REPLIGEN CORP (Form: 10-Q, Received: 05/05/2016 14:58:11)

Large accelerated filer

Accelerated filer

Non-accelerated filer

¨ (Do not check if a smaller reporting company)

Smaller reporting company

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 10-Q

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

¨	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 000-14656

REPLIGEN CORPORATION

(Exact name of registrant as specified in its charter)


Delaware		04-2729386
(State or other jurisdiction of incorporation or organization)		(I.R.S. Employer Identification No.)

41 Seyon Street, Bldg. 1, Suite 100 Waltham, MA		02453
(Address of principal executive offices)		(Zip Code)

Registrant’s telephone number, including area code: (781) 250-0111

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 ¨

Indicate by check mark whether the registrant has submitted electronically and posted on its corporate website, 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 ¨

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 the 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 ¨ No x

Indicate the number of shares outstanding of each of the issuer’s classes of common stock, as of April 29, 2016.


Class		Number of Shares
Common Stock, par value $.01 per share		33,638,643

Table of Contents


		PAGE
PART I	FINANCIAL INFORMATION

Item 1.	Unaudited Condensed Consolidated Financial Statements

	Condensed Consolidated Balance Sheets as of March 31, 2016 and December 31, 2015		3

	Condensed Consolidated Statements of Comprehensive Income (Loss) for the Three-Month Periods Ended March 31, 2016 and 2015		4

	Condensed Consolidated Statements of Cash Flows for the Three-Month Periods Ended March 31, 2016 and 2015		5

	Notes to Unaudited Condensed Consolidated Financial Statements		6

Item 2.	Management’s Discussion and Analysis of Financial Condition and Results of Operations		18

Item 3.	Quantitative and Qualitative Disclosures About Market Risk		23

Item 4.	Controls and Procedures		24

PART II	OTHER INFORMATION		25

Item 1.	Legal Proceedings		25

Item 1A.	Risk Factors		25

Item 2.	Unregistered Sales of Equity Securities and Use of Proceeds		25

Item 3.	Defaults Upon Senior Securities		26

Item 4.	Mine Safety Disclosures		26

Item 5.	Other Information		26

Item 6.	Exhibits		26

Signatures			28

REPLIGEN CORPORATION

CONDENSED CONSOL IDATED BALANCE SHEETS

(Unaudited)


(in thousands, except share data)	March 31, 2016			December 31, 2015
Assets
Current assets:
Cash and cash equivalents	$	53,213		$	54,092
Marketable securities		16,482			17,682
Accounts receivable, less reserve for doubtful accounts of $19 and $31, respectively		12,574			11,300
Other receivables		331			82
Inventories		21,318			17,998
Prepaid expenses and other current assets		1,327			2,098

Total current assets		105,245			103,252

Property, plant and equipment, net		13,611			13,801
Long-term marketable securities		1,217			1,633
Intangible assets, net		12,455			12,755
Goodwill		14,346			14,346
Restricted cash		450			450

Total assets	$	147,324		$	146,237

Liabilities and stockholders’ equity
Current liabilities:
Accounts payable	$	5,144		$	6,724
Accrued liabilities		10,677			12,057

Total current liabilities		15,821			18,781
Other long-term liabilities		2,617			4,708
Commitments and contingencies (Note 11)
Stockholders’ equity:
Preferred stock, $.01 par value, 5,000,000 shares authorized, no shares issued or outstanding		—			—
Common stock, $.01 par value, 80,000,000 shares authorized, 33,097,903 shares at March 31, 2016 and 32,949,353 shares at December 31, 2015 issued and outstanding		331			329
Additional paid-in capital		205,142			202,527
Accumulated other comprehensive loss		(6,670	)		(8,566	)
Accumulated deficit		(69,917	)		(71,542	)

Total stockholders’ equity		128,886			122,748

Total liabilities and stockholders’ equity	$	147,324		$	146,237

The accompanying notes are an integral part of these condensed consolidated financial statements.

REPLIGEN CORPORATION

CONDENSED CONSOLIDATED STAT EMENTS OF COMPREHENSIVE INCOME (LOSS)

(Unaudited)


(in thousands, except share and per share data)	Three months ended March 31,
	2016			2015
Product revenue	$	25,094		$	20,816
Operating expenses:
Cost of product revenue		11,069			8,073
Research and development		1,539			1,568
Selling, general and administrative		7,018			6,026
Contingent consideration – fair value adjustments		2,005			1,111

Total operating expenses		21,631			16,778

Income from operations		3,463			4,038
Investment income		61			37
Interest expense		(5	)		(9	)
Other income (expense)		(979	)		132

Income before income taxes		2,540			4,198
Income tax provision		915			1,268

Net income	$	1,625		$	2,930

Earnings per share:
Basic	$	0.05		$	0.09

Diluted	$	0.05		$	0.09

Weighted average shares outstanding:
Basic		33,024,681			32,754,862

Diluted		33,493,575			33,450,611

Other comprehensive income:
Unrealized gain (loss) on investments		15			(17	)
Foreign currency translation gain (loss)		1,881			(3,849	)

Comprehensive income (loss)	$	3,521		$	(936	)

The accompanying notes are an integral part of these condensed consolidated financial statements.

REPLIGEN CORPORATION

CONDENSED CONSOLID ATED STATEMENTS OF CASH FLOWS

(Unaudited)


(In thousands)	Three months ended March 31,
	2016			2015
Cash flows from operating activities:
Net income	$	1,625		$	2,930
Adjustments to reconcile net income to net cash used in operating activities:
Depreciation and amortization		1,150			1,150
Stock-based compensation expense		922			702
Deferred tax expense		—			87
Loss on revaluation of contingent consideration		2,005			1,111
Loss on disposal of assets		3			—
Changes in assets and liabilities:
Accounts receivable		(1,149	)		(7,237	)
Other receivables		(249	)		(155	)
Inventories		(3,092	)		(514	)
Prepaid expenses and other current assets		781			314
Accounts payable		(1,600	)		435
Accrued liabilities		(4,277	)		1,380
Long-term liabilities		70			(2,508	)

Net cash used in operating activities		(3,811	)		(2,305	)

Cash flows from investing activities:
Purchases of marketable securities		(3,969	)		(3,287	)
Redemptions of marketable securities		5,600			4,838
Purchases of property, plant and equipment		(431	)		(1,272	)

Net cash provided by investing activities		1,200			279

Cash flows from financing activities:
Exercise of stock options		821			402
Payment of contingent considerations		(498	)		(99	)

Net cash provided by financing activities		323			303

Effect of exchange rate changes on cash and cash equivalents		1,409			(2,430	)

Net increase (decrease) in cash and cash equivalents		(879	)		(4,153	)
Cash and cash equivalents, beginning of period		54,092			35,363

Cash and cash equivalents, end of period	$	53,213		$	31,210

Supplemental disclosure of non-cash activities:
Income taxes paid	$	1,039		$	1,100

Payment of contingent consideration in common stock	$	875		$	—

The accompanying notes are an integral part of these condensed consolidated financial statements.

REPLIGEN CORPORATION

NOTES TO CONDENSED CONS OLIDATED FINANCIAL STATEMENTS

(Unaudited)

1. Basis of Presentation

The consolidated financial statements included herein have been prepared by Repligen Corporation (the “Company,” “Repligen” or “we”) in accordance with generally accepted accounting principles in the United States (“U.S. GAAP”) and pursuant to the rules and regulations of the Securities and Exchange Commission (“SEC”), for Quarterly Reports on Form 10-Q and Article 10 of Regulation S-X and do not include all of the information and footnote disclosures required by U.S. GAAP. These consolidated financial statements should be read in conjunction with the audited consolidated financial statements and accompanying notes thereto included in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2015.

The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates.

The consolidated financial statements include the accounts of the Company and its wholly-owned subsidiaries, Repligen Sweden AB and Repligen Singapore Pte. Ltd. All significant intercompany accounts and transactions have been eliminated in consolidation.

In the opinion of management, the accompanying unaudited consolidated financial statements include all adjustments, consisting of only normal, recurring adjustments necessary for a fair presentation of the financial position, results of operations and cash flows. The results of operations for the interim periods presented are not necessarily indicative of results to be expected for the entire year.

Recently Issued Accounting Pronouncements

In May 2014, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) No. 2014-09, “Revenue from Contracts with Customers (Topic 606),” which supersedes the revenue recognition requirements in Accounting Standards Codification Topic 605, Revenue Recognition , and creates a new Topic 606, Revenue from Contracts with Customers . Two adoption methods are permitted: retrospectively to all prior reporting periods presented, with certain practical expedients permitted; or retrospectively with the cumulative effect of initially adopting the ASU recognized at the date of initial application. The FASB has issued several updates to this ASU. In August 2015, the FASB issued ASU 2015-14, “Revenue from Contracts with Customers (Topic 606): Deferral of the Effective Date,” which deferred the effective date of ASU 2014-09 to annual reporting periods beginning after December 15, 2017. Early adoption is permitted as of annual reporting periods beginning after December 15, 2016. In March 2016, the FASB issued ASU 2016-08, “Revenue from Contracts with Customers (Topic 606): Principal versus Agent Considerations (Reporting Revenue Gross versus Net),” which clarifies the implementation guidance on principal versus agent considerations. Additionally, in April 2016, the FASB issued ASU 2016-10, “Revenue from Contracts with Customers (Topic 606): Identifying Performance Obligations and Licensing,” which clarifies the implementation guidance on identifying performance obligations in a contract and determining whether an entity’s promise to grant a license provides a customer with either a right to use the entity’s intellectual property (which is satisfied at a point in time) or a right to access the entity’s intellectual property (which is satisfied over time). The Company has not yet determined which adoption method it will utilize or the effect that the adoption of this guidance will have on its consolidated financial statements.

In July 2015, the FASB issued ASU 2015-11, “Inventory (Topic 330): Simplifying the Measurement of Inventory.” (“ASU 2015-11”) ASU 2015-11 requires inventory be measured at the lower of cost and net realizable value, and options that currently exist for market value be eliminated. ASU 2015-11 defines net realizable value as estimated selling prices in the ordinary course of business, less reasonably predictable costs of completion, disposal, and transportation. The guidance is effective prospectively for reporting periods beginning after December 15, 2016 and interim periods within those fiscal years with early adoption permitted. The Company does not expect the adoption of ASU 2015-11 to have a material impact on its consolidated financial statements.

In February 2016, the FASB issued ASU No. 2016-02, “Leases (Topic 842).” (“ASU 2016-02”) ASU 2016-02 requires lessees to recognize a right-of-use asset and a lease liability for most leases. Extensive quantitative and qualitative disclosures, including significant judgments made by management, will be required to provide greater insight into the extent of revenue and expense recognized and expected to be recognized from existing contracts. The accounting applied by a lessor is largely unchanged from that applied under the current standard. The standard must be adopted using a modified retrospective transition approach and provides for certain practical expedients. The ASU is effective for public entities for fiscal years beginning after December 15, 2018, with early adoption permitted. The Company has not yet completed its assessment of the impact of the new standard on its consolidated financial statements.

In March 2016, the FASB issued ASU No. 2016-09, “Compensation—Stock Compensation (Topic 718): Improvements to Employee Share-Based Payment Accounting”, which aims to simplify several aspects of the accounting for share-based payment transactions, including the income tax consequences, classification of awards as either equity or liabilities, classification of certain items on the statement of cash flows and accounting for forfeitures. The ASU is effective for public entities for fiscal years beginning after December 15, 2016, with early adoption permitted. The Company has not yet completed its assessment of the impact of the new standard on its consolidated financial statements.

2. Revenue Recognition

Product Sales

The Company’s revenue recognition policy is to recognize revenues from product sales and services in accordance with ASC 605, Revenue Recognition . These standards require that revenues are recognized when persuasive evidence of an arrangement exists, product delivery, including customer acceptance when required, has occurred or services have been rendered, the price is fixed or determinable and collectability is reasonably assured. Determination of whether these criteria have been met are based on management’s judgments primarily regarding the fixed nature of the fee charged for the product delivered and the collectability of those fees. The Company has a few longstanding customers who comprise the majority of revenue and have excellent payment histories and therefore the Company does not require collateral. The Company has had no significant write-offs of uncollectible invoices in the periods presented. When more than one element such as equipment, consumables, and services are contained in a single arrangement, the Company allocates revenue between the elements based on each element’s relative selling price, provided that each element meets the criteria for treatment as a separate unit of accounting. An item is considered a separate unit of accounting if it has value to the customer on a stand-alone basis. The selling price of the undelivered elements is determined by the price charged when the element is sold separately, or in cases when the item is not sold separately, by third-party evidence of selling price or management’s best estimate of selling price.

The Company’s product revenues are from the sale of bioprocessing products, equipment devices, and related consumables used with these equipment devices to customers in the life science and biopharmaceutical industries. On product sales to end customers, revenue is recognized, net of discounts, when both the title and risk of loss have transferred to the customer, as determined by the shipping terms provided there are no uncertainties regarding acceptance, and all obligations have been completed. Generally, our product arrangements for equipment sales are multiple element arrangements, and may include services, such as installation and training, and multiple products, such as consumables and spare parts. In accordance with ASC 605-25, based on terms and conditions of the product arrangements, the Company believes that these services and undelivered products can be accounted for separately from the delivered product element, as the delivered products have value to our customers on a standalone basis. Accordingly, revenue for services not yet performed at the time of product shipment are deferred and recognized as such services are performed. The relative selling price of any undelivered products is also deferred at the time of shipment and recognized as revenue when these products are delivered. For product sales to distributors, the Company recognizes revenue for both equipment and consumables upon delivery to the distributor unless direct shipment to the end user is requested. In this case, revenue is recognized upon delivery to the end user’s location. In general, distributors are responsible for shipment to the end customer along with installation, training and acceptance of the equipment by the end customer. Sales to distributors are not contingent upon resale of the product.

At the time of sale, the Company also evaluates the need to accrue for warranty and sales returns. The supply agreements the Company has with its customers and the related purchase orders identify the terms and conditions of each sale and the price of the goods ordered. Due to the nature of the sales arrangements, inventory produced for sale is tested for quality specifications prior to shipment. Since the product is manufactured to order and in compliance with required specifications prior to shipment, the likelihood of sales return, warranty or other issues is largely diminished. Furthermore, there is no customer right of return in our sales agreements. Sales returns and warranty issues are infrequent and have not had a material impact on the Company’s financial statements historically.

Shipping and handling fees are recorded as a component of product revenue, with the associated costs recorded as a component of cost of product revenue.

Therapeutics Licensing Agreements

Activities under licensing agreements are evaluated in accordance with ASC 605-25 to determine if they represent a multiple element revenue arrangement. The Company identifies the deliverables included within the agreement and evaluates which deliverables represent separate units of accounting. The Company accounts for those components as separate units of accounting if the following two criteria are met:

•

The delivered item or items have value to the customer on a stand-alone basis.

•

If there is a general right of return relative to the delivered items, delivery or performance of the undelivered items is considered probable and within the Company’s control.

Factors considered in this determination include, among other things, whether any other vendors sell the items separately and if the licensee could use the delivered item for its intended purpose without the receipt of the remaining deliverables. If multiple deliverables included in an arrangement are separable into different units of accounting, the Company allocates the arrangement consideration to those units of accounting. The amount of allocable arrangement consideration is limited to amounts that are fixed or determinable. Arrangement consideration is allocated at the inception of the arrangement to the identified units of accounting based on their relative selling price. Revenue is recognized for each unit of accounting when the appropriate revenue recognition criteria are met.

Future milestone payments, if any, under a license agreement will be recognized under the provisions of ASC 605-28, which the Company adopted on January 1, 2011. The Company has elected to recognize a payment that is contingent upon the achievement of a substantive milestone in its entirety in the period in which the milestone is achieved. A milestone is substantive if:

•

It can only be achieved based in whole or in part on either the Company’s performance or the occurrence of a specific outcome resulting from the Company’s performance;

•

There is substantive uncertainty at the date an arrangement is entered into that the event will be achieved; and

•

It would result in additional payments being due to the entity.

The commercial milestone payments and royalty payments received under license agreements, if any, will be recognized as revenue when they are earned.

Sale of Intellectual Property to BioMarin

In January 2014, the Company entered into an asset purchase agreement (the “BioMarin Asset Purchase Agreement”) with BioMarin Pharmaceutical Inc. (“BioMarin”) to sell Repligen’s histone deacetylase inhibitor (HDACi) portfolio. Pursuant to the terms of the BioMarin Asset Purchase Agreement, the Company received $2 million from BioMarin as an upfront payment on January 30, 2014 and a $125,675 payment on September 3, 2014 upon completion of the Technology Transfer. The Company is entitled to receive up to $160 million in potential future milestone payments for the development, regulatory approval and commercial sale of portfolio compounds included in the agreement. These potential milestone payments are approximately 37% related to clinical development and 63% related to initial commercial sales in specific geographies. In addition, Repligen is eligible to receive royalties on sales of therapeutic products originating from the HDACi portfolio. The royalty rates are tiered and begin in the mid-single-digits for the first HDACi portfolio product and for the first non-HDACi portfolio product with lesser amounts for any backup products developed under the BioMarin Asset Purchase Agreement. Repligen’s receipt of these royalties is subject to customary offsets and deductions. There are no refund provisions in this agreement. Any milestones earned upon specified clinical development or commercial sales events or future royalty payments, under the BioMarin Asset Purchase Agreement will be recognized as revenue when they are earned.

Activities under this agreement were evaluated in accordance with ASC 605-25 to determine if they represented a multiple element revenue arrangement. The Company identified the following deliverables in the BioMarin agreement:

•

The assignment by Repligen to BioMarin of the Repligen Technology (“Repligen Know-How” and “Repligen Patents”) and the Scripps Agreement (the “Transferred Assets”);

•

The transfer of certain notebooks, data, documents, biological materials (if any) and other such documents in our possession that might be useful to further development of the program (the “Technology Transfer”).

Two criteria must be met in order for a deliverable to be considered a separate unit of accounting. The first criterion requires that the delivered item or items have value to the customer on a stand-alone basis. The second criterion, which relates to evaluating a general right of return, is not applicable because such a provision does not exist in the BioMarin Asset Purchase Agreement. The deliverables outlined above were deemed to have stand-alone value and to meet the criteria to be accounted for as separate units of accounting. Factors considered in this determination included, among other things, BioMarin’s right under the agreement to assign the Transferred Assets, whether any other vendors sell the items separately and if BioMarin could use the delivered item for its intended purpose without the receipt of the remaining deliverables. If multiple deliverables included in an arrangement are separable into different units of accounting, the multiple-element arrangements guidance addresses how to allocate the arrangement consideration to those units of accounting. The amount of allocable arrangement consideration is limited to amounts that are fixed or determinable. Arrangement consideration is allocated at the inception of the arrangement to the identified units of accounting based on their relative selling price.

The Company identified the arrangement consideration to allocate among the units of accounting as the $2.0 million non-refundable up-front payment and the $125,675 payment to be received upon completion of the Technology Transfer. The Company excluded the potential milestone payments provided for in the BioMarin Asset Purchase Agreement from the arrangement consideration as they were not considered fixed or determinable at the time the BioMarin Asset Purchase Agreement was signed. Because Repligen had not

sold these items on a standalone basis previously, Repligen had no vendor-specific objective evidence of selling price. Furthermore, Repligen did not have detailed third-party evidence of selling price, and as a result we used our best estimate of selling price for each item. In determining these prices, Repligen considered what Repligen would be willing to sell the items for on a standalone basis, what the market would bear for such items and what another party might charge for these items.

The up-front arrangement consideration allocated to the Transferred Assets was recognized upon execution of the BioMarin Asset Purchase Agreement as the risks and rewards associated with the Transferred Assets transferred at that time. The Company used a discounted cash flow analysis to determine the value of the Transferred Assets. Key assumptions in the analysis included: the estimated market size for a compound targeted at Friedreich’s Ataxia, the estimated remaining costs of development and time to commercialization, and the probability of successfully developing and commercializing the program. Based on this analysis, the Company allocated $2,115,000 to the value of the Transferred Assets. However, as the recognized revenue is limited to the non-contingent consideration received, the Company recognized $2,000,000, the amount of the up-front payment, as revenue in the three months ended March 31, 2014.

In addition to the $2.1 million up-front payment, the Company is also eligible to receive up to $160 million in potential milestone payments from BioMarin comprised of:

•

Up to $60 million related to the achievement of specified clinical and regulatory milestone events; and

•

Up to $100 million related to the achievement of specified commercial sales events, specifically the first commercial sale in specific territories.

The Company evaluated the potential milestones in accordance with ASC 605-28, which allows an entity to make an accounting policy election to recognize a payment that is contingent upon the achievement of a substantive milestone in its entirety in the period in which the milestone is achieved. This evaluation included an assessment of the risks that must be overcome to achieve the respective milestone as well as whether the achievement of the milestone was due in part to our initial clinical work, the level of effort and investment required to achieve the respective milestone and whether the milestone consideration is reasonable relative to all deliverables and payment terms in the arrangement. There is considerable judgment involved in determining whether a milestone satisfies all of the criteria required to conclude that a milestone is substantive. Milestones that are not considered substantive are recognized as earned if there are no remaining performance obligations or over the remaining period of performance, assuming all other revenue recognition criteria are met.

The Company believes that the $60 million of specified clinical and regulatory milestone payments are substantive. Therefore, any such milestones achieved will be recognized as revenue when earned.

Any milestones achieved upon specified commercial sales events or future royalty payments are considered contingent revenue under the BioMarin Asset Purchase Agreement, and will be recognized as revenue when they are earned as there are no undelivered elements remaining and no continuing performance obligations under the arrangement.

3. Accumulated Other Comprehensive Income

The following table summarizes the changes in accumulated other comprehensive income by component (in thousands):


(In thousands)	Unrealized gain (loss) on investments			Foreign currency translation gain (loss)			Total
Balance at December 31, 2015	$	(11	)	$	(8,555	)	$	(8,566	)
Other comprehensive income		15			1,881			1,896

Balance at March 31, 2016	$	4		$	(6,674	)	$	(6,670	)

4. Earnings Per Share

The Company reports earnings per share in accordance with Accounting Standards Codification Topic 260, “Earnings Per Share,” which establishes standards for computing and presenting earnings per share. Basic earnings per share is computed by dividing net income available to common shareholders by the weighted-average number of common shares outstanding during the period. Diluted earnings per share is computed by dividing net income available to common shareholders by the weighted-average number of common shares and dilutive common share equivalents then outstanding. Potential common share equivalents consist of restricted stock awards and the incremental common shares issuable upon the exercise of stock options. Under the treasury stock method,

unexercised “in-the-money” stock options and warrants are assumed to be exercised at the beginning of the period or at issuance, if later. The assumed proceeds are then used to purchase common shares at the average market price during the period. Share-based payment awards that entitle their holders to receive non-forfeitable dividends before vesting are considered participating securities and are considered in the calculation of basic and diluted earnings per share. There were no such participating securities outstanding during the three-month periods ended March 31, 2016 and 2015.

Basic and diluted weighted average shares outstanding were as follows:


	Three Months Ended March 31,
	2016		2015
Weighted average common shares		33,024,681		32,754,862
Dilutive common stock options and restricted stock units		468,894		695,749

Weighted average common shares, assuming dilution		33,493,575		33,450,611

At March 31, 2016, there were outstanding options to purchase 1,312,508 shares of the Company’s common stock at a weighted average exercise price of $11.50 per share. For the three-month period ended March 31, 2016, 520,030 options to purchase shares of the Company’s common stock were excluded from the calculation of diluted earnings per share because the exercise prices of the stock options were greater than or equal to the average price of the common shares, and were therefore anti-dilutive.

At March 31, 2015, there were outstanding options to purchase 1,295,312 shares of the Company’s common stock at a weighted average exercise price of $9.44 per share. For the three-month period ended March 31, 2015, 199,580 options to purchase shares of the Company’s common stock were excluded from the calculation of diluted earnings per share because the exercise prices of the stock options were greater than or equal to the average price of the common shares, and were therefore anti-dilutive.

5. Cash, Cash Equivalents and Marketable Securities

At March 31, 2016 and December 31, 2015, the Company’s investments included money market funds as well as short-term and long-term marketable securities. These marketable securities are classified as available-for-sale. Marketable securities are investments with original maturities of greater than 90 days. Long-term marketable securities are securities with maturities of greater than one year. The average remaining contractual maturity of marketable securities at March 31, 2016 is approximately 4.12 months.

Management reviewed the Company’s investments as of March 31, 2016 and December 31, 2015 and concluded that there are no securities with other than temporary impairments in the investment portfolio. The Company does not intend to sell any investments in an unrealized loss position, and it is not more likely than not that the Company will be required to sell the investments before recovery of their amortized cost bases.

Investments in marketable securities consisted of the following at March 31, 2016 (in thousands):


	March 31, 2016
	Amortized Cost		Gross Unrealized Gain		Gross Unrealized Loss			Fair Value
Marketable securities:
U.S. Government and agency securities	$	5,778	$	—	$	—		$	5,778
Corporate and other debt securities		10,700		7		(3	)		10,704

		16,478		7		(3	)		16,482
Long-term marketable securities:
U.S. Government and agency securities		417		—		—			417
Corporate and other debt securities		800		—		—			800

		1,217		—		—			1,217

Total	$	17,695	$	7	$	(3	)	$	17,699

At March 31, 2016, the Company’s investments included sixteen securities in unrealized loss positions with a total unrealized loss of approximately $3,000 and a total fair market value of approximately $6,122,000. All investments with gross unrealized losses have been in unrealized loss positions for less than 12 months. The unrealized losses were caused primarily by current economic and market conditions. There was no change in the credit risk of the securities. There were no realized gains or losses on the investments for the three months ended March 31, 2016 or the three months ended March 31, 2015.

Investments in marketable securities consisted of the following at December 31, 2015 (in thousands):


	December 31, 2015
	Amortized Cost		Gross Unrealized Gain		Gross Unrealized Loss			Fair Value
Marketable securities:
U.S. Government and agency securities	$	7,029	$	—	$	(6	)	$	7,023
Corporate and other debt securities		10,659		7		(7	)		10,659

		17,688		7		(13	)		17,682
Long-term marketable securities:
U.S. Government and agency securities		838		—		(2	)		836
Corporate and other debt securities		800		—		(3	)		797

		1,638		—		(5	)		1,633

Total	$	19,326	$	7	$	(18	)	$	19,315

The contractual maturities of money market funds and marketable securities at March 31, 2016 were as follows:


	Amortized Cost		Fair Value
Due in 1 year or less	$	16,478	$	16,482
Due in 1 to 2 years		1,217		1,217

	$	17,695	$	17,699

6. Inventories

Inventories relate to the Company’s bioprocessing business. The Company values inventory at cost or, if lower, market value, using the first-in, first-out method. The Company reviews its inventories at least quarterly and records a provision for excess and obsolete inventory based on its estimates of expected sales volume, production capacity and expiration dates of raw materials, work-in-process and finished products. Expected sales volumes are determined based on supply forecasts provided by key customers for the next 3 to 12 months. The Company writes down inventory that has become obsolete, inventory that has a cost basis in excess of its expected net realizable value, and inventory in excess of expected requirements to cost of product revenue. Manufacturing of bioprocessing finished goods is done to order and tested for quality specifications prior to shipment. Reserves for excess and obsolete inventory were approximately $343,000 at March 31, 2016 and December 31, 2015.

A change in the estimated timing or amount of demand for the Company’s products could result in additional provisions for excess inventory quantities on hand. Any significant unanticipated changes in demand or unexpected quality failures could have a significant impact on the value of inventory and reported operating results. During all periods presented in the accompanying financial statements, there have been no material adjustments related to a revised estimate of inventory valuations.

Work-in-process and finished products inventories consist of material, labor, outside processing costs and manufacturing overhead. Inventories consist of the following (in thousands):


	March 31, 2016		December 31, 2015
Raw Materials	$	12,576	$	10,671
Work-in-process		3,387		1,586
Finished products		5,355		5,741

Total	$	21,318	$	17,998

7. Property, Plant and Equipment

Property, plant and equipment consist of the following (in thousands):


	March 31, 2016			December 31, 2015
Leasehold improvements	$	13,365		$	13,306
Equipment		14,418			13,758
Furniture and fixtures		2,961			2,808
Construction in progress		282			425

Total property, plant and equipment		31,026			30,297
Less: accumulated depreciation		(17,415	)		(16,496	)

Property, plant and equipment, net	$	13,611		$	13,801

Depreciation expense totaled approximately $751,000 and $749,000 for the three-month periods ended March 31, 2016 and 2015, respectively.

8. Intangible Assets

Intangible assets, except for the Refine Technology, LLC tradename and in-process research and development, are amortized over their useful lives using the estimated economic benefit method, as applicable, and the amortization expense is recorded within selling, general and administrative expense in the Company’s statements of comprehensive income (loss). The Refine Technology, LLC tradename and in-process research and development are not amortized. The Company reviews its indefinite-lived intangible assets not subject to amortization to determine if adverse conditions exist or a change in circumstances exists that would indicate an impairment. Intangible assets and their related useful lives are reviewed at least annually to determine if any adverse conditions exist that would indicate the carrying value of these assets may not be recoverable. More frequent impairment assessments are conducted if certain conditions exist, including a change in the competitive landscape, any internal decisions to pursue new or different technology strategies, a loss of a significant customer, or a significant change in the marketplace, including changes in the prices paid for our products or changes in the size of the market for our products. An impairment results if the carrying value of the asset exceeds the estimated fair value of the asset. If the estimate of an intangible asset’s remaining useful life is changed, the remaining carrying amount of the intangible asset is amortized prospectively over the revised remaining useful life. The Company continues to believe that its intangible assets are recoverable at March 31, 2016.

Intangible assets consisted of the following at March 31, 2016 (in thousands):


	Gross Carrying Amount		Accumulated Amortization			Weighted Average Useful Life (in years)
Technology – developed	$	3,315	$	(854	)		12
In process research and development		1,600		—			—
Patents		240		(185	)		8
Customer relationships		11,985		(4,346	)		9
Trademark/ tradename		700		—			—

Total intangible assets	$	17,840	$	(5,385	)		10

Intangible assets consisted of the following at December 31, 2015 (in thousands):


	Gross Carrying Amount		Accumulated Amortization			Weighted Average Useful Life (in years)
Technology – developed	$	3,295	$	(782	)		12
In process research and development		1,600		—			—
Patents		240		(177	)		8
Customer relationships		11,805		(3,926	)		9
Trademark/ tradename		700		—			—

Total intangible assets	$	17,640	$	(4,885	)		10

Amortization expense for amortized intangible assets was approximately $399,000 and $401,000 for the three months ended March 31, 2016 and 2015, respectively. As of March 31, 2016, the Company expects to record amortization expense as follows (in thousands):


Years Ending	Amortization Expense
December 31, 2016 (nine months remaining)	$	1,279
December 31, 2017		1,705
December 31, 2018		1,541
December 31, 2019		1,526
December 31, 2020		1,190

9. Accrued Liabilities

Accrued liabilities consist of the following (in thousands):


	March 31, 2016		December 31, 2015
Employee compensation	$	2,888	$	4,680
Taxes		9		166
Current portion of contingent consideration		4,168		4,480
Professional fees		485		269
Unearned revenue		411		258
Other accrued expenses		2,716		2,204

Total	$	10,677	$	12,057

10. Stock-Based Compensation

For the three months ended March 31, 2016 and 2015, the Company recorded stock-based compensation expense of approximately $922,000 and $702,000, respectively, for share-based awards granted under the Second Amended and Restated 2001 Repligen Corporation Stock Plan (the “2001 Plan”) and the Repligen Corporation Amended and Restated 2012 Stock Option and Incentive Plan (the “2012 Plan,” and collectively with the 2001 Plan and the 1992 Repligen Corporation Stock Option Plan, the “Plans”).

The following table presents stock-based compensation expense included in the Company’s consolidated statements of comprehensive income (loss):


	Three Months Ended March 31,
	2016		2015
Cost of product revenue	$	60	$	43
Research and development		80		69
Selling, general and administrative		782		590

Total	$	922	$	702

The 2012 Plan allows for the granting of incentive and nonqualified options to purchase shares of common stock, restricted stock and other equity awards. Incentive options granted to employees under the Plans generally vest over a three to five-year period, with 20%-33% vesting on the first anniversary of the date of grant and the remainder vesting in equal yearly installments thereafter. Nonqualified options issued to non-employee directors under the Plans generally vest over one year. Options granted under the Plans have a maximum term of ten years from the date of grant and generally, the exercise price of the stock options equals the fair market value of the Company’s common stock on the date of grant. At March 31, 2016, options to purchase 1,312,508 shares were outstanding under the Plans. At March 31, 2016, 2,085,727 shares were available for future grant under the 2012 Plan.

The Company uses the Black-Scholes option pricing model to calculate the fair value of stock option awards on the grant date, and the Company uses the value of the common stock as of the grant date to value restricted stock units. The Company measures stock-based compensation cost at the grant date based on the estimated fair value of the award, and recognizes awards with service based vesting as expense over the employee’s requisite service period on a straight-line basis. The Company records the expense for share-based awards subject to performance-based milestone vesting over the remaining service period when management determines that achievement of the milestone is probable. Management evaluates whether the achievement of a performance-based milestone is probable as of the reporting date. The Company has no awards that are performance-based or subject to market conditions. The Company recognizes stock-based compensation expense for options that are ultimately expected to vest, and accordingly, such compensation expense has been adjusted for estimated forfeitures.

Information regarding option activity for the three months ended March 31, 2016 under the Plans is summarized below:


	Options Outstanding			Weighted- Average Exercise Price Per Share		Weighted- Average Remaining Contractual Term (in years)		Aggregate Intrinsic Value (in thousands)
Options outstanding at January 1, 2016		1,240,935		$	10.44
Granted		244,220			13.44
Exercised		(113,747	)		6.86
Forfeited/Cancelled		(58,900	)		6.15

Options outstanding at March 31, 2016		1,312,508		$	11.50		7.34	$	20,679

Options exercisable at March 31, 2016		517,769		$	7.91		5.11	$	9,792

Vested and expected to vest at March 31, 2016 (1)		1,221,408		$	11.61		7.26	$	19,133

⁽¹⁾

This represents the number of vested options as of March 31, 2016 plus the number of unvested options expected to vest as of March 31, 2016 based on the unvested outstanding options at March 31, 2016 adjusted for estimated forfeiture rates of 8% for awards granted to non-executive level employees and 3% for awards granted to executive level employees.

The aggregate intrinsic value in the table above represents the total pre-tax intrinsic value (the difference between the closing price of the common stock on March 31, 2016 of $26.82 and the exercise price of each in-the-money option) that would have been received by the option holders had all option holders exercised their options on March 31, 2016.

The weighted average grant date fair value of options granted during the three months ended March 31, 2016 and 2015 was $19.57 and $19.67, respectively. The total fair value of stock options that vested during the three months ended March 31, 2016 and 2015 was approximately $1,387,000 and $671,000, respectively.

As of March 31, 2016, there was approximately $9,764,000 of total unrecognized compensation cost related to unvested share-based awards. This cost is expected to be recognized over a weighted average remaining requisite service period of 2.93 years. The Company expects 703,639 unvested options to vest over the next five years.

11. Income Taxes

For the three months ended March 31, 2016, the Company had income before taxes of approximately $2,540,000 and recorded a tax provision of approximately $915,000 for an effective tax rate of approximately 36.0%. For the three months ended March 31, 2015, the Company had income before taxes of approximately $4,198,000 and recorded a tax provision of $1,268,000 for an effective tax rate of approximately 30.2%. This was based on expected effective tax rates of 26.5% and 25.9% for the years ending December 31, 2016 and 2015, respectively. The effective income tax rate is based upon the forecasted income by jurisdiction. The effective tax rate for the three months ended March 31, 2016 is higher than the U.S. statutory tax rate mainly due to the tax treatment of contingent consideration expense. The effective tax rate for the three months ended March 31, 2015 is lower than the U.S. statutory tax rate due to the lower statutory tax rate in Sweden.

The Company has net operating loss carryforwards of approximately $46,984,000 and business tax credit carryforwards of approximately $1,920,000 available to reduce future federal income taxes, if any. The net operating loss and business tax credits carryforwards will continue to expire at various dates through December 2035. Net operating loss carryforwards and available tax credits are subject to review and possible adjustment by the Internal Revenue Service and may be limited in the event of certain changes in the ownership interest of significant stockholders.

As of December 31, 2015, we concluded that realization of deferred tax assets beyond December 31, 2015 is not more likely than not, and as such, as of December 31, 2015 we maintained a valuation allowance against the majority of our remaining deferred tax assets. As of March 31, 2016, we concluded that realization of deferred tax assets beyond March 31, 2016 is not more likely than not, and as such, as of March 31, 2016 we maintained a valuation allowance against the majority of our remaining deferred tax assets.

The fiscal years ended December 31, 2012, 2013, 2014 and 2015 are subject to examination by U.S. federal, state and Sweden taxing authorities.

12. Fair Value Measurement

In determining the fair value of its assets and liabilities, the Company uses various valuation approaches. The Company employs a hierarchy for inputs used in measuring fair value that maximizes the use of observable inputs and minimizes the use of unobservable inputs by requiring that observable inputs be used when available. Observable inputs are inputs that market participants would use in pricing the asset or liability based on market data obtained from sources independent of the Company. Unobservable inputs are inputs that reflect the Company’s assumptions about the inputs that market participants would use in pricing the asset or liability and are developed based on the best information available in the circumstances. The fair value hierarchy is broken down into three levels based on the source of inputs as follows:


Level 1 –		Valuations based on unadjusted quoted prices in active markets for identical assets or liabilities that the Company has the ability to access

Level 2 –		Valuations based on quoted prices for similar assets or liabilities in active markets, quoted prices for identical or similar assets or liabilities in markets that are not active and models for which all significant inputs are observable, either directly or indirectly

Level 3 –		Valuations based on inputs that are unobservable and significant to the overall fair value measurement

The availability of observable inputs can vary among the various types of financial assets and liabilities. To the extent that the valuation is based on models or inputs that are less observable or unobservable in the market, the determination of fair value requires more judgment. In certain cases, the inputs used to measure fair value may fall into different levels of the fair value hierarchy. In such cases, for financial statement disclosure purposes, the level in the fair value hierarchy within which the fair value measurement is categorized is based on the lowest level input that is significant to the overall fair value measurement.

The Company’s fixed income investments are comprised of obligations of U.S. government agencies and corporate marketable securities. These investments have been initially valued at the transaction price and subsequently valued, at the end of each reporting period, utilizing third party pricing services or other market observable data. The pricing services utilize industry standard valuation models, including both income and market based approaches and observable market inputs to determine value. These observable market inputs include reportable trades, benchmark yields, credit spreads, broker/dealer quotes, bids, offers, current spot rates and other industry and economic events. At least annually, the Company validates the prices provided by third party pricing services by reviewing their pricing methods and matrices, obtaining market values from other pricing sources, analyzing pricing data in certain instances and confirming that the relevant markets are active. The Company did not adjust or override any fair value measurements provided by the pricing services as of March 31, 2016.

