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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

Form 10-Q

 

Quarterly Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

For the quarterly period ended: June 30, 2018 or

Transition Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

For the transition period from                      to                     

Commission file number: 001-36066

 

PARATEK PHARMACEUTICALS, INC.

(Exact name of registrant as specified in its charter)

 

 

Delaware

 

33-0960223

(State or other jurisdiction of

incorporation or organization)

 

(I.R.S. Employer

Identification No.)

 

75 Park Plaza

Boston, MA 02116

(617) 807-6600

(Address, including zip code, and telephone number, including area code, of registrant’s principal executive office)

 

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

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

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

Large accelerated filer        

Accelerated filer

 

 

 

 

Non-accelerated filer

  (Do not check if a smaller reporting company)

Smaller reporting company

Emerging growth company

 

 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

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

As of July 31, 2018 there were 31,729,649 shares of the registrant's common stock, par value $0.001 per share, outstanding.

 

 

 

 


 

TABLE O F C O N TE N TS

 

 

 

 

Page

PART I FINANCIAL INFORMATION

 

 

 

 

 

 

Item 1.

Financial Statements (unaudited)

 

2

 

 

 

 

 

Condensed Consolidated Balance Sheets as of June 30, 2018 and December 31, 2017

 

2

 

 

 

 

 

Condensed Consolidated Statements of Operations and Comprehensive Loss for the Three and Six Months Ended June 30, 2018 and 2017

 

3

 

 

 

 

 

Condensed Consolidated Statements of Cash Flows for the Six Months Ended June 30, 2018 and 2017

 

4

 

 

 

 

 

Notes to Unaudited Condensed Consolidated Financial Statements

 

5

 

 

 

 

Item 2.

Management’s Discussion and Analysis of Financial Condition and Results of Operations

 

26

 

 

 

 

Item 3.

Quantitative and Qualitative Disclosures About Market Risk

 

36

 

 

 

 

Item 4.

Controls and Procedures

 

37

 

 

 

 

PART II OTHER INFORMATION

 

 

 

 

 

 

Item 1.

Legal Proceedings

 

37

 

 

 

 

Item 1A.

Risk Factors

 

37

 

 

 

 

Item 5.

Other Information

 

37

 

 

 

 

Item 6.

Exhibits

 

39

 

 

 

 

 

SIGNATURES

 

41

 

 

 

 

 

 

 

 

1


 

PART I – FINANCI AL INFORMATION

Item 1.

Financial Statements

Paratek Pharmaceuticals, Inc.

Condensed Consolidated Balance Sheets

(in thousands, except for share and par value amounts)

(unaudited)

 

 

 

June 30,

2018

 

 

December 31,

2017

 

Assets

 

 

 

 

 

 

 

 

Current assets

 

 

 

 

 

 

 

 

Cash and cash equivalents

 

$

56,082

 

 

$

35,416

 

Short-term available-for-sale securities

 

 

207,967

 

 

 

116,307

 

Restricted cash

 

 

266

 

 

 

162

 

Accounts receivable

 

 

19

 

 

 

5,041

 

Other receivable

 

 

866

 

 

 

848

 

Prepaid and other current assets

 

 

2,696

 

 

 

2,712

 

Total current assets

 

 

267,896

 

 

 

160,486

 

Restricted cash

 

 

250

 

 

 

250

 

Long-term available-for-sale securities

 

 

57,096

 

 

 

 

Fixed assets, net

 

 

1,462

 

 

 

1,711

 

Intangible assets, net

 

 

50

 

 

 

142

 

Goodwill

 

 

829

 

 

 

829

 

Other long-term assets

 

 

245

 

 

 

280

 

Total assets

 

$

327,828

 

 

$

163,698

 

Liabilities and stockholders’ equity

 

 

 

 

 

 

 

 

Current liabilities

 

 

 

 

 

 

 

 

Accounts payable

 

$

2,666

 

 

$

3,555

 

Other accrued expenses

 

 

8,978

 

 

 

8,270

 

Accrued contract manufacturing costs

 

 

6,537

 

 

 

4,964

 

Current portion of long-term debt

 

 

15,814

 

 

 

 

Total current liabilities

 

 

33,995

 

 

 

16,789

 

Long-term debt

 

 

202,717

 

 

 

59,186

 

Contingent obligations

 

 

25

 

 

 

71

 

Other liabilities

 

 

5,599

 

 

 

5,174

 

Total liabilities

 

 

242,336

 

 

 

81,220

 

Commitments and contingencies (Note 15)

 

 

 

 

 

 

 

 

Stockholders’ equity

 

 

 

 

 

 

 

 

Preferred stock:

 

 

 

 

 

 

 

 

Undesignated preferred stock: $0.001 par value; 5,000,000 shares authorized;

   no shares issued and outstanding

 

 

 

 

 

 

Common stock, $0.001 par value; 100,000,000 shares authorized; 31,714,649 and

   27,941,015 shares issued and outstanding at June 30, 2018 and December 31, 2017,

   respectively

 

 

32

 

 

 

28

 

Additional paid-in capital

 

 

613,279

 

 

 

552,720

 

Accumulated other comprehensive loss

 

 

(226

)

 

 

(158

)

Accumulated deficit

 

 

(527,593

)

 

 

(470,112

)

Total stockholders’ equity

 

 

85,492

 

 

 

82,478

 

Total liabilities and stockholders’ equity

 

$

327,828

 

 

$

163,698

 

 

See accompanying notes to unaudited condensed consolidated financial statements.

 

 

2


 

Paratek Pharmaceuticals, Inc.

Condensed Consolidated Statements of Operations and Comprehensive Loss

(in thousands, except share and per share amounts)

(unaudited)

 

 

 

Three Months Ended

June 30,

 

 

Six Months Ended

June 30,

 

 

 

2018

 

 

2017

 

 

2018

 

 

2017

 

License and royalty revenue

 

$

40

 

 

$

7,514

 

 

$

50

 

 

$

7,532

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

 

14,802

 

 

 

15,079

 

 

 

29,665

 

 

 

33,735

 

General and administrative

 

 

12,912

 

 

 

8,716

 

 

 

24,785

 

 

 

17,080

 

Impairment of intangible asset

 

 

86

 

 

 

682

 

 

 

86

 

 

 

682

 

Changes in fair value of contingent consideration

 

 

(31

)

 

 

(318

)

 

 

(46

)

 

 

(549

)

Total operating expenses

 

 

27,769

 

 

 

24,159

 

 

 

54,490

 

 

 

50,948

 

Loss from operations

 

 

(27,729

)

 

 

(16,645

)

 

 

(54,440

)

 

 

(43,416

)

Other income and expenses:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Interest expense

 

 

(2,904

)

 

 

(1,126

)

 

 

(4,410

)

 

 

(2,258

)

Interest income

 

 

894

 

 

 

349

 

 

 

1,369

 

 

 

590

 

Other gain (loss), net

 

 

6

 

 

 

(8

)

 

 

(1

)

 

 

(15

)

Loss before income taxes

 

$

(29,733

)

 

$

(17,430

)

 

$

(57,482

)

 

$

(45,099

)

Provision for income taxes

 

 

 

 

 

753

 

 

 

 

 

 

753

 

Net loss

 

 

(29,733

)

 

 

(18,183

)

 

 

(57,482

)

 

 

(45,852

)

Other comprehensive income:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Unrealized loss on available-for-sale securities, net of tax

 

 

(47

)

 

 

(42

)

 

 

(67

)

 

 

(80

)

Comprehensive loss

 

$

(29,780

)

 

$

(18,225

)

 

$

(57,549

)

 

$

(45,932

)

Net loss per share - basic and diluted

 

$

(0.94

)

 

$

(0.66

)

 

$

(1.85

)

 

$

(1.78

)

Weighted average common shares outstanding

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Basic and diluted

 

 

31,581,275

 

 

 

27,347,941

 

 

 

31,076,788

 

 

 

25,780,756

 

 

See accompanying notes to unaudited condensed consolidated financial statements.

 

 

 

3


 

Paratek Pharmaceuticals, Inc.

Condensed Consolidated Statements of Cash Flows

(in thousands)

(unaudited)

 

 

 

For the Six Months Ended

June 30,

 

 

 

2018

 

 

2017

 

Net loss

 

$

(57,482

)

 

$

(45,852

)

Adjustments to reconcile net loss to net cash used in operating activities:

 

 

 

 

 

 

 

 

Depreciation and amortization

 

 

290

 

 

 

655

 

Stock-based compensation expense

 

 

8,870

 

 

 

8,936

 

Noncash interest expense

 

 

1,884

 

 

 

293

 

Impairment of intangible asset

 

 

86

 

 

 

682

 

Change in fair value of contingent consideration

 

 

(46

)

 

 

(549

)

Changes in operating assets and liabilities

 

 

 

 

 

 

 

 

Accounts receivable and other current assets

 

 

5,391

 

 

 

646

 

Purchase of prepaid interest - marketable securities

 

 

(548

)

 

 

(207

)

Accounts payable and accrued expenses

 

 

(631

)

 

 

(5,809

)

Other liabilities and other assets

 

 

459

 

 

 

519

 

Net cash used in operating activities

 

 

(41,727

)

 

 

(40,686

)

Investing activities

 

 

 

 

 

 

 

 

Purchase of fixed assets, net

 

 

(54

)

 

 

(1,128

)

Purchase of marketable securities

 

 

(220,732

)

 

 

(93,887

)

Proceeds from maturities of marketable securities

 

 

72,300

 

 

 

45,000

 

Net cash used in investing activities

 

 

(148,486

)

 

 

(50,015

)

Financing activities

 

 

 

 

 

 

 

 

Proceeds from the issuance of long-term convertible debt, net of costs

 

 

159,291

 

 

 

 

Proceeds from the issuance of long-term debt, net of costs

 

 

 

 

 

9,915

 

Proceeds from exercise of stock options

 

 

176

 

 

 

20

 

Proceeds from sale of common stock

 

 

51,516

 

 

 

78,690

 

Net cash provided by financing activities

 

 

210,983

 

 

 

88,625

 

Net increase (decrease) in cash, cash equivalents and restricted cash

 

 

20,770

 

 

 

(2,076

)

Cash, cash equivalents and restricted cash at beginning of period

 

 

35,828

 

 

 

54,028

 

Cash, cash equivalents and restricted cash at end of period

 

$

56,598

 

 

$

51,952

 

SUPPLEMENTAL DISCLOSURES OF CASH FLOW INFORMATION

 

 

 

 

 

 

 

 

Cash paid for interest

 

$

2,380

 

 

$

1,606

 

Convertible debt costs incurred but unpaid at period end

 

$

317

 

 

$

 

 

See accompanying notes to unaudited condensed consolidated financial statements.

 

 


 

4


 

P a r at e k P h a r m a c e u t i c a l s , In c.

Not e s to U naud i t e d Con d e n s e d Co nso l i dat e d F i nan c i al Stat e m e nts

( u n a u d i t e d )

 

 

1.   Description of the business  

Paratek Pharmaceuticals, Inc., or the Company or Paratek, is a Delaware corporation with its corporate office in Boston, Massachusetts and an office in King of Prussia, Pennsylvania.  

The Company is a clinical stage biopharmaceutical company focused on the development and commercialization of innovative therapeutics based upon tetracycline chemistry.  The Company has used its expertise in biology and tetracycline chemistry to create chemically diverse and biologically distinct small molecules derived from the minocycline core structure. The Company’s two lead product candidates are the antibacterials omadacycline and sarecycline.

Prior to October 30, 2014, the name of the Company was Transcept Pharmaceuticals, Inc., or Transcept. On October 30, 2014, Transcept completed a business combination with privately-held Paratek Pharmaceuticals, Inc., or Old Paratek, in accordance with the terms of the Agreement and Plan of Merger and Reorganization, dated as of June 30, 2014, by and among Transcept, Tigris Merger Sub, Inc., or Merger Sub, Tigris Acquisition Sub, LLC, or Merger LLC, and Old Paratek, or the Merger Agreement, pursuant to which Merger Sub merged with and into Old Paratek, with Old Paratek surviving as a wholly-owned subsidiary of Transcept, followed by the merger of Old Paratek with and into Merger LLC, with Merger LLC surviving as a wholly-owned subsidiary of Transcept (the Company refers to these mergers together as the Merger). Immediately following the Merger, Transcept changed its name to “Paratek Pharmaceuticals, Inc.”, and Merger LLC changed its name to “Paratek Pharma, LLC.” Following the completion of the Merger, the business conducted by Old Paratek became primarily the business conducted by Paratek.

The Company has incurred significant losses since its inception in 1996. The Company has generated an accumulated deficit of $527.6 million through June 30, 2018 and will require substantial additional funding in connection with the Company’s continuing operations to support commercial activities associated w ith its lead product candidate, omadacycline. Based upon the Company’s current operating plan, the Company anticipates that its existing cash, cash equivalents and marketable securities of $321.1 million as of June 30, 2018 will enable the Company to fund operating expenses and capital expenditure requirements  through at least the next 12 months from the filing date of this Quarterly Report on Form 10-Q. The Company expects to finance future cash needs primarily through a combination of public or private equity offerings, debt or other structured financings, strategic collaborations and grant funding.  The Company is subject to risks common to companies in the biopharmaceutical industry, including, but not limited to, risks of failure of preclinical studies and clinical trials, the need to obtain additional financing to fund the future development of the Company’s product candidates, the need to obtain compliant product from third party manufacturers, the need to obtain marketing approval for the Company’s product candidates, the need to successfully commercialize and gain market acceptance of product candidates, the risks of manufacturing product with an external supply chain, dependence on key personnel, and compliance with government regulations as well as those risks discussed in the “ Risk Factors ” section of the Company’s Annual Report on Form 10-K for the year ended December 31, 2017, as filed with the Securities and Exchange Commission, or the SEC, on March 6, 2018, in the “Risk Factors” section of the Quarterly Report on Form 10-Q for the quarter ended March 31, 2018, as filed with the SEC on May 8, 2018, and in this Quarterly Report on Form 10-Q.  

 

 

2.   Summary of Significant Accounting Policies and Basis of Presentation

Summary of Significant Accounting Policies

The significant accounting policies and estimates used in preparation of the condensed consolidated financial statements are described in the Company’s audited consolidated financial statements as of and for the year ended December 31, 2017, and the notes thereto, which are included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2017, as filed with the SEC on March 6, 2018.

 

 

5


 

Statement of Cash Flows

 

On January 1, 2018, the Company adopted ASU No. 2016-18,  Statement of Cash Flows (Topic 230) Restricted Cash , or ASU 2016-18. The Company’s restricted cash is now included with cash and cash equivalents when reconciling the beginning-of-period and end-of-period total amounts shown on the Company’s condensed consolidated statement of cash flows. The following table provides a reconciliation of cash, cash equivalents, and restricted cash reported within the condensed consolidated statement of cash flows that sum to the total of the same such amounts shown in the condensed consolidated statement of cash flows.

 

 

 

June 30,

2018

 

 

December 31,

2017

 

 

June 30,

2017

 

 

December 31,

2016

 

Cash and cash equivalents

 

$

56,082

 

 

$

35,416

 

 

$

51,587

 

 

$

52,962

 

Short-term restricted cash

 

 

266

 

 

 

162

 

 

 

115

 

 

 

816

 

Long-term restricted cash

 

 

250

 

 

 

250

 

 

 

250

 

 

 

250

 

Total cash, cash equivalents and restricted cash shown

   on the condensed consolidated statement of cash flows

 

$

56,598

 

 

$

35,828

 

 

$

51,952

 

 

$

54,028

 

 

Revenue Recognition

 

Effective January 1, 2018, the Company adopted Accounting Standards Codification, or ASC, Topic 606,  Revenue from Contracts with Customers , or ASC 606, using the full retrospective transition method. Under this method, the Company will revise its consolidated financial statements for the years ended December 31, 2017 and 2016, and applicable interim periods within those years, as if ASC 606 had been effective for those periods. This standard applies to all contracts with customers, except for contracts that are within the scope of other standards, such as leases, insurance, and financial instruments. Under ASC 606, an entity recognizes revenue when its customer obtains control of promised goods or services, in an amount that reflects the consideration that the entity expects to receive in exchange for those goods or services. To determine revenue recognition for arrangements that an entity determines are within the scope of ASC 606, the entity performs the following five steps: (i) identify the contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) the entity satisfies a performance obligation. The Company only applies the five-step model to contracts when it is probable that the entity will collect the consideration it is entitled to in exchange for the goods or services it transfers to the customer. At contract inception, once the contract is determined to be within the scope of ASC 606, the Company assesses the goods or services promised within each contract and determines those that are performance obligations and assesses whether each promised good or service is distinct. The Company then recognizes as revenue the amount of the transaction price that is allocated to the respective performance obligation when (or as) the performance obligation is satisfied as services are rendered.

 

The Company enters into collaboration agreements for research, development, manufacturing and commercial services that are within the scope of ASC 606, under which it licenses certain rights to its product candidates to third parties. The terms of these arrangements typically include payment to the Company of one or more of the following: non-refundable, upfront license fees; reimbursement of certain costs; customer option exercise fees; development, regulatory and commercial milestone payments; and royalties on net sales of licensed products. The amount of variable consideration is constrained until it is probable that the revenue is not at a significant risk of reversal in a future period. The contracts into which the Company enters generally do not include significant financing components.

 

As part of the accounting for these arrangements, the Company must use significant judgment to determine: (a) the transaction price under step (iii) above and (b) the timing of revenue recognition, including the appropriate measure of progress in step (v) above. The Company uses judgment to determine whether milestones or other variable consideration, except for royalties, should be included in the transaction price, as described further below. The transaction price is allocated to each performance obligation on a relative stand-alone selling price basis, for which the Company recognizes revenue as or when the performance obligations under the contract are satisfied. If a milestone or other variable consideration relates specifically to the Company’s efforts to satisfy a single performance obligation or to a specific outcome from satisfying the performance obligation, the Company generally allocates the milestone amount entirely to that performance obligation once it is probable that a significant revenue reversal would not occur.

Amounts received prior to revenue recognition are recorded as deferred revenue. Amounts expected to be recognized as revenue within the 12 months following the balance sheet date are classified as current portion of deferred revenue in the accompanying consolidated balance sheets. Amounts not expected to be recognized as revenue within the 12 months following the balance sheet date are classified as deferred revenue, net of current portion.

 

 

6


 

Licenses of intellectual property

 

In assessing whether a license is distinct from the other promises, the Company considers factors such as the research, development, manufacturing and commercialization capabilities of the collaboration partner and the availability of the associated expertise in the general marketplace. In addition, the Company considers whether the collaboration partner can benefit from a license for its intended purpose without the receipt of the remaining promise(s), whether the value of the license is dependent on the unsatisfied promise(s), whether there are other vendors that could provide the remaining promise(s), and whether it is separately identifiable from the remaining promise(s). For licenses that are combined with other promises, the Company utilizes judgment to assess the nature of the combined performance obligation to determine whether the combined performance obligation is satisfied over time or at a point in time and, if over time, the appropriate method of measuring progress for purposes of recognizing revenue. The Company evaluates the measure of progress each reporting period and, if necessary, adjusts the measure of performance and related revenue recognition.

 

Customer options  

 

If an arrangement is determined to contain customer options that allow the customer to acquire additional goods or services, the goods and services underlying the customer options are not considered to be performance obligations at the outset of the arrangement, as they are contingent upon option exercise. The Company evaluates the customer options for material rights, or options to acquire additional goods or services for free or at a discount. If the customer options are determined to represent or include a material right, the material right is recognized as a separate performance obligation at the outset of the arrangement. The Company allocates the transaction price to material rights based on the relative standalone selling price, which is determined based on the identified discount and the probability that the customer will exercise.  Amounts allocated to a material right are not recognized as revenue until, at the earliest, the option is exercised.

 

Milestone payments

 

At the inception of each arrangement that includes development milestone payments, the Company evaluates whether the milestones are considered probable of being achieved and estimates the amount to be included in the transaction price usin g the most likely amount method. If it is probable that a significant reversal of cumulative revenue would not occur, the associated milestone value is included in the transaction price. Milestone payments that are not within the control of the Company or the licensee, such as regulatory approvals, are not considered probable of being achieved until those approvals are received. The Company evaluates factors such as the scientific, clinical, regulatory, commercial, and other risks that must be overcome to achieve the particular milestone in making this assessment. There is considerable judgment involved in determining whether it is probable that a significant reversal of cumulative revenue would not occur. At the end of each subsequent reporting period, the Company reevaluates the probability of achievement of all milestones subject to constraint and, if necessary, adjusts its estimate of the overall transaction price. Any such adjustments are recorded on a cumulative catch-up basis, which would affect revenues and earnings in the period of adjustment.

 

Royalties

 

For arrangements that include sales-based royalties, including milestone payments based on a level of sales, and the license is deemed to be the predominant item to which the royalties relate, the Company recognizes revenue at the later of (i) when the related sales occur, or (ii) when the performance obligation to which some or all of the royalty has been allocated has been satisfied (or partially satisfied).

 

Contract costs

 

The Company recognizes as an asset the incremental costs of obtaining a contract with a customer if the costs are expected to be recovered. As a practical expedient, the Company recognizes the incremental costs of obtaining a contract as an expense when incurred if the amortization period of the asset that we otherwise would have recognized is one year or less. To date, the Company has not incurred any incremental costs of obtaining a contract with a customer.

 

Impact of adoption

 

The adoption of ASC 606 on January 1, 2018 did not result in significant changes to the revenue recognition pattern for any of the Company’s license and collaboration agreements. For further discussion of the adoption of this standard, and for a discussion of accounting for collaboration revenue, see Note 8, License and Collaboration Agreements .

 

7


 

There have been no other material changes in the Company’s significant accounting policies during the six months ended June 30, 2018.

Basis of Presentation

 

The accompanying condensed consolidated financial statements have been prepared in accordance with generally accepted accounting principles of the United States of America, or U.S. GAAP, as found in the ASC and ASU of the Financial Accounting Standards Board, or FASB, and pursuant to the rules and regulations of the SEC.

 

The accompanying condensed consolidated financial statements are unaudited. The unaudited interim condensed consolidated financial statements have been prepared on the same basis as the audited consolidated financial statements as of and for the year ended December 31, 2017, except as described above related to the adoption of ASU 2016-15 and ASC 606 and, in the opinion of management, reflect all normal recurring adjustments necessary for the fai r presentation of the Company’s financial position, results of operations and cash flows for the interim period ended June 30, 2018.  Beginning January 1, 2018, the Company presented “accrued contract manufacturing costs” as a separate line item on its condensed consolidated balance sheet. As such, the Company reclassified the December 31, 2017 accrued contract manufacturing costs balance of $5.0 million, from “other accrued expenses” into “accrued contract manufacturing costs”. Beginning on January 1, 2018, the Company also reclassified the balance of “accrued contract research” of $2.4 million as of December 31, 2017, previously presented as a separate line within the Company’s consolidated balance sheet, into “other accrued expenses” on the condensed consolidated balance sheet.

The results of operations for the interim periods are not necessarily indicative of the results of operations to be expected for the year ending December 31, 2018. These unaudited interim condensed consolidated financial statements should be read in conjunction with the audited consolidated financial statements as of and for the year ended December 31, 2017, and notes thereto, which are included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2017, as filed with the SEC on March 6, 2018.

Convertible Debt

For convertible debt that may only be settled with common shares, the Company accounts for the debt net of any discounts or issuance costs on its condensed consolidated balance sheet. The Company recognizes debt issuance cost amortization using the effective interest method as part of interest expense in its condensed consolidated statements of operations.

Principles of Consolidation

The accompanying unaudited condensed consolidated financial statements include the results of operations of Paratek Pharmaceuticals, Inc. and its wholly-owned subsidiaries, Paratek Pharma, LLC, Paratek Securities Corporation, Transcept Pharma, Inc., Paratek UK, Ltd, Paratek Bermuda Ltd., and Paratek Ireland Limited. All significant intercompany accounts and transactions have been eliminated in consolidation.

Use of Estimates

The preparation of the accompanying unaudited condensed consolidated financial statements, in conformity with U.S. GAAP, requires the Company to make estimates and judgments that affect the reported amounts of assets, liabilities, and expenses and the disclosure of contingent liabilities in the Company’s financial statements. On an ongoing basis, the Company evaluates its estimates and judgments, including those related to, among other items, intangible assets, goodwill, contingent liabilities, stock-based compensation arrangements, useful lives for depreciation and amortization of long-lived assets and valuation allowances on deferred tax assets. Actual results could differ from those estimates.

Segment and Geographic Information

Operating segments are defined as components of an enterprise engaging in business activities for which discrete financial information is available and regularly reviewed by the chief operating decision maker in deciding how to allocate resources and in assessing performance. The Company views its operations and manages its business in one operating segment.

 

3.   Cash and Cash Equivalents and Marketable Securities 

 

The following is a summary of available-for-sale securities as of June 30, 2018 and December 31, 2017 (in thousands):

 

8


 

 

 

 

Amortized Cost

 

 

Unrealized Gains

 

 

Unrealized Losses

 

 

Fair Value

 

June 30, 2018

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

U.S. treasury securities

 

$

265,289

 

 

$

 

 

$

(226

)

 

$

265,063

 

Total

 

$

265,289

 

 

$

 

 

$

(226

)

 

$

265,063

 

December 31, 2017

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

U.S. treasury securities

 

$

114,666

 

 

$

 

 

$

(158

)

 

$

114,508

 

Government agency securities

 

 

1,799

 

 

 

 

 

 

 

 

 

1,799

 

Total

 

$

116,465

 

 

$

 

 

$

(158

)

 

$

116,307

 

 

No available-for-sale securities held as of June 30, 2018 and December 31, 2017 had remaining maturities greater than eighteen months and twelve months, respectively.

 

 

4.   Restricted Cash

 

Short-term restricted cash

As of June 30, 2018 and December 31, 2017, restricted cash of $0.3 million and $0.2 million, respectively, represents royalty income received but not yet paid to former Transcept stockholders as part of the royalty sharing agreement, or the Royalty Sharing Agreement, executed by the Company on October 28, 2016 with the Special Committee of the Company’s Board of Directors, or the Special Committee, a committee established in connection with the Merger. See Note 11, Fair Value Measurements , for more information on the Royalty Sharing Agreement. 

Long-term restricted cash

The Company leases its Boston, Massachusetts office space under a non-cancelable operating lease. Refer to Note 15, Commitments and Contingencies , for further details. In accordance with the lease, the Company has a cash-collateralized irrevocable standby letter of credit in the amount of $0.3 million as of June 30, 2018 and December 31, 2017, naming the landlord as beneficiary.

 

 

5.   Fixed Assets

 

Fixed assets, net, consists of the following (in thousands):

 

 

 

June 30,

2018

 

 

December 31,

2017

 

Office equipment

 

$

866

 

 

$

866

 

Computer equipment

 

 

412

 

 

 

412

 

Computer software

 

 

795

 

 

 

787

 

Leasehold improvements

 

 

904

 

 

 

860

 

Construction-in-process

 

 

2

 

 

 

 

     Gross fixed assets

 

 

2,979

 

 

 

2,925

 

Less: Accumulated depreciation and amortization

 

 

(1,517

)

 

 

(1,214

)

     Net fixed assets

 

$

1,462

 

 

$

1,711

 

 

 

6.   Intangible Assets, Net

Intangible assets consist of the following (in thousands):

 

 

 

June 30,

2018

 

 

December 31,

2017

 

Intermezzo product rights

 

$

50

 

 

$

142

 

TO-2070 asset

 

 

170

 

 

 

170

 

Gross intangible assets

 

 

220

 

 

 

312

 

Less: Accumulated amortization

 

 

(170

)

 

 

(170

)

Net intangible assets

 

$

50

 

 

$

142

 

 

 

9


 

Intermezzo product rights and the TO-2070 license rights were acquired through the Merger. Refer to Note 8, License and Collaboration Agreements, for further detail concerning Intermezzo.  Intangible assets are reviewed when events or circumstances indicat e that the assets might be impaired. An impairment loss would be recognized when the estimated undiscounted cash flows to be generated by those assets are less than the carrying amounts of those assets.  If it is determined that the intangible asset is not recoverable, an impairment loss would be calculated based on the excess of the carrying value of the intangible asset over its fair value. The Company recorded impairment of $0.1 million for the three and six months ended June 30, 2018. The Company record ed impairment of $0.7 million for the three and six months ended June 30, 2017.

 

7.   Net Loss Per Share Available to Common Stockholders

Basic net loss per share available to common stockholders is calculated by dividing the net loss available to common stockholders by the weighted-average number of common shares outstanding during the period, without consideration for common stock equivalents. Diluted net loss per share available to common stockholders is computed by dividing the net loss available to common stockholders by the weighted-average number of common share equivalents outstanding for the period determined using the treasury-stock method or the if-converted method, as applicable. For purposes of this calculation, stock options, restricted stock units, or RSUs, warrants to purchase common stock and shares of common stock issuable upon conversion of convertible debt are considered to be common stock equivalents and are only included in the calculation of diluted net loss per share available to common stockholders when their effect is dilutive.

