Exhibit 10.1

 

EXECUTION VERSION

 

Confidential Materials Omitted and Filed Separately with the Securities and
Exchange
Commission Pursuant to a Request for Confidential Treatment under Rule 406 under
the
Securities Act of 1933, as amended. Confidential Portions are marked: [***]

 

ASSET PURCHASE AGREEMENT

 

BETWEEN

 

NOVEN THERAPEUTICS, LLC

 

AND

 

ANI PHARMACEUTICALS, INC.

 

 

 

Dated as of July 1, 2014

 

 

 

 

 

  

Confidential Materials Omitted and Filed Separately with the Securities and
Exchange
Commission Pursuant to a Request for Confidential Treatment under Rule 406 under
the
Securities Act of 1933, as amended. Confidential Portions are marked: [***]

 

TABLE OF CONTENTS

 

        Page Section 1   DEFINITIONS   1           Section 2   THE SALE   5    
      2.1   Sale and Purchase; Assumption of Certain Liabilities   5 2.2  
Consideration; Allocation of Consideration   6 2.3   Closing   7 2.4   Transfer
of Purchased Assets; Cooperation   8           Section 3   REPRESENTATIONS AND
WARRANTIES OF THE SELLER   9           3.1   Organization   9 3.2   Power and
Authorization   9 3.3   Authorization of Governmental Authorities   9 3.4  
Noncontravention   9 3.5   Encumbrances   9 3.6   Purchased Assets   9 3.7  
Intellectual Property   10 3.8   Legal Compliance   10 3.9   Litigation   10
3.10   Ordinary Course   11 3.11   AMP   11 3.12   No Brokers   11 3.13  
Solvency   11 3.14   No Other Representations or Warranties; Schedules   11    
      Section 4   REPRESENTATIONS AND WARRANTIES OF THE BUYER   11           4.1
  Organization   11 4.2   Power and Authorization   12 4.3   Authorization of
Governmental Authorities   12 4.4   No Brokers   12 4.5   Noncontravention   12
4.6   Financial Capability   12 4.7   Solvency   12           Section 5  
COVENANTS AND AGREEMENTS   12           5.1   Expenses   12 5.2   Payment and
Discharge of Liabilities   13 5.3   Further Assurances   13 5.4   Public
Announcements   13 5.5   Customer Notifications   13 5.6   NDC Numbers   13 5.7
  Access After Closing   13 5.8   Inventory   14 5.9   Regulatory Matters   14
5.10   Reporting of and Response to Adverse Drug Experience Reports, Medical
Inquiries and Product Complaints   14 5.11   Rebates; Returns   15 5.12  
Post-Closing Cooperation   15 5.13   Buyer’s Due Diligence Investigation   16

 

i

 

  

Confidential Materials Omitted and Filed Separately with the Securities and
Exchange
Commission Pursuant to a Request for Confidential Treatment under Rule 406 under
the
Securities Act of 1933, as amended. Confidential Portions are marked: [***]

 

TABLE OF CONTENTS

(continued)

 

        Page Section 6   INTENTIONALLY OMITTED   16           Section 7  
INTENTIONALLY OMITTED   16           Section 8   INDEMNIFICATION   16          
8.1   Indemnification by the Seller   17 8.2   Indemnification by the Buyer   17
8.3   Limits   17 8.4   Time for Claims   18 8.5   Procedure   18 8.6  
Exclusive Remedy; Release   18 8.7   Limits on Indemnification   19 8.8  
Treatment of Indemnification Payment by Seller   19 8.9   Consequential Damages
  19           Section 9   CONFIDENTIALITY   19           9.1   General   19 9.2
  Exceptions   20 9.3   Permitted Disclosures   20 9.4   Confidential Terms   20
9.5   Equitable Remedies   20           Section 10   DISPUTE RESOLUTION   20    
      10.1   Jurisdiction; Venue; Service of Process   20           Section 11  
MISCELLANEOUS   21           11.1   Notices   21 11.2   Amendment; Waiver   22
11.3   Entire Agreement   22 11.4   Governing Law   22 11.5   Binding Effect; No
Assignment; No Third-Party Beneficiaries   22 11.6   Section Headings;
Construction; Interpretation   23 11.7   Counterparts   23 11.8   Severability  
23 11.9   Rules of Construction   23 11.10   Bulk Sales Laws   23 11.11  
Independent Contractor   23 11.12   No Implied Waivers   23

 

SCHEDULES     Schedule I - Lithobid® Products Schedule II - Lithobid® Marks
Schedule 2.1(a)(iv) - Worldwide Web Addresses and Domains Schedule 2.2 -
Allocation Schedule Schedule 3.3 - Governmental Authorizations Schedule 3.4(a) -
Noncontravention Schedule 3.4(b) - Consents

 

ii

 

  

Confidential Materials Omitted and Filed Separately with the Securities and
Exchange
Commission Pursuant to a Request for Confidential Treatment under Rule 406 under
the
Securities Act of 1933, as amended. Confidential Portions are marked: [***]

 

TABLE OF CONTENTS

(continued)

 

Page

 

Schedule 3.5 - Encumbrances Schedule 3.7(b) - Intellectual Property
Registrations Schedule 3.8(a) - Regulatory Matters Schedule 3.8(b) - Recalls,
Etc. Schedule 3.8(c) - FDA Correspondence Schedule 3.9 - Litigation Schedule
3.10 - Ordinary Course Schedule 3.11 - AMP Schedule 5.5 - Customer Notification
      EXHIBITS     Exhibit A - Form of Bill of Sale Exhibit B - Form of
Assignment and Assumption Agreement Exhibit C - Form of Assignment of Trademark
Rights Exhibit D - Joint Public Statement Exhibit E - Transfer Letter Exhibit F
- Supply Agreement Termination Letter Exhibit G - Buyer’s Acceptance Letter
Exhibit H - Customer Notification Letter

 

iii

 

 

Confidential Materials Omitted and Filed Separately with the Securities and
Exchange
Commission Pursuant to a Request for Confidential Treatment under Rule 406 under
the
Securities Act of 1933, as amended. Confidential Portions are marked: [***]

 

ASSET PURCHASE AGREEMENT

 

This ASSET PURCHASE AGREEMENT (this “Agreement”) is entered into as of July 1,
2014 (the “Closing Date”), by and between Noven Therapeutics, LLC, a Delaware
limited liability company formerly known as JDS Pharmaceuticals, LLC (the
“Seller”) and ANI Pharmaceuticals, Inc., a Delaware corporation (the “Buyer”).
The Seller and the Buyer are referred to hereinafter individually as a “Party”
and collectively as the “Parties.”

 

RECITALS

 

A.           The Seller is engaged in the promotion, distribution, marketing,
and sale of the Lithobid Products (the “Business”).

 

B.           Pursuant to the terms of that certain Manufacturing and Supply
Agreement, dated December 6, 2007, between Seller and ANIP Acquisition Company,
a wholly owned subsidiary of Buyer (“ANIP Acquisition”), ANIP Acquisition is the
current manufacturer of the Lithobid Products (the “Supply Agreement”).

 

C.           Buyer desires to purchase from Seller and Seller desires to sell to
Buyer, the Purchased Assets for the Consideration and upon the terms and
conditions set forth herein (the “Sale”), and the Board of Directors of each of
the Seller and the Buyer has approved the consummation of the Sale and the
transactions set forth herein.

 

In consideration of the mutual representations, warranties and covenants
contained herein, the Parties hereto agree as follows:

 

Section 1      DEFINITIONS

 

1.1           “Act” means the Federal Food, Drug and Cosmetic Act, as amended,
and the regulations promulgated thereunder from time to time.

 

1.2           “Additional Payment” has the meaning set forth in Section 2.2(b)
below.

 

1.3           “Affiliate” means any person or legal entity controlling,
controlled by or under common control with the person with respect to whom such
status is at issue and shall include, without limitation, any corporation fifty
percent (50%) or more of the voting power of which (or other comparable
ownership interest for an entity other than a corporation) is owned, directly or
indirectly, by the person with respect to whom such status is at issue or any
corporation, person or entity which owns fifty percent (50%) of more of such
voting power of the person with respect to whom such status is at issue.

 

1.4           “Agreement” has the meaning set forth in the preamble above.

 

1.5           “Allocation Schedule” has the meaning set forth in Section 2.2(c)
below.

 

1.6           “AMP” has the meaning set forth in Section 3.11 below.

 

1.7           “Ancillary Agreements” has the meaning set forth in Section 2.3(a)
below.

 

1.8           “ANIP Acquisition” has the meaning set forth in the recitals
above.

 

1.9           “API” means the active pharmaceutical ingredient or
pharmaceutically active compound Lithium Carbonate for use in the Lithobid
Product.

 

 

 

 

Confidential Materials Omitted and Filed Separately with the Securities and
Exchange
Commission Pursuant to a Request for Confidential Treatment under Rule 406 under
the
Securities Act of 1933, as amended. Confidential Portions are marked: [***]

 

1.10         “Assumed Liabilities” has the meaning set forth in Section 2.1(c)
below.

 

1.11         “Books and Records” means the Marketing Materials and Data, and all
of the following, to the extent solely relating to the Lithobid Products or the
Business and to the extent owned by Seller as of the Closing Date: all
documents, if any, relating to the calculation of baseline AMP received by
Seller from Solvay (but excluding any proprietary methodology documents created
by Seller or any of Seller’s Affiliates with respect to the calculation of
baseline AMP); all documents, if any, relating to NonFAMP-Eligible Transactions
from October 1, 2013 through the Closing Date; vendor lists and audits; batch
records; change control reports; all information relating to medical safety,
including complaints and adverse drug event histories and files for the Lithobid
Products; copies of all filings (and supporting documentation and
correspondence) with Regulatory Authorities, including, but not limited to, the
NDA for the Lithobid Products, as well as the Supplement; component and labeling
purchasing specifications; quality assurance/control data; and customer lists
(if any).

 

1.12         “Bulk Sales Laws” means the Laws of any jurisdiction relating to
bulk sales that are applicable to the sale of the Purchased Assets by Seller
hereunder.

 

1.13         “Business” has the meaning set forth in the recitals above.

 

1.14         “Business Day” means any day other than a Saturday, Sunday or
another day on which commercial banks in New York, New York are authorized or
required by law to close.

 

1.15         “Buyer” has the meaning set forth in the preamble above.

 

1.16         “Buyer Indemnified Party” has the meaning set forth in Section 8.1
below.

 

1.17         “Buyer’s Acceptance Letter” has the meaning set forth in
Section 2.3(b)(iii) below.

 

1.18         “Cap” has the meaning set forth in Section 8.3(a) below.

 

1.19         “Closing” has the meaning set forth in Section 2.3 below.

 

1.20         “Closing Date” has the meaning set forth in the preamble.

 

1.21         “Closing Payment” has the meaning set forth in Section 2.3(b)(i)
below.

 

1.22         “Confidential Information” has the meaning set forth in Section 9.1
below.

 

1.23         “Consideration” has the meaning set forth in Section 2.2(b) below.

 

1.24         “Disclosing Party” has the meaning set forth in Section 9.1 below.

 

1.25         “Dollar,” “Dollars” and the symbol “$” each means lawful money of
the United States of America.

