Document:

Development and Supply Agreement

 Exhibit 10.18 
 DEVELOPMENT AND SUPPLY AGREEMENT 
 by and between 

GLAND PHARMA LIMITED, 
 an Indian corporation 
 and 

SAGENT HOLDING CO., 
 a Cayman Islands corporation 
 for Heparin Sodium Injection USP 

Dated: June 27, 2008 

 DEVELOPMENT AND SUPPLY AGREEMENT 

THIS DEVELOPMENT AND SUPPLY AGREEMENT (“Agreement”) is made as of the 27th day of June, 2008 (the
“Effective Date”) by and between GLAND PHARMA LIMITED, an Indian corporation, having a place of business at 6-3-865/1/2, Ameerpet, Hyderabad, India (“Gland”), and SAGENT HOLDING CO., a Cayman Islands
corporation, having a place of business at c/o M&C Corporate Services Limited, PO Box 309 GT, Ugland House, South Church Street, George Town, Grand Cayman, Cayman Islands (“Sagent”). 

RECITALS 

WHEREAS, Gland is experienced in developing, manufacturing, testing and packaging pharmaceutical products; and 

WHEREAS, Sagent is experienced in regulatory matters and has extensive sales and marketing capabilities; and 

WHEREAS, Gland desires to develop the data necessary for the preparation of an ANDA for Heparin Sodium Injection USP (as more
particularly hereinafter defined as the Product), desires to manufacture and supply the Product for sale in the Territory by Sagent, and Sagent desires for Gland to develop the data necessary for the preparation of an ANDA, file and ANDA and
purchase and obtain the Product for sale in the Territory from Gland, in each case on the terms and conditions hereof; and 

WHEREAS, Gland and Sagent are parties to a binding term sheet dated May 29, 2008. 

NOW, THEREFORE, the Parties hereto agree to the following: 

AGREEMENT 
  

	1.	DEFINITIONS. 

 The
following terms for the purpose of this Agreement shall have the following respective meanings: 
 “Active Pharmaceutical
Ingredient” or “API” shall mean Heparin Sodium USP, the active pharmaceutical ingredient in the Product. 
 “Affiliate” shall mean, with respect to either Party, all entities which, directly or indirectly, are controlled by, control or are under common control with such Party. For purposes of
this definition, the word “control” shall mean the possession, directly or indirectly, of the power to direct or cause the direction of the management and policies of an entity, including through ownership of more than fifty percent
(50%) of the voting shares or interest of an entity. 

  
 1 

 CONFIDENTIAL TREATMENT 
 [***] Indicates that text has been omitted which is the subject of a confidential treatment request. This text has been separately filed with the Securities and Exchange Commission 

 

 “ANDA” shall mean an Abbreviated New Drug Application for the Product
submitted to the FDA, including any amendments or supplements thereto. 
 “Annual Period” shall mean the twelve
(12) month period beginning on the Launch Date and each twelve (12) month period beginning on the anniversary of such day thereafter. 
 “API Supplier Royalty” shall mean the royalty of [***] percent ([***]%) of net profits payable by Sagent to the supplier of API for the Products. 

“Batch” means a defined quantity of Product which has been produced during a defined cycle of manufacture, and which is
identified by a unique production number. 
 “Batch Records” shall have the meaning set forth in the Quality
Assurance Agreement. 
 “Components” shall mean all containers, closures, labels, labeling, artwork, inserts and
other packaging components necessary for the manufacture of the Product as finished goods. For the avoidance of doubt, “Components” does not include any API, work in process or Materials. 

“Demand Schedule” shall have the meaning set forth in Section 3.2.1. 

“Designated Distribution Center or Centers” shall mean Sagent’s distribution center in Chicago,
Illinois or such other distribution center or centers in the Territory as may be designated by Sagent from time to time, whether such distribution centers are owned and operated by Sagent, an Affiliate of Sagent or a Third Party under contract with
Sagent or an Affiliate of Sagent. 
 “Development Activities” shall have the meaning set forth in
Section 2.1. 
 “Designated Distribution Center or Centers” shall mean Sagent’s
distribution center in the Territory or such other distribution center or centers in the Territory as may be designated by Sagent from time to time, whether such distribution centers are owned and operated by Sagent, an Affiliate of Sagent or a
Third Party under contract with Sagent or an Affiliate of Sagent. 
 “Exhibit Batches” shall
mean means a batch for use in obtaining registration of the Product shall be of a size that is at least one-tenth
(1/10th) of the commercial Batch size. This batch may
be used in conducting bioequivalence studies, as necessary. 
 “Disclosing Party” shall have the meaning set
forth in Section 11.1. 
 “FDA” shall mean the United States Food and Drug Administration. 

“Force Majeure” shall have the meaning set forth in Section 14.8. 

  
 2 

 CONFIDENTIAL TREATMENT 
 [***] Indicates that text has been omitted which is the subject of a confidential treatment request. This text has been separately filed with the Securities and Exchange Commission 

 

 “Gland’s Facility” shall mean those areas of Gland’s
manufacturing, packaging, laboratory and warehousing facilities utilized in the manufacture, packaging, storage, testing, shipping or receiving of the Product. 
 “cGMP” shall mean current good manufacturing practices required under the United States Food, Drug and Cosmetic Act, as amended, and applicable FDA regulations, policies and guidelines,
in effect at the time in question for the manufacture and testing of pharmaceutical materials. cGMP shall also encompass any local or national governmental authority requirements applicable to Gland’s manufacturing and distribution of the
Products to the extent such requirements do not contravene the United States Food, Drug and Cosmetic Act and FDA regulations, policies, and guidelines. 
 “Indemnified Party” shall have the meaning set forth in Section 8.3. 
 “Indemnifying Party” shall have the meaning set forth in Section 8.3 
 “Initial Term” shall have the meaning set forth in Section 7.1 
 “Launch Date” shall mean the date upon which Sagent first offers the Product for commercial sale in the United States. 

“Laws” shall have the meaning set forth in Article 12. 

“Materials” shall mean all inactive raw materials used in the formulation of the Product necessary for the manufacture of
the Product as finished goods. For the avoidance of doubt, “Materials” does not include any API, Components or work in process. 
 “Net Profit” means Net Sales less the Transfer Price less the API Supplier Royalty. 
 “Net Sales” means, the gross invoiced sales of a Product to all customers less (i) the cost of the Product, including freight in, duty, customs, shipping and all related direct costs
of acquiring the Product; (ii) chargebacks; (iii) freight and insurance charges; (iv) trade discounts, credits or allowances; (v) costs of replacements, returns, recalls or rebates (including but not limited to group purchasing
organization fees and rebates); (vi) discounts or rebates or other payments required by law to be made under Medicaid, Medicare or other governmental special medical assistance programs (vii) wholesaler service charges;
(viii) sales, excise or value added taxes paid on or in relation to sales of the Product; and (ix) [***], as calculated in accordance with United States Generally Accepted Accounting Principles, or US GAAP. 

  
 3 

 “Party” shall mean Sagent or Gland and “Parties” shall
mean Sagent and Gland. “Product” shall mean the product set forth in Exhibit A attached hereto and made a part hereof, in the presentations described on such Exhibit A. 

“Product Information” means all information and data relating to the Products, including but not limited to formulae,
methods of manufacture, product descriptions, test methods, validation of test methods, specifications, and all other supporting documentation, data and reports developed or acquired by Gland or its Affiliates during the Term in connection with the
manufacture and supply of Products, and all applications, submissions, filings and correspondence of Gland or its Affiliates with or to US FDA or any other regulatory authority in the Territory with respect to the Products. 

“Proprietary Information” shall have the meaning set forth in Section 11.1. 

“Purchase Order” shall have the meaning set forth in Section 3.2.1. 

“Receiving Party” shall have the meaning set forth in Section 11.1. 

“Specifications” shall mean the Product description and attributes set forth in Exhibit B attached hereto and made a part
hereof. 
 “Territory” shall mean the United States of America, its commonwealths, territories and possessions.
Additional geographic regions may be added to the Territory upon written agreement of the Parties. 
 “Third
Party” shall mean any person, entity or company other than Sagent or Gland or their respective Affiliates. 

“Transfer Price” shall mean the price, stated in United States currency, which is stated on Exhibit A. The Transfer
Price shall not change during the Initial Term of the Agreement unless the Parties agree in writing to do so. The Parties will meet to discuss any change in the Transfer Price during the Initial Term, including but not limited to in the event of a
significant change in the cost of API, Materials or Components or in the market conditions in the Territory. 
  

	2.	DEVELOPMENT; EXCLUSIVITY; RIGHTS; PAYMENT. 

  

	 	2.1	Product Development 

  

	 	2.1.1	 Gland’s Development Activities. Gland shall expeditiously commence and complete development of a stable, commercially saleable Product in
accordance with cGMP, the Specifications, and all applicable laws, and which is equivalent to the applicable referenced drug and does not infringe or potentially infringe any patents owned or licensed by any third party in the Territory of which
Gland is informed by Sagent, including that Gland will provide Sagent with a completed dossier containing Modules I, II, and III in CTD format, ready for submission to the appropriate regulatory authority as required by Sagent (the foregoing
activities, together with all 

  
 4 

	 	 
other activities undertaken by Gland in respect of such product development, including but not limited to those set forth at Section 2.1.2 below, shall be referred to as the
“Development Activities”) . Gland will keep Sagent currently advised of the progress of the Development Activities, and any and all material problems encountered therein, the efforts being made to overcome such problems, estimates of
completion dates, and such other information as may be requested by Sagent from time to time. At Sagent’s request, Gland will provide Sagent with written reports covering the foregoing. 

 

	 	2.1.2	Additional Development Activities by Gland. Gland agrees to cooperate fully with Sagent and provide such reasonable technical and other assistance as Sagent may request
from time to time, with respect to conducting any studies and obtaining US FDA or other regulatory authority’s approval for marketing and sale in the Territory. Without limiting any of the obligations of Gland as set forth elsewhere in this
Agreement, Gland agrees to do the following, all in accordance with cGMP and applicable law: (a) provide Sagent with any and all Product Information and any other data or information related to Product which is necessary or advisable for the
preparation, prosecution and maintenance of the Product ANDA or marketing and sale of Product, including without limitation, samples, data and information necessary for Sagent to respond to Product ANDA deficiencies, (b) provide to Sagent the
validated assay and degradant methodology data with respect to each Product, (c) make its knowledgeable, qualified personnel available to Sagent for consultation as necessary to effectively transfer the Product Information to Sagent during ANDA
filing, (d) develop and validate analytical methods for Product release and stability testing of the Product, (e) prepare analytical release and stability specifications for the Product and perform the required testing to release the
Product, (f) prepare executed batch records for the Exhibit Batches and all other Batches supplied to Sagent, (g) prepare Product packaging records, (h) manufacture and package Exhibit Batches to support bioequivalence studies, if
required, (i) maintain Product manufacturing and packaging areas in compliance with cGMP and applicable law, (j) conduct stability testing of the Product and maintain research and development and marketed product stability programs,
(k) prepare and issue Batch Records for Product, and (l) prepare a development report to support pre-approval inspection activities and otherwise take such actions as are necessary to cause Gland’s sites to be approved by US FDA. If
Sagent requires additional or supplemental documents from Gland in order to obtain or in connection with approval of a Product ANDA, or in connection with any product recall or adverse drug event or product complaint, Gland shall cooperate with
Sagent and prepare and provide to Sagent such additional or supplemental documentation as may reasonably be requested by Sagent. 

  
 5 

	 	2.1.3.	API. Sagent shall make arrangements for the supply of API to Gland, as well as all regulatory activities related to the API source, including but not limited to the
preparation and/or permission to reference the source’s Drug Master File as filed with the FDA. Gland shall be permitted to use API from the source(s) developed or arranged b Sagent only for Product to be manufactured by Gland and sold to
Sagent pursuant to the terms of this Agreement. 

  

	 	2.1.4.	ANDA. Sagent shall file the ANDA using the Product Information from Gland, and shall be responsible for the maintenance of the ANDA. 

 

	 	2.2	Exclusivity. 

  

	 	2.2.1	Exclusive Rights. All right, title and interest in the ANDA, the Product Information and any other results of the Development Activities related to the
preparation of the ANDA for the Product (in the presentations set forth on Exhibit A hereto) shall be held by Sagent. On and subject to the terms and conditions of this Agreement, Sagent shall have the exclusive right to market, sell and distribute
the Product in the Territory. No party (including Gland or any Affiliate of Gland) other than Sagent (or any Affiliate of Sagent) shall be allowed to market, sell or distribute the Product manufactured or developed by Gland in the Territory. In
exchange for this exclusive right, Sagent agrees to market, sell and distribute in the Territory only Product provided by Gland, subject to Gland’s ability to supply all of Sagent’s requirements for the Product, during the Term. The ANDA
for the Products (covering all presentations) shall be filed and owned by Sagent. 

  

	 	2.2.2	Exception to Exclusivity upon Discontinuation by Sagent. Notwithstanding the provisions of Section 2.2.1, in the event that, during the Initial Term, Sagent
shall determine to discontinue active sales of the Product in the Territory, then Sagent shall allow Gland to supply Product under Sagent’s ANDA to a Third Party, in addition to Sagent, for purposes of marketing, selling and distributing the
Product in the Territory during the remainder of the Iinitial Term of this Agreement; provided that, (i) Gland and such Third Party shall market, sell and distribute the Product under their own label and not in connection with the
“Sagent” name or any other Sagent’s trademark or trade name, (ii) Sagent shall use commercially reasonable efforts to file the labeling of such Third Party in its approved ANDA, at no cost or expense to Sagent, (iii) Gland
will supply the Product to the Third Party on terms no more favorable than the terms on which Gland supplies the Product to Sagent under this Agreement, and (iv) Sagent will allow such Third Party to market, sell and distribute the Product in
the Territory until the expiration of the Initial Term at which time this Agreement will terminate automatically. 

  
 6 

	 	2.2.3	Minimum Market Share. Sagent shall use its best efforts to attain, no later than within the twelve (12) month period following the fourth anniversary of the Launch
Date a minimum market share of at least ten percent (10%) (the “Minimum Market Share”), based upon the IMS data pertaining to said trailing twelve (12) months for which market data is available, If Sagent is not successful in
achieving the Minimum Market Share, then Sagent shall allow Gland to supply Product under Sagent’s ANDA to a Third Party, in addition to Sagent, for purposes of marketing, selling and distributing the Product in the Territory during the
remainder of the Term of this Agreement; provided that, (i) Gland and such Third Party shall market, sell and distribute the Product under their own label and not in connection with the “Sagent” name or any other Sagent’s
trademark or trade name, (ii) Sagent shall use commercially reasonable efforts to file the labeling of such Third Party in its approved ANDA, at no cost or expense to Sagent, (iii) Gland will supply the Product to the Third Party on terms
no more favorable than the terms on which Gland supplies the Product to Sagent under this Agreement, and (iv) Gland’s right to supply the Product to such Third Party shall expire automatically upon expiration of the Initial Term of this
Agreement. 

  

	 	2.3	License; Marketing 

  

	 	2.3.1	License. Gland and its Affiliates hereby grant to SAGENT an exclusive, perpetual royalty-free license to import, promote, use, market, distribute (including by
use of an Affiliate or Third Party to physically distribute Product on behalf of SAGENT including the appointment of distributors, sub-distributors or other agents), and otherwise commercialize the Product, offer for sale and sell the Product in the
Territory, under any Trademark and through any channel of trade, including in combination with other Product and substances, all as Sagent determines in its sole discretion. The foregoing license shall include all rights in the ANDA and the Product
Information and any associated technology relevant to the ANDA. 

  

	 	2.3.2	Marketing. SAGENT shall have the sole right to determine all marketing for the Product in the Territory, including the appointment of distributors,
sub-distributors, or other agents. Sagent and Gland shall agree on any special marketing pieces in advance if the cost of which shall be shared by the Parties. 

  
 7 

	3.	MANUFACTURING SERVICES. 

  

	 	3.1	Supply Obligation. During the term of this Agreement (but subject to all required regulatory approvals for sale of the Product in the Territory), Gland
agrees to manufacture and supply the Product to Sagent in accordance with the Purchase Orders issued by Sagent and in accordance with the terms of this Agreement for marketing and sale by Sagent in the Territory. Gland shall manufacture, process,
and package the Product in accordance with the Specifications. 

  

	 	3.2	Forecasts and Purchase Orders. 

  

	 	3.2.1	Sagent shall provide Gland with twelve (12) month rolling forecasts in whole batch increments, which shall be issued at least six (6) months prior to the
start of each twelve (12) month forecasted period (each, a “Demand Schedule”). The first such Demand Schedule shall be issued by Sagent six months prior to the anticipated Launch Date, unless otherwise agreed to by the Parties
in writing, and updated Demand Schedules shall be issued by Sagent no later than the tenth day of each succeeding calendar month. The first three (3) months of each Demand Schedule will represent a firm Purchase Order (“Purchase
Order(s)”) which Purchase Orders shall set forth the specific quantities needed, delivery date and delivery location and whether or not reasonable quantities of reference standard material and/or impurities material are required.

