laws or their implementing regulations in other countries within the Territory.  For clarity, an Additional Clinical Trial may be conducted using a single dose or regimen or multiple doses or regimens, as appropriate, and such Additional Clinical Trial may be conducted at multiple centers.  The Additional Clinical Trial shall be designed to be a pivotal study or, when appropriate outside the United States, a Phase 3 clinical trial, for such Product.

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for confidential treatment and have been filed separately with the Securities and Exchange Commission.

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1.4                               “Additional Development Activity” has the meaning set forth in Section 2.2(b).

1.5                               “Affiliate” means, with respect to a Person any Person that controls, is controlled by, or is under common control with such Person, for so long as such control exists.  For purposes of the foregoing sentence, “control” means: (a) to possess, directly or indirectly, the power to direct affirmatively the management and policies of such Person, whether through ownership of voting securities or by contract relating to voting rights or corporate governance; (b) in the case of corporate entities, direct or indirect ownership of at least fifty percent (50%) of the stock or shares having the right to vote for the election of directors; or (c) in the case of non-corporate entities, direct or indirect ownership of at least fifty percent (50%) of the equity interest with the power to direct the management and policies of such non-corporate entities, or in each case (a) and (b) such lesser percentage which is the maximum allowed to be owned by a foreign corporation in a particular jurisdiction.

1.6                               “[***] Innovator” means [***] and its Affiliates, or any successor in interest thereto with respect to [***], and Persons acting under authority thereof or in collaboration therewith, whether by contract, pursuant to a joint venture or otherwise.

1.7                               “Allocable Legal Expense Share” means with respect to each Product, fifty percent (50%) for Momenta and fifty percent (50%) for Mylan.

1.8                               “Applicable Law” means all applicable provisions of any and all federal, national, state, provincial, and local statutes, laws, rules, regulations, administrative codes, ordinances, decrees, orders, decisions, injunctions, awards, judgments, permits and licenses of or from any governmental authorities (including Regulatory Authorities) relating to or governing a Party’s obligations and rights under this Agreement.

1.9                               “Approval Batch” means any validation, confirmation or scale-up batch of Product manufactured in support of Regulatory Approval.

1.10                        “Biosimilar” means, with respect to a reference brand biologic product, a [***] that is: (a) [***] to such reference brand biologic product notwithstanding [***] in [***] components; and (b) has no [***] from such reference brand biologic product in terms of [***]; and (c) would be [***] by the FDA [***] elsewhere in the Territory, regardless of whether [***] for commercial purposes.

1.11                        “Biological Entity” means each of: (a) the fusion protein abatacept; (b) the [***]; (c) the [***]; (d) the [***]; (e) the [***]; and (f) the [***], in each case as further described on Exhibit 1.11, along with in each case any [***] to the foregoing that [***] of the biological entities described on Exhibit 1.11.

1.12                        “BLA” means a Biologics License Application filed pursuant to the requirements of the FDA under Section 351(k) of the PHS Act and 12 C.F.R., Section 601.2, to obtain Regulatory Approval for a Product in the United States, or the equivalent application or filing in another country (as applicable).

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for confidential treatment and have been filed separately with the Securities and Exchange Commission.

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Confidential Treatment Requested by Momenta Pharmaceuticals, Inc.

1.13                        “BPCI Act” means the Biologics Price Competition and Innovation Act of 2009 within the Patient Protection and Affordable Care Act, signed into law in March 2010, and as may be subsequently amended.

1.14                        “Business Day” means any day other than a: (a) Saturday or Sunday; (b) day that is a recognized national holiday in the U.S.; or (c) day that commercial banks are authorized to close under the Applicable Laws of, or are in fact closed in, the Commonwealth of Massachusetts or State of New York.

1.15                        “Calendar Quarter” means each of the three (3) month periods ending March 31, June 30, September 30 and December 31; provided, however, that: (a) the first Calendar Quarter of the Term shall extend from the Effective Date to the end of the first complete Calendar Quarter thereafter; and (b) the last Calendar Quarter shall extend from the beginning of the Calendar Quarter in which this Agreement expires or terminates until the effective date of such expiration or termination.

1.16                        “Calendar Year” means: (a) for the first Calendar Year of the Term, the period beginning on the Effective Date and ending on December 31, 2016; (b) for each Calendar Year of the Term thereafter, each successive period beginning on January 1 and ending twelve (12) consecutive calendar months later on December 31; and (c) for the last Calendar Year of the Term, the period beginning on January 1 of the Calendar Year in which the Agreement expires or terminates and ending on the effective date of expiration or termination of this Agreement.

1.17                        “Claims” means, collectively, any and all Third Party demands, claims, actions and proceedings (whether criminal or civil, in contract, tort or otherwise).

1.18                        “Clinical Development” means any and all Development activities to be conducted in humans related to or in furtherance of Regulatory Approval, including all clinical trials and any such post-approval regulatory commitments, or Post-Approval Clinical Trials.  The Clinical Development activities to be performed as part of the Collaboration shall be as described in the applicable Product Work Plan.

1.19                        “Collaboration” means the Development, Manufacturing and Commercialization of, and the conduct of the relevant Legal Activities with respect to, the Products in the relevant countries in the Territory, under this Agreement as described herein and the applicable Product Work Plans.

1.20                        “Collaboration Intellectual Property” means all Collaboration Know-How and Collaboration Patent Rights.  Collaboration Intellectual Property shall exclude Momenta Intellectual Property and Mylan Intellectual Property.

1.21                        “Collaboration Know-How” means Know-How [***] in the course of the Collaboration [***] or their Affiliates or their respective employees, contractors or consultants.  Collaboration Know-How shall exclude [***].

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for confidential treatment and have been filed separately with the Securities and Exchange Commission.

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1.22                        “Collaboration Patent Rights” means Patent Rights [***].  Collaboration Patent Rights shall exclude [***].

1.23                        “Commercialize” “Commercialization” and “Commercialization Activities” means all activities of using, marketing, promoting, distributing, importing, offering for sale or selling a Product related to the Launch and commercialization of such Product in the respective countries of the Territory.  Such Commercialization Activities may include activities with respect to a Product that are directed to: (a) [***]; (b) [***]; (c) [***], including [***]; (d) branding; (e) sales and marketing, including detailing, etailing and online marketing; (f) [***] associated with the Products; (g) [***], including the conduct of [***]; (h) [***] management; (i) [***], including the use of [***] involving key [***]; (j) [***] and mechanisms, including [***] websites; (k) the recruiting, hiring, administration, operation and maintenance of the [***] such Product in the Territory, including [***] and other communications, [***] costs, [***] personnel who support the [***], including any activities of Momenta or Mylan under the [***]; and (l) [***] associated with the Launch and commercialization of the Products, including [***].  For avoidance of doubt, (a) through (l) above sets forth examples of activities that may constitute “Commercialization Activities” rather than a list of activities required to be performed by a Party or limiting the activities that would constitute Commercialization.  The Commercialization Activities to be performed as part of the Collaboration for any specific Product shall be as described in the applicable Commercialization Plan.

1.24                        “Commercialization Expenses” means, with respect to a Product, the [***] costs paid by a Party to a Third Party related to Commercialization and [***] by a Party, after the Effective Date, in connection with Commercialization of such Product by or on behalf of a Party in accordance with the applicable Product Work Plan, as determined from the books and records of the applicable Party or its Affiliates [***].  For clarity, a Product’s Commercialization Expenses excludes the [***] for such Product and includes the [***] costs [***], and the [***], Mylan or Momenta in the conduct of activities under the Co-Commercialization Agreement.  Commercialization Expenses also include [***] associated with [***] and other similar costs associated with the Commercialization of the Products that [***].

1.25                        “Commercialization Plan” shall be a component of each Product Work Plan as further described at Section 2.1(c) herein.

1.26                        “Commercial Scale” means the scale of a chemical or biological process for the Manufacture of a Product in sufficient quantities to support the projected supply requirements for the marketed Product as of the First Commercial Sale of such Product.  Commercial Scale, as it relates to a Product, shall, as appropriate, be further defined in the applicable Product Work Plan.

1.27                        “Commercially Reasonable Efforts” means, with respect to the performing Party, the carrying out of obligations of such Party in a diligent and expeditious manner as is commonly practiced in the pharmaceutical industry, including the allocation of a commercially reasonable level of personnel and financial resources, consistent with (and not materially less than) such level of resources and efforts that an established pharmaceutical company typically devotes to products of similar market potential at a similar stage of development or

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for confidential treatment and have been filed separately with the Securities and Exchange Commission.

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Confidential Treatment Requested by Momenta Pharmaceuticals, Inc.

commercialization in its product lifecycle, taking into account scientific, technical, developmental, regulatory and commercial factors such as the [***] (including [***] the marketplace, cost, profitability, [***] (including [***] or other [***] of the Product, and the [***] and conditions involved.

1.28                        “Competing Product” means, with respect to any Product: (a) the corresponding [***]; (b) a Biosimilar of such [***] (other than such Product); and (c) any biological medicinal product incorporating the [***] in such Product (but excluding, for clarity, products incorporating [***] that result in [***].  For example, a Competing Product to the Product known as M834 would be [***] Orencia®, [***] Orencia®, but would exclude a biological medicinal product incorporating [***] that results from [***] protein abatacept [***] (including [***] abatacept.

1.29                        [***] means [***] version of a [***] (other than [***], which may include: (a) a pharmaceutical product with a [***] (such as [***] products); (b) a pharmaceutical product with a [***] (such as [***]; (c) a pharmaceutical product with a [***] (such as certain [***]; or (d) complete [***] (such as [***] using a [***] or a [***].

1.30                        “Confidential Information” means: (a) all proprietary information and materials, patentable or otherwise, of a Party which is disclosed by or on behalf of such Party to the other Party or its representatives pursuant to and in contemplation of this Agreement, including, without limitation, biological or chemical substances, formulations, techniques, methodology, equipment, data, reports, Know-How, sources of supply, patent positioning, business plans and financial information; and (b) any other information designated by the disclosing Party to the other Party in writing as confidential or proprietary, whether or not related to making, using or selling a Product.  Notwithstanding the foregoing, the term ‘Confidential Information’ shall not include information: (w) which is or becomes generally available to the public other than as a result of disclosure thereof by the receiving Party; (x) which is lawfully received by the receiving Party on a non-confidential basis from a Third Party that is not, to the receiving Party’s knowledge, itself under any obligation of confidentiality or nondisclosure to the disclosing Party or any other Person with respect to such information; (y) which is already known to the receiving Party at the time of disclosure by the disclosing Party; or (z) which can be shown by the receiving Party to have been independently developed by the receiving Party without use of or reference to the disclosing Party’s Confidential Information.

1.31                        “Control” means, with respect to any Patent Rights or any item of Know-How, the possession, whether by ownership or license (other than licensed by one Party to the other Party pursuant to this Agreement), by a Party or any of its Affiliates of the ability to grant access, a license or a sublicense as provided in this Agreement under such item or right without: (a) violating the terms of any agreement or other arrangement with, or any legal rights of, any Third Party; (b) violating the terms of any agreement to which such Party or its Affiliate is a party; or (c) requiring the consent of any Third Party.  For clarity, any such Patent Rights or item of Know-How acquired by a Party after the Effective Date, which is necessary to Develop, Manufacture or Commercialize a Product, shall be [***].

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for confidential treatment and have been filed separately with the Securities and Exchange Commission.

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1.32                        “Cost of Goods Sold” or “COGS” means: (a) with respect to Product that is Manufactured by a Party or its Affiliates, the Manufacturing Cost of such Product; and (b) with respect to Product purchased by a Party or its Affiliates from a Third Party, such Party or its Affiliate’s [***] cost of acquisition of such Product (including the [***] and all other [***] included in, or consumed in the manufacture of, the Product), together in the case of (a) and (b) with: (i) [***] and (ii) [***] paid or payable by such Party or its Affiliates to any Third Parties for [***] of Product where such [***] to make such payment [***], and together in the case of (b) with other costs incurred by such Party or its Affiliates and [***] such Product in [***], including costs of [***].  For clarity, COGS shall include such costs with respect to [***].  If [***], the Parties will [***] the costs of such [***].

1.33                        “Covers” means: (a) with respect to Know-How, that the making, using, selling or offering for sale of a given molecule, product, or item would require the use of such Know-How; and (b) with respect to Patent Rights, that the making, using, selling, offering for sale, or importation of a given molecule, product, or item would infringe a Valid Claim of such Patent Rights (in the absence of ownership of, or a license under, such Patent Rights).

1.34                        “[***] Innovator” means [***] and its Affiliates, or any successor in interest thereto with respect to [***] or [***], and Persons acting under authority thereof or in collaboration therewith, whether by contract, pursuant to a joint venture or otherwise.

1.35                        “Develop”, “Development” and “Development Activities” means with respect to a Product, all activities either related to or in furtherance of the creation or scientific or technical improvement of such Product, or that are necessary or useful to obtain Regulatory Approval of such Product, whether such activities are conducted prior to the filing of an application for Regulatory Approval of such Product in any country in the Territory or thereafter.  Development Activities may include: (a) design of a [***] a Product; (b) creation and selection of a [***] of such Product; (c) [***] activities for the Product, including the creation and implementation of a [***]; (d) [***] of the Product (including for [***]) and associated [***] studies; (e) creation and implementation of the Product [***], including selection of [***]; (f) [***] and [***] of a Product; (g) [***] of such Product and the applicable [***] to determine [***]; (h) [***] and, if applicable, [***], creation of [***] activities associated with a [***] program; (i) creation and design of a [***] for the Product; (j) [***] for the Product prior to obtaining Regulatory Approval to market the Product, including the preparation and filing of [***], and the development and selection of the [***]; and (k) [***] in connection with the foregoing activities.  For avoidance of doubt, (a) through (k) above set forth examples of activities that would constitute “Development Activities” rather than a list of activities required to be performed by a Party or limiting activities to be performed by a Party.  The Development Activities to be performed as part of the Collaboration for any specific Product shall be as described in the applicable Product Work Plan.

1.36                        “Development Expenses” means, with respect to a Product, the costs [***] by or on behalf of a Party, including [***] costs paid by a Party to Third Parties (collectively) [***] in connection with the Development of such Product in accordance with the relevant Product Work Plan, as determined from the books and records of the applicable Party or its Affiliates [***] and

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for confidential treatment and have been filed separately with the Securities and Exchange Commission.

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each Party’s [***].  For clarity, Development Expenses shall include all [***] associated with [***] for the Products as well as [***] associated with [***] of the Products (e.g., costs with respect to [***] of Product that are [***] in support of [***] and that are not [***].

1.37                        “Divest” or “Divestiture” means, with respect to any Competing Product: (a) the sale, exclusive license or other transfer of all of the right, title and interest in and to such Competing Product in the applicable country(ies) in the Territory, including all technology, intellectual property and other assets relating solely thereto, to an independent Third Party, without the retention or reservation of any rights, license or interest (other than solely an economic interest and, in the event of a termination, customary residual rights) in such Competing Product with respect to the applicable country(ies) in the Territory; or (b) the shutdown of activities related to the Competing Product in the applicable country(ies) in the Territory such that no technology, intellectual property or other asset relating thereto is used by the applicable Party or its Affiliates and delivery of written confirmation from such Party to the other Party that the Divesting Party and its Affiliates covenant not to use any technology, intellectual property and assets solely relating to such Competing Product in the applicable country(ies) in the Territory during the Term.

1.38                        “Dollars” or “$” means the legal tender of the United States.