 

1.26         “Excluded Assets” has the meaning set forth in Section 2.1(b)
below.

 

1.27         “FDA” means the Food and Drug Administration or any successor
agency thereof.

 

1.28         “FDA Review” means the FDA’s review of the Supplement.

 

1.29         “Finished Lithobid Product Inventory” has the meaning set forth in
Section 2.1(b) below.

 

1.30         “Fundamental Representations” has the meaning set forth in
Section 8.4(a) below.

 

2

 

 

Confidential Materials Omitted and Filed Separately with the Securities and
Exchange
Commission Pursuant to a Request for Confidential Treatment under Rule 406 under
the
Securities Act of 1933, as amended. Confidential Portions are marked: [***]

 

1.31         “Indemnified Parties” means (i) with respect to claims arising
under Section 8.1, the Buyer Indemnified Parties, and (ii) with respect to
claims arising under Section 8.2, the Seller Indemnified Parties.

 

1.32         “Indemnifying Party” means (i) with respect to claims arising under
Section 8.1, the Seller, and (ii) with respect to claims arising under
Section 8.2, the Buyer.

 

1.33         “Intellectual Property Rights” means any and all of the following
intellectual property rights owned by the Seller or its Affiliates to the extent
primarily used in the formulation, manufacture, packaging, promotion,
distribution, marketing, and sale of the Lithobid Products: (i) patents, patent
applications (filed and unified), invention disclosures and invention
assignments; (ii) trademarks, trade names, trade dress, logos, slogans, rights
of publicity, service marks and service names; (iii) copyrights and other works;
(iv) worldwide web addresses and domain names; (v) Know-How; (vi) Trade Secrets;
(vii) all applications, registrations, or common law or unregistered rights
relating to any of the foregoing; and (viii) all rights to obtain renewals,
continuations, divisions or other extensions of legal protections pertaining to
any of the foregoing. For clarity and for all purposes under this Agreement, the
name “Noven” and all trademarks and other intellectual property rights related
thereto are not Intellectual Property Rights.

 

1.34         “Inventory” means all work-in-process, printed packaging
components, raw materials, including API, and inventories of Finished Lithobid
Product Inventory that is owned by Seller.

 

1.35         “Know-How” means all proprietary methods, processes, techniques,
compositions, technology, information, data, results of tests, studies,
statistical and other analyses and expertise, whether patented or unpatented, in
each case to the extent related solely to the Lithobid Products, owned by the
Seller or any Affiliate of the Seller which are, used solely in the formulation,
manufacture or marketing of the Lithobid Products, including, without
limitation, pharmacology, toxicology, drug stability, manufacturing and
formulation methodologies and techniques, clinical and non-clinical safety and
efficacy studies, marketing studies and absorption, excretion and metabolism
studies, quality control and quality assurance processes, and shall include,
without limitation, all tangible manifestations thereof.

 

1.36         “Knowledge” means, with respect to the Seller and with respect to
any particular matter, the actual knowledge of Jeffrey Mihm, the Chief
Administrative Officer and General Counsel of Seller or Bruce Friedman, Vice
President of the Seller and the knowledge each has or would have after inquiry
to his direct reports who have responsibility for and are likely to have
knowledge of the matter in question.

 

1.37         “Law” means all applicable federal, state and local laws, statutes
or ordinances, including, without limitation, (i) the Act and (ii) all
regulations, rules, or published guidelines or pronouncements having the effect
of law promulgated by any Regulatory Authority.

 

1.38         “Liability” means any liability (whether known or unknown, asserted
or unasserted, absolute or contingent, accrued or unaccrued, liquidated or
unliquidated, and due or to become due), including any liability for Taxes.

 

1.39         “Lithobid Marks” means the trademarks listed on Schedule II hereto.

 

1.40         “Lithobid Products” means the specific products listed on Schedule
I hereto.

 

1.41         “Losses” has the meaning set forth in Section 8.1 below.

 

1.42         “Marketing Materials and Data” means all of the following, to the
extent solely relating to the Lithobid Products and to the extent owned by
Seller and in Seller’s possession: physician lists, customer lists, sales force
training materials, market research materials, advertising and promotional
materials and records of sales and cost data for the twelve (12) months ended
April 30, 2014.

 

3

 

 

Confidential Materials Omitted and Filed Separately with the Securities and
Exchange
Commission Pursuant to a Request for Confidential Treatment under Rule 406 under
the
Securities Act of 1933, as amended. Confidential Portions are marked: [***]

 

1.43         “Material Adverse Effect” means (i) with respect to any Person, a
material adverse effect on the assets, financial condition, or results of
operations of such Person and its subsidiaries, taken as a whole, and (ii) with
respect to the Business, a material adverse effect on the Business taken as a
whole, provided that in no event will any of the following, individually or in
the aggregate, be deemed to constitute, nor shall any of the following be taken
into account in determining whether there has been, or will be, a Material
Adverse Effect with respect to such Person, or with respect to the Business:
(A) any change in general economic or financial market conditions, (B) any
change in the general state of the industry in which such Person or the
Business, as applicable, operates, (C) any act of terrorism or war, or (D) the
announcement of the execution of this Agreement or the transactions contemplated
hereby except to the extent any of the events in clauses (A) - (D) affects such
Person or the Business in a disproportionate manner to other Persons or products
in the industry.

 

1.44         “NDA” means New Drug Application 18-027.

 

1.45         “NDC” has the meaning set forth in Section 5.6 below.

 

1.46         “NonFAMP-Eligible Transactions” means those transactions relating
to the Lithobid Products that are used to calculate the Non-Federal Average
Manufacturer Price as defined by Veteran’s Health Care Act of 1992.

 

1.47         “Party” or “Parties” has the meaning set forth in the preamble
above.

 

1.48         “Permitted Encumbrances” means (i) encumbrances for Taxes not yet
due and payable or being contested in good faith for which adequate reserves
have been established; and (ii) statutory and contractual encumbrances of
landlords, carriers, warehousemen, mechanics, materialmen, suppliers and
repairmen, and other like encumbrances, incurred in the ordinary course of
business and not yet delinquent or being contested in good faith.

 

1.49         “Person” means an individual, a corporation, a general partnership,
a limited partnership, a limited liability company, a limited liability
partnership, an association, a trust or any other entity or organization,
including a governmental authority.

 

1.50         “Product Approval” means with respect to each Lithobid Product, the
NDA set forth opposite the name of such Lithobid Product on Schedule I hereto,
together with the Supplement.

 

1.51         “Product Technology” means the Intellectual Property Rights,
manufacturing technology, and trade secrets, including, but not limited to, the
Know-How, that is owned or used by the Seller or its Affiliates and is necessary
for the formulation, manufacture, packaging, release testing and stability and
shelf life determination of the Lithobid Products, including, but not limited
to, specifications and test methods, manufacturing and packaging instructions,
master formula, validation reports (process, analytical methods and cleaning),
stability data and analytical methods, but excluding any common industry
practice, process or procedure used or usable in the manufacture of
pharmaceutical products.

 

1.52         “Purchased Assets” has the meaning set forth in Section 2.1(a)
below.

 

1.53         “Reasonable Commercial Efforts” means, with respect to a particular
result, such efforts as a reasonably prudent Person desirous of achieving such
result would use in similar circumstances; provided that the applicable Party
shall be required to expend only such resources to achieve such result as are
commercially reasonable in similar circumstances.

 

1.54         “Receiving Party” has the meaning set forth in Section 9.1 below.

 

1.55         “Regulatory Authority” means any governmental or regulatory body,
court, agency, commission, official, or arbitrator, including, without
limitation, the FDA.

 

4

 

 

Confidential Materials Omitted and Filed Separately with the Securities and
Exchange
Commission Pursuant to a Request for Confidential Treatment under Rule 406 under
the
Securities Act of 1933, as amended. Confidential Portions are marked: [***]

 

1.56         “Retained Liabilities” has the meaning set forth in Section 2.1(d)
below.

 

1.57         “Sale” has the meaning set forth in the recitals above.

 

1.58         “Seller” has the meaning set forth in the preamble above.

 

1.59         “Seller Indemnified Party” has the meaning set forth in Section 8.2
below.

 

1.60         “Supplement” means the prior approval Supplement filed by Seller
with the FDA relating to a change in particle size of the active pharmaceutical
ingredients used in the Lithobid Products.

 

1.61         “Supply Agreement” has the meaning set forth in the recitals above.

 

1.62         “Supply Agreement Termination Letter” has the meaning set forth in
Section 2.3(a)(iv) below.

 

1.63         “Tax Return” means any return, declaration, report, claim for
refund, information return or statement or other document relating to Taxes,
including any schedule or attachment thereto, and including any amendment
thereof.

 

1.64         “Taxes” (and with correlative meanings, “Tax” and “Taxable”) means
all taxes of any kind imposed by a federal, state, local or foreign governmental
authority, including, but not limited to, those on, or measured by or referred
to as, income, gross receipts, financial operation, sales, use, ad valorem,
value added, franchise, profits, license, withholding, payroll (including all
contributions or premiums pursuant to industry or governmental social security
laws or pursuant to other laws and regulations), employment, excise, severance,
stamp, occupation, premium, property, transfer or windfall profits taxes,
customs, duties or similar fees, assessments or charges of any kind whatsoever,
together with any interest, surcharges and penalties, additions to tax or
additional amounts imposed by such governmental authority with respect to such
amounts.

 

1.65         “Third Party” means any Person other than the Parties or any of
their respective Affiliates.

 

1.66         “Threshold Amount” has the meaning set forth in Section 8.3(a)
below.

 

1.67         “Trade Secrets” means information solely regarding the Lithobid
Products, including technical and non-technical data, a formula, pattern,
compilation, program device, method, technique, process or other information
similar to any of the foregoing, that (i) derives economic value, actual or
potential, from not being generally known to, and not being readily
ascertainable by proper means by, other Persons who can derive economic value
from its disclosure or use and (ii) is the subject of efforts that are
reasonable under the circumstances to maintain its secrecy.

 

1.68         “Transfer Letter” has the meaning set forth in Section 2.3(a)(iii).

 

Section 2      THE SALE

 

2.1           Sale and Purchase; Assumption of Certain Liabilities.

 

(a)          At the Closing, the Seller is selling, conveying, assigning,
transferring, and, to the extent set forth in this Agreement, delivering to the
Buyer, and the Buyer is purchasing and assuming from the Seller, all of the
Seller’s right, title and interest in and to the following assets (collectively,
the “Purchased Assets”):

 

(i)          the Books and Records;

 

5

 

 

Confidential Materials Omitted and Filed Separately with the Securities and
Exchange
Commission Pursuant to a Request for Confidential Treatment under Rule 406 under
the
Securities Act of 1933, as amended. Confidential Portions are marked: [***]

 

(ii)         the Inventory, except for the Finished Lithobid Product Inventory;

 

(iii)        the Product Approvals (to be effectuated as set forth in
Section 2.4(b)); and

 

(iv)        all the Intellectual Property Rights, including, without limitation,
the Lithobid Marks and worldwide web addresses and domain names listed on
Schedule 2.1(a)(iv).