  

	 	3.2.2	In the event of any conflict between any Purchase Order and this Agreement, this Agreement shall control. 

 

	 	3.3	Orders in Excess of Forecast: Inability. 

 Gland shall not be obligated to supply (a) during the first three months of any Demand Schedule, more than one hundred percent (100%) of the quantity of Product set forth in the applicable
Purchase Order, or (b) during the portion of any Demand Schedule where changes are required of the secondary packaging or (c) during the portion of any Demand Schedule that is not yet represented in a Purchase Order, more than one hundred
and twenty percent (120%) of the quantity of Product set forth in such Demand Schedule that is not yet represented in a Purchase Order; provided that Gland shall use its commercially reasonable efforts to deliver any additional
quantities of Product ordered by Sagent that are in excess of the quantities set forth in any portion of a Demand Schedule. In the event that Gland is unable to meet the requirements herein, Gland shall reimburse Sagent for any and all charges
imposed by Sagent’s customers (or Sagent’s distributors customers) as a result of Sagent’s inability to supply, except if the supply interruption is due to a documented force majeure. 

 

	 	3.4	Delivery of Product. Gland shall supply the Product FOB Hyderabad. 

  
 8 

	4.	REPRESENTATIONS AND WARRANTIES. 

  

	 	4.1	Representations and Warranties of Gland. Gland represents and warrants to Sagent as follows: 

 

	 	(a)	Gland shall perform the Development Activities using its commercially reasonable best efforts. 

 

	 	(b)	Product delivered to Sagent under this Agreement shall, at the time of shipment, conform to the Specifications; 

 

	 	(c)	Gland’s Development Activities, production and shipment of Product shall be conducted in accordance with cGMP. Gland further warrants that, as of the date of each
shipment hereunder to Sagent, and until its date of expiration, the Product shall comply with the provisions of the United States Food, Drug and Cosmetic Act, and such Product shall not, when shipped to Sagent, be adulterated or misbranded within
the meaning of the United States Food, Drug and Cosmetic Act. Gland agrees that no more than three (3) months of the total approved shelf life for each presentation of Product shall have expired at the time such Product is shipped to Sagent;

  

	 	(d)	To the best of its knowledge and information, no claim has been asserted that the importation, manufacture, use, offer for sale, or sale of Product infringes a valid
claim under any patent; 

  

	 	(e)	Gland is a corporation in good standing under the laws of the jurisdiction of its organization and authorized to do business wherever necessary to fulfill the terms and
conditions of this Agreement; 

  

	 	(f)	Gland has the full power and authority to execute and deliver this Agreement and perform its covenants, duties and obligations described in this Agreement;

  

	 	(g)	This Agreement is the valid, legal and binding obligation of Gland, enforceable in accordance with its terms; 

 

	 	(h)	Neither the execution and delivery of this Agreement nor the performance of Gland’s covenants, duties and obligations described in this Agreement constitute or
will constitute a default under or conflict with any judgment, decree or order of any court or other governmental body to which Gland is subject and will not conflict or be inconsistent with or result in the termination, modification, breach or
default under the terms of any contract, commitment, covenant, agreement, instrument, document or understanding to which Gland is a party; 

  
 9 

	 	(i)	Gland is not a party to, nor to Gland’s knowledge is Gland as of the Effective Date threatened with, any legal or equitable action or proceeding before any court,
arbitrator, administrative agency or other tribunal which is reasonably likely to adversely affect its ability to execute and deliver this Agreement or fully and timely perform its covenants, duties and obligations described in this Agreement;

  

	 	(j)	Gland has obtained and continuously maintained all permits, authorizations and licenses issued by all federal, state and local governmental agencies and authorities
necessary for the conduct of Gland’s businesses as of the Effective Date; and 

  

	 	(k)	Gland has and shall continue to follow, comply with and adhere to all Laws necessary for the conduct of Gland’s businesses. 

 

	 	4.2	Representations and Warranties of Sagent. Sagent represents and warrants to Gland as follows: 

 

	 	(a)	Sagent is a corporation in good standing under the laws of the jurisdiction of its organization and authorized to do business wherever necessary to fulfill the terms
and conditions of this Agreement; 

  

	 	(b)	Sagent has the full power and authority to execute and deliver this Agreement and perform its covenants, duties and obligations described in this Agreement;

  

	 	(c)	To the best of its knowledge and information, no claim has been asserted that the importation, manufacture, use, offer for sale, or sale of Product infringes a valid
claim under any patent; 

  

	 	(d)	This Agreement is the valid, legal and binding obligation of Sagent, enforceable in accordance with its terms; 

 

	 	(e)	Neither the execution and delivery of this Agreement nor the performance of Sagent’s covenants, duties and obligations described in this Agreement constitute or
will constitute a default under or conflict with any judgment, decree or order of any court or other governmental body to which Sagent is subject and will not conflict or be inconsistent with or result in the termination, modification, breach or
default under the terms of any contract, commitment, covenant, agreement, instrument, document or understanding to which Sagent is a party; 

  

	 	(f)	Sagent is not a party to, nor to Sagent’s knowledge is Sagent as of the Effective Date threatened with, any legal or equitable action or proceeding before any
court, arbitrator, administrative agency or other tribunal which is reasonably likely to adversely affect its ability to execute and deliver this Agreement or fully and timely perform its covenants, duties and obligations described in this
Agreement; 

  
 10 

 CONFIDENTIAL TREATMENT 
 [***] Indicates that text has been omitted which is the subject of a confidential treatment request. This text has been separately filed with the Securities and Exchange Commission 

 

	 	(g)	Sagent has obtained and continuously maintains all permits, authorizations and licenses issued by all federal, state and local governmental agencies and authorities
necessary for the conduct of Sagent’s businesses as of the Effective Date; and 

  

	 	(h)	Sagent has and shall continue to follow, comply with and adhere to all Laws necessary for the conduct of Sagent’s businesses. 

 

	 	4.3	Disclaimer. THE REPRESENTATIONS AND WARRANTIES SET FORTH IN THIS AGREEMENT ARE THE PARTIES’ ONLY WARRANTIES AND NO OTHER WARRANTY, EXPRESS, IMPLIED OR
STATUTORY, WILL APPLY. EACH PARTY EXPRESSLY DISCLAIMS ALL OTHER WARRANTIES, WHETHER EXPRESS, IMPLIED OR STATUTORY, INCLUDING WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE. FOR THE AVOIDANCE OF DOUBT, EACH PARTY EXPRESSLY
DISCLAIMS ANY AND ALL WARRANTIES OF NON-INFRINGEMENT THAT ARE NOT EXPRESSLY SET FORTH IN THIS AGREEMENT. 

  

	5.	QUALITY ASSURANCE AND REGULATORY REQUIREMENTS. 

 Additional roles and responsibilities of each of the Parties are itemized in the Quality Assurance Agreement attached hereto as Exhibit C and the Adverse Event Reporting Agreement attached as Exhibit D,
each of which is made a part hereof by this reference. 
  

	6.	CONSIDERATION. 

  

	 	6.1	Development Costs. The Parties shall share the cost of the Development Activities, a sum not to exceed $[***]. Sagent shall pay one-half of the cost as
invoiced by Gland, i.e. [***] 

  

	 	6.2	Transfer Price. The price for each Product presentation to be delivered by Gland during the term of this Agreement shall be the Transfer Price on Exhibit
A. Gland shall invoice such amounts upon shipment of the Product to Sagent, and Sagent shall pay the Transfer Price net forty-five (45) days from the date of the invoice of the Product dispatch. 

 

	 	6.3	Additional Consideration. In addition to the Transfer Price, Sagent shall pay Gland [***] of the Net Profits, payable within [***] (the sum of any and all
of Sagent’s payments to Gland hereunder shall be referred to collectively as “Gland’s Net Profit Share”). 

  

	 	6.4	Currency. All payments hereunder shall be made in United States currency. 

  
 11 

	 	6.5	Taxes. All federal, national, regional, district, local or other governmental income tax or similar tax that is imposed on either Party as a result of
income, shall be the responsibility of such Party. 

  

	 	6.6	Inspection of Financial Records. During the term of this Agreement and for a period of one (1) year thereafter, each Party shall have the right, at
its own expense, to have a public accounting firm of national standing, to which the other Party has no reasonable objection, to examine the relevant books and records of account during business hours not more often than once each calendar year to
determine whether appropriate accounting and payment have been made pursuant to this Article 6 or to determine the accuracy of the Transfer Price.. The results of the audit by such accounting firm shall be final and binding upon the Parties. Any
adjustment in the amount of Transfer Price or additional consideration payments made as a result of the audit shall be paid within fifteen (15) days after resolution thereof. 

 

	7.	TERM AND TERMINATION. 

  

	 	7.1	Term and Renewal. The obligations of the Parties hereunder shall commence on the Effective Date and continue until the end of the eigth (8th) Annual
Period (the “Initial Term”). Thereafter, unless a Third Party has rights to market the Product in the Territory under the exception to exclusivity described under Section 2.2.2 or the Agreement has been earlier terminated pursuant to
the provisions of this Article 7, the Agreement will be automatically extended for additional Annual Periods until either Party notifies the other Party in writing not less than twenty-four (24) months prior of that Party’s intent to
terminate the Agreement. 

  

	 	7.2	Termination for Breach. Notwithstanding Section 7.1, this Agreement may be terminated by either Party if the other Party fails to remedy and make
good any material default in the performance of any condition or obligation under this Agreement within ninety (90) days of the date a written notice of such default and intention to terminate is sent to the defaulting Party; provided
that if a defaulting Party has promptly from receipt of notice commenced to cure such default and is diligently attempting to cure such default at the lapse of such ninety (90) days, then such Party shall have such additional time to cure as
may be reasonably required but not to exceed an additional seventy-five (75) days; provided further, that if the default relates to the payment of money, the cure period shall be limited to fifteen (15) days from the date of
notice. 

  

	 	7.3	Termination for Bankruptcy. Notwithstanding Section 7.1, this Agreement may be terminated by either Party, forthwith, or at any time thereafter by
notice to the other if the other becomes bankrupt or insolvent, or enters into liquidation whether compulsorily or voluntarily, or convenes a meeting of its creditors, or has a receiver appointed over all or part of its assets, or ceases for any
reason to carry on business. 

  
 12 

	 	7.4	Termination for Force Majeure. Notwithstanding Section 7.1, this Agreement may be terminated by either Party, upon ninety (90) days written
prior notice in the event of the other Party’s inability to substantially perform its obligations hereunder for more than one hundred eighty (180) days due to an event of Force Majeure, provided that if such condition of Force
Majeure is reasonably expected to be remedied during such ninety (90) day period, then the period of time to remedy such condition shall be extended for an additional ninety (90) day period before termination becomes effective.

  

	 	7.5	No Waiver. The failure of either Party to terminate this Agreement by reason of the breach of any of its provisions by the other Party shall not be
construed as a waiver of the rights or remedies available for any subsequent breach of the terms and provisions of this Agreement. 

  

	 	7.6	Accrued Liabilities. Termination of this Agreement for any reason shall not discharge either Party’s liability for obligations incurred hereunder and
amounts unpaid at the time of such termination. Sagent shall pay Gland for any finished Product ordered by Sagent prior to termination. Sagent shall also pay Gland for any API, Components, work in process and Materials (ordered by Gland) that were
to be used in the manufacture of Product hereunder and that are in Gland’s possession upon termination of this Agreement. All API, Components, Materials, work in process and finished goods of Product ordered by Sagent and in Gland’s
possession at the time of termination shall be delivered to Sagent upon Sagent’s payment to Gland of the cost incurred by Gland in respect thereof, including costs incurred in connection with the delivery thereof to Sagent. Without limiting the
generality of the foregoing, the termination of this Agreement shall not impair Sagent’s obligation to continue to make gross profit share payments to Gland with respect to all finished Product manufactured by Gland prior to the date of
termination. 

  

	 	7.7	Property. In the event of termination of this Agreement for whatever cause, in addition to the other obligations of the Parties hereunder, each Party
shall return to the other Party or to the other Party’s designee no later than thirty (30) days after the effective date of termination all of such other Party’s property, including all proprietary information, in its possession,
except to the extent required to be retained by law or to comply with such Party’s continuing obligations hereunder. 

  
 13 

	8.	LITIGATION AND INDEMNIFICATION. 

  

	 	8.1	Indemnification by Gland. Gland agrees to indemnify, defend and hold harmless Sagent, its distributors, its Affiliates and their respective employees,
servants and agents against any and all third-party claims, including claims made against Sagent by any of its distributors, losses, damages and liabilities, including reasonable attorney’s fees, incurred by any of them (a) arising out of
any defect in the Product supplied by Gland hereunder, (b) any breach of a representation, obligation, warranty or covenant hereunder by Gland, (c) any negligent or intentionally wrongful act or omission by Gland in connection with its
manufacturing services hereunder, or (d) arising in any way out of Product manufactured by Gland and sold by Gland to a Third Party or a sale by such Third Party in the event of an exception to exclusivity pursuant to Section 2.2.2 or
Sagent’s failure to maintain the Minimum Market Share pursuant to Section 2.2.3 of this Agreement. 

  

	 	8.2	Indemnification by Sagent. Sagent agrees to indemnify, defend and hold harmless Gland, its Affiliates and their respective employees, servants and agents
against any and all third-party claims, losses, damages and liabilities, including reasonable attorney’s fees, incurred by any of them arising out of any breach of a representation, obligation, warranty or covenant hereunder by Sagent, any
negligence or intentionally wrongful act or omission in the in the design or development of the Product, or any negligent or intentionally wrongful act or omission by Sagent in connection with the marketing, distribution or sale of the Product in
the Territory. 

  

	 	8.3	 Indemnification Process. If Sagent, its distributors, Affiliates or their respective employees, servants or agents, or Gland, its
Affiliates or their respective employees, servants or agents (in each case an “Indemnified Party”), receive any written claim which such Indemnified Party believes is the subject of indemnity hereunder by the other Party hereto (an
“Indemnifying Party”), the Indemnified Party shall, as soon as reasonably practicable after forming such belief, give notice thereof to the Indemnifying Party, provided that the failure to give timely notice to the
Indemnifying Party as contemplated hereby shall not release the Indemnifying Party from any liability to the Indemnified Party unless the Indemnifying Party demonstrates that the defense of such claim is prejudiced by such failure. The Indemnifying
Party shall have the right, by prompt notice to the Indemnified Party to assume the defense of such claim at its cost, with counsel reasonably satisfactory to the Indemnified Party. If the Indemnifying Party does not so assume the defense of such
claim or, having done so, does not diligently pursue such defense, the Indemnified Party may assume the defense, with counsel of its choice, but at the cost of the Indemnifying Party. If the Indemnifying Party so assumes the defense, it shall have
absolute control of the litigation; the Indemnified Party may, nevertheless, participate therein through counsel of its choice and at its cost. The Party not assuming the defense of any such claim shall render all reasonable assistance to the Party
assuming such defense, and out-of-pocket costs of such assistance shall be for the 

  
 14 

 CONFIDENTIAL TREATMENT 
 [***] Indicates that text has been omitted which is the subject of a confidential treatment request. This text has been separately filed with the Securities and Exchange Commission 

 

	 	 
account of the Indemnifying Party. No such claim shall be settled other than by the Party defending the same, and then only with the consent of the other Party, which consent shall not be
unreasonably withheld; provided that the Indemnified Party shall have no obligation to consent to any settlement of any such claim which (i) imposes on the Indemnified Party any liability or obligation which cannot be assumed or
performed in full by the Indemnifying Party, (ii) does not unconditionally release the Indemnified Party, (iii) does require a statement as to or an admission of fault, culpability or failure to act by or on behalf of Indemnified Party or
any of its Affiliates or (iv) does impose any restrictions on the conduct of business by the Indemnified Party or its Affiliates. 

  

	9.	INSURANCE. 

  

	 	9.1	Insurance Requirements. Each Party shall obtain and keep in force during the term of this Agreement product liability insurance covering such occurrence
of bodily injury and property damage with a well established insurance carrier that generally does business in the Territory and is reasonably acceptable to the other Party for all claims in an amount of not less than $[***] combined single limit
for such year. 

  

	 	9.2	Continuation of Insurance. Each Party shall carry the insurance coverage set forth herein during the term of this Agreement and for two (2) years
following the termination of this Agreement or the latest expiration date of any Product sold and delivered hereunder, whichever is longer. 

  

	 	9.3	Certificates of Insurance. Each Party shall have the right to request from the other Party certificates of insurance and shall require at least thirty
(30) days written notice to such Party prior to any cancellation, nonrenewal or material change in coverage. 

  

	10.	REMEDIES AND LIMITATION OF LIABILITY. 

  

	 	10.1	Sagent Cover. If Gland is unable to supply Product manufactured by Gland to Sagent in the quantities and upon the delivery schedules specified by Sagent
in accordance with the terms of Article 2, Sagent reserves the right to seek to cover from an alternate FDA-approved source. In addition, Sagent shall be permitted, and Gland shall cooperate if requested, at Sagent’s expense, to add an
additional manufacturing site to the Product ANDA, at which site, notwithstanding any contrary provision in this Agreement, Sagent (directly or indirectly) shall be entitled (but shall not be obligated) to produce Product (a) in the event Gland
cannot meet Sagent’s requirements pursuant to this Agreement, (b) upon termination of this Agreement for any reason, or (c) in quantities sufficient to secure and maintain FDA approval of such alternate site. 