 

The following outstanding shares subject to stock options, RSUs and warrants to purchase common stock and common shares issuable upon conversion of convertible debt were antidilutive due to a net loss in the periods presented and, therefore, were excluded from the dilutive securities computation as of the three and six months ended June 30, 2018 and 2017 as indicated below:

 

 

 

June 30,

 

 

 

2018

 

 

2017

 

Excluded potentially dilutive securities (1) :

 

 

 

 

 

 

 

 

Common stock issuable upon conversion of the 4.75% Convertible Senior Subordinated Notes due 2024

 

 

10,377,361

 

 

 

 

Shares subject to outstanding options to purchase

   common stock

 

 

3,713,967

 

 

 

3,467,049

 

Unvested restricted stock units

 

 

1,924,774

 

 

 

954,003

 

Shares subject to warrants to purchase common stock

 

 

84,828

 

 

 

84,828

 

Shares issuable under employee stock purchase plan

 

 

36,539

 

 

 

36,539

 

Totals

 

 

16,137,469

 

 

 

4,542,419

 

 

(1)

The number of shares is based on the maximum number of shares issuable on exercise or conversion of the related securities as of June 30, 2018. Such amounts have not been adjusted for the treasury stock method or weighted average outstanding calculations as required if the securities were dilutive.

 

 

8.   License and Collaboration Agreements

 

Zai Lab (Shanghai) Co., Ltd.

On April 21, 2017, Paratek Bermuda Ltd., a wholly-owned subsidiary of Paratek Pharmaceuticals, Inc., and Zai Lab (Shanghai) Co., Ltd., or Zai, entered into a License and Collaboration Agreement, or the Zai Collaboration Agreement. Under the terms of the Zai Collaboration Agreement, Paratek Bermuda Ltd. granted Zai an exclusive license to develop, manufacture and commercialize omadacycline, or the licensed product, in the People’s Republic of China, Hong Kong, Macau and Taiwan, or the territory, for all human therapeutic and preventative uses other than biodefense. Zai will be responsible for the development, manufacturing and commercialization of the licensed product in the territory, at its sole cost with certain assistance from Paratek Bermuda Ltd.

Under the terms of the Zai Collaboration Agreement, Paratek Bermuda Ltd. earned an upfront cash payment of $7.5 million, before taxes, and is eligible to receive up to $14.0 million in potential regulatory milestone payments and $40.5 million in potential commercial milestone payments, the next being $5.0 million upon approval by the U.S. Food & Drug Administration, or the FDA, of a New Drug Application, or NDA, submission in the CABP indication. Zai will also pay Paratek Bermuda Ltd. tiered royalties at a low double digit to mid-teen percent on net sales of the licensed product in the territory.

 

10


 

The Zai Collaboration Agreement will c ontinue, on a region-by-region basis, until the expiration of and payment by Zai of all Zai’s payment obligations, which is until the later of: (i) the abandonment, expiry or final determination of invalidity of the last valid claim within the Paratek pate nts that covers the licensed product in the region in the territory in the manner that Zai or its affiliates or sublicensees exploit the licensed product or intend for the licensed product to be exploited; or (ii) the eleventh anniversary of the first comm ercial sale of such licensed product in such region.

The Company evaluated the Zai Collaboration Agreement under ASC 606. The Company determined that there were six material promises under the Zai Collaboration Agreement: (i) an exclusive license to develop, manufacture and commercialize omadacycline in the territory, (ii) the initial technology transfer (ii) a transfer of certain materials and materials know-how, (iv) optional manufacturing services, (v) optional regulatory support and (vi) optional commercialization support. The Company determined that the exclusive license and initial technology transfer were not distinct from one another, as the license has limited value without the transfer of the Company’s technology; which will allow Zai to develop the manufacturing process and commercialize omadacycline in the territory in the timeline anticipated under the agreement . Without the technology transfer, Zai would incur additional costs to recreate the Company’s know-how. Therefore, the license and initial technology transfer are combined as a single performance obligation.  The transfer of materials is a single distinct performance obligation.  The Company evaluated the option rights for manufacturing services, regulatory support and commercialization support to determine whether they represent or include material rights to Zai and concluded that the options were not issued at a discount, and therefore do not represent material rights. As such, they are not considered performance obligations at the outset of the arrangement.

Based on these assessments, the Company determined that two performance obligations existed at the outset of the Zai Collaboration Agreement: (i) the exclusive license combined with the initial technology transfer and (ii) the transfer of certain materials.  

The Company determined that the upfront payment of $7.5 million constituted the entirety of the consideration to be included in the transaction price as of the outset of the Zai Collaboration Agreement. Future potential milestone payments were excluded from the transaction price as they are fully constrained as the risk of significant reversal has not yet been resolved. The achievement of the future potential milestones is not within the Company’s control and is subject to certain research and development success or regulatory approvals and therefore carry significant uncertainty. The Company will reevaluate the likelihood of achieving future milestones at the end of each reporting period. As all performance obligations have been satisfied, if the risk of significant reversal is resolved, any future milestone revenue from the arrangement will be recognized as revenue in the period the risk is relieved.

The Company satisfied both performance obligations and recognized the upfront payment of $7.5 million as revenue in the three months ended June 30, 2017.

The Company did not recognize revenue under the Zai Collaboration Agreement in the three and six months ended June 30, 2018. During the three months and six months ended June 30, 2017, the Company recognized revenue under the Zai Collaboration Agreement of $7.5 million, which represents the upfront payment. There was no deferred revenue as of June 30, 2018.

Allergan plc

In July 2007, the Company and Warner Chilcott Company, Inc. (now part of Allergan plc, or Allergan), entered into a collaborative research and license agreement, or the Allergan Collaboration Agreement, under which the Company granted Allergan an exclusive license to research, develop and commercialize tetracycline products for use in the United States for the treatment of acne and rosacea. Since Allergan did not exercise its development option with respect to the treatment of rosacea prior to initiation of a Phase 3 trial for the product, the license grant to Allergan converted to a non-exclusive license for the treatment of rosacea as of December 2014. Under the terms of the Allergan Collaboration Agreement, the Company and Allergan are responsible for, and are obligated to use, commercially reasonable efforts to conduct specified development activities for the treatment of acne and, if requested by Allergan, the Company may conduct certain additional development activities to the extent the Company determines in good faith that the Company has the necessary resources available for such activities. Allergan has agreed to reimburse the Company for its costs and expenses, including third-party costs, incurred in conducting any such development activities.

Under the terms of the Allergan Collaboration Agreement, Allergan is responsible for and is obligated to use commercially reasonable efforts to develop and commercialize tetracycline compounds that are specified in the agreement for the treatment of acne. The Company has agreed during the term of the Allergan Collaboration Agreement not to directly or indirectly develop or commercialize any tetracycline compounds in the United States for the treatment of acne and rosacea, and Allergan has agreed during the term of the Allergan Collaboration Agreement not to directly or indirectly develop or commercialize any tetracycline compound included as part of the agreement for any use other than as provided in the agreement.

 

11


 

The Allergan Collaboration Agreement contains two performance obligations: (i) an exclusive license to researc h, develop and commercialize tetracycline products for use in the United States for the treatment of acne and rosacea and (ii) research and development services . The performance obligation to deliver the license was satisfied upon execution of the Allergan Collaboration Agreement in July 2007.  All research and development services were completed by December 2010.   The options provided to Allergan for additional development services do not provide Allergan with a material right as these services will not be provided at a significant or incremental discount.  As such, the option services are not performance obligations.

The Company received an upfront fee in the amount of $4.0 million upon the execution of the Allergan Collaboration Agreement, $1.0 million upon filing of an Investigational New Drug Application in 2010, $2.5 million upon initiation of Phase 2 trials in 2012 and $4.0 million upon initiation of Phase 3 trials associated with the Allergan Collaboration Agreement in December 2014.

In December 2017, the FDA’s acceptance of Allergan’s NDA for sarecycline, or Seysara™ was received, triggering the next eligible milestone payment of $5.0 million earned upon acceptance of an NDA for a product licensed under the Allergan Collaboration Agreement. As the performance obligation to deliver the license was satisfied in 2007 and research and development services completed by December 2010, all subsequent milestone payments are recognized as revenue when the risk of significant reversal is resolved, generally when the milestone event occurs.  Therefore, the $5.0 million milestone payment was recognized in December 2017 and subsequently collected in the first quarter of 2018.

Allergan may be required, if the Company receives FDA approval, to pay the Company a future milestone payment of $12.0 million upon receipt of regulatory approval from the FDA. Allergan is also obligated to pay the Company tiered royalties, ranging from the mid-single digits to the low double digits, based on net sales of tetracycline compounds developed under the Allergan Collaboration Agreement, with a standard royalty reduction post patent expiration for such product for the remainder of the royalty term. Allergan’s obligation to pay the Company royalties for each tetracycline compound it commercializes under the Allergan Collaboration Agreement expires on the later of the expiration of the last to expire patent that covers the tetracycline compound in the United States and the date on which generic drugs that compete with the tetracycline compound reach a certain threshold market share in the United States.

The Company has not recognized any revenue under this arrangement for the three and six months ended June 30, 2018 or June 30, 2017. The future potential milestone payment was excluded from the transaction price as it is fully constrained as the risk of significant reversal has not yet been resolved. Royalty payments would be recognized when the sale occurs.

Purdue Pharma L.P.

In July 2009, the Company and Purdue Pharma L.P., or Purdue Pharma, entered into a license and collaboration agreement, or the Purdue Collaboration Agreement, which grants an exclusive license to Purdue Pharma to commercialize Intermezzo in the United States and pursuant to which:

 

Purdue Pharma paid the Company a $25.0 million non-refundable license fee in August 2009, and non-refundable intellectual property milestone payments of $10.0 million in each of December 2011 and August 2012;

 

The Company transferred the Intermezzo NDA to Purdue Pharma, and Purdue Pharma is obligated to assume the expense associated with maintaining the NDA and further development of Intermezzo in the United States, including any expense associated with post-approval studies;

 

Purdue Pharma is obligated to commercialize Intermezzo in the United States at its expense using commercially reasonable efforts;

 

Purdue Pharma is obligated to pay the Company tiered base royalties on net sales of Intermezzo in the United States ranging from the mid-teens up to the mid-20% level, with each such royalty tiers subject to an increase by a percentage in the low single digits upon a specified anniversary of regulatory approval of Intermezzo. The base royalty is tiered depending upon the achievement of certain fixed net sales thresholds by Purdue Pharma, which net sales levels reset each year for the purpose of calculating the royalty. The royalty tiers are subject to reductions upon generic entry and patent expiration. Purdue Pharma is obligated to pay royalties until the later of 15 years from the date of first commercial sale in the United States or the expiration of patent claims related to Intermezzo; and

 

Purdue Pharma is obligated to pay the Company up to an additional $70.0 million upon the achievement of certain net sales targets for Intermezzo in the United States.

 

12


 

The Purdue Collaboration Agreement expires on the expiration of Purdue P harma’s royalty obligations. Purdue Pharma has the right to terminate the Purdue Collaboration Agreement at any time upon advance notice of 180 days. The Purdue Collaboration Agreement is also subject to termination by Purdue Pharma in the event of FDA or governmental action that materially impairs Purdue Pharma’s ability to commercialize Intermezzo or the occurrence of a serious event with respect to the safety of Intermezzo. The Purdue Collaboration Agreement may be terminated by the Company upon Purdue P harma commencing an action that challenges the validity of Intermezzo related patents or if Purdue Pharma is excluded from participation in federal healthcare programs. The Purdue Collaboration Agreement may be terminated by either party in the event of a material breach by or insolvency of the other party.

The Company also granted Purdue Pharma and an associated company the right to negotiate for the commercialization of Intermezzo in Mexico in 2013 but retained the rights to commercialize Intermezzo in the rest of the world.

During the first quarter of 2014, Purdue Pharma discontinued use of the Purdue Pharma sales force to actively market Intermezzo to healthcare professionals.

In October 2014, the Company announced that its Board of Directors had approved a special dividend of, among other things, the right to receive, on a pro rata basis, 100% of any royalty income received by the Company pursuant to the Purdue Collaboration Agreement and 90% of any cash proceeds from a sale or disposition of Intermezzo, less fees and expenses incurred in connection with such activity, to the extent that either occurred prior to the second anniversary of the closing date of the Merger. On October 28, 2016, in satisfaction of the Company’s payment obligation of the proceeds of sale or disposition of the Intermezzo assets to the former Transcept stockholders under the Merger Agreement, the Company executed the Royalty Sharing Agreement pursuant to which the Company agreed to pay to the former Transcept stockholders fifty percent of all royalty income received by the Company pursuant to the Purdue Collaboration Agreement, net of all costs, fees and expenses incurred by the Company in connection with the Purdue Collaboration Agreement, related agreements, the Intermezzo product and the administration of the royalty income to the former Transcept stockholders.

As of December 2011, the Company completed all obligations under the Purdue Collaboration Agreement. As such, all subsequent milestone payments are recognized as revenue when the risk of significant reversal is resolved.  Future potential milestone payments were excluded from the transaction price as they are fully constrained as the risk of significant reversal has not yet been resolved. Royalty payments would be recognized when the sale occurs.

Tufts University

In February 1997, the Company and Tufts University, or Tufts, entered into a license agreement under which the Company acquired an exclusive license to certain patent applications and other intellectual property of Tufts related to the drug resistance field to develop and commercialize products for the treatment or prevention of bacterial or microbial diseases or medical conditions in humans or animals or for agriculture. The Company subsequently entered into eleven amendments to that agreement, collectively the Tufts License Agreement, to include patent applications filed after the effective date of the original license agreement, to exclusively license additional technology from Tufts, to expand the field of the agreement to include disinfectant applications, and to change the royalty rate and percentage of sublicense income paid by the Company to Tufts under sublicense agreements with specified sublicensees. The Company is obligated under the Tufts License Agreement to provide Tufts with annual diligence reports and a business plan and to meet certain other diligence milestones. The Company has the right to grant sublicenses of the licensed rights to third parties, which will be subject to the prior approval of Tufts unless the proposed sublicensee meets a certain net worth or market capitalization threshold. The Company is primarily responsible for the preparation, filing, prosecution and maintenance of all patent applications and patents covering the intellectual property licensed under the Tufts License Agreement at its sole expense. The Company has the first right, but not the obligation, to enforce the licensed intellectual property against infringement by third parties.

The Company issued Tufts 1,024 shares of the Company’s common stock on the date of execution of the original license agreement, and the Company may be required to make certain payments of up to $0.3 million to Tufts upon the achievement by products developed under the agreement of specified development and regulatory approval milestones. The Company has already made a payment of $50,000 to Tufts for achieving the first milestone following commencement of the Phase 3 clinical trial for omadacycline and a payment of $100,000 to Tufts for achieving the second milestone following its first marketing application (NDA) submitted in the United States. The Company is also obligated to pay Tufts a minimum royalty payment in the amount of $25,000 per year. In addition, the Company is obligated to pay Tufts royalties based on gross sales of products, as defined in the agreement, ranging in the low single digits depending on the applicable field of use for such product sale. If the Company enters into a sublicense under the agreement, based on the applicable field of use for such product, the Company will be obligated to pay Tufts (i) a percentage, ranging from 10% to 14% (ten percent to fourteen percent) for compounds other than omadacycline, and a percentage in the single digits for the compound omadacycline, of that portion of any sublicense issue fees or maintenance fees received by the Company that are reasonably attributable to the sublicense of the rights granted to the Company under the Tufts License Agreement and (ii) the lesser of (a) a percentage, ranging from the low tens to the high twenties based on the applicable field of use for such product, of the royalty payments made to the Company by the sublicensee or (b) the amount of royalty payments that would have been paid by the Company to Tufts if it had sold the product. The Company paid a sublicense issue fee to Tufts during the year ended December 31, 2017 upon earning the $7.5 million upfront payment under the Zai Collaboration Agreement.

 

13


 

Unless terminated earlier, the Tufts License Agree ment will expire at the same time as the last-to-expire patent in the patent rights licensed to the Company under the agreement and after any such expiration the Company will continue to have an exclusive, fully-paid-up license to such intellectual propert y licensed from Tufts. Tufts has the right to terminate the agreement upon 30 days’ notice should the Company fail to make a material payment under the Tufts License Agreement or commit a material breach of the agreement and not cure such failure or breach within such 30-day period, or if, after the Company has started to commercialize a product under the Tufts License Agreement, the Company ceases to carry on its business for a period of 90 consecutive days. The Company has the right to terminate the Tufts License Agreement at any time upon 180 days’ notice. Tufts has the right to convert the Company’s exclusive license to a non-exclusive license if the Company does not commercialize a product licensed under the agreement within a specified time period.  

Past Collaborations

Novartis

In September 2009, the Company and Novartis International Pharmaceutical Ltd., or Novartis, entered into a Collaborative Development, Manufacture and Commercialization License Agreement, or the Novartis Agreement, which provided Novartis with a global, exclusive patent and technology license for the development, manufacturing and marketing of omadacycline. The Novartis Agreement was terminated by Novartis without cause in June 2011 and the termination was effective 60 days later. We and Novartis subsequently entered in a letter agreement in January 2012, or the Novartis Letter Agreement, as amended, pursuant to which we reconciled shared development costs and expenses and granted Novartis a right of first negotiation with respect to commercialization rights of omadacycline following approval of omadacycline from the FDA, EMA, or any regulatory agency, but only to the extent the Company had not previously granted such commercialization rights related to omadacycline to another third party as of any such approval. The Company also agreed to pay Novartis a 0.25% royalty, to be paid from net sales received by the Company in any country following the launch of omadacycline in that country and continuing until the later of expiration of the last active valid patent claim covering such product in the country of sale and 10 years from the date of first commercial sale in such country. The amended Novartis Letter Agreement resulted in a long-term liability in the amount of $3.6 million for the six months ended June 30, 2018 and year ended December 31, 2017 included within “Other Long-Term Liabilities” on the Company’s consolidated balance sheet. There are no other payment obligations to Novartis under the Novartis Agreement or the amended Novartis Letter Agreement.

9.   Capital Stock

 

In October 2015 and February 2017, the Company entered into Controlled Equity Offering SM Sales Agreements, or the 2015 Sales Agreement and 2017 Sales Agreement, respectively, and collectively, the Sales Agreements, with Cantor Fitzgerald & Co., or Cantor, under which the Company could, at its discretion, from time to time sell shares of its common stock, with a sales value of up to $50 million under each Sales Agreement through Cantor. The Company provided Cantor with customary indemnification rights, and Cantor was entitled to a commission at a fixed rate of 3% of the gross proceeds per share sold.  Sales of the shares under the Sales Agreements were to be made in transactions deemed to be “at the market offerings”, as defined in Rule 415 under the Securities Act of 1933, as amended. The Company has sold all $50 million of shares of its common stock under the 2015 Sales Agreement. The Company received $1.8 million in proceeds, after deducting commissions of $0.1 million, from the sale of 96,308 shares of common stock, during the six months ended June 30, 2018, under the 2017 Sales Agreement. As of July 31, 2018, $0.8 million remains available for sale under the 2017 Sales Agreement.

 

Warrants to Purchase Common Stock

Warrants to purchase preferred stock with intrinsic value issued to HBM Healthcare Investments (Cayman) Ltd., Omega Fund III, L.P., and K/S Danish BioVenture, all beneficial owners of more than 5% of the Company’s common stock, were exchanged for 9,614 warrants to purchase common stock in connection with the Merger. These 9,614 warrants to purchase common stock have an exercise price of $0.15 per share and will, if not exercised, expire in 2021.

 

14


 

As described in Note 13, Debt , in connection with a Loan and Security Agreement, or the Hercules Loan Agreement, into which the Company entered with Hercules Technology II, L.P. and Hercule s Technology III, L.P., together, Hercules, and certain other lenders and Hercules Technology Growth Capital, Inc. (as agent), the Company issued to each of Hercules Technology II, L.P. and Hercules Technology III, L.P. a warrant to purchase 16,346 shares of its common stock (32,692 shares of common stock in total) at an exercise price of $24.47 per share, or the Hercules Warrants, on September 30, 2015, which expire five years from issuance or at the consummation of a Public Acquisition, as defined in each of the Hercules Warrant agreements.

As described in Note 13, Debt , in connection with the second amendment to the Hercules Loan Agreement on December 12, 2016, the Company issued to each of Hercules Technology II, L.P. and Hercules Technology III, L.P. a warrant to purchase 18,574 shares of its common stock (37,148 shares of common stock in total) at an exercise price of $13.46 per share, or the Loan Amendment Warrants. Additionally, in connection with the borrowing of the Third Tranche (as defined in Note 13, Debt ) on June 27, 2017, the Company issued an additional warrant to Hercules Capital, Inc. to purchase 5,374 shares of its common stock at an exercise price of $23.26 per share, or the Additional Warrant.

As described in Note 13, Debt , in connection with the fifth amendment to the Hercules Loan Agreement, or the Fifth Amendment, on August 1, 2018, the Company issued to Hercules Capital, Inc. a warrant to purchase up to 19,627 shares of its common stock at an exercise price of $10.19 per share, or the Fifth Amendment Warrant.

The Hercules Warrants, Loan Amendment Warrants, Additional Warrant and the Fifth Amendment Warrant, collectively referred to as the Warrants, may be exercised on a cashless basis.  The Warrants are exercisable for a term beginning on the date of issuance and ending on the earlier to occur of five years (or seven years, in the case of the Fifth Amendment Warrant) from the date of issuance or the consummation of certain acquisitions of the Company as set forth in the various agreements for the Warrants.

 

10.   Other Accrued Expenses

Other accrued expenses consist of the following (in thousands):

 

 

 

June 30,

2018

 

 

December 31,

2017

 

Accrued legal costs

 

$

385

 

 

$

257

 

Accrued compensation

 

 

3,064

 

 

 

3,403

 

Intermezzo payable

 

 

 

 

 

124

 

Accrued professional fees

 

 

2,500

 

 

 

953

 

Accrued contract research

 

 

2,043

 

 

 

2,360

 

Accrued commercial

 

 

776

 

 

 

911

 

Accrued other

 

 

210

 

 

 

262

 

Total

 

$

8,978

 

 

$

8,270

 

 

 

11.   Fair Value Measurements

Financial instruments, including cash, cash equivalents, restricted cash, money market funds, U.S. treasury and government agency securities, accounts receivable, accounts payable, accrued expenses, contingent obligations and the Intermezzo reserve are carried on the condensed consolidated financial statements at amounts that approximate fair value. The fair value of the Company’s long-term debt is determined using current applicable rates for similar instruments as of the balance sheet date.  The carrying value of the Company’s debt (including the Notes) approximates its fair value as the interest rate is near current market rates. The fair value of the Company’s debt was determined using Level 3 inputs.  Fair values are based on assumptions concerning the amount and timing of estimated future cash flows and assumed discount rates, reflecting varying degrees of perceived risk.

 

15


 

The following table presents information about the Company’s financial assets and liabilities that have been measured at fair value as of June 30, 2018 and December 31, 2017 and indicate the fair value hierarchy of the valuation inputs utilized to determine such fair value. In general, fair valu es determined by Level 1 inputs utilize quoted prices (unadjusted) in active markets for identical assets or liabilities. Fair values determined by Level 2 inputs utilize observable inputs other than Level 1 prices, such as quoted prices for similar assets or liabilities or other inputs that are observable market data. Fair values determined by Level 3 inputs utilize unobservable data points for the asset or liability, and include situations where there is little, if any, market activity for the asset or li ability (in thousands):  

 

Description

 

Quoted

Prices in

Active

Markets

(Level 1)

 

 

Significant

Other

Observable

Inputs

(Level 2)

 

 

Significant

Unobservable

Inputs

(Level 3)

 

 

Total

 

June 30, 2018

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Assets:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

U.S. treasury securities

 

$

265,063

 

 

$

 

 

$

 

 

$

265,063

 

Total Assets

 

$

265,063

 

 

$

 

 

$

 

 

$

265,063

 

Liabilities:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Contingent obligations

 

$

 

 

$

 

 

$

25

 

 

$

25

 

Total Liabilities

 

$

 

 

$

 

 

$

25

 

 

$

25

 

December 31, 2017

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Assets:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

U.S. treasury securities

 

$

114,508

 

 

$

 

 

$

 

 

$

114,508

 

Government agency securities

 

 

 

 

 

1,799

 

 

 

 

 

 

1,799

 

Total Assets

 

$

114,508

 

 

$

1,799

 

 

$

 

 

$

116,307

 

Liabilities:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Contingent obligations

 

$

 

 

$

 

 

$

71

 

 

$

71

 

Total Liabilities

 

$

 

 

$

 

 

$

71

 

 

$

71

 

 

Marketable Securities

U.S. treasury securities fair values can be obtained through quoted market prices in active exchange markets and are therefore classified as Level 1. The pricing on government agency securities was primarily sourced from independent third-party pricing services, overseen by management, and is based on valuation models that consider standard input factor such as deal quotes, market spreads, cash flows, the U.S. Treasury yield curve, live trading levels, trade execution data, market consensus prepayment spreads, credit information and the bond’s terms and conditions, among other things, and are therefore classified as Level 2.

Contingent Consideration

 

On October 28, 2016, in satisfaction of the Company’s payment obligation of the proceeds of sale or disposition of the Intermezzo product rights to the former Transcept stockholders under the Merger Agreement, the Company executed the Royalty Sharing Agreement with the Special Committee. Under the Royalty Sharing Agreement, the Company agreed to pay to the former Transcept stockholders fifty percent of all royalty income received by the Company pursuant to the Purdue Collaboration Agreement, net of all costs, fees and expenses incurred by the Company in connection with the Purdue Collaboration Agreement, related agreements, the Intermezzo product and the administration of the royalty income to the former Transcept stockholders.  

The significant unobservable inputs used in the fair value measurement of the contingent obligation to former Transcept stockholders with respect to the Intermezzo product rights as of June 30, 2018 and December 31, 2017 were estimated future Intermezzo product revenues and associated royalties due to the Company as well as the appropriate discount rate given consideration to the market and forecast risk involved. The results of this valuation yielded a decrease in the contingent obligation to former Transcept stockholders of $46,000 during the six months ended June 30, 2018. Significant increases or decreases in any of those inputs would result in a substantially lower or higher fair value measurement.

 

16


 

The following table provides a roll forward of the fair value of contingent obligations categorized as Level 3 instruments, for the six months ended June 30, 2018 (in thousands):

 

 

 

Contingent

liability—

former

Transcept

stockholders

 

Balances at December 31, 2017

 

$

71

 

Change in fair value

 

 

(46

)

Balances at June 30, 2018

 

$

25

 

 

 

12.   Stock-Based Compensation

 

The following table presents stock-based compensation expense included in the Company’s condensed consolidated statements of operations (in thousands):

 

 

 

Three Months Ended June 30,

 

 

Six Months Ended June 30,

 

 

 

2018

 

 

2017

 

 

2018

 

 

2017

 

Research and development expense

 

$

1,554

 

 

$

1,714

 

 

$

3,014

 

 

$

3,055

 

General and administrative expense

 

 

2,949

 

 

 

3,177

 

 

 

5,856

 

 

 

5,881

 

Total stock-based compensation expense

 

$

4,503

 

 

$

4,891

 

 

$

8,870

 

 

$

8,936

 

 

Stock-based compensation expense is estimated as of the grant date based on the fair value of the award and is recognized as expense over the requisite service period, which generally represents the vesting period. The Company estimates the fair value of its stock options using the Black-Scholes option-pricing model. The weighted-average assumptions used to determine the fair value of the stock option grants is as follows:

 

 

 

Six Months Ended June 30,

 

 

 

2018

 

 

2017

 

Volatility

 

 

68.1

%

 

 

76.2

%

Weighted average risk-free interest rate

 

 

2.7

%

 

 

2.0

%

Expected dividend yield

 

 

0.0

%

 

 

0.0

%

Expected life of options (in years)

 

 

5.9

 

 

 

5.8

 

 

Stock Option Plan Activity

The Company’s Board of Directors adopted the Paratek Pharmaceuticals, Inc. 2015 Equity Incentive Plan, or the 2015 Plan, which was approved by Company stockholders at the annual meeting of shareholders held on June 9, 2015, reserving 1,200,000 shares of common stock for the grant of incentive stock options, non-statutory stock options, stock appreciation rights, restricted stock awards, RSU awards, performance stock awards, performance cash awards and other stock awards to directors, officers, employees and consultants. The 2015 Plan is intended to be the successor to and continuation of the Paratek Pharmaceuticals, Inc, 2006 Incentive Award Plan and the Paratek Pharmaceuticals, Inc.  2014 Equity Incentive Plan, or collectively, the Prior Plans.  When the 2015 Plan became effective, no additional stock awards were granted under the Prior Plans, although all outstanding stock awards granted under the Prior Plans will continue to be subject to the terms and conditions as set forth in the agreements evidencing such stock awards and the terms of the Prior Plans. On January 1, 2018, 1 ,397,05 0 shares of common stock were automatically added to the shares authorized for issuance under the 2015 Plan pursuant to a “Share Reserve” provision contained in the 2015 Plan.  The Share Reserve automatically increases on January 1 st  of each year, for the period commencing on (and including) January 1, 2016 and ending on (and including) January 1, 2025, in an amount equal to 5% of the total number of shares of common stock outstanding on December 31 st of the preceding calendar year. Notwithstanding the foregoing, the Board of Directors of the Company may act prior to January 1 st of a given year to provide that there will be no January 1 st   increase in the Share Reserve for such year or that the increase in the Share Reserve for such year will be a lesser number of shares of common stock than would otherwise automatically occur.   Total shares available for future issuance under the 2015 Plan are 232,452 shares as of June 30, 2018.