1.39                        “[***] Innovator” means [***] and its Affiliates, or any successor in interest thereto with respect to [***] and Persons acting under authority thereof or in collaboration therewith, whether by contract, pursuant to a joint venture or otherwise.

1.40                        “Effective Date” means the HSR Clearance Date, as defined in Section 12.12.

1.41                        “EMA” or “European Medicines Agency” means the European Union agency for the evaluation of medicinal products, or any successor entity thereto.

1.42                        “Enforcement Litigation” shall have the meaning set forth at Section 5.4(b).

1.43                        “EU” means the European Union.

1.44                        “Fault” means, with respect to a Party: (a) the breach of this Agreement by such Party, including a breach of a Party’s representations or warranties under Article 11; (b) the violation of Applicable Law in the performance of the Collaboration; or (c) the (i) negligence or gross negligence; (ii) willful misconduct; (iii) intentional misrepresentation; (iv) recklessness; or (v) fraud of or by such Party, in each case ((i) - (v)) in the Development or Manufacture for, or Commercialization in, the Territory of a Product or otherwise in the performance of any other rights or obligations under this Agreement.

1.45                        “FDA” or “Food and Drug Administration” means the U.S. Food and Drug Administration, or any successor entity thereto.

1.46                        “Field” means use for all therapeutic indications in humans.

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for confidential treatment and have been filed separately with the Securities and Exchange Commission.

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1.47                        “Final Legal Clearance” means with respect to a Product that [***], on a country-by-country basis, the earliest of: (a) receipt by a Party or any of its Affiliates of [***]: (i) [***]; (ii) [***]; or (iii) [***], in any case that determines that the [***] of such Product [***] the relevant [***] in such country (due to [***] (b) receipt by a different Third Party of [***]: (i) [***]; (ii) [***]; or (iii) [***], in any case that determines that the [***] of such Product [***] the relevant [***] in such country (due to [***] or (c) in the event that, pursuant to Section 2.4(f), Mylan Launches such Product [***] as described in clause (a) or (b) above, Momenta’s provision of written notice to Mylan indicating that [***] with respect to such Product;  provided however that [***] pursuant to this clause (c) shall not be effective until the earlier of: (I) at least [***] after Mylan’s Launch of such Product; or (II) the [***] as described in clause (a) or (b) above.

1.48                        “First Commercial Sale” means, with respect to any Product, the first sale of such Product by a Party, its Sublicensee or any of their respective Affiliates to a Third Party following receipt of Regulatory Approval of such Product in the country of sale.

1.49                        “FTE” means the equivalent of the work of one (1) employee full-time for one (1) year (consisting of a total of [***] per year, or such other number as may be agreed by the JSC) on or directly related to the Collaboration.  Any individual who devotes less than [***] per year (or such other number as may be agreed by the JSC) shall be treated as an FTE on a pro-rata basis upon the actual number of hours worked divided by [***] (or such other number as may be agreed by the JSC).  Unless modified by the JSC, the [***] figure shall be used without regard to the [***] of the [***] that [***].

1.50                        “FTE Costs” means the actual fully burdened cost per FTE on an annual basis and are intended to capture [***] costs and [***] the activities of such FTE.

1.51                        “GAAP” means U.S. Generally Accepted Accounting Principles.

1.52                        “GMP” or “Good Manufacturing Practice” means the current good manufacturing practice regulations of the FDA, including as described in the U.S. Code of Federal Regulations, Parts 210, 211, 601, and 606, or any applicable corresponding foreign regulations or their respective successor regulations.

1.53                        “Hold Separate Transaction” means any “hold separate” transaction (whether through the establishment of a trust or otherwise) involving the proposed sale of a Competing Product in the applicable country(ies) in the Territory pursuant to an agreement with any governmental authority responsible for antitrust laws.

1.54                        “IND” means: (a) an Investigational New Drug Application as defined in the United States Food, Drug and Cosmetic Act and applicable regulations promulgated thereunder by the FDA, including 21 C.F.R., part 312; or (b) a Clinical Trial Application or equivalent application in the EU, the filing of which is necessary to commence clinical testing of a pharmaceutical product in humans in a particular jurisdiction.

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for confidential treatment and have been filed separately with the Securities and Exchange Commission.

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1.55                        “IND Acceptance” means, with respect to a Product, the earlier to occur of the date that: (a) written notice of a waiver of, or exemption from, the need to file an IND is received by a Party from the applicable Regulatory Authority and such waiver or exemption becomes effective, in each case either in the U.S. or the EU; or (b) authorization is obtained from the applicable Regulatory Authority in the U.S. or the EU to initiate dosing in humans, based on such Regulatory Authority’s review of analytical data comparing such Product to the Reference Product, which in the U.S. means: (i) thirty (30) days after FDA receives the IND, unless FDA notifies the sponsor that the investigations described in the IND are subject to a clinical hold; or (ii) on written notification by FDA that the clinical investigations in the IND may begin.  For avoidance of doubt, the written notice referred to in subsection (a) above may be in the form of a letter from the relevant Regulatory Authority approving the development plan of the Parties that does not require human clinical trials as adequate to support Regulatory Approval of the applicable Product or an actual written waiver of an IND.

1.56                        “Initial Clinical Trial” means a human clinical trial of a Product (as required by the applicable Regulatory Authority) conducted to generate pharmacokinetic and pharmacodynamic (if relevant pharmacodynamic measures exist) data that is comparative to the applicable Reference Product, for purposes of supporting an application for Regulatory Approval under Section 351(k) of the PHS Act, or equivalent in other countries within the Territory.  The Initial Clinical Trial shall be designed to be a Phase 1 clinical trial for such Product but may also include additional features that could facilitate a waiver or targeting of the Additional Clinical Trial.

1.57                        “Initial Press Releases” shall have the meaning set forth at Section 7.2 herein.

1.58                        “Innovator” means the Abatacept Innovator, the [***] Innovator, the [***] Innovator, the [***] Innovator, the [***] Innovator, or the [***] Innovator, as applicable.

1.59                        “[***] Innovator” means [***] and its Affiliates, or any successor in interest thereto with respect to [***], and Persons acting under authority thereof or in collaboration therewith, whether by contract, pursuant to a joint venture or otherwise.

1.60                        “Joint Steering Committee” or “JSC” shall have the meaning set forth in Section 3.1.

1.61                        “Know-How” means information and materials, including, without limitation, ideas, concepts, discoveries, inventions, developments, improvements, know-how, expertise, trade secrets, designs, devices, equipment, process conditions, physical materials (including chemical or biological materials), production processes and designs, specifications, computer programs, formulas, techniques, methods, procedures, assay systems and applications, experimental results, data (including, without limitation, analytical, toxicological, pharmacological, clinical, bioequivalence, and stability data), documentation, and reports, whether patentable or otherwise.  For clarity, Know-How excludes Patent Rights.

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for confidential treatment and have been filed separately with the Securities and Exchange Commission.

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Confidential Treatment Requested by Momenta Pharmaceuticals, Inc.

1.62                        “Launch” means, with respect to any Product, to make (or the making of, as context requires) the First Commercial Sale of such Product.

1.63                        “Legal Activities” means legal work and advice relating to the Collaboration including: (a) [***] and other activities under the [***]; (b) legal work pertaining to [***], including [***] proceedings (including [***] and related litigation); (c) [***], including [***] and litigation under [***] (or other similar [***] as applicable to any Product; (d) creation of a [***] for any Product; (e) management of [***] related to any Product; and (f) [***] activities related to any Product.

1.64                        “Legal Expenses” means, with respect to a Product, the costs [***] by or on behalf of a Party on or after the Effective Date, including [***] expenses, in connection with Legal Activities for such Product conducted pursuant to this Agreement.  For avoidance of doubt, Legal Expenses includes the costs of [***] in connection with [***], and any [***] payable to Third Parties in connection with [***].

1.65                        “Losses” means any and all liabilities, penalties, damages costs, fines, and expenses (including [***] and other [***] expenses).

1.66                        “Major Country” means each of the [***].

1.67                        “Manufacture,” “Manufacturing” and “Manufacturing Activities” means, with respect to a Product, all activities involved in the production, storing, handling, packaging, labeling and distribution of Product to be Developed or Commercialized under this Agreement.  Such Manufacturing Activities may include: (a) creation and design of the Product packaging; (b) the creation and implementation of a commercial inventory and Product supply chain distribution strategy; (c) the manufacture of clinical and commercial inventory for the Product; (d) the manufacture of a delivery device for the Product; (e) the manufacture of the packaging for the Product; (f) quality control and quality assurance of the Product; (g) release of the Product; and (h) the distribution, delivery and storage of the Product.  For avoidance of doubt, (a) through (h) above sets forth examples of activities that would constitute “Manufacturing Activities” rather than a list of activities required to be performed by a Party.  The Manufacturing Activities to be performed as part of the Collaboration for any specific Product shall be as described in the applicable Product Work Plan.

1.68                        “Manufacturing Cost” means, with respect to a Product, the [***] costs incurred by a Party or its Affiliates determined in accordance [***] and consistent with such [***], for the Manufacture of such Product (provided that any such [***] to such Product), which costs may include:

(a)                                 the cost of [***], in each case including [***] and other similar costs associated with acquiring such items;

(b)                                 [***] (including [***], including [***] to the manufacture of such Product;

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for confidential treatment and have been filed separately with the Securities and Exchange Commission.

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(c)                                  the [***] cost or credit of any [***] paid or utilized (and not reimbursed or reimbursable) on account of such Product;

(d)                                 [***] costs for the manufacture of such Product, including [***] costs;

(e)                                  manufacturing [***] (including [***] costs and [***] in the manufacture of such Product;

(f)                                   costs for [***] (including the costs of [***] of such Product, including the costs of [***]; and

(g)                                  other costs [***] the manufacture of such Product, including [***] for the Product in the Field consistent with the Product Work Plan), [***].

For clarity, Manufacturing Cost shall exclude [***] and other costs [***].

1.69                        “Momenta Improvement(s)” means any Patent Rights or Know-How [***] of the Products pursuant to this Agreement that are [***] in the course of the Collaboration [***] Momenta, its Affiliates or their respective employees, contractors or consultants.  For clarity, any such Patent Rights or Know-How acquired by Momenta shall be [***].

1.70                        “Momenta Intellectual Property” means all Momenta Know-How, Momenta Patent Rights and Momenta Improvements.

1.71                        “Momenta Know-How” means all Know-How that is within the Control of Momenta and its Affiliates [***], that: (a) [***] a Product; or (b) is [***] for Mylan to exercise the rights licensed to it under the Agreement or to perform its obligations under the Agreement.

1.72                        “Momenta Patent Rights” means all Patent Rights that are within the Control of Momenta and its Affiliates [***], that: (a) [***] a Product; or (b) [***] for Mylan to exercise the rights licensed to it under the Agreement or to perform its obligations under the Agreement.

1.73                        “Mylan Improvement(s)” means any Patent Rights or Know-How [***] of the Products pursuant to the Agreement that [***] in the course of the Collaboration [***] Mylan, its Affiliates or their respective employees, contractors or consultants.  For clarity, any such Patent Rights or Know-How acquired by Mylan shall be [***].

1.74                        “Mylan Intellectual Property” means all Mylan Know-How, Mylan Patent Rights, and Mylan Improvements.

1.75                        “Mylan Know-How” means all Know-How that is within the Control of Mylan and its Affiliates [***], that: (a) [***] a Product; or (b) [***] for Momenta to exercise the rights licensed to it under the Agreement or to perform its obligations under the Agreement.

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for confidential treatment and have been filed separately with the Securities and Exchange Commission.

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1.76                        “Mylan Patent Rights” means all Patent Rights that are within the Control of Mylan and its Affiliates [***], that: (a) [***] a Product; or (b) [***] for Momenta to exercise the rights licensed to it under the Agreement or to perform its obligations under the Agreement.

1.77                        “Net Sales” means, with respect to a Product, the gross amount invoiced for the sale of such Product by a Party or its Affiliates (or, solely in the case of determining Net Sales when a royalty is owed on Net Sales of such Product pursuant to Section 10.6(a), 10.6(b) or 12.3(c), its Sublicensee) (“Selling Party”) to a Third Party (whether an end user, distributor, Sublicensee or otherwise), less the following calculated in accordance with Accounting Standards: (a) cash, trade, prompt payment, quantity and other discounts; (b) refunds, rebates, chargebacks, retroactive price adjustments, sales deductions, shelf stock or floor stock adjustments, billing errors, rejected goods, expired product, product recalls, and any other allowances which effectively reduce the gross selling price; (c) credits and allowances for damaged goods, product returns and uncollectible accounts; and (d) credits, charge-backs, discounts, rebates, reimbursements, fees and other allowances provided to distributors, wholesalers, pharmacies, selling agents (excluding sales representatives of a Party or any of its Affiliates), group purchasing organizations, and managed care entities, buying groups, health insurance carriers/agencies, government institutions/agencies, health care organizations and other institutions or customers; (e) freight, insurance and handling costs (to the extent not paid by the Third Party customer); and (f) sales tax, value-added tax (“VAT”) and other taxes, duties or government charges levied on or measured by the billing amount, as adjusted for rebates or refunds, that are borne by the Selling Party and that are not refundable and to the extent non-creditable.  Net Sales shall exclude samples distributed in the usual course of business.

In the case of any sale of a Product between or among a Selling Party or its Affiliates for resale, Net Sales shall be calculated as above only on the value charged or invoiced on the first arm’s length sale thereafter to a Third Party.  If no such separate sales are made, Net Sales shall be determined by the Parties in good faith.  If the consideration for Products includes any non-cash element, then, in any such transaction, the Net Sales applicable to such transaction shall be the fair market value for the applicable quantity for the period in question in the applicable country of the Territory.  The fair market value shall be determined, wherever possible, by reference to the average selling price of the relevant Product in arm’s length transactions in the relevant country in the Territory.  Any Product transferred in connection with clinical and non-clinical research or clinical trials, Product promotional samples, compassionate sales or use, or indigent patient programs shall not be counted toward Net Sales; except that any Product sold as part of a named patient use program (or similar program where a Product can be sold in a country prior to Regulatory Approval being obtained for such Product in such country) will be counted toward Net Sales.

If any Product is sold in combination with one or more other products (e.g., a delivery device) or active ingredients which are not the subject of this Agreement (as used in this definition of Net Sales, a “Combination”), then the gross amount invoiced for that Product shall be calculated by multiplying the gross amount invoiced for such Combination by the fraction A/(A+B), where “A” is the gross amount invoiced for the Product sold separately and “B” is the

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for confidential treatment and have been filed separately with the Securities and Exchange Commission.

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gross amount invoiced for the other active ingredient(s) sold separately.  If the other product or active ingredient is not sold separately, then the gross amount invoiced for that Product shall be calculated by multiplying the gross amount invoiced for the Combination by the fraction A/C, where “A” is the gross invoice amount for the Product, if sold separately, and “C” is the gross invoice amount for the Combination.

Notwithstanding anything herein to the contrary, neither Party shall price, discount or bundle payments received in any transaction, for the purpose of reducing or disadvantaging the Net Sales of the Product in favor of any other product provided by such Party.

1.78                        “Other Collaboration Litigation” means all: (a) [***] and litigation process contemplated by Section 5.5(a) and corresponding laws of other countries; (b) [***] procedures (including [***] and similar proceedings with respect to [***]) contemplated by Section 5.5(a); (c) [***] contemplated by Section 5.5(a); and (d) patent infringement litigation filed by Third Parties against Mylan or Momenta relating to the Products and other litigation matters contemplated by Section 5.5(b), including [***] related to such litigation matters.