  
 15 

	 	10.2	Exhaustion of Inventory. Notwithstanding anything to the contrary, Sagent acknowledges and agrees that it shall not be entitled to seek any compensation
from Gland or any other remedy against Gland under this Article 10 until Sagent has exhausted its inventory of the Product. 

  

	 	10.3	Limitation of Damages. IN NO EVENT SHALL EITHER PARTY BE LIABLE FOR ANY CONSEQUENTIAL, SPECIAL OR PUNITIVE DAMAGES OR LOST PROFITS ARISING UNDER OR
RELATING TO THIS AGREEMENT, PROVIDED THAT SUCH LIMITATIONS SHALL NOT APPLY TO AMOUNTS PAYABLE WITH RESPECT TO ANY EXPRESS INDEMNITY PROVIDED UNDER ARTICLE 8. 

 

	11.	CONFIDENTIALITY AND PUBLICITY. 

  

	 	11.1	Confidentiality. Each Party to this Agreement (the “Receiving Party”) shall treat as confidential all information received in writing
marked “confidential” or if received orally, reduced to writing and marked “confidential” within thirty (30) days after the initial disclosure, which information is received from the other Party to this Agreement or any of
its employees, agents, consultants or Affiliates (the “Disclosing Party”) in connection with this Agreement (the “Proprietary Information”). The Receiving Party shall use at least the same standard of care as it
uses to protect is own proprietary information to ensure that its employees, agents, consultants, Affiliates, sub distributors and clinical investigators do not disclose or make any unauthorized use of information provided by the Disclosing Party.
The Receiving Party’s obligation of confidentiality, as aforesaid, shall continue during the term of this Agreement and after its termination or expiration in accordance with Section 14.9, with the exception that such obligation of
confidentiality on the Receiving Party shall not be applicable if: 

  

	 	(a)	the Receiving Party can demonstrate (by reference to competent evidence) that such Proprietary Information was either in the public domain or known to it before
disclosure by the Disclosing Party; 

  

	 	(b)	the Proprietary Information was lawfully disclosed to the Receiving Party after the date of this Agreement by any third party not in violation of any obligation to the
Disclosing Party; or 

  

	 	(c)	such Proprietary Information was independently developed by the Receiving Party as established by competent evidence; or 

 

	 	(d)	the Proprietary Information is required to be disclosed by legal or regulatory process; provided, in each case, that the Receiving Party timely informs the
Disclosing Party of such and uses reasonable efforts to limit the disclosure and maintain the confidentiality of the Proprietary Information to the extent possible and permits the Disclosing Party to intervene and contest or attempt to limit the
disclosure of such Proprietary Information. 

  
 16 

	 	11.2	Events upon Termination. Upon termination of this Agreement, if requested, the Receiving Party shall return to the Disclosing Party all documentation
containing Proprietary Information. 

  

	 	11.3	Confidentiality Agreement. The Parties acknowledge that they entered into a Mutual Confidential Disclosure Agreement on August 28, 2007_(the
“CDA”). The CDA shall govern disclosures between the Parties that occurred prior to the Effective Date of this Agreement according to its terms, and this Article 11 shall govern any disclosures between the Parties on or after the
Effective Date of this Agreement. 

  

	 	11.4	Terms and Existence of this Agreement. Neither Party shall disclose the terms or existence of this Agreement to a third party (whether by press release or
otherwise) without obtaining the prior written consent of the other Party, except as required by law. If any such disclosure is required by law, the disclosing Party shall give the other Party an opportunity to review and comment on the content of
such disclosure to the greatest extent practicable. 

  

	12.	COMPLIANCE WITH LAW. 

Each Party shall comply with, and shall not be in violation of, any valid applicable international, national, state or local statutes,
laws, ordinances, rules, regulations, or other governmental orders (“Laws”) of any country in which the Product is either manufactured or sold which materially affect the manufacture, processing, packaging, shipment, or storage of
the Product; provided that Gland shall only be required to comply with Laws of countries other than the United States upon specific written notice by Sagent of such Laws and inclusion in the Specifications, if applicable. 

 

	13.	TRADE NAMES AND TRADEMARKS. 

  

	 	13.1	Gland’s Rights. Sagent hereby acknowledges that it does not have, and shall not acquire by virtue of this Agreement, any rights to or under any
goodwill, trademark, trade name, copyright, patent or other intellectual property of Gland. Sagent agrees to do nothing by act or omission which would impair Gland’s or its Affiliates’ rights, ownership and title in the aforementioned.

  

	 	13.2	Sagent’s Rights. Gland hereby acknowledges that it does not have, and shall not acquire by virtue of this Agreement, any rights to or under any
goodwill, the ANDA for the Product, trademark, trade name, copyright, patent or other intellectual property of Sagent, nor in any of Sagent’s trademarks or trade names appearing on the label or packaging materials of the Product. Gland agrees
to do nothing by act or omission which would impair Sagent’s or its Affiliates’ rights, ownership and title in the aforementioned. 

  
 17 

	 	13.3	No Contest. Each Party further agrees not to contest, deny or dispute the validity of any trademarks or trade names owned by the other Party appearing on
the labels or packaging materials of the Product or the title of such other Party thereto, and not to assist others in doing so, and not to take action of any kind inconsistent with the holding of all such trademark rights by such other Party.

  

	 	13.4	Use. Neither Party shall use the trademarks or trade names owned by the other Party under which the Product is manufactured on any other goods or Product,
except as provided hereunder. Gland shall affix the trademark(s) of Sagent to the Product to be supplied to Sagent pursuant to this Agreement pursuant to the guidelines communicated by Sagent to Gland in writing. 

 

	 	13.5	Infringement. Each Party shall immediately report in writing to the other Party upon learning through any source whatsoever of any and all infringements
or threatened infringements of the trade names or trademarks owned by such other Party appearing on the labels and packaging materials of the Product, and any attempt on the part of anyone to register, copy, infringe upon or imitate such trademarks
or trade names, and if required by such Party, the notifying Party will, at the other Party’s sole expense, cooperate with the other Party in protecting the other Party’s rights. 

 

	 	13.6	Labeling. Sagent shall determine all labeling of the Product. Gland shall obtain prior written authorization from Sagent for all changes to the
Components in accordance with the terms of the Quality Agreement. Each use of a trademark, trade name or logo owned or used by Sagent on or in connection with the Product shall inure to the benefit of Sagent and its parent company. Should any such
use vest in Gland any rights in a trademark, trade name or logo used by Sagent, Gland shall and hereby does transfer such rights to Sagent or its designee upon request of Sagent, and Gland specifically disclaims and forfeits to Sagent any rights in
such trademarks, trade names or logos used by Sagent. Sagent shall indemnify and hold Gland harmless from any third-party claim arising out of the text of labels, inserts or packaging, provided such text has been used by Gland pursuant to
Sagent’s written directions. 

  

	14.	MISCELLANEOUS. 

  

	 	14.1	Dispute Resolution. 

  

	 	(a)	Choice of Law; Consent to Jurisdiction. This Agreement shall be governed by and construed in accordance with the laws of the State of New York, without
regard to its conflicts of laws rules. This Agreement shall not be construed against the Party preparing it, but shall be construed as if both Parties jointly prepared it. 

  
 18 

	 	(b)	Good Faith Negotiations. Any controversy, claim or dispute arising out of or relating to this Agreement or the breach thereof shall be settled, if
possible, through good faith negotiation between the Parties. Such good faith negotiation shall commence promptly upon a Party’s receipt of notice of any claim or dispute from the other Party and continue for a period of sixty (60) days.

  

	 	(c)	Arbitration. If any dispute addressed in Section 14.1(b) cannot be resolved by the senior executives within sixty (60) days after its
submission, then such dispute shall be settled by arbitration to be held in New York, NY in accordance with the Center for Public Resources Rules for Non-Administered Arbitration of Business Disputes except that (a) there shall be three U.S.
licensed attorneys acting as arbitrators, and (b) payment of the expenses of the arbitration, including legal fees for both Parties and the fee of the arbitrators, shall be assessed by the arbitrators based on the extent to which each Party
prevails. Each Party shall select one arbitrator. The two arbitrators selected by the Parties shall select the third arbitrator. At least one of the arbitrators shall be a licensed attorney who has represented pharmaceutical companies for at least
ten years and is knowledgeable concerning the subject matter at issue in the dispute. The award of the arbitrators shall be binding, and judgment upon the award rendered by the arbitrators may be entered in any federal court in the State of New
York. Nothing in this Agreement bars the right of Gland or Sagent to obtain preliminary or permanent injunctive relief against threatened conduct that will cause it loss or damage, in accordance with the rules for obtaining injunctive relief in any
jurisdiction, including the applicable rules for obtaining restraining orders and preliminary injunctions. 

  

	 	14.2	Integration and Amendment. This Agreement and the Exhibits hereto contain the complete agreement between the Parties with respect to the subject matter
hereof. All previous and collateral agreements, representations, warranties, promises and conditions relating to the subject matter of this Agreement are superseded by this Agreement. This Agreement may only be amended by a written instrument duly
executed by the Parties hereto. 

  

	 	14.3	Assignment. During the term of this Agreement the rights of either Party under this Agreement shall not be assigned, nor shall the performance of either
Party’s duties be delegated without the other Party’s prior written consent, except either Party may assign this Agreement to an Affiliate or a purchaser of all or substantially all of such Party’s business. Notice of assignment shall
be given to the other Party at least thirty (30) days prior to the effective date of said assignment. 

  
 19 

 CONFIDENTIAL TREATMENT 
 [***] Indicates that text has been omitted which is the subject of a confidential treatment request. This text has been separately filed with the Securities and Exchange Commission 

 

	 	14.4	Waiver. No waiver of any default by either Party shall be deemed to constitute a waiver of any subsequent default with respect to the same or any other
provision hereof. No waiver shall be effective unless made in writing with specific reference to this Agreement and signed by a duly authorized representative of the Party granting the waiver. 

 

	 	14.5	Notice. Any notice or request expressly provided for or permitted under this Agreement shall be in writing, delivered manually or by mail, telegram,
telefax or cable and shall be deemed sufficiently given if and when received by the Party to be notified at its address first set forth below, or if and when mailed by registered mail or certified mail, postage prepaid, addressed to such Party at
such address. Either Party, by notice to the other, may change its address for receiving such notices. 

  

					
	If to Gland:	    	Gland Pharma Limited
		    	6-3-865/1/2, Ameerpet
		    	Hyderabad, India 500016
		    	Attn: Managing Director
		    	Telephone:	  	 [***]

		    	Facsimile:	  	 [***]

		
	If to Sagent:	    	Sagent Holding Co.
		
		    	c/o M&C Corporate Services Limited
		
		    	PO Box 309 GT, Ugland House
		
		    	South Church Street
		
		    	George Town, Grand Cayman, Cayman Islands
		
	With a copy to:	    	Sagent Pharmaceuticals
		    	1901 N. Roselle Road, Suite 700
		    	Schaumburg, IL 60195 USA
		    	Attn: Jeffrey M. Yordon, CEO
		    	Telephone:	  	847-908-1600
		    	Facsimile:	  	847-908-1601

  

	 	14.6	 Severability Of Provisions. Each provision of this Agreement shall be treated as a separate and independent clause, and the
unenforceability of any one clause shall in no way impair the enforceability of any of the other clauses herein. Moreover, if one or more of the provisions contained in this Agreement shall for any reason be held to be excessively broad as to scope,
activity, subject or otherwise so as to be unenforceable at law, such 

  
 20 

	 	 
provision or provisions shall be construed by the appropriate judicial body or arbitration panel by limiting or reducing such provision or provisions, so as to be enforceable to the maximum
extent allowable under the applicable law as such law shall then be. 

  

	 	14.7	Independent Contractors. Each Party hereto shall be an independent contractor of the other. Neither Party shall be the legal agent of the other for any
purpose whatsoever and therefore has no right or authority to make or underwrite any promise, warranty or representation, to execute any contract or otherwise to assume any obligation or responsibility in the name of or on behalf of the other Party,
except to the extent specifically authorized in writing by the other Party. Neither Party shall be bound by or liable to any third persons for acts or obligations or debts incurred by the other toward such third party, except to the extent
specifically agreed to in writing by the Party to be so bound. 

  

	 	14.8	Force Majeure. Neither Party shall be liable to the other for default or delay in the performance of any of its obligations under this Agreement if such
default or delay shall be caused directly or indirectly by accident, fire, flood, riot, war, terrorism, act of God, embargo, strike, failure or delay of normal source of supply of materials, or delay of carriers, equipment failure or complete or
partial shutdown of plant by any of the foregoing causes or other causes beyond its reasonable control, including FDA action (“Force Majeure”), provided same are not due to the fault or neglect of such Party and
provided further that any such delay or failure shall be remedied by such Party as soon as possible after the cause of such failure or delay. 

 

	 	14.9	Survival. The obligations of the Parties contained in Sections 7.7, Article 8, Section 9.2 and Article 11 and paragraphs 1, 3, 4, 13, 15,
16, 20, 27, 28, 29, and 30 of the Quality Assurance Agreement shall survive the termination of this Agreement indefinitely. The obligations of the Parties contained in Article 11 shall survive until the later of (i) five years after the
Proprietary Information at issue is disclosed to the Receiving Party and (ii) five years after termination of this Agreement under Article 7 hereof. 

  

	 	14.10	Environmental Health & Safety. Gland represents, warrants and certifies that it complies with all environmental health and safety laws applicable
to Gland’s manufacture and sale of the Product and has determined that it is in compliance with such laws, and, subject to Article 8, Gland agrees to indemnify Sagent in the event that Gland does not comply with any such laws, and such
non-compliance results in any liability to any third party by Sagent. 

  

	 	14.11	 Diversity. This Section shall apply only to the extent that Gland is required to comply with United States federal or state law regarding
equal opportunity. Gland represents, warrants and certifies that it has made a 

  
 21 

	 	 
commercially reasonable good faith effort to recruit, hire, train, promote and retain persons of diverse backgrounds in its own labor force, and, at a minimum, is in compliance with all
affirmative action orders and regulations and decrees applicable to it. Gland also represents, warrants and certifies that it prohibits any form of unlawful discrimination in the facilities where the manufacturing and delivery of the Product occurs.
Gland agrees to allow reasonable access to its records, documents, persons, or premises during normal business hours if reasonably requested by Sagent for the purpose of determining whether Gland has complied with the above provisions in connection
with the manufacturing and delivery of the Product. 

  

	 	14.12	Headings; Interpretation. The section headings contained in this Agreement are for convenience of reference only, do not form a part of this Agreement and
shall not affect in any way the meaning or interpretation of this Agreement. Whenever the context may require, any pronoun shall include the corresponding masculine, feminine and neuter forms. The words “include,” “includes” and
“including” shall be deemed to be followed by the phrase “but not limited to.” All references herein to Articles, Sections and Exhibits shall be deemed references to Articles and Sections of, and Exhibits to, this Agreement
unless the context shall otherwise require. All Exhibits attached to this Agreement shall be deemed incorporated herein by reference as if fully set forth herein. Words such as “herein,” “hereof,” “hereto,”
“hereby” and “hereunder” refer to this Agreement and to the Exhibits, taken as a whole. Except as otherwise expressly provided herein: (a) any reference in this Agreement to any agreement shall mean such agreement as
amended, restated, supplemented or otherwise modified from time to time; (b) any reference in this Agreement to any law shall include corresponding provisions of any successor law and any regulations and rules promulgated pursuant to such law
or such successor law; and (c) all terms of an accounting or financial nature shall be construed in accordance with generally accepted accounting principles, as in effect in the United States from time to time. 

 

	 	14.13	Counterparts. This Agreement may be executed by the Parties hereto in separate counterparts, each of which when so executed and delivered shall be deemed
an original and all of which counterparts taken together shall constitute but one and the same instrument. 

  

	 	14.14	Further Assurances. The Parties shall execute such other instruments and make such further agreements as may be necessary and consistent with the
provisions of this Agreement and not inconsistent with any legitmate and substantive interest of such Party. 

  
 22 

 EXECUTION 
 IN WITNESS WHEREOF, the Parties have caused this Development and Manufacturing Agreement to be executed by their respective duly authorized representatives as of the day and year first above
written. 
  

			
	SAGENT HOLDING CO.
		