During the six months ended June 30, 2018, the Company’s Board of Directors granted 60,800 stock options and 1,154,370 RSUs to directors, executives and employees of the Company under the 2015 Plan. The stock option awards are subject to time-based vesting over a period of one to four years.  The RSU awards made to directors of the Company in February 2018 are subject to time-based vesting, with 100% of the shares of common stock subject to the RSUs vesting one year from the grant date. The RSU award made to a director of the Company in April 2018 vests in equal installments on each of the first three anniversaries of the grant date. The RSU awards made to executives and employees are subject to time-based vesting over a period of three years from the grant date.  

 

17


 

The grants also included performance-based RSU, or PRSU, awards to certain executives and employees of the Company. The PRSU awards issued during the six months ended June 30, 2018 have vested or will vest as follows: (a) 10/55 shall be earned and time vest on achievement of European Medicines Agency, or EMA, filing preliminary validation, (b) 20/55 shall be earned and time vest on achievement of EMA approval, and (c) 25/55 shall be earned on achievement of the launch of Omadacycline in the U.S. and time vest on the date that is 15 months following such launch date.

The Company recognizes the compensation cost of awards subject to performance-based vesting conditions over the requisite service period, to the extent achievement of the performance condition is deemed probable relative to targeted performance using the accelerated attribution method. If achievement of the performance condition is not probable, but the award will vest based on the service condition, the Company recognizes the expense over the requisite service period. A change in the requisite service period that does not change the estimate of the total compensation cost (i.e., it does not affect the grant-date fair value or quantity of awards to be recognized) is recognized prospectively over the remaining requisite service period. Since the Company believes it is probable that milestone (a) above will be achieved, the Company recognized compensation cost, for a total of $0.7 million for the performance condition during the six months ended June 30, 2018 using the accelerated attribution method.

The Company’s Board of Directors adopted the Paratek Pharmaceuticals, Inc. 2015 Inducement Plan, or the 2015 Inducement Plan, in accordance with Nasdaq Rule 5635(c)(4), reserving 360,000 shares of common stock solely for the grant of inducement stock options to employees entering into employment or returning to employment after a bona fide period of non-employment with the Company. The Company has not made any grants under the 2015 Inducement Plan since December 31, 2015. Although the Company does not currently anticipate the issuance of additional grants under the 2015 Inducement Plan, as of June 30, 2018, 106,500 shares remain available for grant under that plan, as well as any shares underlying outstanding stock options that may become available for grant pursuant to the plan’s terms. It is therefore possible that the Company may, based on the business and recruiting needs of the Company, issue additional stock options under the 2015 Inducement Plan. 

In June 2017, the Company’s Board of Directors adopted the Paratek Pharmaceuticals, Inc. 2017 Inducement Plan, or the 2017 Inducement Plan, in accordance with Nasdaq Rule 5635(c)(4), reserving 550,000 shares of common stock solely for the grant of inducement stock options and RSU awards to employees entering into employment or returning to employment after a bona fide period of non-employment with the Company. During the six months ended June 30, 2018, the Company’s Board of Directors granted 139,150 stock options and 53,700 RSUs to employees of the Company under the 2017 Inducement Plan. The stock option awards are subject to time-based vesting over a period of one to four years. The RSU awards are subject to time-based vesting, with 100% of the shares of common stock subject to the RSU award vesting three years from the grant date. As of June 30, 2018, 101,150 shares remain available for grant under the 2017 Inducement Plan, as well as any shares underlying awards that may become available for grant pursuant to the plan’s terms.  

Stock options

 

A summary of stock option activity for the six months ended June 30, 2018 is as follows:

 

 

 

Number

of Shares

 

 

Weighted

Average

Exercise

Price

 

 

Weighted

Average

Remaining

Contractual

Term

(in years)

 

 

Aggregate

Intrinsic

Value

(in thousands)

 

Outstanding at December 31, 2017

 

 

3,608,907

 

 

$

17.01

 

 

 

7.78

 

 

$

13,311

 

Granted

 

 

199,950

 

 

 

13.87

 

 

 

 

 

 

 

 

 

Exercised

 

 

(28,699

)

 

 

6.15

 

 

 

 

 

 

 

 

 

Cancelled or forfeited

 

 

(26,191

)

 

 

18.08

 

 

 

 

 

 

 

 

 

Expired

 

 

(40,000

)

 

 

29.80

 

 

 

 

 

 

 

 

 

Outstanding at June 30, 2018

 

 

3,713,967

 

 

$

16.78

 

 

 

7.42

 

 

$

3,745

 

Exercisable at June 30, 2018

 

 

2,519,732

 

 

$

16.47

 

 

 

6.93

 

 

$

3,545

 

 

 

18


 

Restricted Stock Units

A summary of RSU activity for the six months ended June 30, 2018 is as follows: 

 

 

 

Number

of Shares

 

 

Weighted

Average

Grant Date

Fair Value

 

Unvested Balance at December 31, 2017

 

 

1,167,703

 

 

$

18.43

 

Granted

 

 

1,208,070

 

 

 

14.21

 

Released

 

 

(443,499

)

 

 

19.54

 

Forfeited

 

 

(7,500

)

 

 

15.10

 

Unvested Balance at June 30, 2018

 

 

1,924,774

 

 

$

15.54

 

 

Total unrecognized compensation expense for all stock-based awards was $22.6 million as of June 30, 2018. This amount will be recognized over a weighted average period of 2.10 years.

 

2018 Employee Stock Purchase Plan  

The Company’s board of directors adopted, and in June 2018 Company’s stockholders approved, the 2018 employee stock purchase plan, or the 2018 ESPP. The maximum aggregate number of shares of our common stock that may be purchased under the 2018 ESPP will be 943,294 shares, or the ESPP Share Pool, subject to adjustment as provided for in the 2018 ESPP.  The ESPP Share Pool represented 3% of the total number of shares of our common stock outstanding as of March 31, 2018 . The 2018 ESPP allows eligible employees to purchase shares during certain offering periods, which will be six   -month periods commencing May 15 and ending November 14 and commencing November 15 and ending May 14 of each year.   The first offering under the 2018 ESPP is November 14, 2018.

 

 

13.   Debt

 

Loan Agreement

 

On September 30, 2015, the Company entered into the Hercules Loan Agreement with Hercules and certain other lenders, and Hercules Technology Growth Capital, Inc. (as agent).  Under the Hercules Loan Agreement, Hercules provided the Company with access to term loans with an aggregate principal amount of up to $40.0 million, or collectively, the Term Loan. The Company initially drew a principal amount of $20.0 million, which was funded on September 30, 2015. The remaining $20.0 million under the Hercules Loan Agreement was available to be drawn at the Company’s option in minimum increments of $10.0 million through December 31, 2016, or the Draw Period. The Term Loan was repayable in monthly installments commencing on April 1, 2018 through maturity on September 1, 2020. The interest rate was equal to the greater of (i) 8.5%, or (ii) the sum of 8.5%, plus the “prime rate” as reported in The Wall Street Journal minus 5.75% per annum. An end of term charge equal to 4.5% of the issued principal balance of the Term Loan was payable at maturity, including in the event of any prepayment, and was being accrued as interest expense over the term of the loan using the effective interest method. Borrowings under the Hercules Loan Agreement were collateralized by substantially all of the assets of the Company.

Upon an Event of Default, an additional 5.0% interest would be applied and Hercules could, at its option, accelerate and demand payment of all or any part of the loan together with the prepayment and end of term charges. An Event of Default is defined in the Hercules Loan Agreement as (i) failure to make required payments; (ii) failure to adhere to financial, operating and reporting loan covenants; (iii) an event or development occurs that would be reasonably expected to have a material adverse effect; (iv) false representations in the Hercules Loan Agreement; (v) insolvency, as described in the Hercules Loan Agreement; (vi) levy or attachments on any of the Company's assets; and (vii) default of any other agreement or subordinated debt greater than $1.0 million. In the event of insolvency, this acceleration and declaration would be automatic. In addition, in connection with the Hercules Loan Agreement, the Company agreed to provide Hercules with a contingent security interest in the Company's bank accounts. The Company's control of its bank accounts is not adversely affected unless Hercules elects to obtain unilateral control of the Company's bank accounts by declaring that an Event of Default has occurred. The principal of the Term Loan which was not due within 12 months of June 30, 2018 has been classified as long-term debt as the Company determined that a material adverse effect resulting in Hercules exercising its rights under the subjective acceleration clause is remote.

Subject to certain terms, pursuant to the Hercules Loan Agreement, Hercules was also granted the right to participate in an amount of up to $2.0 million in subsequent sales and issuances of the Company's equity securities to one or more investors for cash for financing purposes in an offering that is broadly marketed to multiple investors and at the same terms as the other investors. On September 30, 2015, Hercules Technology Growth Capital, Inc. entered into a Stock Purchase Agreement with the Company to purchase 44,782 shares of common stock resulting in proceeds to the Company of approximately $1.0 million.  The excess of proceeds received by the Company over the fair value of the common stock issued was allocated as a reduction of the fees paid to Hercules in conjunction with obtaining the initial $20.0 million draw of the Term Loan.

 

19


 

Debt issuance costs of $511,000 were ratably allocated to the initial $20.0 million draw and the remaining unfunded $20.0 million. Debt issuance costs related to the initial $20.0 million draw were presented on the consolida ted balance sheet as a direct deduction from the related debt liability. Issuance costs related to the unfunded amount were capitalized as prepaid asset and were to be amortized ratably through the end of the Draw Period.  

In connection with the Hercules Loan Agreement, the Company issued to each of Hercules Technology II, L.P. and Hercules Technology III, L.P., a warrant to purchase 16,346 shares of the Company’s common stock (32,692 shares of common stock in total) at an exercise price of $24.47 per share. The Hercules Warrants’ total relative fair value of $288,000 at September 30, 2015 was determined using a Black-Scholes option-pricing model. The relative fair value of the Hercules Warrants was included as a discount to the Term Loan and also as a component of additional paid-in capital.  See Note 9, Capital Stock , for further description of the Hercules Warrants.

In addition to the Hercules Warrants, the Company paid fees to Hercules in conjunction with obtaining the Term Loan. The Hercules Warrants fair value and fees paid to Hercules, an aggregate of $572,000, were ratably allocated to the initial $20.0 million draw and the remaining unfunded $20.0 million. The $208,000 of costs allocated to the initial $20.0 million draw were recorded as a debt discount and are being amortized as additional interest expense over the term of the loan using the effective interest method. The $364,000 of costs allocated to the unfunded $20.0 million was recorded as prepaid expenses and were being amortized ratably through the end of the Draw Period. In the event the Company exercised its option to borrow additional funds, the remaining unamortized prepaid asset balance related would be reclassified and recorded as debt discount based upon a ratable allocation of the amount drawn compared to the remaining unfunded amount available to the Company and would amortize over the remaining life of the term loan using the effective interest method.

On December 12, 2016, the Company and Hercules entered into a second amendment to the Hercules Loan Agreement, or the Second Amendment, which extended the date on which the Company must begin making amortization payments under the Hercules Loan Agreement from April 1, 2018 to January 1, 2019, or the Amortization Date. Upon commencement of the Amortization Date, the Company will make amortization payments based upon an amortization schedule equal to thirty consecutive months, with the balance of outstanding loans due on the original maturity date of the Hercules Loan Agreement.  The Second Amendment also increased the amount that the Company may borrow by $10.0 million, from up to $40.0 million to up to $50.0 million in multiple tranches. In connection with the Second Amendment the Company paid Hercules a $0.4 million amendment fee. In connection with the Second Amendment, the Company issued to each one of Hercules Technology II, L.P. and Hercules Technology III, L.P. a warrant to purchase 18,574 shares of its common stock (37,148 shares of common stock in total) at an exercise price of $13.46 per share.

Under the Second Amendment the end of term charge was equal to 4.5% of the issued principal balance of the Hercules Loan Agreement, and was payable at maturity, including in the event of any prepayment, and is being accrued as interest expense over the term of the loan using the effective interest method. Borrowings under the Hercules Loan Agreement are still collateralized by substantially all of the assets of the Company.

On June 27, 2017, the Company and Hercules entered into a third amendment to the Hercules Loan Agreement, or the Third Amendment. The Third Amendment increased the amount that the Company may borrow by $10.0 million, from up to $50.0 million to up to $60.0 million, in multiple tranches. The additional $10.0 million tranche, or the Fourth Tranche, was available at the Company’s option through December 15, 2017. The Fourth Tranche shall bear interest and have the same maturity as all other loans outstanding under the Hercules Loan Agreement, as amended. 

The Company borrowed the first tranche of $20.0 million upon the closing of the Hercules Loan Agreement on September 30, 2015, and the second tranche of $20.0 million on December 12, 2016, or collectively, the Initial Tranches.  Concurrently with the closing of the Third Amendment, the Company borrowed a third tranche of $10.0 million, or the Third Tranche.  The Third Amendment extended the date on which the Company is required to begin making monthly principal installments under the Hercules Loan Agreement from January 1, 2019 to January 1, 2020, subject to the Company’s receipt of marketing approval for the Company’s lead product candidate, omadacycline, or the Interest Only Period Extension Event.  Beginning on January 1, 2019, or, if the Company achieves the Interest Only Period Extension Event, beginning on January 1, 2020, the Company is obligated to make payments in equal monthly installments of principal and interest, with the balance of outstanding loans due on the original maturity date of the Hercules Loan Agreement. In connection with the Third Amendment, the Company paid Hercules a $0.1 million amendment fee. 

The Third Amendment reduced the end of term charge due with respect to the Third Tranche from to 4.5% to 2.25% if the obligations under the Hercules Loan Agreement were repaid in full on or prior to September 30, 2017, following Hercules’ election not to consent to a proposed third-party, non-equity financing arrangement (excluding any stock issuance).  The end of term charge with respect to the Fourth Tranche is 2.25%.

 

20


 

In connection with the borrowing of the Third Tranche, on June 27, 2017, the Company issued an additional warrant to Hercules Capital, Inc. that is exercisable for a n aggregate of 5,374 shares of common stock at an exercise price of $23.26 per share. The Additional Warrant may be exercised on a cashless basis. The Additional Warrant is exercisable for a term beginning on the date of issuance and ending on the earlier to occur of five years from the date of issuance or the consummation of certain acquisitions of the Company as set forth in the Additional Warrant.

In connection with the offering of the Notes, discussed below, on April 17, 2018, the Company entered into a fourth amendment to the Hercules Loan Agreement, or the Fourth Amendment. The Fourth Amendment increases the amount of permitted indebtedness to an amount not to exceed $2.0 million and permits the Company to issue convertible notes in an aggregate principal amount of not more than $172.5 million provided that such convertible notes meet certain stipulations.

On August 1, 2018, the Company and Hercules entered into a fifth amendment to the Hercules Loan Agreement, or the Fifth Amendment. The Fifth Amendment increased the amount that the Company may borrow by $30.0 million, from up to $60.0 million to up to $90.0 million, in multiple tranches. 

Concurrently with the closing of the Fifth Amendment, the Company borrowed a fifth tranche of $10.0 million, or the Fifth Tranche.  Two additional tranches of up to $10.0 million each ($20.0 million total), or the Additional Tranches, may be available to the Company, subject to determination by Hercules, in its sole discretion, whether to provide such tranches. As such there can be no assurance as to whether or not the Additional Tranches shall be funded.  The Fifth Amendment extended the date on which the Company is required to begin making monthly principal installments on loans previously outstanding under the Hercules Loan Agreement, or the Prior Tranches, from January 1, 2019 to January 1, 2021, subject to the Company’s receipt of marketing approval for the Company’s lead product candidate, omadacycline, or the Interest Only Period Extension Event.  Beginning on January 1, 2019, or, if the Company achieves the Interest Only Period Extension Event, beginning on January 1, 2021, the Company is obligated to make payments in equal monthly installments of principal and interest with respect to the Prior Tranches, with the balance of outstanding amounts under the Prior Tranches due on the maturity date of September 1, 2020, but which the Fifth Amendment extends to September 1, 2021 if the Company achieves the Interest Only Period Extension Event . In connection with the Fifth Amendment, the Company paid Hercules a $0.1 million amendment fee. 

The Fifth Tranche is repayable in monthly installments commencing on September 1, 2020 (or March 1, 2021 or September 1, 2021, if certain revenue milestones are satisfied by the Company) through maturity on August 1, 2022. The interest rate with respect to the Fifth Tranche is a floating per annum rate equal to the greater of (i) 7.85%, or (ii) the sum of 7.85%, plus the “prime rate” as reported in The Wall Street Journal minus 5.75%. An end of term charge equal to 6.95% of the issued principal balance of the Fifth Tranche will be payable at maturity, including in the event of any prepayment, and will be accrued as interest expense over the term of the Fifth Tranche using the effective interest method.

The Fifth Amendment amended the prepayment charges applicable to all loans outstanding under the Hercules Loan Agreement, such that prepayment fees equaling 1% to 2.5% will apply to principal amounts prepaid prior to dates between January 1, 2019 and January 1, 2020, varying depending on the applicable tranche and whether the Interest Only Period Extension Event has occurred.

In connection with the borrowing of the Fifth Tranche, on August 1, 2018, the Company issued an additional warrant to Hercules Capital, Inc. that is exercisable for a minimum of up to 19,627 shares of common stock (and additional shares if the Additional Tranches are funded) at an exercise price of $10.19 per share. The Fifth Amendment Warrant may be exercised on a cashless basis. The Fifth Amendment Warrant is exercisable for a term beginning on the date of issuance and ending on the earlier to occur of seven years from the date of issuance or the consummation of certain acquisitions of the Company as set forth in the Fifth Amendment Warrant.

 

The following table summarizes how the issuance of Hercules Loan Agreement, as amended, is reflected in the Company’s consolidated balance sheets at June 30, 2018 and December 31, 2017:

 

 

 

 

 

 

 

June 30,

2018

 

 

December 31, 2017

 

Gross proceeds

 

$

60,000

 

 

$

60,000

 

Unamortized debt issuance costs

 

 

(601

)

 

 

(814

)

Carrying value

 

$

59,399

 

 

$

59,186

 

 

 

21


 

Future principal payments, which exclude the end of term charge in connection with the Hercules Loan Agreement, as amended, as of June 30, 2018, are as follows (in thousands):

 

Fiscal Year

 

 

 

 

2018

 

$

 

2019

 

 

33,140

 

2020

 

 

26,860

 

2021

 

 

 

2022 and Thereafter

 

 

 

Total

 

$

60,000

 

 

Convertible Senior Subordinated Notes

On April 18, 2018, the Company entered into a Purchase Agreement, or the Purchase Agreement, with several initial purchasers, or the Initial Purchasers, for whom  Merrill Lynch, Pierce, Fenner & Smith Incorporated  and Leerink Partners LLC acted as representatives, relating to the sale of $135.0 million aggregate principal amount of 4.75% Convertible Senior Subordinated Notes due 2024, or the Notes, to the Initial Purchasers. The Company also granted the Initial Purchasers an option to purchase up to an additional $25.0 million aggregate principal amount of Notes, which was exercised in full on April 20, 2018.

The Purchase Agreement includes customary representations, warranties and covenants. Under the terms of the Purchase Agreement, the Company has agreed to indemnify the Initial Purchasers against certain liabilities.

In addition, J. Wood Capital Advisors LLC, the Company’s financial advisor, purchased $5.0 million aggregate principal amount of Notes in a separate, concurrent private placement on the same terms as other investors.

The Notes were issued by the Company on April 23, 2018, pursuant to an Indenture, dated as of such date, or the Indenture, between the Company and U.S. Bank National Association, as trustee, or the Trustee. The Notes bear cash interest at the annual rate of 4.75%, payable on November 1 and May 1 of each year, beginning on November 1, 2018, and mature on May 1, 2024 unless earlier repurchased, redeemed or converted.  The Company will settle conversions of the Notes through delivery of shares of common stock of the Company, in accordance with the terms of the Indenture. The initial conversion rate for the Notes is 62.8931 shares of common stock (subject to adjustment as provided for in the Indenture) per $1,000 principal amount of the Notes, which is equal to an initial conversion price of approximately $15.90 per share, representing a conversion premium of approximately 20% above the closing price of the common stock of $13.25 per share on April 18, 2018.

Holders of the Notes may convert all or any portion of their Notes, in multiples of $1,000 principal amount, at their option at any time prior to the close of business on the second scheduled trading day immediately preceding the stated maturity date.

The Company may not redeem the Notes prior to May 6, 2021. The Company may redeem for cash all or part of the Notes, at its option, on or after May 6, 2021 if the last reported sale price of the Company’s common stock has been at least 130% of the conversion price then in effect for at least 20 trading days (whether or not consecutive) during any 30 consecutive trading day period (including the last trading day of such period) ending on, and including, the trading day immediately preceding the date on which the Company provides notice of redemption at a redemption price equal to 100% of the principal amount of the Notes to be redeemed, plus accrued and unpaid interest to, but excluding, the redemption date.

If the Company experiences a fundamental change, as described in the Indenture, prior to the maturity date of the Notes, holders of the Notes will, subject to specified conditions, have the right, at their option, to require the Company to repurchase for cash all or a portion of their Notes at a repurchase price equal to 100% of the principal amount of the Notes to be repurchased, plus accrued and unpaid interest, if any, to, but not including, the fundamental change repurchase date. In addition, following certain corporate events that occur prior to the maturity date of the Notes and following a notice of redemption of the notes, the Company will increase the conversion rate for a holder who elects to convert its Notes in connection with such corporate event or redemption.

The Indenture provides for customary events of default. In the case of an event of default with respect to the Notes arising from specified events of bankruptcy or insolvency, all outstanding Notes will become due and payable immediately without further action or notice. If any other event of default with respect to the Notes under the Indenture occurs or is continuing, the Trustee or holders of at least 25% in aggregate principal amount of the then outstanding Notes may declare the principal amount of the Notes to be immediately due and payable.

 

22


 

In certain circumstances if, at any time during the six-month period beginning on, and including, the date that is six months after the last date of original issuance of the Notes, the Company fails to timely file certain documents or reports required under the Securities Exchange Act of 1934, as amended, o r the Notes are not otherwise freely tradable by holders of the Notes other than the Company’s affiliates or holders that were the Company’s affiliates at any time during the three months immediately preceding, additional interest will accrue on the Notes during the first 90-day period in which its failure to file has occurred and is continuing or such Notes are not otherwise freely tradable by holders other than the Company’s affiliates (or holders that were the Company’s affiliates at any time during the three months immediately preceding).

In addition, if, and for so long as, the restrictive legend on the Notes has not been removed, the Notes are assigned a restricted CUSIP number or the Notes are not otherwise freely tradable by holders other than the Company’s affiliates or holders that were our affiliates at any time during the three months immediately preceding (without restrictions pursuant to U.S. securities laws or the terms of the Indenture or the Notes) as of the 380th day after the last date of original issuance of the Notes, the Company will pay additional interest on the Notes outstanding during the period in which the Notes remain so restricted.

After deducting costs incurred of $6.0 million, t he Company raised net proceeds from the issuance of long-term convertible debt of $159.0 million during the three and six months ended June 30, 2018. All costs were deferred and are being amortized over the life of the Notes at an effective interest rate of 5.47% and recorded as additional interest expense.

The Company recognized coupon interest expense of $1.5 million and amortization expense on the debt issuance costs of $0.2 million for the three and six months ended June 30, 2018.

The Company has evaluated the Indenture for derivatives pursuant to ASC 815, Derivatives and Hedging , and identified an embedded derivative that requires bifurcation as the feature is not clearly and closely related to the host instrument. The embedded derivative is a default provision, which could require additional interest payments. The Company has determined that the fair value of this embedded derivative was nominal as of June 30, 2018.

The Company evaluated the conversion feature and determined it was not within the scope of ASC 815 and therefore is not required to be accounted for separately. The Company concluded that the embedded conversion option is not subject to separate accounting pursuant to either the cash conversion guidance or the beneficial conversion feature guidance.  Under the general conversion guidance in ASC 470, Debt, all of the proceeds received from the Notes was recorded as a liability on the condensed consolidated balance sheet.

The following table summarizes how the issuance of the Notes is reflected in the Company’s consolidated balance sheets at June 30, 2018 and December 31, 2017:

 

 

 

 

 

 

 

June 30,

2018

 

 

December 31, 2017

 

Gross proceeds

 

$

165,000

 

 

$

 

Unamortized debt issuance costs

 

 

(5,868

)

 

 

 

Carrying value

 

$

159,132

 

 

$

 

 

Current and non-current debt on the Company’s consolidated balance sheets at June 30, 2018 and December 31, 2017 includes the carrying value of the Hercules Loan Agreement, as amended, and the Notes.

 

14 .    Income Taxes

The Company recorded no provision for income taxes for the three or six months ended June 30, 2018. The Company recorded a provision for income taxes in the three and six months ended June 30, 2017 of $0.8 million. The provision for income taxes consists of current tax expense, which represents China withholding taxes on the upfront payment earned under the Zai Collaboration Agreement.

Deferred tax assets and deferred tax liabilities are recognized based on temporary differences between the financial reporting and tax bases of assets and liabilities using statutory rates. Management of the Company has evaluated the positive and negative evidence bearing upon the realizability of its deferred tax assets, which are comprised principally of net operating loss carryforwards and research and development credits. Under the applicable accounting standards, management has considered the Company’s history of losses and concluded that it is more likely than not that the Company will not recognize the benefits of federal and state deferred tax assets. Accordingly, a full valuation allowance has been established against the Company’s otherwise recognizable net deferred tax assets.  

 

23


 

On December 22, 2017, the new tax reform law, which is commonly referred to as the T ax Cuts and Jobs Act, or the Act, was signed into law by President Trump. The Act includes a number of provisions, including the lowering of the U.S. corporate tax rate from 35 percent to 21 percent, effective January 1, 2018 and the establishment of a ter ritorial-style system for taxing foreign-source income of domestic multinational corporations. The Company is in the process of quantifying the tax impacts of the Act. Due to the Company's full valuation allowance, no provisional tax expense or benefit ass ociated with the re-measurement was recognized in the Company's consolidated statement of operations and comprehensive loss for the three and six months ended June 30, 2018.

The Company has recognized the provisional tax impacts related to the revaluation of the deferred tax assets and liabilities and included these amounts in its consolidated financial statements for the year ended December 31, 2017.

On December 22, 2017, the SEC staff issued SAB 118 to address the application of GAAP in situations when a registrant does not have the necessary information available, prepared or analyzed (including computations) in reasonable detail to complete the accounting for certain income tax effects of the Act. The Company has recognized the provisional tax impacts related to the revaluation of the deferred tax assets and liabilities and included these amounts in its consolidated financial statements for the year ended December 31, 2017. The ultimate impact may differ from these provisional amounts due to, among other things, additional analysis, changes in interpretations and assumptions the Company has made, additional regulatory guidance that may be issued, and actions the Company may take as a result of the Act, which could result in changes to the provisional tax impacts during 2018.

 

 

15.   Commitments and Contingencies

 

There have been no material changes to the Company’s contractual obligations and commitments reported in its Annual Report on Form 10-K for the year ended December 31, 2017, as filed with the SEC on March 6, 2018, with the exception of the CIPAN Agreement discussed below.

 

CIPAN Agreement

On April 18, 2018, the Company and CIPAN-Companhia Industrial Produtora de Antibioticos, S.A., or CIPAN, entered into an Amended and Restated Manufacturing and Services Agreement, or the CIPAN Agreement, which provides the terms and conditions under which CIPAN will manufacture and supply to the Company minocycline starting material and crude omadacycline. Pursuant to the CIPAN Agreement, the Company agreed to pay CIPAN certain amounts in connection with CIPAN’s renovation of an existing manufacturing area.