 

(b)          Notwithstanding any other provision of this Agreement, the
Purchased Assets do not include, and the Seller shall retain all rights, title
and interest in and to, all assets, properties and rights of the Seller and its
Affiliates, including all finished Lithobid Product Inventory bearing Seller’s
NDC code (“Finished Lithobid Product Inventory”), other than those assets
specifically enumerated as Purchased Assets in Section 2.1(a) (collectively, the
“Excluded Assets”). Without limiting the generality of the foregoing, the
Parties agree and acknowledge that the Purchased Assets shall not include any
property, plant or equipment, accounts receivable, cash, employees, or credit or
refund of Taxes attributable to any period of time prior to the Closing Date.
Buyer acknowledges and agrees that Seller may retain a copy of all or part of
the documentation that it delivers to Buyer hereunder.

 

(c)          At the Closing, as further consideration for the Purchased Assets,
the Buyer shall only assume and agree to pay, perform and discharge (i) all
Liabilities and obligations arising out of the conduct of the Business and/or
the operation and/or use of the Purchased Assets by Buyer following the Closing,
(ii) all product liability, product warranty and other Liabilities and
obligations arising out of or relating to the manufacture, distribution and/or
sale of any Lithobid Products sold using Buyer’s NDC after the Closing Date or
the use thereof; (iii) all regulatory responsibilities relating to the Lithobid
Products arising after the Closing Date; (iv) notwithstanding any provision of
this Agreement to the contrary, all Liabilities (including for product
liability, breach of warranty or any other action or claim) for which Buyer,
ANIP Acquisition or any of their respective Affiliates has Liability or in the
future would have Liability pursuant to the Supply Agreement, including relating
to voluntary and involuntary recalls and market withdrawals of the Lithobid
Product); and (v) any Liabilities relating to any clinical study or any data
associated therewith which arise from and after the Closing Date, if such
clinical study was required or requested by any Regulatory Authority after the
Closing Date (collectively, the “Assumed Liabilities”).

 

(d)          All Liabilities of the Seller other than the Assumed Liabilities
(the “Retained Liabilities”) shall be retained by and shall remain the sole
responsibility of the Seller and its Affiliates, as applicable.

 

2.2           Consideration; Allocation of Consideration.

 

(a)          As consideration for the Purchased Assets, at the Closing, the
Buyer is paying to Seller, the Closing Payment by wire transfer of readily
available US dollars to an account specified by Seller in writing.

 

(b)          In the event that on or prior to June 30, 2015 the FDA informs
Buyer that the FDA Review has been completed and the proposed Supplement
accepted without any additional requirement that Buyer conduct any further
clinical trial in order to qualify or permit the requested change to the
Lithobid Products specified in the Supplement, then, no later than ten (10)
Business Days following the Buyer’s receipt of the approval thereof from the
FDA, the Buyer will make an additional payment to Seller of One Million Dollars
($1,000,000), by wire transfer of immediately available funds (the “Additional
Payment”). However, in the event that in connection with the FDA Review the FDA
informs Buyer that any such further clinical trial is required or otherwise
fails to approve the proposed Supplement on or prior to June 30, 2015, then no
Additional Payment shall be made by Buyer to Seller hereunder. Each Party shall
use (after Reasonable Commercial Efforts by Buyer to obtain such approval)
Reasonable Commercial Efforts to obtain approval of the Supplement. The
aggregate of the Closing Payment plus any Additional Payment and the Assumed
Liabilities is referred to herein as the “Consideration”.

 

6

 

 

Confidential Materials Omitted and Filed Separately with the Securities and
Exchange
Commission Pursuant to a Request for Confidential Treatment under Rule 406 under
the
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(c)          The Consideration shall be allocated in accordance with
Schedule 2.2 (the “Allocation Schedule”). Each of the Parties agrees to
(i) prepare and timely file all Tax Returns, in respect of all affected taxable
periods (or portions thereof), in a manner consistent with the Allocation
Schedule, and (ii) act in accordance with the Allocation Schedule for all Tax
purposes, unless otherwise required by Law. Any unresolved disputes regarding
the Allocation Schedule, including any amendments thereto, shall be promptly
submitted to a jointly-retained third party accounting firm for determination,
which shall be final and binding on the Parties. The cost and expenses of such
third party accounting firm shall be borne equally by the Buyer and Seller.

 

(d)          Any Taxes in the nature of a sales, transfer or use Tax payable on
the sale or transfer of all or any portion of the Purchased Assets or the
consummation of any other transaction contemplated hereby (but specifically
excluding any income tax liabilities) shall be borne equally by the Seller and
Buyer. The Buyer shall not be entitled to deduct and/or withhold from the
Consideration otherwise payable to Seller pursuant to this Agreement under any
provision of federal, state, local or foreign Tax Law.

 

2.3           Closing. The closing (the “Closing”) of the Sale is taking place
on the Closing Date, concurrently with the execution and delivery of this
Agreement at the offices of Dentons US, LLP, located at 1221 Avenue of the
Americas, New York, NY 10020. The effective time of the Closing shall be 12:01
am, Eastern Daylight Time on the Closing Date. The parties hereby agree that the
Closing may take place by delivery of the documents to be delivered at the
Closing by facsimile or other electronic transmission. All deliveries by one
party to another party at Closing shall be deemed to have occurred
simultaneously and none shall be effective until and unless all have occurred.
At the Closing:

 

(a)          The Seller shall deliver to the Buyer counterparts of the following
documents, duly executed by the Seller (collectively referred to herein as the
“Ancillary Agreements”):

 

(i)          a Bill of Sale and Assignment and Assumption Agreement effecting
the transfer of the Purchased Assets and the assignment and assumption of the
Assumed Liabilities, in the form and substance of Exhibits A and B,
respectively, hereto, executed by the Seller;

 

(ii)         an assignment of the Lithobid Marks, in the form and substance of
Exhibit C, executed by the Seller;

 

(iii)        a letter of transfer from Seller to the FDA in the form of Exhibit
E (the “Transfer Letter”);

 

(iv)        a letter from Seller confirming that the Supply Agreement is
terminated except for Section 2.9, Article III, Article V, Article VI, Article
VII, Article VIII, Article XII and Article XIII (other than Section 13.9), in
the form of Exhibit F (the “Supply Agreement Termination Letter”); and

 

(v)         such other documents, instruments and certificates as the Seller and
Buyer reasonably agree are necessary to effect the transactions herein
described.

 

(b)          The Buyer shall deliver to the Seller:

 

(i)          the aggregate sum of Eleven Million Dollars ($11,000,000) (the
“Closing Payment”) by wire transfer of immediately available funds in accordance
with Section 2.2(a);

 

(ii)         counterparts of each of the Ancillary Agreements, duly executed by
the Buyer as applicable;

 

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(iii)        a letter from Buyer to the FDA notifying it of Buyer’s acceptance
of the transfer of the NDA referred to in the Transfer Letter in the form of
Exhibit G (“Buyer’s Acceptance Letter”); and

 

(iv)        the Supply Agreement Termination Letter duly executed by ANIP
Acquisition.

 

2.4           Transfer of Purchased Assets; Cooperation.

 

(a)          On or as promptly as practicable after the Closing Date, the Seller
shall (i) transfer (or implement arrangements reasonably satisfactory to Buyer
for the transfer and delivery of physical possession of) all tangible assets
included in the Purchased Assets to the Buyer or its designated representatives,
and (ii) upon request of the Buyer, notify all of its agents that hold files or
other tangible material included in the Purchased Assets that, effective as of
the Closing, the Buyer owns such Purchased Assets, with directions to transfer
such Purchased Assets to Buyer in accordance with the Buyer’s instructions.
Buyer shall pay for any costs or expenses associated with taking possession of
the Purchased Assets. Notwithstanding the foregoing, to the extent not delivered
at Closing, Seller shall deliver all of the non-electronic Books and Records
related to the Product Approvals to Buyer no later than August 1, 2014, and on
or before July 15, 2014, except as otherwise provided in Section 5.12(c), Seller
shall provide to Buyer (1) all of the electronic Books and Records related to
the Product Approvals, to the extent not previously delivered and (2) all case
files since April 27, 2014, including readable .pdf copies of PADER listings and
completed FDA form 3500As and source documents.

 

(b)          Following the Closing, Seller shall file with the FDA all of the
documents and the information required of a former owner, including, but not
limited to, the Transfer Letter and Buyer shall file with the FDA the
information required of a new owner or agent in respect thereof in the form of
the Buyer’s Acceptance Letter, in each case, at each Party’s own expense. Seller
may retain an archival copy of each Product Approval, including supplements and
records that are required to be kept under 21 CFR §314.81.

 

(c)          Notwithstanding anything to the contrary contained in this
Agreement, if the sale, assignment, transfer, conveyance or delivery or
attempted sale, assignment, transfer, conveyance or delivery to the Buyer of any
asset that would be a Purchased Asset is (i) prohibited by any applicable Law or
(ii) would require any authorization, approval, consent or waiver from a Third
Party or Regulatory Authority and such authorization, approval, consent or
waiver shall not have been obtained prior to the Closing, then nothing contained
herein or in any Ancillary Agreement shall constitute or effect the sale,
assignment, transfer, conveyance or delivery of any such asset. In such event,
following the Closing, the Parties shall use their Reasonable Commercial
Efforts, and cooperate with each other in good faith, to obtain promptly such
authorization, approval, consent or waiver; provided, however, that the Buyer
shall not be required to pay any consideration or fee or otherwise incur any
expense (all such consideration, fees and expenses to be borne exclusively by
the Seller) to obtain any such authorization, approval, consent or waiver.
Pending such authorization, approval, consent or waiver, the Parties shall
cooperate with each other in good faith in any reasonable and lawful
arrangements that will provide to the Buyer the benefits of use of such asset,
including any indemnities, that, in each case, it would have obtained had the
asset been conveyed to the Buyer at the Closing. If authorization, approval,
consent or waiver for the sale, assignment, transfer, conveyance or delivery of
any such asset not sold, assigned, transferred, conveyed or delivered at the
Closing is obtained, the Seller shall assign, transfer, convey and deliver such
asset to the Buyer at no additional cost to the Buyer.

 

(d)          Buyer shall be responsible for, and shall bear all costs associated
with, completing the recordation of any trademark assignment for the Lithobid
Marks with the appropriate Regulatory Authorities in each country in which the
Lithobid Marks are registered; provided that Seller shall, for a period of three
(3) years after the Closing, upon the reasonable request of Buyer, cooperate
with Buyer to execute any additional documentation required to record and give
effect to the assignment of the Lithobid Marks in any jurisdiction in accordance
with this Agreement.

 

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Section 3 REPRESENTATIONS AND WARRANTIES OF THE SELLER

 

Except as otherwise disclosed to Buyer in the correspondingly numbered section
of the disclosure schedules delivered to Buyer by the Seller on the date hereof,
the Seller hereby represents and warrants to the Buyer as follows:

 

3.1           Organization. Seller is duly organized, validly existing and in
good standing under the laws of Delaware.

 

3.2           Power and Authorization. The execution and delivery by the Seller
of this Agreement and each Ancillary Agreement, and the performance of the
Seller’s obligations hereunder and thereunder and the consummation of the Sale
are within the power and authority of the Seller and have been duly authorized
by all necessary action on the part of the Seller. Each of this Agreement and
each Ancillary Agreement (a) has been duly executed and delivered by a duly
authorized representative of the Seller and (b) is a legal, valid and binding
obligation of the Seller, enforceable against the Seller in accordance with its
terms, except as enforceability may be limited by applicable bankruptcy,
insolvency, reorganization, moratorium or other similar laws now or hereafter in
effect relating to or affecting creditors’ rights generally.