The following fair value hierarchy table presents information about each major category of the Company’s assets measured at fair value on a recurring basis as of March 31, 2016 (in thousands):


	Fair value measurement at reporting date using:
	Quoted prices in active markets for identical assets (Level 1)		Significant other observable inputs (Level 2)		Significant unobservable inputs (Level 3)		Total
Assets:
Money market funds	$	11,331	$	—	$	—	$	11,331
U.S. Government and agency securities		5,896		300		—		6,196
Corporate and other debt securities		—		11,503		—		11,503

Total	$	17,227	$	11,803	$	—	$	29,030

Liabilities:
Contingent consideration – short-term		—		—		4,018		4,018
Contingent consideration – long-term		—		—		145		145

Total	$	—	$	—	$	4,163	$	4,163

The Company has no other assets or liabilities for which fair value measurement is either required or has been elected to be applied. The liabilities for contingent consideration recorded in connection with the BioFlash Partners, LLC (“BioFlash”) and Refine Technology, LLC (“Refine”) business combinations. The contingent consideration related to BioFlash is valued using management’s estimates of royalties to be paid to the former shareholders of BioFlash based on sales of the acquired assets. The contingent consideration related to the Refine is valued using management’s estimates of expected future milestone payments based on forecasted sales and a portion of any receipts that might be received in connection with the resolution, withdrawal or settlement of certain patent disputes with a third party to be paid to Refine. These valuations are Level 3 valuations as the primary inputs are unobservable.

Changes in the fair value of contingent consideration in the three-month period ended March 31, 2016 are primarily attributable to an increase to the expected 2016 Refine milestone payment of $1,999,000, a $4,350,000 milestone payment to Refine and a $130,000 minimum royalty payment made to BioFlash, which were previously accrued. The following table provides a rollforward of the fair value of the contingent consideration (in thousands):


Balance at December 31, 2015	$	6,788
Payments		(4,480	)
Changes in fair value		2,005

Balance at March 31, 2016	$	4,313

The following tables provide quantitative information associated with the fair value measurement of the Company’s contingent consideration related to Refine using Level 3 inputs (in thousands):


		Contingent Consideration
		Refine
Fair value as of March 31, 2016		$4,018
Valuation technique		Probability-adjusted discounted cash flow
Remaining period in which milestones can be achieved		2016


	Fixed Earn-out		Maximum Variable Earn-out		Accrued Balance
2016		4,250		1,300		4,018

The significant unobservable inputs used in the fair value measurement of Refine’s contingent consideration are the probabilities of successful achievement of 2016 sales milestones. During the first quarter of 2016, the estimated fair value of the 2016 contingent payment was increased by $1,999,000 to $4,018,000 based on revised sales forecasts. Increases or decreases in the Company’s projected sales during 2016 may result in a significantly higher or lower fair value measurement, respectively and could result in a reversal of the current accrual.

There were no remeasurements to fair value during the three months ended March 31, 2016 of financial assets and liabilities that are not measured at fair value on a recurring basis.

13. Commitments and Contingencies

Future minimum rental commitments under the amended lease as of March 31, 2016 are as follows (in thousands):


	Minimum Rental Commitments
2016	$	2,126
2017		1,907
2018		1,437
2019		1,420
2020		1,371
Thereafter		2,700

14. Segment Reporting

The Company views its operations, makes decisions regarding how to allocate resources and manages its business as one operating segment. As a result, the financial information disclosed herein represents all of the material financial information related to the Company’s principal operating segment.

The following table represents the Company’s total revenue by geographic area (based on the location of the customer):


	Three months ended March 31,
	2016			2015
United States		30	%		28	%
Sweden		24	%		38	%
United Kingdom		13	%		19	%
Other		33	%		15	%

		100	%		100	%

Revenue from significant customers as a percentage of the Company’s total revenue is as follows:


	Three months ended March 31,
	2016			2015
GE Healthcare		24	%		37	%
MilliporeSigma		28	%		39	%

Significant accounts receivable balances as a percentage of the Company’s total trade accounts receivable are as follows:


	March 31, 2016			December 31, 2015
GE Healthcare		45	%		13	%
MilliporeSigma		20	%		32	%
Bioprocessing Customer C		—			21	%

15. Subsequent Event – Acquisition of Atoll GmbH

On April 1, 2016, pursuant to the terms of a Share Purchase Agreement dated as of March 31, 2016, Repligen Sweden AB, a wholly-owned subsidiary of the Company, acquired Atoll GmbH (“Atoll”) from UV-Cap GmbH & Co. KG (the “Seller”). Atoll, headquartered in Weingarten, Germany, is an innovator and manufacturer of MediaScout ^® pre-packed chromatography columns used in process development and clinical manufacturing of biologic drugs.

Under the terms of the Share Purchase Agreement, Repligen Sweden paid to the Seller in consideration for all of the equity interests in Atoll GmbH a purchase price of $9.1 million in cash and 538,700 shares of the Company’s common stock. The Share Purchase Agreement includes a future contingent payment by Repligen Sweden to the Seller consisting of €1.0 million in cash if Atoll’s revenue increases by a specified amount from calendar year 2015 to calendar year 2016.

Because the Company is still in the process of valuing acquired assets and liabilities, the Company determined it was impracticable to provide all the disclosures required for a business combination pursuant to ASC 805, Business Combinations , and will do so in connection with filing its Form 10-Q as of and for the three- and six-month periods ended June 30, 2016.

ITEM 2.

MANAGEMENT’S DISCUSSION AN D ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

Overview

We are a bioprocessing company that develops, manufactures and markets innovative products and solutions used to manufacture biologic drugs. Biologics, or principally monoclonal antibodies, recombinant proteins, and vaccines, are produced through a complex process involving the use of live cells to produce the drug, followed by multiple separation and purification processes, where they are used to enhance production yields for the manufacturer while lowering costs and reducing risks through increased process efficiencies.

For over twenty years, we have been a global market leader in native and recombinant forms of Protein A, a critical reagent used in the downstream purification of therapeutic monoclonal antibodies, or mAbs, one of the largest and fastest-growing class of biologic drugs on the market. Our Protein A reagents are currently used in the commercial production of over 50 mAbs, and in clinical stage production of over 300 investigational mAbs. We also supply several growth factor products and cell filtration products used to increase cell culture productivity during the bioproduction process. In the expanding area of flexible biomanufacturing technologies, we have developed and currently market a series of OPUS ^® chromatography columns for use in clinical-scale manufacturing. These pre-packed, “plug-and-play” columns are uniquely customizable to our customers’ media and size requirements.

Through strategic acquisitions and internal product development, we have expanded our portfolio of products that we sell direct to end users (biopharmaceutical companies and contract manufacturing organizations). This expansion includes our acquisition of the Alternating Tangential Flow (“ATF”) System, which we acquired from Refine Technology LLC, or Refine. The ATF System is a best-in-class device for generating extremely high cell concentrations to allow for improved drug yield and more robust, large scale manufacturing. On June 2, 2014, we purchased all of the assets and assumed certain specified liabilities related to Refine’s ATF System. This acquisition strengthened our bioprocessing business by adding a complementary product line while expanding its sales presence worldwide.

Additionally, on April 1, 2016, we acquired Atoll GmbH (“Atoll”), an innovator and manufacturer of MediaScout ^® pre-packed chromatography columns used in process development and clinical manufacturing of biologic drugs, from UV-Cap GmbH & Co. KG. This acquisition strengthens and compliments our growing OPUS ^® product line of pre-packed chromatography columns.

We generally manufacture and sell Protein A and growth factors to life sciences companies under supply agreements and sell our chromatography columns, our media and quality test kits, and our ATF products directly to biopharmaceutical companies or contract manufacturing organizations or through distributors. We refer to these activities as our bioprocessing business. Our manufacturing facilities are located in the United States, Sweden and Germany.

Historically, Repligen also conducted activities aimed at developing proprietary therapeutic drug candidates, often with a potential of entering into a collaboration with a larger commercial stage pharmaceutical or biotechnology company in respect of these programs. As part of our strategic decision in 2012 to focus our efforts on our core bioprocessing business, we reduced our efforts on our clinical development programs and increased our efforts to find collaboration partners to pursue the development and, if successful, the commercialization of these drug programs.

Critical Accounting Policies and Estimates

A “critical accounting policy” is one which is both important to the portrayal of the Company’s financial condition and results and requires management’s most difficult, subjective or complex judgments, often as a result of the need to make estimates about the effect of matters that are inherently uncertain. For additional information, please see the discussion of our critical accounting policies in Management’s Discussion and Analysis and our significant accounting policies in Note 2 to the Financial Statements included in our Annual Report on Form 10-K for the year ended December 31, 2015.

Results of Operations

Three months ended March 31, 2016 vs. March 31, 2015

Revenues

Sales of bioprocessing products for the three months ended March 31, 2016 and 2015 were $25,094,000 and $20,816,000, respectively, representing an increase of $4,278,000, or 21%. This increase was primarily due to increases in orders for our chromatography columns and ATF products from our key bioprocessing customers. Sales of our bioprocessing products are impacted by the timing of orders, development efforts at our customers or end-users and regulatory approvals for biologics that incorporate our products, which may result in significant quarterly fluctuations. Such quarterly fluctuations are expected, but they may not be predictive of future revenue or otherwise indicate a trend.

Costs and operating expenses

Total costs and operating expenses for the three-month periods ended March 31, 2016 and 2015 were comprised of the following:


	Three months ended March 31,				% Change
	2016		2015		2016 vs. 2015
	(in thousands, except percentages)
Cost of product revenue	$	11,069	$	8,073		37	%
Research and development		1,539		1,568		(2	%)
Selling, general and administrative		7,018		6,026		16	%
Contingent consideration – fair value adjustments		2,005		1,111		80	%

Total costs and operating expenses	$	21,631	$	16,778		29	%

Cost of product revenue was approximately $11,069,000 and $8,073,000 for the three-month periods ended March 31, 2016 and 2015, respectively, an increase of $2,996,000 or 37%. This increase is primarily due to the increased product revenue noted above. Gross margins may fluctuate over the remainder of 2016 based on expected production volume and shipments, and product mix.

Research and development expenses were approximately $1,539,000 and $1,568,000 for the three-month periods ended March 31, 2016 and 2015, respectively, a decrease of $29,000 or 2%. This decrease is primarily related to the timing and scale of our bioprocessing product development projects. Expenses generally include personnel costs, external development costs, supplies and other expenses related to our new products in development.

Selling, general and administrative expenses were approximately $7,018,000 and $6,026,000 for the three-month periods ended March 31, 2016 and 2015, respectively, an increase of $992,000, or 16%. This increase is primarily due to the continued buildout of our administrative infrastructure to support future growth, the expansion of our customer-facing activities to drive sales of our bioprocessing products and costs incurred related to the acquisition of Atoll on April 1, 2016.

Contingent consideration fair value adjustments were approximately $2,005,000 and $1,111,000 for the three-month periods ended March 31, 2016 and 2015, respectively, an increase of $894,000 or 80%. The increase in the fair value adjustment during the first quarter of 2016 relates to the increased probability of achieving the 2016 Refine sales milestone.

Investment income

Investment income includes income earned on invested cash balances. Investment income was approximately $61,000 and $37,000 for the three-month periods ended March 31, 2016 and 2015, respectively. This increase of $24,000, or 65%, is primarily attributable to higher average invested cash balances.

Other income (expense)

Other expense was approximately ($979,000) and other income was approximately $132,000 for the three-month periods ended March 31, 2016 and 2015, respectively, and was primarily attributable to foreign currency gains and losses related to amounts due from non-Swedish kronor-based customers and cash balances denominated in U.S. dollars and British pounds held by our Sweden operations.

Provision for income taxes

For the three months ended March 31, 2016, we had income before taxes of approximately $2,540,000 and recorded a tax provision of approximately $915,000 for an effective tax rate of approximately 36.0%. The effective income tax rate is based upon the estimated income for the year and the composition of the income in different jurisdictions. The effective tax rate differs from the U.S. statutory tax rate primarily due to the tax treatment of contingent consideration expense recorded in the first quarter of 2016.

Non-GAAP Financial Measures

We provide non-GAAP adjusted income from operations, non-GAAP adjusted net income and adjusted EBITDA as supplemental measures to GAAP measures regarding our operating performance. These financial measures exclude the impact of certain acquisition related items and, therefore, have not been calculated in accordance with GAAP. A detailed explanation and a reconciliation of each non-GAAP financial measures to its most comparable GAAP financial measures are described below.

We include this financial information because we believe these measures provide a more accurate comparison of our financial results between periods and more accurately reflect how management reviews its financial results. We excluded the impact of certain acquisition related items because we believe that the resulting charges do not accurately reflect the performance of our ongoing operations for the period in which such charges are incurred.

Non-GAAP Adjusted Income from Operations

Non-GAAP adjusted income from operations is measured by taking income from operations as reported in accordance with GAAP and excluding acquisition costs and contingent consideration expenses booked through our consolidated statements of comprehensive income. The following is a reconciliation of income from operations in accordance with GAAP to non-GAAP adjusted income from operations for the three-month periods ended March 31, 2016 and 2015 (in thousands):


	Three Months Ended March 31,
	2016		2015
Income from operations	$	3,463	$	4,038
Non-GAAP adjustments to income from operations:
Acquisition costs		393		—
Contingent consideration – fair value adjustments		2,005		1,111

Non-GAAP adjusted income from operations	$	5,861	$	5,149

Non-GAAP Adjusted Net Income

Non-GAAP adjusted net income is measured by taking net income as reported in accordance with GAAP and excluding acquisition costs and contingent consideration expenses booked through our consolidated statements of comprehensive income. The following is a reconciliation of net income in accordance with GAAP to non-GAAP adjusted net income for the three-month periods ended March 31, 2016 and 2015:


	Three Months Ended March 31,
	2016				2015
	(in thousands) Amount		Fully Diluted Earnings per Share		(in thousands) Amount		Fully Diluted Earnings per Share
Net income	$	1,625	$	0.05	$	2,930	$	0.09
Non-GAAP adjustments to net income:
Acquisition costs		393		0.01		—		—
Contingent consideration – fair value adjustments		2,005		0.06		1,111		0.03

Non-GAAP adjusted net income	$	4,023	$	0.12	$	4,041	$	0.12

Adjusted EBITDA

Adjusted EBITDA is measured by taking net income as reported in accordance with GAAP, excluding investment income, interest expense, taxes, depreciation and amortization, and excluding acquisition costs and contingent consideration expenses booked through our consolidated statements of comprehensive income. The following is a reconciliation of net income in accordance with GAAP to adjusted EBITDA for the three-month periods ended March 31, 2016 and 2015 (in thousands):


	Three Months Ended March 31,
	2016			2015
Net income	$	1,625		$	2,930
Non-GAAP adjustments to net income from operations:
Investment income		(61	)		(37	)
Interest expense		5			9
Tax provision		915			1,268
Depreciation		751			749
Amortization		399			401

EBITDA		3,634			5,320

Other non-GAAP adjustments:
Acquisition costs		393			—
Contingent consideration – fair value adjustments		2,005			1,111

Adjusted EBITDA	$	6,032		$	6,431

Liquidity and capital resources

We have financed our operations primarily through revenues derived from product sales, and research grants, as well as proceeds and royalties from license arrangements and a litigation settlement and sales of equity securities. Our revenue for the foreseeable future will primarily be limited to our bioprocessing product revenue.

At March 31, 2016, we had cash and marketable securities of $70,912,000 compared to $73,407,000 at December 31, 2015. Cash and marketable securities as of March 31, 2016 do not reflect the cash consideration paid to acquire Atoll GmbH (“Atoll”), as described below. A deposit for leased office space of $450,000 is classified as restricted cash and is not included in cash and marketable securities totals as of March 31, 2016 and December 31, 2015.

On April 1, 2016, pursuant to the terms of a Share Purchase Agreement dated as of March 31, 2016, Repligen Sweden AB, our wholly-owned subsidiary, acquired Atoll from UV-Cap GmbH & Co. KG (the “Seller”). Under the terms of the Share Purchase Agreement, Repligen Sweden paid to the Seller in consideration for all of the equity interests in Atoll GmbH a purchase price of $9.1 million in cash and 538,700 shares of our common stock. The Share Purchase Agreement includes a future contingent payment by Repligen Sweden to the Seller consisting of €1.0 million in cash if Atoll’s revenue increases by a specified amount from calendar year 2015 to calendar year 2016.

Operating activities

For the three-month period ended March 31, 2016, our operating activities consumed cash of $3,811,000 reflecting net income of $1,625,000 and non-cash charges totaling $4,077,000 including depreciation, amortization, stock-based compensation charges and the revaluation of contingent consideration. An increase in accounts receivable consumed $1,149,000 of cash, and was primarily due to the 21% quarter over quarter increase in revenues. An increase in inventories consumed $3,092,000 of cash to support future revenues. A decrease in accounts payable consumed $1,600,000 of cash, which was primarily due to the timing of purchases and payments to vendors. Payments of accrued liabilities consumed $4,277,000 of cash, and was mainly due to the payment of contingent consideration to Refine related to 2015 sales milestones. The remaining cash flow used in operations resulted from net unfavorable changes in various other working capital accounts.

For the three-month period ended March 31, 2015, our operating activities consumed cash of $2,305,000 reflecting net income of $2,930,000 and non-cash charges totaling $3,050,000 including depreciation, amortization, stock-based compensation charges and the revaluation of contingent consideration. An increase in accounts receivable consumed $7,237,000 of cash, and was primarily due to the 28% quarter over quarter increase in revenues as well as timing of sales and payments from customers. The remaining cash flow used in operations resulted from net unfavorable changes in various other working capital accounts.

Investing activities

We place our marketable security investments in high quality credit instruments as specified in our investment policy guidelines. Our investing activities provided $1,200,000 for the three-month period ended March 31, 2016, primarily due to net redemptions of marketable securities of $1,631,000 offset by $431,000 used for fixed asset additions. For the three-month period ended March 31, 2015, our investing activities provided $279,000, primarily due to net redemptions of marketable debt securities of $1,551,000, offset by $1,272,000 used for fixed asset additions.

Financing activities

For the three-month period ended March 31, 2016 and 2015, our financing activities provided cash of $323,000 and $303,000, respectively. For the three-month period ended March 31, 2016, proceeds from exercises of $821,000 were partially offset by contingent consideration payments of $498,000 which stemmed from the initial valuation of the likelihood that the 2015 ATF sales milestone would be achieved. For the three-month period ended March 31, 2015, proceeds from exercises of $402,000 were partially offset by contingent consideration payments of $99,000 which stemmed from the initial valuation of the likelihood that the 2014 ATF sales milestone would be achieved.

We do not currently use derivative financial instruments.

Working capital increased by approximately $4,953,000 to $89,424,000 at March 31, 2016 from $84,471,000 at December 31, 2015 due to the various changes noted above.

Our future capital requirements will depend on many factors, including the following:

•

the expansion of our bioprocessing business;

•

the ability to sustain sales and profits of our bioprocessing products;

•

market acceptance of our new products;

•

our ability to acquire additional bioprocessing products;

•

the resources required to successfully integrate the acquisitions of Refine and Atoll and recognize expected synergies;

•

the scope of and progress made in our research and development activities;

•

the extent of any share repurchase activity; and

•

the success of any proposed financing efforts.

Absent acquisitions of additional products, product candidates or intellectual property, we believe our current cash balances are adequate to meet our cash needs for at least the next 24 months. We expect operating expenses in the year ending December 31, 2016 to increase as we continue to expand our bioprocessing business. We expect to incur continued spending related to the development and expansion of our bioprocessing product lines and expansion of our commercial capabilities for the foreseeable future. Our future capital requirements may include, but are not limited to, purchases of property, plant and equipment, the acquisition of additional bioprocessing products and technologies to complement our existing manufacturing capabilities, and continued investment in our intellectual property portfolio.

We plan to continue to invest in our bioprocessing business and in key research and development activities associated with the development of new bioprocessing products. We actively evaluate various strategic transactions on an ongoing basis, including monetizing existing assets and licensing or acquiring complementary products, technologies or businesses that would complement our existing portfolio of development programs. We continue to seek to acquire such potential assets that may offer us the best opportunity to create value for our shareholders. In order to acquire such assets, we may need to seek additional financing to fund these investments. This may require the issuance or sale of additional equity or debt securities. The sale of additional equity may result in additional dilution to our stockholders. Should we need to secure additional financing to acquire a product, fund future investment in research and development, or meet our future liquidity requirements, we may not be able to secure such financing, or obtain such financing on favorable terms because of the volatile nature of the biotechnology marketplace.

Off-Balance Sheet Arrangements

We do not have any special purpose entities or off-balance sheet financing arrangements as of March 31, 2016.

Contractual obligations

As of March 31, 2016, we had the following fixed obligations and commitments:


	Payments Due by Period
(In thousands)	Total		Less than 1 Year		1 - 3 Years		3 - 5 Years		More than 5 Years
Operating lease obligations	$	10,961	$	2,126	$	3,278	$	2,808	$	2,749
Purchase obligations ⁽¹⁾		5,729		5,729		—		—		—
Contingent consideration ⁽²⁾		4,313		4,168		145		—		—

Total	$	21,003	$	12,023	$	3,423	$	2,808	$	2,749

⁽¹⁾	Primarily represents purchase orders for the procurement of raw material for manufacturing.

⁽²⁾

Represents the current estimated fair value of contingent consideration amounts relating to the Bioflash and Refine acquisitions and does not include any contingent consideration related to the acquisition of Atoll. These amounts are recorded in accrued expenses and long term liabilities on our consolidated balance sheets.

Cautionary Statement Regarding Forward-Looking Statements

This Quarterly Report on Form 10-Q contains forward-looking statements which are made pursuant to the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). The forward-looking statements in this Quarterly Report on Form 10-Q do not constitute guarantees of future performance. Investors are cautioned that statements in this Quarterly Report on Form 10-Q which are not strictly historical statements, including, without limitation, express or implied statements or guidance regarding current or future financial performance and position, potential impairment of future earnings, management’s strategy, plans and objectives for future operations or acquisitions, product development and sales, litigation strategy, product candidate research, development and regulatory approval, selling, general and administrative expenditures, intellectual property, development and manufacturing plans, availability of materials and product and adequacy of capital resources and financing plans constitute forward-looking statements. Such forward-looking statements are subject to a number of risks and uncertainties that could cause actual results to differ materially from those anticipated, including, without limitation, risks associated with: the success of current and future collaborative or supply relationships, including our agreement with BioMarin and General Electric, our ability to successfully grow our bioprocessing business, including as a result of acquisition, commercialization or partnership opportunities, and our ability to develop and commercialize products, our ability to obtain required regulatory approvals, our compliance with all Food and Drug Administration regulations, our ability to obtain, maintain and protect intellectual property rights for our products, the risk of litigation regarding our patent and other intellectual property rights, the risk of litigation with collaborative partners, our limited sales and marketing experience and capabilities, our limited manufacturing capabilities and our dependence on third-party manufacturers and value-added resellers, our ability to hire and retain skilled personnel, the market acceptance of our products, reduced demand for our products that adversely impacts our future revenues, cash flows, results of operations and financial condition, our ability to compete with larger, better financed life sciences companies, our history of losses and expectation of incurring losses, our ability to generate future revenues, our ability to successfully integrate Repligen Sweden, Refine and Atoll, our ability to raise additional capital to fund potential acquisitions, our volatile stock price, and the effects of our anti-takeover provisions. Further information on potential risk factors that could affect our financial results are included in the filings made by us from time to time with the Securities and Exchange Commission including under the section entitled “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2015 and in this Quarterly Report on Form 10-Q.

ITEM 3.

QUANTITATI VE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

Interest rate risk

We have investments in commercial paper, U.S. Government and agency securities as well as corporate bonds and other debt securities. As a result, we are exposed to potential loss from market risks that may occur as a result of changes in interest rates, changes in credit quality of the issuer or otherwise.

We generally place our marketable security investments in high quality credit instruments, as specified in our investment policy guidelines. A hypothetical 100 basis point increase in interest rates would result in an approximate $61,000 decrease in the fair value of our investments as of March 31, 2016. We believe, however, that the conservative nature of our investments mitigates our interest rate exposure, and our investment policy limits the amount of our credit exposure to any one issuer, (with the exception of U.S. agency obligations) and type of instrument. We do not expect any material loss from our marketable security investments and therefore believe that our potential interest rate exposure is limited.

Foreign exchange risk

The reporting currency of the Company is U.S. dollars. Transactions by our subsidiary, Repligen Sweden, may be denominated in Swedish kronor, British pound sterling, U.S. dollars, or in Euros while the entity’s functional currency is the Swedish krona. Certain sales transactions made by the U.S. entity related to ATF system products are denominated in foreign currencies. Exchange gains or losses resulting from the translation between the transactional currency and the functional currency are included in net income (loss). Fluctuations in exchange rates may adversely affect our results of operations, financial position and cash flows. We currently do not seek to hedge this exposure to fluctuations in exchange rates.

ITEM 4.

CONTR OLS AND PROCEDURES

Disclosure Controls and Procedures

The Company’s management, with the participation of the principal executive officer and the principal financial officer, has evaluated the effectiveness of the Company’s disclosure controls and procedures (as defined in Rules 13a-15(e) or 15d-15(e) under the Securities Exchange Act of 1934, as amended (the “Exchange Act”)) as of the end of the period covered by this report. Based on such evaluation, the principal executive officer and principal financial officer have concluded that, as of the end of such period, the Company’s disclosure controls and procedures were effective in ensuring that information required to be disclosed by the Company in the reports that it files or submits under the Exchange Act is recorded, processed, summarized and reported, on a timely basis, and is accumulated and communicated to the Company’s management, including the Company’s principal executive officer and the Company’s principal financial officer, as appropriate, to allow timely decisions regarding required disclosure.

Changes in Internal Control

There was no change in the Company’s internal control over financial reporting that occurred during the period covered by this Quarterly Report on Form 10-Q that has materially affected, or is reasonably likely to materially affect, the Company’s internal control over financial reporting.

PART II. OT HER INFORMATION

ITEM 1.

L EGAL PROCEEDINGS

From time to time, we may be subject to legal proceedings and claims in the ordinary course of business. We are not currently aware of any such proceedings or claims that we believe will have, individually or in the aggregate, a material adverse effect on our business, financial condition or results of operations.

ITEM 1A.

RI SK FACTORS

The matters discussed in this Form 10-Q include forward-looking statements that involve risks or uncertainties. These statements are neither promises nor guarantees, but are based on various assumptions by management regarding future circumstances, over many of which Repligen has little or no control. A number of important risks and uncertainties, including those identified under the caption “Risk Factors” in Item 1A in our Annual Report on Form 10-K for the year ended December 31, 2015 and subsequent filings as well as risks and uncertainties discussed elsewhere in this Form 10-Q, could cause our actual results to differ materially from those in the forward-looking statements. There are no material changes to the Risk Factors described in our Annual Report on Form 10-K for the fiscal year ended December 31, 2015, other than as set forth below to update for the acquisition of the Atoll business.

Our acquisitions , such as our recent acquisition of Atoll GmbH, expose us to risks that could adversely affect our business, and we may not achieve the anticipated benefits of acquisitions of business or technologies. Moreover, our expanded commercial and manufacturing footprint in Europe as a result of our acquisition of Atoll GmbH may divert our resources from other aspects of our business, and will subject us to additional and different regulations. Failure to manage these economic, financial, business and regulatory risks may adversely impact our growth in Europe and other results of operations.

In April 2016, we acquired Atoll GmbH, a business based in Germany (the “Atoll Acquisition”). Any acquisition involves numerous risks and operational, financial, and managerial challenges, including difficulties in integrating new operations, or underperformance of any acquired technologies or products relative to our expectations and the price we paid. Furthermore, we expect a portion of our future revenue growth to come from introducing new products and technologies from our Atoll Acquisition, such as the MediaScout® pre-packed chromatography columns. The commercial success will depend on, among other factors, our successful integration of the Atoll business, and the acceptance of the new products and technologies by the life science and biopharmaceutical industries. As a result, there can be no assurance that these new products and technologies, even if successfully developed and introduced, will be accepted by customers. If customers do not adopt our new products and technologies, our results of operations may suffer and, as a result, the market price of our common stock may decline. Moreover, in connection with the Atoll Acquisition, we expanded our commercial and manufacturing footprint into Europe that may require us to make substantial investment, which could divert resources from other aspects of our business. In addition, we may incur difficulties in staffing and managing our European operations, and face fluctuations in currency exchange rates, exposure to additional regulatory requirements, including certain trade barriers, changes in political and economic conditions, and exposure to additional and potentially adverse tax regimes. Our success in Europe will depend, in part, on our ability to anticipate and effectively manage these and other risks. Our failure to manage these risks may adversely affect our growth in Europe and lead to increased administrative costs.

We may record a significant amount of intangible assets in connection with the Atoll Acquisition, and if the value of our recorded intangible assets become impaired, we could have to take significant charges against earnings.

In connection with the accounting for the Novozymes Acquisition and the Refine Acquisition, we recorded a significant amount of intangible assets, including developed technology and customer relationships. In connection with the Atoll Acquisition, we may have to record a significant amount of intangible assets. Under U.S. GAAP, we must assess, at least annually and potentially more frequently, whether the value of intangible assets has been impaired. Intangible assets will be assessed for impairment in the event of an impairment indicator. Any reduction or impairment of the value of intangible assets will result in a charge against earnings, which could materially adversely affect our results of operations and shareholders’ equity in future periods.

ITEM 2.

UNRE GISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS

In June 2008, the Board of Directors authorized a program to repurchase up to 1.25 million shares of our common stock to be repurchased at the discretion of management from time to time in the open market or through privately negotiated transactions. The repurchase program has no set expiration date and may be suspended or discontinued at any time. We did not repurchase any shares of common stock during the three-month period ended March 31, 2016. As of March 31, 2016, there are 657,173 shares remaining under this authorization.

In June 2014, in connection with the Refine Acquisition, we issued and sold 215,285 unregistered shares of our common stock to Refine

Technology, LLC, an accredited investor, in exchange for certain of Refine’s assets and contract rights related to its ATF system. This issuance was intended to be exempt from the registration requirements pursuant to Section 4(2) of the Securities Act of 1933 and Rule 506(b) promulgated under Regulation D.

In April 2016, in connection with the acquisition of the Atoll business, we issued and contributed 538,700 shares of our common stock to our wholly-owned subsidiary, Repligen Sweden AB, to enable Repligen Sweden AB to fulfill its obligation to deliver the aforementioned shares under the share purchase agreement we entered into with Repligen Sweden AB and the seller of Atoll GmbH. This issuance was intended to be exempt from the registration requirements pursuant to Section 4(2) of the Securities Act of 1933 and Rule 506(b) promulgated under Regulation D.

ITEM 3.

DE FAULTS UPON SENIOR SECURITIES

None.

ITEM 4.

MI NE SAFETY DISCLOSURES

Not applicable.

ITEM 5.

OTH ER INFORMATION

None.

ITEM 6.

EX HIBITS

(a) Exhibits


Exhibit Number		Document Description

3.1		Restated Certificate of Incorporation, dated June 30, 1992 and amended September 17, 1999 (filed as Exhibit 3.1 to Repligen Corporation’s Quarterly Report on Form 10-Q for the quarter ended September 30, 1999 and incorporated herein by reference). (File No. 000-14656)

3.2		Amended and Restated By-Laws (filed as Exhibit 3.2 to Repligen Corporation’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2003 and incorporated herein by reference). (File No. 000-14656)

3.3		Amendment No. 1 to the Amended and Restated By-Laws (filed as Exhibit 3.1 to Repligen Corporation’s Current Report on Form 8-K filed on December 20, 2011 and incorporated herein by reference).

3.4		Amendment No. 2 to the Amended and Restated By-Laws (filed as Exhibit 3.1 to Repligen Corporation’s Current Report on Form 8-K filed on May 25, 2012 and incorporated herein by reference).

3.5		Certificate of Amendment to the Certificate of Incorporation of Repligen Corporation, effective as of May 16, 2014 (filed as Exhibit 3.1 to Repligen Corporation’s Current Report on Form 8-K filed on May 19, 2014 and incorporated herein by reference).

10.1 + ±		Strategic Supplier Alliance Agreement, by and between GE Healthcare Bio-Sciences AB and Repligen Corporation, dated as of January 28, 2010, as amended to date.

10.2 + ±		Strategic Supplier Alliance Agreement – Contract Manufacturing, by and between GE Healthcare Bio-Sciences AB and Repligen Sweden AB (as successor-in-interest to Novozymes Biopharma Sweden AB), dated as of July 7, 2011, as amended to date.

31.1 +		Rule 13a-14(a)/15d-14(a) Certification.

31.2 +		Rule 13a-14(a)/15d-14(a) Certification.

32.1 *		Certification pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.


Exhibit Number		Document Description

101+		The following materials from Repligen Corporation on Form 10-Q for the quarterly period ended March 31, 2016, formatted in Extensible Business Reporting Language (xBRL): (i) Condensed Consolidated Statements of Comprehensive Income (Loss), (ii) Condensed Consolidated Balance Sheets, (iii) Condensed Consolidated Statements of Cash Flows, and (iv) Notes to Condensed Consolidated Financial Statements, tagged as blocks of text.

+	Filed herewith.

*	Furnished herewith.

±	Confidential treatment has been requested for portions of the exhibit and is pending clearance with the Securities and Exchange Commission.

SIGN ATURES

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.


	REPLIGEN CORPORATION

Date: May 5, 2016	By:	/ S / T ONY J. H UNT
		Tony J. Hunt
		President and Chief Executive Officer
		(Principal executive officer)
		Repligen Corporation

Date: May 5, 2016	By:	/ S / J ON S NODGRES
		Jon Snodgres
		Chief Financial Officer
		(Principal financial officer)
		Repligen Corporation

Exhibit 10.1

STRATEGIC SUPPLIER ALLIANCE AGREEMENT – CONTRACT MANUFACTURING EMEA

GE HEALTHCARE


GE Healthcare entity (“GEHC”)		Other Party (the “Supplier”)
GE Healthcare Bio-Sciences AB		Repligen Corporation
Address		Address
Björkgatan 30, 751 84 Uppsala, Sweden		41 Seyon Street Building #1 suite 100
Registration number		Waltham, MA 02453 USA
556108-1919		Registration number


AGREEMENT		GEHC REF:

The Parties hereby agree that the following terms and conditions shall apply:

Purpose

GEHC and the Supplier are entering into this Agreement for the outsourcing by GEHC of the manufacture of the Products by the Supplier. Pursuant to the terms and condition of this Agreement, the Supplier shall manufacture and sell to GEHC, and GEHC shall purchase from the Supplier the Products meeting the specifications referred to in Attachment C (the “Products”) in such amounts as GEHC may order from time to time on the terms and conditions set out in this Agreement. GEHC shall pay the price of the Products specified in Attachment C (the “Prices”) .

Documents

The following attachments are an integral part of this Agreement (the “ Attachments ”). The provisions of each Attachment shall be incorporated by reference into and deemed to be part of this Agreement. The order of precedence shall be as follows, unless otherwise agreed:

QUALITY & INTEGRITY TERMS

Attachment A - Supplier Quality Requirements

Attachment B - Supplier Integrity Statement

BUSINESS TERMS

Attachment C - Products, Prices, Specifications (if any),

Attachment D - Business Terms

GENERAL TERMS

Attachment E - General Terms and Conditions

TECHNICAL TERMS

Attachment F - GEHC Production Know-How

Term

Effective Date: 2010-01-01

Agreement Term: This Agreement shall commence on the Effective Date and, subject to the rights of termination in clause 16 of Attachment E, shall continue for a period of five (5) years. The Parties shall negotiate eighteen (18) months prior to the expiration of the Term to decide whether to renew this Agreement.

This Agreement has been duly executed by each of the Parties


Signed for and on behalf of GEHC		Signed for and on behalf of the Supplier

Signature	/s/ Peter Ehrenheim	Signature	/s/ Walter C. Herlihy

Name (capitals)	PETER EHRENHEIM	Name (capitals)	WALTER C. HERLIHY

Title	President and CEO	Title	President and CEO

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential treatment under Rule 24b-2 of the Exchange Act; [*] denotes omissions.

Attachment A

Purchased Material Quality Terms

Supplier Name: Repligen Corporation

Version No.:

The Parties are committed to quality in the performance of this Agreement. Accordingly, all Products shall conform to the Purchased Material Quality Requirements set forth below.

Applicable To All Suppliers:

Section 1 - Quality Systems: The Supplier shall maintain a documented quality system, and the Supplier shall be in compliance with ISO 9001 or equivalent. Key components of a robust quality system are properly implemented quality procedures for collection and processing defects (parts or services), appropriate statistical techniques to analyze defects and identifying opportunities for corrective and preventive actions, along with evidence of validation that actions are effective in eliminating and preventing further defects. Upon request from GE Healthcare, the Supplier shall provide documented corrective action plans to prevent future deviations from the specification within thirty (30) days from receiving a corrective action request from GE Healthcare.

To ensure products and services provided to GE Healthcare shall meet or exceed GE Healthcare requirements, GE Healthcare may audit the Supplier’s quality system at periodic intervals upon 30 days written advance notification, to inspect and observe the Supplier’s manufacture of Products, to audit the Supplier’s quality control and inspection procedures, and to have access to all data and documentation from such control of the Products and to take samples and make such other investigations as GEHC deems necessary. The Supplier shall reserve the right for GEHC to perform such inspections on the premises of subcontractors engaged by the Supplier, such inspections to be scheduled by the Supplier following reasonable prior notice by GEHC and to be carried out jointly by representatives of both Parties and at the sole expense of GEHC. GEHC’s right of inspection under this head shall not diminish the Supplier’s obligation to deliver Products which comply with the specifications of this Agreement. GE Healthcare may also request periodic, joint quality assurance meetings at the Supplier’s facility to discuss and resolve product quality and reliability issues.

Section 2 - Quality Record Retention: If the Supplier is required to perform acceptance activities per GE Healthcare written agreement or purchase specification, the Supplier shall maintain records of the acceptance activities for the services performed and/or products and services delivered to GE Healthcare. These records may include as appropriate test/inspection criteria, revision level of documents/equipment/software used, operating procedures (planning, routing or traveler sheets), dates of test/inspection, and the results. The records required shall be retained until GE Healthcare notifies the Supplier that the product life has ended or for a minimum of ten (10) years, whichever is longer, unless the required records are submitted to GE Healthcare by written agreement or purchase specification.

Section 3 - Compliance: The Supplier shall comply with the terms of the Purchase Order or purchase agreement with GE Healthcare (“Agreement”). The Supplier shall maintain compliance with any and all laws and government regulations that apply in the manufacturing and delivery of its products or services. Such laws may include, but are not limited to, regulations and directives, labor laws, environmental laws, Custom Trade Partnership Against Terrorism (CTPAT) and product safety laws. The Supplier shall provide GE Healthcare all information requested that is necessary to enable GE Healthcare to comply with the laws and regulations applicable to the GE Healthcare sale and use of GE Healthcare products. As per GE Healthcare purchase specifications or for OEM (Original Equipment Manufacturer) items, the Supplier shall maintain compliance to industry standards and product listings for all Products delivered to GE Healthcare.