	By:	 	     /s/ Jeffrey M.
Yordon

			
	Name/Title:	 	 Jeffrey M. Yordon

		 	 Chief Executive Officer

 

			
	GLAND PHARMA LIMITED
		
	By:	 	 /s/ Srinivas Sadu

	Name:	 	Srinivas Sadu
	Title: Director of Business Development

  
 23 

 CONFIDENTIAL TREATMENT 
 [***] Indicates that text has been omitted which is the subject of a confidential treatment request. This text has been separately filed with the Securities and Exchange Commission 

 

 EXHIBIT A 
 PRODUCT AND TRANSFER PRICE 

Product:                    
                                         
                                         
           Heparin Sodium Injection USP for human use in vials 
  

					
	 Concentration

(USP Heparin Units/mL)
	 	 Fill Volume / Vial size
	 	 Initial Transfer Price*

(in US Currency)

	 1,000
	 	1 mL/ 2 mL	 	[***] / vial
	 1,000
	 	10 mL/ 10 mL	 	[***] / vial
	 1,000
	 	30 mL/ 30 mL	 	[***] / vial
	 1,000 (Preservative free)
	 	2 mL/ 2 mL	 	[***] / vial
	 5,000
	 	1 mL/ 2 mL	 	[***] / vial
	 5,000
	 	10 mL/ 10 mL	 	[***] / vial
	 10,000
	 	1 mL/ 2 mL	 	[***] / vial
	 10,000
	 	4 mL/ 5mL	 	[***] / vial
	 20,000
	 	1 mL/ 2 mL	 	[***] / vial

  

	 	•	Note: Transfer prices are applicable considering the API price [***]. Any change in the API price will accordingly change the Transfer prices

  
 24 

 CONFIDENTIAL TREATMENT 
 [***] Indicates that text has been omitted which is the subject of a confidential treatment request. This text has been separately filed with the Securities and Exchange Commission 

 

 EXHIBIT B 
 PRODUCT SPECIFICATIONS 
 Heparin Sodium Injection (USP)

 This specification is subject to change in accordance with the terms of the Agreement. 

 

			
	 Test
	  	Specification

[***] 
  

  
 25 

 EXHIBIT C 
 QUALITY ASSURANCE AGREEMENT 
  

			
	1.	  	Definitions
	2.	  	Product Warranty
	3.	  	Product Shelf Life
	4.	  	Product Inspections
	5.	  	Disputes with respect to Rejection
	6.	  	Master Formula
	7.	  	Manufacturing Conditions
	8.	  	Good Manufacturing Practices
	9.	  	Chemical and Packaging Components Inspection and Release
	10.	  	Documentation
	11.	  	cGMP Records and Reporting
	12.	  	Labeling
	13.	  	Change Control
	14.	  	Batch Records
	15.	  	Batch Documents to be Included with each Shipment of Product to Sagent
	16.	  	Shipping
	17.	  	Retention Samples
	18.	  	Product Complaint
	19.	  	Process Validation
	20.	  	Regulatory Visits
	21.	  	Changes to Specifications
	22.	  	Commercial Stability
	23.	  	Quality Audits
	24.	  	Additional Suppliers
	25.	  	Provision of Documents to Customers
	26.	  	Regulatory Approval
	27.	  	Regulatory Contacts
	28.	  	Recall Action
	29.	  	Recall Expenses
	30.	  	Recall Records
	31.	  	Debarment
	32.	  	Product Release
	33.	  	Drug Pedigree

  
 26 

 Sagent Holding Co. (“Sagent”) and Gland Pharma Limited (“Gland”) have
entered into a Contract Manufacturing Agreement (“Agreement”) for Gland to manufacture Amiodarone (the “Product”). This Quality Assurance Agreement (the “Quality Agreement”) covers specific quality and regulatory
requirements for this activity. 
 1. Definitions. Unless expressly defined herein, all definitions in this Exhibit have the same meaning
as in the Agreement to which this Exhibit is attached. 
 2. Product Warranty. Gland warrants the Products supplied by Gland at the time
of delivery shall conform to the Specifications therefore, and shall have been manufactured in accordance with current Good Manufacturing Practices as listed in 21 CFR 211. Gland further warrants and guarantees that, as of the date of each shipment
hereunder to Sagent, or its designee, of any Product subject to the provisions of the United States Food and Drug and Cosmetic Act (the “FDA Act”), such Product shall not, when shipped, be adulterated or misbranded within the meaning of
the FDA Act, or be an article which may not, under the provisions of the FDA Act, be sold in the Territory. The warranties contained herein shall not apply to any Product which after delivery (i) has been tampered with or otherwise altered
other than by Gland, (ii) has been subject to misuse, negligence or accident other than by Gland, or (iii) has been stored, handled or used in a manner contrary to the FDA requirements other than by Gland. EXCEPT AS OTHERWISE EXPRESSLY
PROVIDED BY THIS AGREEMENT, GLAND MAKES NO OTHER WARRANTIES, EITHER EXPRESS, IMPLIED OR OTHERWISE, AND SPECIFICALLY DISCLAIMS ANY IMPLIED WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE. 

3. Product Shelf Life. Product supplied by Gland shall, at the time of delivery to Sagent, have no more than four months time exhausted from the
total approved shelf life of the Product. In situations in which Gland proposes to supply Product that does not meet the foregoing shelf life specification, Sagent agrees to review such exceptions on an individual basis. 

4. Product Inspections. Within forty-five (45) days after receipt of Product by Sagent at its facility or at the time of rejection by a
Sagent Quality Manager, Sagent must notify Gland in writing if the Product does not meet the Specifications as determined by Sagent’s testing and inspection of the product, except for any latent defect which shall be reported to Gland within
thirty (30) calendar days after discovery; provided, however, that there shall be no time restrictions on Sagent’s provision of notice to Gland in the event Gland has breached any of its representations, warranties or obligations under the
terms of the Agreement. If Gland agrees, Gland shall replace the Product at no charge as soon as reasonably possible and shall pay for shipping charges to deliver Product or replacement Product to Sagent. Non-conforming Product that is not in
Gland’s possession shall, upon mutual agreement by the parties and at Gland’s sole expense, either (i) be returned to Gland within a reasonable period of time or (ii) be destroyed by Sagent. If requested by Sagent, Gland shall
assist Sagent in the transfer of the required analytical test methods to monitor the product to Sagent or Sagent’s designee including an independent FDA approved testing organization as provided for in Section 5 of the Quality Agreement.
If required, Gland will provide all required analytical methodology, the associated documentation and required standards. The warranties given by Gland in this agreement shall survive until the expiration date on the Product not withstanding any
failure to reject by Sagent pursuant to this Section. 

  
 27 

 5. Disputes with Respect to Rejection. If Gland disputes Sagent’s right to reject all or part of
any shipment of the Products as set forth above, and such dispute is not resolved by mutual agreement of the parties within sixty days of Sagent’s notice of rejection, such dispute shall be resolved by an independent FDA approved testing
organization or recognized expert consultant mutually agreed upon by the parties, the appointment of which shall not be unreasonably withheld or delayed by either party. The determination of such entity with respect to all or part of any shipment
shall be final and binding upon all parties, but only as to reasons given by Sagent in rejecting the shipment or portion thereof and shall have no effect on any matter for which said entity did not render a determination. The fees and expenses of
the third party making the determination shall be paid by the party against which the determination is made. 
 6. Master Formula. The
composition of Products to be sold in the U.S. will be as stated in the applicable Product DMF and NDA or ANDA. 
 7. Manufacturing
Conditions. Gland represents that it has, or will have, adequate premises and equipment and sufficient knowledge and experience to carry out activities relating, directly or indirectly, to the manufacture and supply of Product to Sagent in
accordance with the terms of the Agreement. Gland represents that it has a formal program to train and document training of its employees. Gland represents that all employees are fully trained and qualified to perform their duties. Gland is an FDA
approved manufacturer of pharmaceuticals and is, as such, under the inspection of the U.S. Food and Drug Administration and other regulatory agencies. 
 8. Good Manufacturing Practices. Products will be manufactured and packaged by Gland or by agreed upon third-party manufacturers in accordance with current Good Manufacturing Practices
(“cGMP”) and the applicable approved DMF and NDA or ANDA. 
 9. Chemical and Packaging Component Inspection and Release. Gland
shall test, inspect and release all API and inspect and release all Materials and Components used in the manufacture of Product. Gland shall inspect and release all labels, package inserts, and labeling utilized for Product for conformance with such
approved masters. Gland shall inspect and release all other packaging components in compliance with Specifications. All APIs, Components and Material for Product to be sold in the U.S. will be procured, by Gland in accordance with the applicable
approved U.S. ANDA. Any proposed change to such Gland’s, tests or release requirements shall be subject to the procedure described herein. Gland agrees that Sagent may at its option participate in quality audits of all API, Material and
Component; however, Gland has sole responsibility for all Materials and Component vendor qualifications as required under cGMPs. 
 10.
Documentation. Upon request, Gland shall provide to Sagent complete, written manufacturing and testing procedures and other documentation necessary for the manufacture of the Product prior to Gland’s commencement of manufacturing or
packaging operations with respect to the Product. Such procedures must be supplied at least three months prior to delivery of Product to Sagent. Gland will update such information to reflect changes in the manufacture and/or packaging of the Product
with new information prior to implementing such changes. 

  
 28 

 11. cGMP Records and Reporting. Commencing with inception of manufacturing, Gland shall keep all
records required under the cGMPs in accordance with document retention requirements of the cGMPs. All such records shall be made available to Sagent for inspection at any time during Gland’s normal business hours. 

 

	12.	Labeling. 

 (a) All labels
for Products shall use the Sagent name and the Sagent NDC number. Gland shall be permitted to use such labels only on Products delivered to Sagent hereunder. Sagent shall provide in a timely manner the camera-ready artwork for labeling for the
containers, package inserts and shipping containers in the form specified by Gland at Sagent’s cost. Sagent shall have approved all such labeling in writing in advance of initial printing. From time to time, Sagent may request Gland modify the
artwork or Labeling. Sagent and Gland shall mutually develop the timeline for implementation of the revised labeling. Gland shall make all reasonable efforts to implement the revised Labeling in accordance with the Sagent schedule. Unless otherwise
agreed, labeling approved by Sagent shall be the only labeling used by Gland for Products, provided that any labels and package inserts shall be consistent with FDA and Gland’s requirements with regard to physical dimensions and specifications
relating to the methods of handling and affixing on container. Gland may modify artwork as necessary to meet its requirements or the print vendor requirements and equipment design specifications; however, in such cases, Gland will submit final
proofs of artwork and labeling to Sagent for final approval. Sagent shall have approved all such Labeling in writing in advance of initial printing and Gland shall have a system for control of master labeling. Any label artwork preparation and setup
charge shall be billed to Sagent on a pass through cost basis. In addition, all costs associated with any labeling changes required by Sagent or required by the FDA, including the costs associated with any labeling or packaging rendered obsolete by
such changes, shall be borne by Sagent. 
 (b) All code or product specific printed material or labeling, excluding promotional
and advertising material, shall be 100% electronically verified or printed on line. Gland shall be responsible for the appropriate barcoding per cGMP requirements. 
 (c) Gland will monitor the Reference Listed Drug package insert text. Gland and Sagent will consult from time to time on the need for changes in prescribing information (package insert) or in the labeling
of packaging and containers of the Products or in the Product information supplied to customers, the medical profession or patients. Gland and Sagent will comply with all regulatory requirements. 

(d) The shipping label shall be in Healthcare Distribution Management Association (HDMA) format and shall include the following
information: 
  

	 	•	 	 Name and address of Company 

  

	 	•	 	 NDC number 

  

	 	•	 	 Lot number 

  

	 	•	 	 Lot Expiration Date 

  

	 	•	 	 Quantity 

  

	 	•	 	 Storage and special transportation conditions 

  
 29 

 13. Change Control. Gland will notify Sagent in writing of any proposed change, including changes to
the APIs or components of the Product, process specifications and/or controls, as well as the manufacturing and/or packaging of Product, if the proposed change requires FDA notification. Gland will notify Sagent in writing of any other critical
change, which does not require FDA notification, including changes to specifications, in-process specifications and process validation. Sagent shall have the opportunity to review and comment on any such changes; however, final approval for
implementation or submission to regulatory authorities rests with Gland. Notwithstanding the foregoing, in the event that any proposed change is required by any governmental authority which contravenes the requirements of the United States Food,
Drug and Cosmetic Act, Gland shall deliver written notice to Sagent specifying such change required by such governmental authority. Such change shall be deemed to have been accepted by Sagent unless within thirty (30) days after Sagent’s
receipt of such notice, it shall notify Gland in writing that it cannot, in good faith, agree to such a change. If Sagent determines that such change required by such governmental authority cannot be so agreed to, then Sagent and Gland shall
negotiate, in good faith, an amendment to the Agreement deleting the Product to which the proposed changes are applicable and altering or adding such other terms as may be just and equitable in the circumstances. Gland will provide official copies
of revised documents to Sagent within five (5) working days after internal Gland’s approval. 
 14. Batch Records. Records
which include the information relating to the manufacturing, packaging and quality operation for each lot of Product shall be prepared by Gland for each lot at the time at which such operations occur. The records shall include, but are not limited
to, the following documentation: manufacturing, raw materials and components charge-in-records; mixing and filling records; packaging component charge-in records; packaging records; container and component traceability records; in-process and final
laboratory testing results; in-process and final product physical inspection results; yield reconciliation for bulk and finished product; label samples; deviations and/or excursions from approved procedure (as well as the Gland investigation and
corrective actions) incurred during the processing and packaging of the lot. Sagent may review the original documents for each lot at its request when auditing the sites of manufacture of Products. Copies of all batch records and deviation/exception
reports are to be sent to Sagent’s QA organization for release review for the first three lots of Product and every tenth lot thereafter. Copies of all batch records and deviation / exception reports shall also be made available upon reasonable
request. 
 15. Batch Documents to be Included With Each Shipment of Product to Sagent. The following outlines the minimum batch
documentation required to be sent to Sagent’s QA organization for release review and included with each lot of Product shipped to Sagent or Sagent’s designee: 
  

	 	•	 	 Packaging Bill of Materials 

  

	 	•	 	 Copies of Certificate of Analysis for each lot 

  

	 	•	 	 Certificate of Compliance 

  

	 	•	 	 Sagent’s Batch Record Package Approval Form (form controlled under Sagent’s internal standard operating procedure and to be provided to
Gland). 

  

	 	•	 	 Packaging Lits (to be shipped with product to Sagent’s Distributor) which shall include the following information: 

 

	 	•	 	 NDC Number 

  

	 	•	 	 NDC Description 

  

	 	•	 	 Lot Number 

  

	 	•	 	 Lot Expiration Date 

  

	 	•	 	 Quantity 

  
 30 

 The certificate of analysis, signed by the responsible quality official, must include the numerical results
for each test (chemical, microbiological and bacteriological) performed to assure results are in compliance with Product Specifications, the date of manufacture and expiration date of the Product, as well as a statement that the subject lot was
produced in accordance to the applicable ANDA and in compliance with all applicable cGMP requirements. 
 16. Shipping. Gland shall
assure that Product is handled and shipped under approved storage and packaging conditions without damage to Product, until risk of loss has passed to Sagent. Upon request, Gland shall provide documentation to Sagent of all packaging validations for
the Products. 
 17. Retention Samples. Gland is responsible for storing, annual inspection, and maintaining retention samples of
Products from each lot supplied to Sagent to meet regulatory requirements. Gland is responsible for storing and maintaining retention samples of each lot of raw material utilized in the manufacture of Products in accordance with all FDA regulatory
requirements. 
 18. Product Complaint. Sagent shall report all Product complaints to Gland as soon as possible but in no event later
than within ten (10) working days. Gland shall be responsible for investigating Product complaints by analyzing Product and Materials to determine the cause, if any, of an alleged Product manufacturing defect or failure. Upon reasonable request
from Gland, Sagent shall assist as is reasonably necessary. Gland shall use commercially reasonable efforts to provide a written report of its determination within twenty (20) days of receipt of Sagent ‘s written request and samples of the
involved Products. Sagent shall be responsible to ensure that Gland receives samples of the Products to be investigated. In the event that Gland determines that any reasonable additional physical, chemical, biological, or other evaluation should be
conducted by Gland in relation to a product complaint, Gland shall conduct the necessary evaluation and advise Sagent of the results. In the event that Sagent requests that any reasonable additional physical, chemical, biological, or other
evaluation be conducted by Gland in relation to a product complaint, Sagent shall so advise Gland. In the event that Gland determines after evaluation that such testing is reasonable to be done, Gland shall conduct the necessary evaluation and
advise Sagent of the results. Sagent shall correspond with complainants on all product complaints associated with Products. Each Party shall maintain written records of complaints in accordance with cGMPs and shall make such records reasonably
available for review during audits or in the course of complaint investigations. 
 19. Process Validation. Gland shall validate, at its
sole cost, all processes, equipment, utilities, facilities and computers utilized in the manufacture, packaging, storage, testing and release of Products for regulatory submissions and commercial sale in conformance with all current FDA guidelines
and regulations and, subject to Section 1 hereof, the guidelines of other applicable regulatory agencies outside the U.S. Gland shall be responsible for and shall ensure that all validated systems are maintained according to FDA guidelines
(and, subject to Section 1 hereof, the guidelines of other applicable regulatory agencies outside the U.S.) and that all required periodic revalidations are performed according to these guidelines. Sagent shall reserve the right to review all
Master Validation Plans and/or the corresponding protocols if no Master Plan exists prior to the execution of such validation. 