 

3.3           Authorization of Governmental Authorities. Except for actions and
filings disclosed on Schedule 3.3 and for the Transfer Letter and Buyer’s
Acceptance Letter (and FDA’s acceptance thereof to the extent required), no
action by or in respect of, or filing with, any Regulatory Authority is required
by the Seller for, or in connection with, the valid and lawful
(i) authorization, execution and delivery by the Seller of this Agreement and
each Ancillary Agreement or (ii) the consummation of the Sale by the Seller.

 

3.4           Noncontravention.

 

(a)          Except as disclosed on Schedule 3.4(a), the execution, delivery and
performance by the Seller of this Agreement and the Ancillary Agreements do not
(i) violate any Law or any decree or judgment of any court or other Regulatory
Authority applicable to the Seller, the Business or any of the Purchased Assets;
(ii) violate or conflict with, result in a breach of, constitute a default (or
an event which, with or without notice or lapse of time or both, would
constitute a default) under, permit cancellation of, or result in the creation
of any encumbrance (other than Permitted Encumbrances) upon any of the Purchased
Assets under, any contract to which the Seller is a party or by which it is
bound (subject to Seller’s obtaining the consents set forth on Schedule 3.4(b));
or (iii) violate or conflict with any provision of the Certificate of
Incorporation or By-laws of the Seller.

 

(b)          Except as set forth on Schedule 3.4(b) and for the Transfer Letter
and Buyer’s Acceptance Letter (and FDA’s acceptance thereof to the extent
required), no consents or approvals of, or filings or registrations by the
Seller with any Regulatory Authority or any other Third Party are necessary in
connection with the execution, delivery and performance of this Agreement or the
Ancillary Agreements by the Seller.

 

3.5           Encumbrances. Except as disclosed on Schedule 3.5 and except for
Permitted Encumbrances and/or Encumbrances created by or at the express
direction of Buyer, there are no encumbrances on any of the Purchased Assets.

 

3.6           Purchased Assets. At Closing, the Seller shall convey to the Buyer
good and marketable title to and/or an enforceable right to use, all of the
Purchased Assets, subject to Encumbrances created by or at the express direction
of Buyer.

 

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3.7           Intellectual Property.

 

(a)          The current use by the Seller of the Intellectual Property Rights
in the formulation, manufacture, packaging, promotion, distribution, marketing,
and sale of the Lithobid Products does not interfere with, infringe upon,
misappropriate, or otherwise conflict with any intellectual property rights of
any Third Party. The Seller has not received any written charge, complaint,
claim, demand, or notice since June 1, 2011 alleging any interference,
infringement, misappropriation, or violation (including any claim that the
Seller or any of its Affiliates must license or refrain from using any of the
Intellectual Property Rights). To the Knowledge of the Seller, no Third Party
(i) currently interferes or has since June 1, 2011 interfered with,
(ii) currently infringes or has since June 1, 2011 infringed upon, or (iii) has
since June 1, 2011 misappropriated any of the Intellectual Property Rights.

 

(b)          Schedule 3.7(b) identifies all current and unexpired trademark and
patent registrations that have been issued to the Seller or its predecessors
that solely relate to the Lithobid Products. Each item identified in
Schedule 3.7(b) is valid, subsisting and in full force and effect, and the
Seller has taken all reasonable steps necessary to maintain such registrations,
including the payment when due of all registration and maintenance fees and
annuities and the filing of all necessary renewals, statements and
certifications, and all necessary material documents and certificates in
connection with such registered Intellectual Property Rights have been filed
with the relevant patent, copyright or other governmental or Regulatory
Authorities for the purposes of maintaining such registered Intellectual
Property Rights.

 

(c)          Section 3.6 (solely with respect to Product Approvals that
constitute Intellectual Property Rights) and this Section 3.7 represent the sole
and exclusive representations and warranties of the Seller regarding
Intellectual Property Rights and no other representation and/or warranty in this
Agreement shall apply to any Intellectual Property Rights.

 

3.8           Legal Compliance.

 

(a)          Except as disclosed on Schedule 3.8(a), since June 1, 2009, the
Seller has conducted its operations as they pertain to the Business in
compliance, in all material respects, with all applicable Laws.

 

(b)          Except as set forth on Schedule 3.8(b), the Seller has not received
any written notice of a material violation of any applicable Law from any
Regulatory Authority relating to the Purchased Assets or Business, including the
promotion, distribution, marketing, and sale of the Lithobid Products since June
1, 2011.

 

(c)          Except as set forth on Schedule 3.8(c), with respect to the
Business, including the promotion, distribution, marketing, and sale of the
Lithobid Products, the Seller has not received in writing since June 1, 2011,
any warning letters or other correspondence from the FDA or any other Regulatory
Authority in which the FDA or such other Regulatory Authority asserted that the
promotion, distribution, marketing, or use and sale of any Lithobid Product was
not in compliance with applicable Law. Except as disclosed on Schedule 3.8(b),
with respect to the promotion, distribution, marketing, and sale of the Lithobid
Products, there has not been, since June 1, 2011, any product recall, market
withdrawal or replacement, or post-sale warning conducted by or on behalf of the
Seller concerning the Lithobid Products or, to the Knowledge of the Seller, any
product recall, market withdrawal or replacement conducted by or on behalf of
any Third Party as a result of any alleged defect in the Lithobid Products.

 

(d)          Seller has provided to Buyer readable .pdf copies of all PADERs or
PADER listings from 2004 through April 27, 2014 and Medwatch forms for all
expedited cases from 2009 through April 27, 2014. Since April 27, 2011 , each
PADER and annual report relating to the Lithobid Products was timely filed by
the Seller with the FDA.

 

3.9           Litigation. Except as disclosed on Schedule 3.9, there is no
lawsuit relating to the Purchased Assets of which Seller has Knowledge, or to
the Knowledge of the Seller, threatened which would reasonably be expected to
have a Material Adverse Effect on the Business. There is no lawsuit pending, or
to the Knowledge of the Seller, threatened, which in any manner challenges or
seeks the rescission of, or seeks to prevent, enjoin, alter or materially delay
the consummation of, or otherwise relates to, this Agreement or the Sale. The
Seller is not the plaintiff in and currently does not intend to initiate any
lawsuit involving the Purchased Assets.

 

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3.10         Ordinary Course. As of June 30, 2014, the Finished Lithobid Product
Inventory at the Company’s three largest wholesalers in the aggregate is not
more than 1600 units. Schedule 3.10 sets forth a summary, by week, of the
shipments of Lithobid Products sold by or on behalf of the Seller to customers
from April 1, 2014 through June 29, 2014.

 

3.11         AMP. Schedule 3.11 sets forth the baseline Average Manufacturers
Price (“AMP”) for the Lithobid Products as of March 31, 2014. As of the Closing
Date, Seller has delivered to Buyer any and all Books and Records relating to
the calculation of baseline AMP received by Seller from Solvay when Seller
acquired the rights to Lithobid from Solvay (which for purposes of clarity
excludes any proprietary methodology documents created by Seller or any of
Seller’s Affiliates with respect to the calculation of baseline AMP).

 

3.12         No Brokers. The Seller has no liability of any kind to, and is not
subject to any claim of, any broker, finder or agent in connection with the Sale
other than those which will be borne by the Seller.

 

3.13         Solvency. Immediately after giving effect to the Closing and the
transactions contemplated by this Agreement, the Seller and each of its
subsidiaries will be able to pay their respective debts as they become due and
shall own property which has a fair saleable value greater than the amounts
required to pay their respective debts (including a reasonable estimate of the
amount of all contingent liabilities). Immediately after giving effect to the
transactions contemplated by this Agreement, the Seller and each of its
subsidiaries shall have adequate capital to carry on their respective
businesses. No transfer of property is being made and no obligation is being
incurred in connection with the transactions contemplated by this Agreement with
the intent to hinder, delay or defraud either present or future creditors of the
Seller or its subsidiaries.

 

3.14         No Other Representations or Warranties; Schedules.

 

(a)          EXCEPT FOR THE REPRESENTATIONS AND WARRANTIES EXPRESSLY SET FORTH
IN SECTION 3, THE SELLER DISCLAIMS ALL LIABILITY AND RESPONSIBILITY FOR ANY
REPRESENTATION, WARRANTY, STATEMENT MADE OR INFORMATION COMMUNICATED (WHETHER
ORALLY OR IN WRITING) TO BUYER, ITS AFFILIATES AND REPRESENTATIVES (INCLUDING
ANY OPINION, INFORMATION OR ADVICE WHICH MAY HAVE BEEN PROVIDED TO BUYER, ITS
AFFILIATES OR REPRESENTATIVES BY ANY DIRECTOR, OFFICER, EMPLOYEE, ACCOUNTING
FIRM, LEGAL COUNSEL, OR OTHER AGENT, CONSULTANT, OR REPRESENTATIVE OF THE
SELLER). ANY AND ALL STATEMENTS MADE OR INFORMATION COMMUNICATED BY THE SELLER
OR ANY OF ITS REPRESENTATIVES OUTSIDE OF THIS AGREEMENT (INCLUDING BY WAY OF THE
DOCUMENTS PROVIDED IN RESPONSE TO BUYER’S WRITTEN DILIGENCE REQUESTS AND ANY
MANAGEMENT PRESENTATIONS PROVIDED), WHETHER VERBALLY OR IN WRITING, ARE DEEMED
TO HAVE BEEN SUPERSEDED BY THIS AGREEMENT, IT BEING INTENDED THAT NO SUCH PRIOR
OR CONTEMPORANEOUS STATEMENTS OR COMMUNICATIONS OUTSIDE OF THIS AGREEMENT, OR
ANY WARRANTY OF MERCHANTABILITY OR WARRANTY OF FITNESS FOR A PARTICULAR PURPOSE,
SHALL SURVIVE THE EXECUTION AND DELIVERY OF THIS AGREEMENT.

 

Section 4      REPRESENTATIONS AND WARRANTIES OF THE BUYER

 

The Buyer hereby represents and warrants to the Seller as of the date of this
Agreement, as follows:

 

4.1           Organization. The Buyer is duly organized, validly existing and in
good standing under the laws of Delaware.

 

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4.2           Power and Authorization. The execution, delivery and performance
by the Buyer of this Agreement and each Ancillary Agreement and the consummation
of the Sale are within the power and authority of the Buyer and have been duly
authorized by all necessary action on the part of the Buyer. Each of this
Agreement and each Ancillary Agreement (a) has been duly executed and delivered
by a duly authorized representative of the Buyer and (b) is a legal, valid and
binding obligation of the Buyer, enforceable against the Buyer in accordance
with its terms, except as enforceability may be limited by applicable
bankruptcy, insolvency, reorganization, moratorium or other similar laws now or
hereafter in effect relating to or affecting creditors’ rights generally.