The Company’s total commitment under the CIPAN Agreement is in the low seven-digit U.S. Dollar range, subject to fulfillment by CIPAN of particular milestones in connection with CIPAN’s renovation of an existing manufacturing area. The Company paid the first milestone in the high six-digit U.S. Dollar range during the quarter ended June 30, 2018. CIPAN achieved the second milestone in the mid six-digit U.S. Dollar range, which became due subsequent to the quarter ended June 30, 2018. The remaining milestone payments are owed to CIPAN upon fulfillment by CIPAN of future milestone events.

 

Leases

The Company leases its Boston, Massachusetts and King of Prussia, Pennsylvania office spaces under non-cancelable operating leases expiring in 2021 and 2024, respectively.

 

As of June 30, 2018, future minimum lease payments under operating leases are as follows:

 

Fiscal Year

 

 

 

 

Remainder of 2018

 

$

579

 

2019

 

 

1,156

 

2020

 

 

1,178

 

2021

 

 

964

 

2022

 

 

508

 

2023 and Thereafter

 

 

914

 

Total

 

$

5,299

 

 

24


 

Other Legal Proceedings

In the ordinary course of business, the Company is from time to time involved in lawsuits, claims, investigations, proceedings, and threats of litigation relating to intellectual property, commercial arrangements, employment and other matters. While the outcome of these proceedings and claims cannot be predicted with certainty, as of June 30, 2018, the Company was not party to any other legal or arbitration proceedings that may have, or have had in the recent past, significant effects on the Company’s financial position. No governmental proceedings are pending or, to the Company’s knowledge, contemplated against the Company. The Company is not a party to any material proceedings in which any director, member of executive management or affiliate of the Company is either a party adverse to the Company or the Company’s subsidiaries or has a material interest adverse to the Company or the Company’s subsidiaries.

 

 

16.   Recent Accounting Pronouncements

From time to time, new accounting pronouncements are issued by the FASB or other standard setting bodies and adopted by the Company as of the specified effective date. Unless otherwise discussed, the Company believes that the impact of recently issued standards that are not yet effective will not have a material impact on its financial position or results of operations upon adoption.

In February 2016, the FASB issued ASU No. 2016-02, Leases (Topic 842) . The amendment requires a lessee to recognize assets and liabilities for leases with a maximum possible term of more than 12 months. A lessee would recognize a liability to make lease payments (the lease liability) and a right-of-use asset representing its right to use the leased asset (the underlying asset) for the lease term. This ASU is effective for fiscal years and interim periods beginning after December 15, 2018. The Company is in the process of reviewing its portfolio of existing leases and current accounting policies to identify and assess the potential differences that would result from applying the requirements of the new standard. The Company anticipates that the amended guidance will result in the recognition of additional right-of-use assets and corresponding liabilities on its condensed consolidated balance sheets.

In October 2016, the FASB issued ASU No. 2016-16, Intra-Entity Transfers of Assets Other Than Inventory , or ASU 2016-16. The amendments in ASU 2016-16 require an entity to recognize the income tax consequences of intra-entity transfers of assets other than inventory at the time that the transfer occurs. Current guidance does not require recognition of tax consequences until the asset is eventually sold to a third party. ASU 2016-16 is effective for fiscal years, and interim periods beginning after December 15, 2017. Early adoption is permitted as of the first interim period presented in a year. A reporting entity must apply the amendments in ASU 2016-16 using a modified retrospective approach by recording a cumulative-effect adjustment to equity as of the beginning of the fiscal year of adoption. The Company adopted this standard on January 1, 2018 and such adoption did not have a material impact on the Company’s consolidated financial statements.

In January 2017, the FASB issued ASU No. 2017-04, Simplifying the Test for Goodwill Impairment , or ASU 2017-04. The amendments in ASU 2017-04 eliminate the current two-step approach used to test goodwill for impairment and require an entity to apply a one-step quantitative test and record the amount of goodwill impairment as the excess of a reporting unit's carrying amount over its fair value, not to exceed the total amount of goodwill allocated to the reporting unit. ASU 2017-04 is effective for fiscal years and interim periods beginning after December 15, 2019 (upon the first goodwill impairment test performed during that fiscal year). Early adoption is permitted for interim or annual goodwill impairment tests performed on testing dates after January 1, 2017. A reporting entity must apply the amendments in ASU 2017-04 using a prospective approach. The Company does not expect the adoption of ASU 2017-04 to have a material impact to its consolidated financial position or results of operations.

In May 2017, the FASB issued ASU 2017-09,  Compensation – Stock Compensation  (Topic 718): Scope Modification Accounting .  This standard is intended to reduce the diversity in practice and cost and complexity when applying the guidance in Topic 718 to a change to the terms or conditions of a share-based payment award.  In June 2018, the FASB issued Update 2018-07— Compensation—Stock Compensation (Topic 718): Improvements to Nonemployee Share-Based Payment Accounting, or ASC 2018-07 . A SU 2018-07 simplifies the accounting for share-based payments to non-employees by aligning it with the accounting for share-based payments to employees, with certain exceptions. The new standards will be effective beginning January 1, 2019.  The adoption of these standards is not expected to have a material impact on the Company’s consolidated financial position or results of operations upon adoption.

 

 

25


 

Item 2.

Management’s Discussion and Analysis of Financial Condition and Results of Operations

You should read the following discussion and analysis of our financial condition and results of operations in conjunction with our unaudited condensed consolidated financial statements and related notes included in Part I, Item 1 of this Quarterly Report on Form 10-Q. All references to “Paratek,” “we,” “us,” “our” or the “Company” in this Quarterly Report on Form 10-Q mean Paratek Pharmaceuticals, Inc. and our subsidiaries.

This discussion contains certain forward-looking statements that involve risks and uncertainties. We make such forward-looking statements pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and other federal securities laws. Forward-looking statements are identified by words such as “believe,” “will,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “expect,” “predict,” “could,” “potentially” or the negative of these terms or similar expressions. You should read these statements carefully because they discuss future expectations, contain projections of future results of operations or financial condition, or state other “forward- looking” information. These statements relate to our future plans, objectives, expectations, intentions and financial performance and the assumptions that underlie these statements. These forward-looking statements are subject to certain risks and uncertainties that could cause actual results to differ materially from those anticipated in the forward-looking statements. Factors that might cause such a difference include, but are not limited to, those discussed in the “Risk Factors” section of our Annual Report on Form 10-K for the year ended December 31, 2017, as filed with the Securities and Exchange Commission, or the SEC, on March 6, 2018, the “Risk Factors” section of the Quarterly Report on Form 10-Q for the quarter ended March 31, 2018, as filed with the SEC on May 8, 2018, and in this Quarterly Report on Form 10-Q. Forward-looking statements are based on our management’s beliefs and assumptions and on information currently available to our management. These statements, like all statements in this report, speak only as of their date, and except as required by law, we undertake no obligation to update or revise these statements in light of future developments. We caution investors that our business and financial performance are subject to substantial risks and uncertainties.

Company Overview

We are a clinical stage biopharmaceutical company focused on the development and commercialization of innovative therapeutics based upon tetracycline chemistry.  We have used our expertise in biology and tetracycline chemistry to create chemically diverse and biologically distinct small molecules derived from the minocycline core structure. We have generated innovative small molecule therapeutic candidates based upon medicinal chemistry-based modifications, according to structure-based activity, of all positions of the core tetracycline molecule. These efforts have yielded molecules with broad-spectrum antibiotic properties and narrow-spectrum antibiotic properties, and molecules with potent anti-inflammatory properties to fit specific therapeutic applications. This proprietary chemistry platform has produced many compounds that have shown interesting characteristics in various  in vitro  and  in vivo  efficacy models. Omadacycline and sarecycline are examples of molecules that were synthesized from this chemistry discovery platform. Our two lead product candidates are the antibacterials omadacycline and sarecycline.

If approved, omadacycline will be the first in a new class of aminomethylcycline antibiotics. Omadacycline is a broad-spectrum, well-tolerated, once-daily oral and intravenous, or IV, antibiotic. We believe that omadacycline has the potential to become the primary antibiotic choice of physicians for use as a broad-spectrum monotherapy antibiotic for acute bacterial skin and skin structure infections, or ABSSSI, community-acquired bacterial pneumonia, or CABP, urinary tract infection, or UTI, and other serious community-acquired bacterial infections where resistance is of concern. We believe omadacycline, if approved, will be used in the emergency room, hospital and community care settings. We have designed omadacycline to provide potential advantages over existing antibiotics, including activity against resistant bacteria, broad-spectrum antibacterial activity, oral and IV formulations with once-daily dosing, no dosing adjustments for patients on concomitant medications, and a generally safe and well-tolerated profile.

In the fall of 2013, the U.S. Food and Drug Administration, or the FDA, agreed to the design of our omadacycline Phase 3 studies for ABSSSI and CABP through the Special Protocol Assessment, or SPA, process. In addition, the FDA confirmed that positive data from the individual studies for ABSSSI and CABP would be sufficient to support approval of omadacycline for each indication and for both oral and IV formulations in the United States, or the U.S.  In addition to Qualified Infectious Disease Product, or QIDP, designation, on November 4, 2015, the FDA granted Fast Track designation for the development of omadacycline in ABSSSI, CABP, and complicated urinary tract infection, or cUTI. Fast Track designation facilitates the development and expedites the review of drugs that treat serious or life-threatening conditions and that fill an unmet medical need. In February 2016, we reached agreement with the FDA on the terms of the omadacycline pediatric program associated with the Pediatric Research Equity Act. The FDA has granted Paratek a waiver for conducting studies with omadacycline in children less than eight years old due to the risk of teeth discoloration, a known class effect of tetracyclines.  In addition, the FDA has granted a deferral on conducting studies in children eight years and older until safety and efficacy is established in adults. In May 2016, we received confirmation from the FDA that the oral-only ABSSSI study design was acceptable and consistent with the currently posted guidance for the industry.  In September 2017, both the oral and IV formations of omadacycline were granted an additional QIDP designation by the FDA for the treatment of uncomplicated urinary tract infection, or uUTI.

 

26


 

Scientific advice received thr ough the centralized procedure in Europe confirmed general agreement on the design and choice of comparators of the Phase 3 clinical trials for ABSSSI and CABP and noted that approval based on a single study in each indication could be possible but would b e subject to more stringent statistical standards than Market Authorization Applications, or MAA, programs that conduct two pivotal Phase 3 studies per indication. We believe that the inclusion of the second Phase 3 oral-only study in ABSSSI strengthens th e data package for submission of an MAA filing for approval in the European Union, or the EU. In the second quarter of 2018, we held pre-submission meetings with the European Medicines Agency, or the EMA, our assigned Rapporteur, and our assigned Co-Rappor teur.  The outcomes of these meetings further support our planned MAA submission in the second half of 2018.

To date, we have conducted more than 20 Phase 1 studies of omadacycline to characterize the effects of the drug on humans including how it is absorbed, metabolized, and excreted. These Phase 1 studies also included evaluation in special populations like hepatic and renal failure patients.  We have also conducted and completed three successful Phase 3 clinical studies. Our first two Phase 3 clinical studies were for the treatment of ABSSSI (OASIS-1) and CABP (OPTIC).  Both studies utilized initiation of IV therapy with transitions to oral-therapy based upon clinical response. Our third Phase 3 clinical study (OASIS-2) was an oral-only administration of omadacycline in ABSSSI compared to oral-only linezolid. All three Phase 3 clinical studies resulted in omadacycline demonstrating positive efficacy results and a generally safe and well tolerated profile. Omadacycline met all required FDA and EMA, primary endpoints in each study and demonstrated a generally safe and well-tolerated profile. We included these pivotal phase 3 clinical data in our New Drug Application, or NDA, submissions to the FDA completed in February 2018 for our once-daily oral and IV formulations of omadacycline for the treatment of ABSSSI and CABP. We intend to include these clinical data in the MAA submission to the EMA, which we plan to submit in the second half of 2018.

In April 2018, the FDA accepted our NDAs. In the NDA acceptance letter, the FDA stated that no filing or potential review issues were identified.  NDA acceptance starts the final review period of our applications and sets the final Prescription Drug User Fee Act, or PDUFA, action date.  Since we received priority review designation, our PDUFA action date is expected to occur in early October 2018. As part of the NDA review process, the FDA is planning to hold an advisory committee meeting to review these applications on August 8, 2018.

We have initiated sites for the first of our two planned Phase 2 clinical trials evaluating omadacycline for the treatment of UTI. The first study will evaluate the efficacy, safety, tolerability and pharmacokinetics of omadacycline in female patients with cystitis, a common uUTI. The second study, which we plan to initiate in the second half of 2018, will evaluate the efficacy, safety, tolerability and pharmacokinetics of omadacycline in patients with acute pyelonephritis, a common cUTI. We plan to enroll approximately 200 patients in each study at multiple sites. The results of the Phase 2 UTI program are expected in the second half of 2019.  

In October 2016, we announced that Paratek entered into a Cooperative Research and Development Agreement with the U.S. Army Medical Research Institute of Infectious Diseases to study omadacycline against pathogenic agents causing infectious diseases of public health and biodefense importance. These studies are designed to confirm humanized dosing regimens of omadacycline in order to study the efficacy of omadacycline against biodefense pathogens, including Yersinia pestis, or plague, and Bacillus anthracis, or anthrax. Funding support for the trial has been made available through the Defense Threat Reduction Agency, or DTRA/ Joint Science and Technology Office and Joint Program Executive Office for Chemical and Biological Defense / Joint Project Manager Medical Countermeasure Systems / BioDefense Therapeutics.

During the third quarter of 2018, we anticipate the onboarding of our sales force leadership team.  We expect to start hiring our hospital representatives in the fourth quarter of 2018, and will continue through 2019, toward our target of 80 to 85 hospital  representatives, which we believe is sufficient to address key U.S. hospital accounts. 

Our second antibacterial product candidate, sarecycline, also known as Seysara™ in the U.S. is a new, once-daily, tetracycline-derived compound designed for use in the treatment of acne and rosacea. We believe that, based upon the data generated to-date, sarecycline possesses favorable anti-inflammatory activity, plus narrow-spectrum antibacterial activity relative to other tetracycline-derived molecules, oral bioavailability, does not cross the blood-brain barrier, and favorable pharmacokinetic properties that we believe make it particularly well-suited for the treatment of inflammatory acne in the community setting. We have exclusively licensed U.S. development and commercialization rights to sarecycline for the treatment of acne to Allergan plc, or Allergan, while retaining development and commercialization rights in the rest of the world.

In March 2017, Allergan announced that two Phase 3 studies of sarecycline for the treatment of moderate to severe acne vulgaris met their 12-week primary efficacy endpoints. In addition, a nine-month long-term safety extension study was completed. The safety results from the long-term study are generally consistent with results from the two 12-week studies. Based on these clinical data, Allergan submitted an NDA to the FDA, which was accepted in December 2017 for the treatment of moderate to severe acne, and we anticipate approval in the second half of 2018.

 

27


 

Allergan currently holds a nonexclusive license to develop and commercialize sarecycline for the treatment of rosacea in the U.S. There are currently no clinical trials with sarecycline in rosacea underway.

To date, we have devoted a substantial amount of our resources to research and development efforts, including conducting clinical trials for omadacycline, protecting our intellectual property and providing general and administrative support for these operations. We have not yet submitted any other product candidates for approval by regulatory authorities. We do not currently have rights to any products that have been approved for marketing in any territory. We have not generated any revenue from product sales and to date have financed our operations primarily through sale of our common and convertible preferred stock, debt financings, strategic collaborations, and grant funding. 

We have incurred significant losses since our inception in 1996. Our accumulated deficit at June 30, 2018 was $527.6 million and our net loss for the six months ended June 30, 2018 was $57.5 million. A substantial amount of our net losses resulted from costs incurred in connection with our research and development programs and general and administrative costs associated with our operations. The net losses and negative operating cash flows incurred to date, together with expected future losses, have had, and likely will continue to have, an adverse effect on our stockholders’ equity and working capital. The amount of future net losses will depend, in part, on the rate of future growth of our expenses and our ability to generate offsetting revenue, if any. We expect to continue to incur significant expenses and operating losses for the foreseeable future.

We do not expect to generate revenue from product sales unless and until we or either of our partners, Allergan or Zai Lab (Shanghai) Co., Ltd., or Zai, obtain marketing approval for and commercialize one or more of our product candidates. Accordingly, we anticipate that we will need to raise additional capital in order to complete the development and commercialization of omadacycline and to advance the development of our other product candidates. Until we can generate a sufficient amount of product revenue to finance our cash requirements, we expect to finance our future cash needs primarily through a combination of public or private equity offerings, debt or other structured financings, strategic collaborations and grant funding. We may be unable to raise capital when needed or on attractive terms, which would force us to delay, limit, reduce or terminate our development programs or commercialization efforts. We will need to generate significant revenue to achieve and sustain profitability, and we may never be able to do so.

Recent Financing Activities

In October 2015 and February 2017, we. entered into Controlled Equity Offering SM Sales Agreements, or the 2015 Sales Agreement and 2017 Sales Agreement, respectively, and collectively, the Sales Agreements, with Cantor Fitzgerald & Co., or Cantor, under which we could, at our discretion, from time to time sell shares of our common stock, with a sales value of up to $50 million under each Sales Agreement through Cantor. We provided Cantor with customary indemnification rights, and Cantor was entitled to a commission at a fixed rate of 3% of the gross proceeds per share sold.  Sales of the shares under the Sales Agreements were to be made in transactions deemed to be “at the market offerings”, as defined in Rule 415 under the Securities Act of 1933, as amended, or the Securities Act. We have sold all $50 million of shares of our common stock under the 2015 Sales Agreement. We received $1.8 million in proceeds, after deducting commissions of $0.1 million, from the sale of 96,308 shares of common stock during the six months ended June 30, 2018 under the 2017 Sales Agreement. As of July 31, 2018, $0.8 million remains available for sale under the 2017 Sales Agreement.

On January 22, 2018, we completed an underwritten offering of 3,205,128 shares of our common stock, resulting in total proceeds of $50.0 million. Offering expenses incurred were $0.2 million.

On April 18, 2018, we entered into a Purchase Agreement, or the Purchase Agreement, with several initial purchasers, or the Initial Purchasers, for whom  Merrill Lynch, Pierce, Fenner & Smith Incorporated  and Leerink Partners LLC acted as representatives, relating to the sale of $135.0 million aggregate principal amount of 4.75% Convertible Senior Subordinated Notes due 2024, or the Notes, to the Initial Purchasers. We also granted the Initial Purchasers an option to purchase up to an additional $25.0 million aggregate principal amount of Notes, which was exercised in full on April 20, 2018.  In addition, J. Wood Capital Advisors LLC, the Company’s financial advisor, purchased $5.0 million aggregate principal amount of Notes in a separate, concurrent private placement on the same terms as other investors. After deducting costs incurred of $6.0 million, we raised net proceeds from the sale of the Notes of $159.0 million during the three and six months ended June 30, 2018.

 

28


 

Financial Operations Overview

Revenue

We have not yet generated any revenue from product sales. All of our revenue to date has been derived from license fees, milestone payments, royalty income, reimbursements for research, development and manufacturing activities under licenses and collaborations, grant payments received from the National Institute of Health and other non-profit organizations.  If the FDA approves our NDA for omadacycline on the anticipated timeline, we intend to begin selling omadacycline in the first quarter of 2019.

Collaboration revenue represents upfront fees and milestone payments received in connection with our collaboration agreements. Royalty revenue represents fifty percent of Intermezzo royalty income received pursuant to the royalty sharing agreement, or the Royalty Sharing Agreement, entered into by us in October 2016 with the Special Committee of our Board of Directors.

Research and Development Expense

Research and development expenses consisted primarily of costs directly incurred by us for the development of our product candidates, which include:

 

expenses incurred under agreements with clinical research organizations, or CROs, and investigative sites that conduct our clinical trials;

 

the cost of acquiring and manufacturing preclinical and clinical study materials and developing manufacturing processes;

 

direct employee-related expenses, including salaries, benefits, travel and stock-based compensation expense of our research and development personnel;

 

allocated facilities, depreciation, and other expenses, which include rent and maintenance of facilities, insurance and other supplies; and

 

costs associated with preclinical activities and regulatory compliance.

Research and development costs are expensed as incurred. Costs for certain development activities are recognized based on an evaluation of the progress to completion of specific tasks using information and data provided to us by our vendors and our clinical sites.

We cannot determine with certainty the duration and completion costs of the current or future clinical trials of our product candidates or if, when, or to what extent we will generate revenues from the commercialization and sale of any of our product candidates for which we or any partner obtain regulatory approval. We may never succeed in achieving regulatory approval for any of our product candidates. The duration, costs and timing of clinical trials and development of our product candidates will depend on a variety of factors, including:

 

the scope, rate of progress, and expense of our ongoing, as well as any additional, clinical trials and other research and development activities;

 

future clinical trial results;

 

potential changes in government regulation; and

 

the timing and receipt of any regulatory approvals.

A change in the outcome of any of these variables with respect to the development of a product candidate could mean a significant change in the costs and timing associated with the development of that therapeutic candidate. For example, if the FDA, or another regulatory authority, were to require us to conduct clinical trials beyond those that we currently anticipate will be required for the completion of the clinical development of product candidates, or if we experience significant delays in the enrollment in any clinical trials, we could be required to expend significant additional financial resources and time on the completion of clinical development.

 

29


 

We manage certain activities, such as clinical trial operations, manufacture of clinical trial material, and preclinical animal toxicology studies, through third-party contract organizations. The only costs we track by each product candidate are external c osts such as services provided to us by CROs, manufacturing of preclinical and clinical drug product, and other outsourced research and development expenses. We do not assign or allocate to individual development programs internal costs such as salaries an d benefits, facilities costs, lab supplies and the costs of preclinical research and studies. Our external research and development expenses for omadacycline and other projects during the three and six months ended June 30, 2018 and 2017 are as follows (in thousands):  

 

 

 

Three Months Ended

June 30,

 

 

Six Months Ended

June 30,

 

 

 

2018

 

 

2017

 

 

2018

 

 

2017

 

Omadacycline costs

 

$

8,813

 

 

$

9,632

 

 

$

17,885

 

 

$

23,993

 

Other research and development costs

 

 

5,989

 

 

 

5,447

 

 

 

11,780

 

 

 

9,742

 

Total

 

$

14,802

 

 

$

15,079

 

 

$

29,665

 

 

$

33,735

 

 

General and Administrative Expense

General and administrative expense consists primarily of salaries and other related costs for personnel and professional, legal and consulting fees.

Interest Expense

Interest expense r epresents interest incurred on the Hercules Loan Agreement (as defined below), as amended, and the Notes, as well as the adjustment of our marketable securities to amortized cost.

Interest Income

Interest income r epresents interest earned on our money market funds and marketable securities.

Results of Operations

Comparison of the three months ended June 30, 2018 and 2017

 

 

 

Three Months Ended

June 30,

 

 

 

 

 

(in thousands)

 

2018

 

 

2017

 

 

$ Change

 

License and royalty revenue

 

$

40

 

 

$

7,514

 

 

$

(7,474

)

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

 

14,802

 

 

 

15,079

 

 

 

(277

)

General and administrative

 

 

12,912

 

 

 

8,716

 

 

 

4,196

 

Impairment of intangible asset

 

 

86

 

 

 

682

 

 

 

(596

)

Changes in fair value of contingent consideration

 

 

(31

)

 

 

(318

)

 

 

287

 

Total operating expenses

 

 

27,769

 

 

 

24,159

 

 

 

3,610

 

Loss from operations

 

 

(27,729

)

 

 

(16,645

)

 

 

(11,084

)

Other income and expenses:

 

 

 

 

 

 

 

 

 

 

 

 

Interest expense

 

 

(2,904

)

 

 

(1,126

)

 

 

(1,778

)

Interest income

 

 

894

 

 

 

349

 

 

 

545

 

Other loss, net

 

 

6

 

 

 

(8

)

 

 

14

 

Loss before income taxes

 

$

(29,733

)

 

$

(17,430

)

 

$

(12,303

)

Provision for income taxes

 

 

 

 

 

753

 

 

 

(753

)

Net loss

 

$

(29,733

)

 

$

(18,183

)

 

$

(11,550

)

 

 

30


 

Revenue

Revenue for the three months ended June 30, 2018 represents fifty percent of net royalties earned pursuant to the Royalty Sharing Agreement. Revenue for the three months ended June 30, 2017 represents an upfront license payment of $7.5 million earned under the Zai Collaboration Agreement as well as fifty percent of net royalties earned pursuant to the Royalty Sharing Agreement.

Research and Development Expense

Research and development expenses were $14.8 million for the three months ended June 30, 2018, compared to $15.1 million for the three months ended June 30, 2017. The decrease was driven primarily by lower clinical study costs, offset by an increase in manufacturing production costs for omadacycline and higher salaries, benefits and recruiting fees.

We anticipate that research and development expenses will increase modestly in the second half of 2018 as a result of our Phase 2 UTI program, as well as the costs associated with building our medical affairs team and production of omadacycline commercial supply, each of which will be classified as research and development expense until such time as the FDA may grant approval of omadacycline.

General and Administrative Expense

General and administrative expenses were $12.9 million for the three months ended June 30, 2018 compared to $8.7 million for the three months ended June 30, 2017.  The increase was primarily due to increased headcount and higher marketing, market access and other commercial consulting costs.

We anticipate that our general and administrative expenses will increase in future periods as we prepare for commercial launch of omadacycline, if approved by the FDA.

Impairment

During the three months ended June 30, 2018 and 2017, we recorded an impairment charge of $0.1 million and $0.7 million, respectively, in connection with an expected decline in Intermezzo sales.

Changes in Fair Value of Contingent Obligations

During the three months ended June 30, 2018 and 2017, we recorded a $31,000 decrease and $0.3 million decrease, respectively, in the fair value of our contingent obligation to former Transcept Pharmaceuticals, Inc., or Transcept, stockholders. The decrease in the fair value of our contingent obligation reflects a corresponding decline in projected Intermezzo sales.

Other Income and Expenses

Interest expense for the three months ended June 30, 2018 represents interest incurred on the Hercules Loan Agreement, as amended, of $1.6 million and the Notes of $1.6 million, partially offset by the net accretion of our marketable securities of $0.3 million. Interest income for the three months ended June 30, 2018 represents interest earned on our money market funds and marketable securities of $0.9 million. Interest expense for the three months ended June 30, 2017 represents interest incurred on the Hercules Loan Agreement, as amended, of $1.1 million and the net amortization of our marketable securities of $0.1 million. Interest income for the three months ended June 30, 2017 represents interest earned on our money market funds and marketable securities of $0.3 million.

Provision for Income Taxes

We recorded no provision for income taxes for the three months ended June 30, 2018. Provision for income taxes for the three months ended June 30, 2017 represents China withholding taxes on the upfront license payment we received under the Zai Collaboration Agreement.

 

31


 

Comparison of the six months ended June 30, 2018 and 2017

 

 

 

Six Months Ended

June 30,

 

 

 

 

 

(in thousands)

 

2018

 

 

2017

 

 

$ Change

 

License and royalty revenue

 

$

50

 

 

$

7,532

 

 

$

(7,482

)

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

 

29,665

 

 

 

33,735

 

 

 

(4,070

)

General and administrative

 

 

24,785

 

 

 

17,080

 

 

 

7,705

 

Impairment of intangible asset

 

 

86

 

 

 

682

 

 

 

(596

)

Changes in fair value of contingent consideration

 

 

(46

)

 

 

(549

)

 

 

503

 

Total operating expenses

 

 

54,490

 

 

 

50,948

 

 

 

3,542

 

Loss from operations

 

 

(54,440

)

 

 

(43,416

)

 

 

(11,024

)

Other income and expenses:

 

 

 

 

 

 

 

 

 

 

 

 

Interest expense

 

 

(4,410

)

 

 

(2,258

)

 

 

(2,152

)

Interest income

 

 

1,369

 

 

 

590

 

 

 

779

 

Other loss, net

 

 

(1

)

 

 

(15

)

 

 

14

 

Loss before income taxes

 

$

(57,482

)

 

$

(45,099

)

 

$

(12,383

)

Provision for income taxes

 

 

 

 

 

753

 

 

 

(753

)

Net Loss

 

$

(57,482

)

 

$

(45,852

)

 

$

(11,630

)

Revenue

Revenue for the six months ended June 30, 2018 represents fifty percent of net royalties earned pursuant to the Royalty Sharing Agreement. Revenue for the six months ended June 30, 2017 represents an upfront license payment of $7.5 million earned under the Zai Collaboration Agreement as well as fifty percent of net royalties earned pursuant to the Royalty Sharing Agreement.

Research and Development Expense

Research and development expenses were $29.7 million for the six months ended June 30, 2018, compared to $33.7 million for the six months ended June 30, 2017. The decrease was driven primarily by lower clinical study costs, offset by an increase in manufacturing production costs for omadacycline, higher salaries, benefits and recruiting fees, and NDA user fees.