  
 31 

 20. Regulatory Visits. Gland shall, within two (2) working days, notify Sagent in the event of
any FDA or other regulatory authority inspection regarding Products. In the event of an inspection by the FDA that results in a concern by the FDA specifically related to Product (s), then Sagent through its designee, Sagent will be notified within
two (2) business days of such concern. Gland shall furnish to Sagent, not later than five (5) business days prior to the time it provides to the FDA, copies of proposed responses or explanations relating to the Products in each case purged
of Confidential Information that is unrelated to the Products. Gland shall allow Sagent the opportunity to review and comment on any proposed response to the FDA and shall consider in good faith any comments proposed by Sagent on the proposed
responses. After the filing of a response with the FDA, Gland shall notify Sagent and provide Sagent with copies of any further contacts with the FDA relating to the subject matter of the response. 

21. Changes to Specifications. Changes to Specifications of the Products shall be made in accordance with the Change Control requirements of the
Quality Agreement. In the event that Sagent desires any change to the Specifications of the Products, Sagent shall deliver written notice to Gland specifying such change desired by Sagent and Gland shall respond to any such notice within thirty
(30) days after Gland’s receipt thereof. 
 22. Commercial Stability. Gland shall be responsible for the generation of all data
and associated reports for all stability studies in support of the currently approved ANDA in accordance with the on-going marketed protocol for each of the Products. Gland shall provide Sagent on an annual basis with copies of stability data and
reports at the time Gland performs their annual review. If any out of specification result is confirmed, Gland will consult with Sagent on the situation and any corrective actions. 
 23. Quality Audits. Sagent shall have the right, at least once every twelve (12) months, or more frequently as circumstances require, and on reasonable prior notice (which notice shall be
waived if circumstances warrant), to inspect those sections of the manufacturing, packaging, laboratory and warehousing facilities utilized in the manufacture, packaging, storage, testing, shipping or receiving of Products. Such inspections may
include cGMP inspections, APIs, the work in process and Products as well as all batch records. The frequency and extent of inspections shall be determined by mutual agreement of Gland and Sagent in accordance with the Quality Agreement. Sagent shall
have the right to station a quality manager or Sagent designee at the manufacturing facilities for the Products on substantially a full-time basis, when there is work being conducted that relates to the Products, for the purpose of monitoring the
production, and quality assurance activities and reviewing batch records with respect to the Products. Gland will provide an appropriate working area for the Sagent quality manager or Sagent designee to perform these required duties. 

24. Additional Suppliers. Unless requested by Sagent, all costs incurred in qualifying additional Suppliers of APIs, Materials, and Components for
the Product in addition to the cost of qualifying the primary Gland thereof shall be borne by Gland. If Sagent requests the qualification of additional Suppliers, the cost of qualifying the additional Gland will be borne by Sagent. 

  
 32 

 25. Provision of Documents to Customers. Gland will provide, at Sagent’s request, specific
documentation relating to the quality of manufacturing operations and regulatory history for the Products as requested by Sagent’s customers when such document request is considered reasonable by Gland or when such documents would be available
under the Freedom of Information Act. 
 26. Regulatory Approval. Gland represents that prior to the first commercial sale of Product by
Sagent, and at all time thereafter during the Term of the Agreement, it will have an FDA approved ANDA for each of the Products. 
 27.
Regulatory Contacts. Gland will be responsible for all regulatory contacts and filings with the FDA. If Gland is required to submit documentation to the FDA or otherwise communicates with the FDA, which documents or communications relate
directly to the Product or that could reasonably be anticipated to affect the Product, Sagent or its representatives may review and comment at its discretion on all such documents and other communications prior to their submission. Gland shall
consider in good faith any comments proposed by Sagent on the proposed responses. Gland shall notify Sagent promptly (within 1 business day) of any adverse finding related to the submission of such documentation by the FDA that relates directly to
the Product or that could affect the Product. 
  

	28.	Recall Action. 

 (a) In
the event Sagent should be required or should voluntarily decide to initiate a recall, Product withdrawal, or field correction of any Products in the Territory pursuant to this Agreement, Sagent through its designee shall notify Gland and provide a
copy of its proposal, including the recall letter, for review prior to initiation of such action, and shall consult with Gland prior to initiation of such action; provided, however, that Sagent shall not be prohibited hereunder from taking any
action that it is required to take by applicable law. In conjunction with such recall, Gland shall assist in the investigation to determine the cause and extent of the problem. 

(b) In the event that Gland independently believes that a recall, Product withdrawal, or field correction for Products may be necessary
or appropriate, Gland shall notify Sagent through Sagent’s designee of Gland’s belief, and the parties shall fully cooperate with each other concerning the necessity and nature of such action. 

29. Recall Expenses. In the event that any Product is recalled as a result of (1) the supply by Gland of Product that does not conform
to any requirement set forth in the Agreement or (2) the negligent or intentionally wrongful act of Gland or its representatives, then Gland shall bear all of the out-of-pocket costs and expenses of such recall including without limitation
expenses related to communications and meetings with all required regulatory agencies, expenses of replacement stock, the cost of notifying customers and costs associated with shipment of recalled Product from customers and shipment of an equal
amount of replacement Product to those customers. In the event that any Product is recalled as a result of the negligent or intentionally wrongful act of Sagent, or its representatives (including, without limitation, negligent or

  
 33 

 
intentionally wrongful acts in connection with label copy supplied by Sagent or in storing or shipping the Product), then Sagent shall bear all of the costs and expenses of such recall, including
without limitation expenses related to communications and meetings with all required regulatory agencies, expenses of replacement stock, the cost of notifying customers and costs associated with shipment of recalled Product from customers and
shipment of an equal amount of replacement Product to those customers. In the event that the reason for any recall of Product hereunder is in part the responsibility of Gland and in part the responsibility of Sagent then the expenses shall be
allocated in an equitable manner between the parties. 
 30. Recall Records. Each of the parties shall maintain complete and accurate
recall records of Products for such periods as may be required by applicable law, but in no event less than three (3) years. 
 31.
Debarment. Gland represents that it is not debarred under the Generic Drug Enforcement Act of 1992 and that Gland does not employ or use the services of any individual who is debarred or has engaged in activity that could lead to debarment.

 32. Product Release. Gland, as manufacturer and owner of the ANDAs for the Products, is responsible for quality control release of the
products to commerce. Sagent, as a private label distributor, is responsible for further distribution of the Products once dispositioned by Gland for release. Sagent’s further distribution to commerce shall be based on Sagent’s internal
procedures and the batch records and any other production and technical document package provided by Gland in accordance with this Agreement. 

33. Drug Pedigree. Sagent shall be responsible for assuring compliance with all applicable United States Federal and State drug pedigree
requirements. For the sole purpose of complying with such drug pedigree requirements, Gland authorizes Sagent to designate on behalf of Gland Sagent’s distributors as Authorized Distributors of Record. Gland shall assist Sagent in complying
with drug pedigree requirements including but not limited to maintaining a publically available list of Sagent’s Authorized Distributors of Record. 
  

			
	GLAND PHARMA LTD.
		
	By:	 	  

			
	Title: Vice President of Quality
	GLAND PHARMA LIMITED,
	6-3-865/1/2, Ameerpet, Hyderabad-5000 016, India
	Date:	 	                    

			
	
	SAGENT HOLDING CO.
		
	By:	 	  

			
	Title:	 	
	Date:	 	                    

  
 34 

 EXHIBIT D 
 ADVERSE EVENT REPORTING AGREEMENT 
  

	1.	PURPOSE: 

 Sagent Holding
Co. (“Sagent”) and Gland Pharma Limited (“Gland”) have entered into a Contract Manufacturing Agreement (“Agreement”) for Gland to manufacture Amiodarone (the “Product”). This Adverse Event Reporting Agreement
(the “AE Agreement”) sets forth the terms for the exchange of information between Gland and Sagent regarding any category of adverse drug experience or any safety issue, as defined in Section 4 below, involving the Product(s), and to
set forth each Party’s reporting responsibilities. Capitalized terms used in this AE Agreement, which are not defined herein, shall have the meanings given to those terms in the Agreement. 

 

	2.	SCOPE: 

 This Agreement
applies to all categories of adverse drug experiences, as defined in Section 4 below, reported to either Sagent or Gland, including those spontaneously reported (i.e., ADEs occurring post-market), and those reported during a clinical trial
(i.e., ADEs occurring pre-market). 
  

	3.	REFERENCES: 

  

	 	3.1	Title 21 of the United States Code of Federal Regulations, Section 312.32, 310.305 and 314.80. 

 

	 	3.2	FDA Guideline for Reporting Post-Marketed Adverse Drug Experiences. 

  

	 	3.3	ICH Guideline E2A – Clinical Safety Data Management: Definitions and Standards for Expedited Reporting. 

 

	 	3.4	Development and Supply Agreement between Sagent and Gland. 

  
 35 

	4.	DEFINITIONS: 

  

	 	4.1	Adverse Drug Experience (“ADE”) 

 Any undesirable medical experience or event occurring in a subject /patient administered a Product(s). This includes any unfavorable and unintended sign (including any abnormal laboratory finding),
symptom or disease temporarily associated with the use of a Product. If such experience or event occurs during a clinical trial, it will be considered an ADE whether or not it is considered causally related to the Product(s). The following are types
of ADEs: 
  

	 	a.	Serious Adverse Drug Experience (“SAE”) 

 Any ADE that results in any one or more of the following outcomes: death, a life threatening experience, in-patient hospitalization or prolongation of existing hospitalization, a persistent or significant
disability/incapacity, or causes congenital anomaly / birth defect. Medical events or experiences that do not result in death, are not life-threatening, nor require hospitalization may be considered an SAE when based upon appropriate medical
judgment, such event or experience jeopardizes the patient and may require medical or surgical intervention to prevent one of the outcomes listed above. 
 During a clinical trial, with respect to results obtained from tests on laboratory animals, an SAE includes any experience suggesting a significant risk for human subjects, including any finding of
mutagenicity, teratogenicity or carcinogenicity. 
  

	 	b.	Life-Threatening Adverse Drug Experience 

 Any ADE that puts the patient at immediate risk of death. It does not include a reaction that, had it occurred in a more serious form, might have caused death. 

 

	 	c.	Unexpected Adverse Drug Experience 

 Any ADE that is not identified in nature, severity, or frequency in the current source documents (i.e., the investigator brochure, or, if an investigator brochure is not required, that is not identified
in nature, severity, or frequency in the risk information described in the general investigational plan or elsewhere in the current application, as amended). 
  

	 	d.	Non-Serious Adverse Drug Experience 

 Any ADE associated with the use of a drug in humans which does not fall within the definition of any of the preceding categories will be defined as a non-serious ADE, for purposes of this Agreement.

  

	 	4.2	Reporting Party 

 The
Reporting Party is Gland. 
  

	 	4.3	Minimum Criteria 

 The
minimum criteria required for an ADE report, which must include the following: 
  

	 	•	 	 Name of the drug, 

  

	 	•	 	 Event or outcome, 

  

	 	•	 	 Patient identifier (any one or more of name, initials or clinical investigation number, age, sex ore weight), and 

 

	 	•	 	 Identifiable source of the report. 

  
 36 

	 	4.4	Receipt Date of an Adverse Drug Experience (“Receipt Date”) 

 The date of the receipt of an ADE is considered to be the date on which the minimum criteria to consider a report of an ADE is received by the Reporting Party or designee. 

 

	 	4.5	Investigational Stage 

Any clinical study of the Product(s) conducted in the pre-approval phase or any study conducted in the post-marketing phase that is under
an investigational new drug application (“IND”) or equivalent document. 
  

	 	4.6	Marketing Stage 

 Any
study that is conducted after applicable governmental approval or licensing of the Product(s) allows for commercialization of the Product(s). 
  

	 	4.7	Significant Safety Issue 

Any and all other issues/and or problems, which fall outside the above categories of ADEs as, defined in Section 4. A significant
safety issue includes product recall, mislabeling, etc. 
  

	5.	TYPES OF REPORTS; REPORTING TO REGULATORY AUTHORITIES 

  

	 	5.1	Expedited Adverse Drug Experience Reports For Clinical Studies 

 All ADEs that are serious, unexpected and associated with the Product that is being studied are subject to expedited reporting to the regulatory authorities. This applies to reports from any type of
clinical or epidemiological investigation, independent of design or purpose. It also applies to cases not reported directly to the Party sponsoring the clinical study or to the Party manufacturing the Product(s) (for example, those found in
regulatory authority-generated ADE registries or in publications). The source of a report (i.e., investigation, spontaneous, other) should always be specified. Expedited Adverse Drug Experience Reports for Clinical Studies are subject to the
following reporting requirements: 
 a) Fatal or life-threatening, unexpected ADEs that occur in clinical investigations and are
associated with the Product being studied must be reported by the Reporting Party, as defined in Section 4.2, above, to the appropriate regulatory authorities as soon as possible (by telephone, fax or in writing), but no later than five 5
calendar days following Receipt Date. This initial report must be followed within ten (10) additional calendar days by a supplemental written report from the Reporting Party to the appropriate regulatory authorities that contains as much of the
completed information as possible. This supplemental report must include an assessment of the importance and implication of the findings, including relevant previous experience with the same or similar medicinal products. 

  
 37 

 b) All other serious, unexpected ADEs that occur in clinical investigations and which are
related to the Product being studied must be reported by the Reporting Party to the appropriate regulatory authorities, and the other Party, as soon as possible but no later than 15 calendar days after Receipt Date. 

 

	 	5.2	Non-Expedited Reports For Clinical Studies 

 An SAE that occurs in a clinical investigation and that does not meet the requirements for expedited reporting, as set forth in Section 5.1 above, is subject to periodic reporting (e.g. US IND Annual
Report, UK CTX renewal) by the Reporting Party. Events that must be reported in a non-expedited manner include those that are not serious or life threatening, but that occur frequently in the study. Non-Serious Adverse Drug Experiences occurring in
a clinical investigation shall be reported on a “study by study” basis at the end of the study for inclusion in an annual report, and inclusion in a study report. 

 

	 	5.3	Expedited Adverse Drug Experience Reports For Post–Market ADEs 

 All ADEs reported post-market that are both serious and unexpected are subject to expedited reporting. This applies to reports received from spontaneous sources and from any type of clinical or
epidemiological investigation, independent of design or purpose. It also applies to cases not reported directly to a Party (for example, those found in regulatory authority generated ADE registries or in publications). The source of a report (i.e.,
investigation, spontaneous, other) should always be specified. 
 All serious, unexpected ADEs that occur post-market must be
reported by the Reporting Party to the appropriate regulatory authorities as soon as possible, but no later than 15 calendar days after Receipt Date. 
  

	 	5.4	Non-expedited Reports For Post-Market ADEs 

 ADEs which are reported post-market and which do not meet the criteria for Expedited Reporting as set forth in Section 5.3, above, shall be reported on a periodic basis (e.g. NDA Periodic Report, UK
CTX renewal) by the Reporting Party. 
  

	 	5.5	Follow-up Reports For Clinical Studies and Post-Market ADEs 

 Follow-up Reports must be submitted by the Reporting Party when revised or additional information is received on an already reported ADE within the same time periods required for the initial report as set
forth in Sections 5.1-5.4. If the Reporting Party receives additional information that changes the status of a non-expedited ADE to an expedited ADE, the Reporting Party shall submit a Follow-up Report within the applicable time periods specified in
Section 5.1 or Section 5.3. 
  

	6.	REPORTING BETWEEN THE PARTIES 

  

	 	6.1	Adverse Drug Experience Reporting Responsibility for Product(s) where Sagent is not the Reporting Party 

  
 38 

 Sagent will report all ADEs it receives that result in a fatality to the Reporting Party
within one (1) working day of Receipt Date by phone or fax. If the report is made by phone, Sagent must forward a full report to the Reporting Party within five (5) calendar days of Receipt Date. Legible fax copies will be acceptable.
Sagent will report all other ADEs within five (5) calendar days of Receipt Date. Fax copies will be acceptable. The Reporting Party will send copies of 15-day reports to Sagent concurrent with regulatory authority submission. The Reporting
Party will forward to Sagent copies of periodic safety reports within thirty (30) days of submission of the report to regulatory authorities. Any exceptions will be handled on a case-by-case basis. 

 

	 	6.2	Adverse Drug Experience Reporting Responsibility for Product(s) where Gland is not the Reporting Party 

Gland will report all ADEs it receives that result in a fatality to the Reporting Party within on (1) working day of Receipt Date by
phone or fax. If the report is made by phone, the Gland must forward a full report to Sagent within five (5) calendar days of Receipt Date. Legible fax copies will be acceptable. Gland will report all other ADEs within five (5) calendar
days of Receipt Date. Fax copies will be acceptable. The Reporting Party will send copies of 15-day reports to Gland concurrent with regulatory authority submission. The Reporting Party will forward to Gland copies of periodic safety reports within
thirty (30) days of submission of the report to regulatory authorities. Any exceptions will be handled on a case-by-case basis. 
  