 

4.3           Authorization of Governmental Authorities. No action by or in
respect of, or filing with, any governmental authority is required by the Buyer
for, or in connection with, the valid and lawful (a) authorization, execution,
delivery and performance by the Buyer of this Agreement and each Ancillary
Agreement or (b) the consummation of the Sale by the Buyer.

 

4.4           No Brokers. The Buyer has no liability of any kind to, and is not
subject to any claim of, any broker, finder or agent with respect to the Sale
for which the Buyer will be liable.

 

4.5           Noncontravention.

 

(a)          The execution, delivery and performance by the Buyer of this
Agreement and the Ancillary Agreements to which the Buyer is a party do not and
will not (i) violate any Law or any decree or judgment of any court or other
Regulatory Authority applicable to the Buyer; (ii) violate or conflict with,
result in a breach of, constitute a default (or an event which, with or without
notice or lapse of time or both, would constitute a default) under, or permit
cancellation of, any contract, agreement or obligation to which the Buyer is a
party or by which it is bound; or (iii) violate or conflict with any provision
of the Certificate of Incorporation or Bylaws of the Buyer.

 

(b)          Except for any that have heretofore been obtained or made, no
material consents or approvals of, or filings or registrations by the Buyer
with, any Regulatory Authority or any other Third Party are necessary in
connection with the execution, delivery and performance of this Agreement or the
Ancillary Agreements by the Buyer.

 

4.6           Financial Capability. The Buyer has sufficient funds or credit
resources to pay the Consideration and to perform and consummate the
transactions contemplated by this Agreement, on the terms and subject to the
conditions set forth herein.

 

4.7           Solvency. Immediately after giving effect to the Closing and the
transactions contemplated by this Agreement, the Buyer and each of its
subsidiaries will be able to pay their respective debts as they become due and
shall own property which has a fair saleable value greater than the amounts
required to pay their respective debts (including a reasonable estimate of the
amount of all contingent liabilities). Immediately after giving effect to the
transactions contemplated by this Agreement, the Buyer and each of its
subsidiaries shall have adequate capital to carry on their respective
businesses. No transfer of property is being made and no obligation is being
incurred in connection with the transactions contemplated by this Agreement with
the intent to hinder, delay or defraud either present or future creditors of the
Buyer or its subsidiaries.

 

Section 5     COVENANTS AND AGREEMENTS

 

5.1           Expenses. Except to the extent otherwise expressly set forth in
this Agreement, the Seller and the Buyer shall each bear their respective
expenses incurred in connection with the preparation, execution and performance
of this Agreement, including, without limitation, all fees and expenses of
agents, representatives, counsel and accountants.

 

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5.2           Payment and Discharge of Liabilities. The Seller shall pay or
otherwise satisfy in the ordinary course of business and as and when due,
whether before or after the Closing Date, all of the Retained Liabilities in
accordance with the terms thereof and in a manner consistent with their past
practices in relation to the Business. The Buyer shall pay or otherwise satisfy
in the ordinary course of business and as and when due, after the Closing Date,
all of the Assumed Liabilities.

 

5.3           Further Assurances. Each Party shall exercise its Reasonable
Commercial Efforts to execute such documents, further instruments of transfer
and assignment and other papers and take such further actions as may be
reasonably required to carry out the provisions hereof and the transactions
contemplated hereby and by the Ancillary Agreements in accordance with the terms
hereof and thereof.

 

5.4           Public Announcements. Exhibit D sets forth Seller’s form of press
release regarding the terms of this Agreement and the transactions set forth
herein, and, except as set forth in Section 9, none of the Parties or their
respective Affiliates or their respective directors, officers, employees and
agents shall issue any press release or otherwise make any public statement in
deviation or contravention of the contents of such press release without the
approval of Buyer, in the case of any disclosure by Seller, or Seller in the
case of a disclosure by Buyer.

 

5.5           Customer Notifications. As promptly as practicable after the
Closing Date, the Buyer and Seller shall send the joint letter attached hereto
as Exhibit H to all wholesale distributors, pharmacies and other customers of
the Seller listed on Schedule 5.5.

 

5.6           NDC Numbers. Buyer has established new National Drug Code (“NDC”)
numbers for the Lithobid Products. The Buyer shall apply such new NDC numbers to
all Lithobid Products manufactured or sold on or after the Closing Date.

 

5.7           Access After Closing.

 

(a)          Following the Closing, for so long as such information is retained
by the Buyer, the Buyer shall permit the Seller and its authorized
representatives to have reasonable access to, and to make photocopies of, the
Books and Records transferred to the Buyer that relate to the Purchased Assets
with respect to the period prior to Closing, to the extent that such access may
be required in connection with (i) the preparation of any accounting records or
Tax returns or any audit involving the Lithobid Products or the Purchased
Assets, (ii) any suit, claim, action, proceeding or investigation relating to
the Purchased Assets, (iii) any regulatory filing or matter, or (iv) in
connection with any other valid legal or business purpose of the Seller or its
Affiliates. Such access shall be afforded during normal business hours and upon
reasonable prior written notice from the Seller. The Buyer shall retain all
Books and Records of the nature described above for a period of six (6) years
following the Closing Date unless the Buyer gives the Seller notice of its
intention to destroy any such records and affords the Seller a reasonable
opportunity to take possession or make copies of any such records proposed to be
destroyed.

 

(b)          Subject to Section 2.4(c), following the Closing, for so long as
such information is retained by the Seller, the Seller shall permit the Buyer
and its authorized representatives to have reasonable access to, and to make
photocopies of, the Books and Records retained by the Seller that relate to the
Purchased Assets with respect to the period prior to Closing, to the extent that
such access may be required in connection with (i) the preparation of any
accounting records or Tax returns or any audit involving the Lithobid Products
or the Purchased Assets, (ii) any suit, claim, action, proceeding or
investigation relating to the Purchased Assets, (iii) any regulatory filing or
matter or (iv) in connection with any other valid legal or business purpose of
the Buyer or its Affiliates. Such access shall be afforded during normal
business hours and upon reasonable prior written notice from the Buyer. The
Seller shall retain all Books and Records of the nature described above for a
period of six (6) years following the Closing Date unless the Seller gives the
Buyer notice of its intention to destroy any such records and affords the Buyer
a reasonable opportunity to take possession or make copies of any such records
proposed to be destroyed.

 

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5.8           Inventory. Immediately following Closing, Seller and Buyer shall
jointly notify Cardinal SPS in writing of the consummation of the Sale and
Seller shall instruct Cardinal SPS to destroy the Finished Lithobid Product
Inventory held by Cardinal SPS, and Buyer shall destroy any Finished Lithobid
Product Inventory in its possession. Buyer shall pay or promptly reimburse
Seller for any costs or expenses associated with Cardinal SPS’s and/or Buyer’s
destruction of the Finished Lithobid Product Inventory. All accounts receivable
and other amounts owed to Buyer or ANIP Acquisition or their respective
Affiliates with respect to Inventory shall be deemed paid and satisfied in full
by Seller. Buyer and Seller each agrees that in no event following the Closing
Date will Buyer or Seller sell any Lithobid Products which are labeled with the
Seller’s name. Not in any way limiting any provision of this Agreement, Seller
shall have no obligation to reimburse Buyer or ANIP Acquisition or their
respective Affiliates for any Methylene Chloride purchased by Buyer or ANIP
Acquisition or their respective Affiliates pursuant to the terms of the Supply
Agreement or otherwise. Immediately following the Closing, Seller shall
terminate its sample program with J. Knipper and Company and shall promptly
cause any Finished Lithobid Product Inventory in the possession of J. Knipper
and Company to be destroyed, at the sole cost and expense of Seller.

 

5.9           Regulatory Matters.

 

(a)          Responsibility for the Lithobid Products. From and after the
Closing Date, except as otherwise required by Law, the Buyer shall be solely
responsible for all regulatory responsibilities under applicable Law, with
respect to reporting and otherwise, in connection with the Lithobid Products,
including (i) all regulatory responsibility with respect to the formulation,
manufacture, packaging, promotion, distribution, marketing, use and sale of
Lithobid Products; (ii) adverse drug experience reporting relating to the
Lithobid Products, and (iii) NDAs with respect to the Lithobid Products (it
being understood and agreed that nothing in this clause (a) shall in anyway be
deemed to limit any right to indemnification Buyer and/or Seller may have under
Section 8).

 

(b)          Communications with Regulatory Agencies. From and after the Closing
Date, the Buyer shall have responsibility for all communication with the FDA
with respect to the matters relating to the formulation, manufacture, packaging,
promotion, distribution, marketing, use and sale of the Lithobid Products
including without limitation, with respect to the Supplement and any clinical
trials required following the FDA Review. To the extent any such communication
relates to the Supplement, Buyer shall consult with Seller regarding the content
of such communication and shall provide Seller with a copy of any material
correspondence received from the FDA.

 

(c)          Fee Obligations. From and after the Closing Date, Buyer shall
assume all responsibility for any and all fee obligations for holders or owners
of approved INDs, NDAs and Regulatory Approvals relating to the Lithobid
Products after the Closing Date, including those defined under the Prescription
Drug User Fee Act of 1992, as the same may be amended from time to time (it
being understood and agreed that nothing in this clause (c) shall in anyway be
deemed to limit any right to indemnification Buyer and/or Seller may have under
Section 8).

 

5.10         Reporting of and Response to Adverse Drug Experience Reports,
Medical Inquiries and Product Complaints. From and after the Closing Date, Buyer
shall be responsible for responding to all adverse drug experience reports,
complaints and medical inquiries with respect to the Lithobid Products in
accordance with applicable Law and the Buyer’s customary internal procedures for
responding to such reports, complaints and inquiries. These adverse drug
experience reports and Lithobid Product complaints and medical inquiries may
arise from any sources such as (but not limited to) direct telephone calls, the
filing of lawsuits, or written correspondence to either Party. Following the
Closing, the Seller shall refer all reports of adverse drug experience and
Lithobid Product complaints and medical inquiries that it receives to the Buyer
within five (5) days after receipt thereof. As used herein, “adverse drug
experience” shall have the meaning set forth in 21 CFR 314.80.

 

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Commission Pursuant to a Request for Confidential Treatment under Rule 406 under
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Securities Act of 1933, as amended. Confidential Portions are marked: [***]

 

5.11         Rebates; Returns.

 

(a)          Each Party shall be responsible, at its own cost and expense, for
the processing, payment, administration and support of any rebates, credits or
allowances or other expenses for which it has contractual or other liability to
any third party, regardless of when incurred, which relate to or arise out of
sales of the Lithobid Product under its own NDC number.