Strategic Supplier Alliance Agreement - GEHC Directs EMEA Contract Manufacturing / Version Supply 1.0		2 (30)

Section 4 - Change Notification: Changes proposed by Supplier, both material and process or software changes, which may affect form, fit, function, reliability, serviceability, performance, functional interchangeability, regulatory compliance, safety, options or spare parts interchangeability or interface capability with GE Healthcare Product must be submitted along with a written change notice, for GE Healthcare approval. This includes, but is not limited to, changes of sources of material and parts, changes in manufacturing processes, test procedures, manufacturing locations, relocation or replacement of equipment and any similar changes that are anticipated by Sub-Suppliers. Items affected by such changes may not be delivered to GE Healthcare until the Supplier has received written approval for the changes from GE Healthcare. At minimum, the change notice must include the Supplier’s affected part number or software revision, date of implementation, serial number effectivity of the assembly that is changed, reason for the change, specific details of the change and, if available, supporting data that demonstrates that part reliability has not been impacted negatively. The change must not be implemented without prior written consent from GE Healthcare, which shall not be unreasonably withheld. In addition, GE Healthcare has the right to request samples for evaluation prior to approval by GE Healthcare of such changes.

Section 5 - Specifications: The Supplier is responsible to meet or exceed the part requirements and Specifications as referenced in the Agreement. The Supplier is accountable to ensure that delivered items meet the requirements of the revisions and/or versions specified on the applicable Agreement.

The Supplier shall ensure that GE Healthcare documentation is controlled and distributed with the correct revision level to the appropriate personnel that produce the product for GE Healthcare. The Supplier shall also ensure that all GE Healthcare documentation is treated as proprietary and confidential.

For GE Healthcare designed Products, the Supplier is responsible for ensuring that all applicable GE Healthcare documentation is provided to all of the Supplier’s Sub-Suppliers involved in the supply of product for GE Healthcare. The Supplier shall ensure that both they and their Sub-Suppliers that use GE Healthcare engineering documentation are maintained in compliance with all accepted Engineering Change Requests/Engineering Change Orders issued by GE Healthcare.

Upon request from GE Healthcare, the Supplier shall ensure that part qualification is conducted and documents are submitted as required. The part qualification requirements shall be determined by GE Healthcare and shall consist of at a minimum a part layout plan, capability study, and a process control plan.

Section 6 - Electrostatic Discharge: I F E LECTROSTATIC D ISCHARGE (ESD) SENSITIVE DEVICES ARE SUPPLIED TO GE H EALTHCARE , THE S UPPLIER MUST HAVE AN ACTIVE ESD PROGRAM AND USE PROPER ESD HANDLING AND PACKAGING PROCEDURES . A PPLICABLE COMPONENTS INCLUDE CIRCUIT BOARDS , ELECTRONIC ASSEMBLIES WITH EXPOSED COMPONENTS OR CONNECTORS , SEMI - CONDUCTORS AND ANY OTHER DEVICES THAT MAY REQUIRE ESD PROTECTION . S UPPLIERS MUST MAINTAIN RECORDS OF THE TESTING DONE AND TRAINING PROVIDED .

Section 7 - Packaging and Shipping Methods: The Supplier shall provide packaging and shipping methods to prevent cosmetic, mechanical and electrical damage to the Product. The Supplier shall meet or exceed the detailed specifications of the GE Healthcare packaging requirements found in the Specification

Section 8 - Order of Precedence: This attachment A shall be an addendum to the Strategic Supplier Alliance Agreement (SSAA) between Supplier and GE Healthcare. Any conflict between this Attachment A and the other Attachments of the SSAA regarding the minimum material quality requirements shall be resolved pursuant to the latter. Any conflict between this Attachment A and the Purchase Order regarding the minimum material quality requirements shall be resolved pursuant to the terms of this Attachment A.


Strategic Supplier Alliance Agreement - GEHC Directs EMEA Contract Manufacturing / Version Supply 1.0		3 (30)

By signing below, you agree to the terms hereof and consent to meet all requirements that apply for any and all products and services provided to GE Healthcare.


Agreed to and Accepted by Supplier

Signature:		/s/ Daniel P. Witt, PhD

Printed Name:		Daniel P. Witt, PhD

Title:		Vice President, Operations

Date:		2/2/2010

Supplier Name:		Repligen Corporation

Agreed to and Accepted by the General Electric Company on Behalf of its Division, GE Healthcare

Signature:		/s/ Peter Ehrenheim

Printed Name:		Peter Ehrenheim

Title:		President and CEO

Date:		1/27/2010


Strategic Supplier Alliance Agreement - GEHC Directs EMEA Contract Manufacturing / Version Supply 1.0		4 (30)

Attachment B

Supplier Integrity Statement

Supplier Integrity, Business Conduct, and Compliance Requirements

Supplier agrees (a) to comply with all applicable legal, as well as GEHC policy, requirements (including those relating to labor, the environment, health and safety, wages, hours and conditions of employment, occupational safety, discrimination, sexual harassment, immigration, minority owned businesses, intellectual property rights and improper payments); (b) that Supplier is responsible for ensuring that Supplier’s employees, contractors, representatives and sub-suppliers understand and comply with the same legal and GEHC policy requirements; and (c) that the requirements referenced in (a) and (b) above include the following:

(1)	Code of Conduct . Maintain and enforce written company policies requiring high ethical conduct and strict adherence to lawful business practices, including a prohibition against bribery of government officials.

(2)	Labor Matters .

(i)

Employ only workers above the applicable minimum age requirement or the age of 16 whichever is higher.

(ii)

No use of forced, prison or indentured labor, workers subject to any form of compulsion or coercion, or labor in violation of minimum wage, hour of service, or overtime laws in the country of manufacture, and prohibit physical, sexual or psychological harassment or coercion.

(iii)

Allow workers to freely choose whether to organize or join associations for the purpose of collective bargaining as provided by local law.

(iv)

Assure that workers are hired, paid and otherwise subject to terms and conditions of employment based on their ability to do the job, not on the basis of their personal characteristics such as race, national origin, sex, religion, ethnicity, disability, maternity, age, and other characteristics protected by local law; provided, however, that the foregoing does not bar compliance with affirmative preferences that may be required by local law.

(3)

Environmental Compliance . Comply with all applicable environmental laws and regulations, including: (i) maintaining and enforcing written and comprehensive environmental management programs that are subject to periodic audit by GEHC or its representatives; (ii) continuing compliance with all required environmental permits; and (iii) strictly not negligently permitting any discharge to the environment in violation of law, or that would otherwise have an adverse impact on the environment.

(4)	Health & Safety . Provide workers with a safe workplace that complies with applicable health and safety standards as well as appropriate living conditions.

(5)

Improper Payments and Business Dealings . Not offer or provide, directly or indirectly, anything of value (including cash, illegal political contributions, bribes or kickbacks or other improper payments) to any GEHC employee, representative, customer, government official, or other third party in connection with any GEHC procurement, transaction or business dealing. Prohibitions include offering or providing (directly or indirectly): (i) any consulting, employment or similar position to any GEHC employee (or their family member or significant other) involved with a GEHC procurement; (ii) GEHC employees and representatives with any gifts, other than gifts of nominal value to commemorate or recognize a particular GEHC-supplier business transaction or activity; and/or (iii) GEHC employees and/or representatives with the opportunity to participate in any contest, game or promotion. In addition to the foregoing, comply with all applicable laws of the United States and other countries relating to such matters.

(6)

Business Entertainment of GEHC Employees and Representatives . Comply with the business entertainment (including travel and living) policies established by GEHC and which govern GEHC employees and representatives, including understanding those business entertainment policies of the applicable GEHC component or operation before offering or providing any GEHC employee or representative any form of business entertainment. Never offer to a GEHC employee or representative any form of business entertainment under circumstances that would create the appearance of an impropriety.

(7)

Collusive Conduct and GEHC Procurements . Comply with all applicable competition laws, including, but not limited to: (i) not engage in prohibited communications or enter into agreements with competitors that can affect competition; (ii) not share or exchange any price, cost or other competitive information, nor engage in any other collusive conduct with any other third party supplier or bidder to GEHC with respect to any proposed, pending or current GEHC procurement; and (iii) avoid even the appearance of improper conduct.

(8)

Intellectual & Other Property Rights . Respect the intellectual and other property rights of others, including GEHC’s. Only use GEHC information and property (including tools, drawings and specifications) for the purpose for which they are expressly provided and for no other purposes. Take all necessary steps to safeguard and maintain the confidentiality of GEHC proprietary information, including maintaining it in confidence, only in secure work areas, and not disclose it to any third parties without the prior written permission of GEHC. Only transmit GEHC information over the Internet on an encrypted basis. Observe and respect all GEHC patents, trademarks, trade secrets, and copyrights, as well as comply with such restrictions or prohibitions on their use as GEHC may from time to time establish.

(9)	Export and International Trade Controls & Customs Matters . Comply with all applicable import and export control laws and regulations, including those of the United States, and not transfer GEHC technical information to any third party


Strategic Supplier Alliance Agreement - GEHC Directs EMEA Contract Manufacturing / Version Supply 1.0		5 (30)

without the express prior written permission of GEHC. Without limitation to the foregoing: (i) comply with all applicable export controls laws and regulations in the export or re-export of GEHC technical information, including any restrictions on access and use applicable to non-U.S. nationals; (ii) ensure that all invoices and any customs or similar documentation submitted to GEHC or governmental authorities in connection with transactions involving GEHC accurately describe the goods and services provided or delivered and the price thereof; and (iii) not participate in any boycotts or restrictive trade practices prohibited by U.S. laws. Supplier will also obtain all applicable permits and licenses necessary to perform its obligations under this Agreement, and upon GEHC’s request, will provide GEHC with copies of such permits and licenses. Where Products contain United States components, Supplier will also provide GEHC with details of the United States content value as a percentage of the Product price upon GEHC’s request. Additionally and upon request, Supplier will provide ECCN and Harmonized Tariff numbers assigned to Products.

(10)

Privacy . With respect to data and personal information (including information of GEHC employees, its customers, suppliers, business partners, and patient health information handled and processed on behalf of its customers) (collectively, “PI”): (i) comply with all applicable privacy and data protection laws globally, or generally acceptable privacy principles where comprehensive privacy laws are not available; (ii) report any improper use or disclosure of PI, as well as successful security breaches, immediately upon becoming aware; (iii) ensure that any employees, contractors, representatives and sub-suppliers to whom it provides PI and/or access to information systems, agree to the same restrictions and conditions set forth herein; (iv) facilitate audits by making its internal practices, books and records relating to the use and disclosure of PI available to GEHC and government agencies (including, the Secretary of the Department of Health and Human Services) for purposes of determining compliance with applicable laws, rules, and regulations; (v) when requested by GEHC, promptly return or destroy, as well as certify in writing to the return and destruction of, all PI and information in any form that allows access to GEHC information systems, and retain no copies of such PI and information; (vi) safeguard PI upon taking possession or exposure to employees and all third parties; (vii) ensure that formal security management systems are employed that eliminates the risk of PI-related security breaches; and (viii) notify GEHC in writing whenever PI will be exported from jurisdictions with data transfer restrictions, or transfer PI to countries without comprehensive data protections laws.

(11)	Money Laundering Prevention . Comply with all applicable anti-money laundering laws and regulations and GEHC policies established for money laundering prevention.

(12)	Prohibition of Use of Sub-Suppliers or Third Parties to Evade Requirements . Not use sub-suppliers or other third parties to evade any applicable legal and/or GEHC policy requirements, including those enumerated above.

(13)

Security Measures . Supplier warrants and represents that it will review and adopt industry standard security measures which are consistent with accepted programs including the US Customs-Trade Partnership Against Terrorism (“C-TPAT”), the European Union’s Authorized Economic Operator program and other similar programs where applicable. Supplier furthermore agree that it will make reasonable efforts to become a member of C-TPAT, or any similar EU/other organization aimed at strengthening and improving supply chain security, in a timely manner if it is eligible to do so.

(14)

Country of Origin . In accordance with and as required by applicable trade and customs laws, Supplier will mark each Product, as well as Product packaging, containers, labels, and invoices, with the country of origin for the Product. Supplier will also provide acceptable and auditable documentation that establishes the country of origin for all Products, including, without limitation and as applicable, certifications of origin for Products qualifying for EFTA/EU and other preferential duty provisions, as applicable. Without limitation to the foregoing and in marking the Products, Supplier will comply with the requirements of the custom authorities of the country of receipt.

GEHC policy requirements, including those enumerated above, are subject to modification by GEHC at any time. Supplier agrees to contact its GEHC representative if Supplier has any questions about the foregoing and/or their application to particular circumstances.

B.	Products provided by Supplier may be subject to environmental, health and safety laws and regulations. As a result, Supplier agrees to the following without limitation:

(1)	Supplier represents, warrants, certifies and covenants that Supplier shall perform all activities required under this Agreement in compliance with all applicable national, EU, state/provincial and local labor, environmental, health and safety laws and regulations.

(2)

Supplier represents, warrants, certifies and covenants that each chemical substance constituting or contained in Products sold or otherwise transferred to GEHC hereunder is on the list of chemical substances compiled and published by (a) the Administrator of the Environmental Protection Agency pursuant to the Toxic Substances Control Act (15 USC Section 2601 et seq.) as amended; and (b) the equivalent lists in the other jurisdictions to which GEHC informs Supplier or Supplier knows the Products will likely be shipped to or through; or is exempt from the foregoing lists, in which case Supplier shall provide adequate documentation of the validity of the claimed exemption if so requested by GEHC;

(3)

Supplier will, when relevant, timely provide GEHC with supporting documentation, including without limitation, (a) the exact weight by weight percentage of any REACH candidate list substance constituting or contained in the Products, (b) all relevant information that GEHC requires to meet the obligations under REACH to communicate safe use to GEHC’s customers.


Strategic Supplier Alliance Agreement - GEHC Directs EMEA Contract Manufacturing / Version Supply 1.0		6 (30)

(4)

Supplier represents, warrants, certifies and covenants that none of the Products supplied under this Agreement contain any above limits stated in law: (i) lead, mercury, cadmium, hexavalent chromium, polybrominated biphenyls (PBB), polybrominated diphenyl ethers (PBDE) or any other hazardous substances the use of which is restricted under EU Directive 2002/95/EC (27 January 2003) (RoHS Directive), as amended; (ii) arsenic, asbestos, benzene, polychlorinated biphenyls (PCBs), or carbon tetrachloride; (iii) any chemical restricted under the Montreal Protocol on ozone-depleting substances; or (iv) any other chemical or hazardous material the use of which is restricted in any other jurisdictions to which GEHC informs Supplier or Supplier knows the Products are likely to be shipped to or through, unless GEHC expressly agrees otherwise in writing to Supplier referencing this Agreement and Supplier identifies an applicable exemption from any relevant legal restriction on the inclusion of such chemicals or hazardous materials in the Products sold or transferred to GEHC. Upon GEHC’s request and subject to the confidentiality provisions of this Agreement and GEHC’s ability to meet its compliance obligations, Supplier will provide GEHC with the chemical composition, including proportions, of any substance, preparation, mixture, alloy or goods supplied under this Agreement and any other relevant information or data regarding the properties, including, without limitation, test data and hazard information.

(5)

Supplier will use all commercially reasonable efforts to establish and maintain an effective program to ensure that the activities of any suppliers it utilizes to provide any chemicals, substances, goods or services that will be incorporated into the Products supplied under this Agreement will be conducted in conformance with Sections B(1) to B(4) above.

(6)

With respect to any Products or other materials sold or otherwise transferred to GEHC hereunder, Supplier shall provide all relevant information, including without limitation, safety data sheets in the language and the legally required format of the location to which the Products will be shipped and mandated labeling information, required pursuant to applicable requirements such as: (i) the Occupational Safety and Health Act (OSHA) regulations codified at 29 CFR 1910.1200; or (ii) REACH or EU Directive 67/548/EEC, as amended, if applicable, and (iii) any other applicable law, rule or regulation or any similar requirements in any other jurisdictions to which GEHC informs Supplier that the Products are likely to be shipped.

(7)

With respect to any Products or other materials sold or otherwise transferred to GEHC hereunder, Supplier shall notify GEHC in writing of the presence of any nanoscale material (defined for these purposes as any substance with at least one dimension of such substance known to be less than 100 nano meters in length). With respect to all such nanoscale materials, Supplier shall provide a description of its legal status in the relevant jurisdiction, and any safety data or other notifications that are appropriate in the EU, US and the relevant jurisdiction.


AGREED TO AND ACCEPTED BY SUPPLIER

BY:		Daniel P. Witt, PhD



TITLE:		Vice President, Operations



DATE:		/s/ Daniel P. Witt, PhD 2/2/2010



SUPPLIER NAME:		Repligen Corporation


Strategic Supplier Alliance Agreement - GEHC Directs EMEA Contract Manufacturing / Version Supply 1.0		7 (30)

Attachment C

Products, Prices and Specifications


Currency:		USD

Delivery term:		FCA Waltham, Massachusetts

Revision date:		22 January 2010

A.
Product Name		Zäta
GEHC Article number		28-4048-76

Supplier Article Number/unit size

20-2501-00		[*]
20-2501-01		[*]
20-2501-02		[*]
20-2501-03		[*]
20-2501-04		[*]

*[]**

Lead time (PO):		[*]

Lead Times for Safety Stock Replenishment

Requirement		Lead time Zata

*[]**

Level of Supplier’s Safety Stock

[*] based on the average of the [*] of the then current [*] rolling Forecast distributed by GEHC and the prior [*] by GEHC of each of the Products based on [*] .


*Shelf life []**

B.
Product Name		rPA
GEHC Article number		30-6000-60

Supplier Article Number/unit

20-1501-00		[*]
20-1501-01		[*]
20-1501-02		[*]
20-1501-03		[*]

*[]**

Lead time (PO):		[*]


Strategic Supplier Alliance Agreement - GEHC Directs EMEA Contract Manufacturing / Version Supply 1.0		8 (30)

Lead Times for Safety Stock Replenishment

Requirement Lead time rPA

[*]

Level of Supplier’s Safety Stock

[*] based on the average of the [*] of the then current [*] rolling forecast distributed by GEHC and the prior [*] by GEHC of each of the Products based on [*] .

Shelf life [*]

C. General Price Terms

All prices above are per gram and shall be set [*] based on the [*] in each of the [*] for the Products that corresponds to the [*] of each of the Products based on the [*] . The price for each of the Products shall be set on the [*] of each [*] and shall remain fixed for that [*] . Example:

[*]

The prices agreed herein do not include the costs of transportation, packaging, shipping or taxes (including VAT) for the Products and will be paid by GEHC. The costs of packaging will be charged to GEHC by Supplier directly and shall be clearly specified on the invoice.

Additional charges: Unless otherwise agreed in this Agreement the Prices include all costs relating to the supply of the Products and GEHC shall not be obliged to reimburse the Supplier for any additional charges or any other costs relating to the supply of the Products that are not specified herein or otherwise agreed in writing by the Parties.


Strategic Supplier Alliance Agreement - GEHC Directs EMEA Contract Manufacturing / Version Supply 1.0		9 (30)

Specifications

LOGO

A NALYTICAL S PECIFICATION R AW M ATERIAL

30-6000-60 Ed. AG

Issued by

QA/ A Elb-Jorde

Established by

R&D/ J Daicic

Valid from

2008-10-17

Supersedes

30-6000-60 Ed. AF

Page

1 (2)

rProtein A

Code No: 30-6000-60


1 Packaging instruction
		The package shall be suitable for storage of the material.

2 Terms of transportation
		At -18 °C or below

3 Storage conditions
		Preserve in a well-closed container at or below -18 °C.

4 Shelf life
		Estimated shelf life is *[]** from the date of manufacture.
		Final shelf life is to be decided from stability studies.

5 Other name(s)
		rPa – GE Healthcare

6 Formula and mass
		Theoretical Mr. 34 318 Dalton calculated from amino acid sequence.

7 Description
		rProtein A is a recombinant engineered form of Staphylococcus aureus Protein A, produced by fermentation of Escherichia coil . The protein is produced with chemicals and materials of non-animal origin.

		The product is supplied as a clear, amber frozen liquid free from particulates.

70-5043-16 / AB Valid from 2007-01-24


Strategic Supplier Alliance Agreement - GEHC Directs EMEA Contract Manufacturing / Version Supply 1.0		10 (30)

LOGO

A NALYTICAL S PECIFICATION R AW M ATERIAL

30-6000-60 Ed. AG


				Page 2 (2)
8 Requirements on properties
	Characteristic	Tolerance limit	Test method	Remark

	1 Visual examination	*[]**	45-2006-68

	2 igG-binding activity: %	*[]**	04-0008-64

	3 Purity by size exclusion chromatography: %	*[]**	04-0008-66

	4 SDS-PAGE	*[]**	04-0008-65

	5 Protein concentration (A ₂₇₅ ); mg/ml	*[]**	QCP-1156	1

	6 Microbial contamination CFU/ml	*[]**	M-QCP-1003	1

	7 Endotoxin activity EU/mg rProtein A	*[]**	M-QCP-1017	1

Comment:

1) Supplier method, to be available by the supplier on request from GE Healthcare.


GE and GE monogram are trademarks of General Electric Company.
© 1999- 2008 General Electric Company - All rights reserved.		70-5043-16 /AB
GE Healthcare Bio-Sciences AB, a General Electric Company.

LOGO

A NALYTICAL S PECIFICATION R AW M ATERIAL

14-0037-84 Ed. AC

Issued by

QA/ A Elb-Jorde

Established by

R&D/ J Daicic

Valid from

2008-08-19

Supersedes

14-0037-84 Ed. AB

Page

1 (2)

ZätA protein 905

Code No: 28-4048-76


1 Packaging instruction
		The package shall be suitable for storage of the material.

2 Terms of transportation
		At or below -18 °C

3 Storage conditions
		Preserve in a well-closed container at or below -18 °C.

4 Shelf life
		Estimated shelf life is *[]** from the date of manufacture.
		Final shelf life is to be decided from stability studies.

5 Formula and mass
		Theoretical Mr: 26 748 Dalton calculated from amino acid sequence.

6 Description
		ZätA protein is a recombinant protein produced by a Genetically Modified Organism (GMO) in a fermentation process.
		The substance is a clear, yellowish frozen liquid free from particulates, supplied in a buffer:
		20 mM potassium phosphate
		150 mM sodium chloride
		2 mM EDTA
		pH 7.0

		The bulk is to be manufactured according to our Base Method, number 14-0040-44.
		The protein is produced with chemicals and materials of non-animal origin.

70-5043-16/AB Valid from 2007-01-24

LOGO

A NALYTICAL S PECIFICATION R AW M ATERIAL

14-0037-84 ED. AC


				Page 2 (2)
7 Requirements on properties
	Characteristic	Tolerance limit	Test method	Remark

	1 Visual examination	*[]**	45-2006-68

	2 IgG-binding activity; %	*[]**	04-0008-64

	3 Purity by size exclusion chromatography; %	*[]**	04-0008-66

	4 SDS – PAGE	*[]**	04-0008-65

	5 Quantification; mg/ml	*[]**	04-0013-21

	6 Microbial contamination CFU/ml	*[]**	M-QCP-1003	1

	7 Endotoxin activity EU/mg ZatA Protein	*[]**	M-QCP-1166	1

Comment:

1) Supplier method, to be available by the supplier on request from GE Healthcare.


GE and GE monogram are trademarks of General Electric Company.
© 2006-2008 General Electric Company – All rights reserved.		70-5043-16 / AB
GE Health Bio-Sciences AB, a General Electric Company.

Annual Business Attachment / Performance Goals

The purpose of the performance goals are primarily for the Supplier to plan the operations at the Supplier’s site and take preventive initiatives so that the set performance goals can be achieved. The results of the Supplier’s performance in below areas should be a part of the business updates between the two Parties. While the performance goals are targets and non-achievement of such goals shall not be considered as material breach of contract the Suppler agrees to use all commercially reasonable efforts to achieve the performance goals.

Performance goals:

1.	Deliveries within Specification, agreed lead times and quantities; performance goal is *[]** according to the terms in Attachment C)

2.	Number of complaint reports sent to the Supplier by GEHC; performance goal is *[]**

3.	Business contingency plan and or Quality audits performed and with the result approved; performance goal is *[]** .


Strategic Supplier Alliance Agreement - GEHC Directs EMEA Contract Manufacturing / Version Supply 1.0		14 (30)

Attachment D

Business Terms

1.	Specifications

The Products to be supplied in accordance with the terms of this Agreement are set forth in Products and Prices, Attachment C. A technical specification in relation to a specific Product is referred to as the “ Specification ” as set forth in Attachment C.

2.	Delivery documentation

With each shipment the Supplier shall deliver the following documents to GEHC:

Certificate of Analysis, Packing slip and the Commercial Invoice.

With each shipment the Supplier shall issue a Shipper’s Letter of Instructions and an Export Declaration as applicable.

3.	Prices and Payment Terms

Firm Prices. The Prices of the Products are firm for the Term of this Agreement.

Taxes. Unless prohibited by law, the Supplier will separately indicate on its Invoice any tax that is required to be imposed on the sale of Products.

Payment Terms. GEHC shall settle any undisputed invoices arising under this Agreement [*] ( [*] ) days after receiving an Invoice prepared in accordance with the terms of this Agreement. All sums to be paid by GEHC under this Agreement shall be in the currency specified in Attachment C. Interest for late payments shall not apply to payments that GEHC contests in good faith and shall in no event exceed applicable statutory interest rate.

Productivity improvement. In the event the Parties have jointly contributed to productivity improvements or cost savings achieved by the Supplier the Parties agree to negotiate in good faith a reasonable price adjustment. Price conditions will be changed only upon mutual agreement.

Invoicing requirements. The Supplier’s Invoices shall contain the GEHC Purchase Order number and other such information as may be required by law or requested from time to time by GEHC. Each cost item shall be specified in the invoice. Invoices shall be addressed to GEHC or the GEHC affiliate who has placed the purchase order with the Supplier.

GEHC mandated changes. It is recognized and agreed by the Parties that GEHC mandated changes in the manufacturing process, quality requirements or standard or in the components and materials used in the process or any other changes in the requirements for the Products may result in an increase in the cost of the Products. The Parties agree to negotiate in good faith to adjust the prices accordingly, provided that the Supplier notifies GEHC in writing of any possible cost increases in advance of the initiation of any such changes.

4.	Components and Materials

At GEHC’s option, GEHC may instruct the Supplier to procure or provide all materials and components necessary for the manufacture of the Products from an approved supplier, in which case an approved suppliers list shall be maintained by the Supplier. GEHC confirms its approval of the currently used suppliers as notified to GEHC in approved raw material specifications. Any new suppliers selected by the Supplier in connection with the Agreement must be approved by GEHC, whereupon they may be added to such approved suppliers list. The Parties may from time to time agree on materials that can be sourced by the Supplier from different sub-suppliers without GEHC’s consent.


Strategic Supplier Alliance Agreement - GEHC Directs EMEA Contract Manufacturing / Version Supply 1.0		15 (30)

5.	Additional Suppliers

The Supplier shall, at GEHC’s written request, provide reasonable assistance to GEHC with regard to GEHC’s efforts to have a designated alternative supplier for the Products (i) by providing GEHC or such designee with copies of all written SOP’s and access at Suppliers facility to completed batch records or other tangible forms of recorded manufacturing documentation of the Products, that are reasonably necessary for the manufacture of the Product, and (ii) by making relevant personnel available within reason for consultation on the phone or at Supplier’s facility with respect to clauses (i) above.

6.	Forecast and Commitment

Forecasting . [*] ( [*] ) days before the end of each quarter, GEHC shall submit to the Supplier in writing a [*] ( [*] ) month rolling quarterly forecast (“Forecast”) for its estimated needs of the Products during the subsequent [*] ( [*] ) month period. Supplier shall use the Forecast as the basis for its production planning and shall adjust the Safety Stock according to the new Forecast within the agreed lead times. In the event that GEHC does not timely submit a Forecast to the Supplier, Supplier will notify GEHC in writing and GEHC will have [*] ( [*] ) business days to provide the Supplier with the updated Forecast or if GEHC fails to provide the updated Forecast, the Forecast will revert to [*] ( [*] ).

The Forecast . The [*] of every Forecast provided by GEHC for Products shall be [*] on GEHC and the Supplier. [*] . The Supplier agrees to use all commercially reasonable efforts to be responsive and supply Product in excess of any firm and binding [*] if so requested by GEHC, provided such excess shall not exceed [*] % of the then firm and binding [*] .

General Supply Commitment . The Supplier represents and warrants that it has the capacity and expertise necessary to [*] . In the event that the market demand exceeds this volume, GEHC and Supplier will work together and make best efforts to meet the market demand.

Purchase Commitment . As a result of this Agreement, the Supplier will become one of the preferred suppliers of GEHC for the Products. GEHC agrees that the [*] shall include quantities of the Products, which corresponds to at least [*] ( [*] ) percent of GEHC’s total actual requirements in [*] for the Products. For any year thereafter the requirement in the [*] shall be at least [*] ( [*] ) percent of GEHC’s total actual requirements in [*] for the Products per year and at least [*] ( [*] ) percent of GEHC’s actual requirements in [*] of each of the Products. While GEHC has to adjust its production levels to market changes GEHC shall use all reasonable efforts to distribute orders evenly during the year and to avoid to have quarters without any orders at all. Further, GEHC agrees to purchase at least [*] ( [*] ) percent of its total requirements in [*] of the Products during the years [*] of this Agreement or any shortened period of [*] in the event this Agreement is terminated in accordance with 16.6 and 16.7 in Attachment E. In the event GEHC should fail to fulfill its purchase obligations hereunder it shall as its sole liability immediately issue a purchase order for the missing quantities upon the Supplier’s written request thereto. The Supplier agrees to maintain the equivalent ability to manufacture the Products for GEHC. The Parties may from time to time mutually agree in writing on separate arrangements for certain time periods in order to accommodate specific requirement and planning needs which may deviate from the above commitment. GEHC shall be free to decide on the mix between Products under the above purchase obligations and in the [*] forecast, provided that the binding part of the forecast shall be fixed. In the event there is a requirement in excess of [*] % of the firm and committed [*] and the Supplier is unable to deliver within the agreed lead times as specified in Attachment C then GEHC shall be free to purchase any such additional quantities as Supplier is unable to deliver that [*] from other suppliers.


Strategic Supplier Alliance Agreement - GEHC Directs EMEA Contract Manufacturing / Version Supply 1.0		16 (30)

If the Supplier during a certain [*] is unable to timely supply Products complying with agreed quality standards in quantities specified in GEHC’s committed Forecast, then GEHC’s purchasing commitment hereunder shall be reduced with a quantity corresponding to the quantity to which such inability relates.

No Obligation . Other than as set out in subsection b) and d) above, it is the express understanding of the Parties that GEHC shall have no obligation to purchase Products exclusively from the Supplier or to purchase any minimum amount of Products, and may use other suppliers for any and all Products, or similar products.

7.	Contract Managers and Communication

Contract Manager . Both the Supplier and GEHC will appoint a contract manager to manage their respective obligations under this Agreement, to act as focal points between the two organizations and review progress on a quarterly basis. The contract manager shall be as specified below or such other person as subsequently communicated to the other Party.


GEHC:		*[]**

Supplier:		*[]**

Legal Notices (as set forth in Section 18 in Attachment E) .


GEHC:		Björkgatan 30
		751 84 Uppsala, Sweden
		Fax No. *[]**

Supplier:		41 Seyon Street Bldg #1 suite 100
		Waltham, MA 02453 USA
		Phone: 781 250-0111 (main)
		Fax: 781 250-0115

Crisis Communication . The Supplier must maintain the ability to contact or receive contact from GEHC on a twenty-four (24) hour per day, seven (7) days per week basis in order to communicate and manage crisis situations that threaten to or interrupt the supply chain.

8.	Insurance and Liability

The Supplier undertakes to maintain a comprehensive liability insurance policy with a reputable insurer including cover for third party liability and product liability on terms customary to the business. Such insurance shall be for an insured sum of not less than USD [*] ( [*] ) [*] and the Supplier shall supply GEHC with a copy of the relevant policy on request.

The Supplier shall be liable to compensate GEHC for direct and indirect damage and loss it has caused GEHC under this Agreement up to USD [*] ( [*] ) [*] . In the event of any loss or damage in excess of this amount the Supplier shall not be liable to compensate for such excess damage or loss, unless: (i) caused by its gross negligence or willful misconduct, (ii) caused by its breach of confidentiality obligations under this Agreement, or (iii) relating to its intellectual property indemnification obligations under this Agreement.

9.	Safety Stock and Consignment Stock

The Supplier shall keep a Safety Stock at the Supplier’s premises, corresponding to the minimum set inventory values and the replenishment times in Attachment C.

The inventory levels stated in Attachment C shall be based on the latest [*] Forecast distributed by GEHC. In case a new Forecast leads to replenishment actions for the safety stock the Supplier shall use all commercially reasonable efforts to replenish the Safety Stock as soon as practical and always within the agreed lead times set forth in Attachment C.


Strategic Supplier Alliance Agreement - GEHC Directs EMEA Contract Manufacturing / Version Supply 1.0		17 (30)

GEHC is reviewing the possibility to introduce a consignment stock arrangement, ie having the Supplier to own certain stock of Product at GEHC premises. The Supplier agrees to negotiate the terms and conditions in good faith.

10.	Manufacturing Process

For clarity it is stated that all written manufacturing or production documentation relating solely to the Products, including without limitation the manufacturing documents specified in Attachment F shall be the sole property of GEHC. The Supplier shall document and GEHC shall have access to review all written manufacturing or production records relating to any of the Products at Suppliers facility and upon request from GEHC, the Supplier is obliged to send GEHC copies of the requested manufacturing or production documents (including SOP’s and records) and such a request shall not be unreasonably withheld by the Supplier.

The Supplier shall keep a master list of production documents showing the name, identity and version number for each of the production documents that is used in the production of the Products. The Supplier shall always keep and maintain the master list of production documentation and shall send upon GEHC’s request an update of any of the documents included in the master list of production documentation.

11.	Business interruption

The Supplier undertakes to keep GEHC informed about any circumstances that might reasonably impact on the Supplier’s ability to supply the Products, timely and in accordance with applicable quality standards, including any plans to close or divest the business relating to all or any of the Products. If such circumstance should arise or may reasonably be possible to arise the Supplier shall immediately inform GEHC and propose a plan on how to mitigate the consequences thereof. The Parties shall then in good faith conduct negotiations concerning the actions to be taken and the costs to avoid or mitigate the risks.

12.	Reports

GEHC will provide Supplier within [*] of the close of each [*] period a report of the total quantity of each of the Products purchased by GEHC from all suppliers during the period.

The Supplier will provide GEHC with finished goods inventory and Safety Stock levels of Products within [*] of the close of each [*] period.

13.

Audit

Supplier shall have the right to have an independent third party reasonably acceptable to GEHC, such as one of the global auditing firms, to conduct an annual audit of GEHC’s records to ensure compliance with GEHC’s commitments according to Section 6 d in this Section of the Agreement.

14.	Supply of GEHC products for the manufacture of Products

During the term of this agreement the Supplier shall have the right to purchase the following products from GEHC at following price conditions:


Name	Article No:	Price:

*[]**


Strategic Supplier Alliance Agreement - GEHC Directs EMEA Contract Manufacturing / Version Supply 1.0		18 (30)

Delivery conditions: CIF

Lead time: [*]

Credit term: [*] days from date of invoice

Order handling: all order shall be submitted to the Contract Manager, together with a declaration of the intended use for the Products.

The sale of the goods to the Supplier shall be subject to GEHC Conditions of Sale.

The products ordered in accordance with this Clause 15 may only be used in the manufacture of the Products for delivery to GEHC. Any other use of the products ordered is strictly forbidden.

15.	ELISA Kits

GEHC acknowledges that the Supplier manufactures and sells ELISA analytic kits for protein leakage testing. During the term of this Agreement Repligen shall have the right to use MabSelect SuRe™ ligands and the MabSelect SuRe trademark, but only in connection with the manufacture, sale and marketing of ELISA analytical kits for protein leakage testing. The Supplier agrees to use the GEHC trademarks in accordance with GEHC’s written instructions from time to time.

16.	Cell banks

The biological starting material used in the fermentation process originates from the cell banks kept and owned by GEHC. Such material may only be used in connection with the manufacture of the Products and shall be returned to GEHC, alternatively destroyed upon termination of this agreement for what ever reason. Supplier shall not disclose or provide such material to any third parties, unless GEHC has given its prior written consent thereto. The Supplier agrees not to sequence, extract or in any other way use the plasmid, the chromosome or any of the DNA codes present in the cell banks.

The supplier may order starting material according to the following conditions:

Lead time: [*] days, unless otherwise agreed.

Orders: written orders in accordance with form provided by GEHC specifying product, campaign, numbers of vials and requested delivery date. The order will be sent to:


GE Healthcare Bio-Sciences AB
Att: *[]**
BL3-2
Björkgatan 30
751 84 UPPSALA
Sweden

tel:		*[]**
fax:		*[]**

GEHC will confirm order without delay and provide a notice two weeks before the estimated delivery date.

Supplier shall confirm receipt of the cell bank.

Transportation: GEHC will coordinate with Repligen to ensure appropriate delivery time and arrangements for the cell banks and will arrange and pay for transportation.

Documentation: The cell banks will be accompanied by a Certificate of Analysis in accordance with the documents listed in Attachment F.

Repligen shall provide GEHC at the beginning of every [*] a report of the total quantity of seed stock for each of the Products as well as the planned consumption of the seed stock for the following [*] months. GEHC shall use this information for their internal planning purposes.


Strategic Supplier Alliance Agreement - GEHC Directs EMEA Contract Manufacturing / Version Supply 1.0		19 (30)

17.	Other products

The Parties have agreed to enter into a separate agreement covering the Supplier´s supply of [*] . The Parties intend to enter into a separate agreement concerning supply of [*] .


Strategic Supplier Alliance Agreement - GEHC Directs EMEA Contract Manufacturing / Version Supply 1.0		20 (30)

Attachment E – General Terms and Conditions

ORDER AND SUPPLY

1.	Purchase Orders

1.1	Purchase Order Contents . GEHC shall issue purchase orders to the Supplier stating the quantity and delivery date for Products (a “ Purchase Order ”). The Purchase Orders shall be written and sent through an electronic purchasing system or by fax, e-mail or other agreed method.

1.2

Orders from Affiliates . From time to time Affiliates of GEHC may also issue purchase orders for Products and, if requested by such GEHC Affiliate, the Supplier agrees to supply Products to such affiliate on the terms of this Agreement. The ordering GEHC Affiliate entity shall be solely contractually liable for such order.