	 	6.3	Reporting Responsibility for Literature ADEs 

 The Reporting Party for a Product shall search for evidence of ADEs published in literature by conducting a search of widely used systematic literature review and reference database, such as Medline,
Excepta Medica or Embase, at least once a month. The Reporting Party for a Product(s) shall ensure that relevant publications in each member state are reviewed. If any ADE is found in the literature, the Reporting Party shall report such ADE to the
appropriate regulatory authorities and to the other Party pursuant to the applicable procedures and timeframes set forth in this Agreement. For purposes of this Agreement, a literature ADE is considered to be found on the day that any personnel of
the Reporting Party or its designee become aware of the publication. 
  

	 	6.4	Significant Safety Issues 

Any significant safety issues and/or problems brought to the attention of the either Party will be communicated to the other Party within
one (1) working day. 
  

	7.	CLASSIFICATION OF ADVERSE DRUG EXPERIENCES 

 Each Party shall make an initial assessment as to the seriousness of an ADE in accordance with the definitions set forth in Section 4; however, each Party is entitled to have its own medical advisors
change the initial classification of an ADE according to the regulatory requirements of the reporting country and the approved labeling information. The ultimate responsibility for classification of an ADE resides with the Reporting Party, unless
otherwise specified in the ED Agreement. 

  
 39 

	8.	PROCESSING OF INFORMATION 

  

	 	8.1	Standard Operating Procedures 

 The Reporting Party will process the ADE information as per its standard operating procedures. 
  

	 	8.2	Supporting Documentation 

Each ADE report shall be accompanied by all supporting documentation or reports that are available to the Reporting Party. 

 

	 	8.3	Information 

 The Parties
will use their best efforts to obtain from the reporting source the information requested on the most current version of the FDA Medwatch or CIOMS I form. 
  

	 	8.4	Report Language 

 All
reports will be prepared in English. 
  

	9.	FOLLOW-UP RESPONSIBILITY 

In the event that all the required information is not obtained in the first report of any ADE, the Parties agree to use their best
efforts, as defined by each Party’s procedures, to follow up with the reporting source to obtain as much information as possible. The Party receiving the initial report is responsible for obtaining any and all follow-up information from the
reporting source. The Party receiving any follow-up information shall inform the other Party pursuant to the reporting requirements set forth in this Agreement. 
  

	10.	RECORD-KEEPING RESPONSIBILITY 

  

	 	10.1	Record-keeping Responsibilities for the Reporting Party 

 Each Party will be responsible for maintaining the original file(s) of all regulatory and safety-related information for any and all ADEs that occur in its respective territories of regulatory
responsibility and reporting (including sublicensed territories, as defined in the ED Agreement) per its internal standard operating procedures. 
  

	 	10.2	Record-keeping Responsibilities for the Non-Reporting Party 

 In the event that a Party receives any ADE information about a Product(s) for which it does not have regulatory responsibility, such Party shall maintain files containing initial contact information,
confirmation of transmission, follow-up information relating to the ADEs including any telephone contact reports, along with copies of any supporting documentation it transmitted to the Reporting Party. 

  
 40 

 CONFIDENTIAL TREATMENT 
 [***] Indicates that text has been omitted which is the subject of a confidential treatment request. This text has been separately filed with the Securities and Exchange Commission 

 

	11.	CONTACTS 

 Sagent
Pharmaceuticals 
              

             

Attn:              

Telephone:              

Telecopy:              

Gland Pharma Limited 
 6-3-862, Ameerpet 
 Hyderabad, India 

500016 
 Attn:
[***], Director - Technical 
 Telephone:     [***] 

Facsimile:      [***] 
 IN WITNESS WHEREOF, the Parties have executed this Adverse Event Reporting Agreement effective as of the date of the Development and Supply Agreement. 

 

	
	GLAND PHARMA LTD.
	
	By:                             
                                         
                    
	
	Title:                            
                                         
                  
	Head of Quality
	GLAND PHARMA LIMITED,
	6-3-865/1/2, Ameerpet, Hyderabad-5000 016,
	India
	
	SAGENT HOLDING CO.
	
	By:                             
                                         
                    
	
	Title:                            
                                         
                  

  
 41 

 CONFIDENTIAL TREATMENT 
 [***] Indicates that text has been omitted which is the subject of a confidential treatment request. This text has been separately filed with the Securities and Exchange Commission 

 

 FIRST AMENDMENT TO 

DEVELOPMENT AND SUPPLY AGREEMENT 
 FOR HEPARIN SODIUM INJECTION USP 
 THIS FIRST
AMENDMENT TO DEVELOPMENT AND SUPPLY AGREEMENT FOR HEPARIN SODIUM INJECTION USP (“Amendment”) is made as of the 1st day of September 2010 by and between GLAND PHARMA LIMITED, an Indian corporation, having a place of business at
6-3-865/1/2, Ameerpet, Hyderabad, India (“Gland”), and SAGENT HOLDING CO., a Cayman Islands corporation, having a place of business at c/o M&C Corporate Services Limited, PO Box 309 GT, Ugland House, South Church Street,
George Town, Grand Cayman, Cayman Islands (“Sagent”) with respect to that certain DEVELOPMENT AND SUPPLY AGREEMENT by and between Gland and Sagent dated as of June 27, 2008 (the “Original Agreement”). 

RECITALS 

WHEREAS, Gland and Sagent entered into the Original Agreement as of June 27, 2008; 

WHEREAS, the parties launched Heparin Sodium Injection USP on or about July 1, 2010; and 

WHEREAS, the parties learned that the Original Agreement contained two typographical errors and desire to correct the same by this
Amendment; 
 NOW, THEREFORE, the Parties hereto agree to the following: 

 

	 	1.	DEFINITIONS: 

“Agreement” shall mean the Original Agreement (as that term is defined above) as amended by this Amendment (as that term is
defined above). 
  

	 	2.	AMENDMENT 

 The terms Net
Profits and Net Sales as defined in the Original Agreement shall be deleted in their entirety and replaced with the definitions set forth below for all purposes under the Agreement: 

“Net Profit” means Net Sales less (i) [***] 
 “Net Sales” means, the gross invoiced sales of a Product to all customers less (i) the cost of the Product, including freight in, duty, customs, shipping and all related direct costs
of acquiring the Product; (ii) chargebacks; (iii) freight and insurance charges; (iv) trade discounts, credits or allowances; (v) costs of replacements, returns, recalls or rebates (including but not limited to group

  
 1 

 
purchasing organization fees and rebates); (vi) discounts or rebates or other payments required by law to be made under Medicaid, Medicare or other governmental special medical
assistance programs (vii) wholesaler service charges; and (viii) sales, excise or value added taxes paid on or in relation to sales of the Product, all as calculated in accordance with United States Generally Accepted Accounting
Principles, or US GAAP. 
  

	 	3.	EFFECT OF AMENDMENT 

 The
Original Agreement as modified by this Amendment shall remain in full force and effect on the terms set forth herein and in the Original Agreement. 
 IN WITNESS WHEREOF, the Parties have caused this First Amendment to Development and Manufacturing Agreement for Heparin Injection USP to be executed by their respective duly authorized
representatives as of the day and year first above written. 
  

			
	 SAGENT HOLDING CO.

		
	 By: 
	 	 /s/ Michael Logerfo

		
	 Name:
	 	 Michael Logerfo

		
	 Title: 
	 	 Corporate Vice President

	
	 GLAND PHARMA LIMITED

		
	 By: 
	 	 /s/ Srinivas Sadu

		
	 Name:
	 	 Srinivas Sadu

		
	 Title: 
	 	 Director

  
 2Employment Agreement

 Exhibit 10.19 
 EMPLOYMENT AGREEMENT 
 This EMPLOYMENT AGREEMENT (“Agreement”) is
entered into as of this 20th day of January, 2011 (the “Effective Date”), by and between Sagent Pharmaceuticals, Inc., a Wyoming corporation (the “Employer” or the “Company”), and Jeffrey Yordon, an
individual (the “Executive”). 
 WHEREAS, the Executive is currently employed as the President and Chief
Executive Officer; and 
 WHEREAS, the Employer and the Executive desire to enter into this Agreement to set out the terms and
conditions for the continued employment relationship of the Executive with the Employer. 
 NOW, THEREFORE, in consideration of
the mutual covenants and agreements set forth herein and for other good and valuable consideration, the receipt and sufficiency of which hereby are acknowledged, the parties hereto agree as follows: 

1. Employment Agreement. On the terms and conditions set forth in this Agreement, the Employer agrees to continue to employ the
Executive and the Executive agrees to continue to be employed by the Employer for the Employment Period set forth in Section 2 and in the positions and with the duties set forth in Section 3. Terms used herein with initial
capitalization not otherwise defined are defined in Section 26. 
 2. Term. The initial term of employment
under this Agreement shall be for a three-year period commencing on the Effective Date (the “Initial Term”). The term of employment shall be automatically extended for an additional consecutive 12-month period (the “Extended
Term”) on the third anniversary of the Effective Date and each subsequent anniversary thereof, unless and until the Employer or Executive provides written notice to the other party in accordance with Section 14 hereof not less
than 60 days before such anniversary date that such party is electing not to extend the term of employment under this Agreement (“Non-Renewal”), in which case the term of employment hereunder shall end as of the end of such
Initial Term or Extended Term, as the case may be, unless sooner terminated as hereinafter set forth. Such Initial Term and all such Extended Terms are collectively referred to herein as the “Employment Period.” Anything herein to
the contrary notwithstanding, if on the date of a Change in Control the remaining term of the Employment Period is less than 24 months, the Employment Period shall be automatically extended to the end of the 24-month period following such
Change in Control. 
 3. Position and Duties. During the Employment Period, the Executive shall serve as the President
and Chief Executive Officer. In such capacities, the Executive shall report exclusively to the Board and shall have the duties, responsibilities and authorities customarily 

 
associated with such position(s) in a company the size and nature of the Employer. The Executive shall devote the Executive’s reasonable best efforts and full business time to the
performance of the Executive’s duties hereunder and the advancement of the business and affairs of the Employer; provided that the Executive shall be entitled to serve as a member of the board of directors of a reasonable number
of other companies, to serve on civic, charitable, educational, religious, public interest or public service boards, and to manage the Executive’s personal and family investments, in each case, to the extent such activities do not materially
interfere with the performance of the Executive’s duties and responsibilities hereunder. 
 4. Place of Performance.
During the Employment Period, the Executive shall be based primarily at the Employer’s headquarters in Schaumburg, IL, except for reasonable travel on the Employer’s business consistent with the Executive’s position. 

5. Compensation and Benefits; Options; Change in Control. 

(a) Base Salary. During the Employment Period, the Employer shall pay to the Executive a base salary (the
“Base Salary”) at the rate of no less than $410,000 per calendar year, less applicable deductions, and prorated for any partial year. The Base Salary shall be reviewed for increase by the Employer no less frequently than annually
and shall be increased in the discretion of the Employer and any such adjusted Base Salary shall constitute the “Base Salary” for purposes of this Agreement. The Base Salary shall be paid in substantially equal installments in accordance
with the Employer’s regular payroll procedures. The Executive’s Base Salary may not be decreased during the Employment Period. 
 (b) Annual Bonus. For each calendar year ending during the Employment Period, the Executive shall be paid an annual cash performance bonus (an “Annual Bonus”), to the extent earned
based on performance against objective, reasonably attainable performance criteria; provided that subjective criteria may be used to determine the Executive’s Annual Bonus to the extent the Company’s Chief Executive Officer
agrees to the use of non-subjective performance measures. The performance criteria for any particular calendar year shall be determined in good faith by the Board, after consultation with the Employer’s Chief Executive Officer, no later than
sixty (60) days after the commencement of the relevant bonus period. The Executive’s annual bonus opportunity for a calendar year shall equal 80% of the Executive’s Base Salary (the “Target Bonus”) for that year if
target levels of performance for that year are achieved, and shall be adjusted in accordance with the Company’s annual bonus plan applicable to senior executives generally to the extent that the applicable target performance criteria is not
achieved or is exceeded. The Executive’s Annual Bonus for a bonus period shall be determined by the Board in accordance with this Section 5(b) after the end of the applicable bonus period and shall be paid to the Executive when
annual bonuses for that year are paid to other senior executives of the Employer generally, but in no event later than March 15 of the year following 

  
 2 

 
the year to which such Annual Bonus relates. In carrying out its functions under this Section 5(b), the Board shall at all times act uniformly, reasonably and in good faith.

 (c) Vacation; Benefits. During the Employment Period, the Executive shall be entitled to vacation in
accordance with the Employer’s policies then in effect. In addition, the Employer shall provide to the Executive employee benefits and perquisites on a basis that is comparable in all material respects to that provided to other executives of
the Employer. Subject to the terms of this Agreement, the Employer shall have the right to change insurance carriers and to adopt, amend, terminate or modify employee benefit plans and arrangements at any time and without the consent of the
Executive. 
 (d) Car Allowance. During the Employment Period, the Executive shall be paid a monthly car
allowance of $1,100. 
 6. Expenses. The Executive is expected and is authorized to incur reasonable expenses in the
performance of his duties hereunder. The Employer shall reimburse the Executive for all such expenses reasonably and actually incurred in accordance with policies which may be adopted from time to time by the Employer promptly upon periodic
presentation by the Executive of an itemized account, including reasonable substantiation, of such expenses. 
 7.
Confidentiality, Non-Disclosure and Non-Competition Agreement. The Employer and the Executive acknowledge and agree that during the Executive’s employment with the Employer, the Executive will have access to and may assist in developing
Company Confidential Information and will occupy a position of trust and confidence with respect to the Employer’s affairs and business and the affairs and business of the Company Affiliates. The Executive agrees that the following obligations
are necessary to preserve the confidential and proprietary nature of Company Confidential Information and to protect the Employer and the Company Affiliates against harmful solicitation of employees and customers, harmful competition and other
actions by the Executive that would result in serious adverse consequences for the Employer and the Company Affiliates: 
 (a) Non-Disclosure. During and after the Executive’s employment with the Employer, the Executive will not knowingly use, disclose or transfer any Company Confidential Information other than as
authorized in writing by the Employer or within the scope of the Executive’s duties with the Employer as determined reasonably and in good faith by the Executive. Anything herein to the contrary notwithstanding, the provisions of this
Section 7(a) shall not apply (i) when disclosure is required by law or by any court, arbitrator, mediator or administrative or legislative body (including any committee thereof) with actual or apparent jurisdiction to order the
Executive to disclose or make accessible any information; (ii) with respect to any other litigation, arbitration or mediation involving this Agreement, including, but not limited to, the enforcement of this Agreement; (iii) as to
information that becomes generally known to the public or within the relevant trade or industry other than due to the Executive’s violation of this Section 7(a); (iv) as to information that is or becomes available to the
Executive on a non-confidential basis from a source which is entitled to disclose it to the Executive; or 

  
 3 

 
(v) as to information that the Executive possessed prior to the commencement of employment with the Employer. 

(b) Materials. The Executive will not remove any Company Confidential Information or any other property of the
Employer or any Company Affiliate from the Employer’s premises or make copies of such materials except for normal and customary use in the Employer’s business as determined reasonably and in good faith by the Executive. The Employer
acknowledges that the Executive, in the ordinary course of the Executive’s duties, routinely uses and stores Company Confidential Information at home and other locations. The Executive will return to the Employer all Company Confidential
Information and copies thereof and all other property of the Employer or any Company Affiliate at any time upon the request of the Employer and in any event promptly after termination of Executive’s employment. The Executive agrees to attempt
in good faith to identify and return to the Employer any copies of any Company Confidential Information after the Executive ceases to be employed by the Employer. Anything to the contrary notwithstanding, nothing in this Section 7 shall
prevent the Executive from retaining a home computer, papers and other materials of a personal nature, including diaries, calendars and Rolodexes, information relating to his compensation or relating to reimbursement of expenses, information that he
reasonably believes may be needed for tax purposes, and copies of plans, programs and agreements relating to his employment. 
 (c) No Solicitation or Hiring of Employees. During the Non-Compete Period, the Executive shall not solicit, entice, persuade or induce any individual who is employed by the Employer or the Company
Affiliates (or who was so employed within 180 days prior to the Executive’s action) to terminate or refrain from continuing such employment or to become employed by or enter into contractual relations with any other individual or entity
other than the Employer or the Company Affiliates, and the Executive shall not hire, directly or indirectly, as an employee, consultant or otherwise, any such person. Anything to the contrary notwithstanding, the Employer agrees that (i) the
Executive’s responding to an unsolicited request from any former employee of the Employer for advice on employment matters; and (ii) the Executive’s responding to an unsolicited request for an employment reference regarding any former
employee of the Employer from such former employee, or from a third party, by providing a reference setting forth his personal views about such former employee, shall not be deemed a violation of this Section 7(c)). Notwithstanding the
foregoing, this Section 7(c) shall not preclude the Executive from soliciting for employment or hiring any person who has been discharged by the Employer or any Company Affiliate without cause. 