 

(b)          As of the Closing, each Party shall be operationally responsible
for processing, acceptance and exchange/refund with respect to the return of all
Lithobid Products bearing its NDC in accordance with its standard return terms
and conditions. Financial responsibility for returns shall be as follows:
(i) Buyer shall be financially responsible for returns related to Lithobid
Product sold bearing its NDC number and (ii) Seller shall be financially
responsible for returns related to Lithobid Products sold on or prior to the
Closing Date under its NDC number. If any quantities of Lithobid Products are
returned after the Closing Date to a Party that are properly allocated to the
other Party as set forth above, the receiving Party shall inform the other Party
as soon as practicable and, (1) if the Seller has received the return, Seller
shall deliver to Buyer (at Buyer’s expense if such return is allocated to Buyer)
or destroy, at Buyer’s election, such returned Lithobid Product, or (2) if the
Buyer has received the return and if such return is allocated to the Seller,
Buyer shall destroy or return, at Seller’s election and expense, such returned
Lithobid Product. Seller shall direct any requests to exchange returned Lithobid
Product to Buyer for handling.

 

5.12         Post-Closing Cooperation. Following the Closing, the Parties agree
to use Reasonable Commercial Efforts to transition the Business to the Buyer. In
this regard:

 

(a)          Seller shall send a copy of the Transfer Letter to the FDA
immediately following the Closing, and Buyer will send a copy of Buyer’s
Acceptance Letter to the FDA immediately following the Closing;

 

(b)          Seller and Buyer shall cooperate to effect a transfer of the
pharmacovigilance relating to the Lithobid Products on the Closing Date and in
this regard, Seller agrees to forward all customer inquiries, ADEs and customer
questions received by it in respect of the Lithobid Products to the call center
of Buyer previously identified to Seller;

 

(c)          Seller and Buyer shall cooperate to effect the transfer, at Buyer’s
expense, of a copy of the Seller’s safety database with respect to the Lithobid
Products to Buyer (i.e., JDS files) no later than September 30, 2014; provided
that such materials shall be provided in exclusively electronic form except for
documents related to the pre-2004 period that are solely available in paper
form;

 

(d)          Seller shall promptly remove the Lithobid Products from the
DailyMed website following the expiration of the last to expire lot of Lithobid
Products sold by Seller under Seller’s NDC code; and

 

(e)          Seller shall provide Buyer with reasonable assistance with
preparing any FDA sufficiency response, including with respect to any additional
information which is in the possession of Seller and requested by the FDA in
connection with the Supplement. Buyer shall draft any responses to deficiencies
the FDA identifies with respect to the Supplement, and Seller shall use
Reasonable Commercial Efforts to provide Buyer with information it needs to
prepare and file with the FDA the regulatory filings required to be filed by
Buyer for the manufacture, marketing and distribution of the Lithobid Products,
including, without limitation, the applicable PADER and NDA annual report for
2015 (with applicable domestic distribution data). Each Party shall pay their
own expenses incurred in connection with obtaining acceptance by the FDA of the
Supplement; however, any third party costs, fees and/or other expenses
associated with obtaining acceptance by the FDA of the Supplement shall be paid
by Buyer.

 

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Commission Pursuant to a Request for Confidential Treatment under Rule 406 under
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5.13         Buyer’s Due Diligence Investigation.

 

(a)          Buyer acknowledges and agrees that, for the purposes of this
Agreement, none of the Seller, its Affiliates or representatives has made any
representations or warranties regarding the Seller, the Business, the Purchased
Assets or otherwise in connection with the transactions set forth herein or in
the Ancillary Agreements, on which it relied other than the representations and
warranties expressly made by the Seller in Section 3. Without limiting the
generality of the foregoing, Buyer acknowledges and agrees that no projections,
forecasts and predictions, other estimates, data, financial information,
documents, reports, statements (oral or written), summaries, abstracts,
descriptions, presentations (including any management presentation or facility
tour), memoranda, or offering materials with respect to the Business or the
Purchased Assets, is or shall be deemed to be a representation or warranty by
the Seller or any of its Affiliates to Buyer, under this Agreement, or
otherwise, and that Buyer has not relied thereon in determining to execute this
Agreement and proceed with the transaction set forth herein. Buyer further
acknowledges and agrees that to the extent materials it has received from the
Seller and its agents and representatives include projections, forecasts and
predictions relating to the Purchased Assets and the Business; that there are
uncertainties inherent in attempting to make such projections, forecasts and
predictions; that Buyer is familiar with such uncertainties and is taking full
responsibility for making its own evaluation of the adequacy and accuracy of all
projections, forecasts, predictions and information so furnished; that Buyer
shall not have any claims against the Seller, its officers, directors,
Affiliates or representatives, with respect thereto; and that Buyer has not
relied thereon. Buyer acknowledges that no Person has been authorized by the
Seller to make any representation or warranty regarding the Seller, the
Business, the Purchased Assets, or the transactions set forth in this Agreement
and in the Ancillary Agreements and, if made, such representation or warranty
may not be relied upon as having been authorized by the Seller.

 

(b)          Buyer acknowledges and agrees that it (i) has made its own inquiry
and investigation into, and, based thereon and on the representations and
warranties set forth in Section 3 and has formed an independent judgment
concerning, the Purchased Assets and the Business, and (ii) has conducted such
investigations of the Purchased Assets and the Business as Buyer deems necessary
to satisfy itself as to the operations and conditions thereof, and will rely
solely on such investigations and inquiries, and the express representations and
warranties of the Seller set forth in Section 3. Buyer further acknowledges and
agrees that it will not at any time assert any claim against the Seller or any
of its present and former directors, officers, managers, partners, shareholders,
employees, agents, Affiliates, consultants, investment bankers, attorneys,
advisors or representatives, or attempt to hold any of such Persons liable, for
any inaccuracies, misstatements or omissions with respect to the information
furnished by such Persons concerning the Purchased Assets and/or the Business,
other than any inaccuracies or misstatements in the representations and
warranties expressly set forth in Section 3 (subject to the limitations and
expiration set forth in Section 8).

 

(c)          Further, without limiting any representation, warranty or covenant
of the Seller expressly set forth herein, Buyer acknowledges that it has waived
and hereby waives any further due diligence reviews, inspections or examinations
with respect to the Seller, the Purchased Assets and the Business, including
with respect to financial, operational, regulatory and legal compliance matters.

 

Section 6         INTENTIONALLY OMITTED

 

Section 7        INTENTIONALLY OMITTED

 

Section 8           INDEMNIFICATION

 

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8.1           Indemnification by the Seller. Subject to the limitations set
forth in this Section 8, the Seller will indemnify and hold harmless the Buyer,
its Affiliates and the Buyer’s and its Affiliates’ respective employees,
officers, directors and representatives (each, a “Buyer Indemnified Party”),
from, against and in respect of any and all actions, liabilities, governmental
orders, encumbrances, losses, damages, bonds, dues, assessments, fines,
penalties, Taxes, fees, costs, expenses (including reasonable legal fees, costs
and/or expenses incurred in defending a Third Party claim) or amounts paid in
settlement (which, except in respect of reasonable legal fees, costs and/or
expenses incurred in defending a Third Party claim, shall be subject to the
terms of Section 10.1(e)) (collectively, “Losses”), incurred or suffered by the
Buyer Indemnified Parties or any of them as a result of, arising out of, or
directly or indirectly relating to: (a) any breach of, or inaccuracy in, any
representation or warranty made by the Seller in Section 3 of this Agreement;
(b) any breach, nonperformance, or violation of any covenant or agreement of the
Seller (including, without limitation, under this Section 8) contained in this
Agreement or any Ancillary Agreement, or (c) any Retained Liability.

 

8.2           Indemnification by the Buyer. The Buyer will indemnify and hold
harmless the Seller, its Affiliates and the Seller’s and its Affiliates’
respective employees, officers, directors and representatives (each, a “Seller
Indemnified Party”), from, against and in respect of any and all Losses incurred
or suffered by the Seller Indemnified Parties or any of them as a result of,
arising out of, or directly or indirectly relating to: (a) any breach of, or
inaccuracy in, any representation or warranty made by the Buyer in Section 4 of
this Agreement; (b) any Assumed Liability asserted against any Seller
Indemnified Party; or (c) any breach, nonperformance, or violation of any
covenant or agreement of the Buyer (including, without limitation, under this
Section 8) contained in this Agreement or any Ancillary Agreement.

 

8.3           Limits.

 

(a)          The Buyer Indemnified Parties shall not be entitled to any
indemnification in respect of Losses incurred by the Buyer Indemnified Parties
pursuant to Section 8.1(a) for breaches of non-Fundamental Representations
unless and until the aggregate amount of such Losses exceeds $[***] (the
“Threshold Amount”), in which event if the aggregate amount of Losses exceeds
the Threshold Amount, the Buyer Indemnified Parties may only recover the amount
of such Losses in excess of the Threshold Amount. The maximum aggregate amount
required to be paid by Seller to the Buyer Indemnified Parties pursuant to
Section 8.1(a) for breaches of non-Fundamental Representations shall not exceed
$[***] (the “Cap”). Not in any way limiting the provisions of this Section 8.3,
the Seller will not have any obligation to indemnify the Buyer Indemnified
Parties pursuant to this Section 8 to the extent that the aggregate amount of
all such Losses incurred or suffered by such Indemnified Parties exceeds the
Consideration paid by the Buyer. Notwithstanding the foregoing, the Threshold
Amount and Cap shall not apply to Losses arising out of or resulting from actual
(and not constructive) fraud committed by the Seller against the Buyer.

 

(b)          Except as provided in this Section 8, nothing in this Agreement or
any Ancillary Agreement shall impair, limit or otherwise affect any
indemnification obligation of either Party to the other Party arising under any
other agreement, including the Supply Agreement, between the Parties and any of
their Affiliates. In this regard, it is understood and agreed that if any Losses
for which Buyer would otherwise be entitled to indemnification under Section 8.1
are finally determined to have been caused by any occurrence for which Seller is
otherwise entitled to indemnification under the Supply Agreement or any other
act or omission by Buyer, ANIP Acquisition or any of their respective
Affiliates, Seller shall have no obligation to indemnify Buyer to the extent
thereof, and Buyer and its Affiliates shall indemnify Seller to the extent
Seller is entitled to indemnification under the Supply Agreement and/or this
Agreement.

 

(c)          Buyer shall use Reasonable Commercial Efforts to avoid or mitigate
any Loss which it or any Buyer Indemnified Party may suffer in consequence of
any fact, matter or circumstance giving rise to a claim for indemnification
under this Agreement or likely to give rise to a claim for indemnification under
this Agreement.

 

(d)          Where the Seller has made a payment to a Buyer Indemnified Party in
relation to any claim and Buyer Indemnified Party is entitled to recover
(whether by insurance, payment, discount, credit, relief or otherwise) from a
Third Party a sum which indemnifies or compensates Buyer Indemnified Parties (in
whole or in part) in respect of the Liability or Loss which is the subject of a
claim, Buyer or its relevant Affiliates shall (i) promptly notify the Seller of
the fact and provide such information as the Seller may reasonably require,
(ii) take all Reasonable Commercial Efforts as the Seller may require to enforce
such right and (iii) pay to the Seller, as soon as practicable after receipt, an
amount equal to the amount recovered from the Third Party (net of taxation and
less any reasonable costs of recovery).