1.3

Acceptance of Purchase Order . The Supplier shall be deemed to have accepted a Purchase Order upon receipt from GEHC so long as the terms are consistent with those stated in this Agreement. The Supplier shall confirm compliance with the Purchase Order in writing within [*] ( [*] ) business days of the receipt of Purchase Order.

2.	Transportation; Title and Risk of Loss

2.1

Unless otherwise agreed, Products shall be delivered according to the Incoterms FCA (ICC Incoterms 2000) at the address set out in Attachment D. This means that the possession and title will transfer upon delivery to the carrier. The Supplier will be responsible for export declaration and shall arrange for transportation at GEHC’s cost and in accordance with GEHC’s instructions. GEHC will take care of the import declaration.

2.2	If the delivery term agreed in Products and Prices in Attachment C or Purchase Order, if any, is an Incoterm such term of delivery shall be construed according to the edition of Incoterms in force at the Effective Date.

3.	Delivery

3.1	The Supplier shall deliver the Products on the date and in quantity set forth in the Purchase Order. The Supplier may only deliver prior to the agreed delivery date with the written consent of GEHC.

3.2	Deliveries shall not be regarded as completed until the Delivery Documentation in Specific Requirements Attachment D has been provided.

3.3	The lead time as specified in Attachment C for the Product shall count from the date of issue of the Purchase Order to receipt of the Products at GEHC premises, including receipt of any agreed documentation.

3.4	In the event that the Supplier anticipates or expects a delay in delivery it shall immediately notify GEHC and at the same time explain the causes and the steps that it is taking to minimize the delay. GEHC may, acting reasonably, require the Supplier to take

further or other steps, including the deployment of additional resources, at the Supplier’s cost, to minimize the said delay. If unless otherwise mutually agreed by the Parties, the delivery is delayed by more than [*] days then GEHC may: (i) terminate the delayed Purchase Order and, if applicable, return to the Supplier some or all of the Products that relate to such order at the expense of the Supplier; and/or either to (ii) purchase substitute Products elsewhere and charge the Supplier with the increased cost thereof (if any) or (iii) claim as liquidated damages for such default [*] per cent of the total value of the delivery for each calendar day delivery is delayed limited to a maximum of [*] per cent of the total value of the delivery in aggregate. Such rights are without prejudice to any other rights that GEHC may have in respect of late delivery by the Supplier.

4.	Inspection Period

All Products delivered to GEHC by the Supplier must meet the terms and conditions of this Agreement and the related Purchase Order. All Products shall be received subject to GEHC’s acceptance or rejection on or before the end of the Inspection Period. GEHC may reject an entire order based upon a reasonable sampling of Products. “Inspection Period” means [*] ( [*] ) business days. Partial or total payment by GEHC for Products under this Agreement prior to the end of the Inspection Period shall not constitute its acceptance thereof, nor shall such payment remove the Supplier’s responsibility for any non-conforming items.

The Supplier acknowledges that GEHC’s inspection of the goods may be based on the review of the Certificate of Analysis issued by the Supplier and that GEHC shall not be prevented from raising any claims under the warranty in clause 11 after the expiration of the Inspection Period.

5.	Safety Stock

Supplier shall maintain at its’ own cost and risk the safety stock agreed as set forth in Attachment C. The safety stock shall be managed in accordance with first in - first out principle.

6.	Changes to Products

6.1

GEHC Proposed Changes . GEHC may [*] per year propose changes to the Specification or the manufacturing method for the Products by submitting the proposed changes to the Supplier. The Supplier agrees to use all commercially reasonable efforts to accommodate any such proposals of GEHC and shall respond in writing to GEHC within [*] ( [*] ) days after receipt of such changes with the following information, as


Strategic Supplier Alliance Agreement - GEHC Directs EMEA Contract Manufacturing / Version Supply 1.0		21 (30)

applicable: (a) time required to implement proposed changes; (b) impact of proposed changes on pricing of Product; and (c) impact of proposed changes on the lead time of the Product. If the Parties agree on the changes to the Specification they shall amend this Agreement accordingly. If the Parties fail to agree on the amendments to be made to the Agreement to reflect the changes to the Specification the terms in effect prior to commencement of the negotiations shall remain in full force and effect and the Supplier shall continue to supply the Product to the existing Specification.

6.2

Supplier’s Proposed Changes . The Supplier may [*] per year propose, a change to the Specifications (including, but not limited to, changes which may affect quality, form, fit, function, reliability, regulatory compliance, safety or interface capability with GEHC products) or a change in its manufacturing method (including, but not limited to changes of sources of materials and changes in manufacturing processes or locations) but the Supplier shall not implement such change without the prior written consent of GEHC, which shall not be unreasonably withheld. The Supplier shall make such proposals in writing explaining the reason for the changes and providing reasonable detail sufficient for GEHC to evaluate the proposal. GEHC agrees to use all commercially reasonable efforts to accommodate any such proposals. Upon request of GEHC, the Supplier shall provide samples of the Products manufactured according to the proposed new specification or manufacturing method for evaluation purposes.

7.	Packaging and marking

The Supplier shall be responsible for the safe and suitable packaging and labeling of the Products, for complying with the packaging and marking requirements in the Specifications, if any, and all applicable laws and regulations relating to the packaging, marking and transport of the Products.

8.	Health and Safety

8.1

The Supplier shall ensure that all information held by or reasonably available to it regarding any changes occurring after the Effective Date with regard to potential hazards known or believed to exist in the transport, handling, or use of any Products and/or performance of any services shall be received by GEHC in writing prior to delivery of the Products and/or performance of the services.

8.2	Employees, agents and representatives of the Supplier visiting any of GEHC’s sites shall be subject to such safety and security regulations as may be in force on that site.

9.	Business Contingency Planning

9.1	Business Contingency Plan . Upon GEHC’s request, the Supplier shall provide to GEHC a summary of Suppliers Business Contingency Plan that outlines the Supplier’s internal contingency arrangements to ensure GEHC continuity of supply if the Supplier or

any of the Supplier’s suppliers are unable to provide Products or components to such Products to GEHC.

9.2	GEHC shall have the right to carry out audits of the Supplier’s Business Contingency Plan on a regular *[] basis with []* ( *[]** ) days prior notice.

10.

Compliance

10.1

Applicable Laws . The Supplier represents and warrants that its performance under this Agreement and its manufacture of the Products will comply with all applicable laws and regulations, and all conventions and standards issued by relevant authorities and that the Supplier has obtained all applicable permits and licenses necessary to perform its obligations under this Agreement

10.2

Assistance . The Supplier shall at GEHC’s request give reasonable assistance necessary to obtain any licenses required by GEHC with respect to the importation, exportation, marketing and use of the Products and provide GEHC with all information in relation to the Products which may be required by any regulatory authority.

10.3

Regulatory Approvals and other Governmental Registrations . GEHC shall be responsible for identifying, obtaining, and maintaining at its sole cost and expense all FDA and other applicable clearances and approvals and corresponding approvals in other countries that are required for the development, manufacture, or sale of any Product. The Supplier shall provide GEHC with reasonable support and assistance in obtaining any such approvals, which may include providing test reports and data necessary to meet the country specific regulatory requirements.

10.4

Regulatory Agency Inquiries . If the FDA or any other regulatory body with authority over the end products to which the Products form part, provides written notice to the Supplier to inquire about or investigate any Product or conduct any audit or inspection of facilities used for the manufacture, storage or distribution of Products or request any information related to the manufacture of any Product, the Supplier shall give notice thereof to GEHC within one working day of receipt of such contact from the FDA or other body.

10.5

Security Measures . The Supplier agrees that it will adopt industry standard security measures which are consistent with accepted programs including the US Customs-Trade Partnership Against Terrorism (“C-TPAT”), the European Union’s Authorized Economic Operator program and other similar programs where applicable.

10.6

Export Restrictions . If any Products are subject to export restrictions in the country of manufacture or shipment the Supplier shall supply GEHC prior to dispatch with any relevant ECCN and ECN numbers and copies of any export licenses or other certificates required in the country of manufacture or shipment and, where Products contain US components, details of the value as a percentage of the Products price.


Strategic Supplier Alliance Agreement - GEHC Directs EMEA Contract Manufacturing / Version Supply 1.0		22 (30)

10.7

Country of Origin . In accordance with GEHC´s request the Supplier will mark each Product, and, as appropriate, Product packaging, labels, or invoices with the country of origin for the Product, in accordance with the applicable trade and customs laws. The Supplier will also upon request from GEHC provide acceptable and auditable documentation that establishes the country of origin for a Product and including the raw materials used to manufacture such Product for the whole supply chain, including without limitation, certifications of origin for Products qualifying for NAFTA or EEA preferential duty provisions, as applicable.

10.8

Personal Data Protection . With regard to personal data received from GEHC, the Supplier agrees (i) not to use it other than for its intended purpose, (ii) not to disclose it to any third parties, and (iii) not to transfer it to any countries outside the European Union , unless GEHC has given its prior written consent thereto. The Supplier shall use appropriate measures to ensure security and confidentiality of GEHC personal data. Supplier shall notify GEHC in the most expedient time possible and without unreasonable delay of any Security Breach involving any GEHC personal data where “Security Breach” is defined as any event involving an actual, potential or threatened compromise of the security, confidentiality or integrity of the data, including but not limited to any unauthorized access or use. GEHC shall have the right to use personal data received from the Supplier in conformity with applicable data protection laws. Upon termination of this Agreement, for whatsoever reason, Supplier shall stop the Processing of GEHC Personal, unless otherwise agreed by GEHC, and these undertakings shall remain in force until such time as Supplier no longer possesses GEHC Personal Data. For the purpose of this provision the definition of “personal data” is that provided in EU Directive 95/46/EC.

WARRANTY, INDEMNIFICATION AND LIABILITY

11.

Warranty

11.1	Product Warranty . The Supplier represents and warrants that the Products will:

(a)

conform strictly to and be manufactured in accordance with the Specifications referred to in Attachment C;

(b)

be free from defects in title, material, and workmanship, whether latent or otherwise;

11.2

Supplier Intellectual Property Warranty . The Supplier represents and warrants as follows: (i) it owns or has the right to use all of its Process-Related Technology existing as of the Effective Date that it will use to manufacture the Products and to sell the Products to GEHC; and (ii) neither the Supplier’s equipment nor any of its Process-Related Technology used to manufacture the Products infringes or is alleged to infringe any patent or other proprietary right of any other person.

11.3	GEHC Intellectual Property Warranty . GEHC represents and warrants as follows: (i) GEHC owns

or has the right to use all of the Product-Related Technology; and (ii) the Product-Related Technology does not infringe and is not alleged to infringe any patent or other proprietary right of any other person.

11.4

Execution and Performance of Agreement . The Supplier represents and warrants that it has the full right, power, and authority to enter into and perform its obligations under this Agreement. The Supplier further represents and warrants that the performance of its obligations under this Agreement will not result in a violation or breach of, and will not conflict with or constitute a default under any agreement, contract, commitment, or obligation to which Supplier or any of its affiliates are a party or by which it is bound and that it has not granted and will not grant during the term of this Agreement or any renewal thereof any conflicting rights, license, consent, or privilege with respect to the rights granted herein.

11.5

Survival of Warranties . The Supplier agrees that (i) the warranties set forth in this section shall survive the inspection, acceptance, and use of the Products by GEHC, its distributors and sub-distributors for a period of the shorter of either [*] ( [*] ) months from completion of delivery of the Purchase Order or the shelf life as specified in Attachment C (“Warranty Period”) and that they (ii) are for the benefit of GEHC and its successors and assigns; and (iii) are in addition to any warranties and remedies to which the Supplier may otherwise agree or which are provided by law. The Supplier agrees to extend to GEHC any warranties received from the Supplier’s suppliers. The Supplier warrants Products only as set forth in this Agreement and disclaims all other warranties.

11.6

Returns . GEHC may return to the Supplier any Product that does not conform to the representations and warranties. Any such Product shall be returned to the Supplier and then once replaced returned to GEHC at Supplier’s expense (including all transportation and insurance). The Supplier will, at its cost, and as soon as reasonably practicable replace the returned Product to bring the Product in conformance with the warranty, and will return the replacement Product as soon as possible, but in any event within thirty (30) days, after receipt of the non-conforming or defective Product. If the Supplier is unable to return the Product within thirty (30) days, the Supplier shall at GEHC´s request provide GEHC a refund as defined in section 11.8 below.

11.7

Complaints . Any complaint shall be regarded as having been timely lodged if GEHC notifies the Supplier of the fault at any time during the warranty period. Within [*] weeks after any complaint lodged by GEHC concerning a defective Product the Supplier shall make a reasonably detailed report to GEHC on the corrective and preventive action that has been initiated according to the Suppliers standard operating procedure.


Strategic Supplier Alliance Agreement - GEHC Directs EMEA Contract Manufacturing / Version Supply 1.0		23 (30)

11.8

Credits/Refunds . In accordance with this Section 11, the Supplier shall promptly refund GEHC by wire transfer or check for any payment GEHC made with respect to such Product. GEHC may elect, at its sole discretion, to take such credit on any open invoices of the Supplier in the place of such refund.

11.9	Set-off . GEHC may set-off any amount owed from the Supplier or any of Supplier’s affiliates against any amount payable at any time by GEHC.

11.10

Remedies . The remedies contained in this Section 11 are in addition to all other remedies available at law or in equity.

11.11

Recalls and Field Corrections . If any recall, product withdrawal or field correction of any Product is required by a governmental agency or by GEHC for safety or efficacy reasons resulting from (a) the supply by the Supplier of any Product not complying with the terms and conditions of the Agreement (including all warranties included in the Agreement) or (b) the negligent or intentionally wrongful act or omission of the Supplier or its affiliates or their representatives, then the Supplier shall bear all costs and expenses, including but not limited to the costs and expenses related to such recall or field correction, communications and meetings with all required regulatory agencies, replacement stock, service labor, installation, travel, notifying customers of such recall and any replacement product to be delivered to those same customers, including shipping costs. To the extent that any such recall or field correction is due in part to the negligent or intentional acts or omissions of GEHC, GEHC shall be responsible for such costs and expenses equitably in proportion to its fault.

11.12

Testing In the case of disagreement between the Parties concerning the quality of Products delivered and such disagreement relates to the provisions in this Section 11, a sample shall be submitted to an independent laboratory to be agreed upon by the Parties and the report from such laboratory shall finally settle whether or not the delivery has met the specification or not. The cost for the laboratory shall be borne by the failing party.

12.

Indemnification

12.1

Supplier Indemnity . Subject to Section 14 below, the Supplier agrees to defend, indemnify, protect, and hold harmless GEHC and GEHC’s Affiliates, employees, agents, servants, and representatives from and against any and all claims, damages, losses, liabilities, and expenses of whatever nature, arising out of or relating to: (i) the breach by the Supplier of any term of this Agreement or any term contained in any Attachments or (ii) any negligent act or omission, or willful misconduct of the Supplier or its agents, employees, or subcontractors. GEHC shall notify the Supplier of any such claim, suit, or proceeding, and Supplier will assist (at the Supplier’s expense) in the defense of the same.

12.2	GEHC Indemnity . Subject to Section 14 below, GEHC agrees to defend, indemnify, protect, and hold harmless the Supplier and its Affiliates, employees,

agents, servants, and representatives from and against any and all claims, damages, losses, liabilities, and expenses of whatever nature, arising out of or relating to: (i) the breach by GEHC of any term of this Agreement or any term contained in any Attachments or (ii) any negligent act or omission, or willful misconduct of GEHC or its agents, employees, or subcontractors. Supplier shall notify GEHC of any such claim, suit, or proceeding, and GEHC will assist (at GEHC expense) in the defense of the same.

12.3

Intellectual Property Indemnity . With the exclusion of any GEHC Technology, the Supplier agrees to defend, indemnify, protect, and hold harmless GEHC and GEHC’s affiliates, employees, agents, servants, and representatives from and against any and all claims, damages, losses, liabilities, and expenses of whatever nature, resulting from a claim or allegation that the use (for uses made known to the Supplier) or sale of a Product infringes or otherwise violates an intellectual property right of any third party. If GEHC has reason to believe that (i) the use of any Supplier Process-Related Technology is enjoined by a court, the Supplier will first use best efforts to either procure the necessary licenses to continue manufacturing under the Supplier Process-Related Technology or adjust the manufacturing process at its sole-cost to avoid infringing such other party’s intellectual property (provided that such an adjustment can be made by the Supplier without otherwise breaching the Agreement); and (ii) if after using best efforts, the first two options are not commercially reasonable, the Supplier may terminate the Agreement, refund to GEHC any amounts paid thereunder for Products that cannot be sold by GE as a result of the injunction and reimburse GEHC for any related costs incurred.

CONFIDENTIALITY AND GE PROPERTY

13.

Confidentiality

13.1


Strategic Supplier Alliance Agreement - GEHC Directs EMEA Contract Manufacturing / Version Supply 1.0		24 (30)

confidential nature . The Recipient will protect the Confidential Information with the same degree of care as the Recipient uses for its own similar information, but no less than a reasonable degree of care. Confidential Information may only be used by those employees, contractors and advisors of the Recipient and its affiliates (“Representatives”) who have a need to know such information for the purposes related to this Agreement and who are bound by equivalent confidentiality obligations, and the Recipient shall inform such Representatives of the confidential nature of such Confidential Information and the obligations of the Recipient hereunder. The Recipient shall be responsible for any breach of this Agreement by it or any Representative to the same extent as though such Representatives were Parties hereto. The Parties acknowledge that trade secrets are deemed Confidential Information to be protected indefinitely. The Parties also agree that all other information, including but not limited to technical information (which is not intellectual property rights) and forecasts disclosed during the Term or prior to the formation of this Agreement are deemed Confidential Information to be protected during the term and for a period of [*] ( [*] ) years thereafter.

13.2	Exclusions The undertakings in clause 13.1 shall not apply to information which:

(a)

is publicly available through no fault of the Recipient;

(b)

the Recipient can show by reasonable written record was in his possession at the time of disclosure and which was not acquired directly or indirectly from the Discloser;

(c)

is rightfully received from a third party with no duty of confidentiality;

(d)

has been developed by the Recipient independently of the Confidential Information received from the Discloser; or

(e)

the Recipient notifies the Discloser is required to be disclosed by the Recipient pursuant to a legally enforceable order, direction or other regulation but any disclosure shall only be so far as necessary to give effect thereto.

13.3

Return of Confidential Information . All Confidential Information supplied to or acquired by each Party and all copies thereof shall be returned to the other Party within [*] ([*]) days after termination of this Agreement All information consisting of documents, notes and other writings prepared by one Party based on non-public data of the other Party shall be destroyed.

13.4	Development . The confidentiality terms in this Clause shall not be construed to limit GEHC’s or Suppliers right to independently develop or acquire products without use of the other Parties Confidential Information.

13.5	Restrictions on Use of Design Materials and Know How . During and after the Term the Supplier shall be prohibited from selling to any third party any Product or equivalent product that is either (i)

developed for GEHC under this Agreement; (ii) incorporates any GEHC Confidential Information; or (iii) is specifically designed or configured for use with GEHC’s products using information received or know how developed in connection with this Agreement.

13.6

Previous undertakings of confidentiality . The Parties agree that the provisions in this Clause 13 shall replace all previous undertakings of confidentiality and shall apply to all Confidential Information whether disclosed in connection with this Agreement or any preceding supply agreement between the Parties concerning any of the Products.

14.

Indirect Loss

In no event shall GEHC be liable for any indirect or consequential loss or damage in connection with this Agreement. The Supplier shall not be liable for any indirect or consequential loss or damage other than what is set forth in Clause 8 in Attachment D.

15.

Technology

15.1	Definitions .

(a)

“Technology” means any idea, invention, technique, modification, process, or improvement (whether patentable or not), trade secret, industrial design (whether registerable or not), patent, copyright or work of authorship (whether or not copyright protection may be obtained for it), excluding, however, any of the foregoing that is within the public domain.

(b)

“Product-Related Technology” means any Technology owned at any time during the Term (whether owned as of the Effective Date or thereafter acquired or developed) by either of the parties that is related directly and solely to the structure of the Products.

(c)

“Process-Related Technology” means any Technology owned at any time during the Term (whether owned as of the Effective Date or thereafter acquired or developed) by either of the parties that is required for the manufacture of the Products.

15.2	Licenses .

(a)

During the Term and only for the purpose of fulfilling its duties and obligations under the Agreement, GEHC hereby grants to the Supplier a royalty-free and nonexclusive right and license to use any Product- Related Technology or Process-Related Technology owned by GEHC that is necessary or useful to the Supplier for manufacture of the Products. Supplier acknowledges and agrees that no other use shall be made by the Supplier, its affiliates or authorized contractors of the GEHC Technology without the express written authorization of GEHC.

(b)

During and after the Term, the Supplier hereby grants to GEHC a royalty-free and nonexclusive right and license to use any Process-Related Technology owned by the Supplier that is necessary to GEHC for the manufacture, either directly or


Strategic Supplier Alliance Agreement - GEHC Directs EMEA Contract Manufacturing / Version Supply 1.0		25 (30)

through a third party manufacturer, sale, distribution, and use of the Products. GEHC acknowledges and agrees that no other use shall be made by GEHC, its affiliates or authorized contractors of the Process-Related Technology of the Supplier, without the express written authorization of the Supplier.

15.3	Ownership of Technology .

(a)

GEHC Property . All tools, dies, drawings, plans, manufacturing aids, testing or other equipment or materials, and all intellectual property rights in the foregoing, which GEHC furnishes to the Supplier, or which is developed or acquired at GEHC’s expense or at its direction in the performance of work hereunder, shall be GEHC’s property (the “GEHC Property”). The Supplier hereby assigns and agrees to assign to GEHC, all such property. All such GEHC Property shall be safely maintained separate from the Supplier’s property, and marked “Property of General Electric Company.” The Supplier agrees not to substitute any property for GEHC Property and not to use such property except for performance of work hereunder or as authorized in writing by GEHC. The Supplier also agrees to insure any GEHC Property at full replacement cost. GEHC Property will be held at the Supplier’s own risk, and subject to removal by GEHC at its written request.

(b)

GEHC Technology . Including, but not limited to such GEHC Technology listed in Attachment F, all GEHC Technology (i) that is provided to the Supplier by and/or on behalf of GEHC or that is used by the Supplier with respect to the performance of its obligations hereunder and (ii) that was owned by GEHC prior to being provided to the Supplier shall be and remain the property of GEHC. The Supplier shall acquire no right, title or interest in the GEHC Technology as a result of its performance of its obligations hereunder. At GEHC’s request or upon termination or expiration of the Agreement for any reason, the Supplier shall return to GEHC any and all copies of GEHC Technology and remove all copies of such GEHC Technology from the computers and computer networks of the Supplier, save for one copy which may be retained for the purpose of monitoring the Supplier´s compliance with this provision.

(c)

Supplier Technology . All Supplier Technology that is both (i) provided to GEHC by and/or on behalf of the Supplier or that is used by the Supplier with respect to the performance of its obligations under the Agreement and (ii) owned by the Supplier prior to the performance of any of its obligations under the Agreement or acquired by the Supplier thereafter shall remain the property of the Supplier. GEHC shall acquire no right, title or interest in any such existing Supplier

Technology as a result of the Supplier’s performance of its obligations hereunder.

(d)

Newly Created Works . All Technology, that is either Product-Related Technology or Process-Related Technology, developed by the Supplier as a result of the Supplier’s manufacture and supply of the Products or otherwise derived from GEHC Technology (collectively, the “Works”) shall also be deemed GEHC Technology and solely owned by GEHC. Such Works shall be considered “works made for hire” pursuant to the Copyright Act of 1976, as amended, and all intellectual property rights in and to such Works, including any copyright, trade secret and patent rights, shall be solely and exclusively owned by GEHC. The Supplier shall disclose to GEHC in a timely manner any and all Works, and such disclosures by the Supplier shall include a reasonably detailed written description of such Works. To the extent that all applicable intellectual property rights in the Works are not deemed “works made for hire” and transferred and assigned to GEHC by operation of law, the Supplier hereby does and will transfer and assign, and cause its employees and agents to transfer and assign, now and in the future, all right, title and interest in the Works to GEHC. GEHC may transfer such Works to any third party or use the Works for any purpose without further payment to the Supplier. In the event GEHC decides to file one or more patent applications covering any such Works, the Supplier shall at GEHC’s request and expense assist GEHC in the preparation and prosecution of such patent application (s) and shall execute all documents (and cause its employees or agents to execute all documents) deemed necessary by GEHC for the filing thereof and/or the vesting in GEHC of all title thereto. Such Works shall be deemed GEHC Confidential Information under the Agreement.

15.4

No Rights . The Supplier shall acquire no right, title or interest in any of the trademarks, patents, trade secrets, service marks or copyrights belonging to GEHC except as otherwise stated in Exhibit D Section 15 herein. No rights are granted to the Supplier under any GEHC patents, copyrights, trade secrets, or other property rights except as may be expressly agreed to by GEHC in writing. The Supplier shall not use or incorporate into Products any intellectual property of others without their prior written permission.

15.5

Removal of Marks . Subject to clause 16 in Attachment D the Supplier agrees not to sell, transfer, distribute or otherwise convey any part, component, Product or service bearing or incorporating any GEHC trademark, trade name or service mark, part numbers or other identifiers, including any GEHC packaging, copyrights or code (“GEHC Marks”), to any party other than to GEHC or any affiliate of GEHC except as otherwise stated in


Strategic Supplier Alliance Agreement - GEHC Directs EMEA Contract Manufacturing / Version Supply 1.0		26 (30)

Exhibit D Section 15 herein. The Supplier shall not have the right to sell rejected, returned or unpurchased Products to any third parties. The Supplier will defend and indemnify GEHC against any claims, losses, liabilities, costs or expenses that GEHC may incur as a result of the Supplier’s breach of this obligation.

15.6	Co-operation . The Supplier shall reasonably cooperate with GEHC to secure any intellectual property rights developed under this Agreement by, for example, assisting in the filing and prosecution of patent applications, and executing such documents as GEHC may reasonably request at GE expense.

15.7	Survival . The obligations under this Clause shall survive the termination of this Agreement.

TERMINATION

16.

Termination

16.1	Mutual Termination . Either Party may terminate this Agreement:

(a)

at any time upon written notice if the other Party (the “ Defaulting Party ”) materially defaults in the performance of one or more of its obligations hereunder and the Defaulting Party fails to cure the default within thirty (30) days after receiving written notice of such, provided that if the default is not reasonably susceptible to cure within such period, then the non-defaulting Party shall have the right to terminate this Agreement immediately upon written notice; or

(b)

immediately if any proceeding under the bankruptcy or insolvency laws is brought against the Defaulting Party, a receiver is appointed for the Defaulting Party or the Defaulting Party makes an assignment for the benefit of creditors, except as provided otherwise under applicable law.

16.2

GEHC Termination for cause . GEHC shall have the right to terminate this agreement and/or, at GEHC’s discretion, relevant Purchase Orders, with immediate effect in the event of (i) material breach by the Supplier of the Minimum Purchased Material Quality Requirements set forth in Attachment A (ii) a repeated breach of any term of this Agreement, (iii) consistent failure by the Supplier to meet required delivery dates, (iv) a delay in delivery that has exceeded more than [*] ( [*] ) days, (iv) material breach by the Supplier of the Supplier Integrity Statement set forth in Attachment B.

16.3

Purchase Orders . If GEHC terminates this Agreement in accordance with clause 16.1 or 16.2 it may also terminate all unfulfilled Purchase Orders without any liability except for the price of any Products previously delivered and accepted by GEHC (subject to any set-off available to GEHC). If GEHC terminates this Agreement in accordance with clause 16.3 or if the Agreement expires, GEHC and the Supplier agree that any unfulfilled Purchase Orders issued prior to such termination or expiry

but not yet delivered shall survive until fully performed.

16.4	Any advance termination of this Agreement shall not relieve the Defaulting Party of its obligations and the non-defaulting Party shall retain all legal and equitable remedies after such termination.

16.5

In the event of termination whether for cause or otherwise, unless attributable to Suppliers material breach of contract as set forth in Clause 16.1 and 16.2, GEHC shall purchase the remaining Product in the Suppliers Safety stock and with regard to any other finished goods inventory of the Supplier, up to three months consumption of each of the Products according to the latest Forecast., provided the Products comply with at least [*] remaining shelf life and otherwise fully complies with the applicable specifications.

16.6

GEHC shall have the right to terminate the Agreement with eighteen (18) months written notice if the Supplier or any of its Affiliates markets or sells any immobilized chromatography products that is functionally substitutable (based on technical performance) with GEHC’s chromatography products containing the Products (as exemplified by MabSelect and MabSelect SuRe), provided that GEHC prior to termination shall give Repligen thirty (30) days written notice of its intent to terminate the agreement and should Repligen provide reasonable explanation of compliance or stop selling or marketing such product during the thirty day period, as certified by Repligen to GEHC in writing, then GEHC shall not have the right to terminate the agreement referring to such circumstances.

16.7	GEHC shall have the right to terminate the Agreement with twelve (12) months written notice if the control of the Supplier or its non-therapeutic protein A business is acquired by a company, which is a direct competitor to GEHC in the field of chromatography media or bioprocess hardware products.

COMMUNICATION AND MISCELLANEOUS

17.

Electronic Data Interchange

17.1

Access . GEHC, in its sole discretion, may permit the Supplier to have online access to designated computer systems of GEHC in order to facilitate the Supplier’s ability to perform its obligations under this Agreement. If such access is granted, the Supplier shall give to GEHC the names of the Supplier’s employees who have a legitimate business need for such access to GEHC’s computer systems, and GEHC shall provide a separate user identification code for each person. The Supplier, at its own expense, shall provide and maintain any hardware, telecommunications services and software not furnished by GEHC, which are needed to communicate reliably with GEHC’s computer systems. GEHC, in its sole discretion, may terminate the Supplier’s access to GEHC’s computer network at any time.


Strategic Supplier Alliance Agreement - GEHC Directs EMEA Contract Manufacturing / Version Supply 1.0		27 (30)

17.2

Use Restrictions . The Supplier shall ensure that: (i) computer access is limited to those employees with a legitimate business need whose names have been furnished to GEHC; and (ii) such employees with access agree to keep any information so obtained strictly confidential, to use such information only to perform the Supplier’s contract obligations to GEHC and to cease accessing GEHC’s computer systems when no longer required to perform work under this Agreement. The Supplier shall promptly notify GEHC if it becomes aware of any unauthorized access to GEHC’s computer systems or unauthorized use of the information on the systems.

18.

Notices

18.1

All notices expressly required to be in writing (Legal notices) shall be, if required by either party, in English or at least accompanied by a translation into English, and shall be sufficiently served if delivered by hand (including by courier) or if sent by pre-paid first class post, special delivery, registered mail, or pre-paid air mail or by fax. In all cases notices shall be delivered to the respective Parties at the addresses specified on the front page of this Agreement.

18.2	A notice shall be deemed to have been received:

(a)

if delivered by hand, at the time of delivery;

(b)

in the case of pre-paid first class post, special delivery or registered mail, two business days after the date of posting;

(c)

in the case of pre-paid airmail, four business days after the date of posting.

(d)

in the case of fax, upon completion of transmission

18.3	For the avoidance of doubt, notices under this Agreement may not be served by email, unless the Parties agree at the time of service.

19.

Miscellaneous

19.1	Independent Contractor . The relationship of the Parties hereunder shall be that of independent contractors. Nothing in this Agreement shall be deemed to create a partnership, joint venture, or similar relationship between the Parties, and no Party shall be deemed to be an agent of the other Party.

19.2	Subcontractors . None of the obligations to be performed by the Supplier under this Agreement shall be performed by any subcontractor or other third party unless such performance shall have been approved by GEHC in writing.

19.3	Governing Law . This Agreement shall be governed by and construed in accordance with the laws of State of New York without giving effect to the conflict of law principles thereof. The United Nations Convention on Contracts for International Sales of Goods shall not apply to this Agreement.

19.4

which Rules are deemed to be incorporated by reference into this Clause. The seat of the arbitration shall be Boston in the event the Supplier is the defendant and Uppsala if GEHC is the defendant. The language of the arbitration shall be English, if requested by either Party. The cost of the arbitration will be shared equally by the Parties. The arbitrator will have the authority to apportion liability between the Parties, but will not have the authority to award any damages or remedies not available under the express terms of this Agreement. With regards to any action for breach of confidentiality or intellectual property obligations, nothing in this section shall preclude either party from seeking interim equitable relief but such request shall not be deemed a waiver of the obligation to arbitrate hereunder.

19.5	Force Majeure .

(a)

The obligations of either Party hereunder shall be excused or suspended to the extent performance is prevented or delayed by any future condition, which (i) is beyond the reasonable control, and without the fault or negligence, of the Party affected thereby, (ii) was not foreseeable by such Party at the time this Agreement was entered into, and (iii) could not have been prevented by such Party taking reasonable steps. Such conditions shall include, but not be limited to, war mobilisation, riots, fire, explosion, flood, insurrection, embargo, currency restriction, and acts or omissions of governments in their sovereign capacity.

(b)

The Party invoking relief hereunder, shall, within seven (7) days after commencement of the event of force majeure, give written notice thereof and of the anticipated consequences thereof, to the other Party.

(c)

In the event of any case of force majeure, the Party affected thereby shall take all reasonable measures to mitigate and minimise the effect of such case, and to resume as promptly as possible the diligent performance of its obligations under this Agreement, however GEHC shall be permitted during such time to acquire substitute or replacement items from one or more alternative sources. If the delay lasts more than thirty (30) days GEHC may terminate this Agreement and any applicable Purchase Orders.

(d)

Notwithstanding anything in this Agreement to the contrary, no delay or failure of a Party to perform its obligations hereunder shall be excused if and to the extent that it is caused by labour problems of such Party, its subcontractors’ and/or its suppliers such as strikes.

19.6	Assignment . This Agreement is personal to the Parties and no Party shall without the prior written consent of the other Party, assign this Agreement or any part of it. Any such action shall be declared null and void. No Party shall sub-contract or


Strategic Supplier Alliance Agreement - GEHC Directs EMEA Contract Manufacturing / Version Supply 1.0		28 (30)

delegate in any manner any or all of its obligations under this Agreement to a third party or agent without the other Party’s consent. Notwithstanding the foregoing, GEHC may assign its rights and obligations under this Agreement without the Supplier’s consent: to an affiliate and in conjunction with the transfer of all or substantially all of its business or that part to which this Agreement relates. This Agreement shall be binding upon and shall inure to the benefit of the Parties hereto and their respective heirs, successors, and permitted assigns. The Supplier may not assign this Agreement to any third parties unless GEHC gives its written consent thereto in writing.

19.7

Publicity . The Supplier shall not issue any press release or announcement, use any of GEHC’s products or its name or trademarks in promotional activity, or otherwise publicly announce or comment on this Agreement without GEHC’s prior written consent except as provided for in Exhibit D section 15 herein or as may be otherwise required by law. Repligen has right to issue a press release on completion of this Agreement subject to prior review and approval by GEHC.

19.8

Amendment; Waiver; Survival . This Agreement may be modified only by a writing signed by both Parties. Any failure to enforce any provision of this Agreement is not a waiver of that provision or of either Party’s right to later enforce each and every provision. The terms of this Agreement that by their nature are intended to survive its expiration will continue in full force and effect after its expiration.

19.9

Severability . If any provision of this Agreement is determined to be legally unenforceable or invalid, it shall not affect the validity or enforceability of the remainder of the Agreement, and the remaining provisions will continue in full force and effect. The Parties will substitute a provision that most closely approximates the economic intent of the invalid provision.

19.10

Battle of Forms . This Agreement contains the entire agreement and understanding of the Parties and supersedes all prior agreements, understandings or arrangements (both oral and written) relating to the subject matter of this Agreement. For the avoidance of doubt, the Supply Agreement between the Parties dated May 26, 1999 as amended and the License Agreement between the Parties dated May 1, 1999 as amended are both hereby terminated. Any Orders placed under this Agreement shall be solely governed by the terms and conditions of this Agreement. No general terms and conditions of either Party referred to in purchase orders, order confirmations or elsewhere shall apply, unless expressly agreed in writing.

19.11

Affiliate . For the purposes of this Agreement, an Affiliate of a party shall mean any company controlled by or under common control with the relevant party where “control” means direct or indirect ownership of at least 50 percent of the

voting stock or interest in a company or control of the composition of the board of directors.

19.12

Interpretation . In this Agreement, reference to a clause, section or Attachment are, except where otherwise stated, a reference to an Attachment of this Agreement and a clause or section of the relevant Attachment. Clause, section or Attachment headings in this Agreement and any descriptive notes in brackets are for convenience only and shall not affect the construction or interpretation of this Agreement. References to the words “include(s)” or “including” shall be construed without limitation to the generality of the preceding words. Unless the context otherwise requires, references to the singular include the plural and vice versa, references to any gender include all other genders and references to “persons” shall include individuals, bodies corporate, unincorporated associations, businesses and partnerships. Any reference to a day shall be to a calendar day unless specified otherwise. Any reference to a Business Day shall mean any day which is not a Saturday, Sunday or public holiday in the country in which GEHC or its relevant Affiliate or the Supplier is located unless specified otherwise.


Strategic Supplier Alliance Agreement - GEHC Directs EMEA Contract Manufacturing / Version Supply 1.0		29 (30)

Attachment F

GE Technology

Production know-how covering [*] with regard to rPA and ZätA protein, in particular as described in the following documentation.


Documentation – title		GEHC Doc No. (when applicable)

rPA
*[]**

ZätA
*[]**

For avoidance of doubt, the above is not an exhaustive list of GE Technology, but describes certain key elements of the manufacturing process and test methods relating to the Products.


Strategic Supplier Alliance Agreement - GEHC Directs EMEA Contract Manufacturing / Version Supply 1.0		30 (30)

Addendum No. 1 to Strategic Supplier Alliance Agreement between GE Healthcare Biosciences AB and Repligen Corporation

This Addendum No. 1 to the Strategic Supplier Alliance Agreement (defined below) is made, effective as of August 31, 2010 (“Amendment Date”), by and between,

1.	Repligen Corporation having its address at 41 Seyon Street Bldg #1, Waltham, MA 02453, USA (“The Supplier”), and

2.	GE Healthcare Biosciences AB, having its address at Bjorkgatan 30, S-751 84 Uppsala, Sweden (“GEHC”).

RECITALS

A.	GEHC and the Supplier have entered into a Strategic Supplier Alliance Agreement effective January 1, 2010 (the “Supply Agreement”) concerning the supply of certain recombinant protein ligand products to GEHC; and

B.	GEHC has obtained an exclusive license from [*****] who has developed certain technology in the field of production and use of recombinant Protein L (“rPL”) and who possesses certain intellectual property rights and know-how relating thereto; and

C.	GEHC wishes to out-source the process development, scale-up, process validations and commercial manufacture of rPL and the Supplier has declared its willingness to develop the process, scale-up, perform process validations of and to manufacture rPL commercially on behalf of GEHC; and

GEHC desires to enter into a technology transfer program concerning all the know-how in GEHC’s possession relevant for the manufacture of rPL and the Supplier is willing to accept such technology transfer for the purpose of the Supplier’s process development, scale-up and commercial manufacture of rPL.