(d) Non-Competition. 
 (i) During the Non-Compete Period, the Executive shall not, directly or indirectly, (A) solicit or encourage any client or customer of the Employer or a Company Affiliate, or any person or entity who
was such a client or customer within 180 days prior to Executive’s action to terminate, reduce or alter in a manner adverse to the Employer or the Company Affiliate, any existing business arrangements with the Employer or a Company
Affiliate or to transfer existing business from the Employer or a Company Affiliate to any other person or entity, (B) provide services to any entity if (I) the entity competes with the Employer

  
 4 

 
or any direct or indirect subsidiary of the Employer by engaging in any business engaged in by the Employer or any direct or indirect subsidiary of the Employer, or (II) the services to be
provided by the Executive are competitive with the Employer or any direct or indirect subsidiary of the Employer and substantially similar to those previously provided by the Executive to the Employer; provided, however, that following
a Change in Control this Section 7(d)(i)(B) shall not apply to the Executive, or (C) own an interest in any entity described in Section 7(d)(i)(B)(I) immediately above; provided, however, that Executive may
own, as a passive investor, securities of any such entity that has outstanding publicly traded securities so long as the Executive’s direct holdings in any such entity shall not in the aggregate constitute more than 5% of the voting power of
such entity. The Executive agrees that, before providing services, whether as an employee or consultant, to any entity during the Non-Compete Period, the Executive will provide a copy of this Agreement to such entity, and such entity shall
acknowledge to the Employer in writing that it has read this Agreement. The Executive acknowledges that this covenant has a unique, very substantial and immeasurable value to the Employer, that the Executive has sufficient assets and skills to
provide a livelihood for the Executive while such covenant remains in force and that, as a result of the foregoing, in the event that the Executive breaches such covenant, monetary damages would be an insufficient remedy for the Employer and
equitable enforcement of the covenant would be proper. 
 (ii) If the restrictions contained in
Section 7(d)(i) shall be determined by any court of competent jurisdiction to be unenforceable by reason of their extending for too great a period of time or over too great a geographical area or by reason of their being too extensive in
any other respect, Section 7(d)(i) shall be modified to be effective for the maximum period of time for which it may be enforceable and over the maximum geographical area as to which it may be enforceable and to the maximum extent in all
other respects as to which it may be enforceable. 
 (e) Publicity. During the Employment Period, the
Executive hereby grants to the Employer the right to use, in a reasonable and appropriate manner, the Executive’s name and likeness, without additional consideration, on, in and in connection with technical, marketing or disclosure materials,
or any combination thereof, published by or for the Employer or any Company Affiliate. 
 (f) Enforcement.
The Executive acknowledges that in the event of any breach of this Section 7, the business interests of the Employer and the Company Affiliates will be irreparably injured, the full extent of the damages to the Employer and the Company
Affiliates will be impossible to ascertain, monetary damages will not be an adequate remedy for the Employer and the Company Affiliates, and the Employer will be entitled to enforce this Agreement by a temporary, preliminary and/or permanent
injunction or other equitable relief, without the necessity of posting bond or security, which the Executive expressly waives. The Executive understands that the Employer may waive some of the requirements expressed in this Agreement, but that such
a waiver to be effective must be made in writing and should not in any way be deemed a waiver of the Employer’s right to enforce any other requirements or provisions of this Agreement. The Executive agrees that each of the Executive’s
obligations specified in this Agreement is a separate and independent covenant and that the unenforceability of any of 

  
 5 

 
them shall not preclude the enforcement of any other covenants in this Agreement. The Executive further agrees that any breach of this Agreement by the Employer prior to the Date of Termination
shall not release the Executive from compliance with the Executive’s obligations under this Section 7, so along as the Employer fully complies with Sections 9, 10, 11 and 12. The Employer further agrees
that any breach of this Agreement by the Executive that does not result in the Executive’s being terminated for Cause, other than a willful (as defined in the definition of “Cause”) and material breach of Sections
7(d)(i)(A) or 7(d)(i)( B) after the Date of Termination, shall not release the Employer from compliance with its obligations under this Agreement. Notwithstanding the foregoing two sentences, neither party shall be precluded from pursuing
judicial remedies as a result of any such breaches. 
 8. Termination of Employment. 

(a) Permitted Terminations. The Executive’s employment hereunder may be terminated during the Employment
Period under the following circumstances: 
 (i) Death. The Executive’s employment hereunder shall
terminate automatically upon the Executive’s death; 
 (ii) By the Employer. The Employer may
terminate the Executive’s employment: 
 (A) Disability. If the Executive shall have been
substantially unable to perform the Executive’s material duties hereunder by reason of illness, physical or mental disability or other similar incapacity, which inability shall continue for 180 consecutive days or 270 days in any
24-month period (a “Disability”) (provided, that until such termination, the Executive shall continue to receive the Executive’s compensation and benefits hereunder, reduced by any benefits payable to the Executive under any
applicable disability insurance policy or plan); or 
 (B) Cause. For Cause or without Cause; 

(iii) By the Executive. The Executive may terminate the Executive’s employment for any reason (including Good
Reason) or for no reason. 
 (b) Termination. Any termination of the Executive’s employment by the
Employer or the Executive (other than because of the Executive’s death) shall be communicated by written Notice of Termination to the other party hereto in accordance with Section 13 hereof. For purposes of this Agreement, a
“Notice of Termination” shall mean a notice which shall indicates the specific termination provision in this Agreement relied upon, if any, and sets forth in reasonable detail the facts and circumstances claimed to provide a basis
for termination of the Executive’s employment under the provision so indicated. Termination of the Executive’s employment shall take effect on the Date of Termination. The Executive agrees, in the event of any dispute under
Section 8(a)(ii)(A) as to whether a Disability exists, and if requested by the Employer, to submit to a physical examination by a licensed physician selected by mutual 

  
 6 

 
consent of the Employer and the Executive, the cost of such examination to be paid by the Employer. The written medical opinion of such physician shall be conclusive and binding upon each of the
parties hereto as to whether a Disability exists and the date when such Disability arose. This Section shall be interpreted and applied so as to comply with the provisions of the Americans with Disabilities Act and any applicable state or local
laws. 
 9. Compensation Upon Termination. 

(a) Termination by the Employer for Cause or Termination by the Executive without Good Reason. If, during the
Employment Period, the Employer terminates the Executive’s employment for Cause pursuant to Section 8(a)(ii)(B) or the Executive terminates his employment without Good Reason, the Employer shall pay to the Executive the Accrued
Benefits. Except as set forth herein, the Employer shall have no further obligations to the Executive under this Agreement. 
 (b) Termination due to Death or Disability, Termination by the Employer without Cause or Termination by the Executive with Good Reason. Subject to Section 9(c), if the Executive’s
employment is terminated during the Employment Period (i) due to the Executive’s death or Disability, (ii) by the Employer for a reason other than for Cause or (iii) by the Executive with Good Reason (any termination described in
clauses (i), (ii) or (iii), a “Qualifying Termination”) then (A) the Employer shall pay the Executive (I) the Accrued Benefits, (II) a pro rata portion (based on the number of days during the applicable fiscal period
prior to the Date of Termination) of the Annual Bonus the Executive would have earned absent such termination, with such payment to be made at the time bonus payments are made to executives of the Company generally, and (III) a cash lump sum in
an amount equal to the product of two and the sum of the Executive’s Base Salary and Target Bonus (the “Cash Severance Payment”); (B) provided the Executive elects continued welfare coverage pursuant to COBRA, the Company
shall pay during the period the Executive actually continues such coverage, but in any event not to exceed 18 months, the same percentage of the monthly premium costs for COBRA continuation coverage as it pays of the monthly premium costs for
medical coverage for senior executives generally; provided that the Company may pay this amount by paying the Executive a monthly amount equal on an after-tax basis to such amount (the “Monthly Payments”); and (C) the Company
shall reimburse the Executive for reasonable outplacement services (which shall not exceed $30,000 in the aggregate) incurred during the two-year period following the Date of Termination. 

(c) Change in Control. This Section 9(c) shall apply if (i) the Executive’s employment with
the Company is terminated due to a Qualifying Termination during the Employment Period in the two-year period following a Change in Control; or (ii) there is a termination of the Executive’s employment by the Employer for a reason other
than for Cause or due to the Executive’s Disability prior to a Change in Control, if the termination was at the request of a third party or otherwise arose in anticipation of a Change in Control (a termination described in either clause
(i) or clause (ii), a “CIC Termination”). If any such termination occurs, (A) the Executive shall receive benefits set forth in Section 9(b), except that the Cash Severance Payment shall be equal to the product
of three and the sum of the Executive’s Base 

  
 7 

 
Salary and Target Bonus, (B) all outstanding equity-related awards held by the Executive shall immediately vest and all options, stock appreciation rights or similar awards shall remain
exercisable for the full original term of the award and (C) Section 10 of this Agreement shall apply to the Executive. For the sake of clarity, Section 10 shall not apply unless the Executive’s employment with the
Company and its subsidiaries is terminated in a CIC Termination. 
 (d) Liquidated Damages. The parties
acknowledge and agree that damages which will result to the Executive for termination by the Employer of the Executive’s employment without Cause or by the Executive for Good Reason shall be extremely difficult or impossible to establish or
prove, and agree that the amounts, excluding the Accrued Benefits, payable to the Executive under Section 9(b) (the “Severance Benefits”) shall constitute liquidated damages for any such termination. The Executive agrees
that, except for such other payments and benefits to which the Executive may be entitled as expressly provided by the terms of this Agreement or any other applicable benefit plan, such liquidated damages shall be in lieu of all other claims that the
Executive may make by reason of any such termination of his employment and that, as a condition to receiving the Severance Benefits, the Executive must execute a release of claims substantially in the form attached hereto as Exhibit A (the
“Release”), which shall be delivered to the Executive for execution within 5 business days of the Date of Termination. To be eligible for Severance Benefits, the Executive must execute and deliver the Release, and such Release must
become irrevocable, within 60 days of the Date of Termination. The Cash Severance Payment shall be made, and the Monthly Payments shall commence, promptly after the Release becomes irrevocable; provided that to the extent required by
Code Section 409A, such payments shall be made or commence, as applicable, on the 60th day following the Date of Termination and in the case of the Monthly Payments, shall include all payments that otherwise would have been made before such
date. 
 (e) No Offset. In the event of termination of his employment, the Executive shall be under no
obligation to seek other employment and there shall be no offset against amounts due to him on account of any remuneration or benefits provided by any subsequent employment he may obtain. The Employer’s obligation to make any payment pursuant
to, and otherwise to perform its obligations under, this Agreement shall not be affected by any offset, counterclaim or other right that the Employer or its affiliates may have against him for any reason. 

10. Certain Additional Payments by the Employer. This Section 10 shall apply to the Executive only if the Executive
terminates employment with the Company and its subsidiaries in a CIC Termination. 
 (a) If the Executive’s
employment with the Company and its subsidiaries terminates in a CIC Termination and if it is determined that any benefit provided to the Executive or payment or distribution by or for the account of the Employer to or for the benefit of the
Executive, whether provided, paid or payable or distributed or distributable pursuant to the terms of this Agreement or otherwise (a “Payment”) would be subject to the excise tax imposed by Section 4999 of the Internal Revenue
Code of 1986, as amended (the “Code”), or any interest or penalties are incurred by the Executive with respect to such excise tax resulting from any 

  
 8 

 
action or inaction by the Employer (such excise tax, together with any such interest and penalties, collectively, the “Excise Tax”), then the Executive shall be entitled to
receive an additional payment (a “Gross-Up Payment”) in an amount such that after payment by the Executive of the Excise Tax and all other income, employment, excise and other taxes that are imposed on the Gross-Up Payment, the
Executive retains an amount of the Gross-Up Payment equal to the sum of (A) the Excise Tax imposed upon the Payments and (B) the product of any deductions disallowed because of the inclusion of the Gross-up Payment in the Executive’s
adjusted gross income and the highest applicable marginal rate of federal income taxation for the calendar year in which the Gross-Up Payment is to be made. 
 (b) Subject to the provisions of Section 10(c), all determinations required to be made under this Section 10, including whether and when a Gross-Up Payment is required and the
amount of such Gross-Up Payment and the assumptions to be used in arriving at such determination, shall be made by the Employer’s independent, certified public accounting firm or such other certified public accounting firm as may be designated
by the Executive and shall be reasonably acceptable to the Employer (the “Accounting Firm”) which shall provide detailed supporting calculations both to the Employer and the Executive within 15 business days of the receipt of
notice from the Executive that there has been a Payment, or such earlier time as is requested by the Employer. If the Accounting Firm is serving as accountant or auditor for the individual, entity or group effecting a change in the ownership or
effective control (as defined for purposes of Section 280G of the Code) of the Employer, the Executive shall appoint another nationally recognized accounting firm which is reasonably acceptable to the Employer to make the determinations
required hereunder (which accounting firm shall then be referred to as the Accounting Firm hereunder). All fees and expenses of the Accounting Firm shall be borne solely by the Employer. Any Gross-Up Payment, as determined pursuant to this
Section 10, shall be paid by the Employer to the Executive within five days of the receipt of the Accounting Firm’s determination, but in any event no later than 30 days after the end of the year in which the Executive pays any tax
imposed pursuant to Section 4999 of the Code. Any determination by the Accounting Firm shall be binding upon the Employer and the Executive. As a result of the uncertainty in the application of Section 4999 of the Code at the time of the
initial determination by the Accounting Firm hereunder, it is possible that additional Gross-Up Payments shall be required to be made to compensate the Executive for amounts of Excise Tax later determined to be due, consistent with the calculations
required to be made hereunder (an “Underpayment”). If the Employer exhausts its remedies pursuant to Section 10(c) and the Executive is required to make a payment of any Excise Tax, the Accounting Firm shall determine
the amount of the Underpayment that has occurred and any such Underpayment shall be promptly paid by the Employer to or for the benefit of the Executive. 
 (c) The Executive shall notify the Employer in writing of any claim by the Internal Revenue Service that, if successful, would require the payment by the Employer of the Gross-Up Payment. Such
notification shall be given as soon as practicable but no later than 10 business days after the Executive is informed in writing of such claim and shall apprise the Employer of the nature of such claim and the date on which such claim is
requested to be paid. The Executive shall not pay such claim prior to the expiration of the 30-day period following the date on which it gives such notice to the Employer (or such shorter period ending on the date that

  
 9 

 
any payment of taxes with respect to such claim is due). If the Employer notifies the Executive in writing prior to the expiration of such period that they desire to contest such claim, the
Executive shall: 
 (i) give the Employer any information reasonably requested by the Employer relating to such
claim; 
 (ii) take such action in connection with contesting such claim as the Employer shall reasonably request
in writing from time to time, including, without limitation, accepting legal representation with respect to such claim by an attorney reasonably selected by the Employer; 

(iii) cooperate with the Employer in good faith effectively to contest such claim; and 

(iv) permit the Employer to participate in any proceedings relating to such claim; provided, however, that the Employer
shall bear and pay directly all costs and expenses (including additional interest and penalties incurred in connection with such contest) and shall indemnify and hold the Executive harmless, on an after-tax basis, for any Excise Tax or income tax
(including interest and penalties with respect thereto) imposed as a result of such representation and payment of costs and expenses. 
 11. Indemnification. During the Employment Period and thereafter, the Employer agrees to indemnify and hold the Executive and the Executive’s heirs and representatives harmless, to the maximum
extent permitted by law, against any and all damages, costs, liabilities, losses and expenses (including reasonable attorneys’ fees) as a result of any claim or proceeding (whether civil, criminal, administrative or investigative), or any
threatened claim or proceeding (whether civil, criminal, administrative or investigative), against the Executive that arises out of or relates to the Executive’s service as an officer, director or employee, as the case may be, of the Employer,
or the Executive’s service in any such capacity or similar capacity with an affiliate of the Employer or other entity at the request of the Employer, both prior to and after the Effective Date, and to promptly advance to the Executive or the
Executive’s heirs or representatives such expenses upon written request with appropriate documentation of such expense upon receipt of an undertaking by the Executive or on the Executive’s behalf to repay such amount if it shall ultimately
be determined that the Executive is not entitled to be indemnified by the Employer. During the Employment Period and thereafter, the Employer also shall provide the Executive with coverage under its current directors’ and officers’
liability policy to the same extent that it provides such coverage to its other executive officers. If the Executive has any knowledge of any actual or threatened action, suit or proceeding, whether civil, criminal, administrative or investigative,
as to which the Executive may request indemnity under this provision, the Executive will give the Employer prompt written notice thereof; provided that the failure to give such notice shall not affect the Executive’s right to indemnification.
The Employer shall be entitled to assume the defense of any such proceeding and the Executive will use reasonable efforts to cooperate with such defense. To the extent that the Executive in good faith determines that there is an actual or potential
conflict of interest 