1.79                        “Patent Activities” means all activities of the Parties with respect to researching and analyzing [***], and the [***] the Momenta Patent Rights licensed under Section 6.1, the Mylan Patent Rights licensed under Section 6.2 and Collaboration Patent Rights, including [***] (such as the handling of [***] and similar proceedings with respect to the Momenta Patent Rights, Mylan Patent Rights or Collaboration Patent Rights, as applicable) as well as [***] in the U.S. and other countries in the Territory.

1.80                        “Patent Rights” means all: (a) U.S. patents (including all reissues, substitutions, confirmations, re-registrations, re-examinations, validations, extensions, renewals or restorations); (b) U.S. patent applications (including all provisional applications, non-provisional application, continuations, continuations-in-part, divisional, continued prosecution applications, reissue applications or re-examination applications); and (c) all non-U.S. or international counterparts of any of the foregoing, or as applicable portions thereof or individual claims therein.

1.81                        “Person” means any individual, partnership, joint venture, limited liability company, corporation, firm, trust, association, unincorporated organization, or any other entity not specifically listed herein.

1.82                        “PHS Act” means the Public Health Services Act (Title 42, U.S.C., Chapter 6A).  As used herein the PHS Act shall refer, more specifically, to 42 USC § 262, which governs the regulation of biological products.

1.83                        “Post-Approval Clinical Trial” means a clinical trial of a Product that is completed after receipt of Regulatory Approval of such Product and that is not required by the applicable Regulatory Authority as a condition to receiving such Regulatory Approval.  A Post-Approval Clinical Trial may include epidemiological studies, modeling and pharmacoeconomic

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for confidential treatment and have been filed separately with the Securities and Exchange Commission.

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studies, and investigator-sponsored clinical trials studying Product that are approved by the JSC and that otherwise fit the foregoing definition.

1.84                        “Product(s)” means any and all biological products [***] incorporating a Biological Entity [***], including each of the following Biosimilars:  (a) Momenta’s development compound referred to as “M834”, a fusion protein for which abatacept (the product known as Orencia®) is the reference brand biologic; (b) Momenta’s development compound referred to as [***], a [***] for which [***] (the product known as [***] is the reference brand biologic; (c) Momenta’s development compound referred to as [***], a [***] for which [***] (the product known as [***] is the reference brand biologic; (d) Momenta’s development compound referred to as [***], a [***] for which [***] (the product known as [***] is the reference brand biologic; (e) Momenta’s development compound referred to as [***], a [***] for which [***] (the product known as [***] is the reference brand biologic; and (f) Momenta’s development compound referred to as [***], a [***] for which [***] (the product known as [***] or [***] is the reference brand biologic.  At any time prior to the applicable Continuation Decision, each Product shall be eligible for substitution in accordance with Section 2.6(b).

1.85                        “Product Work Plan” means, with respect to a Product, the Product-specific plan, developed by the applicable Sub-Committee and approved by the JSC, outlining the Development, Manufacturing and Commercialization (including the pursuit of Regulatory Approval) of such Product in the Territory, including a Commercialization Plan developed by Mylan and reviewed (but not approved, except for the [***]) by the JSC and other information as provided in Section 2.1(b).

1.86                        “Profits (Losses)” means, with respect to a Product and a Calendar Quarter, the Net Sales for such Product: (a) less Shared Other Expenses; and (b) plus Sublicense Revenue.

1.87                        “Profit Share” means Profits (Losses) multiplied by the Profit Share Percentage.

1.88                        “Profit Share Percentage” means, with respect to each Party, fifty percent (50%), subject to adjustments made pursuant to Section 2.4(f)(v), if any.

1.89                        “Reference Product” means the reference brand biologic product for each Product, which as of the Effective Date are: (a) with respect to Momenta’s development compound referred to as “M834”, the fusion protein abatacept, as marketed and manufactured by or on behalf of Abatacept Innovator as Orencia®; (b) with respect to Momenta’s development compound referred to as [***], the [***] as marketed and manufactured by or on behalf of [***] Innovator as [***]; (c) with respect to Momenta’s development compound referred to as [***], the [***] as marketed and manufactured by or on behalf of [***] Innovator as [***]; (d) with respect to Momenta’s development compound referred to as [***], the [***] as marketed and manufactured by or on behalf of [***] Innovator as [***]; (e) with respect to Momenta’s development compound referred to as [***], the [***] as marketed and manufactured by or on behalf of [***] Innovator as [***]; and (f) with respect to Momenta’s development compound referred to as [***], the [***] manufactured and marketed by or on behalf of [***] Innovator as [***] or [***].

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for confidential treatment and have been filed separately with the Securities and Exchange Commission.

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1.90                        “Regulatory Approval” means, with respect to a country, all approvals, licenses, registrations, and regulatory authorizations required to make, store, import, transport, market and sell a Product in such country as granted by the relevant Regulatory Authority, including any such pricing, labeling or reimbursement approvals.

1.91                        “Regulatory Authority” means the FDA or any other counterpart or applicable government authority, court, tribunal, arbitrator, agency, legislative body, commission or other instrumentality of: (a) any national government of any country or territory or (b) any supranational body, in each case in the Territory that is responsible for granting applicable Regulatory Approvals.

1.92                        “Regulatory Submission” means any application to a Regulatory Authority seeking (a) approval to administer an investigational Product to humans, including INDs, or (b) Regulatory Approval.

1.93                        “Shared Other Expenses” means, for each Product, the Commercialization Expenses, Excess Further Expenses, COGS, Legal Expenses (subject to Article 5), Sublicense Expenses, and Third Party Intellectual Property Payment associated with such Product.

1.94                        “Sublicense Expenses” all [***] by a Party or its Affiliate to a Third Party Sublicensee pursuant to an agreement granting such Third Party a Sublicense, [***] of such Sublicense.

1.95                        “Sublicense Revenue” means all consideration received by a Party or its Affiliates with respect to a sublicense granted to a Third Party(ies) to Develop, Manufacture or Commercialize any Product in the relevant country in the Territory (such a grant, a “Sublicense” and such Third Party, a “Sublicensee”), but excluding: (a) consideration received by such Party or its Affiliates as payments for [***] for [***] undertaken by such Party or its Affiliates for, or in collaboration with, such Third Party(ies) or their Affiliates, which costs [***] the other Party [***]; (b) consideration received by such Party or its Affiliates from such Third Party(ies) or their Affiliates as the [***] for such Party’s or any of its Affiliates’ [***], except that consideration that [***] shall not be so excluded; (c) consideration paid by such Third Party(ies) to such Party or its Affiliates for [***] of such Product, which shall be [***]; (d) any [***], including with respect to costs associated with the [***]; and (e) amounts received in consideration for [***] of such Party or Affiliate, or [***] of such Party or Affiliates related to this Agreement (whether by [***].

1.96                        “Territory” means with respect to the Products, the world.

1.97                        “Third Party” means any Person other than Momenta or Mylan or any Affiliate of either Party.

1.98                        “Third Party Intellectual Property Payments” means, with respect to a Product in the relevant country in the Territory, any [***] or other [***] payments made by a Party or its Affiliates to any Third Party in consideration of a license(s), [***], under Patent Rights or

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for confidential treatment and have been filed separately with the Securities and Exchange Commission.

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Know-How or other intellectual property rights that are owned or controlled by such Third Party when such license is [***] or otherwise determined [***] such Product [***] such Third Party Patent Rights, Know-How or other intellectual property rights.

1.99                        “United States” or “U.S.” means the United States of America, and its territories, districts and possessions.

1.100                 “[***] Innovator” means [***] and its Affiliates, or any successor in interest thereto with respect to [***], and Persons acting under authority thereof or in collaboration therewith, whether by contract, pursuant to a joint venture or otherwise.

1.101                 “Valid Claim” means: (a) a claim in issued Patent Rights that has not: (i) expired or been canceled; (ii) been declared invalid by an unreversed and unappealable (or unappealed) decision of a court or other appropriate body of competent jurisdiction; (iii) been admitted to be invalid or unenforceable through reissue, disclaimer or otherwise; or (iv) been abandoned by mutual written agreement of the Parties; or (b) a claim [***] Patent Rights that [***] by the applicable governmental authority or court for whatever reason (and [***].

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for confidential treatment and have been filed separately with the Securities and Exchange Commission.

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Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for confidential treatment and have been filed separately with the Securities and Exchange Commission.

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Confidential Treatment Requested by Momenta Pharmaceuticals, Inc.

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for confidential treatment and have been filed separately with the Securities and Exchange Commission.

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Confidential Treatment Requested by Momenta Pharmaceuticals, Inc.

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for confidential treatment and have been filed separately with the Securities and Exchange Commission.

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ARTICLE 2.
DEVELOPMENT, MANUFACTURE AND COMMERCIALIZATION OF THE PRODUCTS

From and after the Effective Date, the Parties intend and agree [***] to Develop, Manufacture and Commercialize the Products as described in this Agreement and in accordance with the applicable Product Work Plan.

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for confidential treatment and have been filed separately with the Securities and Exchange Commission.

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2.1                               Product Work Plans.

(a)                                 The initial Product Work Plan for each Product shall be prepared and approved by the JSC within [***] of the Effective Date of this Agreement. These initial Product Work Plans shall incorporate any remaining Initial Development Activities. Thereafter, the JSC shall review, update as appropriate and (other than with respect to the Commercialization Plan included therein except for the [***]) approve Product Work Plans on at least an [***] basis and may modify Product Work Plans more frequently as may be deemed necessary by the Parties from time-to-time.  Each revised Product Work Plan for a Product shall contain substantially the level of detail and cover at least the same matters (as described in Section 2.1(b) below, to the extent applicable based on the then-current stage of Development or Commercialization) as the initial Product Work Plan for such Product.  Momenta is authorized to perform the Development Activities (“Initial Development Activities”) and incur the Development Expenses associated therewith, in each case as set forth in Exhibit 2.1(a)(1) hereto, following the Effective Date and prior to the time the initial Product Work Plan is approved. For clarity, the Product Work Plan for a Product will not include Commercialization Activities until the first Commercialization Plan for such Product is provided pursuant to Section 2.1(c) below.

(b)                                 The Product Work Plan for each Product shall include, as appropriate: (i) [***] of the Collaboration [***]; (ii) the [***] each Party, or by Third Parties, in support of the Continuation Decision (as applicable), Development, Manufacturing and, subject to Section 2.1(c), Commercialization of the Product for the [***], and, if all planned Regulatory Approvals have not yet been obtained, in support of Regulatory Approval for such Product; (iii) [***] for such Product [***]; (iv) [***] associated with Development Activities, Manufacturing Activities and Commercialization Activities described in clause (ii), including [***] for applicable Development [***]; (v) an [***] reflecting the [***] by each Party in support of the Development, Manufacturing and Commercialization of the Product [***], along with a detailed [***] following the end of such [***]; and (vi) a [***], setting forth a high level overview of items (i)-(iv) above, as well as [***] underlying such [***] and such other information requested by the JSC.

(c)                                  The initial Commercialization plan (the “Commercialization Plan”) for each Product will be prepared [***] and provided to the JSC no later than [***] to the planned submission of the first application for Regulatory Approval for such Product in a Major Country as part of the Product Work Plan: (i) [***] for Commercialization Activities, which [***]; and (ii) [***] of the [***] for Commercialization Activities set forth in such Commercialization Plan during the [***]; and (iii) [***] of the aggregate [***] the period covered by such [***]; provided that [***] obligation to provide such [***] shall be contingent upon [***] completion of its [***], which [***] shall [***] to complete in time to provide such [***] with the applicable Commercialization Plan. If [***], is unable to provide such [***] with the applicable Commercialization Plan, [***] shall [***] to provide such [***]. The Commercialization Plan shall: (A) contain the depth and detail that are [***] for similar products; and (B) reflect the Commercialization Activities [***] of the Product in the applicable Major Country(ies) over the subsequent [***] after Launch.  [***] shall update the Commercialization Plan for each Product

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for confidential treatment and have been filed separately with the Securities and Exchange Commission.

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[***] after its initial submission and re-submit each such updated Commercialization Plan to the JSC: (1) [***] for Commercialization Activities, which [***]; and (2) [***]; and (3) [***] of the aggregate [***] the period covered by such [***].

2.2                               Development Responsibilities and Diligence.

(a)                                 Diligence.  Each Party will [***] conduct the Development Activities (including all regulatory activities) assigned to it in the applicable Product Work Plan.  All such Development Activities shall be conducted in accordance with this Agreement, the applicable Product Work Plan and Applicable Law.  Momenta will be primarily responsible, in collaboration with Mylan, for managing execution, and contracting with Third Parties (other than Third Parties for supply of Product) for the conduct, of pre-clinical Development Activities, Initial Clinical Trials and Additional Clinical Trial(s) for M834 and for pre-clinical Development Activities and Initial Clinical Trials for the other Products. Mylan will be primarily responsible, in collaboration with Momenta, for managing execution, and contracting with Third Parties (other than Third Parties for supply of Product) for the conduct, of Additional Clinical Trial(s) of the Products (other than M834).  Notwithstanding the preceding allocations of responsibility, the Parties may, as appropriate and as mutually agreed, assign specific Development Activities to either Party.  Notwithstanding the foregoing allocation of responsibility for contracting with Third Parties, the Parties will cooperate with respect to the negotiation of such contracts with the goals of minimizing costs and maximizing quality, efficiency and effectiveness of such Third Party services.

(b)                                 Additional Development Activities.  If a Party (the “Proposing Party”) wishes to conduct Development Activities that are not covered by an approved Product Work Plan (“Additional Development Activities”), then the Proposing Party shall provide the JSC with a proposal for such Additional Development Activities, including a description of, and rationale for, the activities, timelines for the activities and a projected budget for such activities, for review and approval, and shall incorporate reasonable comments from the JSC.  If the JSC approves such Additional Development Activities, then such Additional Development Activities shall be incorporated into the existing Product Work Plan (thereby becoming Development Activities), and the costs of such Additional Development Activities [***] pursuant to Section 4.2(a)(i).

(c)                                  Regulatory.  Unless otherwise determined by the JSC or as set forth in the applicable Product Work Plan: (i) Mylan shall be responsible for preparing and filing the initial IND for each Product outside the United States, which shall be [***], and which shall be submitted to the applicable Regulatory Authorities [***]; (ii) Momenta shall be responsible for preparing and filing the initial IND for each Product in the United States, which shall be [***], and which shall be submitted to the FDA and other Regulatory Authorities [***]; (iii) the Parties shall cooperate in the preparation of all applications for Regulatory Approvals for the Products in accordance with the Product Work Plans; (iv) all applications for Regulatory Approvals and other Regulatory Submissions outside the U.S. for the Product shall be filed in Mylan or its Affiliate’s name; and (v) all applications for Regulatory Approvals and other Regulatory Submissions in the U.S. for the Product shall be filed in Momenta or its Affiliate’s name; except

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for confidential treatment and have been filed separately with the Securities and Exchange Commission.