Considering the above and in consideration of the mutual covenants contained in this Addendum No. 1, the Parties have entered into the following amendment to the Supply Agreement

AMENDMENT

1.	Definition of product and specifications for rPL

1.1

Upon completion of the Technology Transfer Program as defined below in this Addendum No. 1, the “Products” in Section A of the Supply Agreement shall be deemed to include rPL and to the extent that nothing in this Addendum states anything to the contrary, all of the terms and conditions of the Supply Agreement shall apply to rPL accordingly. However, with regard to the TTP all other relevant provisions in the Supply Agreement, including but not limited to Attachment D, Section 10 (Manufacturing Process) and Section16 (Cellbanks) and Attachment E, Section 13 (Confidentiality) and 15 (Technology) shall apply.

1.2	For avoidance of doubt, Attachment C and the following sections of Attachment D to the Supply agreement shall be exempted for rPL; section 6d, section 12 and section 13, and otherwise the Supply Agreement shall apply.

1.3	The prices and Specifications for rPL as attached hereto as Appendix 1 shall form part of Attachment C of the Supply Agreement.

1.4	A Calendar Year shall be defined as each calendar year commencing with the first full calendar year following the Amendment Date.

2.	Technology Transfer

2.1

The Parties have agreed to conduct a Technology Transfer Program (“TTP”), as set forth in the tentative plan in Appendix 2, with the objective to establish by the Supplier a validated manufacturing process and quality control methods for rPL in commercial scale. The Start Date shall be defined as the day upon which the Supplier receives both of: [*****]. Each party agrees to use all reasonable efforts to fulfill their respective part of the TTP in order to complete the TTP no later than [*****] after the Start Date.

2.2

The Process Technology relating to rPL, including but not limited to raw material sourcing, manufacturing, quality controls and quality assurances and all records and documents, including any related intellectual property rights, whether generated before or during the TTP shall be the sole property of GEHC. Such Process Technology shall be deemed Confidential Information under the terms of the Supply Agreement. The Supplier is hereby granted a right to use Process Technology relating to rPL only for the purpose of manufacturing rPL for the supply to GEHC under the Supply Agreement and this Addendum No. 1.

2.3	Both Parties shall assign a project team including one project leader per Party, including key competences needed to perform and complete the TTP. The project leaders shall establish a final technology transfer project plan.

2.4	The parties have agreed to the TTP in accordance with the following principles.

(a)

Except as provided herein or as may be otherwise agreed, each party shall carry its own costs in connection with the TTP.

(b)

The commercial production process for rPL (the “Documented Process”) developed by The Supplier and delivered to GEHC at the end of the TTP shall contain all necessary steering documents for the commercial production, including but not limited to, raw material sourcing, manufacturing, quality control testing and quality assurance. The Documented Process shall be developed, implemented, and validated in accordance with the Supplier’s policies and procedures. The Documented Process shall be based on the production know-how

transferred from GEHC in accordance with Appendix 2 and the results and experiences from productions in laboratory scale and from the productions in commercial scale.

(c)

The Supplier shall have the right to purchase all consumables required for the TTP and the manufacture of rPL, which are available from GEHC, from GEHC at the same terms and conditions as for the products listed in Section 14 in Attachment D to the Supply Agreement.

(d)

Documentation for the technical batch/es/, that will be produced at commercial scale prior to the first validation batch will not be issued or controlled by the Supplier’s QA Department.

(e)

GEHC shall ensure that its QA Department reviews and approves documents such as the validation plan and final validation report within [*****] of receipt from the Supplier. If GEHC determines that any such documents require revisions prior to approval, GEHC shall inform the Supplier about the requested changes within [*****] of receipt from the Supplier.

(f)

GEHC shall have the right to terminate the TTP for convenience at any time prior to reaching MS8 whereupon this Addendum no. 1 shall terminate. For the avoidance of doubt, following completion of MS8 GEHC shall no longer have the right to terminate this Addendum no.1 and any termination by either of GEHC or Supplier shall be solely in accordance with the terms and conditions of the Supply Agreement. If GEHC’s termination rights pursuant to this Section 2.4(f) are exercised, termination shall become effective [*****] after receipt by Supplier of GEHC’s written notification of its intent to terminate, whereupon GEHC shall pay Supplier a sum corresponding to USD [*****] for each full [*****] that has passed between the Start Date and the date of receipt of notice of termination, less any milestones payments made, subject to GEHC’s receipt of an invoice with [*****] credit period. The maximum compensation paid by GEHC, including milestone payments, shall never exceed USD [*****]. Following payment by GEHC of the amounts due under this Section 2.4(f), Supplier shall promptly make the deliveries to GEHC in accordance with Section 2.4(i).

(g)

In the event the milestone MS8 has not been reached within [*****] from the Start Date either Party shall have the right to terminate this Agreement with immediate effect provided that, if GEHC terminates the TTP in accordance with this Section 2.4(g), GEHC shall be obligated to compensate Supplier pursuant to the terms of Section 2.4(f) unless the delay mainly is due to circumstances related to the Supplier whereupon no compensation shall be paid and, if the delay is due to circumstances beyond the control of both parties, GEHC shall be obligated to compensate Supplier by paying the sum that would be due if the next coming milestone had been achieved.

(h)

A party shall also have the right to terminate the TTP, subject to written notice, in the event the other Party commits a material breach of its obligations hereunder, provided such breach is not remedied within [*****] from receipt of written notice.

(i)

As a result of a termination, the Supplier shall deliver to GEHC copies of all Process Technology related to rPL and copies of the Documented Process and all rPL manufactured and stored in any state. GEHC shall pay for shipping costs for such rPL and documentation.

3.	Manufacturing

3.1

After the validation has been completed in accordance with the TTP, the Supplier shall manufacture and supply rPL in accordance with the Documented Process and the Supplier shall also manufacture, test and deliver rPL according to the Specifications. The Supplier shall be responsible for documenting the production process in accordance with ISO 9001 or equivalent.

3.2

GEHC hereby warrants and represents that GEHC shall only use the technical batch/es/ of rPL, which is delivered according to Milestone 4 (Appendix 2), for GEHC’s internal technical purposes and that GEHC shall not sell or otherwise transfer any materials made with such technical batch/es/ to any third party.

3.3	For avoidance of doubt any future scale up activities of the rPL Process, shall be considered to be controlled by the terms in Attachment A, section 4 in the Supply Agreement.

4.	Project Milestones and Payments

4.1	GEHC shall pay the Supplier [*****] upon execution of MS2 in Appendix 2.

4.2	GEHC shall pay the Supplier [***] upon receipt and approval of [***] (MS3 in Appendix 2).

4.3	GEHC shall pay the Supplier [*****] upon approval of MS4 in Appendix 2.

4.4

GEHC shall issue a Purchase Order for the [*****] validation batches at the time of completion of MS7 and GEHC shall pay Supplier [*****] within [*****] following completion of MS8, i.e. [*****] and upon receipt of the validation report (MS8 in Appendix 2). The milestone payment of [*****] will constitute payment in full for the [*****] of rPL delivered to GEHC, which payment is consistent with the agreed upon pricing in Appendix 1.

4.5	GEHC shall pay the Supplier [*****] upon the completion of MS9 in Appendix 2.

5.	Purchase and Price of rPL

5.1	GEHC agrees that it will purchase rPL exclusively from the Supplier for a period of [*****] from the date of MS8 achievement. In the event that the Supply Agreement is not extended such that the period of exclusivity ends with the expiration of the Supply

Agreement, GEHC shall make a compensatory payment of [*****] to Supplier and also agrees to purchase all inventories of rPL that Supplier holds in compliance with this Addendum and the Supply Agreement, provided the rPL comply with at least [*****] remaining shelf life and otherwise fully complies with the applicable specifications and, for avoidance of doubt, the price conditions in Appendix 1 shall apply.

5.2

The Parties have agreed on the price conditions for rPL as set forth in Appendix 1 hereto. Such prices shall remain in effect throughout the [*****] period of exclusivity specified in Section 5.1, unless otherwise agreed. The [*****] period of exclusivity of rPL supply at the agreed prices is intended to provide a means by which the Supplier may be more fully compensated for its investments made during the TTP.

5.3

The price conditions set forth in Appendix 1 shall remain in effect for [*****] and shall thereafter be adjusted [*****] in accordance with the U.S. Consumer Price Index. However if and when the stability of the rPL intermediate, defined as the [*****], has been confirmed to be longer than [*****] and once the cumulated amount of ordered rPL from GEHC in a [*****] has reached or exceeded [*****], a general discount of [*****] shall be applied on the calculated price for all other purchases thereafter. [*****].

Any other price adjustments shall only be by the written mutual agreement of the parties.

6.	Miscellaneous

6.1	Capitalized terms used in this Addendum No. 1 and not otherwise defined in this Addendum No. 1 shall have the meaning defined in the Supply Agreement.

6.2	Except as expressly amended herein, all terms and conditions of the Supply Agreement are hereby ratified and confirmed and shall remain in full force and effect.

6.3	This Addendum No. 1 shall be effective as from the Amendment Date. The term Supply Agreement as used in this Amendment No. 1 shall from and after the Amendment Date be deemed a reference to the Supply Agreement as amended by this Addendum No. 1.

This Addendum No. 1 may be executed in counterparts each of which shall be deemed an original and all such counterparts shall constitute one and the same instrument. The Parties have executed this Addendum No. 1 in two originals whereof the Parties have taken one each.


REPLIGEN CORPORATION		GE HEALTHCARE BIO-SCIENCES AB

By:	/s/ Walter C. Herlihy	By:	/s/ Magnus Lundgren

Name:	Walter C. Herlihy, PhD	Name:	Magnus Lundgren

Title:	President and Chief Executive Officer	Title:	Global Sourcing Executive

Appendix 1: Products, Prices and Specifications - rPL

Product name: rPL

GEHC Article Number: To be determined

Supplier Article Number/unit: To be determined


[ ***** ]		[ ***** ]
[ ***** ]		[ ***** ]
[ ***** ]		[ ***** ]
[ ***** ]		[ ***** ]

Currency: USD

Delivery term: FCA Waltham, Massachusetts


Revision date: 16 April 2010

Terms of transportation

At or below-18 °C.

Storage conditions

Preserve in a well-closed container at or below -18 °C.

Shelf life

To be determined by GEHC from stability studies

Mass

[*****]

Description

To be determined in the TTP

Requirements on properties


Characteristic	Tolerance limit	Test method	Remark
[*****]	[*****]	[*****]
[*****]	[*****]	[*****]
[*****]	[*****]	[*****]
[*****]	[*****]	[*****]
[*****]	[*****]	[*****]
[*****]	[*****]	[*****]	[*]
[*****]	[*****]	[*****]	[*]

Comment:

1)	Repligen’s method.

2)	A final lower value may be decided later by mutual agreement, based on the result from validation batches.

Prices validation batches

The following prices will apply for the purchase of rPL by GEHC through the first Calendar Year:


Quantity purchased by GEHC in that Calendar Year	Price per gram
First [*****]	$	[*****	]
Next [*****]	$	[*****	]
Next [*****]	$	[*****	]
Any amounts in excess of [*****]	$	[*****	]

For the avoidance of doubt the following example is intended to describe the use of the price ladder above:

GEHC places the following orders:

[*****]

Lead time (PO) : [*****] for orders in line with committed portion of the Forecast

Lead Times for Safety Stock Replenishment


Requirement		Lead time rPL
[*****]		[*****]
[*****]		[*****]
[*****]		[*****]
[*****]		[*****]

Level of Supplier’s Safety Stock

[*****] of the previous [*****] purchase by GEHC, to commence in the [*****].

Tentative Technology Transfer Program concerning the manufacturing process for rPL

(TO BE COMPLETED)

Scope

GEHC has developed a manufacturing process for rPL in lab scale. The manufacturing process includes fermentation, primary recovery, acid precipitation, chromatography purification and final concentration and formulation of the protein.

The Parties agree that certain process development work is required in order to optimize the process toward the intended production equipment and to secure a smooth scale up of the process to commercial scale and that such work shall be included in the scope of the TTP.

GEHC has also developed analysis methods to be used for characterization of the protein as well as analysis methods to be used for in process analysis.

Technological goals

•

[*****]

•

[*****]

•

[*****]

•

[*****]

Specifications of rPL

See Appendix 1

Time schedule

Time schedule, including critical time lines and responsible persons, to be finalized by the project team

Milestones and Deliveries


MS0		[*****]

MS1:		[*****]

MS2:		[*****]

MS3:		[*****]

MS4:		[*****]

MS5:		[*****]



MS6:		[*****]

MS7:		[*****]

MS8:		[*****]

MS9:		[*****]

Deliveries

From GEHC Ú The Supplier

[*****]

From The Supplier Ú GEHC

[*****]

All documents transferred between the Parties shall be in the form of controlled copies if approved documents are being transferred. In case a draft version is being transferred between the Parties, the version number and draft date are mandatory. Acceptable ranges for all parameters, for critical parameters Proven Acceptable Ranges (PAR) is recommended for the purpose of Manufacturing Formula and Process validation, shall be included in the methods transferred to Repligen.

Resources

Allocated by GEHC


Project leader:		[*****]
Fermentation:		[*****]
Down Stream Process:		[*****]
Analysis:		[*****]
QA:		[*****]

Allocated by Repligen
Project leader:		[*****]
Fermentation:		[*****]


Down Stream Process:		[*****]
Analysis:		[*****]
QA:		[*****]
Production:		[*****]

Contact persons


REPLIGEN:		[*****]
GEHC:		[*****]

Progress reports

The project team will establish [*****] short written communications on project status, timing and performance of the TTP.

AMENDMENT NO. 1 TO STRATEGIC SUPPLIER ALLIANCE AGREEMENT

THIS AMENDMENT NO. 1 (the “ Amendment ”) to that certain Strategic Supplier Alliance Agreement dated as of January 28, 2010 (the “ Supplier Agreement ”), by and between Repligen Corporation, a Delaware corporation (“ Supplier ”), and GE Healthcare Bio-Sciences AB, a company organized under the laws of Sweden (“ GEHC ”), is entered into on October 27, 2011, by and between Supplier and GEHC.

W I T N E S S E T H :

WHEREAS, Supplier expects to enter into an agreement (the “ Purchase Agreement ”) on or about the date hereof, by and among Supplier, Novozymes Biopharma DK A/S, a company organized under the laws of Denmark (“ Novozymes Denmark ”), and the other parties thereto, pursuant to which Novozymes Denmark proposes to sell the manufacturing and supply business of cell culture ingredients and protein A affinity ligands for use in industrial cell culture, stem and therapeutic cell culture and biopharmaceutical manufacturing run by Novozymes Denmark and Novozymes Biopharma Sweden AB, a company organized under the laws of Sweden and a wholly-owned subsidiary of Novozymes Denmark (“ Novozymes Sweden ”), to an affiliate of Supplier (the “ Transaction ”);

WHEREAS, Section 19.8 of Attachment E (General Terms and Conditions) to the Supplier Agreement provides that the Supplier Agreement may be modified only by a writing signed by both Supplier and GEHC; and

WHEREAS, Supplier and GEHC desire to amend the Supplier Agreement and Attachments thereto as provided in this Amendment.

AGREEMENT :

NOW, THEREFORE, in consideration of the mutual agreements herein set forth, and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the parties hereto agree as follows:

1. Defined Terms . Capitalized terms used herein, unless otherwise defined herein, shall have the meanings ascribed to them in the Supplier Agreement.

2. Amendment to the Supplier Agreement .

(a) The second paragraph titled “Agreement Term” of Section C of the Supplier Agreement shall be amended and restated in its entirety as follows:

“ Agreement Term: This Agreement shall commence on the Effective Date and, subject to the rights of termination in clause 16 of Attachment E, shall continue until January 28, 2015 (the “Term”); provided that the Term shall continue until December 31, 2021 if the manufacturing and supply business of cell culture ingredients and protein A affinity ligands for use in industrial cell culture, stem and therapeutic cell culture and biopharmaceutical manufacturing run by Novozymes Biopharma DK A/S, a company organized under the laws of Denmark (“Novozymes Denmark”), and Novozymes Biopharma DK A/S, a company organized under the laws of Denmark and a wholly-owned subsidiary of Novozymes Denmark (“Novozymes Sweden”), is transferred to Supplier or an affiliate of Supplier (the “Transaction”) by December 31, 2011 (the “Outside Date”). The Parties shall negotiate eighteen (18) months prior to the expiration of the Term (including any extensions thereof as provided herein) to decide whether to renew this Agreement.”

(b) Attachment C of the Supplier Agreement shall be amended by replacing each of the two (2) occurrences of the phrase “Price ladder 2014” with the phrase “ [*] ”.

“The Supplier and GEHC agree to each use commercially reasonable efforts to define Supplier’s internal contingency arrangements to support GEHC’s continuity of supply regarding both (a) Supplier and its main operating facility as of the date hereof in Waltham, Massachusetts, United States and (b) if the Transaction is consummated, Novozymes Sweden and its main operating facility as of the date hereof in Lund, Sweden in order to meet GEHC’s customers’ requirements for documenting security of supply to the extent reasonably practicable. The Supplier agrees to provide GEHC with a revised draft of such contingency arrangements for review. GEHC agrees to notify the Supplier in writing of any proposed revisions to such draft contingency arrangements within [*] ( [*] ) days of receipt, which proposed revisions shall thereafter be considered by Supplier, and mutually discussed by Supplier and GEHC, each acting reasonably, until promptly resolved; provided that if GEHC fails to deliver any such written notice of any proposed revisions to Supplier within [*] ( [*] ) days of receipt, then GEHC will be deemed to have accepted such contingency arrangements submitted by Supplier.”

3. Effect of Amendment . In the event that the Transaction is not consummated by December 31, 2011, GEHC and Supplier shall each have the right to terminate unilaterally this Amendment by giving the other party hereto written notice no later than fifteen (15) days following such date and, if such notice is delivered, this Amendment and the changes to the Agreement contemplated hereby shall be of no force or effect. The parties hereto agree that except as otherwise set forth herein, all terms of the Supplier Agreement shall remain in full force and effect. In the event of any inconsistency or conflict between the Supplier Agreement and this Amendment, the terms, conditions and provisions of this Amendment shall govern and control.

6. Entire Agreement . This Amendment and the Supplier Agreement, including the Attachments, exhibits, schedules and other documents referred to therein which form a part thereof, contain the entire understanding of the parties hereto with respect to the subject matter contained herein and therein. From and after the execution of a counterpart hereof by the parties hereto, any reference to the Supplier Agreement shall be deemed to be a reference to the Supplier Agreement as amended hereby.

7. Governing Law . This Amendment and any disputes hereunder shall be governed by and construed in accordance with the laws of State of New York without giving effect to the conflict of law principles thereof. The United Nations Convention on Contracts for International Sales of Goods shall not apply to this Amendment.

8. Counterparts . This Amendment may be executed in any number of counterparts and any party hereto may execute any such counterpart, each of which when executed and delivered shall be deemed to be an original and all of which counterparts taken together shall constitute but one and the same instrument. Any signature page delivered by a facsimile machine shall be binding to the same extent as an original signature page with regard to any agreement subject to the terms hereof or any amendment thereto.

[SIGNATURE PAGES FOLLOW]

IN WITNESS WHEREOF, the undersigned have caused this Amendment to be executed and delivered as of the date first above written.


SUPPLIER :

		Repligen Corporation

By:		/s/ Walter Herlihy
		Name: Walter Herlihy
		Title: Authorized Signatory

GEHC :

General Electric Company on Behalf of its Division, GE
Healthcare

By:		/s/ Magnus Lundgren
		Name: Magnus Lundgren
		Title: Global Sourcing Executive

Temporary Terms 2013 (The “2013 Amendment”)

The following temporary terms shall apply for the Products rPA and Zäta, during the, period 21 ^th of February 2013 up to 31 ^st of December 31 ^st 2013 (the “ Period ”) purchased and delivered from the 2 sites Lund and Waltham and accordingly amending the Attachment C in the SSAA between Repligen Corporation and GE Healthcare Bio-Sciences AB, dated 2010-01 01, (the “ Repligen Agreement ”) and the Attachment C in the SSAA between Repligen Sweden AB (formerly known as Novozymes Biopharma Sweden AB) and GE Healthcare Bio-Sciences AB, dated 2011-07 07, (the “ Novozymes Agreement ”).

1.	Prerequisites: Volume requirements per Product and site including fixed prices for the Products purchased and delivered during the Period as follows:


		Total spend
[***] Zäta delivered from Waltham @[***]		[*****]
[***] Zäta delivered from Lund@[***]		[*****]

		Total Zäta [*****]

[***] rPA delivered from Lund @[***]		[*****]
[***] rPA delivered from Waltham@[***]		[*****]

		Total rPA[*****]

		Total rPA and Zäta: [*****]

2.	For total combined volumes of Zäta during the Period that is outside the range [*****] the following mechanisms shall apply for the prices:

For total combined purchases of such quantities exceeding [*****]:


	Discounts
Volume exceeding [*****] Zäta	Buy&Pay site Waltham	Buy&Pay site Lund
[*****]	[*****]	[*****]
[*****]	[*****]	[*****]
[*****]	[*****]	[*****]
[*****]	[*****]	[*****]

For the avoidance of doubt the discounts in the table above do not apply retroactively and only apply to the amounts exceeding [*****] Increments.

For total combined purchases if such combined purchases fall below [*****]: GEHC shall pay to Repligen the sum of [*****] for each shortfall of [*****] less than [*****], meaning that if GLTIC purchases only [*****] of Zäta in calendar year 2013; GEHC shall pay to Repligen the sum of [*****] as a “true-up” with any such payment to be made in 2013 or before [*****].

3.	For total combined volumes of rPA during the Period that is outside the range [*****], the following mechanisms shall apply for the prices:

For total combined purchases of such quantities exceeding [*****]:


	Discounts
Volume exceeding [*****] rPA	Buy&Pay site Waltham	Buy&Pay site Lund
[*****]	[*****]	[*****]
[*****]	[*****]	[*****]
[*****]	[*****]	[*****]
[*****]	[*****]	[*****]

For the avoidance of doubt the discounts in the table above do not apply retroactively and only apply to the amounts exceeding [*****] increments

For total combined purchases if such combined purchases fall below [*****]: GEHC shall pay to Repligen the sum of [*****] for each shortfall of [*****] less than [*****], meaning that if GEHC purchases only [*****] of rPA in calendar year 2013; GEHC shall pay to Repligen the sum of [*****] as a “true-up” with any such payment to be made In 2013 or before [*****].

4.	As a basis for the price to be applied for 2011 for each of the Products the Parties revert to the Terms and Conditions in Repligen Agreement, including that the price ladders in the Repligen Agreement shall be applied using the below agreed cumulated [*****] purchases of Products.

For the sole purpose to reestablish a basis of the price calculations for [*****], the total cumulated volume of Zäta and rPA delivered from the 2 sites during 1 ^st of January to 31 ^th of December 2013, [*****] shall be deemed as it was delivered from the Waltham site and [*****] shall be deemed as it was delivered from the Lund site.

Furthermore the volume referred to have been delivered from the Waltham site shall be split even over the [*****] in 2013, as shown in the below example;

Assume [*****] of Zäta was delivered from the 2 sites during 1 ^st of January to 31 ^st of December 2013. Then the volume to be deemed to have been delivered from the Waltham site respectively the Lund site during 2013shall be split as follows:

Total

Waltham

[*****

]

[*****

]

[*****

]

[*****

]

[*****

]

Lund

[*****

]

[*****

]

Assume [*****] of rPA was delivered from the 2 sites during 1 ^st of January to 31 ^st of December 2013. Then the volume to be referred to have been delivered from the Waltham site respectively the Lund site in 2013 shall be split as follows:

Total

Waltham

[*****

]

[*****

]

[*****

]

[*****

]

[*****

]

Lund

[*****

]

[*****

]

If any of the production sites; Lund or Waltham, face supply problems for any of the Products during the Period meaning that each of the above volume requirements per site in section 1 cannot be fulfilled, [*****] per Product as stated in section 1 shall be applied. In such a situation and in case the volumes purchased arid delivered are outside the amounts of [*****] Zäta respectively [*****] rPA the price mechanism according to the terms in section 2 and 3 shall be applied.


Agreed and accepted by Repligen Corporation

Signature	/s/ Jonathan Lieber

Printed name		Jonathan Lieber

Title	CFO

Date	2/21/13

Agreed and accepted by GEHC Bio-Sciences AB

Signature	/s/ David Raw

Printed name		David Raw

Title	Sourcing Manager

Date	February 22, 2013

AMENDMENT NO. 4 TO STRATEGIC SUPPLIER ALLIANCE AGREEMENT

This Amendment No. 4 (the “fourth Amendment”) to that certain Strategic Supplier Alliance Agreement with an Effective Date of January 1, 2010 (the “Supplier Agreement”) and made by and between Repligen Corporation, a Delaware corporation (the “Supplier”) and GE Healthcare Bio-Sciences AB, a company organized under the laws of Sweden (“GEHC”), with the terms hereof being effective from February 22, 2016 (the “Effective Date”), by and between Supplier and GEHC.

WITNESSETH

WHEREAS, the Supplier Agreement has previously been three times amended in accordance with; in the first instance, an amendment made effective August 31, 2010 (titled “Addendum No. 1”), in the second instance, an amendment made effective as of October 27, 2011 (titled “Amendment No. 1”), in the third instance, an amendment made effective February 22, 2013 (titled “2013 Amendment”); altogether the “Previous Amendments”; and

WHEREAS, Supplier and GEHC mutually wish to make certain further modifications to the terms and conditions of the Supplier Agreement as amended by the Previous Amendments; and

WHEREAS, Clause 19.8 of Attachment E to the Supplier Agreement provides that the Supplier Agreement may be modified only by a writing signed by both parties; and

WHEREAS, (i) a certain related Strategic Supplier Alliance Agreement, dated July 7, 2011, amended through Amendment No. 1, dated October 27, 2011, the Amendment No. 2, dated February 22, 2013 and the Amendment No. 3 dated January 1, 2016 (jointly hereinafter the “Related Agreement”, are in effect by and between GEHC and Repligen Sweden AB, a wholly owned subsidiary and Affiliate of Repligen;

AGREEMENT

NOW, THEREFORE, in consideration of the mutual agreements set forth herein, and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties agree to further amend the Supplier Agreement as amended by the Previous Amendments in accordance with terms and conditions of this Fifth Amendment which are as follows:

Defined Terms. Capitalized terms used herein, unless otherwise defined or modified herein, shall have the same meaning as defined in the Supplier Agreement. If not previously defined in the Supplier Agreement or a Previous Amendment, terms that are defined as follows or are capitalized in this Fifth Amendment shall have the meaning defined herein.

a.	“Recombinant Product(s)” shall mean either or both of the Products rPA and Zäta but shall be understood to exclude rPL which, in accordance with Addendum No. 1, is a Product under the Agreement.

Named Parties. All references to Parties in this Amendment may include either or both of Supplier and its wholly owned Affiliate Repligen Sweden AB together with GEHC. All subsequent references to “Repligen” in this Amendment shall be understood to be inclusive of both Supplier and its Affiliate, Repligen Sweden AB. “Lund Site” shall mean Repligen’s manufacturing site in Lund, Sweden and “Waltham Site” shall mean the Supplier’s manufacturing site in Waltham, Massachusetts, USA and “Site” shall mean either the Lund Site or the Waltham Site and “Sites” shall mean both of them.

3.	Amendment to the Supplier Agreement.

a.	The second paragraph, titled “Agreement Term” of Section C of the Supplier Agreement, as previously amended by Amendment No. 1, shall be amended and restated in its entirety as follows:

“This Agreement shall commence on the Effective Date and, subject to the rights of termination in Clause 16 of Attachment E (as amended hereby), shall remain in effect until December 31, 2021 (the “Term”). The Parties shall renegotiate [*****] prior to the expiration of the Term (including any extensions thereof as provided herein) to decide whether to renew this Agreement.”

Attachment C (revision date 22 January, 2010) entitled “Products, Prices, and Specifications; as previously amended by Addendum No. 1,; shall be deleted and replaced in its entirety by Revised Attachment C (revision date January 1, 2016 attached hereto. Attachment C shall be a complete current list of all Products, Prices and Specifications applicable at the time of the signing of this Amendment.

c.	The first sentence of Clause 3(c) of Attachment D, entitled “Payment Terms”, is deleted and replaced with the following sentence:

“GEHC shall settle any undisputed invoices arising under this Agreement [*****] after receiving an invoice prepared in accordance with the terms of this Agreement.”

d.	A new clause 3(g) of Attachment D, entitled “Productivity Improvement and Cost Reductions”, is hereby added for the Recombinant Products as follows

[*****]

e.	The first two sentences of Clause 6(a) of Attachment D, entitled “Forecasting”, are hereby amended as follows (changes underlined):

“Forecasting. [*****]days before the end of each quarter, GEHC shall submit to Repligen in writing a [*****] month rolling quarterly forecast (“Forecast”) for its total estimated needs of the Products during the subsequent [*****] month period from Repligen. Repligen shall use the Forecast as the basis for its production planning and shall replenish the Safety Stock according to the agreed lead-times set forth in the Revised Attachment C, as amended herein. Repligen shall further allocate production between its Sites in accordance with the provisions of Clause 6(d) of Attachment D as amended herein. As a consequence of the Forecast, GEHC will propose and send Repligen a purchase plan, showing the required delivery weeks and specifying the amount to be delivered to GEHC for the first quarter of each said Forecast. If GEHC for any reason don’t send a purchase plan to Repligen, GEHC shall instead issue purchase orders reflecting the amount for the binding quarter according to section 6b in Attachment D in the Supplier Agreement. The purchase plan shall be deemed accepted in the case where the amounts in the purchase plan are within the Safety Stocks reported to GEHC, as per the 4 ^th sentence of Section 9 of Attachment D, as amended herein. GEHC acknowledges that accepted orders within the Safety Stocks levels may require use of safety stock. In the case the stated amounts in the purchase plan exceed the inventories reported for each Site as per above, the Parties shall negotiate in good faith a new purchase plan and Repligen shall use [*****] to accommodate to such a new purchase plan.”

f.	A new paragraph shall be added to Clause 6(d) of Attachment D, entitled “Purchase Commitment”, according to the following:

“Supply of Product. GEHC acknowledges that, pursuant to this Agreement and section 6D of Attachment D in the Related Agreement : (a) GEHC has an obligation to purchase no less than [*****] of its requirements for each of the two Recombinant Products in the aggregate from both Sites so long as (i) both the Supplier Agreement and the Related Agreement remain in effect or (ii)GEHC has not used its right to reduce its minimum Purchase Commitment for any Products from the Lund Site, according to section 16.1 of Attachment E in the Related Agreement and the purchase orders issued by GEHC for the Recombinant Products, shall be split between the Waltham site and Lund site as follows: [*****] to the Waltham site and [*****] to the Lund site, as close as possible per every [*****] with an allowance to deviate from the above split not more than [*****] per Recombinant Product during any calendar year, measured through the actual invoiced amount in [*****] from the Waltham site and the Lund site. Both Parties shall aim to minimize the above mentioned deviation, through adjustments of the concerned purchase orders and or shipment amounts in the 4 ^th [*****] of the calendar year. Deviations exceeding [*****] per Recombinant Product shall be balanced in the subsequent calendar year. To the extent GEHC uses its right to reduce its minimum purchase commitments for

any or all Products from the Lund Site [*****] the purchase commitment, as regards the two Recombinant Products shall be reduced accordingly and what is set out in Section 6 d Attachment D of the Supplier Agreement shall apply, meaning that if the purchase commitment from the Lund Site is for example [*****], the purchase commitment from the Waltham Site remain according to what is set out in clause 6d in Attachment D in the Supplier Agreement, that is at least to [*****] of GEHC´s total requirements of Recombinant Products per calendar year. For further clarification, if GEHC reduces its purchase commitment of Recombinant Products to Repligen to between [*****]then all of GEHC orders to Repligen will be delivered as per this section 3f, that is [*****] to Waltham site and [*****] to Lund site for such Recombinant Products not terminated by the Lund site.

Below summarizes the different scenarios of Purchase Commitment and the resulting distribution of Purchase Orders of the Recombinant Products, see also Table 1; Recombinant Products:

Prerequisite scenario 1 is in effect:

•

GEHC has not used it right to reduce the Purchase Commitment to Lund or

•

GEHC has used its right to reduce the Purchase Commitment to Lund to between [*****]

•

GEHC has used its right to reduce the Purchase Commitment to Lund below [*****] however Supplier has not terminated its commitment to supply Products from Lund.

then the purchase orders of Recombinant Products to Repligen shall on a [*****] basis be distributed as follows:

•

[*****] towards the Waltham site

•

[*****] towards the Lund site

Prerequisite scenario 2 is in effect:

•

GEHC has used its right to reduce the Purchase Commitment of Recombinant Products to Lund below [*****] and the Supplier has terminated its commitment to supply Products from Lund Site to GEHC or

•

GEHC has used its right to reduce the Purchase Commitment of Recombinant Products to Lund to [*****]

then at least [*****] of GEHC’s total requirements of Recombinant Products shall be placed as purchase orders to the Waltham site. For avoidance of doubt Supplier’s commitment according to 6c Attachment D remain in force

[*****]

GEHC hereby agrees and affirms that Repligen shall have the right to apportion manufacturing of either or both Recombinant Products between the Sites as it chooses and Repligen may, in its sole discretion, choose so long as:

a)	GEHC’s total requirement of Recombinant Products as specified in the committed Forecast are timely delivered to GEHC in accordance with the terms and conditions of the Supplier Agreement

b)	Repligen manufactures each of the Recombinant Products at each of the Lund Site and the Waltham Site respectively with a minimum of [***] of GEHC’s yearly requirement in [***], at each Site, during each rolling twelve month period, commencing with the Effective Date of the Amendment, and

c)	Repligen maintains its required Safety Stock as set out in Attachment C to this Amendment. Repligen shall apportion and control the Safety Stocks of Products in accordance with the provisions of the Attachment C to this Amendment”

d)	The Parties have agreed that under the Agreement and the Related Agreement, the Supplier may choose to fulfill the purchase orders issued by GEHC as per the following:

(i)	a purchase order placed to the Waltham Site can be delivered from the Lund site and the concerned invoice shall be issued by the Waltham site, and

(ii)	a purchase order placed to the Lund site can be delivered from the Waltham site and the concerned invoice shall be issued by the Lund site,

For clarity,

•

any costs incurred associated with the use of the process set out in (d) (i) and (ii) shall be born solely by the [*****] and

•

first in first out (FIFO) principle shall be applied for the total inventory on both Sites

g.	The 4 ^th and 5 ^th sentence of Clause 9 of Attachment D is deleted and replaced with the following sentence:

“The Supplier shall in good faith provide GEHC on a [*****] basis with a report of inventory levels of finished goods of the Products, showing the current inventory levels and the planned levels for the forthcoming [*****], no later than the [*****] in every calendar [*****] with the following details: Forthcoming [*****], inventory levels at the end of the respective [*****]; forthcoming [*****], inventory levels at the end of [*****] respectively.”

h.	The first 2 sentences of Clause 2.1 in Attachment E shall be amended as follows:

“Unless otherwise agreed Products shall be delivered according to the Incoterms 2010 set out in Attachment C and title shall transfer at the same time as the risk transfer in accordance with such Incoterms”

i.	A new clause 6.3 is added to the Attachment E as follows:

[*****]

j.	Clause 16.6 of Attachment E is hereby amended and restated in its entirety as follows :

“GEHC shall have the right to terminate the Agreement with eighteen (18) months written notice if the Supplier or any of its Affiliates markets or sells any immobilized chromatography products which is functionally substitutable (based on technical performance) with GEHC’s chromatography products containing the Products (as exemplified by MabSelect and MabSelect Sure). For the avoidance of doubt, GEHC is aware that Repligen markets and sells certain immobilization chromatography media products currently known as IPA-300 and CaptivA, which due to their current product specifications and technical performances are not functionally substitutable with MabSelect family products and GEHC acknowledges that marketing and sale of such products is not in violation of this Clause 16.6”

k.	Clause 16.7 of Attachment E, is amended and restated in its entirety as follows:

“GEHC shall have the right to terminate the Agreement with twelve (12) months written notice if (i) the Supplier’s protein manufacturing operation in the Lund Site is transferred outside of the Repligen group of companies or moved outside of Sweden or the protein manufacturing operation in the Waltham Site is transferred outside of the Repligen group of companies or moved outside of US(ii) if the control of Repligen or the Repligen group of companies is taken over by a direct competitor of GEHC in the field of chromatography media or bioprocess hardware products whereby control shall mean directly or indirectly (i) holding fifty percent (50%) or more of its issued shares, or (ii) of the voting power therein, or (iii) of the interest in the income of such corporation, partnership or other entity, or (iv) having the power to appoint the majority of its directors or (v) otherwise having the power to direct its business activities.

4.	Effect of Amendment . In the event of the expiration or termination for any reason of the Related Agreement, the provisions of this Amendment shall continue to be effective.

Entire Agreement. This Amendment, together with the Supplier Agreement as amended by the Previous Amendments and the Attachments, exhibits, schedules, and other documents referred to therein contain the entire understanding of the Parties with respect to the subject matter contained herein and therein. From and after the effective date of this Amendment, any reference to the Supplier Agreement shall be deemed a reference to the Supplier Agreement and its Previous Amendments as further amended hereby.

(SIGNATURE PAGES FOLLOW)

IN WITNESS WHEREOF, the undersigned have caused this Fifth Amendment to executed and delivered as of the date first above written.


SUPPLIER:

BY:		/s/ Howard Benjamin

Name:		Howard Benjamin

Title:		VP, BD

GEHC

By:		/s/ Bo Lundström

Name:		Bo Lundström

Title:		Managing Director

GEHC

By:		/s/ Jan Erneberg

Name:		Jan Erneberg

Title:		Chairman

Revised Attachment C

Products, Prices, and Specifications

GEHC Biosciences/Repligen Corporation SSAA


Currency:		USD

Delivery Terms:		FCA Waltham, Massachusetts

Revision Date:		January 1, 2016

A. RECOMBINANT PRODUCT


Product Name		Zäta
GEHC Article number		[*****]

Unit size:

At least [*****] Zäta per bottle meaning that the content per bottle shall be [*****]. Each bottle shall be labeled with [*****] Zäta. For remains achieved during filling the actual quantity in gram shall be stated on each bottle.