  
 10 

 
between the Employer and the Executive in connection with the defense of a proceeding, the Executive shall so notify the Employer and shall be entitled to separate representation at the
Employer’s expense by counsel selected by the Executive (provided that the Employer may reasonably object to the selection of counsel within ten (10) business days after notification thereof) which counsel shall cooperate, and coordinate
the defense, with the Employer’s counsel and minimize the expense of such separate representation to the extent consistent with the Executive’s separate defense. This Section 11 shall continue in effect after the termination of
the Executive’s employment or the termination of this Agreement. 
 12. Attorney’s Fees. The Employer shall
advance the Executive (and his beneficiaries) any and all costs and expenses (including without limitation attorneys’ fees and other charges of counsel) incurred by the Executive (or any of his beneficiaries) in resolving any controversy,
dispute or claim arising out of or relating to this Agreement, any other agreement or arrangement between the Executive and the Employer, the Executive’s employment with the Employer, or the termination thereof; provided that the Executive
shall reimburse the Employer any advances on a net after-tax basis to cover expenses incurred by the Executive for claims (a) brought by the Employer on account of the Executive’s alleged breach of Section 7 of this Agreement,
breach of the Executive’s fiduciary duty of loyalty, or fraud or material misconduct, if it is judicially determined that the Employer is the prevailing party, or (b) brought by the Executive that are judicially determined to be frivolous
or advanced in bad faith. Pending the resolution of any such claim, the Executive (and his beneficiaries) shall continue to receive all payments and benefits described in Section 5 of this Agreement. This Section 12 shall
continue in effect after the termination of the Executive’s employment or the termination of this Agreement. 
 13.
Notices. All notices, demands, requests, or other communications which may be or are required to be given or made by any party to any other party pursuant to this Agreement shall be in writing and shall be hand delivered, mailed by
first-class registered or certified mail, return receipt requested, postage prepaid, delivered by overnight air courier, or transmitted by facsimile transmission addressed as follows: 

 

	 	(i)	If to the Employer: 

 Sagent
Pharmaceuticals, Inc. 
 1901 N. Roselle Road 
 Suite 700 
 Schaumburg, IL 60195 

Attn: Chief Executive Officer 

  
 11 

  

	 	(ii)	If to the Executive: 

 Jeffrey
Yordon 
 Address last shown on the Employer’s Records 

Each party may designate by notice in writing a new address to which any notice, demand, request or communication may
thereafter be so given, served or sent. Each notice, demand, request, or communication that shall be given or made in the manner described above shall be deemed sufficiently given or made for all purposes at such time as it is delivered to the
addressee (with the return receipt, the delivery receipt, confirmation of facsimile transmission or the affidavit of messenger being deemed conclusive but not exclusive evidence of such delivery) or at such time as delivery is refused by the
addressee upon presentation. 
 14. Severability. The invalidity or unenforceability of any one or more provisions of
this Agreement shall not affect the validity or enforceability of the other provisions of this Agreement, which shall remain in full force and effect. 
 15. Effect on Other Agreements. The provisions of this Agreement shall supersede the terms of any plan, policy, agreement, award or other arrangement of the Employer (whether entered into before or
after the Effective Date) to the extent application of the terms of this Agreement is more favorable to the Executive. 
 16.
Survival. It is the express intention and agreement of the parties hereto that the provisions of Sections 7, 9, 10, 11, 12, 13, 16, 17, 18, 20, 21, 23
and 24 hereof and this Section 16 shall survive the termination of employment of the Executive. In addition, all obligations of the Employer to make payments hereunder shall survive any termination of this Agreement on the
terms and conditions set forth herein. 
 17. Assignment. The rights and obligations of the parties to this Agreement
shall not be assignable or delegable, except that (i) in the event of the Executive’s death, the personal representative or legatees or distributees of the Executive’s estate, as the case may be, shall have the right to receive any
amount owing and unpaid to the Executive hereunder and (ii) the rights and obligations of the Employer hereunder shall be assignable and delegable in connection with any subsequent merger, consolidation, sale of all or substantially all of the
assets or equity interests of the Employer or similar transaction involving the Employer or a successor corporation. The Employer shall require any successor to the Employer to expressly assume and agree to perform this Agreement in the same manner
and to the same extent that the Employer would be required to perform it if no such succession had taken place. 
 18.
Binding Effect. Subject to any provisions hereof restricting assignment, this Agreement shall be binding upon the parties hereto and shall inure to the benefit of the parties and their respective heirs, devisees, executors, administrators,
legal representatives, successors and assigns. 

  
 12 

 19. Amendment; Waiver. This Agreement shall not be amended, altered or modified
except by an instrument in writing duly executed by the party against whom enforcement is sought. Neither the waiver by either of the parties hereto of a breach of or a default under any of the provisions of this Agreement, nor the failure of either
of the parties, on one or more occasions, to enforce any of the provisions of this Agreement or to exercise any right or privilege hereunder, shall thereafter be construed as a waiver of any subsequent breach or default of a similar nature, or as a
waiver of any such provisions, rights or privileges hereunder. 
 20. Headings. Section and subsection headings contained
in this Agreement are inserted for convenience of reference only, shall not be deemed to be a part of this Agreement for any purpose, and shall not in any way define or affect the meaning, construction or scope of any of the provisions hereof.

 21. Governing Law. This Agreement, the rights and obligations of the parties hereto, and any claims or disputes
relating thereto, shall be governed by and construed in accordance with the laws of the State of Illinois (but not including any choice of law rule thereof that would cause the laws of another jurisdiction to apply). 

22. Entire Agreement. This Agreement constitutes the entire agreement between the parties respecting the employment of the
Executive, there being no representations, warranties or commitments except as set forth herein. 
 23. Counterparts.
This Agreement may be executed in two counterparts, each of which shall be an original and all of which shall be deemed to constitute one and the same instrument. 
 24. Withholding. The Employer may withhold from any benefit payment under this Agreement all federal, state, city or other taxes as shall be required pursuant to any law or governmental regulation
or ruling; provided that any withholding obligation arising in connection with the exercise of a stock option or the transfer of stock or other property shall be satisfied through withholding an appropriate number of shares of stock or appropriate
amount of such other property. 
 25. Section 409A. The intent of the parties is that payments and benefits under
this Agreement comply with Section 409A of the Code and the regulations and guidance promulgated thereunder (collectively “Code Section 409A”) and, accordingly, to the maximum extent permitted, this Agreement shall be
interpreted to be in compliance therewith. If the Executive notifies the Employer (with specificity as to the reason therefor) that the Executive believes that any provision of this Agreement (or of any award of compensation, including equity
compensation or benefits) would cause the Executive to incur any additional tax or interest under Code Section 409A and the Employer concurs with such belief or the Employer (without any obligation whatsoever to do so) independently makes such
determination, the Employer shall, after consulting with the Executive, reform such provision to attempt to comply with Code Section 409A through good faith modifications to the minimum extent reasonably

  
 13 

 
appropriate to conform with Code Section 409A. To the extent that any provision hereof is modified in order to comply with Code Section 409A, such modification shall be made in good
faith and shall, to the maximum extent reasonably possible, maintain the original intent and economic benefit to the Executive and the Employer of the applicable provision without violating the provisions of Code Section 409A. In no event
whatsoever shall the Employer be liable for any additional tax, interest or penalty that may be imposed on the Executive by Code Section 409A or damages for failing to comply with Code Section 409A. With respect to any payment or benefit
considered to be nonqualified deferred compensation under Section 409A, a termination of employment shall not be deemed to have occurred for purposes of any provision of this Agreement providing for the payment of any amounts or benefits upon
or following a termination of employment unless such termination is also a “separation from service” within the meaning of Code Section 409A and, for purposes of any such provision of this Agreement, references to a
“termination,” “termination of employment” or like terms shall mean “separation from service.” Notwithstanding anything to the contrary in this Agreement, if the Executive is deemed on the date of termination to be a
“specified employee” within the meaning of that term under Code Section 409A(a)(2)(B), then with regard to any payment or the provision of any benefit that is considered nonqualified deferred compensation under Code Section 409A
payable on account of a “separation from service,” such payment or benefit shall not be made or provided until the date which is the earlier of (A) the expiration of the six (6)-month period measured from the date of such
“separation from service” of the Executive, and (B) the date of the Executive’s death, to the extent required under Code Section 409A. Upon the expiration of the foregoing delay period, all payments and benefits delayed
pursuant to this Section 25 (whether they would have otherwise been payable in a single sum or in installments in the absence of such delay) shall be paid or reimbursed to the Executive in a lump sum, and any remaining payments and
benefits due under this Agreement shall be paid or provided in accordance with the normal payment dates specified for them herein. To the extent that reimbursements or other in-kind benefits under this Agreement constitute “nonqualified
deferred compensation” for purposes of Code Section 409A, (A) all expenses or other reimbursements hereunder shall be made on or prior to the last day of the taxable year following the taxable year in which such expenses were incurred
by the Executive, (B) any right to reimbursement or in-kind benefits shall not be subject to liquidation or exchange for another benefit, and (C) no such reimbursement, expenses eligible for reimbursement, or in-kind benefits provided in
any taxable year shall in any way affect the expenses eligible for reimbursement, or in-kind benefits to be provided, in any other taxable year. For purposes of Code Section 409A, the Executive’s right to receive any installment payments
pursuant to this Agreement shall be treated as a right to receive a series of separate and distinct payments. Whenever a payment under this Agreement specifies a payment period with reference to a number of days, the actual date of payment within
the specified period shall be within the sole discretion of the Employer. Notwithstanding any other provision of this Agreement to the contrary, in no event shall any payment under this Agreement that constitutes “nonqualified deferred
compensation” for purposes of Code Section 409A be subject to offset by any other amount unless otherwise permitted by Code Section 409A. 
 26. Definitions. 

  
 14 

 “Accrued Benefits” means (i) Base Salary through the
Date of Termination; (ii) accrued and unused vacation pay; (iii) any earned but unpaid Annual Bonus; (iv) any amounts owing to the Executive for reimbursement of expenses properly incurred by the Executive prior to the Date of
Termination and which are reimbursable in accordance with Section 6; and (v) any other benefits or amounts due and owing to the Executive under the terms of any plan, program or arrangement of the Employer. Amounts payable pursuant
to the clauses (i) - (iii) shall be paid promptly after the Date of Termination and all other amounts will be paid in accordance with the terms of the applicable plan, program or arrangement (as modified by this Agreement). 

“Board” means the Board of Directors of the Company. 

“Cause” shall be limited to the following events (i) the Executive’s conviction of, or plea of
nolo contendere to, a felony (other than in connection with a traffic violation) under any state or federal law; (ii) the Executive’s willful and continued failure to substantially perform his essential job functions hereunder after
receipt of written notice from the Employer that specifically identifies the manner in which the Executive has substantially failed to perform his essential job functions and specifying the manner in which the Executive may substantially perform his
essential job functions in the future; (iii) a material act of fraud or willful and material misconduct with respect, in each case, to the Employer, by the Executive; (iv) a willful and material breach of Section 7; or
(v) a willful and material violation of a material policy of the Company. For purposes of this provision, no act or failure to act, on the part of the Executive, shall be considered “willful” unless it is done, or omitted to be done,
by the Executive in bad faith or without reasonable belief that the Executive’s action or omission was in the best interests of the Employer. Anything herein to the contrary notwithstanding, the Executive shall not be terminated for
“Cause” hereunder unless (A) written notice stating the basis for the termination is provided to the Executive, (B) as to clauses (ii), (iii), (iv) or (v) of this paragraph, the Executive is given 30 days to
cure the neglect or conduct that is the basis of such claim (it being understood that any errors in expense reimbursement may be cured by repayment), (C) if the Executive fails to cure such neglect or conduct, the Executive has an opportunity
to be heard with counsel before the full Board prior to any vote regarding the existence of Cause and (D) there is a vote of a majority of the members of the Board to terminate the Executive for Cause. 

“Change in Control” means the occurrence of one or more of the following events: (i) any
“person” (as such terms is used in Sections 3(a)(9) and 13(d) of the Securities Exchange Act of 1934 as amended (the “Act”)) or “group” (as such term is used in Section 14(d)(d) of the Act) is or
becomes a “beneficial owner” (as such term is used in Rule 13d-3 promulgated under the Act) of more than 30% of the Voting Stock of the Employer (excluding acquisitions pursuant to a Business Combination (as defined below) that is not
considered to be a Change in Control under clause (v) below; (ii) the majority of the Board consists of individuals other than Incumbent Directors, which term means the members of the Board on the Effective Date; provided that any person
becoming a director subsequent to such date whose election or nomination for election was supported by two-thirds of the directors who then comprised the Incumbent Directors shall be considered to be an Incumbent Director (excluding any person who
received such support in connection with the settlement of a proxy contest); (iii) the Employer 

  
 15 

 
adopts any plan of liquidation providing for the distribution of all or substantially all of its assets; (iv) the Employer transfers all or substantially all of its assets or business
(unless the shareholders of the Employer immediately prior to such transaction beneficially own, directly or indirectly, in substantially the same proportion as they owned the Voting Stock of the Employer, all of the Voting Stock or other ownership
interests of the entity or entities, if any, that succeed to the business of the Employer); or (v) any merger, reorganization, consolidation or similar transaction (a “Business Combination”) unless, immediately after
consummation of such Business Combination, (A) the shareholders of the Employer immediately prior to the Business Combination hold, directly or indirectly, more than 50% of the Voting Stock of the Employer or the Employer’s ultimate parent
company if the Employer is a subsidiary of another corporation, and (B) no person or group beneficially owns more than 30% of the Voting Stock of the Employer or the ultimate parent company of the Employer if the Employer is a subsidiary of
partner corporation. For purposes of this Change in Control definition, the “Employer” shall include any entity that succeeds to all or substantially all of the business of the Employer and “Voting Stock” shall mean
securities of any class or classes having general voting power under ordinary circumstances, in the absence of contingencies, to elect the directors of a corporation. 

“Company Affiliate” means any entity controlled by, in control of, or under common control with, the
Employer. 
 “Company Confidential Information” means information known to the Executive to
constitute trade secrets or proprietary information belonging to the Employer or other confidential financial information, operating budgets, strategic plans or research methods, personnel data, projects or plans, or non-public information regarding
the terms of any existing or pending lending transaction between Employer and an existing or pending client or customer (as the phrase “client or customer” is defined in Section 7(d)(i) hereof), in each case, received by the
Executive in the course of his employment by the Employer or in connection with his duties with the Employer. Notwithstanding anything to the contrary contained herein, the general skills, knowledge and experience gained during the Executive’s
employment with the Employer, information publicly available or generally known within the industry or trade in which the Employer competes and information or knowledge possessed by the Executive prior to his employment by the Employer, shall not be
considered Company Confidential Information. 
 “Date of Termination” means (i) if the
Executive’s employment is terminated by the Executive’s death, the date of the Executive’s death; (ii) if the Executive’s employment is terminated because of the Executive’s Disability, 30 days after Notice of
Termination, provided that the Executive shall not have returned to the performance of the Executive’s duties on a full-time basis during such 30-day period; or (iii) if the Executive’s employment is terminated by the Employer
pursuant to Section 8(a)(ii)(B) or by the Executive pursuant to Section 8(a)(iii), the date specified in the Notice of Termination. 
 “Good Reason” means, unless otherwise agreed to in writing by the Executive, (i) any diminution or adverse change in the Executive’s titles; (ii) reduction in the
Executive’s Base Salary or Target Bonus; ( iii) a change adverse to the Executive in the Executive’s reporting 

  
 16 

 
obligations; (iv) a material diminution in the Executive’s authority, responsibilities or duties or material interference with the Executive’s carrying out his duties; (v) the
assignment of duties inconsistent with the Executive’s position or status with the Employer as of the date hereof; (vi) a relocation by the Company of the Executive’s primary place of employment specified in Section 4 to a
location more than 25 miles further from the Executive’s primary residence than the current location of the Executive’s primary place of employment; (vii) any other material breach of the terms of this Agreement or any other agreement
that breach is not cured within ten days after the Executive’s delivery of a written notice of such breach to the Employer; (viii) any purported termination of the Executive’s employment by the Employer that is not effected in
accordance with the applicable provisions of this Agreement; (ix) the failure of the Employer to obtain the assumption in writing of its obligations under this Agreement by any successor to all or substantially all of the assets of the Employer
within 15 days after a merger, consolidation, sale or similar transaction; or (x) the delivery of a notice of Non-Renewal by the Employer. In order to invoke a termination for Good Reason, the Executive must terminate his employment, if at
all, within 60 days of the occurrence of any event of “Good Reason”. 
 “Non-Compete
Period” means the period commencing on the Effective Date and ending twelve months after the earlier of the expiration of the Employment Period or the Executive’s Date of Termination. 

  
 17 

 IN WITNESS WHEREOF, the undersigned have duly executed and delivered this Agreement, or have
caused this Agreement to be duly executed and delivered on their behalf. 
  

			
	SAGENT PHARMACEUTICALS, INC.
		
	By:	 	/s/ Michael Logerfo
	Name:	 	Michael Logerfo
	Title:	 	Chief Legal Officer, Corporate Vice President and Secretary

 

	
	EXECUTIVE
	
	/s/ Jeffrey Yordon
	Jeffrey Yordon

Source: [{"source": "alea-institute/alea-institute/kl3m-data-edgar-agreements/train-00183-of-00352.parquet"}, [{"source": "alea-institute/alea-institute/kl3m-data-edgar-agreements/train-00183-of-00352.parquet"}]]