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that, [***] during the Term as part of the Collaboration, Momenta shall [***].  Unless otherwise determined by the JSC or as set forth in the applicable Product Work Plan: (A) Mylan shall be primarily responsible for correspondence and interactions with Regulatory Authorities with respect to the Products in the Territory outside the United States; and (B) Momenta shall be primarily responsible for correspondence and interactions with Regulatory Authorities with respect to the Products in the United States until [***] for a Product, after which [***] shall be primarily responsible for such correspondence and interactions with respect to such Product.  All Regulatory Submissions shall be subject to review and approval by both Parties.  Each Party shall provide the other Party with copies of all material correspondence with Regulatory Authorities with respect to the Products.  Appropriate individuals from each Party will be invited as meeting participants and have the right to attend and participate in any meetings with Regulatory Authorities in the Territory with respect to the Products.  The foregoing activities shall be described in more detail in the [***].

(d)                                 Clinical Trial Protocols.  All protocols for Clinical Development of the Products to be conducted pursuant to the Collaboration shall be subject to review and approval by the JSC.  Upon the request of either Party, the Parties shall [***] one or more pharmacovigilance agreements to govern safety data exchange and reporting with respect to any such Clinical Development of the Products.

(e)                                  Development Activity Reports.  Each Party will report on Development Activities undertaken by it in performance of the Product Work Plan.  Such reports shall be provided in connection with meetings of the JSC and as otherwise reasonably requested by the other Party.

(f)                                   Data Access.  Without limiting the reporting obligations set forth in Section 2.2(e) above, each Party shall provide the other Party with access to [***] data, including but not limited to [***] related to the Products within its and its Affiliates’ Control[***], including but not limited to [***], or (if requested by a Party in writing) [***] by the other Party with respect to the Products, as [***] for the Development, Manufacture and Commercialization of the Products in accordance with this Agreement.  After receipt of a Party’s written request, the other Party shall [***] any and all documents [***] to grant the requesting Party such [***].  For clarity, all such data, [***] shall be included in the such Party’s Know-How and subject to the rights and licenses granted to the other Party in Section 6.1 or Section 6.2, if any.

2.3                               Manufacturing Responsibilities and Diligence

(a)                                 Diligence.  Each Party shall [***] conduct the Manufacturing Activities assigned to it under the applicable Product Work Plan.  All such Manufacturing Activities shall be conducted in accordance with this Agreement, the applicable Product Work Plan and Applicable Law. Momenta will be primarily responsible for entering into contracts with Third Parties for clinical supply of the Products and Mylan will be primarily responsible for entering into contracts with Third Parties for Commercial Supply of the Products (except M834). Notwithstanding the preceding allocations of responsibility, the Parties may, as appropriate and

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for confidential treatment and have been filed separately with the Securities and Exchange Commission.

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Confidential Treatment Requested by Momenta Pharmaceuticals, Inc.

as mutually agreed, assign specific Manufacturing responsibilities to either Party. Notwithstanding the foregoing allocation of responsibility for contracting with Third Parties, the Parties will cooperate with respect to the negotiation of such contracts with the goals of minimizing costs and maximizing quality, efficiency and effectiveness of such Third Party manufacturing.

(b)                                 The Party that bears primary responsibility for Manufacturing Activities for a Product, as set forth in the Product Work Plan, shall [***] ensure adequate supply of pre-clinical and clinical supply of Product (including the bulk process intermediate and finished Product) to Develop such Product as contemplated by the Product Work Plan, and [***] to ensure adequate Manufacturing capacity to meet forecasted commercial demand for such Product.

(c)                                  Third Party Manufacturers.  If a Party uses any Third Party to fulfill its Manufacturing obligations under this Agreement, the Third Party and the terms of the agreement with such Third Party [***], which shall be responsible for selecting such Third Party manufacturer.  Each Party shall have the right to conduct quality inspection(s) of each Third Party manufacturer of the Products or any component of the Products for use in the clinical trials included in the Product Work Plans or with respect to commercial supply, and a Party may withhold or withdraw its approval of such Third Party manufacturers in the event any such inspection reveals material quality issues.  The Parties shall cooperate with respect to the transfer of the manufacturing process for each Product as may be reasonably necessary to enable each such approved Third Party manufacturer to manufacture the applicable Product(s).

(d)                                 Manufacturing Activity Reports.  Each Party will report on Manufacturing Activities undertaken by or on behalf of it in performance of the Product Work Plan.  Such reports shall be provided in connection with each meeting of the JSC and as otherwise reasonably requested by the other Party.  The reports provided by each Party pursuant to this Section 2.3(d) shall include, as applicable, [***] regarding the development of the manufacturing processes for the Products, any [***] that arise in the conduct of the Product Work Plans, and progress reports with respect to any [***] being taken with respect to the manufacture of the Products.

(e)                                  Transfer of Manufacturing Process.  Upon a Party’s request, and otherwise in accordance with the applicable Product Work Plan, the other Party shall cooperate with such request to transfer any manufacturing processes for the Products (including cell lines and drug substance) developed by or on behalf of the transferring Party to the other Party or its designee for purposes of Developing and Commercializing the Products in accordance with this Agreement.

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for confidential treatment and have been filed separately with the Securities and Exchange Commission.

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Confidential Treatment Requested by Momenta Pharmaceuticals, Inc.

2.4                               Commercialization Responsibilities and Diligence

(a)                                 Diligence. The Commercialization Plan shall consist of [***] Commercialization Activities consistent with those undertaken by [***] with respect to products of similar market potential at a similar stage of commercialization in their product life cycle to successfully launch and commercialize such Products, taking into account [***] such as the [***] (including [***] the marketplace, cost, profitability, [***] and other [***] of the Product, and the [***] and condition involved. Each Party shall [***] conduct the Commercialization Activities assigned to it in the applicable Product Work Plan.  All such Commercialization Activities shall be conducted in accordance with this Agreement, the applicable Product Work Plan and Applicable Law.  Mylan will lead the global Commercialization efforts with respect to the Products in the Territory.  Mylan shall [***] Launch each Product within each Major Country promptly after: (i) obtaining Regulatory Approval for such Product within such Major Country; (ii) any [***] required by [***] have expired; and (iii) [***] have been completed to the Parties’ mutual satisfaction; provided that [***] of [***] Product is available.

(b)                                 Mylan Responsibilities.  Except as specifically provided otherwise in the applicable Product Work Plan, Mylan shall, with respect to each Product, [***] to undertake, and have the right [***] with respect to the following activities, in each case in performance of the applicable Commercialization Plan:

(i)                                     sales and marketing strategy;

(ii)                                  the design, creation and implementation of patient support programs and services;

(iii)                               selling and marketing;

(iv)                              setting pricing terms and conditions; and

(v)                                 Product recalls and all interactions and correspondence with Regulatory Authorities associated with such Product recalls and other aspects of the Commercialization Plan,

except that Mylan’s right to Launch the Products shall be subject to Section 2.4(f).

(c)                                  Commercial Information Reports.  Within [***] and updated regularly, as appropriate, the Parties shall share with each other material market information collected or prepared by or on behalf of such Party relating to each Product, including: (i) any information relating to [***] and [***]; (ii) projected [***] revenue through [***]; and (iii) market research, including [***]; and (vi) other information relevant to the commercial opportunity of a Product.

(d)                                 Commercialization Activity Reports.  Each Party will report on the Commercialization activities undertaken by it in performance of the applicable Product Work Plan in connection with each meeting of the JSC, including [***] to date for the applicable year.

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for confidential treatment and have been filed separately with the Securities and Exchange Commission.

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In addition, commencing no later than the First Commercial Sale of a Product, each Party will, on a Product-by-Product and a country-by-country basis, no more frequently than [***] (unless otherwise agreed by the Parties), provide to the other Party upon request, [***] reflecting [***] affecting [***], such as changes in the [***].

(e)                                  Product Recalls.  Each Party shall promptly notify the other Party of any information received by it that could reasonably form the basis for a recall, market withdrawal or other corrective action of a Product, in sufficient detail to allow the Parties to comply with any and all Applicable Law to the extent such level of detail is available to the reporting Party.  Each Party shall promptly notify the other Party of any material actions to be taken with respect to any recall or market withdrawal or other corrective action related to a Product prior to such action to permit each Party a reasonable opportunity to consult with the other Party with respect thereto.  All costs and expenses incurred by the Parties and not reimbursed by a Third Party, with respect to a recall, market withdrawal or other corrective action with respect to the Products shall be Commercialization Expenses, shared by the Parties in accordance with the Profit Share Percentage.  All final decisions with respect to any recall, market withdrawals or any other corrective action related to the Product in the Territory shall be made by Mylan as the Regulatory Approval holder, except that [***] associated with any such recall, market withdrawals or any other corrective action will be [***].  Each Party will keep the other Party reasonably informed with respect to any recalls, market withdrawals or other corrective action with respect to the Products in the Territory and will consider any comments from such other Party with respect thereto [***].

(f)                                   Legal Clearance and Launch.

(i)                                     The Parties agree that Mylan may[***] Launch (on a country-by-country basis) any Product without obtaining Momenta’s prior consent after the Product has obtained Final Legal Clearance in such country.  Prior to the Product obtaining Final Legal Clearance in any country, Mylan may[***] Launch such Product in such country without obtaining Momenta’s prior consent solely by following the process described in subsections (ii) — (v) of this Section 2.4(f).

(ii)                                  Relevant Patents.

(1)                                 At least [***] prior to the anticipated Launch of a Product in a country as indicated in the most recent Commercialization Plan (“Anticipated Launch Date”), [***] shall meet and discuss any Patent Rights [***] the applicable [***] and any Patent Rights of [***] that is a [***] of such Product in such country, in each case that may be [***] of the Product.

(2)                                 Any such Patent Rights [***], to Mylan by written notice at least [***] prior to the Anticipated Launch Date [***] of such Product shall be referred to as [***].

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for confidential treatment and have been filed separately with the Securities and Exchange Commission.

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Confidential Treatment Requested by Momenta Pharmaceuticals, Inc.

(3)                                 Momenta may update the [***], by providing written notice of such update to Mylan, at any time that is at least [***] prior to the Anticipated Launch Date solely to [***] any other [***] or such a [***] that is a [***] of such Product in the applicable country, which raise, [***] based on the [***] of such Product; provided that such [***] or such a [***] that is a [***] of such Product in the applicable country (A) on or after [***] prior to the Anticipated Launch Date and before such [***] notice date, or (B) prior to such [***] date if such [***] occurs or only became [***] (or, if earlier, [***] or less prior to such [***] date (any such [***] added pursuant to this Section 2.4(f)(ii)(3) may also be referred to herein as, [***]).

(iii)                               Beginning no earlier than [***] prior to the Anticipated Launch Date, on a country-by-country basis, if Mylan desires to Launch a Product in such country before such Product has obtained Final Legal Clearance in such country, then Mylan shall so notify Momenta in writing, and, along with such notice, Mylan shall provide Momenta with Mylan’s [***] of such Launch in such country[***] and [***] shall discuss the [***].  Within [***] of receipt of such notice and [***] from Mylan, Momenta shall notify Mylan if Momenta consents to the Launch of such Product in such country.  Such consent shall be [***] solely by a written notice provided by Momenta to Mylan together with, and as a result of, an update to the [***] made by Momenta pursuant to Section 2.4(f)(ii)(3), pursuant to which [***] Momenta may [***] its consent to the Launch of such Product in such country solely based on any [***], and such [***] shall be the only [***] with respect to such Product in such country (such a [***], a [***]).

(iv)                              If Momenta either consents to the Launch of such Product in such country, or if Momenta does not notify Mylan of Momenta’s consent within [***] of Momenta’s receipt of such notice and assessment from Mylan, then Mylan may Launch such Product in such country and the Profit Share Percentage with respect to such Product shall remain unchanged, unless Momenta revokes such consent in writing pursuant to a [***] made in accordance with the last sentence of Section 2.4(f)(iii).

(v)                                 If Momenta (A) notifies Mylan that Momenta does not consent to the Launch of such Product in such country within [***] of Momenta’s receipt of such notice and assessment from Mylan or (B) subsequently withdraws its consent to the Launch of such Product in such country pursuant to a [***] made in accordance with the last sentence of Section 2.4(f)(iii), then Mylan may Launch such Product in such country; provided, however, that if Mylan Launches such Product in such country, then notwithstanding anything to the contrary herein, the following shall apply:

(1)                                 The Profit Share Percentage of Mylan for such Product in such country will automatically and immediately increase to [***], and the Profit Share Percentage of Momenta for such Product in such country will automatically and immediately decrease to [***], in each case during the period between the Launch of such Product in such country and the Final Legal Clearance of such Product in such country.  After the Final Legal Clearance of such Product in such country has been obtained, the Profit Share Percentage of Mylan and Momenta for such Product in such country will automatically and immediately each revert to fifty percent (50%), subject to paragraph 5 below.

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for confidential treatment and have been filed separately with the Securities and Exchange Commission.

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Confidential Treatment Requested by Momenta Pharmaceuticals, Inc.

(2)                                 In consideration for the decrease in the Profit Share Percentage of Momenta described in Section 2.4(f)(v)(1), Momenta’s liability to Third Parties for infringement related to the Launch and Commercialization of such Product in such country during the period between the Launch of such Product and the Final Legal Clearance of such Product will be automatically and immediately limited as follows in subsections (3) — (4).

(3)                                 As part of Momenta’s notifications (including any [***]) described in Section 2.4(f)(v) (or any notification of [***] pursuant to Section 2.4(f)(ii)(3)), Momenta shall identify in writing [***] any such [***] if an update notice is given solely in connection with and as a result of an update notification by Momenta pursuant to Section 2.4(f)(ii)(3)) of the [***] within the [***] upon which Momenta has [***]; provided that such [***] may not include any [***] with respect to which either Party has been [***] based on such Product [***] Momenta’s notification of such [***] pursuant to Section 2.4(f)(ii) unless Momenta provides notification of such [***] as [***] no later than [***] of Momenta receiving service of such [***] or notification from Mylan that Mylan has been [***] (such [***], the [***]).

(4)                                 Mylan agrees to [***] and [***], and [***] and [***] at Mylan’s cost and expense, and will [***] and [***] the [***] Momenta [***].  [***] means all [***] or [***] from any [***] a [***] or Mylan or [***] or [***] Mylan’s receipt of Momenta’s notice in accordance with Section 2.4(f)(ii) and arising or resulting from [***], or [***], of the [***] with respect to the Launch or Commercialization of the Product in such country during the period between the Launch and the Final Legal Clearance of such Product, in each case solely with respect to the [***].  If any such [***] any [***] arises, Momenta shall promptly notify Mylan in writing of the [***] and Mylan shall manage and control, at its sole expense, the [***] of the [***] and its [***].  Notwithstanding the foregoing, no [***] of any such [***] shall be finalized without obtaining Momenta’s prior written consent, which shall not be unreasonably withheld, delayed or conditioned, except that in the case of a [***] that does not require an [***] or [***] on the part of [***], and does not [***] or its ability to comply with its obligations hereunder, Momenta’s consent shall not be required so long as Momenta is [***] all [***] in such [***], subject to reimbursement of [***] pursuant to Section 2.4(f)(v)(5) below.  Momenta shall cooperate with Mylan and may, at its discretion and expense, be [***] in any such [***] or [***].  Mylan shall not be liable for any [***], or [***], by Momenta [***] without Mylan’s written authorization.  For clarity, any [***] arising or resulting from [***], or [***] based on the Development, Manufacture or Commercialization of the Products, of [***] other than the [***] shall not be subject to the [***] set forth in this Section 2.4(f)(v)(4), and each Party shall be responsible for its [***] of such [***].