We anticipate that research and development expenses will increase modestly in the second half of 2018 as a result of our Phase 2 UTI program, as well as the costs associated with building our medical affairs team and production of omadacycline commercial supply, each of which will be classified as research and development expense until such time as the FDA may grant approval of omadacycline.

General and Administrative Expense

General and administrative expenses were $24.8 million for the six months ended June 30, 2018 compared to $17.1 million for the six months ended June 30, 2017.  The increase was primarily due to increased headcount and higher marketing, market access and other commercial consulting costs.

We anticipate that our general and administrative expenses will increase in future periods as we prepare for commercial launch of omadacycline, if approved by the FDA.

Impairment

During the six months ended June 30, 2018 and 2017, we recorded an impairment charge of $0.1 million and $0.7 million, respectively, in connection with an expected decline in Intermezzo sales.

Changes in Fair Value of Contingent Obligations

During the six months ended June 30, 2018 and 2017, we recorded a $46,000 decrease and $0.5 million decrease, respectively, in the fair value of our contingent obligation to former Transcept stockholders. The decrease in the fair value of our contingent obligation reflects a corresponding decline in projected Intermezzo sales.

 

32


 

Other Income and Expenses

Interest expense for the six months ended June 30, 2018 represents interest incurred on the Hercules Loan Agreement, as amended, of $3.2 million and the Notes of $1.6 million, partially offset by the net accretion of our marketable securities of $0.4 million. Interest income for the six months ended June 30, 2018 represents interest earned on our money market funds and marketable securities of $1.4 million. Interest expense for the six months ended June 30, 2017 represents interest incurred on the Hercules Loan Agreement, as amended, of $2.1 million and the net amortization of our marketable securities of $0.1 million. Interest income for the six months ended June 30, 2017 represents interest earned on our money market funds and marketable securities of $0.6 million.

Provision for Income Taxes

We recorded no provision for income taxes for the six months ended June 30, 2018. Provision for income taxes for the six months ended June 30, 2017 represents China withholding taxes on the upfront license payment we received under the Zai Collaboration Agreement.

Liquidity and Capital Resources

On September 30, 2015, we entered into a Loan and Security Agreement, or the Hercules Loan Agreement, with Hercules Technology II, L.P. and Hercules Technology III, L.P, together, Hercules, and certain other lenders and Hercules Technology Growth Capital, Inc. (as agent). We executed four amendments to the Hercules Loan Agreement subsequent to September 30, 2015, providing access to term loans with an aggregate principal amount of up to $60.0 million. As of June 30, 2018, we have drawn down on the full $60.0 million available to us. The third amendment, which was executed in June 2017, extended the date on which we are required to begin making monthly principal installments from January 1, 2019 to January 1, 2020, subject to our receipt of marketing approval for our lead product candidate, omadacycline, or the Interest Only Period Extension Event.  Beginning on January 1, 2019, or, if we achieve the Interest Only Period Extension Event, beginning on January 1, 2020, we are obligated to make payments in equal monthly installments of principal and interest, with the balance of outstanding loans due on the original maturity date of the Hercules Loan Agreement, as amended. To date, we have issued to each of Hercules Technology II, L.P. and Hercules Technology III, L.P., a warrant to purchase 16,346 shares of our common stock (32,692 shares of common stock in total) at an exercise price of $24.47 per share and a warrant to purchase 18,574 shares of our common stock (37,148 shares of common stock in total) at an exercise price of $13.46 per share. We also have issued a warrant to Hercules Capital, Inc. that is exercisable for an aggregate of 5,374 shares of our common stock at an exercise price of $23.26 per share. On August 1, 2018, we entered into a fifth amendment to the Hercules Loan Agreement, or the Fifth Amendment. The Fifth Amendment increased the amount that we may borrow by $30.0 million, from up to $60.0 million to up to $90.0 million, in multiple tranches. 

Concurrently with the closing of the Fifth Amendment, we borrowed a fifth tranche of $10.0 million, or the Fifth Tranche.  Two additional tranches of up to $10.0 million each ($20.0 million total), or the Additional Tranches, may be available to us, subject to determination by Hercules, in its sole discretion, whether to provide such tranches.  As such there can be no assurance as to whether or not the Additional Tranches shall be funded.  The Fifth Amendment extended the date on which we are required to begin making monthly principal installments on loans previously outstanding under the Hercules Loan Agreement, or the Prior Tranches, from January 1, 2019 to January 1, 2021, subject to the Company’s receipt of marketing approval for the Company’s lead product candidate, omadacycline, or the Interest Only Period Extension Event.  Beginning on January 1, 2019, or, if we achieve the Interest Only Period Extension Event, beginning on January 1, 2021, we are obligated to make payments in equal monthly installments of principal and interest with respect to the Prior Tranches, with the balance of outstanding amounts under the Prior Tranches due on the maturity date of September 1, 2020, but which the Fifth Amendment extends to September 1, 2021 if we achieve the Interest Only Period Extension Event.

In October 2015 and February 2017, we entered into the 2015 Sales Agreement and 2017 Sales Agreement, respectively, with Cantor, under which we could, at our discretion, from time to time sell shares of our common stock, with a sales value of up to $50 million under each Sales Agreement through Cantor. We provided Cantor with customary indemnification rights, and Cantor was entitled to a commission at a fixed rate of 3% of the gross proceeds per share sold.  Sales of the shares under the Sales Agreements were to be made in transactions deemed to be “at the market offerings”, as defined in Rule 415 under the Securities Act. We have sold all $50 million of shares of our common stock under the 2015 Sales Agreement. We received $1.8 million in proceeds, after deducting commissions of $0.1 million, from the sale of 96,308 shares of common stock, during the six months ended June 30, 2018, under the 2017 Sales Agreement. As of July 31, 2018, $0.8 million remain available for sale under the 2017 Sales Agreement.

On October 16, 2015, we filed a registration statement on Form S-3 with the SEC, which was declared effective on October 29, 2015, to sell certain of our securities in an aggregate amount of up to $100.0 million. Under this shelf registration statement on January 22, 2018, we completed an underwritten offering on January 22, 2018 of 3,205,128 shares of our common stock, resulting in total proceeds of $50.0 million. Offering expenses incurred were $0.2 million. As of June 30, 2018, $50.0 million remains available on this shelf registration statement.

 

33


 

On December 12, 2016, we filed a registration statement on Form S-3 with the SEC, which was declared effective on December 20, 2016, to sell certain of our securities in an aggregate amount of up to $225.0 million. As of June 30, 2018, $175.0 million remains available on this shelf registration statement.

Additionally, on December 1, 2017, we filed a registration statement on Form S-3 with the SEC, which was declared effective on December 8, 2017, to sell certain of our securities in an aggregate amount of up to $250.0 million. As of June 30, 2018, $250.0 million remains available on this shelf registration statement.

On April 18, 2018, we entered into the Purchase Agreement with the Initial Purchasers for whom  Merrill Lynch, Pierce, Fenner & Smith Incorporated  and Leerink Partners LLC acted as representatives, relating to the sale of $135.0 million aggregate principal amount of 4.75% Convertible Senior Subordinated Notes due 2024 to the Initial Purchasers. We also granted the Initial Purchasers an option to purchase up to an additional $25.0 million aggregate principal amount of Notes, which was exercised in full on April 20, 2018. In addition, J. Wood Capital Advisors LLC, the Company’s financial advisor, purchased $5.0 million aggregate principal amount of Notes in a separate, concurrent private placement on the same terms as other investors. After deducting costs incurred of $6.0 million, we received proceeds from the sale of the Notes of $159.0 million during the three and six months ended June 30, 2018.

We have used and we intend to continue to use the net proceeds from the above offerings of our common stock and the Notes, as well as from the Hercules Loan Agreement, as amended, together with our existing capital resources, to fund our ongoing and future clinical studies of omadacycline, to fund commercial launch, and for working capital and other general corporate purposes.

As of June 30, 2018, we had cash, cash equivalents and marketable securities of $321.1 million.

The following table summarizes our cash provided by and used in operating, investing and financing activities (in thousands):

 

 

 

Six Months Ended

June 30,

 

(in thousands)

 

2018

 

 

2017

 

Net cash used in operating activities

 

$

(41,727

)

 

$

(40,686

)

Net cash used in investing activities

 

$

(148,486

)

 

$

(50,015

)

Net cash provided by financing activities

 

$

210,983

 

 

$

88,625

 

 

Operating Activities

Cash used in operating activities for the six months ended June 30, 2018 of $41.7 million is primarily the result of our $57.5 million net loss. This is offset by $11.1 million in non-cash items, including, $8.9 million in stock-based compensation expense, $1.9 million of interest expense and $0.3 million in depreciation and amortization, as well as a $5.4 million decrease in accounts receivable, offset by a $0.6 million decrease in accounts payable and accrued expenses. Cash used in operating activities for the six months ended June 30, 2017 of $40.7 million is primarily the result of our $45.9 million net loss, a $5.8 million decrease in accounts payable and accrued expenses, and a $0.5 million decrease in contingent obligations to former Transcept stockholders. This is offset by $9.9 million in non-cash items, including $9.6 million in depreciation, amortization and stock-based compensation expense and a $0.7 million impairment charge on our intangible asset, as well as a $1.2 million increase in our accounts receivable and other assets.

Investing Activities

Net cash used in investing activities during the six months ended June 30, 2018 consists of $220.7 million investment in short-term marketable securities (U.S. treasury and government agency securities ) offset by proceeds from maturities of marketable securities of $72.3 million. Net cash used in investing activities during the six months ended June 30, 2017 consisted of $93.9 million investment in short-term marketable securities (U.S. treasury securities) offset by proceeds from maturities of marketable securities of $45.0 million. We also purchased $1.1 million of fixed assets for our offices in Boston and King of Prussia.

Financing Activities

Net cash provided by financing activities during the six months ended June 30, 2018 primarily represents net proceeds of $159.3 million (which includes $0.3 million in legal costs paid subsequent to June 30, 2018) raised through the sales of the Notes, net proceeds of $49.8 million raised through our January 2018 public offering of common stock, and net proceeds of $1.8 million raised through the sale of shares of our common stock under the Sales Agreements. Net cash provided by financing activities during the six months ended June 30, 2017 primarily represents net proceeds of $78.7 million received from the sale of shares of our common stock under the Sales Agreements as well as $9.9 million drawn under the Third Tranche under the Hercules Loan Agreement, as amended.

 

34


 

Future Funding Requirements

We have not generated any revenue from product sales. We do not know when, if ever, we will generate any revenue from product sales. We do not expect to generate any revenue from product sales unless and until either we or either of our partners, Allergan or Zai, obtain regulatory approval of and commercialize one or more of our product candidates. Subject to obtaining regulatory approval for any of our product candidates, we anticipate that we will need substantial additional funding in connection with our continuing operations to support pre-launch and commercial activities associated with our lead product candidate, omadacycline.

We have not completed development of any product candidates. We expect to continue to incur significant expenses and increasing operating losses for the foreseeable future. We anticipate that our expenses will increase substantially as we:

 

conduct additional clinical trials of omadacycline;

 

seek regulatory approvals for omadacycline;

 

establish a sales, marketing and distribution infrastructure and increases to our manufacturing demand and capabilities to commercialize omadacycline; and

 

add personnel to support our product development and planned commercialization efforts.

Based upon our current operating plan, we anticipate that our existing cash, cash equivalents and marketable securities of $321.1 million as of June 30, 2018, future contingent regulatory and commercial milestone payments from our collaborations with Allergan and Zai, and estimated omadacycline product sales, if omadacycline is approved by the FDA on its anticipated timeline, will enable us to fund our operating expenses and capital expenditure requirements through the first quarter of 2021.  We have based this estimate on assumptions that may prove to be wrong, and we could use our available capital resources sooner than we currently expect. Because of the numerous risks and uncertainties associated with the development and commercialization of our product candidates, and the unknown extent to which we will enter into collaborations with third parties to participate in the development and commercialization of our product candidates, we are unable to estimate with certainty the amounts of increased capital outlays and operating expenditures associated with our current and anticipated clinical trials. Our future capital requirements will depend on many factors, including:

 

the progress of clinical development of omadacycline;

 

the number and characteristics of other product candidates that we pursue;

 

the scope, progress, timing, cost and results of research, preclinical development and clinical trials;

 

the costs, timing and outcome of seeking and obtaining FDA and non-U.S. regulatory approvals;

 

the costs associated with manufacturing and establishing sales, marketing and distribution capabilities;

 

our ability to maintain, expand and defend the scope of our intellectual property portfolio, including the amount and timing of any payments we may be required to make in connection with the licensing, filing, defense and enforcement of any patents or other intellectual property rights;

 

our need and ability to hire additional management, scientific and medical personnel;

 

the effect of competing products that may limit market penetration of our product candidates;

 

our need to implement additional internal systems and infrastructure, including financial and reporting systems; and

 

the economic and other terms, timing and success of our existing collaboration and licensing arrangements and any collaboration, licensing or other arrangements into which we may enter in the future, including the timing of receipt of any milestone or royalty payments under such arrangements.

 

35


 

Until we can generate a sufficient amount of product revenue to finance our cash requirements, we expect to finance our future cash needs primarily through a comb ination of public or private equity offerings, debt or other structured financings, strategic collaborations and grant funding. We do not have any committed external sources of funds other than contingent milestone payments and royalties under the Allergan Collaboration Agreement and the Zai Collaboration Agreement, which are terminable by Allergan and Zai, respectively, upon prior written notice. To the extent that we raise additional capital through the sale of equity or convertible debt securities, the o wnership interest of our stockholders will be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect stockholders’ rights. Additional debt financing, if available, may involve agreements that include c ovenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends. If we raise additional funds through marketing and distribution arrangements or other collaboratio ns, strategic alliances or licensing arrangements with third parties, we may have to relinquish valuable rights to our technologies, future revenue streams, research programs or product candidates or grant licenses on terms that may not be favorable to us. If we are unable to raise additional funds through equity or debt financings when needed, we may be required to delay, limit, reduce or terminate our product development or commercialization efforts or grant rights to develop and market product candidates that we would otherwise prefer to develop and market ourselves.

Critical Accounting Policies and Estimates

Our management’s discussion and analysis of our financial condition and results of operations are based on our financial statements, which have been prepared in accordance with generally accepted accounting principles of the United States of America. The preparation of these financial statements requires us to make estimates and judgments that affect the reported amounts of assets, liabilities, and expenses and the disclosure of contingent liabilities in our financial statements. On an ongoing basis, we evaluate our estimates and judgments, including those related to, among other items, intangible assets, goodwill, contingent liabilities, stock-based compensation arrangements, useful lives for depreciation and amortization of long-lived assets and valuation allowances on deferred tax assets. Actual results could differ from those estimates.

There have been no material changes in our critical accounting policies during the six months ended June 30, 2018, as compared to those disclosed in the “Management’s Discussion and Analysis of Financial Condition and Results of Operations—Critical Accounting Policies and Estimates” in our Annual Report on Form 10-K for the year ended December 31, 2017, as filed with the SEC on March 6, 2018, with the exception of those discussed in Note 2, Summary of Significant Accounting Policies and Basis of Presentation .

Recent Accounting Pronouncements

Refer to Note 16, Recent Accounting Pronouncements , to our Condensed Consolidated Financial Statements in this Quarterly Report on Form 10-Q.

Off-Balance Sheet Arrangements

During the six months ended June 30, 2018 and the year ended December 31, 2017 we did not engage in any off-balance sheet financing activities, including the use of structured finance, special purpose entities or variable interest entities.

Contractual Obligations and Commitments

There have been no material changes in our contractual obligations and commitments as of June 30, 2018, as compared to those disclosed in “Management’s Discussion and Analysis of Financial Condition and Results of Operations— Contractual Obligations and Commitments” in our Annual Report on Form 10-K for the year ended December 31, 2017, as filed with the SEC on March 6, 2018, with the exception of those discussed in Note 15, Commitments and Contingencies .

Item 3.

Quantitative and Qualitative Disclosures about Market Risks

Our cash, cash equivalents and investments balance as of June 30, 2018 consisted of cash and cash equivalents, U.S. treasury securities and government agency securities. The goals of our investment policy are preservation of capital, fulfillment of liquidity needs and fiduciary control of cash and investments. We also seek to maximize income from our investments without assuming significant risk. Our primary exposure to market risk is interest income sensitivity, which is affected by changes in the general level of interest rates, particularly because our investments are in short-term marketable securities. Due to the short-term duration of our investment portfolio and the low-risk profile of our investments, an immediate 100 basis point change in interest rates would not have a material effect on the fair market value of our portfolio. We have the ability and intention to hold our investments, although they are available for immediate sale, until maturity and, therefore, we would not expect our operating results or cash flows to be affected to any significant degree by the effect of a sudden change in market interest rates on our investment portfolio.

 

36


 

We engage CROs and contract manufacturers on a global scale. We may be subject to fluctuations in foreign currency rates in connection with certain of these agreements. We currently do not hedge any such foreign currency exchange rate risk. Transactions denominated in currencies other than U.S. dollars are recorded based on exchange rates at the time such transactions arise and were less than 10% of total liabilities as of June 30, 2018.

Item 4.

Controls and Procedures

Management’s Evaluation of our Disclosure Controls and Procedures

We maintain disclosure controls and procedures that are designed to ensure that information required to be disclosed in the reports that we file or submit under the Securities Exchange Act of 1934, as amended, is (1) recorded, processed, summarized, and reported within the time periods specified in the SEC’s rules and forms and (2) accumulated and communicated to our management, including our principal executive officer and principal financial officer, to allow timely decisions regarding required disclosure.

As of June 30, 2018, our management, with the participation of our principal executive officer and principal financial officer, evaluated the effectiveness of our disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended). Our management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving their objectives, and management necessarily applies its judgment in evaluating the cost-benefit relationship of possible controls and procedures. Our principal executive officer and principal financial officer have concluded based upon the evaluation described above that, as of June 30, 2018, our disclosure controls and procedures were effective at the reasonable assurance level.

Changes in Internal Control over Financial Reporting

On January 1, 2018, the Company adopted Accounting Standards Codification Topic 606,  Revenue from Contracts with Customers , and implemented appropriate changes to its internal controls to support revenue recognition, including controls to monitor the probability of achievement of contingent milestone payments, and additional revenue-related disclosures under the new standard. During the three months ended June 30, 2018, there have been no other changes in our internal control over financial reporting, as such term is defined in Rules 13a-15(f) and 15(d)-15(f) promulgated under the Securities Exchange Act of 1934, as amended, that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

 

 

PART II

Item 1.

Legal Proceedings

Information in response to this Item is incorporated herein by reference from Note 15, Commitments and Contingencies , to our Condensed Consolidated Financial Statements in this Quarterly Report on Form 10-Q.

 

Item 1A.

Risk Factors

There have been no material changes from the risk factors set forth in the Company’s Annual Report on Form 10-K for the year ended December 31, 2017, as filed with the SEC on March 6, 2018, and in the Company’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2018, as filed with the SEC on May 8, 2018.

 

 

Item 5.

Other Information

On August 1, 2018, the Company and Paratek Pharma, LLC entered into Amendment No. 5, or the Fifth Amendment, to the Loan and Security Agreement dated September 30, 2015, or as amended, the Hercules Loan Agreement, with Hercules Technology II, L.P., Hercules Technology III, L.P., Hercules Capital, Inc., as agent, and, collectively with Hercules Technology II, L.P., Hercules Technology III, L.P. and the several banks and other financial institutions or entities from time to time parties to the Hercules Loan Agreement, the Lender.

The Fifth Amendment increased the amount that the Company may borrow by $30.0 million, from up to $60.0 million to up to $90.0 million, in multiple tranches. Concurrently with the closing of the Fifth Amendment, the Company borrowed a fifth tranche of $10.0 million, or the Fifth Tranche.  Two additional tranches of up to $10.0 million each ($20.0 million total), or the Additional Tranches, may be available to the Company, subject to determination by the Lender, in its sole discretion, whether to provide such tranches.  As such, there can be no assurance as to whether or not the Additional Tranches shall be funded. In connection with the Fifth Amendment, the Company paid the Lender a $0.1 million amendment fee.

 

37


 

The Fifth Amendment extended the date on which the Company is required to begin making monthly principal installments on loans previo usly outstanding u nder the Hercules Loan Agreement, or the Prior Tranches, from January 1, 2019 to January 1, 2021, subject to the Company’s receipt of marketing approval for the Company’s lead product candidate, omadacycline, or the Interest Only Period E xtension Event.  Beginning on January 1, 2019, or, if the Company achieves the Interest Only Period Extension Event, beginning on January 1, 2021, the Company is obligated to make payments in equal monthly installments of principal and interest with respec t to the Prior Tranches, with the balance of outstanding amounts under the Prior Tranches due on the maturity date of September 1, 2020, but which the Fifth Amendment extends to September 1, 20 2 1 if the Company achieves the Interest Only Period Extension E vent.

The Fifth Tranche is repayable in monthly installments commencing on September 1, 2020 (or March 1, 2021 or September 1, 2021, if certain revenue milestones are satisfied by the Company) through maturity on August 1, 2022. The interest rate with respect to the Fifth Tranche is a floating per annum rate equal to the greater of (i) 7.85%, or (ii) the sum of 7.85%, plus the “prime rate” as reported in The Wall Street Journal minus 5.75%. An end of term charge equal to 6.95% of the issued principal balance of the Fifth Tranche will be payable at maturity, including in the event of any prepayment.

The Fifth Amendment amended the prepayment charges applicable to all loans outstanding under the Hercules Loan Agreement, such that prepayment fees equaling 1% to 2.5% will apply to principal amounts prepaid prior to dates between January 1, 2019 and January 1, 2020, varying depending on the applicable tranche and whether the Interest Only Period Extension Event has occurred.

In connection with the borrowing of the Fifth Tranche, on August 1, 2018, the Company issued an additional warrant to Hercules Capital, Inc. that is exercisable for a minimum of up to 19,627 shares of common stock (and additional shares if the Additional Tranches are funded) at an exercise price of $10.19 per share, or the Fifth Amendment Warrant. The Fifth Amendment Warrant may be exercised on a cashless basis. The Fifth Amendment Warrant is exercisable for a term beginning on the date of issuance and ending on the earlier to occur of seven years from the date of issuance or the consummation of certain acquisitions of the Company as set forth in the Fifth Amendment Warrant.

The descriptions of the Fifth Amendment and the Fifth Amendment Warrant contained herein do not purport to be complete and are qualified in their entirety by reference to the complete text of the Fifth Amendment and the Fifth Amendment Warrant attached hereto as Exhibits 4.5 and 10.3, respectively, which are incorporated herein by reference.

 

 

 

 

38


 

Item 6.

Exhibits

EXHIBIT INDEX

 

 

 

 

 

Incorporated by Reference

 

 

Exhibit

No.

 

Exhibit Description

 

Schedule/

Form

 

File Number

 

Exhibit

 

Filing Date

 

 

 

 

 

 

 

 

 

 

 

     3.1

 

Amended and Restated Certificate of Incorporation.

 

Form 8-K

 

001-36066

 

3.1

 

October 31, 2014

 

 

 

 

 

 

 

 

 

 

 

     3.2

 

Certificate of Amendment of Amended and Restated Certificate of Incorporation.

 

Form 8-K

 

001-36066

 

3.2

 

October 31, 2014

 

 

 

 

 

 

 

 

 

 

 

     3.3

 

Certificate of Elimination of Series A Junior Participating Preferred Stock

 

Form 8-K

 

001-36066

 

3.1

 

July 24, 2015

 

 

 

 

 

 

 

 

 

 

 

     3.4

 

Amended and Restated Bylaws.

 

Form 8-K

 

001-36066

 

3.1

 

April 16, 2015

 

 

 

 

 

 

 

 

 

 

 

     4.1

 

Specimen Common Stock Certificate.

 

Form S-3

 

333-201458

 

4.2

 

January 12, 2015

 

 

 

 

 

 

 

 

 

 

 

     4.2

 

Form of Warrant Agreement issued to Hercules        Technology II, L.P. and Hercules Technology III, L.P.    

    

Form 8-K

 

001-36066

 

4.1

 

October 5, 2015

 

 

 

 

 

 

 

 

 

 

 

     4.3

 

Form of Warrant Agreement issued to Hercules Technology II, L.P. and Hercules Technology III, L.P.

 

Form 8-K

 

001-36066

 

4.1

 

December 13, 2016

 

 

 

 

 

 

 

 

 

 

 

     4.4

 

 

     4.5*

 

Warrant Agreement, dated June 27, 2017 issued to Hercules Capital, Inc.

 

Warrant Agreement, dated August 1, 2018 issued to Hercules Capital, Inc.

 

Form 8-K

 

001-36066

 

4.1

 

June 29, 2017

 

 

 

 

 

 

 

 

 

 

 

     4.6

 

Warrant, dated as of April 7, 2014 issued to HBM Healthcare Investments (Cayman) Ltd.

 

Form 10-K

 

001-36066

 

10.22

 

April 2, 2015

 

 

 

 

 

 

 

 

 

 

 

     4.7

 

Warrant, dated as of April 18, 2014 issued to K/S Danish BioVenture.

 

Form 10-K

 

001-36066

 

10.23

 

April 2, 2015

 

 

 

 

 

 

 

 

 

 

 

     4.8

 

    

 

Warrant, dated as of April 7, 2014 issued to Omega Fund III, L.P.

 

Form 10-K

 

001-36066

 

10.24

 

April 2, 2015

   10.1

 

2018 Employee Stock Purchase Plan

 

Form 8-K

 

001-36066

 

10.1

 

June 18, 2018

 

 

 

 

 

 

 

 

 

 

 

   10.2*^

 

Amended and Restated Manufacturing and Services Agreement by and between the Company and CIPAN – Companhia Industrial Produtora de Antibióticos, S.A., dated as of April 18, 2018.

 

 

 

 

 

 

 

 

 

   10.3*

 

Amendment No. 5 to Loan and Security Agreement dated August 1, 2018, by and between Paratek Pharmaceuticals, Inc., Paratek Pharma, LLC, Hercules Technology II, L.P., Hercules Technology III, L.P., and Hercules Capital, Inc.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

   31.1*

 

Certification of the Company’s Chief Executive Officer pursuant to Rule 13a-14(a) and Rule 15d-14(a) of the Securities and Exchange Act of 1934, as amended, pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

   31.2*

 

Certification of the Company’s Chief Financial Officer pursuant to Rule 13a-14(a) and Rule 15d-14(a) of the Securities and Exchange Act of 1934, as amended, pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

39


 

 

 

 

 

Incorporated by Reference

 

 

Exhibit

No.

 

Exhibit Description

 

Schedule/

Form

 

File Number

 

Exhibit

 

Filing Date

 

 

 

 

 

 

 

 

 

 

 

   32.1*

 

Certification of the Company’s Chief Executive Officer pursuant to 18 U.S.C. Section 1350, as adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

   32.2*

 

Certification of the Company’s Chief Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

101.INS*

 

XBRL Instance Document.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

101.SCH*

 

XBRL Taxonomy Extension Schema Document.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

101.CAL*

 

XBRL Taxonomy Extension Calculation Linkbase Document.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

101.DEF*

 

XBRL Taxonomy Extension Definition Linkbase Document.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

101 . L A B*

 

XBRL Ta xono m y E x t e ns i on La b e l s L i nkb a se Do c u m e n t .

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

101.PRE*

 

XBRL Taxonomy Extension Presentation Linkbase Document.

 

 

 

 

 

 

 

 

 

*

Filed herewith.

^

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

 

 

 

40


 

SIGNA TURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized, on the 1 st day of August 2018.

 

Paratek Pharmaceuticals, Inc.

 

By:

 

/s/ Michael F. Bigham

 

 

Michael F. Bigham

 

 

Chairman and Chief Executive Officer

(Principal Executive Officer)

 

By:

 

/s/ Douglas W. Pagán

 

 

Douglas W. Pagán

 

 

Chief Financial Officer

(Principal Financial and Accounting Officer)

 

 

 

 

41

Exhibit 4.5

 

THIS WARRANT AND THE SHARES ISSUABLE UPON EXERCISE HEREOF HAVE NOT BEEN REGISTERED UNDER THE SECURITIES ACT OF 1933, AS AMENDED, OR ANY STATE SECURITIES LAWS. THEY MAY NOT BE SOLD, OFFERED FOR SALE, PLEDGED, OR HYPOTHECATED IN THE ABSENCE OF AN EFFECTIVE REGISTRATION STATEMENT RELATED THERETO OR, SUBJECT TO SECTION 11 HEREOF, AN OPINION OF COUNSEL (WHICH MAY BE COMPANY COUNSEL) REASONABLY SATISFACTORY TO THE COMPANY THAT SUCH REGISTRATION IS NOT REQUIRED UNDER THE SECURITIES ACT OF 1933, AS AMENDED, OR ANY APPLICABLE STATE SECURITIES LAWS.

WARRANT AGREEMENT

To Purchase Shares of the Common Stock of

PARATEK PHARMACEUTICALS, INC.