Supplier Article Number/unit sizes for the remains of a batch


[*****]		[*****]
[*****]		[*****]
[*****]		[*****]
[ ***** ]		[*****]
[*****]		[*****]

Price and [*****] Price Adjustment Procedure

The Actual Price to be paid by GEHC for Zäta in any subsequent calendar [*****] during the Term of the Amendment shall thus be calculated at the end of each actual [*****] in accordance with the following formula based on the [*****] lookback quantities of Zäta ordered from Waltham (WKg):


[*****] lookback	Price formula	Slope
[*****]	[*****]	[*****]
[*****]	[*****]	[*****]
[*****]	[*****]	[*****]
[*****]	[*****]	[*****]

For amounts supplied in aggregate from the Supplier and Repligen Corporation beyond [*****], GEHC and Repligen may agree upon the price mechanisms to get reduced prices for such amounts as may exceed [*****]. Such discussions may include the option of mechanisms to reduce pricing below [*****].

In case the Parties do not reach an agreement on modified prices and/or floors, the current mechanisms will stay in place until the end of the agreement.

Lead Time (PO): Delivery date by the Supplier shall be [*****] from acceptance of PO with commercially reasonable efforts to deliver in [*****]


Remaining shelf life upon delivery:		[*****]

Level of Supplier’s Safety Stock:

Throughout the Term, Repligen shall adjust the level of safety stock which is equal to at least [*****] of the aggregate of the amount of Zäta actually purchased during the preceding [*****] plus the [*****] Forecast The location(s) of said safety stock shall be established by Repligen according to the terms in the Related Amendment, Amendment No. 3, dated January 1 ^st , 2016, Attachment C, A Recombinant Product


Shelf Life		[*****]

Lead Times for Safety Stock Replenishment: Repligen and GEHC undertake to agree to a plan to replenish safety stock within [*****] so long as GEHC has not purchased more than [*****] of the Waltham Site safety stock. If GEHC purchase more than [*****] of the Waltham site safety stock, replacement time of safety stock shall be negotiated between the Parties and Repligen shall use [*****] to accommodate to any such proposal, within [*****].

B. RECOMBINANT PRODUCT


Product Name		rPA
GEHC Article number		[*****]

Unit size:

At least [*****] rPA per bottle meaning that the content per bottle shall be [*****]. Each bottle shall be labeled with [*****] rPA. For remains achieved during filling the actual quantity in [*****] shall be stated on each bottle.

Supplier Article Number/unit


[*****]		[*****]
[*****]		[*****]
[*****]		[*****]
[*****]		[*****]

Price and [*****] Price Adjustment Procedure

The actual price to be paid by GEHC for rPA in any subsequent calendar [*****] during the Term of the Amendment shall thus be calculated at the end of each actual [*****] in accordance with the following formula based on the [*****] lookback quantities of rPA ordered fromWaltham (WKg):


[*****] lookback	Price formula	Slope
[*****]	[*****]	[*****]
[*****]	[*****]	[*****]
[*****]	[*****]	[*****]
[*****]	[*****]	[*****]

In case the Parties do not reach an agreement on modified prices and/or floors, the current mechanisms will stay in place until the end of the agreement.

Lead Time (PO): Delivery date by Repligen shall be [*****] from acceptance of PO with commercially reasonable efforts to deliver in [*****]


Remaining shelf life upon delivery:		[*****]

Level of Supplier’s Safety Stock

Throughout the Term, Repligen shall adjust the level of safety stock which is equal to at least [*****] of the aggregate of the amount of rPA actually purchased during the preceding two quarters plus the upcoming [*****] Forecast The location(s) of said safety stock shall be established by Repligen according to the terms in the Related Amendment, Amendment No. 3, dated January 1, 2016, Attachment C, B Recombinant Product


Shelf Life		[*****]

more than [*****] of the Waltham site safety stock, replacement time of safety stock shall be negotiated between the Parties and Repligen shall use [*****] to accommodate to any such proposal, within [*****].

C. PRODUCT

Product Name rPL

GEHC Article Number: [*****]

Supplier Article Number:

Unit size:

At least [*****] rPL per bottle meaning that the content per bottle shall be [*****]. Each bottle shall be labeled with [*****] rPL. For remains achieved during filling the actual quantity in [*****] shall be stated on each bottle.

Price and [*****] Price Adjustment Procedure:

The actual price to be paid by GEHC for rPL in any subsequent calendar [*****] during the Term of the Amendment shall thus be calculated at the end of each actual [*****] in accordance with the below price ladder based on the [*****] lookback purchases of rPL from Waltham (WKg):


Price ladder		Price per gram
[*****]		[*****]
[*****]		[*****]
[*****]		[*****]

The price above are per [*****] and shall be set at the end of each [*****] based on the price in each of the price ladders for rPL that corresponds to the [*****] look-back purchases of rPL, based on the deliveries received from the Waltham site and accepted by GEHC. The price for rPL shall be set at on the [*****] and shall remain fixed for that [*****], in accordance with tiers:

Assume the [*****] look-back show [*****] between April 1 2016 and March 31 ^st 2017, then the price for Q2 2017 shall be : [*****]

For amounts supplied in aggregate from Repligen beyond [*****], GEHC and Repligen shall negotiate in good faith and agree upon the mechanism for further price decreases.

Lead time (from PO): Delivery date by Repligen shall be [*****] from acceptance of PO with commercially reasonable efforts to deliver in [*****] but or on mutually agreed delivery date in accordance with Section 6(a) Attachment D (as amended).


Remaining shelf life upon delivery:		[*****]

Level of Supplier’s Safety Stock: [*****] of the previous Calendar Year’s purchase by GEHC.


Shelf life:		[*****]

D. General Price Terms

All Prices above are per [*****] and Prices for Recombinant Products shall be set at the beginning of each [*****] based upon the running [*****] prior consumption of each of the Recombinant Products based on the deliveries received from Repligen and accepted by GEHC. The Price for each of the Recombinant Products shall be set on the [*****] and shall remain fixed for that [*****].

By way of hypothetical examples for Zäta:

GEHC has purchased [*****] of Zäta from the Supplier over the course of [*****] between [*****] and [*****]. The price [*****] of [*****] and effective for all purchases made during that [*****] will be [*****] per [*****].

[*****]

GEHC has purchased [*****] of Zäta from the Supplier over the course of [*****] between [*****] and [*****].The price [*****] of [*****] and effective for all purchases made during that [*****] will be [*****] per [*****].

[*****]

By way of hypothetical example for rPA:

GEHC has purchased [*****] of rPA from the Supplier over the course of the [*****] from [*****] and [*****]. The Actual Price [*****] of [*****] and effective for all purchases made during that [*****] will be [*****] per [*****].

[*****]

The prices agreed herein for all Products do not include the costs of transportation, packaging, shipping, or taxes (including VAT) for the Products and will be paid by GEHC. The costs of packaging will be charged to GEHC by Supplier directly and shall be clearly specified on the invoice.

Additional Charges. Unless otherwise agreed in this Agreement the Prices include all costs relating to the supply of the Products and GEHC shall not be obliged to reimburse the Supplier for any additional charges or any other costs relating to the supply of the Products that are not specified herein or otherwise agreed in writing by the Parties.

Revised Attachment D

Business Terms

Clause 14 of Attachment D is amended by replacing the product and prices with the following:

[*****]

Exhibit 10.2

STRATEGIC SUPPLIER ALLIANCE AGREEMENT–CONTRACT MANUFACTURING GE HEALTHCARE

PARTIES


GE Healthcare entity (“GEHC”)		Other Party (the “Supplier”)
GE Healthcare Bio-Sciences AB		Novozymes Biopharma Sweden AB
Address		Address
Björkgatan 30, 751 84 Uppsala, Sweden		St Lars väg 47, 220 09 Lund
Registration number		Registration number
556108-1919		556627-0830

AGREEMENT

		GEHC REF: 132145

The Parties hereby agree that the following terms and conditions shall apply:

A.	Purpose

GEHC and the Supplier are entering into this Agreement for the outsourcing by GEHC of the manufacture of the Products by the Supplier and thereby replacing the Contract Manufacturing and Purchasing Agreement, dated Sep 1 2005, between the Parties as specified below.

Pursuant to above prerequisites and the terms and condition of this Agreement, the Supplier shall manufacture and sell to GEHC, and GEHC shall purchase from the Supplier the Products, defined in Attachment C (the “ Products ”) in such amounts as GEHC may order from time to time on the terms and conditions set out in the Agreement. GEHC shall pay the price of the Products specified in Attachment C (the “ Prices ”). The Parties have agreed to jointly perform technology transfer projects (“TT Programs”) enabling the Supplier to manufacture Recombinant Products Zäta and rPA as set forth in Attachment L below.

The Parties agree that the scope of the contract manufacturing services performed hereunder (including packaging and quality control) will be specified by Production Documents as defined below.

Effective 12 December 2008 GEHC has granted Supplier’s parent company a license to develop, manufacture, use, sell and have sold nPA (as defined herein), and hereunder to purchase chromatography media and receive working cell banks from GEHC for the practice of the license on the terms of the existing contract manufacturing agreement between GEHC and the Supplier. Said purchasing chromatography media and receiving working cell banks shall be governed by this Agreement, once effective.

B.	Documents

The following attachments are an integral part of this Agreement (the “Attachments”). The provisions of each Attachment shall be incorporated by reference into and deemed to be part of this Agreement. The order of precedence shall be as follows, unless otherwise agreed:

QUALITY & INTEGRITY TERMS

Attachment A – Supplier Quality Requirements

Attachment B – Supplier Integrity Statement

BUSINESS TERMS

Attachment C – Products, Prices, Specifications (if any),

Attachment D – Business Terms

Attachment I – GEHC initial 24 months rolling forecast starting from effective date

Attachment J – Media lead time schedule

GENERAL TERMS

Attachment E – General Terms and Conditions

TECHNICAL TERMS

Attachment F – GEHC Production know-how of the Recombinant Product

Attachment G – GEHC Production know-how Native Products

Attachment H – GEHC Production know-how Lego Products

Attachment K – Production Documents generated by the Supplier

Attachment L – TT Programs

Term

Effective Date: The date of the last of the below signatures

Agreement Term : This Agreement shall commence on the Effective Date and, subject to the rights of termination in clause 16 of Attachment E, shall continue up to 31st of December 2016. The Parties shall negotiate eighteen (18) months prior to the expiration of the Term to decide whether to renew this Agreement.

This Agreement has been duly executed by each of the Parties


Signed for and on behalf of GEHC		Signed for and on behalf of the Supplier

Date: June 30, 2011		Date: 2011 07 07

Signature	/s/ Magnus Lundgren	Signature	/s/ Mikael Bundgaard-Nielsen

Name (capitals)	Magnus Lundgren	Name (capitals)	Mikael Bundgaard-Nielsen

Title	Global Sourcing Executive	Title	Vice President

		Signed for and on behalf of the Supplier

		Date:

		Signature

		Name (capitals)

		Title

Attachment A

Purchased Material Quality Terms

SUPPLIER NAME:

Version No.:

The Parties are committed to quality in the performance of this Agreement. Accordingly, all Products shall conform to the Purchased Material Quality Requirements set forth below.

SECTION 1 – QUALITY SYSTEMS: The Supplier shall maintain a documented quality system, and the Supplier shall be in compliance with ISO9001 or equivalent. Key components of a robust quality system are properly implemented quality procedures for collection and processing defects (parts or services), appropriate statistical techniques to analyze defects and identifying opportunities for corrective and preventive actions, along with evidence of validation that actions are effective in eliminating and preventing further defects. Upon request from GE Healthcare, the Supplier shall provide documented corrective action plans to prevent future deviations from the specification within thirty (30) days from receiving a corrective action request from GE Healthcare.

To ensure products and services provided to GEHC the Supplier shall meet or exceed GEHC requirements, GEHC may audit the Supplier’s quality system at periodic intervals upon 30 days written advance notification, to inspect and observe the Supplier’s manufacture of Products, to audit the Supplier’s quality control and inspection procedures, and to have access to all data and documentation from such control of the Products and to receive samples and make such other investigations as GEHC deems necessary. The Supplier shall reserve the right for GEHC to perform such inspections on the premises of subcontractors engaged by the Supplier, such inspections to be scheduled by the Supplier following reasonable prior notice by GEHC and to be carried out jointly by representatives of both Parties and at the sole expense of GEHC. GEHC’s right of inspection under this head shall not diminish the Supplier’s obligation to deliver Products which comply with the specifications of this Agreement GEHC may also request periodic, joint quality assurance meetings at the Supplier’s facility to discuss and resolve product quality and reliability issues.

SECTION 2 – QUALITY RECORD RETENTION : If the Supplier is required to perform acceptance and release activities per GEHC written agreement or purchase specification, the Supplier shall maintain records of the acceptance and release activities for the services performed and/or products and services delivered to GEHC. These records may include as appropriate test/inspection criteria, revision level of documents/equipment/software used, operating procedures (planning, routing or traveler sheets), dates of test/inspection, and the results. The records required shall be retained at the Supplier and available for GEHC upon reasonable notice in advance, for at least ten (10) years from the date of manufacture and after 10 years retention at Supplier, the required records shall be submitted to GEHC with a written notice of 30 days, unless the Parties agree to extend the retention of the records at the Supplier or discord the record.

SECTION 3 – COMPLIANCE : The Supplier shall comply with the terms of the Purchase Order or purchase agreement with GE Healthcare (“Agreement”). The Supplier shall maintain compliance with any and all laws and government regulations that apply in the manufacturing and delivery of its products or services. Such laws may include, but are not limited to, regulations and directives, labor laws, environmental laws, Custom Trade Partnership Against Terrorism (CTPAT) and product safety laws. The Supplier shall provide GE Healthcare all information requested that is necessary to enable GE Healthcare to comply with the laws and regulations applicable to the GE Healthcare sale and use of GE Healthcare products. As per GE Healthcare purchase specifications or for OEM (Original Equipment Manufacturer! items, the Supplier shall maintain compliance to industry standards and product listings for all Products delivered to GE Healthcare.

SECTION 4 – CHANGE NOTIFICATION:

Product changes affecting specifications, quality, form, fit, function, regulatory compliance, etc. proposed by the Supplier are governed by Attachment E, Section 6.2 hereof Product changes affecting specifications, quality, form, fit, function, regulatory compliance, etc. proposed by GEHC are governed by the terms of Attachment E, Section 6.1 hereof.

SECTION 5 – SPECIFICATIONS : The Supplier is responsible to meet or exceed the part requirements and Specifications as referenced in the Agreement. The Supplier is accountable to ensure that delivered items meet the requirements of the revisions and/or versions specified on the applicable Agreement.

The Supplier shall ensure that GEHC documentation is controlled and distributed with the correct revision level to the appropriate personnel that produce the product for GEHC. The Supplier shall also ensure that all GEHC documentation is treated as proprietary and confidential, unless otherwise agreed.

For GEHC designed Products, the Supplier is responsible for ensuring that all applicable GEHC documentation is provided to all of the Supplier’s Sub-Suppliers involved in the supply of product for GEHC. The Supplier shall ensure that both they and their Sub-Suppliers that use GEHC engineering documentation are maintained in compliance with all accepted Engineering Change Requests/Engineering Change Orders issued by GEHC.

Supplier shall be responsible for the qualification of all new equipment, computer systems and facilities associated with the manufacture, storage or testing of the Products as required.

SECTION 6 – TRAINING:

Supplier shall ensure that all personnel performing the functions to support the critical systems outlined in this Agreement are trained according to Supplier’s internal procedures and processes.

SECTION 7 – SAMPLES

The Supplier shall retain sufficient samples from each of the Products to perform at least two (2) full retests of the agreed Specification for a period of one (1) year after the expiration of the Product Samples shall be stored at or lower than a temperature of minus 15°C and in standard containers. The Supplier shall advise GEHC before disposal of retained samples.

SECTION 8 – PACKAGING AND SHIPPING METHODS : The Supplier shall provide packaging and shipping methods to prevent cosmetic and mechanical damage to the Product. The Supplier shall meet or exceed the detailed specifications of the GEHC packaging requirements found in the Specification

SECTION 9 – ORDER OF PRECEDENCE : This attachment A shall be an addendum to the Strategic Supplier Alliance Agreement (SSAA) between Supplier and GEHC. Any conflict between this Attachment A and the other Attachments of the SSAA regarding the minimum material quality requirements shall be resolved pursuant to the terms of this Attachment A.

By signing below, you agree to the terms hereof and consent to meet all requirements that apply for any and all products and services provided to GE Healthcare.


AGREED TO AND ACCEPTED BY SUPPLIER

SIGNATURE:		/s/ Mikael Bundgaard-Nielsen

PRINTED NAME:		Mikael Bundgaard-Nielsen

TITLE:		Vice President

DATE:		2011 07.07

SUPPLIER NAME		Novozymes Biopharma Sweden AB

SIGNATURE:

PRINTED NAME:

TITLE:

DATE:

SUPPLIER NAME:

AGREED TO AND ACCEPTED BY THE GENERAL ELECTRIC COMPANY ON BEHALF OF ITS DIVISION, GE HEALTHCARE –

SIGNATURE:		/s/ Magnus Lundgren

PRINTED NAME:		Magnus Lundgren

TITLE:		Global Sourcing Executive

DATE:		Jun 30, 2011

Attachment B

Supplier Integrity Statement

Supplier Integrity, Business Conduct, and Compliance Requirements

Supplier agrees (a) to have appropriate policies and governance in place and shall use its best efforts in order to comply with all applicable legal, as well as GEHC policy communicated to the Supplier requirements (including those relating to labor, the environment, health and safety, wages, hours and conditions of employment, occupational safety, discrimination, sexual harassment, immigration, minority owned businesses, intellectual property rights and improper payments); (b) that Supplier is responsible for ensuring that Supplier’s employees, contractors, representatives and sub-suppliers understand and comply with the same legal and GEHC policy (as communicated to the Supplier) requirements; and (c) that the requirements referenced in (a) and (b) above include the following:

(1)	Code of Conduct . Maintain and enforce written company policies requiring high ethical conduct and strict adherence to lawful business practices, including a prohibition against bribery of government officials.

(2)	Labor Matters .

(i)

Employ only workers above the applicable minimum age requirement or the age of 16 whichever is higher.

(ii)

(iii)

Allow workers to freely choose whether to organize or join associations for the purpose of collective bargaining as provided by local law.

(iv)

(3)

Environmental Compliance . Comply with all applicable environmental laws and regulations, including: (i) maintaining and enforcing required environmental management programs; (ii) establish and maintain safeguards for the continuing compliance with all required environmental permits: and (iii) not permitting any discharge to the environment in violation of law, or that would otherwise have on adverse impact on the environment.

(4)	Health & Safety . Provide workers with a safe workplace that complies with applicable health and safety standards as well as appropriate living conditions.

(5)

Improper Payments and Business Dealings . Not offer or provide, directly or indirectly, anything of value (including cash, illegal political contributions, bribes or kickbacks or other improper payments) to any GEHC employee, representative, customer, government official, or other third party in connection with any GEHC procurement, transaction or business dealing. Prohibitions include offering or providing (directly or indirectly): (i) any consulting, employment or similar position to any GEHC employee (or their family member or significant other) involved with a GEHC procurement: (ii) GEHC employees and representatives with any gifts, other than gifts of nominal value to commemorate or recognize a particular GEHC-supplier business transaction or activity: and/or (iii) GEHC employees and/or representatives with the opportunity to participate in any contest, game or promotion.

(6)

Business Entertainment of GEHC Employees and Representatives . Comply with the business entertainment (including travel and living] policies established and expressly communicated in writing by GEHC and which govern GEHC employees and representatives, including understanding those business entertainment policies of the applicable GEHC component or operation before offering or providing any GEHC employee or representative any form of business entertainment. Never offer to a GEHC employee or representative any form of business entertainment under circumstances that would create the appearance of on impropriety.

(7)

Collusive Conduct and GEHC Procurements . Establish and maintain policies and safeguards and use best efforts to comply with all applicable competition laws, including, but not limited to: (i) not engage in prohibited communications or enter into agreements with competitors that con affect competition; (ii) not share or exchange any price, cost or other competitive information, nor engage in any other collusive conduct with any other third party supplier or bidder to GEHC with respect to any proposed, pending or current GEHC procurement: and (iii) avoid even the appearance of improper conduct.

(8)

Intellectual & Other Property Rights . Respect the intellectual and other property rights of others, including GEHC’s. Only use GEHC information and property (including tools, drawings and specifications! for the purpose for which they are expressly provided and for no other purposes. Take all reasonable steps to safeguard and maintain the confidentiality of GEHC proprietary information, including maintaining it in confidence, only in secure work areas, and not disclose it to any third parties without the prior written permission of GEHC. Observe and respect all GEHC patents, trademarks, trade secrets, and copyrights, as well as comply with such restrictions or prohibitions on their use as GEHC may from time to time establish.

(9)

Export and International Trade Controls & Customs Matters . Establish and maintain policies and safeguards and use best efforts to comply with all applicable import and export control laws and regulations, including those of the United States, and not transfer GEHC technical information to any third party without the

express prior written permission of GEHC. Without limitation to the foregoing: (i) Establish and maintain policies and safeguards and use best efforts to comply with all applicable export controls laws and regulations in the export or re-export of GEHC technical information, including any restrictions on access and use applicable to non-U.S. nationals; and (iii ensure that all invoices and any customs or similar documentation submitted to GEHC or governmental authorities in connection with transactions involving GEHC accurately describe the goods and services provided or delivered and the price thereof. Supplier will also obtain all applicable permits and licenses necessary to perform its obligations under this Agreement, and upon GEHC’s request, will provide GEHC with copies of such permits and licenses. Where Products contain United States components, Supplier will also provide GEHC with details of the United States content value as a percentage of the Product price upon GEHC’s request.

(10)

Privacy . With respect to data and personal information (including information of GEHC employees, its customers, suppliers, business partners, and patient health information handled and processed on behalf of its customers) (collectively, “PI”): (i) Establish and maintain policies and safeguards and use best efforts to comply with all applicable privacy and data protection laws globally, or generally acceptable privacy principles where comprehensive privacy laws are not available; (ii) Establish and maintain policies and safeguards and use best efforts to report any improper use or disclosure of PI, as well as successful security breaches, immediately upon becoming aware; (iii) Establish and maintain policies and safeguards and use best efforts to ensure that any employees, contractors, representatives and sub-suppliers to whom it provides PI and/or access to information systems, agree to the some restrictions and conditions set forth herein: (iv) facilitate audits by making its internal practices, books and records relating to the use and disclosure of PI available to GEHC and government agencies (including, the Secretary of the Department of Health and Human Services) for purposes of determining compliance with applicable laws, rules, and regulations; (v) when requested by GEHC, promptly return or destroy, as well as certify in writing to the return and destruction of, all PI and information in any form that allows access to GEHC information systems, and retain no copies of such PI and information: (vi) safeguard PI upon taking possession or exposure to employees and all third parties; and (vii) ensure that formal security management systems are employed that eliminates the risk of Pl-related security breaches; and (viii) notify GEHC in writing whenever PI will be exported from jurisdictions with data transfer restrictions, or transfer PI to countries without comprehensive data protections laws.

(11)	Money Laundering Prevention . Comply with all applicable anti-money laundering laws and regulations and any reasonable GEHC policies established for money laundering prevention communicated expressly in writing.

(12)	Prohibition of Use of Sub-Suppliers or Third Parties to Evade Requirements . Not use sub-suppliers or other third parties to illegally evade any applicable legal, including those enumerated above.

(13)

Security Measures . Supplier warrants and represents that it will review and if relevant seek to reasonably adopt industry standard security measures which are consistent with accepted programs including the US Customs-Trade Partnership Against Terrorism (“C-TPAT”), the European Union’s Authorized Economic Operator program and other similar programs where applicable…

(14)

Country of Origin . In accordance with and as required by applicable trade and customs laws. Supplier will mark each Product, as well as Product packaging, containers, labels, and invoices, with the country of origin for the Product. Supplier will also provide acceptable and auditable documentation that establishes the country of origin for all Products, including, without limitation and as applicable, certifications of origin for Products qualifying far EFTA/EU and other preferential duty provisions, as applicable.

(15)

Policy Changes . GEHC policy requirements, including those enumerated above, are subject to modification by GEHC at any time. Such modifications shall only apply with regard the Supplier upon communication in writing and provided the Supplier does not object to such modification, which objection shall be mode in writing within 30 days from receipt of the communication. Supplier agrees to contact its GEHC representative if Supplier has any questions about the foregoing and/or their application to particular circumstances.

B.	Products provided by Supplier may be subject to environmental, health and safety laws and regulations. As a result, Supplier agrees to the following without limitation:

(1)	Supplier agrees to comply with all applicable national, EU, state/provincial and local labor, environmental, health and safety laws and regulations in connection with execution of this Agreement.

(2)


AGREED TO AND ACCEPTED BY SUPPLIER

BY:	/s/ Mikael Bundgaard-Nielsen	BY:

TITLE:	Vice President	TITLE:

DATE:	2011 07.07	DATE:

SUPPLIER NAME:	Novozymes Biopharma Sweden AB

Attachment C

Products, Prices and Specifications


Currency:		SEK

Revision date:		April 4 ^th 2011

The reference to Products shall include the two recombinant Products, 1) Zäta with the GEHC article number 28-4048-76 and 2) rPA with the GEHC article number 28-9932-16 (“Recombinant Products) and the product, serum free Native Protein A, with the GEHC article number 30-6001-21 (“Native Product”) and the product Native Protein A (“Lego Product”). All three types of products; Recombinant Products, Native Product and Lego Product are covered by the term Product.

A.	RECOMBINANT PRODUCT :


Product Name		Zäta
GEHC Article number		28-4048-76
Supplier Article Number		6082-221

Unit size:

[*] Zäta per [*] meaning that the content per [*] shall be [*] . Each [*] shall be labeled with [*] Zäta. For remains achieved during filling the last [*] in each batch the actual quantity in [*] shall be stated on the label.

Price

SEK/ [*]

[*]

Zäta ( [*] – [*] )

[*]

Zäta < [*]

[*]

INCOTERMS : CIP GEHC Uppsala, but for any Purchase Order [*] , the parties shall share equally the freight/insurance costs of such shipment subject to the transport invoice.

Lead time (PO):

[*]

Remaining shelf life upon delivery:

[*]

Level of Suppliers Safety Stock:

The safety stock will be [*] based on the average of the [*] of the at any time valid [*] rolling forecast distributed by GEHC and the [*] consumption by GEHC.

For the first year of Zäta supply, [*] safety stock level shall be based solely on the [*] rolling forecast.

Lead Times for Safety Stock Replenishment:

[*] , the lead time for replenishment of purchased safety stock will be [*] .

Shelf life

[*]

B.	RECOMBINANT PRODUCT:


Product Name		rPA
GEHC Article number		28-9932-16
Supplier Article Number		6082-271

Unit size : [*] rPA per [*] meaning that the content per [*] shall be [*] . Each [*] shall be labeled with [*] rPA. For remains achieved during filling the last [*] in each batch the actual quantity in [*] shall be stated on the label.

Price:

SEK/ [*]

[*]

Zäta ( [*] – [*] )

[*]

Zäta < [*]

[*]

The above prices are based on the prerequisite that the total yield is around [*] starting from [*] . If the yield in the [*] is proven to be [*] higher or lower, the price shall be [*] .

INCOTERMS : CIP GEHC Uppsala, but for any Purchase Order less than [*] , the parties shall share equally the freight/insurance costs of such shipment subject to the transport invoice

Lead time IPO):

[*]

Remaining shelf life upon delivery:

[*]

Level of Suppliers Safety Stock:

The safety stock will be at least [*] based on the average of the [*] of the at any time valid [*] rolling forecast distributed by GEHC and [*] consumption by GEHC.

For the [*] rPA supply the [*] safety stock level shall be based solely on the [*] rolling forecast.

Shelf life:

[*]

Lead Times for Safety Stock Replenishment:

[*] the lead time for replenishment of purchased safety stock will be [*] .

C.	NATIVE PRODUCT :


Product Name		Serum free Native Protein A (nPA)
GEHC Article number		30-6001-21
Supplier Article Number		6082-220

Unit size : [*] nPA per [*] meaning that the content per [*] shall be [*] . Each [*] shall be labeled with [*] nPA. For remains achieved during filling the last [*] in each batch the actual quantity in [*] shall be stated on the label.

Price: The price on nPA will be [*] .

INCOTERMS : CIP GEHC Uppsala, but for any Purchase Order less than [*] , the parties shall share equally the freight/ insurance costs of such shipment subject to the transport invoice.

Lead time (PO)

[*]

Remaining shelf life upon delivery:

[*]

Level of Supplier’s Safety Stock:

The safety stock will be [*] based on the average of the [*] of the at any time valid [*] rolling forecast distributed by GEHC and the [*] consumption by GEHC

For [*] the safety stock level shall be [*] .

Shelf life

[*]

Lead Times for Safety Stock Replenishment:

[*] , the lead time for replenishment of purchase safety stock will be [*] .

D .

LEGO PRODUCT:


Product Name		Native Protein A (PA)
GEHC Article number		N/A
Supplier Article Number

Specification : [*] .

Price:

The price on PA will be [*]

INCOTERMS : CIP GEHC Uppsala, but for any Purchase Order less than [*] , the parties shall share equally the freight/insurance costs of such shipment subject to the transport invoice.

Lead time (PO):

[*].

Remaining shelf life upon delivery:

[*]

Level of Supplier’s Safety Stock:

[*]

Shelf life:

[*]

Lead Times for Safety Stock Replenishment:

[*]

Special Terms for Lego Product:

a)	Lego Product is delivered as an *[]** .

b)	Each Purchase Order shall be firm and binding for GEHC and be for *[]** of Lego Product.

c)	GEHC will provide the Supplier with *[]** .

***

GENERAL PRICE TERMS:

Recombinant Products and Native Product :

All prices above are per gram and shall apply for deliveries made in the applicable calendar year.

[*] .

In delivery documentation and invoices the stated quantity delivered shall be based on the unit size [*] . For remains achieved during filling the last [*] in each batch the actual quantity in [*] shall be stated on the label, in the delivery note and in the invoice.

Reference samples for the Recombinant Products and the Native Product, covering [*] , to be provided to GEHC in the deliveries [*] .

Gel Prices:

Throughout the period of the Agreement the below prices are [*] .


Protein	Media			*SEK/[]**
ZätA*		[*	]		[*	]
		[*	]		[*	]
		[*	]		[*	]

nPA		[*	]		[*	]
		[*	]		[*	]

rPA		[*	]		[*	]
		[*	]		[*	]

Additional charges : Unless otherwise agreed in this Agreement the Prices include all costs relating to the supply of the Products and GEHC shall not be obliged to reimburse the Supplier for any additional charges or any other costs relating to the supply of the Products that are not specified herein or otherwise agreed in writing by the Parties.

Specifications

ANALYTICAL SPECIFICATION RAW MATERIAL

30-6000-60 Ed. AH

Issued by

QA/

Johanna Ejdersund

Approved by

R&D/

Philippe Busson

Established by

QA/ Kjell Christensson

Valid from 2001-04-15

Supersedes 30-6000-60 Ed. AG

PAGE 1(1)

rProtein A

Code No: 30-600-60, 28-9932-16


1. Packaging instruction		The package shall be suitable for storage of the material.

2. Terms of transportation		At -18°C or below

3. Storage conditions		Preserve in a well-closed container at or below -18°C.

4. Remaining Shelf life		Shelf life is *[]** from the date of manufacture.

5. Other name		rPa – GE Healthcare

6. Formula and mass		Theoretical Mr: 34 318 Dalton calculated from amino acid sequence

7. Description		rProtein A is a recombinant engineered form of Staphylococcus aureus Protein A, produced by fermentation of Escherichia coli . The protein is produced with chemicals and materials of non- animal origin.

		The product is supplied as a clear, amber frozen liquid free from particulates.

8. Requirements on properties


Characteristic	Tolerance limit	Test method	Remark
1. Visual examination	*[]**	45-2006-68
2. IgG-binding activity, %	*[]**	04-0008-64
3. Purity by size exclusion chromatography; %	*[]**	04-0008-66
4. SDS-PAGE	*[]**	04-0008-65
5. Protein concentration (A ₂₇₅ ): mg/ml)	*[]**	04-0048-69
6. Microbial contamination, CFU/ml	*[]**	45-2006-39
7. Endotoxin activity EU/mg rProtein A	*[]**	45-0306-72

GE and GE monogram are trademarks of General Electric Company.

GE Healthcare Bio-Sciences AB, General Electric Company

LOGO

ANALYTICAL SPECIFICATION RAW MATERIAL

30-6001-60 Ed. AH

Issued by

QA/Johanna Ejdersund

Approved by

R&D/ Herbert

Baumann

Established by

QA/ Christina

Hult-Roos

Valid from

2010-04-29

Supersedes 30-6001-09 Ed.

Page 1(1)

nProtein A

Code No: 30-6001-09, -20, -21



1. Packaging instruction		The package shall be suitable for storage of the material.

2. Terms of transportation		At or below -18°C.

3. Storage conditions		Preserve in a well-closed container at or below -18°C.

4. Shelf life		Established shelf life is *[]** from the date of manufacture.

5. Formula and mass		Theoretical Mr: 46 762 Dalton calculated from amino acid sequence

6. Description		Protein A is produced from a selected strain of Staphylococcus aureus Protein A. The protein binds to the Fc region of the immunoglobulin G and in some cases to immunoglobulin M and A. The substance is supplied as a clear yellowish or yellow-brown frozen liquid free from particles. The protein is produced with chemicals and materials of non-animal origin.

7. Requirements on properties


Characteristic	Tolerance limit	Test method	Remark
1. Visual examination	*[]**	45-2006-68
2. IgG-binding activity, %	*[]**	04-0008-64
3. Purity by size exclusion chromatography; %	*[]**	04-0008-66
4. SDS-PAGE	*[]**	04-0008-65
5. Protein conc (A ₂₇₅ ): mg/ml)	*[]**	45-2006-14
6. Microbial contamination CFU/ml	*[]**	45-2006-39
7. Endotoxin activity; EU/ml	*[]**	45-0306-72
8. Content of endotoxin B µg/g protein A	*[]**	14-0015-63

GE and GE monogram are trademarks of General Electric Company.

GE Healthcare Bio-Sciences AB, General Electric Company

LOGO

ANALYTICAL SPECIFICATION RAW MATERIAL

14-0037-84 Ed. AD

Issued by

QA/ Elb-Jorde

Approved by

R&D/ J Daicic

Valid from

2008-08-19

Supersedes

14-0037-84 Ed.

Page 1(2)

ZätA protein 905

Code No: 28-4048-76



1. Packaging instruction		The package shall be suitable for storage of the material.

2. Terms of transportation		At or below -18°C.

3. Storage conditions		Preserve in a well-closed container at or below -18°C.

4. Shelf life		Established shelf life is *[]** from the date of manufacture. Final shelf life is to be decided by stability studies.

5. Formula and mass		Theoretical Mr: 26 748 Dalton calculated from amino acid sequence

6. Description		ZätA protein is a recombinant protein produced by a Genetically Modified Organism (GMO) in a fermentation process.
		The substance is a clear, yellowish frozen liquid free from particulates, supplied in a buffer:
		20 mM potassium phosphate
		150 mM sodium chloride
		2 mM EDTA
		pH 7.0

		The bulk is to be manufactured according to our Base Method, number 14-0040-44. The protein is produced with chemicals and materials of non-animal origin.

LOGO

ANALYTICAL SPECIFICATION RAW MATERIAL

14-0037-84 Ed. AD

Page 2(2)

7. Requirements on properties


Characteristic	Tolerance limit	Test method	Remark
1. Visual examination	*[]**	45-2006-68
2. IgG-binding activity, %	*[]**	04-0008-64
3. Purity by size exclusion chromatography; %	*[]**	04-0008-66
4. SDS-PAGE	*[]**	04-0008-65
5. Quantification; mg/ml	*[]**	04-0013-21
6. Microbial contamination CFU/ml	*[]**	45-2006-39 Ed. AB
7. Endotoxin activity EU/mg ZätA protein	*[]**	45-0306-72 Ed. AF

Comment:

GE and GE monogram are trademarks of General Electric Company.

GE Healthcare Bio-Sciences AB, General Electric Company

Attachment D

Business Terms

1.	Specifications

2.	Delivery documentation

With each shipment the Supplier shall deliver the following documents to GEHC: Certificate of Analysis, Packing slip and the Commercial Invoice.

3.	Prices and Payment Terms

Firm Prices . The Prices of the Products are firm for the Term of this Agreement. Prices are quoted excl. VAT and other taxes.

Taxes . Unless prohibited by law, the Supplier will separately indicate on its Invoice any tax that is required to be imposed on the sale of Products.

Payment Terms . GEHC shall settle any undisputed invoices arising under this Agreement [*] ( [*] ) days after receiving on Invoice prepared in accordance with the terms of this Agreement. Invoices shall be issued upon delivery. All sums to be paid by GEHC under this Agreement shall be in the currency specified in Attachment C. Interest for late payments shall not apply to payments that GEHC contests in good faith and shall in no event exceed applicable statutory interest rate.

[*] .

Invoicing requirements . The Supplier’s Invoices shall contain the GEHC Purchase Order number and other such information as may be required by law or requested from time to time by GEHC. Each cost item shall be specified in the invoice. The stated and delivered quantities shall match between the invoice, actual delivery and in the delivery documentation, based on the use of the unit size as specified in Attachment C. Invoices shall be addressed to GEHC or the GEHC affiliate who has placed the purchase order with the Supplier.

[*]

4.	Components and Materials

At GEHC’s option, GEHC may instruct the Supplier to procure or provide all materials and components necessary for the manufacture of the Products from on approved supplier, in which case an approved suppliers list shall be maintained by the Supplier. Any new suppliers selected by the Supplier in connection with the Agreement must be approved by GEHC, whereupon they may be added to such approved suppliers list. Any verified change of cost of raw materials resulting from GEHC’s instruction to change supplier, shall effect the price of the concerned Product in the same proportion as the change of the Supplier’s production cost of the concerned Product.

5.	Additional Suppliers

The Supplier shall, at GEHC’s written request, provide reasonable assistance to GEHC with regard to GEHC’s efforts to have back-up manufacturing solutions in place for the Products (i) by providing GEHC or such designee with copies of all written embodiments of Production Document (ii) by making relevant personnel available within reason for consultation. Supplier may charge GEHC a reasonable fee for such services which shall be subject to agreement prior to initiation.

6.	Forecast and Commitment

Forecasting . [*] ( [*] ) days before the end of each quarter, GEHC shall submit to the Supplier in writing a [*] month rolling forecast (“Forecast”) broken down by Product ( [*] ) and into calendar quarters. Supplier shall use the Forecast as the basis for its production planning and shall adjust the Safety Stock according to the new Forecast within the agreed lead times. The Forecast shall reflect GEHC’s best estimate of its need for the Products from the Supplier at the time of the submission, subject to section e) below. If GEHC is unable to provide a timely forecast, GEHC shall upon request be granted an extension of [*] ( [*] )days from the original Forecast due date. If the Forecast is not submitted at such time then the second quarter from the previous Forecast will be firm and binding on GEHC and the Supplier.