(5)                                 Following Final Legal Clearance with respect to the [***], Momenta shall reimburse Mylan for [***] of the [***] incurred by Mylan as set forth below in this Section 2.4(f)(v)(5).  Such reimbursement shall be made by Momenta to Mylan on a Product-by-Product and country-by-country basis through a set-off against Profits payable each Calendar Quarter to Momenta for such Product in such country beginning with the first Calendar Quarter (or portion thereof) following the achievement of Final Legal Clearance with respect to

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for confidential treatment and have been filed separately with the Securities and Exchange Commission.

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Confidential Treatment Requested by Momenta Pharmaceuticals, Inc.

the [***] for such Product in such country.  Such set-off by Mylan shall not exceed (A) [***] of the Profits for such Product in such country otherwise payable to Momenta in the applicable Calendar Quarter until the amounts set-off by Mylan equal the amount of any Profits received by Momenta with respect to such Product prior to Final Legal Clearance and (B) thereafter, [***] of the Profits for such Product in such country otherwise payable to Momenta in such Calendar Quarter.  An example calculation of reimbursement of [***] is set forth in Exhibit 2.4(f).

2.5                               Limitations on [***] Authority.  Notwithstanding the provisions of Section 2.4(b), but without limiting Mylan’s rights described in Section 2.4(f), Mylan shall not exercise its right to [***] to the extent it would: (a) require Momenta to breach an agreement with a Third Party pursuant to which Momenta [***] the Product; (b) require Momenta to otherwise perform any act that Momenta reasonably believes to be inconsistent with any Applicable Law or the terms of this Agreement; (c) modify the [***] of any Product Work Plan; (d) impose a resolution on the Parties with respect to any dispute regarding the existence or amount of any payment to be made under this Agreement; (e) directly impose on Momenta an obligation to [***] in a certain manner; or (f) amend, interpret, modify or waive compliance with this Agreement.

2.6                               Continuation Decisions and Product Substitutions.

(a)                                 Continuation Decisions.  For each Product (other than M834), each Party shall make a continuation decision as to whether to continue the Development, Manufacture and Commercialization of such Product pursuant to this Agreement as set forth in this Section 2.6 (each a “Continuation Decision”) following: (i) the selection of [***] for such Product, (ii) development of [***] for such Product, (iii) development and submission to [***] that includes a detailed [***] for such Product; (iv) completion of adequate [***] to [***] of such Product [***]; and (v) receipt of the [***] as to whether to continue Development, Manufacture and Commercialization of such Product pursuant to this Agreement.  The applicable Sub-Committees shall provide the JSC with the following information for such Product (other than M834) to enable the JSC to make its recommendation regarding the Continuation Decision: an updated Product Work Plan, including an overview of the [***] and preliminary [***] for such Products prepared by [***], an updated review of the applicable Product [***] in the Territory and the [***] of the Product in the Territory [***]; [***] review of the [***]; [***] review of [***] to meet such requirements; estimated [***]; and any other information [***] in making [***] regarding a Continuation Decision. After receipt of such supporting information, the JSC will meet and make a recommendation with respect to each such Continuation Decision.  Each Party shall notify the other Party in writing within [***] after such JSC meeting of the notifying Party’s decision to either continue or not to continue the Development, Manufacture and Commercialization of the applicable Product (other than M834) under the Collaboration.  Notwithstanding anything to the contrary herein, unless otherwise agreed by the Parties in advance in writing, each Party shall notify the other of its Continuation Decision prior to either Party making, or being required to make, any contractual commitments to incur or incurring costs or fees for [***] for such Product.

(1)                                 If Mylan and Momenta each decide to continue with the Development, Manufacture and Commercialization of a given Product (other than M834) under

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for confidential treatment and have been filed separately with the Securities and Exchange Commission.

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Confidential Treatment Requested by Momenta Pharmaceuticals, Inc.

the Collaboration, then Mylan shall make the applicable Continuation Payment for such Product to Momenta pursuant to Section 4.1(b), and the applicable Product Work Plan shall be updated by the JSC as appropriate to reflect such decision.

(2)                                 If Mylan decides to continue with the Development, Manufacture and Commercialization of a given Product (other than M834) under the Collaboration, but Momenta decides not to continue with the Development, Manufacture and Commercialization of such Product (other than M834) under the Collaboration, then Momenta shall terminate (and such decision by Momenta shall be deemed a termination of) its rights under this Collaboration with respect to such Product (other than M834) pursuant to Section 10.2(a).

(3)                                 If Mylan decides not to continue with the Development, Manufacture and Commercialization of a given Product (other than M834) under the Collaboration, but Momenta decides to continue with the Development, Manufacture and Commercialization of such Product under the Collaboration, then Mylan shall terminate (and such decision by Mylan shall be deemed a termination of) its rights under this Collaboration with respect to such Product (other than M834) pursuant to Section 10.2(a).

(4)                                 If Mylan and Momenta each decide not to continue with the Development, Manufacture and Commercialization of a given Product (other than M834) under the Collaboration, the Agreement shall terminate with respect to such Product, neither Section 10.6(a) nor Section 10.6(b) shall be applicable and each Party shall retain its joint ownership interest of Collaboration Intellectual Property and shall have the right to exploit such Collaboration Intellectual Property on a non-exclusive basis.

(b)                                 Product Substitutions.  Prior to the Continuation Decision with respect to each Product (“Substituted Product”), either Party may propose to the other Party that a [***] (“Replacement Product”) be substituted for such Product, and a meeting of the Parties shall be held within [***] of such request to determine whether to make such substitution.  If the Parties [***] agree in writing to such substitution, then the Parties shall [***] the [***] terms under which such Replacement Product shall become a Product and the [***] of such Product shall become a [***] for all purposes of this Agreement.

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for confidential treatment and have been filed separately with the Securities and Exchange Commission.

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Confidential Treatment Requested by Momenta Pharmaceuticals, Inc.

2.7                               Momenta’s Co-Commercialization Option.

(a)                                 In General.  On a Product-by-Product basis, Mylan hereby grants to Momenta an option (each, a “Co-Commercialization Option”) to play a supporting commercial role for such Product in the United States, by performing such activities in support of Mylan’s Commercialization of the Product as determined by the JSC, in accordance with this Agreement, the applicable Commercialization Plan and a separate co-Commercialization agreement (the “Co-Commercialization Agreement”) to be negotiated [***] by the Parties within [***] subsequent to Momenta’s exercise of the Co-Commercialization Option with respect to a particular Product.  If any inconsistency arises between the terms of this Agreement and the terms of a Co-Commercialization Agreement, the terms of this Agreement shall prevail.

(b)                                 Exercise.  Mylan shall give Momenta written notice (the “Co-Commercialization Notice”) at least [***] before [***] as set forth in the then-current Product Work Plan, and shall provide with such notice: (i) [***] U.S.; and (ii) the then-current Commercialization Plan for the U.S., including [***] relating to the Commercialization activities set forth under such plan.  Momenta may exercise its Co-Commercialization Option with respect to such Product by written notice to Mylan no later than [***] after Momenta receives a Co-Commercialization Notice.  The Parties shall continue to share Profits (Losses) in accordance with Section 4.2 with respect to each Product, regardless of whether Momenta exercises or does not exercise its Co-Commercialization Option with respect to any Product.  Momenta shall not have the right to Commercialize any Product, unless and until a Co-Commercialization Agreement, which permits the Commercialization of such Product in the U.S., is entered into by the Parties.  For clarity, Momenta’s role under a Co-Commercialization Agreement may include various [***] activities (e.g., supplying [***]), or [***] activities, in each case in support of Mylan’s Commercialization of the Products [***] for each such Product, as described in Section 5.11.

ARTICLE 3.
GOVERNANCE

From and after the Effective Date, the Parties intend that the Development, Manufacturing and Commercialization Activities and associated Legal Activities and decisions for each Product be conducted and managed using [***] and subject to the oversight of the Joint Steering Committee, and any relevant Sub-Committees or working groups.

3.1                               Generally.  The Parties hereby establish a joint steering committee (“Joint Steering Committee” or “JSC”) composed of senior members from each Party, including one (1) Alliance Manager (as defined in Section 3.7(a)), to oversee the Development, Manufacturing and Commercialization of all Products under this Agreement.  The structure, scope of responsibility and authority of the JSC shall be as set forth in this Article 3.

3.2                               Structure.  The JSC shall initially consist of four (4) representatives, one of which shall be an Alliance Manager as provided in Section 3.7 below, from each of Mylan and Momenta.  Each of the representatives shall be of the seniority and experience appropriate for

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for confidential treatment and have been filed separately with the Securities and Exchange Commission.

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Confidential Treatment Requested by Momenta Pharmaceuticals, Inc.

service on the JSC in light of the functions, responsibilities and authority of the JSC and the status of the Development, Manufacture and Commercialization of the Products subject to the Agreement from time to time.  The JSC shall appoint a chairperson from among its members, which shall initially be a representative from [***], and then alternate annually between the Parties.  The chairperson shall be responsible for notifying the Parties’ representatives of JSC meetings and for leading the meetings.  The initial JSC representatives of each Party (other than the Alliance Managers) are set forth on Exhibit 3.2.  Each Party may replace its representatives by providing written notice to the other Party.  Employees and other representatives of each Party that are not members of the JSC may attend meetings of the JSC and any Sub-Committees (as defined below) as requested by members of the JSC, and subject to the approval of the other Party with respect to non-employee representatives, to further the activities contemplated by this Agreement.

3.3                               Time and Location of Meetings.  The JSC shall meet at such times and places, in person or by telephone conferencing, web-conferencing, video conferencing or other electronic communication, as the JSC shall determine to carry out its responsibilities; provided, however, that the initial meeting of the JSC shall be held in person at such location as mutually agreed upon by the Parties no later than [***] after the Effective Date.  Thereafter, the JSC shall meet in person at least two (2) times each Calendar Year and shall hold regular teleconferences between meetings not less frequently than once during each Calendar Quarter in which no in person meeting of the JSC is held.  A Party may also call a special meeting of the JSC by providing at least [***] prior written notice to the other Party if such Party reasonably believes that a matter within the JSC’s authority must be addressed prior to the next scheduled meeting, in which event such Party shall provide the other Party a proposed agenda, together with such meeting request.  The location of the in-person meetings shall alternate between the sites of the two (2) Parties.  If a representative of a Party cannot attend a meeting, such Party may designate an alternate employee of such Party to attend such meeting in place of the absent representative.

3.4                               Minutes.  The JSC shall designate for each meeting one (1) Alliance Manager who shall be responsible for drafting and issuing minutes of each JSC meeting reflecting all material items discussed and any agreements of the JSC, which minutes shall be distributed to all JSC members for review and approval.  Such minutes shall provide a description in reasonable detail of the discussions held at the meeting and a list of any actions, decisions or determinations approved by the JSC.  The Parties shall endeavor to finalize and approve the minutes of each JSC meeting within [***] after each such meeting.  Approval of minutes shall be indicated by signature by one (1) JSC member from each Party.  Final minutes of each meeting shall be distributed to the members of the JSC by the chairperson.

3.5                               Sub-Committees.  The JSC shall agree upon the formation of certain sub-committees (each a “Sub-Committee”), each with an equal number of representatives from Mylan and Momenta, to address specific issues in greater detail, including (as described below) a Development and regulatory Sub-Committee, a Manufacturing Sub-Committee, a finance Sub-Committee, a Commercialization Sub-Committee, and a Sub-Committee for Legal Activities and intellectual property.

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for confidential treatment and have been filed separately with the Securities and Exchange Commission.

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Confidential Treatment Requested by Momenta Pharmaceuticals, Inc.

3.6                               Scope of Authority; Responsibilities.

(a)                                 The JSC shall perform the functions and assume the responsibilities and have such authority as set forth in this Agreement.  The JSC has the right to establish a joint project team to implement cross-functional aspects of the Product Work Plan, or other team that the JSC deems necessary, and the JSC shall have such other responsibilities as the Parties may agree in writing from time to time.

(b)                                 The JSC’s responsibilities shall be: (i) overseeing the Collaboration; (ii) [***] the Product Work Plan for each Product no less than once per Calendar Year, as well as any amendments thereto, including the [***] included therein; provided that the JSC’s responsibilities with respect to the Commercialization Plan shall be to: (A) [***] the Commercialization Plan with respect to [***] and (B) [***] the [***]; (iii) reviewing and commenting on [***] for each Product (which shall be subject to approval by the Parties); (iv) reviewing all publications described in Section 7.6, and review and approve a publications policy for such publications regarding the Products; (v) coordinating a strategy for [***] for each Product to the extent included in the Commercialization Plan; (vi) facilitating the exchange of [***] and related information for each Product; (vii) making a [***] of each Product (other than M834) [***]; (viii) creating and revising [***] and coordinating the [***] for each Product as part of the Product Work Plan and approval [***]; (ix) overseeing Product [***]; (x) [***], reviewing [***] for each Product, and agreeing with respect to the appropriate course of action to [***] for each Product; (xi) reviewing [***] for each Product; (xii) reviewing [***] for each Product; (xiii) reviewing Product [***]; (xiv) overseeing [***] for each Product, including the selection of [***] (and approval over the scope of activities to be [***] and other [***]; (xv) reviewing and recommending [***] with respect to a Product Work Plan; and (xvi) other matters expressly assigned to the JSC in this Agreement.

(c)                                  For the avoidance of doubt, the JSC shall have no authority to: (i) amend any of the terms of this Agreement, including by means of JSC minutes, Product Work Plans or otherwise; (ii) waive any rights that either Party may otherwise have pursuant to this Agreement or otherwise; (iii) allocate the ownership of any Patent Rights or rights to any Know-How or the Parties’ rights to apply for Patent Rights; (iv) interpret this Agreement, or determine whether or not a Party has met its diligence or other obligations under the Agreement or whether or not a breach of this Agreement has occurred; or (v) require a Party to allocate resources to the Development, Manufacture or Commercialization of the Products other than as set forth in the agreed upon Product Work Plan, or otherwise agreed by such Party in writing.  Notwithstanding the foregoing, the JSC may make recommendations to the Parties for amendment of this Agreement.

3.7                               Alliance Managers.

(a)                                 Appointment.  Each of the Parties shall appoint a single individual to act as a single point of contact between the Parties to assure a successful Collaboration (each, an “Alliance Manager”).  Each Party may change its designated Alliance Manager from time to

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for confidential treatment and have been filed separately with the Securities and Exchange Commission.

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time upon written notice to the other Party.  Any Alliance Manager may designate a substitute to temporarily perform the functions of that Alliance Manager by written notice to the other Party.

(b)                                 Responsibilities.  The Alliance Managers shall be non-voting members of the JSC and each Sub-Committee and shall attend all JSC and Sub-Committee meetings and support the chairpersons of JSC and Sub-Committees in the discharge of their responsibilities, including by (i) preparing and circulating meeting agendas, (ii) keeping written minutes that reflect all decisions made and action items identified at such meetings, (iii) circulating such minutes to JSC members and integrating comments from the JSC members, and (iv) facilitating communications between the Parties.

3.8                               Decisions; Disputes.

(a)                                 Except as expressly set forth in Section 2.4(b), with respect to matters for which the JSC has decision-making authority, the decisions of the JSC (including any Sub-Committee thereof) must be unanimous, with the representatives of Mylan having, collectively, one (1) vote and representatives of Momenta having, collectively, one (1) vote.