 

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Commission Pursuant to a Request for Confidential Treatment under Rule 406 under
the
Securities Act of 1933, as amended. Confidential Portions are marked: [***]

 

8.4           Time for Claims. No claim may be made or suit instituted seeking
indemnification pursuant to this Section 8 unless a written notice describing
the basis for such claim or suit in reasonable detail in light of the
circumstances then known to the Indemnified Party is provided to the
Indemnifying Party:

 

(a)          at any time prior to the expiration of the applicable statute of
limitations, in the case of any claim or suit based upon a breach or inaccuracy
of the representations and warranties set forth in the first sentence and
clause (a) of the second sentence of Section 3.2 (Power and Authorization),
Section 3.6 (Purchased Assets), Section 3.12 (No Brokers), Section 4.2 (Power
and Authorization) or Section 4.4 (No Brokers) (the “Fundamental
Representations”);

 

(b)          at any time, and without limitation as to time, for any claim
arising from the Retained Liabilities, Assumed Liabilities or any covenant to be
performed by either Party at or after the Closing (including with respect to the
Additional Payment); or

 

(c)          at any time prior to the twelve (12) month anniversary of the
Closing Date, in the case of any claim or suit based upon a breach or inaccuracy
of the non-Fundamental Representations.

 

(d)          The representations and warranties made by the Parties under this
Agreement shall survive the Closing for a period contemporaneous with the period
during which the applicable Party may assert a claim in respect of a breach
thereof, as set forth above in this Section 8.4.

 

8.5           Procedure. If any claim arises as to which a right of
indemnification provided in this Section 8 may apply, the Indemnified Party
shall promptly provide a written notice to the Indemnifying Party for its claims
for indemnification, and, to the extent applicable, shall allow the Indemnifying
Party and its insurers the opportunity to assume direction and control of the
defense of such proceeding, at its sole expense, subject to the limitations set
forth in this Section 8, including the settlement thereof at the sole option of
the Indemnifying Party or its insurers; provided, however, that the Indemnifying
Party may not enter into any compromise or settlement without the prior written
consent of the Indemnified Party, which will not be unreasonably delayed,
conditioned or withheld, unless such compromise or settlement is solely for
monetary damages paid entirely by the Indemnifying Party and does not include
any admission of legal wrongdoing on the part of the Indemnified Party and
contains an unconditional release of the Indemnified Party, in which event no
such consent shall be required. The Indemnified Party shall fully cooperate with
the Indemnifying Party and its insurer in the disposition of any such matter and
the Indemnified Party will have the right and option to participate in (but not
control) the defense of any proceeding as to which this Section 8 applies, with
separate counsel at its election and cost. If the Indemnifying Party fails to
assume or declines to assume the defense of any such proceeding within fifteen
(15) days after notice thereof, or fails to prosecute the defense of such claim
in good faith and with reasonable diligence, or, in the opinion of counsel to
the Indemnified Party there is a conflict of interest between the Indemnifying
Party and the Indemnified Party, the Indemnified Party may assume the defense
thereof for the account and at the risk of the Indemnifying Party (including
with respect to reasonable attorney’s fees in connection therewith, but subject
to the limitations set forth in this Section 8). The Indemnifying Party shall
pay promptly to the Indemnified Party any Losses to which the Indemnified Party
is entitled under this Section 8.

 

8.6           Exclusive Remedy; Release. The Parties (and, by their acceptance
of the benefits under this Agreement, each Buyer Indemnified Party and Seller
Indemnified Party) hereby agree that except as otherwise contemplated in
Section 9.5, their sole and exclusive remedy after the Closing with respect to
any and all claims relating to this Agreement and the Sale shall be pursuant to
the indemnification provisions set forth in this Section 8. Notwithstanding the
foregoing, this Section 8.6 shall not, and is in no way intended to, restrict
any Party’s (a) rights or obligations under any Ancillary Agreement or (b) right
to seek a temporary or permanent injunction and/or a decree for specific
performance with respect to a breach or threatened breach of a covenant or
agreement contained in this Agreement. Each of the Parties agrees that, to the
fullest extent permitted by applicable Law, except to the extent of a breach of
an express representation or warranty set forth in this Agreement in which case,
the other Party may seek recourse subject to and in accordance with this Section
8 only against the other Party, the respective directors, officers, employees,
affiliates, controlling persons, agents and representatives of the other Party
shall not have any personal liability or responsibility whatsoever to the
claiming Party or any of its directors, officers, employees, Affiliates,
controlling persons, agents or representatives on any basis (including in
contract or tort, under federal or state securities laws or otherwise) based
upon any information provided or made available, or statements made (or any
omissions therefrom), to the claiming Party or any of its directors, officers,
employees, Affiliates, controlling persons, agents or representatives and each
Party hereby releases the other Party and its Affiliates’ respective directors,
officers, employees, affiliates, controlling persons, agents and representatives
from any such liability or responsibility.

 

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Commission Pursuant to a Request for Confidential Treatment under Rule 406 under
the
Securities Act of 1933, as amended. Confidential Portions are marked: [***]

 

8.7           Limits on Indemnification.

 

(a)          In calculating amounts payable to an Indemnified Party, the amount
of the Losses (i) shall not be duplicative of any other Loss for which an
indemnification claim has been made, and (ii) shall be computed net of any
amounts actually recovered by such Indemnified Party under any insurance policy
with respect to such Loss, net of any reasonable out-of-pocket expenses actually
incurred in collecting such amounts. The Indemnified Party will use Reasonable
Commercial Efforts to collect any amounts available under such insurance
coverage.

 

(b)          Neither Party shall have any right to set off any Losses against
any payments to be made by it or any of its Affiliates pursuant to this
Agreement or any Ancillary Agreement.

 

(c)          In any case where an Indemnified Party recovers from Third Parties
any amount in respect of a matter with respect to which an Indemnifying Party
has indemnified it pursuant to this Section 8, such Indemnified Party shall
promptly pay over to the Indemnifying Party the amount so recovered (after
deducting therefrom the full amount of the expenses incurred by it in procuring
such recovery), but not in excess of the sum of (i) any amount previously so
paid by the Indemnifying Party to or on behalf of the Indemnified Party in
respect of such matter and (ii) any amount expended by the Indemnifying Party in
pursuing or defending any claim arising out of such matter.

 

8.8           Treatment of Indemnification Payment by Seller. Any
indemnification payment made by Seller hereunder shall be treated as a reduction
of the Consideration for Tax purposes.

 

8.9           Consequential Damages. NOTWITHSTANDING ANYTHING TO THE CONTRARY
CONTAINED HEREIN, NO PARTY SHALL BE LIABLE TO ANY OTHER PARTY FOR SPECIAL,
CONSEQUENTIAL, INDIRECT OR INCIDENTAL (INCLUDING WITHOUT LIMITATION LOST
PROFITS), PUNITIVE OR ANY MEASURE OF DAMAGES BASED ON DIMINUTION OF VALUE OR ANY
MULTIPLE OF EARNINGS, EBITDA, CASH FLOW OR SIMILAR CONCEPT UNDER THIS AGREEMENT
EXCEPT TO THE EXTENT SUCH DAMAGES SHALL BE PAYABLE TO A THIRD PARTY.

 

Section 9     CONFIDENTIALITY

 

9.1           General. Pursuant to the terms of this Agreement, the Seller and
the Buyer (in such capacity, the “Disclosing Party”) have each disclosed and
will be disclosing to the other Party, and to its Affiliates and to their
respective officers, directors, employees, agents and/or representatives (in
such capacity, the “Receiving Party”) certain secret, confidential or
proprietary data, Trade Secrets, Know-How, intellectual property, Product
Technology and related information, including, without limitation, operating
methods and procedures, marketing, manufacturing, distribution and sales methods
and systems, sales figures, pricing policies and price lists and other business
information (“Confidential Information”). For purposes of the preceding
definition, Confidential Information included in the Purchased Assets shall be
deemed Confidential Information of the Buyer from and after the Closing. The
Receiving Party shall make no use of any Confidential Information of the
Disclosing Party except in the exercise of its rights and the performance of its
obligations set forth in this Agreement or the Ancillary Agreements. The
Receiving Party (i) shall keep and hold as confidential, and shall cause its
officers, directors, employees, agents and representatives to keep and hold as
confidential, all Confidential Information of the Disclosing Party, and
(ii) shall not disclose, and shall cause its officers, directors, employees,
agents and representatives not to disclose, any Confidential Information of the
Disclosing Party. Confidential Information disclosed by the Disclosing Party
shall remain the sole and absolute property of the Disclosing Party, subject to
the rights granted in this Agreement or the Ancillary Agreements.

 

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Commission Pursuant to a Request for Confidential Treatment under Rule 406 under
the
Securities Act of 1933, as amended. Confidential Portions are marked: [***]

 

9.2           Exceptions. The above restrictions on the use and disclosure of
Confidential Information shall not apply to any information which (i) is already
known to the Receiving Party at the time of disclosure by the Disclosing Party
(other than Confidential Information which forms a part of the Purchased
Assets), as demonstrated by competent proof (other than as a result of prior
disclosure under any agreement between the Parties with respect to
confidentiality) or (ii) is or becomes generally available to the public other
than through any act or omission of the Receiving Party in breach of this
Agreement or the Ancillary Agreements. In addition, nothing in this Section 9
shall be interpreted to limit the ability of either Party to use or disclose its
own Confidential Information in any manner or to any other Person.

 

9.3           Permitted Disclosures. It shall not be a breach of Section 9.1 if
a Receiving Party discloses Confidential Information of a Disclosing Party
(including any terms of this Agreement) (i) pursuant to a binding requirement of
applicable Law or a Regulatory Authority, including obligations under securities
Laws or rules or regulations of any securities exchange or market on which the
Disclosing Party’s or its Affiliates’ stock is traded, or (ii) in a judicial,
administrative or other legal proceeding to enforce or defend such Party’s
rights under this Agreement. In such event, the Receiving Party shall
(A) provide the Disclosing Party with as much advance written notice as possible
and as legally permissible of the required disclosure, (B) reasonably cooperate
with the Disclosing Party in any attempt to prevent or limit the disclosure at
the sole cost of the Disclosing Party, and (C) limit disclosure, if any, to the
specific purpose at issue, or in the case of a disclosure under subsection (i)
of this Section 9.3, to the extent required by such Law or Regulatory Authority.
Without limiting the generality of the foregoing, if Buyer determines that it is
required to file this Agreement as a material agreement under applicable
securities laws, it shall use Reasonable Commercial Efforts to seek to
incorporate the reasonable confidential treatment requests of Seller with
respect to such disclosure, it being understood and agreed that neither the
names of the Lithobid Products nor the Consideration paid will be the subject of
any such confidential treatment request.

 

9.4           Confidential Terms. Each Party acknowledges and agrees that the
terms and conditions of this Agreement shall be considered Confidential
Information of each Party and shall be treated accordingly.

 

9.5           Equitable Remedies. Each Party specifically recognizes that any
breach by it of this Section 9 may cause irreparable injury to the other Parties
and that actual damages may be difficult to ascertain, and in any event, may be
inadequate. Accordingly (and without limiting the availability of legal or
equitable, including injunctive, remedies under any other provisions of this
Agreement), each Party agrees that in the event of any such breach,
notwithstanding the provisions of Section 8.6, the other Parties shall be
entitled to seek, by way of private litigation in the first instance, injunctive
relief and such other legal and equitable remedies as may be available.