Dated as of August 1, 2018 (the “ Effective Date ”)

WHEREAS, Paratek Pharmaceuticals, Inc., a Delaware corporation (the “ Company ”), has entered into a Loan and Security Agreement dated September 30, 2015, as amended by that certain Amendment No. 1 dated November 10, 2015, that certain Amendment No. 2 dated December 12, 2016, that certain Amendment No. 3 dated June 27, 2017, that certain Amendment No. 4 dated April 17, 2018 and that certain Amendment No. 5 of even date herewith (collectively, and as may be further amended and in effect from time to time, the “ Loan Agreement ”) with Hercules Capital, Inc., a Maryland corporation (the “ Warrantholder ”) and the other affiliates of Warrantholder named therein;

WHEREAS, the Company desires to grant to Warrantholder, in consideration for, among other things, the financial accommodations provided for in the Loan Agreement, the right to purchase shares of its Common Stock (as defined below) pursuant to this Warrant Agreement (this “ Warrant ”);

NOW, THEREFORE, in consideration of the premises and the mutual covenants and agreements contained herein, the Company and Warrantholder agree as follows:

SECTION 1. GRANT OF THE RIGHT TO PURCHASE COMMON STOCK.

(a) For value received, the Company hereby grants to the Warrantholder, and the Warrantholder is entitled, upon the terms and subject to the conditions hereinafter set forth, to subscribe for and purchase, from the Company, up to such number of fully paid and non-assessable shares of Common Stock equal to the quotient derived by dividing (a) the Warrant Coverage (as defined below) by (b) the Exercise Price (as defined below), rounded down to the nearest whole share. The number of shares of Common Stock and the Exercise Price of such shares is subject to adjustment as provided in Section 8 . As used herein, the following terms shall have the following meanings:

1934 Act ” means the Securities Exchange Act of 1934, as amended.

Acknowledgment of Exercise ” has the meaning given to it in Section 3(a) .

Act ” means the Securities Act of 1933, as amended, and as the same may be in effect from time to time.

Charter ” means the Company’s Certificate of Incorporation or other constitutional document, as the same may be amended from time to time.

Claims ” has the meaning given to it in Section 12(p) .

Common Stock ” means the Company’s common stock, $0.001 par value per share.

Company ” has the meaning given to it in the preamble to this Warrant.

Effective Date ” has the meaning given to it in the preamble to this Warrant.

Exercise Price ” means $10.19 per share.

Lender ” has the meaning given to it in the Loan Agreement.

Loan Agreement ” has the meaning given to it in the preamble to this Warrant.

Merger Event ” means (a) a merger or consolidation involving the Company in which (i) the Company is not the surviving entity, or (ii) the outstanding shares of the Company’s capital stock are otherwise converted into or exchanged for shares of capital of another entity; or (b) the sale of all or substantially all of the assets of the Company.

Net Issuance ” has the meaning given to it in Section 3(a) .

Notice of Exercise ” has the meaning given to it in Section 3(a) .

Public Acquisition ” means any Merger Event which is effected such that (i) the holders of Common Stock shall be entitled to receive (A) cash and/or (B) shares of stock that are of a publicly traded company listed on a national market or exchange which may be resold without restrictions (other than restrictions to which Warrantholder may separately agree in writing) after the

 


 

consummation of such Merger Event, and (ii) the Company’s stockholders own less than 50% of the voting securities of the surviving entity (or, if such Company stockholders beneficially own 50% or more of the outstanding voting power of the surviving or successor entity as of immediately after the consummation of such Merger Event , such surviving or successor entity is not the Company) .

Purchase Price ” means, with respect to any exercise of this Warrant, an amount equal to the Exercise Price as of the relevant time multiplied by the number of shares of Common Stock requested to be exercised under this Warrant pursuant to such exercise.

Rules ” has the meaning given to it in Section 12(q) .

Transfer Notice ” has the meaning given to it in Section 11 .

Warrant ” has the meaning given to it in the preamble to this Warrant.

“Warrant Coverage” means the sum of $200,000.00 plus, (i) in the event the 2018 Term B Loan Advance is funded, $200,000, plus, (ii) in the event the 2018 Term C Loan Advance is funded, $200,000.  

Warrant Term ” has the meaning given to it in Section 2 .

Warrantholder ” has the meaning given to it in the preamble to this Warrant.

 

SECTION 2. TERM OF THE AGREEMENT.

Except as otherwise provided for herein, the term of this Warrant (the “ Warrant Term ”) and the right to purchase Common Stock as granted herein shall commence on the Effective Date and shall be exercisable for a period ending upon the earlier to occur of (A) seven (7) years from the Effective Date or (B) the consummation of a Public Acquisition, with the Warrant expiring and terminating in its entirety upon the consummation of either of the foregoing events (the “ Termination Date ”).

SECTION 3. EXERCISE OF THE PURCHASE RIGHTS.

(a) Exercise . Subject to the terms and conditions hereof, the purchase rights set forth in this Warrant may be exercised, in whole or in part, at any time, or from time to time, during the Warrant Term, by tendering to the Company at its principal office a notice of exercise in the form attached hereto as Exhibit A (the “ Notice of Exercise ”), duly completed and executed. Promptly upon receipt of the Notice of Exercise and the payment of the Purchase Price in accordance with the terms set forth below, and in no event later than three (3) business days thereafter, the Company shall issue to the Warrantholder a certificate or book entry shares representing the number of shares of Common Stock purchased and shall execute the acknowledgment of exercise in the form attached hereto as Exhibit B (the “ Acknowledgment of Exercise ”) indicating the number of shares which remain subject to future purchases under this Warrant, if any.

The Purchase Price may be paid at the Warrantholder’s election either (i) by cash or check, or (ii) by surrender of all or a portion of the Warrant for shares of Common Stock to be exercised under this Warrant and, if applicable, an amended Warrant representing the remaining number of shares purchasable hereunder, as determined below (“ Net Issuance ”). If the Warrantholder elects the Net Issuance method, the Company will issue Common Stock in accordance with the following formula:

 

 

 

 

 

 

 

 

 

X = Y(A-B)

 

 

 

 

A

 

 

 

     Where:

 

 

 

 

 

 

 

 

 

X =

 

the number of shares of Common Stock to be issued to the Warrantholder.

 

 

 

 

 

 

 

Y = the number of shares of Common Stock requested to be exercised under this Warrant.

 

 

 

 

 

 

 

A = the fair market value of one (1) share of Common Stock at the time of issuance of such shares of Common Stock.

 

 

 

 

 

B =

 

the Exercise Price.

For purposes of the above calculation, the fair market value of one (1) share of Common Stock shall mean:

(i) if the Common Stock is traded on any exchange operated by the NASDAQ Stock Market, LLC or any other national securities exchange, the fair market value of one (1) share of Common Stock shall be deemed to be the volume-weighted average of the closing prices over the thirty (30) consecutive trading days ending two (2) trading days before the day the fair market value of one (1) share of Common Stock is being determined; or

(ii) if at any time the Common Stock is not listed on any securities exchange, the fair market value of one (1) share of Common Stock shall be the highest price per share which the Company could obtain from a willing buyer (not a current employee or director) for shares of Common Stock sold by the Company (based upon the valuation by the Board of Directors of all shares of Common

2.

 


 

Stock), from authorized but unissued shares, as determined in good faith by its Board of Directors, unless this Warrant is being exercised in connection with a Merger Event, in which case the fair market value of one (1) share of Common Stock shall be deemed to be the per share value received by the holders of the Common Stock on a Common Stock equivalent basis pursuant to such Merger Event.

Upon partial exercise by either cash or Net Issuance and surrender of this Warrant, the Company shall promptly issue an agreement substantially in the form of the Warrant representing the remaining number of shares purchasable hereunder. All other terms and conditions of such agreement shall be identical to those contained herein, including, but not limited to the Effective Date hereof.

(b) Exercise Prior to Expiration . To the extent that the Warrantholder has not exercised its purchase rights under this Warrant to all Common Stock subject hereto, and if the fair market value of one share of the Common Stock is greater than the Exercise Price then in effect, this Warrant shall be deemed automatically exercised pursuant to Section 3(a) (even if not surrendered) immediately before the expiration of the Warrant Term. For purposes of such automatic exercise, the fair market value of one share of the Common Stock upon such expiration shall be determined pursuant to Section 3(a) . To the extent this Warrant or any portion thereof is deemed automatically exercised pursuant to this Section 3(b) , the Company agrees to promptly notify the Warrantholder of the number of shares of Common Stock, if any, the Warrantholder is to receive by reason of such automatic exercise.

(c) Legend . Each certificate or book entry shares for the shares of Common Stock purchased upon exercise of this Warrant shall bear the restrictive legend set forth on the first page of this Warrant. Such legend shall be removed and the Company shall, or shall instruct its transfer agent to, issue a certificate or book entry shares without such legend or any other legend to the holder of such shares (i) if such shares are sold or transferred pursuant to an effective registration statement under the Act covering the resale of such shares by the holder thereof, (ii) if such shares are sold or transferred pursuant to Rule 144 under the Act, (iii) if, upon advice of counsel to the Company, such shares are eligible for resale without any restrictions under Rule 144 under the Act, or (iv) upon the request of such holder if such request is accompanied (at such holder’s expense) by a written opinion of counsel reasonably satisfactory to the Company that registration is not required under the Act or any applicable state securities laws for the resale of the shares of Common Stock purchased upon exercise of this Warrant. The removal of such restrictive legend from any certificates or book entry shares representing the shares of Common Stock purchased upon exercise of this Warrant is predicated upon the Company’s reliance that the holder of such shares would sell, transfer, assign, pledge, hypothecate or otherwise dispose of such shares pursuant to either the registration requirements of the Act, including any applicable prospectus delivery requirements, or an exemption therefrom, and that if such shares are sold pursuant to a registration statement, they will be sold in compliance with the plan of distribution set forth therein.

SECTION 4. RESERVATION OF SHARES.

During the Warrant Term, the Company will at all times have authorized and reserved a sufficient number of shares of its Common Stock to provide for the exercise of the rights to purchase Common Stock as provided for herein.

SECTION 5. NO FRACTIONAL SHARES OR SCRIP.

No fractional shares or scrip representing fractional shares shall be issued upon the exercise of this Warrant, but in lieu of such fractional shares the Company shall make a cash payment therefor upon the basis of the Exercise Price then in effect.

SECTION 6. NO RIGHTS AS STOCKHOLDER.

This Warrant does not entitle the Warrantholder to any voting rights or other rights as a stockholder of the Company prior to the exercise of this Warrant.

SECTION 7. WARRANTHOLDER REGISTRY.

The Company shall maintain a registry showing the name and address of the registered holder of this Warrant. Warrantholder’s initial address, for purposes of such registry, is set forth in Section 12(g) . Warrantholder may change such address by giving written notice of such changed address to the Company.

 

SECTION 8. ADJUSTMENT RIGHTS.

The Exercise Price and the number of shares of Common Stock purchasable hereunder are subject to adjustment, as follows:

(a) Merger Event . If at any time there shall be a Merger Event that is not a Public Acquisition, then, as a part of such Merger Event, lawful provision shall be made so that the Warrantholder shall thereafter be entitled to receive, upon exercise of this Warrant, the kind, amount and value of shares of Common Stock or other securities or property of the successor, surviving or purchasing corporation resulting from, or participating in, such Merger Event that would have been issuable if Warrantholder had exercised this Warrant immediately prior to such Merger Event. In any such case, appropriate adjustment (as determined in good faith by the Company’s Board of Directors) shall be made in the application of the provisions of this Warrant with respect to the rights and interests of the Warrantholder after such Merger Event to the end that the provisions of this Warrant (including adjustments of the Exercise Price) shall be applicable in their entirety, and to the greatest extent possible. Without limiting the foregoing, in connection with any Merger Event other than a Public Acquisition, upon the closing thereof, the successor, surviving or purchasing entity shall

3.

 


 

assume the obligations of this Warrant. The provisions of this Section 8(a) shall similarly apply to successive Merger Events. In connection with a Merger Event and upon Warrantholder’s written election to the Company, the Company shall cause this Warrant to be exchanged for the consideration that Warrantholder would have received if Warrantholder chose to exercise its right to have shares issued pursuant to the Net Issuance provisions of this Warrant prior to the Merger Event without actually exercising such right, acquiring such shares and exchanging such shares for such consideration.

(b) Reclassification of Shares . Except as set forth in Section 8(a) , if the Company at any time shall, by combination, reclassification, exchange or subdivision of securities or otherwise, change any of the securities as to which purchase rights under this Warrant exist into the same or a different number of securities of any other class or classes, this Warrant shall thereafter represent the right to acquire such number and kind of securities as would have been issuable as the result of such change with respect to the securities which were subject to the purchase rights under this Warrant immediately prior to such combination, reclassification, exchange, subdivision or other change.

(c) Subdivision or Combination of Shares . If the Company at any time shall combine or subdivide its Common Stock, (i) in the case of a subdivision, the Exercise Price shall be proportionately decreased, and the number of shares of Common Stock issuable upon exercise of this Warrant shall be proportionately increased, or (ii) in the case of a combination, the Exercise Price shall be proportionately increased, and the number of shares of Common Stock issuable upon the exercise of this Warrant shall be proportionately decreased.

(d) Stock Dividends . If the Company at any time while this Warrant is outstanding and unexpired shall:

(i) pay a dividend with respect to the outstanding shares of Common Stock payable in additional shares of Common Stock, then the Exercise Price shall be adjusted, from and after the date of determination of stockholders entitled to receive such dividend or distribution, to that price determined by multiplying the Exercise Price in effect immediately prior to such date of determination by a fraction (A) the numerator of which shall be the total number of shares of Common Stock outstanding immediately prior to such dividend or distribution, and (B) the denominator of which shall be the total number of shares of Common Stock outstanding immediately after such dividend or distribution; or

 

(ii) make any other distribution with respect to the Common Stock, except any distribution specifically provided for in any other clause of this Section 8 , then, in each such case, provision shall be made by the Company such that the Warrantholder shall receive upon exercise of this Warrant a proportionate share of any such distribution as though it were the holder of the Common Stock as of the record date fixed for the determination of the stockholders of the Company entitled to receive such distribution.

(e) Antidilution Rights . To the extent that any antidilution rights applicable to the Common Stock purchasable hereunder may be set forth in the Charter, the Company shall promptly provide the Warrantholder with a copy of any restatement, amendment, modification or waiver of the Charter that impairs or reduces such antidilution rights; provided, that no such amendment, modification or waiver shall impair or reduce the antidilution rights, if any, set forth in the Charter with respect to the Common Stock unless such amendment, modification or waiver affects the rights of Warrantholder with respect to the Common Stock issuable hereunder generally in the same manner as it affects all other holders of Common Stock. The Company shall, within ten (10) business days of the end of each fiscal quarter following the Effective Date, provide Warrantholder with written notice of any issuance of its stock or other equity security during such fiscal quarter that triggered an antidilution adjustment under the antidilution rights applicable to the Common Stock purchasable hereunder, if any, as may be set forth in the Charter, which notice shall include (a) the price at which such stock or security was sold, (b) the number of shares issued, and (c) such other information as reasonably necessary for Warrantholder to verify that such antidilution adjustment occurred and the amount of any such adjustment. For the avoidance of doubt, there shall be no duplicate antidilution adjustment pursuant to this subsection (e), the forgoing subsection (d) and the Charter.

(f) Notice of Adjustments . If: (i) the Company shall declare any dividend or distribution upon its Common Stock, whether in stock, cash, property or other securities (assuming Lender consents to a dividend involving cash, property or other securities under the Loan Agreement, if the consent of Lender is then required by the terms of the Loan Agreement); (ii) the Company shall offer for subscription pro rata to the holders of Common Stock any additional shares of stock of any class or other rights; (iii) there shall be any Merger Event; (iv) the Company shall sell, lease, license or otherwise transfer all or substantially all of its assets; or (v) there shall be any voluntary dissolution, liquidation or winding up of the Company; then, in connection with each such event, the Company shall send to the Warrantholder: (A) at least ten (10) business days’ prior written notice of the date on which the books of the Company shall close or a record shall be taken for such dividend, distribution, subscription rights (specifying the date on which the holders of Common Stock shall be entitled thereto) or for determining rights to vote in respect of such Merger Event, sale, lease, license or other transfer of all or substantially all assets, dissolution, liquidation or winding up; and (B) in the case of any such Merger Event, dissolution, liquidation or winding up, at least ten (10) business days’ prior written notice of the date when the same shall take place (and specifying the date on which the holders of Common Stock shall be entitled to exchange their Common Stock for securities or other property deliverable upon such Merger Event, dissolution, liquidation or winding up).

Each such written notice shall set forth, in reasonable detail, (i) the event requiring the notice, and (ii) if any adjustment is required to be made, (A) the amount of such adjustment, (B) the method by which such adjustment was calculated, (C) the adjusted Exercise Price (if the Exercise Price has been adjusted), and (D) the number of shares subject to purchase hereunder after giving effect to such adjustment, and shall be given by first class mail, postage prepaid, or by reputable overnight courier with all charges prepaid, addressed to the Warrantholder at the address for Warrantholder set forth in the registry referred to in Section 7 .

 

4 .

 


 

(g) Timely Notice . Failure to timely provide such notice required by subsection (f) above shall entitle Warrantholder to retain the benefit of the applicable notice period notwithstanding anything to the contrary contained in any insufficient notice received by Warrantholder; provided, that, notwithstanding anything herein to the contrary, the failure to timely provide such notice or any defect therein shall not affect the validity of the corporate action required to be described in such notice.

SECTION 9. REPRESENTATIONS, WARRANTIES AND COVENANTS OF THE COMPANY.

(a) Reservation of Common Stock . The shares of Common Stock issuable upon exercise of the Warrantholder’s rights have been duly and validly reserved and, when issued in accordance with the provisions of this Warrant, will upon issuance be validly issued, fully paid and non-assessable, and will be free of any taxes, liens, charges or encumbrances of any nature whatsoever; provided , that the Common Stock issuable pursuant to this Warrant may be subject to restrictions on transfer under state and/or federal securities laws. The Company has made available to the Warrantholder publicly through the SEC’s EDGAR system true, correct and complete copies of its Charter and current bylaws. The issuance of certificates for shares of Common Stock upon exercise of this Warrant shall be made without charge to the Warrantholder for any issuance tax in respect thereof, or other cost incurred by the Company in connection with such exercise and the related issuance of shares of Common Stock; provided , that the Company shall not be required to pay any tax which may be payable in respect of any transfer and the issuance and delivery of any certificate in a name other than that of the Warrantholder.

(b) Due Authority . The execution and delivery by the Company of this Warrant and the performance of all obligations of the Company hereunder, including the issuance to Warrantholder of the right to acquire the shares of Common Stock, have been duly authorized by all necessary corporate action on the part of the Company. This Warrant: (1) does not violate the Company’s Charter or current bylaws; (2) does not contravene any law or governmental rule, regulation or order applicable to it; and (3) does not and will not contravene any provision of, or constitute a default under, any indenture, mortgage, contract or other instrument to which it is a party or by which it is bound. This Warrant constitutes a legal, valid and binding agreement of the Company, enforceable in accordance with its terms, except as such enforceability may be limited by bankruptcy, insolvency, reorganization, fraudulent conveyance, moratorium or other laws affecting the enforcement of creditors’ rights in general, and except that the enforceability of this Warrant is subject to general principles of equity.

(c) Consents and Approvals . No consent or approval of, giving of notice to, registration with, or taking of any other action in respect of any state, federal or other governmental authority or agency is required on the part of the Company with respect to the execution, delivery and performance by the Company of its obligations under this Warrant, except for the filing of notices pursuant to Regulation D under the Act and any filing required by applicable state securities law, which filings will be effective by the time required thereby.

(d) Issued Securities . All issued and outstanding shares of Common Stock have been duly authorized and validly issued and are fully paid and non-assessable. All outstanding shares of Common Stock and any other Company securities were issued in compliance with all applicable federal and state securities laws in all material respects. In addition, as of the date immediately preceding the Effective Date, no stockholder of the Company has preemptive rights to purchase new issuances of the Company’s capital stock pursuant to the Charter or the Company’s bylaws.

(e) Exempt Transaction . Subject to the accuracy of the Warrantholder’s representations in Section 10 , the issuance of the Common Stock upon exercise of this Warrant will each constitute a transaction exempt from (i) the registration requirements of Section 5 of the Act, in reliance upon Section 4(a)(2) thereof, and (ii) the qualification requirements of the applicable state securities laws.

(f) Compliance with Rule 144 . If the Warrantholder proposes to sell Common Stock issuable upon the exercise of this Warrant in compliance with Rule 144 promulgated by the SEC, then, upon Warrantholder’s written request to the Company, the Company shall furnish to the Warrantholder, within five days after receipt of such request, a written statement confirming the Company’s compliance with the filing requirements of the SEC as set forth in such Rule, as such Rule may be amended from time to time, and shall, subject to such sale being in compliance with all of the conditions of Rule 144, issue appropriate instructions to its transfer agent to remove the restrictive legend from any certificates evidencing the Common Stock issuable upon the exercise of this Warrant.

(g) Information Rights . During the Warrant Term, Warrantholder shall be entitled to the information rights contained in Sections 7.1(b) and 7.1(c) of the Loan Agreement, and Sections 7.1(b) and 7.1(c) of the Loan Agreement are hereby incorporated into this Warrant by this reference as though fully set forth herein, provided, however, that the Company shall not, once all Indebtedness (as defined in the Loan Agreement) owed by the Company to Lender has been repaid, be required to deliver any information required by Section 7.1 of the Loan Agreement so long as the Company is subject to SEC reporting obligations under Section 13(a) or Section 15(d) of the 1934 Act. Notwithstanding anything to the contrary in this Section 9(g) or elsewhere herein, to the extent that this Warrant is transferred to a third party that is not then a party to the Loan Agreement as Lender or is not an affiliate of Lender, then this Section 9(g) shall automatically terminate and shall have no further force or effect.

(h) Listing of Shares . The Common Stock is listed for trading on the NASDAQ Global Market as of the Effective Date.

SECTION 10. REPRESENTATIONS AND COVENANTS OF THE WARRANTHOLDER.

This Warrant has been entered into by the Company in reliance upon the following representations and covenants of the Warrantholder:

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(a) Investment Purpose . The right to acquire Common Stock or the Common Stock issuable upon exercise of the Warrantholder’s rights contained herein has been, and such shares will be, acquired for investment and not with a view to the sale or distribution of any part thereof, and the Warrantholder has no present intention of selling or engaging in any public distribution of the same except pursuant to a registration under the Act or an exemption from the registration requirements of the Act. Warrantholder is not a registered broker-dealer under Section 15 of the 1934 Act or an entity engaged in a business that would require it to be so registered as a broker-dealer.

(b) Private Issue . The Warrantholder understands (i) that the Common Stock issuable upon exercise of this Warrant is not registered under the Act or qualified under applicable state securities laws on the ground that the issuance contemplated by this Warrant will be exempt from the registration and qualifications requirements thereof, and (ii) that the Company’s reliance on such exemption is predicated on the representations set forth in this Section 10 .

(c) Financial Risk . The Warrantholder has such knowledge and experience in financial and business matters as to be capable of evaluating the merits and risks of its investment, and has the ability to bear the economic risks of its investment.

(d) Risk of No Registration . Without in any way limiting the Company’s obligations under this Warrant, the Warrantholder understands that if the Common Stock is not registered with the SEC pursuant to Section 12 of the 1934 Act or the Company is not required to file reports pursuant to Section 13(a) or Section 15(d) of the 1934 Act, or if a registration statement is not effective under the Act covering the resale of the shares of Common Stock issuable upon exercise of the Warrant when it desires to sell (i) the rights to purchase Common Stock pursuant to this Warrant or (ii) the Common Stock issuable upon exercise of the right to purchase, as applicable, it may be required to hold such securities for an indefinite period. The Warrantholder also understands that any sale of (A) its rights hereunder to purchase Common Stock or (B) Common Stock issued or issuable hereunder which might be made by it in reliance upon Rule 144 under the Act may be made only in accordance with the terms and conditions of that Rule.

(e) Accredited Investor . Warrantholder is, and on each date on which it exercises any portion of this Warrant, it will be, an “accredited investor” within the meaning of the Securities and Exchange Rule 501 of Regulation D, as presently in effect.

(f) No Short Sales . Warrantholder has not engaged, and will not engage, in “short sales” of the Common Stock of the Company at any time on or prior to the Effective Date and until the Termination Date. The term “short sale” shall mean any sale of a security which the seller does not own or any sale which is consummated by the delivery of a security borrowed by, or for the account of, the seller.

SECTION 11. TRANSFERS.

Subject to compliance with applicable federal and state securities laws, this Warrant and all rights hereunder are transferable, in whole or in part, without charge to the holder hereof (except for transfer taxes) upon surrender of this Warrant properly endorsed. Each taker and holder of this Warrant, by taking or holding the same, consents and agrees that this Warrant, when endorsed in blank, shall be deemed negotiable, and that the holder hereof, when this Warrant shall have been so endorsed and its transfer recorded on the Company’s books, shall be treated by the Company and all other persons dealing with this Warrant as the absolute owner hereof for any purpose and as the person entitled to exercise the rights represented by this Warrant. The transfer of this Warrant shall be recorded on the books of the Company upon receipt by the Company of a notice of transfer in the form attached hereto as Exhibit C (the “ Transfer Notice ”), at its principal offices and the payment to the Company of all transfer taxes and other governmental charges imposed on such transfer. Until the Company receives such Transfer Notice, the Company may treat the registered owner hereof as the owner for all purposes. Notwithstanding anything herein or in any legend to the contrary, the Company shall not require an opinion of counsel in connection with any sale, assignment or other transfer by Warrantholder of this Warrant (or any portion hereof or any interest herein) or of any shares of Common Stock issued upon any exercise hereof to an affiliate (as defined in Regulation D) of Warrantholder, provided that such affiliate is an “accredited investor” as defined in Regulation D.  Upon a permitted transfer of this Warrant to another entity, references to “Warrantholder” herein shall, unless the context otherwise requires, refer to such permitted transferee.

SECTION 12. MISCELLANEOUS.

(a) Effective Date . The provisions of this Warrant shall be construed and shall be given effect in all respects as if it had been executed and delivered by the Company on the date hereof. This Warrant shall be binding upon any successors or assigns of the Company and the Warrantholder.

(b) Remedies . In the event of any default hereunder, the non-defaulting party may proceed to protect and enforce its rights either by suit in equity and/or by action at law, including but not limited to an action for damages as a result of any such default, and/or an action for specific performance for any default where Warrantholder will not have an adequate remedy at law and where damages will not be readily ascertainable. The Company expressly agrees that it shall not oppose an application by the Warrantholder or any other person entitled to the benefit of this Warrant requiring specific performance of any or all provisions hereof or enjoining the Company from continuing to commit any such breach of this Warrant.

(c) No Impairment of Rights . The Company will not, by amendment of its Charter or through any other means, avoid or seek to avoid the observance or performance of any of the terms of this Warrant, but will at all times in good faith assist in the carrying out of all such terms and in the taking of all such actions as may be reasonably necessary or appropriate in order to protect the rights of

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the Warrantholder against impairment. Notwithstanding the foregoing, nothing in this Section 12(c) shall negate or otherwise restrict or impair the Company’s right to effect any changes to the rights, preferences, privileges or restrictions associated with the Common Stock so long as such changes do not adversely affect the rights, preferences, privileges or restrictions associated with the shares of Common Stock issuable upon exercise of this Warrant in a manner different from the effect that such changes have generally on the rights, preferences, privileges or restrictions associated with all other shares of Common Stock.

(d) Additional Documents . The Company, upon execution of this Warrant, shall provide the Warrantholder with certified resolutions with respect to the representations and warranties set forth in the first sentence of Section 9(b) .

(e) Attorney’s Fees . In any litigation, arbitration or court proceeding between the Company and the Warrantholder relating hereto, the prevailing party shall be entitled to reasonable attorneys’ fees and expenses and all reasonable costs of proceedings incurred in enforcing this Warrant. For the purposes of this Section 12(e) , attorneys’ fees shall include without limitation reasonable fees incurred in connection with the following: (i) contempt proceedings; (ii) discovery; (iii) any motion, proceeding or other activity of any kind in connection with an insolvency proceeding; (iv) garnishment, levy, and debtor and third party examinations; and (v) post-judgment motions and proceedings of any kind, including without limitation any activity taken to collect or enforce any judgment.

(f) Severability . In the event any one or more of the provisions of this Warrant shall for any reason be held invalid, illegal or unenforceable, the remaining provisions of this Warrant shall be unimpaired, and the invalid, illegal or unenforceable provision shall be replaced by a mutually acceptable valid, legal and enforceable provision, which comes closest to the intention of the parties underlying the invalid, illegal or unenforceable provision.