(b)                                 If, [***], a dispute arises regarding matters within the scope of the decision-making authority of the JSC (other than any JSC disputes under Section 5.3(a)(iii), Section 5.4 or Section 5.5), a subsequent meeting of the JSC shall be held to attempt to resolve such dispute.  If the JSC fails to reach a unanimous decision on its resolution within [***] after the date when the dispute was presented to the JSC at such subsequent meeting, then, except as otherwise set forth in this Agreement, the matter shall be resolved pursuant to Section 12.11(a) and, as necessary, Section 12.11(c).  If a dispute arises regarding matters within the scope of responsibilities of the JSC under Section 5.3(a)(iii), Section 5.4 or Section 5.5, then such disputes will not be resolved pursuant to Section 12.11 and will instead be addressed under Section 5.3(a)(iii), Section 5.4 or Section 5.5 (as applicable).

3.9                               Costs and Expenses.  [***] incurred by its respective representatives in connection with attending the meetings and otherwise being part of the JSC and of the Sub-Committees.  For the avoidance of doubt, [***].

3.10                        Term of the JSC and Sub-Committees.  The JSC and each Sub-Committee, as applicable, shall, unless otherwise mutually agreed by the Parties, continue with respect to each Product through the Term of the Agreement.

3.11                        Development and Regulatory Sub-Committee

(a)                                 Membership. The Parties shall, as soon as practicable and, in any event, no later than [***], form a Development and regulatory Sub-Committee to develop and oversee execution of the plans for Development and regulatory affairs with respect to the Products (the “JDRC”).  The JDRC shall consist of three (3) representatives of Mylan and three (3) representatives of Momenta, or such other equal number of representatives from each Party as the Parties may agree in writing.  Each member of the JDRC will have knowledge and expertise

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for confidential treatment and have been filed separately with the Securities and Exchange Commission.

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in the Development of or regulatory requirements for products similar to the Products, and will have appropriate seniority within the applicable Party.  Subject to the foregoing, each Party may replace its representatives to the JDRC at any time upon written notice to the other Party (subject, however, to such replacement complying with the requirements of this Section 3.11(a)).

(b)                                 Responsibilities of JDRC.  Subject to the terms of this Agreement, the JDRC shall have the following responsibilities:

(i)                                     to develop the portions of the Product Work Plans covering Development Activities and regulatory activities for each Product;

(ii)                                  to oversee the execution of the Development Activities and regulatory activities set forth in each [***] Product Work Plan;

(iii)                               to coordinate and oversee regulatory matters with respect to the Development and Manufacture of Products, [***];

(iv)                              to provide a forum to discuss the Development Activities and regulatory activities hereunder, including any issues related thereto and potential remediation plans for such issues; and

(v)                                 to provide a forum to discuss Third Parties engaged or proposed to be engaged to perform Development Activities and regulatory activities on behalf of a Party and the activities to be performed by such Third Parties.

(c)                                  Meetings.  The JDRC shall meet at least four (4) times per year (or as otherwise agreed to by the Parties), and such meetings may be conducted in person, by videoconference or by teleconference.  [***] in connection with its participation on the JDRC.  In addition, either Party may call a meeting of the JDRC at any time upon [***] notice.  Meetings of the JDRC will be effective only if at least one (1) representative of each Party is present at or participating in such meeting.

(d)                                 JDRC Authority.  Subject to Section 2.2(a), the JDRC shall have decision-making authority with respect to how the day-to-day Development Activities and regulatory activities are being carried out pursuant to the Product Work Plans.

3.12                        Manufacturing Sub-Committee.

(a)                                 Membership. The Parties shall, as soon as practicable and, in any event, no later than [***], form a Manufacturing Sub-Committee to develop and oversee execution of the plans for the Manufacture of the Products (the “JMC”).  The JMC shall consist of three (3) representatives of Mylan and three (3) representatives of Momenta, or such other equal number of representatives from each Party as the Parties may agree in writing.  Each member of the JMC will have knowledge and expertise in the Manufacturing requirements for products similar to the Products, and will have appropriate seniority within the applicable Party.  Subject to the

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for confidential treatment and have been filed separately with the Securities and Exchange Commission.

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foregoing, each Party may replace its representatives to the JMC at any time upon written notice to the other Party (subject, however, to such replacement complying with the requirements of this Section 3.12(a)).

(b)                                 Responsibilities of JMC.  Subject to the terms of this Agreement, the JMC shall have the following responsibilities:

(i)                                     to develop the portions of the Product Work Plans covering Manufacturing Activities for each Product;

(ii)                                  to oversee the execution of the Manufacturing Activities set forth in each [***] Product Work Plan;

(iii)                               to provide a forum to discuss the Manufacturing Activities hereunder, including supply and inventory planning for key raw materials, bulk drug substance and the Products, planning for inventory for Launch of Products, functional-level metrics, performance and potential opportunities for improvement, Third Party sourcing, and any upcoming transfers of Manufacturing location or facility for Products for the Territory;

(iv)                              to provide a forum to discuss any issues relating to the Manufacturing Activities hereunder and propose remediation plans to resolve such issues; and

(v)                                 to provide a forum to discuss Third Parties engaged or proposed to be engaged to perform Manufacturing Activities on behalf of a Party and the activities to be performed by such Third Parties.

(c)                                  Meetings. The JMC shall meet at least four (4) times per year (or as otherwise agreed to by the Parties), and such meetings may be conducted in person, by videoconference or by teleconference.  [***] in connection with its participation on the JMC.  In addition, either Party may call a meeting of the JMC at any time upon [***] notice.  Meetings of the JMC will be effective only if at least one (1) representative of each Party is present at or participating in such meeting.

(d)                                 JMC Authority. Subject to Section 2.3(a), the JMC shall have decision-making authority with respect to how the day-to-day Manufacturing Activities are being carried out pursuant to the Product Work Plans.

3.13                        Finance Sub-Committee.

(a)                                 Membership. The Parties shall, as soon as practicable and, in any event, no later than [***], form a finance Sub-Committee to oversee expenses and Profits (Losses) associated with the Development, Manufacture and Commercialization of the Products, and the sharing thereof (the “JFC”).  The JFC shall consist of two (2) representatives of Mylan and two (2) representatives of Momenta, or such other equal number of representatives from each Party as the Parties may agree in writing.  Each member of the JFC will have knowledge and expertise

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for confidential treatment and have been filed separately with the Securities and Exchange Commission.

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in financial matters for products similar to the Products, and will have appropriate seniority within the applicable Party.  Subject to the foregoing, each Party may replace its representatives to the JFC at any time upon written notice to the other Party (subject, however, to such replacement complying with the requirements of this Section 3.13(a)).

(b)                                 Responsibilities of JFC.  Subject to the terms of this Agreement, the JFC shall have the following responsibilities:

(i)                                     to develop, and oversee the Parties execution of the Product Work Plans against the budgets included in the Product Work Plans;

(ii)                                  to coordinate and oversee the reporting and reconciliation of costs and Profits (Losses) with respect to the Products pursuant to Section 4.2;

(iii)                               to provide a forum to discuss financial and accounting matters with respect to the Development, Manufacturing and Commercialization activities conducted hereunder, including cost overruns and expenses associated with Additional Development Activities;

(iv)                              to review quarterly financial statements and forecasts to ensure consistency with any applicable budgets; and

(v)                                 to work with the other Sub-Committees and the JSC to ensure that their respective activities are in accordance with the budgets set forth in the Product Work Plans.

(c)                                  Meetings. The JFC shall meet at least [***] in connection with the reporting and reconciliation to be conducted pursuant to Section 4.2 (or as otherwise agreed to by the Parties), and such meetings may be conducted in person, by videoconference or by teleconference.  [***] in connection with its participation on the JFC.  In addition, either Party may call a meeting of the JFC at any time upon [***] notice.  Meetings of the JFC will be effective only if at least one (1) representative of each Party is present at or participating in such meeting.

(d)                                 JFC Authority. The JFC shall have decision-making authority with respect to accounting matters related to the reporting done pursuant to Section 4.2.

3.14                        Joint Commercialization Sub-Committee.

(a)                                 Membership. The Parties shall, as soon as practicable and, in any event, no later than [***], form a Commercialization Sub-Committee to oversee execution of the Commercialization Plans (the “JCC”).  The JCC shall consist of four (4) representatives of Mylan and four (4) representatives of Momenta, or such other equal number of representatives from each Party as the Parties may agree in writing.  Each member of the JCC will have knowledge and expertise in the commercialization of products similar to the Products, and will have appropriate seniority within the applicable Party.  Without limiting the foregoing, each

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for confidential treatment and have been filed separately with the Securities and Exchange Commission.

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Party shall have at least one (1) representative to the JCC with expertise in regulatory and medical affairs matters.  Subject to the foregoing, each Party may replace its representatives to the JCC at any time upon written notice to the other Party (subject, however, to such replacement complying with the requirements of this Section 3.14(a)).

(b)                                 Responsibilities of JCC.  Subject to the terms of this Agreement, the JCC shall have the following responsibilities:

(i)                                     to [***] on the Commercialization Plans;

(ii)                                  to [***] of the Commercialization Plans as provided by [***] and reviewed (and approved, as applicable to the [***];

(iii)                               to provide a forum to discuss the Commercialization strategies and activities hereunder;

(iv)                              to provide a forum to discuss any issues relating to the Commercialization activities hereunder, including any safety issues with respect to the Products, and propose remediation plans to resolve such issues; and

(v)                                 to review quarterly financial statements and forecasts to ensure operations are in accordance the Commercialization Plan, including any applicable budgets.

(c)                                  Meetings. The JCC shall meet at least four (4) times per year (or as otherwise agreed to by the Parties), and such meetings may be conducted in person, by videoconference or by teleconference.  [***] in connection with its participation on the JCC.  In addition, either Party may call a meeting of the JCC at any time upon [***] notice.  Meetings of the JCC will be effective only if at least one (1) representative of each Party is present at or participating in such meeting.

(d)                                 JCC Authority. Subject to Section 2.4(a) and (b), the JCC shall have decision-making authority with respect to how the [***] are being carried out pursuant to the Product Work Plans.

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for confidential treatment and have been filed separately with the Securities and Exchange Commission.

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3.15                        Legal Activities and Intellectual Property Sub-Committee.

(a)                                 Membership. The Parties shall, as soon as practicable and, in any event, no later than [***], form a Sub-Committee to develop and oversee the execution of the Collaboration IP Plan for freedom to operate regarding the Products and other Legal Activities with respect to the Products (the “JLC”).  The JLC shall consist of three (3) representatives of Mylan and three (3) representatives of Momenta, or such other equal number of representatives from each Party as the Parties may agree in writing.  One of each of the Parties’ representatives to the JLC shall also be a member of the JDRC or JCC.  Each Party shall bear its own expenses in connection with its participation on the JLC.

(b)                                 Responsibilities of JLC.  Subject to the terms of this Agreement, the JLC shall have the following responsibilities:

(i)                                     to oversee and coordinate all Legal Activities with respect to the Products;

(ii)                                  to develop and administer the Collaboration IP Plan;

(iii)                               to nominate a [***] with respect to [***], for approval [***];

(iv)                              to facilitate alignment between the Parties on the [***], and to provide oversight and direction to the [***] for each [***]; and

(v)                                 to provide a forum to discuss any issues relating to obtaining Final Legal Clearance for the Products.

(c)                                  Meetings. The JLC shall meet at least four (4) times per year (or as otherwise agreed to by the Parties), and such meetings may be conducted in person, by videoconference or by teleconference.  [***] in connection with its participation on the JLC.  In addition, either Party may call a meeting of the JLC at any time upon [***] notice.  Meetings of the JLC will be effective only if at least one (1) representative of each Party is present at or participating in such meeting.

(d)                                 JLC Authority. Except as expressly set forth in Article 5, the JLC shall have decision-making authority with respect to how the day-to-day Legal Activities are being carried out pursuant to the Collaboration IP Plan.

3.16                        Limits on Sub-Committees’ Power.  Notwithstanding the foregoing: (a) any decision that this Agreement provides is to be made by the Parties shall not be within the authority of any Sub-Committee; and (b) no Sub-Committee shall have the authority to: (i) directly impose any financial obligation on either Party or its Affiliates, (ii)  impose a resolution on the Parties with respect to any dispute regarding the existence or amount of any payment to be made under this Agreement, (iii) directly impose on either Party, an obligation to

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for confidential treatment and have been filed separately with the Securities and Exchange Commission.

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allocate such Party’s or its Affiliate’s tangible or intangible resources and assets in a certain manner, or (iv) amend, interpret, modify or waive compliance with this Agreement.

ARTICLE 4.
FINANCIAL TERMS

4.1                               Consideration.

(a)                                 Up-Front Payment.  Within [***], Mylan shall make a non-creditable, non-refundable upfront payment to Momenta of Forty-Five Million U.S. Dollars ($45,000,000).

(b)                                 Continuation Payments. For each Product (other than M834) with respect to which both Parties decide to continue the Development, Manufacture and Commercialization pursuant to Section 2.6(a), Mylan shall make a continuation payment to Momenta of [***] within [***] after each such decision by the Parties (each, a “Continuation Payment”).  For clarity, the total amount of Continuation Payments made to Momenta under this Agreement shall not exceed an aggregate of [***].

(c)                                  Development Milestone.  For M834, Mylan shall pay to Momenta [***] within [***] after the first achievement by or on behalf of Momenta of [***] (the “Development Milestone”).  Such Development Milestone payment shall be payable [***].  For clarity, if such Development Milestone event is not achieved, Mylan shall not owe the corresponding milestone payment.

4.2                               Cost Share and Profit Share.  The Parties shall share all Development Expenses and Shared Other Expenses for each Product, incurred after the Effective Date, as set forth below in this Section 4.2.  The Parties shall share all Profits (Losses) for each Product according to the Profit Share Percentage.  All such Shared Other Expenses and Profits (Losses) for each Product shall be subject to reconciliation, reimbursement and payment pursuant to the Profit Share calculation set forth in Sections 4.2(b) — (d) below.  For clarity, each Shared Other Expense shall be accounted for only once when calculating the Profit Share, even if the activity with respect to which such expense is incurred is described in more than one (1) subcategory of Shared Other Expenses.

(a)                                 Development Expenses and Shared Other Expenses.

(i)                                     Development Expenses.

(1)                                 Incurring Development Expenses.  Subject to Section 4.2(a)(i)(2)-(6), each Party shall initially bear all Development Expenses it incurs as set forth in each Product Work Plan (or as set forth in Exhibit 2.1(a)(1) prior to approval of such Product Work Plan) for each Product.  Without limiting the foregoing, the Party primarily responsible for managing execution, or contracting with Third Parties for the conduct, of a Development Activity under Sections 2.2 or 2.3 shall [***] owed to Third Parties for such Development Activity.

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for confidential treatment and have been filed separately with the Securities and Exchange Commission.

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(2)                                 Mylan Annual Shortfall Exists.  Subject to paragraph (4) below, during the Calendar Year in which the Effective Date falls, and in any Calendar Year thereafter when a Mylan Annual Shortfall exists:

(A)                               If the [***] equals or exceeds the Mylan Annual Shortfall, then the [***] in such Calendar Year shall be [***] and there shall be [***] in such Calendar Year.

(B)                               If the [***] is less than the Mylan Annual Shortfall [***], then the [***] in such Calendar Year shall be [***] and the Mylan Development Reconciliation Payment shall be equal to [***].