The Forecast . The [*] of every rolling Forecast provided by GEHC for the Recombinant Product and for the Native Product shall be [*] on GEHC and the Supplier. [*] . Upon receipt of the Forecast, Supplier shall notify GEHC if Supplier is unable to deliver according to said Forecast (including any specific quarter) included in the forecast. Supplier agrees to provide such notification to GEHC within [*] days.

General Supply Commitment . The Supplier shall use its best commercial efforts to manufacture and deliver the Recombinant Product and the Native Product within [*] . To ensure this is upheld, the Forecast will be assessed as described in section 14. In the event that the market demand exceeds this volume, GEHC and Supplier will work together and make best efforts to meet the market demand. If the Supplier should be unable to meet GEHC’s requirements in accordance with the forecast or should fail to accept any orders in excess of the forecast within agreed time limits, the Parties agree GEHC shall be released from such part of its purchase commitment that the Supplier is unable to deliver on the requested delivery times

Purchase Commitment Recombinant Product . As a result of this Agreement, the Supplier will become a preferred supplier of GEHC for the Recombinant Products. The Parties have agreed that the annual deliveries shall be at least [*] ( [*] ) percent of GEHC’s total actual requirements in [*] for the Recombinant Products. For the avoidance of doubt, the annual deliveries of individual Recombinant Products shall not be lower than [*] % of the total annual requirement for any particular Recombinant Product.

The purchase commitment for a Recombinant Product shall start and be calculated at such time the following criteria for the Recombinant Product are met as part of the TT Programs:

[*] ;

[*]

[*] ,

[*]

In the event GEHC should fail to fulfill its purchase obligations hereunder it shall immediately notify Supplier of such failure and as its sole liability immediately issue a purchase order for the missing quantities upon the Supplier’s written request thereto. The Supplier agrees to maintain the equivalent ability to manufacture the Recombinant Product for GEHC.

If the Supplier during a certain [*] is unable to timely supply the Recombinant Product in quantities specified in GEHC’s Forecast, then GEHC’s purchasing commitment for that quarter shall be reduced with a quantity corresponding to the shortfall.

Purchase commitment Native Product . As a result of this Agreement the Supplier will continue to be the supplier of GEHC for the Native Product. The Parties have agreed that the annual deliveries shall be no less than [*] % of GEHC’s total actual requirements in [*] for the Native Product. GEHC reserves the right to develop alternative sources for the Native Product. In the event that such a project is started GEHC agrees to provide the Supplier with at least [*] months notice prior to the commencement of deliveries from an alternative supplier. In such an event the Parties agree to negotiate in good faith acceptable commercial and project management terms.

No further Obligation . Other than as set out in this Section 6, it is the express understanding of the Parties that GEHC shall have no further obligation to purchase Products exclusively from the Supplier or to purchase any further minimum amount of Products, and may use other suppliers for any and all Products, or similar products in accordance with the stipulated terms herein.

7.	Contract Managers and Communication

GEHC: [*]

Supplier: [*]

Legal Notices (as set forth in Section 18 in Attachment E) .


		GEHC:		Björkgatan 3
				751 84 Uppsala, Sweden
				Fax No. *[]**

		Supplier:		St Lars väg 47,
				220 09 Lund
				Fax No:

8.	Insurance

During the term of this Agreement and for [*] thereafter each party undertakes to maintain a comprehensive liability insurance policy, products liability inclusive, at terms and conditions customary to the business. Such insurance shall be for on insured sum of not less than [*] Swedish kroner ( [*] SEK) (or the equivalent in USD). Each party shall upon request furnish to the other party a certificate evidencing such insurance.

9.	Safety Stock

The Supplier shall keep a Safety Stock at the Supplier’s premises, corresponding to the minimum set inventory values and the replenishment times in Attachment C.

The Supplier shall provide GEHC with finished goods inventory levels and Safety Stock levels within [*] days upon request from GEHC

10.	Manufacturing Process

All written manufacturing or production documentation and records relating to the Products are defined as “Production Document(s)”

For avoidance of doubt the know how listed in attachments F, G, H and K and the know-how to be generated as part of the TT Programs, are deemed to be Production Documents and shall be the sole property of GEHC and may be only used for the purpose of manufacturing the Products on behalf of GEHC under this Agreement unless otherwise agreed in writing by the Parties.

The Supplier shall document and GEHC shall have access to review all required written manufacturing or production records relating to any of the Products and upon request from GEHC, the Supplier is obliged to send GEHC copies of the requested Production Documents

The Supplier shall always keep and maintain the master list of Production Documents generated by the Supplier, initially stated in Attachment K, and the Supplier shall send upon GEHC’s request on update of any of the documents included in the master list of Production Documents.

The approved validation reports for the completion of the tech transfer under the TT programs will act as baseline documents, over the production process for each of the Recombinant Products showing the starting fermentation volume, the yields for each of the process steps and the expected outcome per purification batch, to be used for example as a base in productivity improvement issues.

11.	Business interruption

12.	Reports

Reports:

GEHC will provide Supplier within [*] of the close of each [*] period a report of the total quantity of the Recombinant Products purchased by GEHC from all suppliers during the period.

13.	Performance goals

The purpose of the performance goals are primarily for the Supplier to plan the operations at the Supplier’s site and take preventive initiatives so that the set performance goals con be achieved. The results of the Supplier’s performance in below areas should be a port of the business reviews between the two Parties. While the performance goals are targets and non-achievement of such goals shall not be considered as material breach of contract the Supplier agrees to use all commercially reasonable efforts to achieve the performance goals.

Performance goals – as per GEHC:

Deliveries within Specification, agreed lead times and quantities; performance goal is [*] according to the terms in Attachment C

Number of complaint reports sent to the Supplier by GEHC; performance goal is [*]

Business contingency plan audits and GEHC quality audits performed and with the result approved; performance goal is [*]

14.	Business reviews .

The Parties shall preferably meet face to face and perform quality business reviews [*] with focus on quality, delivery, joint cost savings projects, change requests, forecasts.

The agenda for the [*] business review meetings should cover:

Performance goals – as per GEHC

ii.

Forecast/Commitment

iii.

Purchase commitment, both Parties

iv.

Status on change requests and joint savings projects

Any other businesses

15.

Audit

16.	Supply of GEHC products for the manufacture of Products

During the term of this agreement the Supplier shall have the right to purchase the following products from GEHC at prices stipulated in Attachment C:

Delivery conditions: CIP Lead time: Delivery lead times if Purchase Orders are placed in accordance to lead time schedule in Attachment J Credit term: [*] days from date of invoice

Order handling: all order shall be submitted to [*] and copy to the Contract Managers, together with a declaration of the intended use for the Products.

The sale of the goods to the Supplier shall be subject to GEHC Conditions of Sale and the terms herein.

The products ordered in accordance with this Section may only be used in the manufacture of the Products for delivery to GEHC or products produced by Supplier under license to third party.

17.	Cell banks

The biological starting material used in the fermentation process originates from the cell banks are kept and owned by GEHC. Such material may only be used in connection with the manufacture of the Products and shall be returned to GEHC, alternatively destroyed upon termination of this agreement for whatever reason, unless otherwise agreed by the parties in writing. Supplier shall not disclose or provide such material to any third parties, unless GEHC has given its prior written consent thereto. The Supplier agrees not to sequence, extract or in any other way use the plasmid, the chromosome or any of the DNA codes present in the cell banks.

The Supplier may order starting material at no cost of Supplier according to the following conditions:

Lead time: [*] days, unless otherwise agreed.

Orders: written orders in accordance with form provided by GEHC specifying product, campaign, numbers of vials and requested delivery date. The order will be sent to:

GE Healthcare Bio-Sciences AB

Att: [*]

BL3-2

Björkgatan 30

751 84 UPPSALA

Sweden

tel: [*]

fax: [*]

GEHC will confirm order without delay and provide a notice two weeks before the estimated delivery date.

Supplier shall confirm receipt of the cell bank.

Transportation: GEHC will coordinate with the Supplier to ensure appropriate delivery time and arrangements for the cell banks and will arrange and pay for transportation.

Documentation: The cell banks will be accompanied by a Certificate of Analysis in accordance with the documents listed in Attachment F.

The Supplier shall provide GEHC at the beginning of every [*] a report of the total quantity of seed stock for each of the Products as well as the planned consumption of the seed stock for the following [*] ( [*] ) months. GEHC shall use this information for their internal planning purposes.

Attachment E – General Terms and Conditions

ORDER AND SUPPLY

1.	Purchase Orders

1.1

Purchase Order Contents . GEHC shall issue purchase orders to the Supplier stating the quantity and delivery date for Products (a “ Purchase Order ”) in accordance with the agreed Forecast. The Purchase Orders shall be written and sent through an electronic purchasing system or by fax, e-mail or other agreed method.

1.2

2.	Transportation; Title and Risk of Loss

2.1	Unless otherwise agreed, Products shall be delivered according to the Incoterms set out in Attachment C

2.2	If the delivery term agreed in Products and Prices in Attachment C or Purchase Order, if any, is an Incoterm such term of delivery shall be construed according to the edition of Incoterms in force at the Effective Date.

3.	Delivery

The Supplier shall deliver the Products on the date and in quantity set forth in the Purchase Order. The Supplier may only deliver prior to the agreed delivery date with the written consent of GEHC. Deliveries shall not be regarded as completed until the Delivery Documentation stated in Attachment D has been provided.

3.2.

The lead time as specified in Attachment C for the Product shall count from the date of issue of the Purchase Order to receipt of the Products at GEHC premises, including receipt of any agreed documentation, provided that such Purchase Orders are within the Forecast. Orders exceeding the Forecast are dealt with by the Parties in accordance with Exhibit D, Section 6c).

3.3

Supplier shall inform GEHC immediately of any reasonably expected delays. Such information shall be in writing and state the cause of the expected delay and when delivery con be expected. In such cases it is Supplier’s duty to take all reasonable steps to minimise the expected delay. GEHC shall grant Supplier an appropriate extension of delivery dates if any delay in delivery is attributable to GEHC’s failure to deliver any necessary technical documents, materials, information to be supplied by GEHC under this Agreement or by reason of GEHC’s instructions or lock of instructions or for any other reason attributable to GEHC or any third parties for which GEHC is responsible.

3.4

GEHC and Supplier hereby agree that upon Supplier’s delay of delivery of any of the Products the following shall apply: If delivery of Products according to a specific order position has not beer, completed as per the last agreed delivery date for that order position then Supplier shall use best commercial efforts to manufacture and deliver the delayed Products as soon as practically possible. For any such delayed part of the Products. GEHC shall be granted a discount of [*] percent ( [*] %) of the agreed purchase price for any part of the order position that is delivered after the last agreed delivery date.

3.5

If Supplier is delayed with [*] ( [*] ) weeks or more counting from the last agreed delivery date, then GEHC shall have the right to cancel the order position concerned or the delayed part thereof with immediate effect provided such cancellation is made not later than [*] ( [*] ) business days after the expiration of the [*] ( [*] ) week period.

3.6

Supplier shall not be responsible for any delay (i) caused by force majeure, (ii) caused by Supplier’s carriers if outside the control of Supplier, (iii) caused by or attributable to GEHC or its carriers or subcontractors, (iv) not attributable to Supplier in connection with applying for, obtaining or presenting the relevant export licenses, or other certificates to be prepared by Supplier according to the terms of this Agreement, or (v) caused by delay of or defects in chromatographic products delivered to Supplier By GEHC.

3.7	The remedies of this Section 3 in relation to delay in delivery caused by Supplier shall be GEHC’s sole remedy in the event of delay, except from the termination rights according to Section 16 below and/or indemnification rights due to the gross negligence or wilful misconduct of Supplier.

4.	Inspection Period

All Products delivered to GEHC by the Supplier must meet the terms and conditions of this Agreement and the related Purchase Order, All Products shall be received subject to GEHC’s acceptance or rejection on or before the end of the Inspection Period. GEHC may reject an entire-order based upon a reasonable sampling of Products. “Inspection Period” means [*] ( [*] ) business days. Partial or total payment by GEHC for Products under this Agreement prior to the end of the Inspection Period shall not constitute its acceptance thereof, nor shall such payment remove the Supplier’s responsibility for any non-conforming items.

The Supplier acknowledges that GEHC’s inspection of the goods may be based on the review of the Certificate of Analysis issued by the Supplier and that GEHC shall not he prevented from raising any claims under the warranty in clause 11 after the expiration of the Inspection Period.

5.	Safety Stock

Supplier shall maintain at its’ own cost and risk the safety stock agreed as set forth in Attachment C. The safety stock shall be managed in accordance with first in - first out principle.

6.	Changes to Products

6.1.

GEHC Proposed Changes . GEHC may propose changes to the Specification or the manufacturing method for the Products by submitting the proposed changes to the Supplier in writing. The Supplier agrees to use all commercially reasonable efforts to accommodate any such proposals of GEHC and shall respond in writing to GEHC within [*] ( [*] ) business days after receipt of such changes with the following information, as applicable: (a) time required to implement proposed changes; (b) impact of proposed changes on pricing of Product; and (c) impact of proposed changes on the lead time of the Product. If the Parties agree on the changes to the Specification they shall amend this Agreement accordingly. If the Parties fail to agree on the amendments to be made to the Agreement to reflect the changes to the Specification the terms in effect prior to commencement of the negotiations shall remain in full farce and effect and the Supplier shall continue to supply the Product to the existing Specification, but GEHC may in such event terminate the Agreement with regard to such Products with at least 6 months notice.

6.2.

Supplier’s Proposed Changes. The Supplier may propose, a change to the Specifications (including, but not limited to, changes which may affect quality, form, fit, function, reliability, regulatory compliance, safety or interface capability with GEHC products) or a change in its manufacturing and or quality control methods (including, but not limited to changes of sources of materials, changes in manufacturing processes or locations, changes in manufacturing formula, specifications, analytical methods] but the Supplier shall not implement such change without the prior written consent of GEHC, which, shall, not be unreasonably withheld. GEHC agrees to respond within [*] ( [*] ) business days from receipt of notification The Supplier shall make such proposals in writing explaining the reason for the changes and providing reasonable detail sufficient for GEHC to evaluate the proposal. GEHC agrees to use all commercially reasonable efforts to accommodate any such proposals. Upon request of GEHC, the Supplier shall provide samples of the Products manufactured according to the proposed new specification or manufacturing method or quality control method for evaluation purposes. Once the change has

been approved by GEHC the Supplier shall update the Production Documents accordingly and shall promptly send updated versions to GEHC.

6.3.	The Parties shall agree on a format for notice of proposed changes.

7.	Packaging and marking

8.	Health and Safety

8.1.

The Supplier shall use all reasonable efforts to ensure that all information held by or reasonably available to it regarding any changes occurring after the Effective Date with regard to potential hazards known or believed to exist in the transport, handling, or use of any Products and/or performance of any services shall be received by GEHC in writing prior to delivery of the Products and/or performance of the services.

8.2.	Employees, agents and representatives of the Supplier visiting any of GEHC’s sites shall be subject to such safety and security regulations as may be in force on that site.

9.	Business Contingency Planning

9.1.

Business Contingency Plan . Upon GEHC’s request, the Supplier shall provide to GEHC a summary of Suppliers Business Contingency Plan that outlines the Supplier’s internal contingency arrangements to support GEHC continuity of supply if the Supplier or any of the Supplier’s suppliers are unable to provide Products or components to such Products to GEHC.

9.2.	GEHC shall have the right to carry out audits of the Supplier’s Business Contingency Plan on a regular *[] basis with []* ( *[]** ) days prior notice. Each Party shall bear its own costs during such audits.

10.

Compliance

10.1.

10.2.

support to GEHC as described above and in Section 10.3 - 10.7 below. If such services should go beyond what the Supplier finds reasonable then the Supplier may charge GEHC a reasonable fee for such services provided the Parties agree to it before such services has been conducted.

10.3.

Regulatory Approvals and other Governmental Registrations . GEHC shall be solely responsible for identifying, obtaining, and maintaining at its sole cost and expense all applicable clearances and approvals and approvals that are required for the development, manufacture, or sale of any end products incorporating the Products. The Supplier shall provide GEHC with reasonable support and assistance in obtaining any such approvals, which may include providing test reports and data necessary to meet the country specific regulatory requirements.

10.4.

Regulatory Agency Inquiries . If any other regulatory body with authority over the end products to which the Products form part, provides written notice to the Supplier to inquire about or investigate any Product or conduct any audit or inspection of facilities used for the manufacture, storage or distribution of Products or request any information related to the manufacture of any Product, the Supplier shall give notice thereof to GEHC within one working day of receipt of such contact from the regulatory body.

10.5.

Security Measures . The Supplier agrees that it, if relevant, will adopt industry standard security measures which are consistent with accepted programs including the US Customs-Trade Partnership Against Terrorism (“C-TPAT”), the European Union’s Authorized Economic Operator program and other similar programs where applicable.

10.6.

Export Restrictions . If any Products are subject to export restrictions in the country of manufacture or shipment GEHC shall be solely responsible for any such requirements in connection with the export of the Products. The Supplier shall, if requested by GEHC, support GEHC with information required to establish ECCN and ECN numbers and to obtain export licenses or other certificates or to establish value of US components.

10.7.

Country of Origin . In accordance with GEHC’s request, if required for the sole of Products to GEHC hereunder, the Supplier will mark each Product, and, as appropriate. Product packaging, labels, or invoices with the country of origin for the Product, in accordance with the applicable trade and customs laws. The Supplier will also at the request from GEHC provide reasonable and auditable documentation that establishes the country of origin for a Product and including the raw materials used to manufacture such Product for the whole supply chain, including without limitation, certifications of

origin for Products qualifying for NAFTA or EEA preferential duty provisions, as applicable.

10.8.

Personal Data Protection . With regard to personal data received from GEHC, the Supplier agrees (i) not to use it other than for its intended purpose, (ii) not to disclose it to any third parties, and (iii) not to transfer it to any countries outside the European Union, unless GEHC has given its prior written consent thereto. The Supplier shall use appropriate measures to ensure security and confidentiality of GEHC personal data. Supplier shall notify GEHC in the most expedient time possible and without unreasonable delay of any Security Breach involving any GEHC personal data where “Security Breach” is defined as any event involving an actual, potential or threatened compromise of the security, confidentiality or integrity of the data , including but not limited to any unauthorized access or use. GEHC shall have the right to use personal data received from the Supplier in conformity with applicable data protection laws. Upon termination of this Agreement, for whatsoever reason. Supplier shall stop the Processing of GEHC Personal, unless otherwise agreed by GEHC, and these undertakings shall remain in force until such time as Supplier no longer possesses GEHC Personal Data. For the purpose of this provision the definition of “personal data” is that provided in EU Directive 95/46/EC.

WARRANTY, INDEMNIFICATION AND LIABILITY

11.

Warranty

11.1.

Product Warranty . The Supplier represents and warrants that the Products will:

conform strictly to and be manufactured in accordance with the Specifications referred to in Attachment C and the Production Document:

be free from defects in material and workmanship, whether latent or otherwise.

Supplier does not warrant, represent or in any way undertake any warranties of merchantability or fitness for a particular purpose of any Products.

11.2.

Supplier Intellectual Property Warranty . The Supplier represents and warrants as follows: (i) it owns or has the right to use all of its own Process-Related Technology existing as of the Effective Date that it will use to manufacture the Products and to sell the Products to GEHC; and (ii) neither the Supplier’s equipment nor any of its Process-Related Technology used to manufacture the Products infringes or is alleged to infringe any patent or other proprietary right of any other person.

11.3.

GEHC Intellectual Property Warranty . GEHC represents and warrants as follows: (i) GEHC owns or has the right to use and license to Supplier all of its own Product-Related Technology and/or its own Process-Related Technology; and (ii) the Product-Related

Technology and/or Process-Related Technology that it owns or controls does not infringe and is not alleged to infringe any patent or other proprietary right of any other person in connection with manufacture, use or sale of the Products by GEHC and its direct or indirect customers.

11.4.

Execution and Performance of Agreement . The Supplier represents and warrants that it has the full right, power, and authority to enter into and perform its obligations under this Agreement.

11.5.

Survival of Warranties . The Supplier agrees that (i) the warranties set forth in this section shall survive the inspection, acceptance, and use of the Products by GEHC, its distributors and sub-distributors for a period of the shorter of either [*] ( [*] ) months from completion of delivery of the Purchase Order or the shelf life as specified in Attachment C (“Warranty Period”) and (ii) are in addition to any warranties and remedies to which the Supplier may otherwise agree in writing or which are mandatory by statutory law. The Supplier agrees to extend to GEHC any warranties received from the Supplier’s suppliers. The Supplier warrants Products only as set forth in this Agreement and disclaims all other warranties.

11.6.

Returns . GEHC may return to the Supplier any Product that does not conform to the representations and warranties. Any such Product shall be returned to the Supplier and then once replaced returned to GEHC at Supplier’s expense (including all transportation and insurance). The Supplier will, at its cost, and as soon as reasonably practicable replace the returned Product to bring the Product in conformance with the warranty, and will return the replacement Product as soon as possible, but in any event within thirty (30) days, after receipt of the non-conforming or defective Product. If the Supplier is unable to return the Product within thirty (30) days, the Supplier shall at GEHC’s request provide GEHC a refund as defined in section 11.8 below. In the event of GEHC accepts the refund, this shall be GEHC’s sole remedy with regards to such return.

11.7.

Complaints . Any complaint shall be regarded as having been timely lodged if GEHC notifies the Supplier of the fault at any time during the warranty period. Within [*] weeks after any complaint lodged by GEHC concerning a defective Product the Supplier shall make a reasonably detailed report to GEHC including a root cause analysis and the corrective and preventive action that has been initiated according to the Suppliers standard operating procedure, if warranted by investigation findings.

11.8.

Credits/Refunds . In accordance with this Section 11, the Supplier shall refund GEHC by wire transfer or check for any payment GEHC made with respect to such Product GEHC may elect, at its sole discretion, to take such credit on

any open invoices of the Supplier in the place of such refund.

11.9.

Recalls and Field Corrections . If any recall, product withdrawal or field correction of any end product incorporating the Products is required by a governmental agency or by GEHC for safety or efficacy reasons resulting from the supply by the Supplier of any Product not complying with the warranties included in the Agreement then the Supplier shall bear all costs and expenses, including but not limited to the costs and expenses related to such recall or field correction, communications and meetings with all required regulatory agencies, replacement stock, service labor, installation, travel, notifying customers of such recall and any replacement product to be delivered to those same customers, including shipping costs. To the extent that any such recall or field correction is due in part to the negligent or intentional acts or omissions of GEHC, GEHC shall be responsible for such costs and expenses equitably in proportion to its fault.

11.10.

Testing . In the case of disagreement between the Parties concerning the quality of Products delivered and such disagreement relates to the provisions in this Section 11, a sample shall be submitted to an independent laboratory to be agreed upon by the Parties and the report from such laboratory shall finally settle whether or not the delivery has met the specification or not. The cost for the laboratory shall be borne by the failing party.

11.11.

The Parties agree that the product warranty in Section 11.1 shall not apply with regard to Lego Products. Instead the Supplier represents and warrants that the Lego Product has been subject to the preliminary testing specified in Exhibit H and that the results from such test, nor any other circumstances during the manufacture give reason to believe that the Lego Product may not comply with the Specifications. Any complaints concerning Lego Products shall be submitted not later than ninety (90) days after receipt of Certificate of Analysis. In the event of defective Lego Product, which have been used in the production of GEHC prior to receipt of the Certificate of Analysis, the Supplier agrees to compensate GEHC for direct damage and loss, such as loss of contaminated production batches or cleaning costs, up to a total amount of seven and a half million Swedish kroner (7.500.000 SEK] per calendar year. However, the Supplier shall not be liable to the extent it can verify that the Lego Products have been manufactured strictly in accordance with the manufacturing methods described in Exhibit H and that no preliminary test or any other circumstances have given reason to believe that the Lego Product might be defective.

12.

Indemnification

12.1.

Supplier Indemnity . Subject to Section 14 below, the Supplier agrees to defend, indemnify, protect, and hold harmless GEHC and GEHC’s Affiliates, employees, agents, servants, and representatives from and against any and all claims, damages, losses, liabilities, and expenses of whatever nature, arising out of or relating to: (i) the breach by the Supplier of any material term of this Agreement or (ii) any negligent act or omission, or willful misconduct of the Supplier or its agents, employees, or subcontractors. GEHC shall notify the Supplier of any such claim, suit, or proceeding, and Supplier will assist (at the Supplier’s expense) in the defense of the same.

12.2.

GEHC Indemnity . Subject to Section 14 below, GEHC agrees to defend, indemnify, protect, and hold harmless the Supplier and its Affiliates, employees, agents, servants, and representatives from and against any and all claims, damages, losses, liabilities, and expenses of whatever nature, arising out of or relating to: (i) the breach by GEHC of any material term of this Agreement; (ii) any and all damages, losses, costs and expenses (including, without limitation, reasonable attorney’s fees) arising out of or from any and all successful claims, suits, actions or proceedings for bodily injury, death or property damage or any other injury or damage of any kind whatsoever arising out of GEHC’s or its direct or indirect customers’ promotion, distribution, sale or the use of any of the Products, unless such injury or damage is ascribable to Supplier hereunder; or any negligent act or omission, or willful misconduct of GEHC or its agents, employees, or subcontractors. Supplier shall notify GEHC of any such claim, suit, or proceeding, and GEHC will assist (at GEHC expense) in the defense of the same.

12.3.

Intellectual Property Indemnity . Each party agrees to defend, indemnify, protect, and hold harmless the other Party and its affiliates, employees, agents, servants, and representatives from and against any and all claims, damages, losses, liabilities, and expenses of whatever nature, resulting from a breach of its warranties made in Section 11.2 respectively 11.3. If a party has reason to believe that (i) the use of any its Process-Related Technology is enjoined by a court, it will first use best efforts to either procure the necessary licenses to continue manufacturing under the relevant Process-Related Technology or adjust the manufacturing process at its sole- cost to avoid infringing such third party’s intellectual property (provided that such an adjustment can be made without otherwise breaching the Agreement and (ii) if after using best efforts, the first two options are not commercially reasonable, the other party may terminate the Agreement immediately and be entitled to

prompt reimbursement of unavoidable costs

(hereunder unsold Products) incurred until such termination.

CONFIDENTIALITY AND GE PROPERTY

13.

Confidentiality

13.1.

During the Term of this Agreement and the supply agreements preceding this Agreement, each Party (the “Recipient”) may have received or will receive or have access to certain information of the other Party (the “Discloser”) that is Confidential Information of the Discloser. For purposes of this Agreement, “Confidential Information” shall mean any information disclosed by the Discloser to the Recipient, whether technology-related or business-related, whether furnished before or after the Effective Date and irrespective of the form of communication. All written information must be clearly marked using words such as “confidential” or “proprietary” in order to be treated as Confidential Information, unless of apparent confidential nature. The Recipient will protect the Confidential Information with the same degree of care as the Recipient uses for its own similar information, but no less than a reasonable degree of care. Confidential Information may only be used by those employees, contractors and advisors of the Recipient and its affiliates (“Representatives”) who have a need to know such information for the purposes related to this Agreement and who are bound by equivalent confidentiality obligations, and the Recipient shall inform such Representatives of the confidential nature of such Confidential Information and the obligations of the Recipient hereunder. The Recipient shall be responsible for any breach of this Agreement by it or any Representative to the same extent as though such Representatives were Parties hereto. The Parties acknowledge that trade secrets are deemed Confidential Information to be protected indefinitely. The Parties also agree that all other information, including but not limited to technical information (which is not intellectual property rights) and forecasts disclosed during the Term or prior to the formation of this Agreement are deemed Confidential information to be protected during the term and for a period of [*] ( [*] ) years thereafter.

13.2.

Exclusions . The undertakings in clause 13.1 shall not apply to information which:

(a)

is publicly available through no fault of the Recipient;

(b)

the Recipient can show by reasonable written record was in his possession at the time of disclosure and which was not acquired directly or indirectly from the Discloser;

(c)

is rightfully received from a third party with no duty of confidentiality;

(d)

has been developed by the Recipient independently of the Confidential Information received from the Discloser; or

(e)

13.3.

Return of Confidential Information . All Confidential Information supplied to or acquired by each Party and all copies thereof shall be returned to the other Party within [*] ( [*] ) days after termination of this Agreement. All information consisting of documents, notes and other writings prepared by one Party based on non-public data of the other Party shall be destroyed except for one copy of the Information to be kept in the Recipient’s legal files.

13.4.

Development . The confidentiality terms in this Clause shall not be construed to limit GEHC’s or Suppliers right to independently develop or acquire products without use of the other Parties Confidential information.

13.5.

Restrictions on Use of Design Materials and Know How . During and after the Term the Supplier, unless subject to written agreement between the Parties hereto, shall be prohibited from selling to any third party any Product or equivalent product that is either (i) developed for GEHC under this Agreement; (ii) incorporates any GEHC Confidential Information; or (iii) is specifically designed or configured for use with GEHC’s products using information received or know how developed in connection with this Agreement.

13.6.

14.

Indirect Loss

In no event shall either Party hereto be liable for any indirect or consequential loss or damage whatsoever in connection with this Agreement.

15.

Technology

15.1.

Definitions .

(a)

(b)

“Product-Related Technology” means any Technology owned at any time during the Term (whether owned as of the Effective

Date or thereafter acquired or developed) by either of the ponies that is related directly and solely to the structure of the Products.

(c)

15.2.

Licenses .

(a)

During the Term and only for the purpose of fulfilling its duties and obligations under the Agreement, GEHC hereby grants to the Supplier a royalty-free and nonexclusive right and license to use any Product- Related Technology or Process-Related Technology owned by GEHC that is necessary or useful to the Supplier for manufacture of the Products. Supplier acknowledges and agrees that no other use shall be mode by the Supplier, its affiliates or authorized contractors of the GEHC Technology without the express written authorization of GEHC.

(b)

After the Term, the Supplier, agrees not to assert any claims whatsoever, whether directly or via its Affiliates, against GEHC, its Affiliates, distributors, customers and contract manufacturers with regard to their possible use of any Process-Related Technology owned by the Supplier that is necessary to GEHC for the manufacture, either directly or through a third party manufacturer, sale, distribution, and use of the Products.

15.3.

Ownership of Technology .

(a)

GEHC Property . All tools, dies, drawings, plans, manufacturing aids, testing or other equipment or materials, and all intellectual property rights in the foregoing, which GEHC furnishes to the Supplier, or which is developed or acquired at GEHC’s expense or at its direction in the performance of work hereunder, shall be GEHC’s property (the “GEHC Property”). The Supplier hereby assigns and agrees to assign to GEHC, all such property. All such GEHC Property shall be safely maintained separate from the Supplier’s property, and marked “Property of General Electric Company.” The Supplier agrees not to substitute any property for GEHC Property and not to use such property except for performance of work hereunder or as authorized in writing by GEHC. The Supplier shall use GEHC Property with all due care, but is held at GEHC’s own risk, and subject to removal by GEHC at its written request.

(b)

GEHC Technology . Including, but not limited to such GEHC Technology listed in Attachment F and G, all GEHC Technology (i) that is provided to the Supplier by and/or on behalf of GEHC or that is used by the

Supplier with respect to the performance of its obligations hereunder and (ii) that was owned by GEHC prior to being provided to the Supplier shall be and remain the property of GEHC. The Supplier shall acquire no right, title or interest in the GEHC Technology as a result of its performance of its obligations hereunder. At GEHC’s request or upon termination or expiration of the Agreement for any reason, the Supplier shall return to GEHC any and all copies of GEHC Technology and remove all copies of such GEHC Technology from the computers and computer networks of the Supplier, save for one copy which may be retained for the purpose of monitoring the Supplier’s compliance with this provision.

(c)

Supplier Technology . All Supplier Technology that is (i) provided to GEHC by and/or on behalf of the Supplier or that is used by the Supplier with respect to the performance of its obligations under the Agreement or (ii) owned by the Supplier prior to the performance of any of its obligations under the Agreement or acquired by the Supplier thereafter shall remain the property of the Supplier. GEHC shall acquire no right, title or interest in any such existing Supplier Technology as a result of the Suppliers performance of its obligations hereunder, except as expressly stated in this Agreement.

(d)

Newly Created Works . All Technology, that is either Product-Related Technology or Process-Related Technology, developed by the Supplier specifically for the Supplier’s manufacture and supply of the Products or otherwise derived from GEHC Technology (collectively, the “Works”) shall also be deemed GEHC Technology and solely owned by GEHC. Such Works shall be considered “works mode for hire” pursuant to the Copyright Act of 1976, as amended, and all intellectual property rights in and to such Works, including any copyright, trade secret and patent rights, shall be solely and exclusively owned by GEHC. The Supplier shall disclose to GEHC in a timely manner any and all Works, and such disclosures by the Supplier shall include a reasonably detailed written description of such Works. To the extent that all applicable intellectual property rights in the Works are not deemed “works made for hire” and transferred and assigned to GEHC by operation of law, the Supplier hereby does and will transfer and assign, and cause its employees and agents to transfer and assign, now and in the future, all right, title and interest in the Works to GEHC. GEHC may transfer such Works to any third party or use the Works for any purpose without further payment to the

Supplier. In the event GEHC decides to file one or more potent applications covering any such Works, the Supplier shall at GEHC’s request and expense assist GEHC in the preparation and prosecution of such patent application(s) and shall execute all documents (and cause its employees or agents to execute all documents) deemed necessary by GEHC for the filing thereof and/or the vesting in GEHC of all title thereto. Such Works shall be deemed GEHC Confidential information under the Agreement.

15.4.

No Rights . The Supplier shall acquire no right, title or interest in any of the trademarks, patents, trade secrets, service marks or copyrights belonging to GEHC. No rights are granted to the Supplier under any GEHC patents, copyrights, trade secrets, or other property rights except as may be expressly agreed to by GEHC in writing. The Supplier shall not use or incorporate into Products any intellectual property of others without their prior written permission.

15.5.

Removal of Marks . The Supplier agrees not to sell, transfer, distribute or otherwise convey any part, component, Product or service bearing or incorporating any GEHC trademark, trade name or service mark, part numbers or other identifiers, including any GEHC packaging, copyrights or code (“GEHC Marks”), to any party other thon to GEHC or any affiliate of GEHC. The Supplier shall not have the right to sell rejected, returned or unpurchased Products to any third parties. The Supplier will defend and indemnify GEHC against any claims, losses, liabilities, costs or expenses that GEHC may incur as a result of the Supplier’s breach of this obligation.

15.6.

Co-operation . The Supplier shall reasonably cooperate with GEHC to secure any intellectual property rights developed under this Agreement by, for example, assisting in the filing and prosecution of patent applications, and executing such documents as GEHC may reasonably request at GE expense.

15.7.

Survival . The obligations under this Clause shall survive the termination of this Agreement.

TERMINATION

16.

Termination

16.1.

This Agreement shall commence on the Effective Date and, subject as hereinafter provided, shall continue in effect until 31 December 2016. Notwithstanding the aforementioned, either party hereto may unilaterally terminate this Agreement, subject to two (2) years prior written notice. 16.2 This Agreement may further be terminated under the following conditions:

Either Party may terminate this Agreement at any time by a notice in writing if the other Party materially defaults in the performance of one or more of its obligations hereunder,

provided that the Agreement shall not be so terminated if the Party in default has cured the default within sixty (60) days after the notice has been given. For the purpose of this provision a) default of payments of any undisputed amounts exceeding [*] Swedish kroner ( [*] SEK) and b) breach by the Supplier of any of the quality requirements in Attachment A shall be considered as a material default.

Either party may terminate this Agreement with immediate effect by a notice in writing if the other party shall file a petition in bankruptcy, or shall be adjudicated bankrupt, or shall take advantage of the insolvency law of any state or country, or shall make an assignment for the benefit of creditors, or shall have a receiver, trustee or other court officer appointed for its property.

16.2.

GEHC shall have the right to terminate the Agreement with not less than six (6) months written notice if the Supplier or any of its Affiliates markets or sells any chromatography media products. A chromatography media product means a product that without further processing can be used to separate macromolecules and cells. For avoidance of doubt, a protein ligand shall not be considered as a chromatography media unless immobilized on a bead or other surface.

16.3.

GEHC shall have the right to terminate the Agreement with not less than six months written notice if the control of the Supplier or its protein manufacturing operation is transferred outside of the Novozymes group of companies.

In case of delay with delivery(ies) or defective Products the below Section shall apply instead of the above Section:

16.4.

In the event:

delivery of Product is delayed with more than [*] ( [*] ) months, or

quality defects in Products, provided Supplier is liable for such defects cf. the Product warranties herein, which GEHC notified Supplier of in writing, have not been corrected within [*] ( [*] ) months.

material breach by the Supplier of the Supplier Integrity Statement in Attachment B provided such breach may reasonably cause reputational risks for GEHC

– GEHC has the right to terminate the Agreement with immediate effect.

17.

Notices

17.1.

All notices expressly required to be in writing (Legal notices) shall be, if required by either party, in English or at least accompanied by a translation into English, and shall be sufficiently served if delivered by hand (including by courier) or if sent by courier, special delivery, registered mail, or pre- paid air mail or by fax. In all cases notices shall be delivered to the respective

Parties at the addresses specified on the front page of this Agreement.

17.2.

A notice shall be deemed to have been received:

(a)

if delivered by hand, at the time of delivery;

(b)

in the case of special delivery or registered mail, two business days after the date of posting;

(c)

in the case of fax, upon completion of transmission.

17.3.

For the avoidance of doubt, notices under this Agreement may not be served by email, unless the Parties agree at the time of service.

18.

Miscellaneous

18.1.

Independent Contractor . The relationship of the Parties hereunder shall be that of independent contractors. Nothing in this Agreement shall be deemed to create a partnership, joint venture, or similar relationship between the Parties, and no Party shall be deemed to be an agent of the other Party.

18.2.

Subcontractors . None of the obligations to be performed by the Supplier under this Agreement shall be performed by any subcontractor or other third party unless such performance shall have been approved by GEHC in writing.

18.3.

Governing Law . This Agreement shall be governed by and construed in accordance with the laws of Sweden without giving effect to the conflict of law principles thereof. The United Notions Convention on Contracts for International Sales of Goods shall not apply to this Agreement.

18.4.

Arbitration . The Parties will attempt to resolve any dispute, controversy or claim relating to this Agreement through good faith negotiations within [*] ( [*] ) days, failing which the dispute shall be finally settled by arbitration in accordance with the Rules of the Arbitration Institute of the Stockholm Chamber of Commerce. The proceedings shall be held in the English language, if required by any of the Parties. The seat of the arbitration shall be Stockholm. The language of the arbitration shall be English, if requested by either Party. The cost of the arbitration will be shared equally by the Parties. The arbitrator will have the authority to apportion liability between the Parties, but will not have the authority to award any damages or remedies not available under the express terms of this Agreement. With regards to any action for breach of confidentiality or intellectual property obligations, nothing in this section shall preclude either party from seeking interim equitable relief but such request shall not be deemed a waiver of the obligation to arbitrate hereunder.