 

Section 10       DISPUTE RESOLUTION

 

10.1         Jurisdiction; Venue; Service of Process.

 

(a)          Each party, by its execution hereof, (a) hereby irrevocably attorns
and submits to the exclusive jurisdiction of the state and federal courts of New
York located in New York City, New York, for the purpose of any action between
or among the parties (or any of them) arising in whole or in part under or in
connection with this Agreement, (b) hereby waives and agrees not to assert, by
way of motion, as a defense or otherwise, in any such action, any claim that it
is not subject personally to the jurisdiction of the above-named courts, that
its property is exempt or immune from attachment or execution, that any such
action brought in one of the above-named courts should be dismissed on grounds
of forum non conveniens, should be transferred or removed to any court other
than one of the above-named courts, or should be stayed by reason of the
pendency of some other proceeding in any other court other than one of the
above-named courts, or that this Agreement or the subject matter hereof may not
be enforced in or by such court and (c) hereby agrees not to commence any such
action (including for a declaratory judgment or the like) other than before one
of the above-named courts.

 

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Commission Pursuant to a Request for Confidential Treatment under Rule 406 under
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(b)          Each party agrees that for any action between the parties arising
in whole or in part under or in connection with this Agreement, such party will
bring actions only in the State of New York, in a state or federal court located
in New York City, New York. Each party further waives any claim and will not
assert that venue should properly lie in any other location within the selected
jurisdiction.

 

(c)          Each party hereby (a) consents to service of process in any action
between the parties arising in whole or in part under or in connection with this
Agreement in any manner permitted by the Laws of the State of New York,
(b) agrees that service of process made in accordance with clause (a) or made by
registered or certified mail, return receipt requested, at its address specified
pursuant to Section 11.1, will constitute good and valid service of process in
any such action and (c) waives and agrees not to assert (by way of motion, as a
defense, or otherwise) in any such action any claim that service of process made
in accordance with clause (a) or (b) does not constitute good and valid service
of process.

 

(d)          THE PARTIES HEREBY WAIVE, AND COVENANT THAT THEY WILL NOT ASSERT
(WHETHER AS PLAINTIFF, DEFENDANT OR OTHERWISE), ANY RIGHT TO TRIAL BY JURY IN
ANY ACTION ARISING IN WHOLE OR IN PART UNDER OR IN CONNECTION WITH THIS
AGREEMENT OR ANY OF THE TRANSACTIONS CONTEMPLATED HEREIN, WHETHER NOW EXISTING
OR HEREAFTER ARISING, AND WHETHER SOUNDING IN CONTRACT, TORT OR OTHERWISE. THE
PARTIES AGREE THAT ANY OF THEM MAY FILE A COPY OF THIS PARAGRAPH WITH ANY COURT
AS WRITTEN EVIDENCE OF THE KNOWING, VOLUNTARY AND BARGAINED-FOR AGREEMENT AMONG
THE PARTIES IRREVOCABLY TO WAIVE THEIR RIGHTS TO TRIAL BY JURY IN ANY ACTION
WHATSOEVER BETWEEN OR AMONG THEM RELATING TO THIS AGREEMENT OR ANY OF THE
TRANSACTIONS CONTEMPLATED HEREIN, WHICH ACTION WILL INSTEAD BE TRIED IN A COURT
OF COMPETENT JURISDICTION BY A JUDGE SITTING WITHOUT A JURY.

 

(e)          In the event of litigation between the Parties arising from or
regarding this Agreement, each Party shall bear its own costs and expenses
incurred in connection with the litigation.

 

Section 11       MISCELLANEOUS

 

11.1         Notices. Any notice or other communication required or permitted
hereunder shall be in writing and shall be deemed given when so delivered in
person, by reputable overnight courier, by facsimile transmission (with receipt
confirmed by automatic transmission report) or two (2) Business Days after being
sent by registered or certified mail (postage prepaid, return receipt
requested), as follows:

 

if to the Seller, to:

 

c/o Noven Pharmaceuticals
350 Fifth Avenue, 37th Floor
New York, NY 10118
Attn: General Counsel
Facsimile: 305-232-1836

 

21

 

 

Confidential Materials Omitted and Filed Separately with the Securities and
Exchange
Commission Pursuant to a Request for Confidential Treatment under Rule 406 under
the
Securities Act of 1933, as amended. Confidential Portions are marked: [***]

 

with a copy to:

 

Greenberg Traurig, P.A.
333 S.E. 2nd Avenue
Miami, Florida 33131
Attn: David A. Barkus, Esq.
Facsimile: (305) 961-5724

 

if to the Buyer, to:

 

ANI Pharmaceuticals, Inc.
210 Main Street Baudette, Minnesota 56623
Attn: Chief Executive Officer
Facsimile: 218-634-3540

 

with a copy to:

 

Dentons US LLP
1221 Avenue of the Americas
New York, NY 10020
Attn: Paul A Gajer, Esq.
Facsimile: 212-768-6800

 

Either Party may by notice given in accordance with this Section 11.1 to the
other Parties designate another address or Person for receipt of notices
hereunder.

 

11.2         Amendment; Waiver. This Agreement may not be amended except by an
instrument signed by each of the Parties hereto. Any Party hereto may (a) extend
the time for the performance of any of the obligations or other acts of another
Party hereto or (b) waive compliance with any of the agreements of another Party
or any conditions to its own obligations, in each case only to the extent such
obligations, agreements, or conditions are intended for its benefit; provided,
however, that any such extension or waiver shall be binding upon a Party only if
such extension or waiver is set forth in a writing executed by such Party.

 

11.3         Entire Agreement. This Agreement and the Ancillary Agreements
contain the entire agreement between the Parties with respect to the Sale and
supersede all prior agreements, written or oral, between the Parties with
respect thereto, including that certain Letter of Intent between the Seller and
the Buyer, dated May 1, 2014, which is hereby deemed terminated and of no
further force and effect, and, except for Section 2.9, Article III, Article V,
Article VI, Article VII, Article VIII, Article XII and Article XIII (other than
Section 13.9) of the Supply Agreement, the Supply Agreement (including all
purchase orders thereunder) shall automatically terminate effective as of the
Closing, and the Quality Assurance Agreement, dated July 1, 2008, shall
automatically terminate effective as of the Closing.

 

11.4         Governing Law. This Agreement shall be governed by and construed
exclusively in accordance with the internal laws of the State of New York.

 

11.5         Binding Effect; No Assignment; No Third-Party Beneficiaries.

 

(a)          This Agreement shall be binding upon and inure to the benefit of
the Parties and their respective successors and permitted assigns. Neither the
Seller nor the Buyer may assign any of its rights or delegate any of its
liabilities or obligations hereunder without the prior written consent of the
other; provided, that either Party may assign its rights and obligations under
this Agreement without the other Party’s prior written consent upon written
notice to the other Party in connection with the transfer or sale of all or
substantially all of the assets or business of such Party or any of its
Affiliates or the merger or consolidation with another Person of such Party or
any of its Affiliates; provided that no assignment or delegation hereunder shall
limit or effect the assignor’s obligations hereunder; and, provided further,
that the Buyer may provide its lenders with a security interest in its rights
under this Agreement in accordance with the terms of their security and
collateral agreements in connection with any credit facility provided by such
lenders to the Buyer and that such lenders may foreclose upon such security
interest in accordance with the terms of such security and collateral
agreements.

 

22

 

 

Confidential Materials Omitted and Filed Separately with the Securities and
Exchange
Commission Pursuant to a Request for Confidential Treatment under Rule 406 under
the
Securities Act of 1933, as amended. Confidential Portions are marked: [***]

 

(b)          Nothing in this Agreement, express or implied, is intended to or
shall confer upon any Person other than the Parties and their respective
successors and permitted assigns any right, benefit or remedy of any nature
whatsoever under or by reason of this Agreement.

 

11.6         Section Headings; Construction; Interpretation. The headings of
Sections in this Agreement are provided for convenience only and will not affect
its construction or interpretation. All references to “Section” or “Sections”
refer to the corresponding Section or Sections of this Agreement. All schedules
and exhibits attached to this Agreement constitute an integral part of this
Agreement and are incorporated herein. Unless the context of this Agreement
clearly requires otherwise, (a) the singular shall include the plural and the
plural shall include the singular wherever and as often as may be appropriate;
(b) the masculine shall include the feminine and the feminine shall include the
masculine wherever or as often as may be appropriate; (c) the words “include”
and “including” shall mean “including without limitation”, and (d) the words
“hereof,” “herein,” “hereunder,” and similar terms in this Agreement shall refer
to this Agreement as a whole and not any particular Section or article in which
such words appear.

 

11.7         Counterparts. This Agreement may be executed in two or more
counterparts, each of which shall be deemed an original, and all of which
together shall constitute one and the same instrument.

 

11.8         Severability. If any provision of this Agreement is held invalid or
unenforceable in any legal proceeding held pursuant to Section 10, the other
provisions of this Agreement shall remain in full force and effect. Any
provision of this Agreement held invalid or unenforceable only in part or degree
will remain in full force and effect to the extent not held invalid or
unenforceable. The Parties further agree to replace such invalid or
unenforceable provision of this Agreement with a valid and enforceable provision
that will achieve, to the extent possible, the economic, business and other
purposes of such invalid or unenforceable provision.

 

11.9         Rules of Construction. The Parties hereto agree that they have been
represented by counsel during the negotiation and execution of this Agreement
and, therefore, waive the application of any law, regulation, holding or ruling
of construction providing that ambiguities in an agreement or other document
will be construed against the Party drafting such agreement or document.

 

11.10         Bulk Sales Laws. The Parties hereto waive compliance with the
requirements of the applicable Bulk Sales Laws in connection with the
consummation of the transactions contemplated hereby.

 

11.11         Independent Contractor. Neither the Seller nor the Buyer, together
in each case with their respective employees or representatives, are under any
circumstances to be considered as employees, agents, representatives, partners
or joint venturers of the other by virtue of this Agreement, and neither shall
have the authority or power to bind the other or contract in the other’s name.

 

11.12         No Implied Waivers. No failure on the part of the Seller or the
Buyer to exercise and no delay in exercising any right, power, remedy or
privilege under this Agreement, or provided by statute or at law or in equity or
otherwise, including the right or power to terminate this Agreement, shall
impair, prejudice or constitute a waiver of any such right, power, remedy or
privilege or be construed as a waiver of any breach of this Agreement or as an
acquiescence therein, nor shall any single or partial exercise of any such
right, power, remedy or privilege preclude any other or further exercise thereof
or the exercise of any other right, power, remedy or privilege.

 

[Remainder of page intentionally left blank]

 

23

 

  

IN WITNESS WHEREOF, the Parties have executed this Agreement as of the date
first stated above.

 

  NOVEN THERAPEUTICS, LLC       By:   /s/ Jeffrey Eisenberg   Name: Jeffrey
Eisenberg   Title:  Authorized Representative       ANI PHARMACEUTICALS, INC.  
    By:   /s/ Charlotte C. Arnold   Name: Charlotte C. Arnold   Title: Vice
President & Chief Financial Officer

 

[Signature Page to Asset Purchase Agreement]