(C)                               If a given Calendar Year begins with a [***], and neither Party anticipates (x) [***] will occur [***] or (y) that payment of the [***] payment will occur [***] (but payment of [***] payment could be payable [***] based on the then-current Product Work Plans) [***], then:

I.                                        Such [***] will be reconciled [***] of such Calendar Year;

II.                                   The calculation of the Mylan Development Reconciliation Payment shall be determined for the [***] in such Calendar Year; and

III.                              In making such calculations, each [***] shall be used in lieu of the [***] in applying the applicable defined terms in the calculation of the Mylan Development Reconciliation Payment.

(3)                                 Momenta Annual Shortfall Exists.  Subject to paragraph (4) below, in a Calendar Year when a Momenta Annual Shortfall exists, the Momenta Development Reconciliation Payment for the Calendar Year shall [***]; provided that if a Calendar Year begins with [***], then:

(A)                               Such Development Expenses will be reconciled [***] of such Calendar Year;

(B)                               The calculation of the Momenta Development Reconciliation Payment shall be determined for the [***] in such Calendar Year; and

(C)                               In making such calculations, each [***] shall be used [***] in applying the applicable defined terms in the calculation of the Momenta Development Reconciliation Payment.

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for confidential treatment and have been filed separately with the Securities and Exchange Commission.

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(4)                                 Finalization of the CPM Balance.  In the first Calendar Quarter in which (A) the CPM Balance [***] and there are [***] that will create a new [***] or (B) the Parties do not expect any [***] from performance of any remaining activities under the Product Work Plan (each of (A) and (B) being the “Finalization of the CPM Balance”), then the Parties shall initiate reconciliation of Development Expenses in such Calendar Quarter (and thereafter) [***] and share Development Expenses in a Calendar Quarter as follows:

(A)                               If the [***] is [***], then the Mylan Development Reconciliation Payment in such Calendar Quarter shall [***].

(B)                               If the [***] is [***], then the Momenta Development Reconciliation Payment in such Calendar Quarter shall [***].

(5)                                 Reconciliation of Development Expenses.

(A)                               [***]: Without limiting the reporting obligations in Sections 4.2(b) and (c) below, [***], within [***] after the expiration of the applicable Calendar Year [***], each Party shall provide the other Party with a report of its Development Expenses for all Products for such Calendar Year [***] (individually, a Party’s “Annual Development Expenses”).  If there is a Development Reconciliation Amount owed by a Party for a Calendar Year [***], then it shall be paid to the other Party within [***] after delivery of both Parties’ reports of Annual Development Expenses for such Calendar Year [***].

(B)                               [***]:  Without limiting the reporting obligations in Sections 4.2(b) and (c) below, [***], within [***] after the expiration of the applicable Calendar Quarter, each Party shall provide the other Party with a report of its Development Expenses for all Products for such Calendar Quarter (individually, a Party’s “Quarterly Development Expenses”).  If there is a Development Reconciliation Amount owed by a Party for a Calendar Quarter, then it shall be paid to the other Party within [***] after delivery of both Parties’ reports of Quarterly Development Expenses for such Calendar Quarter.  In addition, any [***] that remains on or after the [***] shall thereafter be reported and [***] payable by Mylan in such Calendar Quarter [***] under Sections 4.2(b)-(d).

(6)                                 Example and Definitions.

An example calculation of this reconciliation process is set forth in Exhibit 4.2(a)(i).  For purposes of the foregoing,

a.                                      “Momenta Annual Development Expenses” means for a Calendar Year [***] incurred by Momenta in such Calendar Year [***].

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for confidential treatment and have been filed separately with the Securities and Exchange Commission.

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b.                                      “Mylan Annual Development Expenses” means for a Calendar Year [***] incurred by Mylan in such Calendar Year [***].

c.                                       “Mylan Annual Shortfall” means [***] the Momenta Annual Development Expenses [***] for any Calendar Year [***].

d.                                      “Mylan Quarterly Shortfall” means [***] the Momenta Quarterly Development Expenses [***] in a Calendar Quarter.

e.                                       “Momenta Annual Shortfall” means [***] the Mylan Annual Development Expenses [***] in a Calendar Year [***].

f.                                        “Momenta Quarterly Shortfall” means [***] the Mylan Quarterly Development Expenses [***] in a Calendar Quarter.

g.                                       “Momenta Development Reconciliation Payment” is the amount determined under [***] and Section 4.2(a)(i)(4)(B) .

h.                                      “Mylan Development Reconciliation Payment” is the amount determined under [***] and Section 4.2(a)(i)(4)(A).

i.                                          The Momenta Development Reconciliation Payment and the Mylan Development Reconciliation Payment may each be referred to herein as a “Development Reconciliation Amount.”

j.                                         “CPM Balance” for a Calendar Year [***] means the [***] paid [***] under this Agreement as of the end of such Calendar Year [***], reduced by the [***] during [***].

k.                                      “CPM Amount Used” for a Calendar Year [***] means the amount of the CPM Balance in each Calendar Year [***] that is [***].

l.                                          “Excess CPM Remaining Amount” shall mean any CPM Balance that [***].

(ii)                                  Commercialization Expenses. The Parties shall share all Commercialization Expenses for Commercialization Activities that are incurred by the Parties in accordance with each Product Work Plan, according to the Profit Share Percentage.

(iii)                               Development and Commercialization Expense Overages.  Each Party shall promptly notify the other Party if the notifying Party reasonably determines that it is likely to otherwise exceed its allocated Development Expenses or Commercialization Expenses under an applicable Product Work Plan, and such excess expenses shall be treated as follows.  If a Party’s anticipated Development Expenses or Commercialization Expenses in any Calendar Quarter exceed those included in the development or [***] for all of such Party’s activities under the Product Work Plan in such Calendar Quarter by [***] (“Excess Further Expenses”), such

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for confidential treatment and have been filed separately with the Securities and Exchange Commission.

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Party shall provide the other Party an explanation and reasonable documentation of such Excess Further Expenses, and such Excess Further Expenses [***] by such Party shall be borne [***] by Momenta and [***] by Mylan; provided that such Excess Further Expenses [***], such Party [***] for such Calendar Year.  If such Excess Further Expenses exceed those included in the Development or [***] for all of such Party’s activities under the applicable Product Work Plan for a Calendar Quarter by [***], the Parties shall [***].  The Excess Further Expenses mechanism is implemented as a tool to monitor and effectively manage quarterly variations in Development Expenses and Commercialization Expenses for timing differences. It does not [***].  If a Party determines or anticipates that its projected Development Expenses or Commercialization Expenses will exceed those included in the Development or [***] for all of such Party’s activities under the applicable Product Work Plan for such Calendar Year, then such Party would need to [***], and the allocation of Development Expenses or Commercialization Expenses in excess of the previously approved budget in the Product Work Plan will be [***].

(iv)                              [***].  The Parties agree and intend that [***] shall not be included in Shared Other Expenses, except as expressly agreed by the Parties pursuant to the applicable Product Work Plan or otherwise by the Parties in writing.  However, the Parties agree and intend that [***], shall be included in Shared Other Expenses.  Subject to the foregoing, Each Party shall have the right to [***] for the Products as it deems necessary or appropriate.

(v)                                 COGS.  The Parties shall share all COGS incurred in connection with the Commercialization of the Product in accordance with each Product Work Plan, according to the Profit Share Percentage.

(vi)                              Legal Expenses.  The Parties’ rights and responsibilities with respect to the Legal Activities, including the financial rights and obligations of the Parties, are described in Article 5 and Section 8.4.

(vii)                           Third Party Intellectual Property Payment Expenses.  Neither Party shall, after the Effective Date, enter into, amend or modify an agreement with a Third Party to obtain a license or rights under Third Party Patent Rights or Know-How necessary to Develop, Manufacture or Commercialize the Product that would result in Third Party Intellectual Property Payments (including without limitation, license fees, annual payments and royalties), without: (A) [***], and (B) [***].  Upon [***], the Parties [***], the Third Party Intellectual Property Payments (including, without limitation [***] payable to the licensor or seller of such Patent Rights and Know-How based on the Development, Manufacture or Commercialization of the Products by or on behalf of the Parties hereunder.

(viii)                        FTEs and FTE Costs.  Each Party shall record and account for its FTE effort for the Development and Commercialization of Products to the extent that such FTE effort is included in Development Expenses or Commercialization Expenses that are, or may in the future be, shared under this Agreement.  Each Party shall report such FTE effort to the JSC on a quarterly basis.  Except to the extent provided herein, each Party shall calculate and maintain records of FTE effort incurred by it [***].  The JSC shall review the FTE Costs and any

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for confidential treatment and have been filed separately with the Securities and Exchange Commission.

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adjustments thereto annually as part of its review, update and approval of the Product Work Plans.

(b)                                 Incurring and Reporting of Shared Other Expenses and Development Expenses; Summary Statements.  Except as expressly provided otherwise in this Agreement and subject to [***] will be responsible for and pay for all such Shared Other Expenses so incurred.  Each Party will maintain the books and records referred to in Section 4.3 and will accrue all Shared Other Expenses, Development Expenses and Net Sales in accordance [***] and [***].  Within ten (10) Business Days after the end of each calendar month, each Party will submit to the other Party a [***] of the Shared Other Expenses accrued, Development Expenses, and, if applicable, Net Sales during the just-ended calendar month.  Within [***] after the end of each Calendar Quarter [***], each Party will submit to the other Party a written report reflecting the accrual of Shared Other Expenses, Development Expenses and Net Sales during the just-ended Calendar Quarter, as well as any Sublicense Revenue, on a Product-by-Product basis (each a “Summary Statement”). To the extent Momenta makes Net Sales pursuant to a Co-Commercialization Agreement, it shall include the information described in Section 4.2(c)(i) - (ii) below in its Summary Statement for each applicable Calendar Quarter.  Such Summary Statements shall [***] all expenses included in such Shared Other Expenses and Development Expenses during such Calendar Quarter and, upon the reasonable request of the other Party, shall be [***].  Each Party shall report the Shared Other Expenses and Development Expenses incurred by it in comparison to the Product Work Plan.  The Parties shall seek to resolve any questions related to such Summary Statements within [***] following receipt by each Party of the other Party’s report hereunder.  The JSC shall facilitate the resolution of any questions concerning such Summary Statements, as appropriate. Each Party shall have the right at reasonable times and upon reasonable prior notice to audit the other Party’s records as provided in Section 4.5 to confirm the accuracy of the other Party’s costs and reports with respect to Shared Other Expenses and Development Expenses that are shared under this Agreement.  Upon the request of either Party [***], the JFC will discuss any questions or issues arising from the Summary Statements, including the basis for the accrual of specific Shared Other Expenses or Development Expenses.

(c)                                  [***].  [***] after the end of the Calendar Quarter, but in any event within [***] after receipt by the Preparing Party (as defined below) of the other Party’s Summary Statement [***], the Preparing Party will prepare a [***] report (reasonable supporting documentation and calculations sufficient to support each Party’s associated [***] requirements and obligations [***] shall be provided upon request) that [***] each Party’s Summary Statement and the Profits (Losses) and Legal Expenses (to the extent not included in [***] pursuant to the [***] on a Product-by-Product basis in accordance with Section 4.2(a) (the “[***]”).  Prior to [***] shall be the Preparing Party for [***] for such Product.  Following [***] shall be the Preparing Party for [***] for such Product.  Without limited the foregoing, following [***], the [***] shall include:

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for confidential treatment and have been filed separately with the Securities and Exchange Commission.

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(i)                                     [***] of all Products on a Product-by-Product and country-by-country basis, [***] each Party and its Affiliates during the Calendar Quarter, including the [***] of each Product sold and the [***] for each Product;

(ii)                                  a [***] of each Product on a Product-by-Product basis (set forth in reasonable detail and, as applicable, including the adjustments to [***];

(iii)                               a [***] on a Product-by-Product basis, including reasonably detailed information on the (A) [***]; (B)   [***]; (C) [***]; and (D) all other [***];

(iv)                              [***] one Party [***] to effect the [***] and allocation of [***] (to the extent not included in [***] pursuant to the [***]; and

(v)                                 The [***] payable to a Party for the applicable Calendar Year or Calendar Quarter, and any [***] for an [***] to be applied to any [***] in such Calendar Quarter.  For clarity, to the extent [***] is not [***] by [***] in the Calendar Quarter reported, it may be [***] and [***] in [***] Calendar Quarters by [***].

(d)                                 Payments of Cost Share and Profit Share.

(i)                                     Based on the [***] for the applicable Calendar Quarter or Calendar Year, the applicable Party (to whom a net amount is owed to achieve the [***] with respect to [***] not included in the [***] and any [***] will invoice the other Party after such [***] is complete, and the receiving Party will pay such invoice within [***] of receipt of invoice.  For clarity, prior to [***] of a Product, the sharing of expenses will be calculated in accordance with this Section 4.2 for such Product, and [***] in the calculation of [***] shall equal [***].  The Parties may, upon mutual agreement, net out payment of a Development Reconciliation Amount owed to one Party under Section 4.2(a)(i) with any payment owed to the other Party under this Section 4.2(d)(i).

(ii)                                  Overdue Payments.  If any payment owed to a Party under this Agreement is not made when due, such outstanding payment shall accrue interest (from the date such payment is due through and including the date upon which full payment is made) at the [***] reported [***] such payment was due in [***] ([***] version at [***] under the “[***]” tab), [***], from the due date until paid in full, provided that in no event shall said annual rate exceed the maximum interest rate permitted by law in regard to such payments.  Such payment, when made, shall be accompanied by all interest so accrued.  Said interest and the payment and acceptance thereof shall not negate nor waive the right of a Party to any other remedy, legal or equitable, to which it is entitled because of the delinquency of the payment.

(e)                                  Efforts to Streamline Reporting. The Parties will cooperate [***], through the JFC, to develop processes and align the reporting timelines set forth in Section 4.2(a), (b) and (c) with each Party’s internal close calendars and internal and external reporting timelines, processes and obligations.

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for confidential treatment and have been filed separately with the Securities and Exchange Commission.

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4.3                               Books and Records.  During the Term of this Agreement, each Party shall keep, and shall ensure that its respective Affiliates and Sublicensees shall keep, [***], complete and accurate records in sufficient detail to make the reports required hereunder, to confirm compliance with the provisions of this Agreement, to properly reflect all amounts billed, owed or reported and to verify the amounts payable hereunder for a period of [***] after such payments are made.

4.4                               Taxes.

(a)                                 Tax Withholding.  Each Party shall be entitled to deduct and withhold from any amounts payable under this Agreement such taxes as are required to be deducted or withheld therefrom under any provision of Applicable Law.  The Party that is required to make such withholding (the “Paying Party”) will: (i) deduct those taxes from such payment, (ii) timely remit the taxes to the proper taxing authority, and (iii) send evidence of the obligation together with proof of tax payment to the recipient Party (the “Payee Party”) on a timely basis following that tax payment; provided, however, that before making any such deduction or withholding, the Paying Party shall give the Payee Party notice of the intention to make such deduction or withholding (such notice, which shall include the authority, basis and method of calculation for the proposed deduction or withholding, shall be given at least a reasonable period of time before such deduction or withholding is required, in order for such Payee Party to obtain reduction of or relief from such deduction or withholding).  Each Party agrees to cooperate with the other Parties in claiming refunds or exemptions from such deductions or withholdings under any relevant agreement or treaty which is in effect to ensure that any amounts required to be withheld pursuant to this Section 4.4(a) are reduced in amount to the fullest extent permitted by Applicable Laws.  In addition, the Parties shall cooperate in accordance with Applicable Laws to minimize indirect taxes (such as value added tax, sales tax, consumption tax and other similar taxes (“Indirect Taxes”)) in connection with this Agreement, as applicable.