(g) Notices . Except as otherwise provided herein, any notice, demand, request, consent, approval, declaration, service of process or other communication that is required, contemplated, or permitted under this Warrant or with respect to the subject matter hereof shall be in writing, and shall be deemed to have been validly served, given, delivered, and received upon the earlier of: (i) the day of transmission by facsimile or hand delivery if transmission or delivery occurs on a business day at or before 5:00 pm in the time zone of the recipient, or, if transmission or delivery occurs on a non-business day or after such time, the first business day thereafter, or the first business day after deposit with an overnight express service or overnight mail delivery service; or (ii) the third calendar day after deposit in the United States mails, with proper first class postage prepaid ( provided , that any Advance Request shall not be deemed received until Lender’s actual receipt thereof), and shall be addressed to the party to be notified as follows:

If to Warrantholder:

HERCULES CAPITAL, INC.

Legal Department

Attention: Chief Legal Officer

400 Hamilton Avenue, Suite 310

Palo Alto, CA 94301

Facsimile: 650-473-9194

Telephone: 650-289-3060

If to the Company:

PARATEK PHARMACEUTICALS, INC.

Attention: Chief Financial Officer (with a copy to General Counsel)

75 Park Plaza, 4 th Floor

Boston, MA 02116

Facsimile: 617-275-0039

Telephone: 617-807-6600

With a copy to (which shall not constitute notice hereunder):

 

ROPES & GRAY LLP

Attention: Christopher D. Comeau

Prudential Tower

800 Boylston Street

Boston, MA 02199

Facsimile: (617) 235-0566

Telephone: (617) 951-7000

or to such other address as each party may designate for itself by like notice.

(h) Entire Agreement; Amendments . This Warrant constitutes the entire agreement and understanding of the parties hereto in respect of the subject matter hereof, and supersede and replace in their entirety any prior proposals, term sheets, letters, negotiations or other documents or agreements, whether written or oral, with respect to the subject matter hereof (including Lender’s proposal letter dated July 13, 2018). None of the terms of this Warrant may be amended except by an instrument executed by each of the parties hereto.

(i) Headings . The various headings in this Warrant are inserted for convenience only and shall not affect the meaning or

7.

 


 

interpretation of this Warrant or any provisions hereof.

(j) Advice of Counsel . Each of the parties represents to each other party hereto that it has discussed (or had an opportunity to discuss) with its counsel this Warrant and, specifically, the provisions of Sections 12(n) , 12(o) and 12(p) .

 

(k) No Strict Construction . The parties hereto have participated jointly in the negotiation and drafting of this Warrant. In the event an ambiguity or question of intent or interpretation arises, this Warrant shall be construed as if drafted jointly by the parties hereto and no presumption or burden of proof shall arise favoring or disfavoring any party by virtue of the authorship of any provisions of this Warrant.

(l) No Waiver . Except for the requirement that this Warrant be exercised (or be deemed exercised), if at all, during the Warrant Term, no omission or delay by either party hereto at any time to enforce any right or remedy reserved to it, or to require performance of any of the terms, covenants or provisions hereof by the other party hereto at any time designated, shall be a waiver of any such right or remedy to which such party is entitled, nor shall it in any way affect the right of such party to enforce such provisions thereafter.

(m) Survival . All agreements, representations and warranties contained in this Warrant or in any document delivered pursuant hereto shall be for the benefit of Warrantholder and the Company, as the case may be, and shall survive the execution and delivery of this Warrant and the expiration or other termination of this Warrant.

(n) Governing Law . This Warrant has been negotiated and delivered to Warrantholder in the State of California, and shall have been accepted by Warrantholder in the State of California. Delivery of Common Stock to Warrantholder by the Company under this Warrant is due in the State of California. This Warrant shall be governed by, and construed and enforced in accordance with, the laws of the State of California, excluding conflict of laws principles that would cause the application of laws of any other jurisdiction.

(o) Consent to Jurisdiction and Venue . All judicial proceedings arising in or under or related to this Warrant may be brought in any state or federal court of competent jurisdiction located in the State of California. By execution and delivery of this Warrant, each party hereto generally and unconditionally: (a) consents to personal jurisdiction in Santa Clara County, State of California; (b) waives any objection as to jurisdiction or venue in Santa Clara County, State of California; (c) agrees not to assert any defense based on lack of jurisdiction or venue in the aforesaid courts; and (d) irrevocably agrees to be bound by any judgment rendered thereby in connection with this Warrant. Service of process on any party hereto in any action arising out of or relating to this Warrant shall be effective if given in accordance with the requirements for notice set forth in Section 12(g) , and shall be deemed effective and received as set forth in Section 12(g) . Nothing herein shall affect the right to serve process in any other manner permitted by law or shall limit the right of either party to bring proceedings in the courts of any other jurisdiction.

(p) Mutual Waiver of Jury Trial . Because disputes arising in connection with complex financial transactions are most quickly and economically resolved by an experienced and expert person and the parties wish applicable state and federal laws to apply (rather than arbitration rules), the parties desire that their disputes arising out of this Warrant be resolved by a judge applying such applicable laws. EACH OF THE COMPANY AND WARRANTHOLDER SPECIFICALLY WAIVES ANY RIGHT IT MAY HAVE TO TRIAL BY JURY OF ANY CAUSE OF ACTION, CLAIM, CROSS-CLAIM, COUNTERCLAIM, THIRD PARTY CLAIM OR ANY OTHER CLAIM (COLLECTIVELY, “ CLAIMS ”) ASSERTED BY THE COMPANY AGAINST WARRANTHOLDER OR ITS ASSIGNEE OR BY WARRANTHOLDER OR ITS ASSIGNEE AGAINST THE COMPANY RELATING TO THIS WARRANT. This waiver extends to all such Claims arising out of this Warrant, including Claims that involve persons other than the Company and Warrantholder, and any Claims for damages, breach of contract, specific performance, or any equitable or legal relief of any kind, arising out of this Warrant.

(q) Arbitration .  If the Mutual Waiver of Jury Trial set forth in Section 12(p) is ineffective or unenforceable, the parties agree that all Claims shall be submitted to binding arbitration in accordance with the commercial arbitration rules of JAMS (the “ Rules ”), such arbitration to occur before one arbitrator, which arbitrator shall be a retired California state judge or a retired Federal court judge.  Such proceeding shall be conducted in Santa Clara County, State of California, with California rules of evidence and discovery applicable to such arbitration.  The decision of the arbitrator shall be binding on the parties, and shall be final and non-appealable to the maximum extent permitted by law.  Any judgment rendered by the arbitrator may be entered in a court of competent jurisdiction and enforced by the prevailing party as a final judgment of such court.

(r) Pre-arbitration Relief .  In the event Claims are to be resolved by arbitration, either party may seek from a court of competent jurisdiction identified in Section 12(o), any prejudgment order, writ or other relief and have such prejudgment order, writ or other relief enforced to the fullest extent permitted by law notwithstanding that all Claims are otherwise subject to resolution by binding arbitration

(s) Counterparts . This Warrant and any amendments, waivers, consents or supplements hereto may be executed in any number of counterparts, and by different parties hereto in separate counterparts, each of which when so delivered shall be deemed an original, but all of which counterparts shall constitute but one and the same instrument.

(t) Specific Performance . The parties hereto hereby declare that it is impossible to measure in money the damages which will accrue to a party hereto by reason of the other party’s failure to perform any of the obligations under this Warrant and agree that the terms of this Warrant shall be specifically enforceable by either party hereto. If a party hereto institutes any action or proceeding to specifically enforce the provisions hereof, any person against whom such action or proceeding is brought hereby waives the claim or

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defense therein that such party has an adequate remedy at law, and such person shall not offer in any such action or proceeding the claim or defense that such remedy at law exists.

(u) Lost, Stolen, Mutilated or Destroyed Warrant .  If this Warrant is lost, stolen, mutilated or destroyed, the Company may, upon receiving an agreement from the Holder as to indemnity or otherwise as it may reasonably require (which shall, in the case of a mutilated Warrant, include the surrender thereof), issue a new Warrant of like denomination and tenor as this Warrant so lost, stolen, mutilated or destroyed.

 

 

 

 

[Remainder of page left blank intentionally; signature page follows]


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IN WITNESS WHEREOF, the parties hereto have caused this Warrant Agreement to be executed by their respective officers thereunto duly authorized as of the Effective Date.

 

COMPANY: PARATEK PHARMACEUTICALS, INC.

 

 

By:      /s/ Douglas W. Pagán

Name:  Douglas W. Pagán

Title:   Chief Financial Officer

 

 

 

 

WARRANTHOLDER: HERCULES CAPITAL, INC.

 

By:     /s/ Jennifer Choe

Name:  Jennifer Choe

Title:   Assistant General Counsel

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

[Signature Page to Warrant – Paratek/Hercules Capital, Inc.]


10.

 


 

EXHIBIT A

 

To: [____________________________]

(1)

The undersigned Warrantholder hereby elects to purchase [_______] shares of the Common Stock of [_________________], pursuant to the terms of the Agreement dated the [___] day of [______, _____] (the “Agreement”) between [_________________] and the Warrantholder, and [CASH PAYMENT: tenders herewith payment of the Purchase Price in full, together with all applicable transfer taxes, if any.] [NET ISSUANCE: elects pursuant to Section 3(a) of the Agreement to effect a Net Issuance.]

(2)

Please issue a certificate or certificates representing said shares of Common Stock in the name of the undersigned or in such other name as is specified below.

 

(Name)

 

 

(Address)

 

WARRANTHOLDER:

HERCULES CAPITAL, INC.

a Maryland corporation

 

 

By:

Name:
Title:

 


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EXHIBIT B

ACKNOWLEDGMENT OF EXERCISE

The undersigned, as representative of Paratek Pharmaceuticals, Inc. (the “ Company ”), hereby acknowledges receipt of the “Notice of Exercise” from Hercules Capital, Inc. (the “ Warrantholder ”), to purchase [   ] shares of the Common Stock of the Company, pursuant to the terms of that certain Warrant Agreement, dated as of August 1, 2018 between the Company and the Warrantholder (the “ Warrant ”), and further acknowledges that [   ] shares remain subject to purchase under the terms of the Warrant.

 

 

 

 

 

 

 

 

 

 

COMPANY:

 

 

 

PARATEK PHARMACEUTICALS, INC.

 

 

 

 

 

 

 

 

 

 

 

By:

  

  

 

 

 

 

 

 

Title:

  

  

 

 

 

 

 

 

Date:

  

  


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EXHIBIT C

TRANSFER NOTICE

FOR VALUE RECEIVED, that certain Warrant Agreement, dated as of August 1, 2018, between Paratek Pharmaceuticals, Inc., as the Company, and Hercules Capital, Inc., as the Warrantholder (the “ Warrant ”), and all rights evidenced thereby are hereby transferred and assigned to

 

 

 

(Please Print)

 

 

 

 

whose address is

  

  

 

 

 

 

 

 

 

 

 

 

Dated:

  

  

 

 

 

 

 

 

 

 

 

 

Holder’s Signature:

  

  

 

 

 

 

 

 

 

 

 

 

Holder’s Address:

  

  

 

 

 

  

 

 

 

 

 

Signature Guaranteed:

  

  

NOTE: The signature to this Transfer Notice must correspond with the name as it appears on the face of the Warrant, without alteration or enlargement or any change whatever. Officers of corporations and those acting in a fiduciary or other representative capacity should file proper evidence of authority to assign the foregoing Warrant.

2346697.4

13 .

 

Exhibit 10.2

 

THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST.  REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.  

 

Confidential

Execution Version

AMENDED AND RESTATED MANUFACTURING AND SERVICES AGREEMENT

THIS AMENDED AND RESTATED MANUFACTURING AND SERVICES AGREEMENT (this “ Agreement ”) is made and entered into as of April 18, 2018 (the “ Effective Date ”), by and between Paratek Pharmaceuticals, Inc., a corporation organized and existing under the laws of Delaware, with an address at 75 Park Plaza, 4 th Floor, Boston, Massachusetts 02116, United States (“ Paratek ”) and CIPAN ̵̶ Companhia Industrial Produtora de Antibióticos, S.A., a corporation organized and existing under the laws of Portugal with an address at Rua da Estação, n o 42, 2600-726 Castanheira do Ribatejo, Portugal (“ CIPAN ” and, collectively with Paratek, the “ Parties ”, and each, a “ Party ”).

RECITALS

WHEREAS, the Parties entered into that certain Manufacturing and Services Agreement dated as of November 2, 2016 (as amended on October 18, 2017, the “ Original Agreement ”) pursuant to which (a) CIPAN is obligated to manufacture Minocycline HCI dihydrate meeting the Specifications (“ Minocycline ”) and crude Omadacycline meeting the Specifications (“ Crude Omadacycline ” and, collectively with Minocycline, the “ Products ”, and each, a “ Product ”) for Paratek and (b) in [* * *];

WHEREAS, [* * *] CIPAN to renovate an existing manufacturing area in the Original Facility (such area, not to include the Original Facility, the “ New Facility Area ”) to permit such New Facility Area to Manufacture Crude Omadacycline and potentially other products to be agreed upon by the Parties;

WHEREAS, [* * *];

WHEREAS, Paratek desires to have CIPAN Manufacture certain Products for Paratek and CIPAN desires to do so all on the terms and subject to the conditions set forth herein.

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

1.

DEFINITIONS

1.1 Definitions .  As used in this Agreement, the following capitalized terms have the meanings indicated below:

1.1.1 Actual Annual Yield ” has the meaning set forth in Section 7.5.2 .

 


THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST.  REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

1.1.2 Affiliate ” means, with respect to any Person, any other Person which directly or indirectly controls, is controlled by, or is under common control with that Person at any time during the period for which the determination of affiliation is being made.  The term “control,” (including, with correlative meaning, the terms “controlling”, “controlled by” and “under common control with”), as used in this Section 1.1.2 with respect to any Person, means the possession, directly or indirectly, of the power to elect a majority of the board of directors (or other governing body) or to direct or cause the direction of the management and policies of such Person, whether through the ownership of voting securities, by contract or otherwise .

1.1.3 Agreement ” has the meaning set forth in the preamble hereto.

1.1.4 Approval Date ” means, with respect to any Batch, the date on which such Batch is approved for release by CIPAN’s quality assurance group in accordance with the Quality Agreement.

1.1.5 Approved Supplier ” means any supplier that (a) has been approved with respect to quality standards by CIPAN and (b) has been agreed to by Paratek by way of Paratek’s approval of the Quality Agreement in which such supplier has been set forth.

1.1.6 Award of Agreements ” means the delivery to Paratek by CIPAN of a written certification executed by a duly authorized officer of CIPAN and reasonable evidence that either (a) CIPAN has duly submitted all New Facility Area Purchase Orders to the applicable Third Party vendor or (sub)contractor or (b) that CIPAN has awarded all necessary or reasonably anticipated construction agreements to Third Parties for the renovation and completion of the New Facility Area and each such agreement is effective and has been fully executed by CIPAN and the relevant Third Party (or Third Parties) that is party to such agreement.

1.1.7 Batch ” means, with respect to a Product at any given time, a discrete output or isolation from a set of unit operations described in the then-current batch record instructions for such Product.  The batch size for each Product shall be related to the capacity of a given equipment train and is dependent on the maximum utilization of the bottle-neck reactor or vessel.  As of the Original Effective Date, a Batch of Minocycline is [* * *] and a Batch of Crude Omadacycline is approximately [* * *].

1.1.8 Business Day ” means a day on which banking institutions in Boston, Massachusetts and Castanheira do Ribatejo, Portugal are open for business.

1.1.9 Business Continuity Plan ” has the meaning set forth in Section 9.4 .

1.1.10 Calendar Quarter ” means, with respect to any given Calendar Year, the respective periods of three (3) consecutive calendar months ending on March 31, June 30, September 30 or December 31; provided , however , that (a) the first Calendar Quarter of the Term shall extend from the Effective Date to the end of the first complete Calendar Quarter thereafter and (b) the last Calendar Quarter of the Term shall end upon the effective date of expiration or termination of this Agreement.

- 2 -


THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST.  REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

1.1.11 Calendar Year ” means each successive period of twelve (12) consecutive months commencing on January 1 and ending on December 31; provided , however , that (a) the first Calendar Year of the Term shall begin on the Effective Date and end on December 31, 2016; and (b) the last Calendar Year of the Term shall end on the effective date of expiration or termination of this Agreement.

1.1.12 Change of Control ” means any transaction or series of transactions wherein (a) the voting securities of CIPAN outstanding immediately prior thereto cease to represent at least fifty percent (50%) of the combined voting power of the surviving entity immediately after such transaction or transactions; (b) the stockholders or equity holders of CIPAN approve a plan of complete liquidation of CIPAN, or an agreement for the sale or disposition by CIPAN of all or substantially all of CIPAN’s assets, other than to an Affiliate; (c) a Third Party becomes the beneficial owner of fifty percent (50%) or more of the combined voting power of the outstanding securities of CIPAN or (d) substantially all of CIPAN’s business or assets which relate to this Agreement are sold or otherwise transferred to a Third Party.

1.1.13 CIPAN ” has the meaning set forth in the preamble hereto.

1.1.14 CIPAN Improvement ” means any Invention that [* * *].

1.1.15 CIPAN Representatives ” has the meaning set forth in Section 14.1.2 .

1.1.16 CIPAN Technology ” means (a) all intellectual property and embodiments thereof, including any Inventions, owned by CIPAN or its Affiliates as of the Original Effective Date that are not Paratek Technology or Joint Technology [* * *] and (b) the CIPAN Improvements.

1.1.17 Confidential Information ” means, with respect to any Party, such Party’s technology, data, know-how, or information whether written or oral, technical or non-technical, including, but not limited to, financial statements, reports, pricing, trade secrets, secret processes, formulae, samples, customer data (including, but not limited to, customer lists), the formulation of pharmaceutical dosage forms and compounds, manufacturing procedures, manufacturing processes, manufacturing equipment, manufacturing batch records, plant layouts, product volumes, quality control procedures, and quality control standards and the like, that is disclosed to the other Party.  Confidential Information of Paratek shall include Manufacturing Information and Paratek Technology.

1.1.18 Critical Material ” has the meaning set forth in Section 2.4 .

1.1.19 Critical Raw Material Safety Stock ” has the meaning set forth in Section 2.4 .

1.1.20 Crude Omadacycline ” has the meaning set forth in the recitals hereto.

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THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST.  REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

1.1.21 Current Good Manufacturing Practice ” or “ cGMP ” means, at any given time, the current standards for the manufacture of pharmaceuticals, as set forth in the FD&C Act and applicable regulations promulgated thereunder, as amended from time to time, and such standards of good manufacturing practice as are required by the applicable laws and regulations of countries in which Products are intended to be sold, to the extent such standards are not inconsistent with GMP under the FD&C Act.

1.1.22 Effective Date ” has the meaning set forth in the preamble hereto.

1.1.23 Facility ” means the Original Facility, the New Facility Area or any other facility approved in writing by the Parties for the Manufacture of Products.

1.1.24 FDA ” means the United States Food and Drug Administration or any successor entity thereto.

1.1.25 FD&C Act ” means the Federal Food, Drug and Cosmetic Act, as the same may be amended or supplemented from time to time.

1.1.26 Firm Forecast Period ” has the meaning set forth in Section 2.2 .

1.1.27 Force Majeure Event ” has the meaning set forth in Article 17 .

1.1.28 Indemnified Party ” has the meaning set forth in Section 14.1.3 .

1.1.29 Indemnifying Party ” has the meaning set forth in Section 14.1.3 .

1.1.30 Initial Term ” means the [* * *] period commencing on the Original Effective Date.

1.1.31 Inspection Period ” has the meaning set forth in Section 10.3.1 .

1.1.32 Invention ” means any development, information, invention, improvement, know-how, data or intellectual property, whether or not reduced to practice and whether or not patentable.

1.1.33 Joint Technology ” has the meaning set forth in Section 12.1.3 .

1.1.34 Key Performance Indicators ” or “ KPIs ” has the meaning set forth in Section 7.5.1 .

1.1.35 Laboratory ” shall mean any independent laboratory mutually acceptable to both Parties that meets all requirements of an outside laboratory as specified in the Quality Agreement.  For the purposes of this definition, an “independent” laboratory shall not include any laboratory whose analysis is the subject of the relevant dispute.

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THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST.  REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

1.1.36 Latent Defect ” shall mean any defect in a Product that is not reasonably discoverable through Paratek’s (or Paratek’s designee’s) normal incoming goods inspection verification methods and procedures, such methods and procedures to be in accordance with the Quality Agreement. By way of example only, the discoloration of a Product over time due to the presence of an excipient that is not compliant with the Specifications would constitute a Latent Defect.

1.1.37 Long Range Forecast ” has the meaning set forth in Section 2.2.2 .

1.1.38 Losses ” has the meaning set forth in Section 14.1.1 .

1.1.39 Manufacture ,” “ Manufactured ” or “ Manufacturing ” means all activities involved in the production of Products to be supplied to Paratek or its Affiliates hereunder, including the preparation, formulation, finishing, testing, storage and packaging for shipment of Products and the handling, storage and disposal of any residues or wastes generated thereby.

1.1.40 Manufacturing Information ” means all information and data relating to the Manufacture of Products provided by Paratek to CIPAN hereunder, including the Specifications, Methods of Analysis and all formulas and processes.

1.1.41 Materials ” means all materials, including all raw materials and ingredients required for the Manufacture of Products.

1.1.42 Maximum Capacity ” has the meaning set forth in Section 5.2 .

1.1.43 Methods of Analysis ” means the methods of analysis for the Products set forth in the Quality Agreement, as such Quality Agreement may be amended from time to time in accordance with its terms.

1.1.44 Minocycline ” has the meaning set forth in the recitals hereto.

1.1.45 New Facility Area ” has the meaning set forth in the recitals hereto.

1.1.46 New Facility Area Purchase Orders” means all necessary firm purchase orders for the purchase of that equipment set forth on Exhibit B under the heading “New Facility Area” by CIPAN.

1.1.47 New Facility Area Renovation Schedule ” has the meaning set forth in Section 5.1 .

1.1.48 Operational Qualification ” means the documented demonstration or verification of whether a facility, process equipment and sub-systems, as installed or modified, perform as intended throughout anticipated operating ranges. Such performance may include whether such systems are capable of consistently operating within established limits and tolerances by testing (at upper and lower operating limits) compliance with the requirements identified in the corresponding design specifications for such facility, individual equipment, or sub-system and confirming whether any newly acquired equipment (or facilities, services or systems) functions as expected, that all parts and components operate correctly, that all controls perform the intended function and that all gauges and

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indicators are calibrated and display the correct value. Operational Qualification should follow on from the installation of the equipment and sub-systems and should include tests that have been developed based on detailed knowledge of equipment, systems or processes.  Following successful completion of the Operational Qualification activities, development batches may be run in preparation for the facility validation activities.

1.1.49 Original Agreement ” has the meaning set forth in the recitals hereto.

1.1.50 Original Effective Date ” means November 2, 2016.

1.1.51 Original Facility ” means CIPAN’s facility located at Rua da Estação, n o 42, Vala do Carregado, 2600-726 Castanheira do Ribatejo, Portugal.

1.1.52 Paratek ” has the meaning set forth in the preamble hereto.

1.1.53 [* * *]

1.1.54 Paratek Improvement ” means any Invention [* * *].

1.1.55 [* * *]

1.1.56 [* * *]

1.1.57 Paratek Licensee ” means any Third Party to whom Paratek grants a license or a right to research, develop, make, have made, use, sell, have sold, import, export or otherwise exploit a Product or Paratek Product.

1.1.58 Paratek Product ” means any pharmaceutical product owned, controlled or sold by Paratek, its Affiliates or Paratek Licensees that incorporates or is derived from a Product.

1.1.59 Paratek Representatives ” has the meaning set forth in Section 14.1.1 .

1.1.60 Paratek Technology ” means (a) all intellectual property and embodiments thereof, including any Inventions, owned by Paratek as of the Effective Date that are not Joint Technology and (b) the Paratek Improvements.

1.1.61 Party ” and “ Parties ” have the meaning set forth in the preamble hereto.

1.1.62 Permitted Third Party Activities ” has the meaning set forth in Section 6.4.2 .

1.1.63 [* * *]

1.1.64 Person ” means any natural person, corporation, general partnership, limited partnership, proprietorship, other business organization, trust, union, association or governmental authority.

1.1.65 Product ” and “ Products ” have the meaning set forth in the recitals hereto.

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THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST.  REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

1.1.66 Quality Agreement ” has the meaning set forth in Section 9.1 .

1.1.67 Recall ” means any recall, withdrawal or corrective action (whether voluntary or mandatory) or issue of an “NDA Field Alert” (as defined in 21 CFR 314.81).

1.1.68 Regulatory Approval ” means all authorizations by the competent Regulatory Authorities which are required for the manufacture, marketing, promotion, pricing and sale of a Product in a given country or regulatory jurisdiction in the Territory.

1.1.69 Regulatory Authority ” means any national, supra-national, regional, state or local regulatory agency, department, bureau, commission, council or other governmental entity involved in the granting of Regulatory Approval for Products in the Territory.

1.1.70 [* * *]

1.1.71 Rejection Notice ” has the meaning set forth in Section 10.3.1 .

1.1.72 Renewal Term ” means each consecutive [* * *] period commencing on the expiration of the Initial Term or immediately preceding Renewal Term, until this Agreement is terminated pursuant to Article 15 .

1.1.73 [* * *]

1.1.74 Rolling Clinical Forecast ” has the meaning set forth in Section 2.2 .

1.1.75 Rolling Commercial Forecast ” has the meaning set forth in Section 2.2 .

1.1.76 Rolling Forecast ” means a Rolling Clinical Forecast or a Rolling Commercial Forecast, as applicable.

1.1.77 Scope of Work ” has the meaning set forth in Section 3.1 .

1.1.78 Seizure ” means any action by FDA or any other Regulatory Authority to detain or destroy Product or prevent the release of Product.

1.1.79 Services ” has the meaning set forth in Section 3.1 .

1.1.80 Shortfall ” has the meaning set forth in Section 7.5.3 .

1.1.81 [* * *]

1.1.82 Specifications ” means the specifications for the Products set forth in the Quality Agreement, as such specifications may be amended from time to time in accordance with the terms of the Quality Agreement.  

1.1.83 Supply Price ” has the meaning set forth in Section 8.1 .

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THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST.  REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

1.1.84 Site Visit ” has the meaning set forth in Section 10.2 .

1.1.85 Target Yield ” has the meaning set forth in Section 7.5.2 .

1.1.86 Term ” means, in the aggregate, the Initial Term and all Renewal Terms, if any.

1.1.87 Territory ” means the United States of America and its territories and possessions and any other countries in the world added to the definition of “Territory” pursuant to Section 2.6 .

1.1.88 Third Party ” means any Person other than Paratek, CIPAN and their respective Affiliates.

1.1.89 [* * *]

1.1.90 [* * *]

1.1.91 [* * *]

1.1.92 Validation Activities ” means (a) those validation activities required for regulatory submissions to the applicable Regulatory Authorities for Regulatory Approval of the Manufacture of the Products and sale of the Paratek Products and [* * *].

1.1.93 Validation Batch ” means a batch or lot produced from a validation run. Each Validation Batch is intended to produce Product that is commercially saleable when contained in a finished Paratek Product.

1.2 Construction of Certain Terms and Phrases .  Unless the context of this Agreement otherwise requires, (i) words of any gender include each other gender; (ii) words using the singular or plural number also include the plural or singular number, respectively; (iii) the term “or” shall have the inclusive meaning of the term “and/or”; (iv) “including” and its cognates shall have the non-limiting meaning of “including, without limitation”; (v) the term “will” shall have the same meaning and import as the term “shall”; (vi) the terms “hereof,” “herein,” “hereby” and derivative or similar words refer to this entire Agreement; (vii) the terms “Article” or “Section” refer to the specified Article or Section of this Agreement; and (viii) Article and Section headings shall not affect the meaning or construction of any provision of this Agreement.

2.

GENERAL; FORECASTS and ORDERS

2.1 Manufacture .  CIPAN shall Manufacture and supply Products to Paratek or Paratek’s designee in such quantities and at such times as ordered by Paratek pursuant to the terms of this Agreement, including Section 5.2 which establishes the Maximum Capacity of the New Facility Area, in exchange for payment of the applicable Supply Price for such Products.  During the Term, CIPAN shall maintain the resources necessary to Manufacture Products pursuant to the terms of this Agreement and shall provide, at its own expense, all Materials and labor necessary to do so.

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2.2 Forecasts .  