18.5.

Force Majeure .

(a)

(ii) was not foreseeable by such Party at the time this Agreement was entered into, and (iii) could not have been prevented by such Party taking reasonable steps. Such conditions shall include, but not be limited to, war mobilization, riots, fire, explosion, flood, insurrection, embargo, currency restriction, and acts or omissions of governments in their sovereign capacity.

(b)

(c)

In the event of any case of force majeure, the Party affected thereby shall take all reasonable measures to mitigate and minimize the effect of such case, and to resume as promptly as possible the diligent performance of its obligations under this Agreement, however GEHC shall be permitted during such time to acquire substitute or replacement items from one or more alternative sources. If the delay lasts more than thirty (30) days GEHC may terminate this Agreement and any applicable Purchase Orders.

(d)

18.6.

Assignment . This Agreement is personal to the Parties and no Party shall without the prior written consent of the other Party, assign this Agreement or any part of it Any such action shall be declared null and void. No Party shall sub-contract or delegate in any manner any or all of its obligations under this Agreement to a third party or agent without the other Party’s consent. Notwithstanding the foregoing, GEHC may assign its rights and obligations under this Agreement without the Supplier’s consent to an affiliate and in conjunction with the transfer of all or substantially all of its business or that part to which this Agreement relates. This Agreement shall be binding upon and shall inure to the benefit of the Parties hereto and their respective heirs, successors, and permitted assigns. The Supplier may not assign this Agreement to any third parties unless GEHC gives its written consent thereto in writing.

18.7.

Publicity . The Supplier shall not issue any press release or announcement with regard to this Agreement, nor use any of GEHC’s products or its name or trademarks in promotional activity, unless otherwise agreed.

18.8.

A mendment; Waiver; Survival . This Agreement may be modified only by a writing signed by both Parties. Any failure to enforce any provision of

this Agreement is not a waiver of that provision or of either Party’s right to later enforce each and every provision. The terms of this Agreement that by their nature are intended to survive its expiration will continue in full force and effect after its expiration,

18.9.

18.10.

Battle of Forms . This Agreement contains the entire agreement and understanding of the Parties and supersedes all prior agreements, understandings or arrangements (both oral and written) relating to the subject matter of this Agreement. For the avoidance of doubt, the Contract Manufacturing and Purchasing Agreement between the Parties effective September 1, 2005, as amended, is hereby terminated. Any Orders placed under this Agreement shall be solely governed by the terms and conditions of this Agreement. No general terms and conditions of either Party referred to in purchase orders, order confirmations or elsewhere shall apply, unless expressly agreed in writing.

18.11.

18.12.

Attachment F

GE Technology

Production know-how covering [*] with regard to rPA and ZätA protein, in particular as described in the following documentation.


Documentation – title		GEHC Doc No. (when applicable)

rPA
*[]**

ZätA
*[]**

For avoidance of doubt, the above is not an exhaustive list of GE Technology, but describes certain key elements of the manufacturing process and test methods relating to the Products.

Attachment G.

GE Technology

Production know-how covering [*] with regard to Native Product, in particular as described in the following documentation.


Documentation – title		Doc No
*[]**		·

For avoidance of doubt, the above is not an exhaustive list of GE Technology, but describes certain key elements of the manufacturing process and test methods relating to the Products.

Attachment H.

GE Technology

Production know-how covering [*] with regard to Lego Product, in particular as described in the following documentation.


Documentation – title		Doc No
*[]**

For avoidance of doubt, the above is not an exhaustive list of GE Technology, but describes certain key elements of the manufacturing process and test methods relating to the Products.

Attachment I

GEHC initial [*] rolling forecast starting from effective date

[*]

Zäta ([*])

[*]

nPA ([*])

[*]

rPA ([*])

[*]

Attachment J

Lead time schedule

[*]

Attachment K: Production Documents generated by the Supplier

The below listed documents represent the top documents in hierarchical document structure and will thus in itself reference to all relevant documents for the Supplier’s production of the respective Products.

The specific documents are:


NZ Doc No		Title
*[]**

Attachment L: TT Programs

rPA

1.	The Parties shall use their respective best efforts to complete the TT Programs without undue delay. The aim with the TT Programs is to transfer GEHC’s manufacturing know-how needed to manufacture the rPA.

2.	The TT Programs consists of the following main activities:

Transfer of analytical and production methods

Implementation, including validation of equipment and raw materials

Validation of process and finished product

Customer approval

On the effective date of this Agreement points 1. and 2. above have been completed, and points 3. and 4. are pending.

3.	Each party will bear its own costs as a general principle. GEHC will pay for any productive material (material validated for use in GEHC production of final products) according to the agreed prices herein.

4.	In case the process does not perform as expected the parties shall in good faith negotiate the cost for the further development needed.

5.	GEHC shall supply Supplier with full documentation of the process and analytical methods including existing validation reports, provided GEHC is allowed to disclose such documentation considering any third party confidentiality obligations.

6.	Approved product from the validation batches performed at Supplier shall be bought by GEHC according to the terms and conditions of this Agreement.

Zäta

1.	The Parties shall use their respective best efforts to complete the TT Programs without undue delay. The aim with the TT Programs is to transfer GEHC’s manufacturing know-how needed to manufacture the Zäta.

2.	The TT Programs consists of the following main activities:

Transfer of analytical and production methods

Implementation including validation of equipment and raw materials

Validation of process and finished product

Customer approval

On the effective date of this Agreement points 1. to 3. have been completed, and point 4. is pending.

3.	Each party will bear its own costs as a general principle. GEHC will pay for any productive material (material validated for use in GEHC production of final products) according to agreed prices herein.

4.	In case the process does not perform as expected the parties shall in good faith negotiate the cost for the development needed.

5.	GEHC shall supply Supplier with full documentation of the process and analytical methods including existing validation reports, provided GEHC is allowed to disclose such documentation considering any third party confidentiality obligations.

6.	Approved product from the validation batches performed at Supplier shall be bought by GEHC according to the terms and conditions of this agreement.

Amendment to Strategic Supply Alliance Agreement

This Amendment to the Agreement (as defined below) is made effective on October 27, 2011 (“Effective Date”), by and between,

1.	Novozymes Biopharma Sweden AB having its address at St Lars Väg 47, 220 09 Lund (the “Supplier”), and

2.	GE Healthcare Bio-Sciences AB having its address at Björkgatan 30, S-751 84 Uppsala, Sweden (“GEHC”).

Recitals

A.	The Parties have entered into a Strategic Supplier Alliance Agreement (the “Agreement”) effective July 7, 2011 concerning the supplies of certain protein ligands to GEHC.

The manufacturing and supply business of cell culture ingredients and protein A affinity ligands for use in industrial cell culture, stem and therapeutic cell culture and biopharmaceutical manufacturing (the “Business”) run by the Supplier and Novozymes Biopharma DK A/S, a company organized under the laws of Denmark and the sole stockholder of the Supplier (“Novozymes Parent”), is expected to be sold to an affiliate of Repligen Corporation, a corporation organized under the laws of the state of Delaware in the United States (“Repligen”), pursuant to a purchase agreement (the “Purchase Agreement”), entered into on or about the date hereof, by and among Novozymes Parent, Repligen and the other parties thereto (the sale of the Business referred to herein is defined as the “Transaction”).

C.	In connection with the Transaction, the Parties wish to have the Agreement amended in accordance with the provisions below.

Considering the above the Parties have entered into the following amendment to the Agreement (the “Amendment”).

Amendment

For purposes hereof and the Agreement, the term “Transaction” shall mean the sale of the manufacturing and supply business of cell culture ingredients and protein A affinity ligands for use in industrial cell culture, stem and therapeutic cell culture and biopharmaceutical manufacturing business run by Supplier and Novozymes Biopharma DK A/S, a company organized under the laws of Denmark and the sole stockholder of Supplier, to an affiliate of Repligen Corporation, a Delaware corporation (“Repligen”), pursuant to an agreement entered into by and among Novozymes Biopharma DK A/S, Repligen and the other parties thereto. Terms not otherwise defined in this Amendment shall have the meanings defined in the Agreement.

2.	Except as expressly amended herein, all terms and conditions of the Agreement shall remain in full force and effect.

3.	The Amendment shall be effective as from the Effective Date.

4.	Section 9 of Attachment E of the Agreement shall be amended to include a new Section 9.3 as follows:

“If the Transaction is consummated, the Supplier and GEHC agree to each use commercially reasonable efforts to define Supplier’s internal contingency arrangements to support GEHC’s continuity of supply regarding both (a) Supplier and its main operating facility as of the date hereof located in Lund, Sweden (the “Lund Facility”) and (b) Repligen and its main operating facility as of the date hereof located in Waltham, Massachusetts, United States (the “Waltham Facility”) in order to meet GEHC’s customers’ requirements for documenting security of supply to the extent reasonably practicable. If the Transaction is consummated, the Supplier agrees to provide GEHC with a revised draft of such contingency arrangements for review. GEHC agrees to notify the Supplier in writing of any proposed revisions to such draft contingency arrangements within [*] ( [*] ) days of receipt, which proposed revisions shall thereafter be considered by Supplier, and mutually discussed by Supplier and GEHC, each acting reasonably, until promptly resolved; provided that if GEHC fails to deliver any such written notice of any proposed revisions to Supplier within [*] ( [*] ) days of receipt, then GEHC will be deemed to have accepted such contingency arrangements submitted by Supplier.”

5.	Section 9 of Attachment E of the Agreement shall be amended to include a new Section 9.4 as follows:

“Until such year as GEHC and its Affiliates purchase from Supplier hereunder and from Repligen, in the aggregate, less than [*] % of the total combined volume of all Recombinant Products Zata and rPA purchased by GEHC and its Affiliates worldwide, the Supplier hereby covenants that [*] percent ( [*] %) [*] of the total combined volume of Recombinant Products Zata and rPA manufactured at the Lund Facility and the Waltham Facility shall be manufactured at the Lund Facility.”

6.	The first paragraph of Section 16.1 of Attachment E of the Agreement shall be amended and restated in its entirety as follows:

“This Agreement shall commence on the Effective Date and, subject as hereinafter provided, shall continue in effect until December 31, 2016. Notwithstanding the aforementioned, [*] upon [*] ( [*] ) year prior written notice to Supplier, provided that GEHC may not issue such notice [*] until after 31 December 2013.”

7.	Section 16.2 of Attachment E of the Agreement shall be amended and restated in its entirety as follows:

notice of its intent to terminate the Agreement and should the Supplier provide reasonable explanation of compliance or stop selling or marketing such product during the thirty day period, as certified by the Supplier to GEHC in writing, then GEHC shall not have the right to terminate the Agreement referring to such circumstances.”

8.	Subject to and contingent upon the consummation of the Transaction, all references to the “Novozymes group of companies” shall be amended to refer to the “Repligen Corporation group of companies (which includes, for the avoidance of doubt, Repligen Corporation and its wholly owned subsidiaries).

9.	GEHC agrees to waive all rights to terminate the Agreement under Section 16.3 of Attachment E of the Agreement with respect to the Transaction.

10.

Effect of Amendment . In the event that the Transaction is not consummated by December 31, 2011, GEHC and Supplier shall each have the right to terminate unilaterally this Amendment by giving the other party hereto written notice no later than fifteen (15) days following such date and, if such notice is delivered, this Amendment and the changes to the Agreement contemplated hereby shall be of no force or effect. The parties hereto agree that except as otherwise set forth herein, all terms of the Agreement shall remain in full force and effect. In the event of any inconsistency or conflict between the Agreement and this Amendment, the terms, conditions and provisions of this Amendment shall govern and control.

11.

Entire Agreement . This Amendment and the Agreement, including the Attachments, exhibits, schedules and other documents referred to therein which form a part thereof, contain the entire understanding of the parties hereto with respect to the subject matter contained herein and therein. Except as provided herein, from and after the execution of a counterpart hereof by the parties hereto, any reference to the Agreement shall be deemed to be a reference to the Agreement as amended hereby.

12.

Governing Law . This Amendment and any disputes hereunder shall be governed by and construed in accordance with the laws of Sweden without giving effect to the conflict of law principles thereof. The United Nations Convention on Contracts for International Sales of Goods shall not apply to this Amendment.

13.

Counterparts . This Amendment may be executed in any number of counterparts and any party hereto may execute any such counterpart, each of which when executed and delivered shall be deemed to be an original and all of which counterparts taken together shall constitute but one and the same instrument. Any signature page delivered by a facsimile machine shall be binding to the same extent as an original signature page with regard to any agreement subject to the terms hereof or any amendment thereto.

[SIGNATURE PAGES FOLLOW]

This Amendment has been executed in two originals whereof the Parties have taken one each.


NOVOZYMES BIOPHARMA SWEDEN AB		GE HEALTHCARE BIO-SCIENCES AB

By:	/s/ Thomas S. Batchelor	By:	/s/ Magnus Lundgren

Name:	Thomas S. Batchelor	Name:	Magnus Lundgren

Title:	Director, M&A	Title:	Global Sourcing Exeuctive

Date:	27 October, 2011	Date:	27 October, 2011

By:	/s/ Niels Münter

Name:	Niels Münter

Title:	Legal Counsel

Temporary Terms 2013 (The “2013 Amendment”)

The following temporary terms shall apply for the Products rPA and Zäta, during the, period 21 ^th of February 2013 up to 31 ^st of December 31 ^st 2013 (the “ Period ”) purchased and delivered from the 2 sites Lund and Waltham and accordingly amending the Attachment C in the SSAA between Repligen Corporation and GE Healthcare Bio-Sciences AB, dated 2010-01 01, (the “ Repligen Agreement ”) and the Attachment C in the SSAA between Repligen Sweden AB (formerly known as Novozymes Biopharma Sweden AB) and GE Healthcare Bio-Sciences AB, dated 2011-07 07, (the “ Novozymes Agreement ”).

1.	Prerequisites: Volume requirements per Product and site including fixed prices for the Products purchased and delivered during the Period as follows:


		Total spend
[***] Zäta delivered from Waltham @[***]		[*****]
[***] Zäta delivered from Lund@[***]		[*****]

		Total Zäta [*****]

[***] rPA delivered from Lund @[***]		[*****]
[***] rPA delivered from Waltham@[***]		[*****]

		Total rPA[*****]

		Total rPA and Zäta: [*****]

2.	For total combined volumes of Zäta during the Period that is outside the range [*****] the following mechanisms shall apply for the prices:

For total combined purchases of such quantities exceeding [*****]:


	Discounts
Volume exceeding [*****] Zäta	Buy&Pay site Waltham	Buy&Pay site Lund
[*****]	[*****]	[*****]
[*****]	[*****]	[*****]
[*****]	[*****]	[*****]
[*****]	[*****]	[*****]

For the avoidance of doubt the discounts in the table above do not apply retroactively and only apply to the amounts exceeding [*****] Increments.

For total combined purchases if such combined purchases fall below [*****]:

GEHC shall pay to Repligen the sum of [*****] for each shortfall of [*****] less than [*****], meaning that if GLTIC purchases only [*****] of Zäta in calendar year 2013; GEHC shall pay to Repligen the sum of [*****] as a “true-up” with any such payment to be made in 2013 or before [*****].

3.	For total combined volumes of rPA during the Period that is outside the range [*****], the following mechanisms shall apply for the prices:

For total combined purchases of such quantities exceeding [*****]:


	Discounts
Volume exceeding [*****] rPA	Buy&Pay site Waltham	Buy&Pay site Lund
[*****]	[*****]	[*****]
[*****]	[*****]	[*****]
[*****]	[*****]	[*****]
[*****]	[*****]	[*****]

For the avoidance of doubt the discounts in the table above do not apply retroactively and only apply to the amounts exceeding [*****] increments

For total combined purchases if such combined purchases fall below [*****]:

GEHC shall pay to Repligen the sum of [*****] for each shortfall of [*****] less than [*****], meaning that if GEHC purchases only [*****] of rPA in calendar year 2013; GEHC shall pay to Repligen the sum of [*****] as a “true-up” with any such payment to be made In 2013 or before [*****].

4.	As a basis for the price to be applied for 2011 for each of the Products the Parties revert to the Terms and Conditions in Repligen Agreement, including that the price ladders in the Repligen Agreement shall be applied using the below agreed cumulated [*****] purchases of Products.

Furthermore the volume referred to have been delivered from the Waltham site shall be split even over the [*****] in 2013, as shown in the below example;

Total

Waltham

[*****

]

[*****

]

[*****

]

[*****

]

[*****

]

Lund

[*****

]

[*****

]

Total

Waltham

[*****

]

[*****

]

[*****

]

[*****

]

[*****

]

Lund

[*****

]

[*****

]


Agreed and accepted by Repligen Corporation

Signature	/s/ Jonathan Lieber

Printed name		Jonathan Lieber

Title	CFO

Date	2/21/13

Agreed and accepted by GEHC Bio-Sciences AB

Signature	/s/ David Raw

Printed name		David Raw

Title	Sourcing Manager

Date	February 22, 2013

AMENDMENT NO. 3 TO STRATEGIC SUPPLIER ALLIANCE AGREEMENT

This Amendment No. 3 (the “Third Amendment”) to that certain Strategic Supplier Alliance Agreement dated as of July 7, 2011 (the “Supplier Agreement”), by and between Repligen Sweden AB, formerly known as Novozymes Biopharma AB, (the “Supplier”), a company organized under the laws of Sweden and a wholly owned subsidiary of Repligen Corporation (“Repligen”), and GE Healthcare Bio-Sciences AB, a company organized under the laws of Sweden (“GEHC”), with the terms hereof being effective from February 22, 2016 (the” Effective Date”), by and between Supplier and GEHC.

WITNESSETH

WHEREAS, the Supplier Agreement has previously been twice amended in accordance with, in the first instance, an amendment made effective as of October 27, 2011 (the “Amendment No. 1”), in the second instance, an amendment made effective February 22, 2013 (the “2013 Amendment”), together the “Previous Amendments”; and

WHEREAS, Supplier and GEHC mutually wish to make certain modifications to the terms and conditions of the Supplier Agreement; and

WHEREAS, Section 18.8 of Attachment E to the Supplier Agreement provides that the Supplier Agreement may be modified only by a writing signed by both parties; and

WHEREAS, (i) a certain related Strategic Supplier Alliance Agreement, dated January 28, 2010, (and amended through Addendum No.1, dated Aug 31 2010 Amendment No. 2, dated Oct 27 2011, and Amendment No. 3 (referred to as 2013 Amendment), dated Feb 22, 2013 and the Amendment No.4, dated Jan 1 2016 (jointly hereinafter the “Related Agreement”), in effect by and between GEHC and Repligen Corporation, the parent company of Supplier.

AGREEMENT

1.	Defined Terms. Capitalized terms used herein, unless otherwise defined or modified herein, shall have the same meaning as defined in the Supplier Agreement. If not previously defined in the Supplier Agreement terms that are capitalized in this Fourth Amendment shall have the meaning defined herein.

a) Named Parties . All references to Parties in this Fourth Amendment may include either or both of Supplier and Repligen Corporation together with GEHC. All subsequent references to “Repligen” in this Fourth Amendment shall be understood to be inclusive of both Supplier and its parent company, Repligen Corporation. “Lund Site” shall mean Supplier’s manufacturing site in Lund, Sweden and “Waltham Site” shall mean Repligen’s manufacturing site in Waltham, Massachusetts, USA and “Site” shall mean either the Lund Site or the Waltham Site and “Sites” shall mean both of them.

2.	Amendment to the Supplier Agreement.

a.	The first sentence of “Agreement Term” under Section C of the Supplier Agreement is hereby amended as follows:

“This Agreement shall commence on the Effective Date and, subject to the rights of termination in Clause 16 of Attachment E, shall continue up to the 31 ^st of December 2019

Attachment C (revision date 04 April, 2011) entitled “Products, Prices, and Specifications” shall be deleted and replaced in its entirety by Revised Attachment C (revision date Jan 1, 2016) attached hereto. Attachment C shall be a complete a current list of all Products, Prices and Specifications at the time of signing this Amendment.

c.	The first sentence of Section 3(c) of Attachment D, entitled “Payment Terms”, is deleted and replaced with the following sentence:

“GEHC shall settle any undisputed invoices arising under this Agreement [*****] after receiving an invoice prepared in accordance with the terms of this Agreement.”

d.	Section 3(d) of Attachment D, entitled “Cost Reductions”, is hereby deleted in its entirety and replaced with the following new Section 3(d):

[*****]

e.	The first two sentences of Section 6(a) of Attachment D, entitled Forecasting, are hereby amended as follows:

As a consequence of the Forecast, GEHC will propose and send Repligen a purchase plan, showing the required delivery weeks and specifying the amount to be purchased by GEHC for the first quarter of each said Forecast. If GEHC for any reason doesn’t send a purchase plan to the Supplier, GEHC shall instead issue purchase orders reflecting the amount for the binding quarter according to section 6b in Attachment D in the Supplier Agreement. The purchase plan or purchase orders as referred to above shall be deemed accepted in the case where the stated amounts in the purchase plan are within the Safety Stocks reported to GEHC, as per the 4th sentence of Section 9 of Attachment D, as amended. GEHC acknowledges that accepted orders within the inventory levels may require use of safety stock. In case the stated amounts in the purchase plan exceed the Safety Stocks reported for each Site as per the above, the Parties shall negotiate in good faith a new purchase plan and Repligen shall use [*****] to accommodate to such a new purchase plan.

f.	The first sentence of Section 6(c) of Attachment D, entitled General Supply Commitment, is hereby amended as follows (changes underlined): The Supplier shall use its best commercial efforts to manufacture and deliver the Recombinant Product and the Native Product within the [*****] Forecast.

g.	A new paragraph shall be added to Section 6(d) of Attachment D, entitled Purchase Commitment Recombinant Product, according to the following:

“Supply of Product. As long as GEHC has not used its right to reduce the minimum purchase commitment for any Products, GEHC acknowledges that, pursuant to this Agreement and the Related Agreement: GEHC has an obligation to purchase no less than [*****] of its requirements for each of the two Recombinant Products from the combined Sites, and the purchase orders issued by GEHC for the Recombinant Products, shall be split between the Waltham site and Lund site as follows: [*****] to the Waltham site and [*****] to the Lund site, as close as possible per every [*****], with an allowance to deviate from the above split not more than [*****] per Recombinant Product during any calendar year, measured through the actual invoiced amount in [*****] from the Waltham site and the Lund site. Both Parties shall aim to minimize the above mentioned deviation, through adjustments of the concerned purchase orders and or shipment amounts in the [*****] of the calendar year. Deviations exceeding [*****] per Recombinant Product shall be balanced in the subsequent calendar year. To the extent GEHC uses its right to reduce its minimum purchase commitments for any or all Products from Supplier hereunder [*****] the purchase commitment, as regards the two Recombinant Products shall be reduced accordingly and what is set out in Section 6 d) Attachment D of the Related Agreement shall apply to purchases under the Related Agreement. GEHC hereby agrees and affirms that if GEHC reduces its purchase commitment to purchase below [*****] of its total requirements of Recombinant Products from the Lund Site, Supplier shall have the right to terminate its supply commitment for all Products from the Lund Site with [*****] notice.

Below summarizes the different scenarios of Purchase Commitment and the resulting distribution of Purchase Orders of the Recombinant Products, see also Table 1: Recombinant Products:

Prerequisite scenario 1 is in effect:

•

GEHC has not used it right to reduce the Purchase Commitment to Lund or

•

GEHC has used its rights to reduce the Purchase Commitment to Lund to between [*****]

•

GEHC has used its right to reduce the Purchase Commitment to Lund below [*****] however Supplier has not terminated its commitment to supply Products from Lund.

then the purchase orders of Recombinant Products to Repligen shall on a [*****] basis be distributed as follows:

•

[*****] towards the Waltham site

•

[*****] towards the Lund site

Prerequisite scenario 2 is in effect:

•

GEHC has used its right to reduce the Purchase Commitment of Recombinant Products to Lund below [*****] and the Supplier has terminated its commitment to supply Products from Lund Site to GEHC or

•

GEHC has used its right to reduce the Purchase Commitment of Recombinant Products to Lund to [*****] of GEHC’s total requirements of Recombinant Products shall be placed as purchase orders to the Waltham site.

[*****]

GEHC hereby agrees and affirms that Repligen shall have the right to apportion manufacturing of either or both recombinant Products between the Sites as it chooses as Repligen may, in its sole discretion, choose so long as:

a) GEHC’s total requirement of recombinant Products as specified in the committed Forecast are timely delivered to GEHC in accordance with the terms and conditions of the Supplier Agreement,

(b) Repligen manufactures each of the Recombinant Products at each of the Lund Site and the Waltham Site respectively with a minimum of [*****] of GEHC’s yearly requirement in [*****], at each Site, during each rolling twelve month period commencing with the Effective Date of the Amendment, and

Repligen shall apportion and control the safety stocks of Products in accordance with the provisions of Attachment C to this Amendment(d) The Parties have agreed that under the Agreement and the Related Agreement, the Supplier may choose to fulfill the purchase orders issued by GEHC as per the following:

(i)	a purchase order placed to the Waltham Site can be delivered from the Lund site and the concerned invoice shall be issued by the Waltham site, and

(ii)	a purchase order placed to the Lund site can be delivered from the Waltham site and the concerned invoice shall be issued by the Lund site,

For clarity,

•

any costs incurred associated with the use of the process set out in (e) (i) and (ii) shall be born solely by the [*****] and

•

first in first out (FIFO) principle shall be applied for the total inventory on both Sites

The second sentence of Section 6(d) of Attachment D, entitled Purchase Commitment Recombinant Product, is hereby amended as follows (changes underlined): Subject to the first paragraph of Section 16.1 of Attachment E, the Parties have agreed that the annual deliveries shall be at least [*****] percent of GEHC total actual requirements in [*****] for the Recombinant Products.

i.	Section 6e of Attachment D entitled Purchase commitment Native Product , shall be replaced by the following:

The Parties have agreed that the annual deliveries from the Supplier shall be no less than [*****] percent of GEHC’s total actual requirements in [*****] for the Native Product.

In the event that GEHC uses it rights to reduce the purchase commitment for the two Recombinant Products, GEHC may also reduce the aforementioned minimum purchase commitment for the Native Product [*****]. For clarification, if GEHC uses its rights to reduce the purchase commitment of any Recombinant Product, Repligen may reduce its supply commitment of Native Product [*****].

j.	The first sentence of Section 2.1 in Attachment E shall be amended as follows (changes underlined) :

k.	Section 6.3 in Attachment E is replaced by the following:

[*****]

l.	The first paragraph of Section 16.1 of Attachment E, as amended by Amendment No. 1, is further amended and restated in its entirety as follows:

“This Agreement shall commence on the Effective Date and, subject as hereinafter provided, shall continue in effect until Dec 31 ^st 2019 Notwithstanding the aforementioned, GEHC may reduce its minimum purchase commitments for any or all Products from Supplier hereunder [*****] upon [*****] written notice to Supplier, provided that GEHC may not issue such notice of reduction until after [*****]. However, in the event GEHC reduces its purchase commitment, what is set out in section 3g shall apply accordingly.

[*****]

m.	Section 16.2 of Attachment E is hereby amended and restated in its entirety as follows :

GEHC shall have the right to terminate the Agreement with eighteen (18) months written notice if the Supplier or any of its Affiliates markets or sells any immobilized chromatography products which is functionally substitutable (based on technical performance) with GEHC’s chromatography products containing the Products ( as exemplified by MabSelect and MabSelect Sure) For the avoidance of doubt, GEHC is aware that Repligen markets and sells certain immobilization chromatography media products currently known as IPA-300 and CaptivA, which due to their current product specifications and technical performances, are not functionally substitutable with MabSelect family products and GEHC acknowledges that marketing and sale of such products is not in violation of this Clause 16.2.”

n.	Section 16.3 of Attachment E, is amended and restated in its entirety as follows::

“GEHC shall have the right to terminate the Agreement with twelve (12) months written notice if (i) the control of the Supplier is transferred outside the Repligen group of companies or (ii) its protein manufacturing operation in the Lund Site is transferred outside of the Repligen group of companies or moved outside of Sweden (iii) if the control of Repligen or the Repligen group of companies is taken over by a direct competitor of GEHC in the field of chromatography media or bioprocess hardware products, whereby control shall mean directly or indirectly (i) holding fifty percent (50%) or more of its issued shares, or (ii) of the voting power therein, or (iii) of the interest in the income of such corporation, partnership or other entity, or (iv) having the power to appoint the majority of its directors or (v) otherwise having the power to direct its business activities.

o.	The 4 ^th sentence of Section 9 of Attachment D, is deleted and replaced with the following sentence:

[*****]

(iii)

Entire Agreement. This Fourth Amendment, together with the Supplier Agreement as amended by the Previous Amendments and the Attachments, exhibits, schedules,

and other documents referred to therein contain the entire understanding of the Parties with respect to the subject matter contained herein and therein. From and after the Effective Date of this Fourth Amendment, any reference to the Supplier Agreement shall be deemed a reference to the Supplier Agreement as amended hereby.

(SIGNATURE PAGES FOLLOW)

IN WITNESS WHEREOF, the undersigned have caused this Fourth Amendment to executed and delivered as of the date first above written.


SUPPLIER:

Place and Date:		3/1/2016	2016-03-17

By:	/s/ Howard Benjamin		/s/ Gustav Silfverdsparde

Name:	Howard Benjamin		Gustav Silfverdsparde

Title:	VP, BD		VP, Operations

GEHC

Place and Date:		2/17/2016

By:	/s/ Bo Lundström

Name:	Bo Lundström

Title:	Managing Director

GEHC

Place and Date:		2/17/2016

By:	/s/ Jan Erneberg

Name:	Jan Erneberg

Title:	Chairman

Revised Attachment C

Products, Prices, and Specifications

GEHC Biosciences/Repligen Sweden AB SSAA


Currency:		SEK

Revision Date:		Jan 1, 2016

A. RECOMBINANT PRODUCT:

Product Name		Zäta
GEHC Article number		[*****]
Supplier Article Number		[*****]

Unit size:

[*****] Zäta per bottle meaning that the content per bottle shall be [*****]. Each bottle shall be labeled with [*****] Zäta. For remains achieved during filling the last bottle in each batch the actual quantity in [*****] shall be stated on the bottle.

Price and [*****] Price Adjustment Procedure:

The Actual Price to be paid by GEHC for Zäta in any subsequent [*****] during the Term of the Amendment shall thus be calculated at the end of each actual [*****] in accordance with the following formula based on the [*****] lookback quantities of Zäta purchased from Lund (LKg):


[*****] lookback	Price formula	Slope
[*****]	[*****]	[*****]
[*****]	[*****]	[*****]
[*****]	[*****]	[*****]

In case the Parties do not reach an agreement on modified prices and/or floors, the current mechanisms will stay in place until the end of the agreement.

INCOTERMS: CIP GEHC Uppsala but for any shipment of Products less than [*****], the Parties shall share equally the freight/insurance costs of such shipment subject to the transport invoice.

Lead Time (PO): Delivery date by Repligen shall be [*****] from acceptance of PO or on mutually agreed delivery date in accordance with Section 6(a) Attachment D (as amended).

Remaining Shelf Life upon delivery: [*****]

Level of Supplier’s Safety Stock

Throughout the Term, Repligen shall adjust the level of safety stock which is equal to at least [*****] of the aggregate of the amount of Zäta actually purchased during the preceding [*****] plus the [*****] Forecast The location(s) of said safety stock shall be established by Repligen as long as [*****]of the total safety stock is held in a secure facility in Sweden and the facility is either under the control or contract of Repligen and available for delivery to GEHC in Uppsala, Sweden within [*****].

Shelf Life [*****]

Lead Times for Safety Stock Replenishment Repligen and GEHC undertakes to agree to a plan to replenish safety stock within [*****] so long as GEHC has not purchased more than [*****] of the Lund Site safety stock. If GEHC purchase more than [*****] of the Lund site safety stock, replacement time of safety stock shall be negotiated between the Parties and Repligen shall use [*****] to accommodate to any such proposal within [*****].

B. RECOMBINANT PRODUCT


Product Name		rPA
GEHC Article number		[*****]
Supplier Article Number		[*****]

Unit size: [*****] rPA per bottle meaning that the content per bottle shall be [*****]. Each bottle shall be labeled with [*****] rPA. For remains achieved during filling the last bottle in each batch the actual quantity in [*****] shall be stated on the bottle.

Price and [*****] Price Adjustment Procedure:

The Actual Price to be paid by GEHC for rPA in any subsequent [*****] during the Term of the Amendment shall thus be calculated at the end of each actual [*****] in accordance with the following formula based on the [*****] lookback quantities of rPA purchased from Lund (LKg):


[*****] lookback	Prices	Slope
[*****]	[*****]	[*****]
[*****]	[*****]	[*****]
[*****]	[*****]	[*****]
[*****]	[*****]	[*****]

In case the Parties do not reach an agreement on modified prices and/or floors, the current mechanisms will stay in place until the end of the agreement.

INCOTERMS: CIP GEHC Uppsala, but for any shipment of Products less than [*****] the Parties shall equally the freight/insurance costs of such shipment subject to the transport invoice.

Lead Time (PO): Delivery date by Repligen shall be [*****] from acceptance of PO or on mutually agreed delivery date in accordance with Section 6(a) Attachment D (as amended).

Remaining shelf life upon delivery: [*****]

Level of Supplier’s Safety Stock

Throughout the Term, Repligen shall adjust the level of safety stock to at least [*****] of the aggregate of the amount of rPA actually purchased during the preceding [*****] plus the upcoming [*****] Forecast of rPA. The location(s) of said safety stock shall be established by Repligen as long as [*****] of the total safety stock is held in a secure facility in Sweden and the facility is either under the control or contract of Repligen and available for delivery to GEHC in Uppsala, Sweden within [*****].

Shelf Life [*****]

Lead Times Safety Stock Replenishment:

Repligen and GEHC undertake to agree to a plan to replenish safety stock [*****] so long as GEHC has not purchased more than [*****] of the Lund Site safety stock. If GEHC purchase more than [*****] of the Lund site safety stock, replacement time of safety stock shall be negotiated between the Parties and Repligen shall use [*****] to accommodate to any such proposal within [*****].

C. NATIVE PRODUCT


Product Name:		Serum free Native Protein A (nPA)
GEHC Article number:		[*****]
Supplier Article number:		[*****]
Unit size

[*****] nPA per bottle meaning that the content per bottle shall be [*****] Each bottle shall be labeled with [*****] nPA. For remains achieved during filling the last bottle in each batch the actual quantity in [*****] shall be stated on the bottle.

Price: The price on nPA will be [*****] per [*****] during the term of the contract.

INCOTERMS: CIP GEHC Uppsala, but for any shipment of Products less than [*****] the Parties shall equally the freight/insurance costs of such shipment subject to the transport invoice.

Lead time (PO): Delivery date by Repligen shall be [*****] from acceptance of PO or on mutually agreed delivery date in accordance with Section 6(a) Attachment D (as amended)

Remaining shelf life upon delivery: [*****]

Level of Supplier’s Safety Stock: The safety stocks at the Supplier will be at least [*****] based on the average of the first [*****] of the, at any time, then valid forecast distributed by GEHC and the prior [*****] consumption by GEHC.

Shelf life: [*****]

Lead Times Safety Stock Replenishment:

Repligen and GEHC undertakes to agree to a plan to replenish safety stock within [*****] so long as GEHC has not purchased more than [*****] of the Lund Site safety stock. If GEHC purchase more than [*****] of the Lund site safety stock, replacement time of safety stock shall be negotiated between the Parties and Repligen shall use [*****] to accommodate to any such proposal within [*****].

For the avoidance of doubt the Parties have agreed to remove the previous section D governing LEGO product since this is no longer a Product pursuant to the Amended Agreement

E. General Price Terms

Native Product:

Price above is per [*****] and shall apply for deliveries made in the applicable [*****].

Reference samples, covering [*****] samples of [*****] each batch, to be provided to GEHC in the deliveries shall be [*****].

Recombinant Products:

All prices above are per [*****] and shall be set at the beginning of each [*****] based upon the [*****] prior consumption of each of the Recombinant Products based on the purchases received from Lund and accepted by GEHC. The price for each of the recombinant Products shall be set on the [*****] of the [*****] and shall remain fixed for that [*****].

By way of hypothetical examples for Zäta:

GEHC has purchased [*****] of Zäta over the course of [*****] between [*****] and [*****]. The price [*****] of [*****] and effective for all purchases made during that [*****] will be [*****] SEK per [*****].

[*****]

By way of hypothetical example for rPA:

GEHC has purchased [*****] of rPA over the course of the [*****] from [*****] and [*****]. The price [*****] of [*****] and effective for all purchases made during that [*****] will be [*****] SEK.

[*****]

Reference samples, covering two samples of [*****] each batch, to be provided to GEHC in the deliveries shall be [*****].

Gel Prices:

During the Term of this Agreement the Supplier shall have the right to purchase the following products from GEHC at the following price conditions:

[*****]

Delivery conditions: CIF

Lead time: normally [*****] but to be confirmed on case by case basis

Credit term: [*****] from date of invoice

The products ordered in accordance with this Attachment C may only be used in the manufacture of Products pursuant to this Agreement.

Exhibit 31.1

CERTIFICATION

I, Tony J. Hunt, certify that:

1. I have reviewed this Quarterly Report on Form 10-Q of Repligen Corporation;

2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;

4. The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:

(a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;

(b) Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;

(c) Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

(d) Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and

5. The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):

(a) All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and

(b) Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.

Date: May 5, 2016

/ S / T ONY J. H UNT

Tony J. Hunt

President and Chief Executive Officer

(Principal executive officer)

Exhibit 31.2

CERTIFICATION

I, Jon Snodgres, certify that:

1. I have reviewed this Quarterly Report on Form 10-Q of Repligen Corporation;

(b) Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.

Date: May 5, 2016

/ S / J ON S NODGRES

Jon Snodgres

Chief Financial Officer

(Principal financial officer)

Exhibit 32.1*

CERTIFICATION PURSUANT TO

18 U.S.C. SECTION 1350,

AS ADOPTED PURSUANT TO

SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002

In connection with the Quarterly Report of Repligen Corporation (the “Company”) on Form 10-Q for the period ending March 31, 2016 as filed with the Securities and Exchange Commission on the date hereof (the “Report”), the undersigned officers of the Company hereby certify, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, to my knowledge, that:

(1)	The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and

(2)	The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.


Date: May 5, 2016	By:	/ S / T ONY J. H UNT
		Tony J. Hunt
		Chief Executive Officer and President
		(Principal executive officer)

Date: May 5, 2016	By:	/ S / J ON S NODGRES
		Jon Snodgres
		Chief Financial Officer
		(Principal financial officer)

This certification shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, or otherwise subject to the liability of that section, nor shall it be deemed to be incorporated by reference into any filing under the Securities Act of 1933 or the Securities Exchange Act of 1934.