(b)                                 Tax [***].  Notwithstanding the foregoing, if: (i) any Party [***] its rights or obligations under this Agreement, (ii) as a result of such [***], such Party (or its assignee) is required by Applicable Law to [***] results in the imposition of [***] applicable, from or in respect of any amount payable under this Agreement, and (iii) such [***] the amount of [***] that would have been applicable [***], then any such amount payable shall be [***] to take into account such [***] as may be necessary so that, [***] all required [***] (including [***] on the [***] and/or [***] such [***], as the case may be, the [***] receives [***] it would have received [***] been made and [***] been imposed.  The obligation to [***] pursuant to the preceding sentence shall not apply, however, to the extent such [***]: (1) would not have been imposed [***] its rights or obligations under this Agreement or the [***], to the extent such [***] occurs after the [***] described in the first sentence of this Section 4.4(b); or (2) are attributable to the [***] the requirements of Section 4.4(c).  Solely for purposes of this Section 4.4, a Party’s [***] shall include its [***] shall include [***] or other action resulting in [***].

(c)                                  Tax Documentation.  Each Party has provided a properly completed and duly executed IRS Form W-9 or applicable Form W-8 to the other Party.  Each Party and any other recipient of payments under this Agreement shall provide to the other Party, at the time or

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for confidential treatment and have been filed separately with the Securities and Exchange Commission.

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times reasonably requested by such other Parties or as required by Applicable Law, such properly completed and duly executed documentation (for example, IRS Forms W-8 or W-9) as will permit payments made under this Agreement to be made without, or at a reduced rate of, withholding for taxes.

(d)                                 [***] Tax Considerations.  The Parties acknowledge and agree that: (i) Mylan is [***] and Momenta is [***]; (ii) [***], [***] contemplated to be payable under this Agreement by Mylan to Momenta [***]; and (iii) Mylan will not, [***] the [***] payable pursuant to Section 4.1(a), any [***] in respect of any [***], provided that Momenta delivers a properly completed and duly executed [***].

(e)                                  U.S. Tax Considerations.  Mylan shall indemnify, defend and hold Momenta harmless from any and all liabilities, claims and losses with respect of U.S. federal, state or local income or withholding taxes attributable to any amounts payable to (or allocable to) Mylan under this Agreement.

(f)                                   Cooperation.  Mylan and Momenta shall [***] cooperate with each other to minimize any adverse tax consequences that may arise with regard to the transactions contemplated by this Agreement and related agreements.

4.5                               Audits and Inspection.  From and after the Effective Date, upon [***] from a Party, the other Party shall permit, and shall ensure that its Affiliates shall permit, an independent certified public accounting firm of recognized national standing, selected by the requesting Party [***], to have access to such Party’s (or their Affiliates) records maintained pursuant to Section 4.3, as may be reasonably necessary to verify the accuracy of any amounts reported, actually paid or payable under this Agreement for any year ending not more than [***] prior to the date of such request; provided that a Party’s records related to any given year shall not be subject to audit pursuant to this Section 4.5 [***].  The audited Party may require such accounting firm to be subject to reasonable and customary confidentiality obligations as a condition to conducting such audit.  Such audits may be made no more than [***], during normal business hours at reasonable times mutually agreed by the Parties; [***].  If such accounting firm concludes that additional amounts were owed to the requesting Party during such period with respect to such country of the Territory as applicable, or if the requesting Party overpaid based on a calculation of the Profit Share, the Development Reconciliation Amount or Legal Expenses not included in the calculation of the Profit Share during the audited period, the other Party shall pay such additional amounts or refund such overpayment (including interest on such additional sums with respect to such country of the Territory in accordance with Section 4.2(d)(ii)) within [***] after the date the requesting Party delivers to the other Party such accounting firm’s written report so concluding.  If such accounting firm concludes that additional amounts were owed to the audited Party during such period with respect to such country of the Territory as applicable, or if the audited Party overpaid based on a calculation of the Profit Share, the Development Reconciliation Amount or Legal Expenses not included in the calculation of the Profit Share during the audited period, the auditing Party shall pay such additional amounts or refund such overpayment (including interest on such additional sums with respect to such country of the Territory in accordance with Section 4.2(d)(ii)) within [***] after the date the requesting Party

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for confidential treatment and have been filed separately with the Securities and Exchange Commission.

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delivers to the other Party such accounting firm’s written report so concluding. The fees charged by such accounting firm shall be paid by the requesting Party; provided, however, that if the audit discloses that the amounts payable to such Party for the audited period are more than [***] of the amounts actually paid for such period in such country of the Territory as applicable, or if the audit discloses that the other Party has overcharged the requesting Party for rates or fees for products or services for such period in such country of the Territory as applicable, by over [***], then the other Party shall pay the reasonable fees and expenses charged by such accounting firm.

ARTICLE 5.
INTELLECTUAL PROPERTY AND LITIGATION

5.1                               Ownership of Intellectual Property.  Mylan shall own and retain all right, title, interest and ownership in Mylan Intellectual Property, including Mylan Intellectual Property that was conceived, derived, acquired or made prior to the Effective Date or independently outside the course of the Collaboration, except as expressly licensed to Momenta under this Agreement.  Momenta shall own and retain all right, title, interest and ownership in the Momenta Intellectual Property, including Momenta Intellectual Property that was conceived, derived, acquired or made prior to the Effective Date or independently outside the course of the Collaboration, except as expressly licensed to Mylan under this Agreement.  The Parties shall jointly own all Collaboration Intellectual Property developed in the course of performing their activities under the Product Work Plan under the Collaboration. Subject to the rights and licenses set forth herein, each Party [***] the Collaboration Intellectual Property [***], the other Party, and each Party hereby [***] under Applicable Laws of any jurisdiction to [***] any such [***].

5.2                               Improvements.  Mylan shall own all right, title, interest and ownership in and to Mylan Improvements created in the course of the Collaboration.  Momenta shall own all right, title, interest and ownership in and to the Momenta Improvements created in the course of the Collaboration.

5.3                               Prosecution and Maintenance of Patent Rights.

(a)                                 Generally.  From and after the Effective Date:

(i)                                     [***] shall have the right and responsibility, [***], to prepare, file, prosecute (including the handling of inter partes review, post grant review, ex parte reexamination, supplemental examination, opposition and similar proceedings with respect to the [***] and maintain patent protection with respect to the [***], taking into account comments from [***] with respect thereto.  [***] shall keep [***] reasonably informed with respect to the status of the [***], including by providing [***] with copies of all material documentation or correspondence concerning the [***] in the Territory.  [***] shall solicit [***] comments prior to filing any new [***] or making additional filings on existing [***] and shall [***] with respect thereto [***].  If [***] decides to abandon, or otherwise fails to prosecute or maintain, any Patent Rights within the [***] in any country in the Territory, [***] shall provide [***] with written notice of such decision at least [***] prior to any applicable filing deadline, and of any such failure promptly after it occurs.  In such case, [***] shall have the right, but not the

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for confidential treatment and have been filed separately with the Securities and Exchange Commission.

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obligation, to prepare, file, prosecute and maintain patent protection with respect to such [***] in such country [***], and such [***] shall be [***] and [***], subject to the [***] in this Agreement.  Furthermore, subject to the terms and conditions of this Agreement, [***], effective as of the Effective Date, a [***], under such [***] under this Section 5.3(a)(i) for [***] under this Agreement that [***].

(ii)                                  [***] shall have the right and responsibility, [***], to prepare, file, prosecute (including the handling of inter partes review, post grant review, ex parte reexamination, supplemental examination, opposition and similar proceedings with respect to the [***]) and maintain patent protection with respect to the [***], taking into account comments from [***] with respect thereto.  [***] shall keep [***] reasonably informed with respect to the status of the [***], including by providing [***] with copies of all material documentation or correspondence concerning the [***] in the Territory.  [***] shall solicit [***] comments prior to filing any new [***] or making additional filings on existing [***] and shall [***] with respect thereto [***].  If Momenta decides to abandon, or otherwise fails to prosecute or maintain, any Patent Rights within the [***] in any country in the Territory, [***] shall provide [***] with written notice of such decision at least [***] prior to any applicable filing deadline, and of any such failure promptly after it occurs.  In such case, [***] shall have the right, but not the obligation, to prepare, file, prosecute and maintain patent protection with respect to such [***] in such country [***], and such [***] shall be [***] and become a [***], subject to the [***].  Furthermore, subject to the terms and conditions of this Agreement, [***], effective as of the Effective Date, a [***], under such [***] under this Section 5.3(a)(ii) for [***] under this Agreement [***].

(iii)                               [***] shall have the responsibility to prepare, file, prosecute (including the handling of inter partes review, post grant review, ex parte reexamination, supplemental examination, opposition and similar proceedings with respect to the Collaboration Patent Rights) and maintain patent protection with respect to Collaboration Patent Rights in the names of both Parties.  [***] for the Collaboration Patent Rights, [***] with respect to the preparation, filing, prosecution (including the handling of inter partes review, post grant review, ex parte reexamination, supplemental examination, opposition and similar proceedings with respect to the Collaboration Patent Rights) and maintenance of the Collaboration Patent Rights. [***] for the Collaboration Patent Rights, [***] with respect to the preparation, filing, prosecution (including the handling of inter partes review, post grant review, ex parte reexamination, supplemental examination, opposition and similar proceedings with respect to the Collaboration Patent Rights) and maintenance of the Collaboration Patent Rights.  The non-controlling Party shall cooperate as reasonably requested by Party assuming control to facilitate control of such filing, prosecution and maintenance of such Collaboration Patent Right by the Party assuming control.

(b)                                 Cooperation.  From and after the Effective Date, each Party shall make available to the Party filing, prosecuting or maintaining any Collaboration Patent Rights, or such Party’s authorized attorneys, agents or representatives, its employees whom such controlling

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for confidential treatment and have been filed separately with the Securities and Exchange Commission.

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Party [***] deems necessary in order to assist it in obtaining patent protection for such Collaboration Patent Rights.

(c)                                  Responsibility for Legal Expenses.  From and after the Effective Date, responsibility for Legal Expenses associated with patent prosecution (including the handling of inter partes review, post grant review, ex parte reexamination, supplemental examination, opposition and similar proceedings) and maintenance shall be as follows:

(i)                                     Momenta Patent Rights/Mylan Patent Rights.  Each Party shall be responsible for [***] of the Legal Expenses associated with the preparation, filing, prosecution and maintenance of the Patent Rights within the Momenta Intellectual Property and the Patent Rights within the Mylan Intellectual Property, in each case that cover or claim Products during the Term; provided that in the event that: (A) Momenta [***] under any [***] within the [***] to [***] products, to [***] during the Term, Mylan’s responsibility with respect to Legal Expenses associated with such Patent Rights shall [***] that reflects [***] being borne by [***] under such Patent Rights; and (B) Mylan [***] under any [***] within the [***] to [***] products, to [***] during the Term, Momenta’s responsibility with respect to Legal Expenses associated with such Patent Rights shall [***] that reflects [***] being borne by [***] under such Patent Rights.

(ii)                                  Collaboration Patent Rights.  Each Party shall be responsible for [***] of the Legal Expenses associated with the preparation, filing, prosecution and maintenance of Collaboration Patent Rights during the Term.

5.4                               Patent Enforcement/Third Party Infringement.

(a)                                 Notice.  Each Party shall promptly report to the other Party during the Term after the Effective Date any known or suspected infringement or unauthorized use of any of the Mylan Intellectual Property, the Momenta Intellectual Property or the Collaboration Intellectual Property, as the case may be, of which such Party becomes aware, and, upon request, shall provide the other Party with all evidence within its possession or control supporting such known or suspected infringement or unauthorized use.

(b)                                 [***].  Promptly following notification to the other Party of any known or suspected infringement or unauthorized use of any of the Mylan Intellectual Property, the Momenta Intellectual Property or Collaboration Intellectual Property based on the Development, Manufacture, or Commercialization of a Product or a Competing Product, [***] shall meet and shall: (i) evaluate the notice of infringement and [***] with respect to enforcement proceedings or Third Party infringement litigation matter (including [***] with respect to such infringement or unauthorized use (“Enforcement Litigation”); and (ii) determine [***] shall [***] the Enforcement Litigation.  As part of the process of determining [***] any Enforcement Litigation matter, [***] shall also decide [***] in such Enforcement Litigation [***].

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for confidential treatment and have been filed separately with the Securities and Exchange Commission.

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(c)                                  [***] Enforcement Litigation.

(i)                                     If the Parties, [***], agree to proceed with an Enforcement Litigation, [***] should take the lead in managing such Enforcement Litigation (such lead Party, the “Lead EL Party” and the other Party the “Non-EL Lead Party”) unless the Parties [***] determine that the JLC should manage such Enforcement Litigation.

(ii)                                  The Parties will engage counsel [***] under a joint representation agreement, unless a conflict arises regarding such joint representation or no agreement on joint counsel is reached in a reasonable period of time under the circumstances.  If a conflict arises or no agreement on joint counsel is reached, each Party may be represented by separate counsel.  The Lead EL Party, or the JLC when selected to manage the Enforcement Litigation, shall have the right to control the Enforcement Litigation, and the Non-EL Lead Party shall [***].  When a Lead EL Party is controlling a matter, [***] shall have the right to [***] the Enforcement Litigation, and [***] and [***] shall provide [***] to the [***] to facilitate [***] unless [***] will be provided [***].

(iii)                               The Parties and their counsel shall [***] Enforcement Litigation [***] recognizing [***] to the Enforcement Litigation.  Counsel to the Parties shall [***] Enforcement Litigation [***] Enforcement Litigation [***] as needed, but no [***].  When a Lead EL Party is controlling a matter, it shall [***] with regard to claims, arguments and strategy in the Enforcement Litigation; provided, however, that if the Parties do not promptly reach agreement on a particular strategy or pleading, then either Party may [***] (in the case of [***] and, in the case of [***] to resolve the matter.  If the matter is not resolved [***] (or such shorter time period as may be necessary to meet a court deadline) [***], then the Lead EL Party shall have the right to [***] shall have the right [***] but shall continue to [***] and to [***].

(iv)                              All Legal Expenses related to an Enforcement Litigation matter [***] with respect to a Product (including any [***] and any recoveries obtained as a result of such Enforcement Litigation shall be allocated between the Parties in accordance with their respective Allocable Legal Expense Shares.  Further, for the avoidance of doubt, [***] that the Parties shall [***] an Enforcement Litigation matter, a Party shall [***] pursuant to Section 5.4(d).

(d)                                 [***] Enforcement Litigation.

(i)                                     If the Parties do not [***] on initiating an Enforcement Litigation matter within [***] (or a shorter period of time if the circumstances warrant immediate action) following notification by one Party to the other Party of any known or suspected infringement or unauthorized use of any of the [***], then the Party [***] such Enforcement Litigation, if such Party is [***] the Patent Rights at issue or if the enforcement action involves [***], shall have the right to determine whether or not to proceed with any Enforcement Litigation.  If such party determines to proceed with the Enforcement Litigation, such Party (hereinafter the “Active EL Party”) shall have the sole and exclusive right to select counsel for the Enforcement Litigation initiated by it pursuant to this Section 5.4(d).  The Party that is not the Active EL Party shall be referred to under this Section 5.4(d) as the “Passive EL Party”.

Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for confidential treatment and have been filed separately with the Securities and Exchange Commission.

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