2.2.1 Within [* * *] after the Effective Date, Paratek shall submit to CIPAN a forecast of clinical supply of Products that Paratek anticipates ordering from CIPAN during the  [* * *] period (broken down by Product and by month and, if applicable, country in the Territory) following the date of such forecast and Paratek shall update such forecast on a rolling [* * *] basis every [* * *] thereafter (each, a “ Rolling Clinical Forecast ”) until Paratek no longer requires any clinical supply of Products.  Beginning [* * *] prior to the anticipated launch of a Paratek Product in the Territory and for the remainder of the Term, Paratek shall submit to CIPAN a forecast of commercial supply of Products that Paratek anticipates ordering from CIPAN during the  [* * *] period (broken down by Product and by month and, if applicable, country in the Territory) following the date of such forecast and Paratek shall update such forecast on a rolling [* * *] basis every [* * *] thereafter (each, a “ Rolling Commercial Forecast ”), provided that Paratek shall provide an updated Rolling Commercial Forecast within [* * *] after such Paratek Product receives Regulatory Approval by the applicable Regulatory Authority in a country in the Territory. Paratek shall place purchase orders for at least the quantity of each Product specified in the first [* * *] of each such Rolling Clinical Forecast or Rolling Commercial Forecast (such period, the “ Firm Forecast Period ”) and the remaining [* * *] of such forecast shall be a good faith estimate.  Except as set forth in the immediately preceding sentence, Paratek shall not be required to order any fixed minimum quantity of either Product, notwithstanding any forecast or prior course of dealing.  

2.2.2 For the purposes of discussion and planning of manufacturing capacity, [* * *] Paratek shall provide CIPAN with a non-binding forecast of Products needed under this Agreement for each of the next [* * *] (“ Long Range Forecast ”).  The Long Range Forecast is to be used for long-range planning purposes only and does not supersede the Rolling Clinical Forecasts and Rolling Commercial Forecasts set forth in Section 2.2.1 nor shall such Long Range Forecast be deemed binding in any manner upon Paratek.

2.3 Orders .  Paratek or a designee of Paratek may submit purchase orders for Products to CIPAN from time to time during the Term and at least [* * *] prior to the requested date of delivery. Each purchase order shall specify (a) the quantity of each Product ordered for delivery; and (b) the delivery date for that order.  CIPAN shall Manufacture and supply Products in accordance with this Agreement and each applicable purchase order.  Within five (5) Business Days after receiving any purchase order from Paratek, CIPAN shall accept such purchase order in writing if it has been submitted and is otherwise in accordance with the terms and conditions of this Agreement and upon CIPAN’s acceptance of such purchase order, CIPAN shall provide Paratek with a Manufacturing schedule for the Products subject to such purchase order; provided that any failure by CIPAN to reject such a purchase order in the five (5) Business Day period following receipt shall be deemed an acceptance of such Purchase Order by CIPAN.   Notwithstanding the foregoing, with respect to any of the [* * *] in the then most recent Firm Forecast Period, CIPAN  may reject, by written notice to Paratek, any portion of any purchase order to the extent that fulfilling the entirety of such purchase order would cause the aggregate number of units of a Product supplied by CIPAN during such month to exceed [* * *] of the units of such Product forecast for such month in the applicable Rolling Forecast; provided , however , that CIPAN will use its reasonable efforts to, but shall not be obligated to, supply such Product in excess of such [* * *] quantity.   Paratek may cancel any firm purchase order at any time as long as any cancellation of a purchase order placed for Product within the Firm Forecast Period for such Product occurs no later than [* * *] prior to the delivery date for such purchase order; provided that [* * *].

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2.4 Safety Stock .  To facilitate timely Product supply in the quantities ordered by Paratek, CIPAN agrees, at all times during the Term, to keep a safety stock of the Materials listed on Exhibit E attached hereto (each product or material listed, a “ Critical Material ” and the safety stock of such Critical Materials, the “ Critical Raw Material Safety Stock ”) in an amount equal, with respect to each Critical Material, to that quantity required to satisfy the production of applicable Product under this Agreement for the number of “Target Months on Hand” set forth for such Critical Material on Exhibit E .  CIPAN shall rotate and replenish any Critical Materials in a timely manner in the event that Supplier requires the use of any Critical Material from the Critical Raw Material Safety Stock to meet a purchase order or if Paratek requests additional Product under the provisions of Section 2.3 .   From time to time, and at least once per year, the Supply and Quality Committee shall (a) review the Critical Raw Material Safety Stock descriptions set forth on Exhibit E and approve any changes thereto to ensure that the information for each Critical Material, including the safety stock target thereof, is accurate and complete , (b) determine whether any additional Materials should be defined as Critical Materials hereunder and (c) determine which additional Materials should also be subject to a safety stock kept by CIPAN.  With respect to clause (c) of this Section 2.4 , CIPAN shall keep a safety stock of any Materials that are not Critical Materials according to the terms agreed upon by the Supply and Quality Committee.

2.5 [* * *]

2.6 Territory Expansion .  At any time during the Term, Paratek may provide written notice to CIPAN of its desire to expand the Territory under this Agreement with respect to one (1) or both Products to include one (1) or more additional countries or territories.  Promptly following such notification, the Supply and Quality Committee shall meet to discuss any expansion of CIPAN’s Manufacturing capabilities that would be necessitated by such expansion in accordance with clause (b) of Section 4.3 and the Parties shall use good faith commercially reasonable efforts to execute an amendment that (a) amends the definition of “Territory” under Section 1.1.87 to include such additional countries or territories and (b) modifies the provisions of this Agreement as necessary in order to reflect the regulatory requirements of such additional countries or territories.  For clarity, Paratek shall not be obligated to amend the definition of Territory at any point during the Term.

2.7 Supply to Paratek Licensees .  In the event Paratek delivers a written request to CIPAN requesting that CIPAN engage in negotiations with a Paratek Licensee on the terms of a definitive agreement pursuant to which CIPAN would Manufacture and supply one (1) or both Products to such Paratek Licensee or a designee of a Paratek Licensee, CIPAN shall use commercially reasonable good faith efforts to negotiate and execute such agreement on substantially the same terms of this Agreement (including pricing, orders, forecasting, delivery, non-conformance, failure to supply, term and termination).  

2.8 Process Improvements .  

2.8.1 During the Term, CIPAN, in coordination with the Supply and Quality Committee, shall use reasonable efforts to reduce the cost of Manufacturing Products [* * *].  In the event that Paratek presents CIPAN with a proposal to lower the costs of Manufacturing any Product (including purchasing strategies, process improvement, equipment selection, layout, etc.), CIPAN shall not unreasonably withhold its approval and implementation of such proposal [* * *]. Any reductions in Manufacturing costs stemming from process improvements or Paratek’s proposals pursuant to this

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Section 2.8.1 [* * *] and upon Paratek’s request, the Parties shall promptly meet to re-evaluate and mutually agree in good faith upon a reduction in the Supply Price for Products reflecting [* * *] of such reduction in Manufacturing costs .

2.8.2 CIPAN will provide to Paratek, subject to applicable confidentiality obligations under this Agreement, [* * *].

3.

Services

3.1 Scopes of Work .  CIPAN shall perform for Paratek certain services related to the development, technology transfer, process improvements and Manufacturing (including scale-up and validation) of the Products (the “ Services ”) as set forth in one (1) or more statements of work to be mutually agreed by the Parties and attached as addenda to this Agreement (each, a “ Scope of Work ”).    Each Scope of Work shall be automatically incorporated by reference into and governed by the terms and conditions of this Agreement.  A Scope of Work shall include the scope of Services to be provided by CIPAN, any deliverables or milestones in connection with such Services, the fees payable for such Services, the applicable standard of service to be provided and any other relevant terms and conditions not already set forth in this Agreement.  In the event of any conflict between this Agreement and any Scope of Work, the terms of this Agreement shall govern unless the Scope of Work explicitly states that its terms and conditions are to supersede this Agreement.  The Parties may amend the activities or costs set forth in any Scope of Work by mutual written agreement.

3.2 Fees . As part of a Scope of Work, the Parties will negotiate reasonable costs for the Services to be performed by CIPAN for Paratek under such Scope of Work.  CIPAN shall submit a cost estimate to Paratek for any such Service, and shall not commence any such Service until Paratek provides written notice of its approval of such cost estimate (or the Parties otherwise mutually agree on the costs for such Service).  As a general principle, any such cost estimate shall reflect [* * *].

4.

SUPPLY AND QUALITY COMMITTEE

4.1 Composition . The Supply and Quality Committee shall be comprised of an equal number of representatives of each Party.  Each Party shall appoint its respective representative to the Supply and Quality Committee within thirty (30) days of the Effective Date, and from time to time, may substitute one (1) or more of its representatives, in its sole discretion, effective upon notice to the other Party of such change.  All Supply and Quality Committee representatives shall have appropriate expertise, seniority, decision-making authority and relevant expertise in matters related to the Manufacturing and supply of Products.  

4.2 Meetings . The Supply and Quality Committee shall meet as necessary to carry out its duties under Section 4.3 , but no more often than once per Calendar Quarter, unless otherwise agreed by its members.  Unless otherwise agreed by the Parties, each Party will request that one or more of its executive officers attend one meeting of the Supply and Quality Committee each Calendar Year.  The Supply and Quality Committee shall meet in-person at Paratek or CIPAN or, alternatively, by means of teleconference, videoconference or other similar communications equipment.

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4.3 Supply and Quality Committee Responsibilities .  The Supply and Quality Committee shall provide a forum for the discussion, coordination and review of all activities under this Agreement (including under any Scope of Work), and shall in particular have responsibility for the following: (a) reviewing key metrics for each Product’s production and quality, and reviewing and monitoring any required remediation with respect to production and quality for each Product; (b) reviewing CIPAN’s capacity and short-term and long-term planning for clinical and commercial supply of each Product, including anticipating any capacity shortfalls and discussing the cost allocation of investments required to increase capacity or improve efficiencies; (c) reviewing and discussing draft Scopes of Work; (d) establishing resource priorities and resolving resource conflicts; [ * * *].

4.4 Decision-Making . All of each Party’s representatives on the Supply and Quality Committee shall collectively have one (1) vote with respect to decisions before the Supply and Quality Committee.  Unless this Agreement provides for a Party to have decision-making authority with respect to a topic within the Supply and Quality Committee’s purview, all decisions of the Supply and Quality Committee must be made by unanimous consent, which shall be documented in written minutes of the Supply and Quality Committee and signed by a representative of each Party.  [* * *]

5.

NeW FACILITY AREA; RELATED INVESTMENT

5.1 New Facility Area Renovation .  [* * *]  To oversee the renovation of the New Facility Area, CIPAN, through its Engineering and Procurement Departments, will contract with an internationally recognized construction firm(s) with a demonstrated experience in industrial facilities. CIPAN shall construct the New Facility Area (i) in accordance with the construction schedule set forth in Exhibit C (the “ New Facility Area Renovation Schedule ”), (ii) to meet cGMPs and (iii) to meet all FDA requirements for equipment qualification and computer system validation.  [* * *]

5.2 New Facility Area Requirements .  CIPAN shall complete the renovation of the New Facility Area as soon as practicable, but in no event later than [* * *] after the Effective Date of this Agreement, at which time (i) the New Facility Area shall be able to produce, on an annual basis, at least [* * *] of Crude Omadacycline, (ii) the Original Facility shall have the capacity to produce, on an annual basis, at least [* * *] of Minocycline and (iii) shall have completed Operational Qualification and the Validation Activities.  By [* * *], CIPAN shall finalize the expansion of the New Facility Area’s annual production capacity to be [* * *] of Crude Omadacycline with a batch size of [* * *] (the “ Maximum Capacity ”) and the Original Facility shall have the capacity to produce on an annual basis at least [* * *] of Minocycline.  Without restricting any other right of Paratek hereunder, [* * *].  For clarity, any breach of this Section 5.2 by CIPAN shall be deemed a breach of CIPAN’s material obligations under this Agreement.

5.3 Ownership . CIPAN covenants that it shall own the Original Facility and the New Facility Area at all times during the Term.  [* * *]

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5.4 Paratek Additional Investment .  Subject to the terms and conditions set forth in this Agreement, in consideration of CIPAN’s commitment to Manufacture Products under this Agreement by renovating the New Facility Area as described in this Agreement, Paratek shall pay to CIPAN the following amounts upon the fulfillment of particular New Facility Area Milestone Events as set forth below:

New Facility Area Milestone Event

Milestone Payment

[* * *]

[* * *]

[* * *]

[* * *]

[* * *]

[* * *]

[* * *]

[* * *]

 


For clarity, in no event shall Paratek be obligated to pay more than [* * *] to CIPAN under this Section 5.4 and each New Facility Area Milestone shall be payable one time only regardless of the number of times that the specified event occurs.  CIPAN shall notify Paratek of the achievement of each New Facility Area Milestone Event with a proforma invoice for the relevant milestone payment, which shall be paid by Paratek within [* * *] of Paratek’s receipt of such invoice, except that Paratek shall pay the milestone payment due upon the Effective Date of this Agreement within [* * *] following the Effective Date.  Each payment made to CIPAN by Paratek under this Section 5.4 shall be [* * *].

6.

[* * *]; ALTERNATIVE SUPPLY AND NEW FACILITY AREA .

6.1 [ * * *]

6.2 [ * * *]

6.3 Alternative Supply .  At any time during the Term, Paratek may elect to qualify one (1) or more alternative manufacturing facilities (whether owned by a Third Party, Paratek or by one of Paratek’s Affiliates) to Manufacture the Products (each, a “ Backup Supplier ”).  Paratek shall be responsible for any costs associated with qualifying Backup Suppliers.  [* * *]  CIPAN shall use commercially reasonable efforts to cooperate with the qualification of any Backup Supplier, including (a) technology transfer of all CIPAN Technology, Joint Technology and, to the extent in its possession, Paratek Technology, necessary or useful for the Manufacture of the Products; provided that, to the extent that such technology and know-how constitutes CIPAN Confidential Information it shall be subject to the provisions of Article 16 and Paratek’s designated Backup Supplier shall be required to enter into a confidentiality agreement with CIPAN containing substantially the same terms as Article 16 and (b) providing Paratek and any Backup Supplier with consulting services related to the Manufacture, quality control and quality assurance of the Products.   Paratek shall reimburse CIPAN for performing such services described in the preceding sentence at [* * *] within [* * *] of invoice.

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6.4 [ * * * ]  

6.4.1 [* * *]

6.4.2 During the Term, CIPAN shall not, and shall cause its Affiliates not to, enter into any agreement or other obligation with a Third Party, including by accepting a purchase order from a Third Party, to manufacture any product or component thereof in, to perform any services in, or to otherwise reserve or use any capacity of, the New Facility Area except to the extent the New Facility Area, after fulfilling Paratek’s demand as estimated in the Rolling Forecasts and the Long Range Forecast, has capacity available for such manufacture or services (such activities that can be conducted utilizing such excess capacity, the “ Permitted Third Party Activities ”).  Permitted Third Party Activities may only take place on terms reasonably acceptable to Paratek and CIPAN shall pay Paratek [* * *] of any [* * *] within [* * *] of CIPAN or its Affiliate’s receipt of such payment.  Each payment made to CIPAN by Paratek under this Section 6.4 [* * *].

6.4.3 [* * *]  

6.4.4 CIPAN will keep and will cause its Affiliates to keep books and accounts of record in connection with [* * *] in sufficient detail to permit accurate determination of royalties on [* * *] to be paid hereunder. CIPAN and its Affiliates will maintain such records for [* * *].  Upon [* * *] prior notice from Paratek, CIPAN will permit an independent certified public accounting firm selected by Paratek to examine, at [* * *] sole expense, the relevant books and records of CIPAN and its Affiliates as may be reasonably necessary to verify the royalties on [* * *] under Section 6.4.2 . The accounting firm will be provided access to such books and records at CIPAN’s or its Affiliates’ facility(ies) during CIPAN’s normal business hours.  Upon completion of the audit, the accounting firm will provide both Parties a written report disclosing any discrepancies in the royalties paid to Paratek, and specific details related thereto.  If such accounting firm concludes that additional royalties were due to Paratek, then CIPAN will pay to Paratek the additional royalties within [* * *] of the receipt of such report. Further, if the amount of such underpayments exceeds more than [* * *] of the amount that was payable to Paratek, then CIPAN will reimburse Paratek for Paratek’s out-of-pocket costs in connection with the audit.

7.

DELIVERY; FAILURE TO SUPPLY

7.1 Delivery .   All Products shall be delivered [* * *].  CIPAN will notify Paratek at least ten (10) Business Days prior to any shipment of Product.  CIPAN is responsible for the arrangement of transport of Products from the Facility to the shipping destination specified in the purchase order.  All Products shall be suitably prepared and packed for shipment in suitable containers in accordance with sound commercial practices to ensure that Products are delivered in an undamaged condition. CIPAN shall mark the relevant purchase order number on each container and enclose an itemized packing slip with such number with the shipment.  [* * *] CIPAN shall hold title to and bear all risk of loss or damage to Products and Materials prior to such item’s delivery to Paratek or its designee hereunder.  Time is of the essence for all deliveries of Products.  CIPAN shall ensure that all Product held in storage is stored in accordance with the Specifications until delivery to Paratek under this Agreement and that all storage areas meet cGMP requirements.  In the event of any delay in delivery of Product from the delivery date on the applicable purchase order for such Product, if such delay is: [* * *], unless, in each case ((a) and (b)), such delay is due to a Force Majeure Event causing a worldwide shortage of the applicable Materials, in which case Article 17 shall apply.

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7.2 Manufacturing Date . CI PAN shall schedule its Manufacturing operations so that all Products delivered have the maximum shelf life possible and in any event no Minocycline delivered hereunder shall have less than [* * *] of shelf life remaining at the time of delivery.  If Product is delivered to Paratek or Paratek’s designee whose shelf life does not conform to the requirements set forth in this Section 7.2 , CIPAN shall promptly, at its cost and expense, refund or replace the non-conforming Product upon Paratek’s request.

7.3 Material Failure of Supply .  If CIPAN, for any reason, fails to supply at least [* * *] of the units of any Product required to be delivered by CIPAN pursuant to valid purchase orders placed by Paratek during any period of [* * *] or longer beginning on the requested delivery date, in addition to and without limiting any other remedies available to Paratek:

7.3.1 Paratek shall be entitled to notify CIPAN of its intent to source from the Backup Supplier all or any of the Products [* * *]; and

7.3.2 After consultation with the Supply and Quality Committee, CIPAN shall promptly take any and all steps or actions necessary to remedy such failure for so long as such failure persists.

7.4 Notice of Failure to Supply .   Without limiting any other obligation of CIPAN or right of Paratek under this Agreement (including under Section 7.3 for a material failure of supply), if CIPAN is unable or anticipates that it will be unable to supply Products meeting Paratek’s forecasted requirements of any Product(s) in a timely manner at any time during the Term, CIPAN shall provide prompt written notice to Paratek.  Following such notice, the Parties shall discuss in good faith how to prevent or mitigate such inability to supply, including the ability of Paratek to seek [* * *] from a Backup Supplier(s).  CIPAN shall implement in good faith any reasonable suggestions of Paratek to prevent or mitigate such inability to supply at its own expense unless otherwise mutually agreed upon by the Parties.

7.5 Metrics Report; Yield Requirements .  

7.5.1 CIPAN shall Manufacture and supply Products under this Agreement so as to meet the pre-defined performance-based targets and reporting requirements set out in Exhibit D and otherwise as mutually agreed by the Parties (“ Key Performance Indicators ” or “ KPIs ”).  CIPAN shall provide to Paratek a performance report, which will record CIPAN’s performance against each of the KPIs Paratek is responsible for reporting pursuant to Exhibit D .  Performance reports shall be reviewed at meetings of the Supply and Quality Committee.  From time to time, and at least once per year, the Supply and Quality Committee shall review the KPIs and the performance data collected and reported by CIPAN.  [* * *]

7.5.2 Target Yield Determination .  After CIPAN has produced a minimum of [* * *] Batches of Crude Omadacycline over a period of at least [* * *] (each, a “ Target Yield ”).  Thereafter, CIPAN will strive to maintain an actual annual yield level for Minocycline for Crude Omadacycline (the “ Actual Annual Yield ”) above the applicable Target Yield.  [* * *] 

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7.5.3 API Usage Variance Calculation If the Actual Annual Yield falls more than [* * *] below the respective Target Yield for the Calendar Year, then the shortfall for the Year (the “ Shortfall ”) will be calculated as follows: [* * *].    Payment for the Shortfall will be due to Paratek from CIPAN not later than 45 days after the end of the Calendar Year or, at Paratek’s request, CIPAN will instead provide, at no cost to Paratek, Minocycline volume with value equal to the Shortfall within such timeframe.

8.

PRICE AND PAYMENT

8.1 Supply Price .  The price of Products to be sold to Paratek during the Term shall be based on the annual volume of each Product ordered by Paratek as set forth in Exhibit A attached hereto, subject to adjustment as set forth in Sections 2.8.1 , 7.1 , 8.2 and 8.3 (such price for a Product, the “ Supply Price ” for such Product). [* * *]  The Supply Price per kilogram invoiced by CIPAN to Paratek for Minocycline during any rolling [* * * ] shall be the [* * *].  The Supply Price for Minocycline shall comply with this Section 8.1 as of the Effective Date. For the avoidance of doubt, the Supply and Quality Committee will not have any responsibilities relating to the Supply Price matters unless such responsibilities are expressly provided in clause (f) of Section 4.3 of this Agreement.

8.2 Price Adjustments .

8.2.1 Beginning prior to [* * *], the Supply Price for each Product for the next Calendar Year shall be adjusted by mutual agreement of the Parties on a yearly basis at least [* * *] prior to the beginning of such Calendar Year, such adjustment to reflect: [* * *].  CIPAN will permit Paratek to promptly review such portions of its internal records, books and any other materials that are necessary in order to substantiate CIPAN’s proposed Supply Price for a Product or any adjustment to the Supply Price for a Product, such materials to be considered CIPAN’s Confidential Information hereunder.  For clarity, under this Section 8.2.1 , Paratek shall have no right to review CIPAN’s records regarding other activities or products that are not relevant to the proposed Supply Price for a Product or any adjustment thereto as set forth in this Section 8.2.1 .

8.3 [* * *]

8.4 Payment .  CIPAN shall invoice Paratek for Products on or after the Approval Date and shall only charge Paratek for Products that are shipped to Paratek or Paratek’s designee pursuant to this Agreement.   Paratek shall pay CIPAN for all supplied quantities of conforming Products within [* * *] from the date of invoice receipt; provided that, pending resolution regarding any disagreement between the Parties as to conformance of a Product to the requirements of this Agreement or the Quality Agreement, Paratek is not obligated for any payment with respect to any Product Paratek believes to be non-conforming.  In this Agreement, unless expressly otherwise stated, all references to money or payments means US Dollars and all payments made hereunder shall be made in that currency.

8.5 Taxes and Other Charges .  All Product prices are inclusive of taxes, any shipping costs incurred through the point of delivery of such Product(s) and other charges.  Paratek and CIPAN shall cooperate to eliminate or minimize the amount of any such taxes imposed on the transactions contemplated in this Agreement.  Paratek is not responsible for any penalties or interest related to the failure of CIPAN to collect sales, use, VAT or similar taxes.

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9.

COMPLIANCE, QUALITY AND ENVIRONMENTAL

9.1 Quality Agreement .  The Parties have entered into the Quality Agreement, dated as of November 2, 2016 (as amended from time to time in accordance with its terms, the “ Quality Agreement ”) .  Each Party agrees to perform its respective obligations under the Quality Agreement in accordance with such agreement.  

9.2 Compliance with Law .  CIPAN shall conduct its Manufacturing operations hereunder in a safe and prudent manner, in compliance with all applicable laws and regulations (including, but not limited to, those dealing with occupational safety and health, those dealing with public safety and health, those dealing with protecting the environment, and those dealing with disposal of wastes), and in compliance with all applicable provisions of this Agreement and the Quality Agreement.  CIPAN shall obtain all necessary registrations and permits pertaining to activities contemplated by this Agreement and the Quality Agreement.  To the extent necessary for the Regulatory Approval of Products, CIPAN shall permit the inspection of the Facility by Regulatory Authorities and shall supply all documentation and information requested by Paratek to obtain or maintain Regulatory Approval of Products.

9.3 Manufacturing Quality . CIPAN shall obtain all Materials from Approved Suppliers and shall pay such suppliers on a timely and current basis.  All Products shall be Manufactured at the Facility. CIPAN shall sample and analyze all Materials upon receipt to ensure that such Materials are free of defects and meet the applicable specifications therefor set forth within the Quality Agreement. Any goods in process (e.g., intermediate goods) and finished goods produced from such Materials shall be in compliance with the Quality Agreement.  CIPAN shall perform periodic audits of all Approved Suppliers for starting Materials to ensure such Approved Supplier’s compliance with this Agreement, the Quality Agreement, cGMPs and applicable laws and regulations with respect to the Materials.  CIPAN shall take all necessary steps to prevent contamination and cross contamination of Products.  Products shall be unadulterated and free from contamination, diluents and foreign matter in any amount.  CIPAN shall immediately notify Paratek in the event it becomes aware of any material issues with the supply of Materials from an Approved Supplier, including delays in delivery or delivery of non-conforming materials.

9.4 Business Continuity Plan .  Within [* * *] following the Effective Date, CIPAN will provide to Paratek a disaster recovery and business continuity plan (the “ Business Continuity Plan ”) that is intended to facilitate the continuous operation and, in the event of an interruption, the recovery of all material business functions necessary for CIPAN to satisfy its obligations under this Agreement. At all times during the Term, CIPAN will maintain and adequately support such Business Continuity Plan, which  will include at a minimum a detailed disaster recovery plan, which describes the management methodology, management team, emergency contact persons, and specific plans for potential risks that may disrupt CIPAN’s operations.  The plan shall meet and be consistent with generally accepted industry standards.  Upon Paratek’s request, CIPAN will promptly provide a copy of the Business Continuity Plan to Paratek.

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10.

QUALITY AUDITS; Testing and Inspection of the Products

10.1 Inspection and Auditing Rights .  Paratek and its representatives (including Third Party health and safety compliance auditors) shall have the right, at Paratek’s expense, to audit, inspect and observe the Facility, the performance by CIPAN of its obligations under this Agreement and the Quality Agreement, CIPAN’s compliance with applicable laws and regulations in the performance of its obligations under this Agreement and the Quality Agreement, and the handling, Manufacture, testing, inspection, storage, disposal and transportation of the Product by CIPAN and its permitted subcontractors, during normal business hours and upon at least [* * *] prior notice, provided that, [* * *].  CIPAN shall make available to Paratek all relevant records and reports and Paratek shall have the right to copy all such records and reports.  CIPAN agrees to respond to Paratek’s audit findings within [* * *] of receipt of Paratek’s audit report, to take prompt corrective action to remedy any observed violations of the terms of this Agreement, the Quality Agreement or of applicable law or regulations and to be responsive to the recommendations contained therein.  Such audits may be conducted no more than [* * *] at [* * *] expense, provided that Paratek may also conduct follow-up audits or inspections at [* * *] expense at any time or times during a Calendar Year that are directed at [* * *].

10.2    Representatives in the Facility .  With respect to each of the Original Facility and the New Facility Area, Paratek will have the option to have up to [* * *] employee representatives of Paratek and/or its Affiliates on site during preparation, production, testing and release activities for Products (each, a “ Site Visit ”) with no advance notice provided to CIPAN from Paratek if such Site Visit is limited to [* * *]. Any Site Visit for longer than a [* * *] will require Paratek to provide CIPAN with notice at least [* * *] prior to the arrival of Paratek representatives on site. Notwithstanding the foregoing, Site Visits to the Original Facility or the New Facility Area for longer than a [* * *] may occur no more than [* * *] per site in accordance with this Section 10.2 , unless otherwise mutually agreed by the Supply and Quality Committee; provided , however , that any Site Visits (regardless of the duration thereof) to the Original Facility or New Facility Area that directly relate to quality assurance actions in connection with any audits conducted pursuant to Section 10.1 or any government inspections conducted pursuant to Section 10.7 shall not be subject to this annual limit or the notice procedures set forth in this Section 10.2 .  Paratek representatives will, strictly for the purpose of ensuring compliance with cGMPs: (i) have full access to the manufacturing operations and laboratories (including facilities, equipment, documentation, and personnel) utilized for the Manufacture of Products when Products under this Agreement are being produced, tested, or released, (ii) have the option to participate in batch record reviews, deviation investigations, customer complaints, quality incidents, and other such activities related to the release of Products, (iii) will conduct periodic meetings with functional areas as appropriate and reasonable with respect to Manufacture of Products,  (iv) participate in routine and for-cause quality audits, (v) review validation data for systems and processes relevant to Products, (vi) ensure appropriate quality metrics are tracked and trended to identify adverse quality trends in both Products and systems relevant to Paratek and (vii) participate in scheduled periodic cGMP audits.

10.3 Product Rejection and Inspection .  

10.3.1 Paratek shall have a period of [* * *] from the date of Paratek’s delivery of Products (the “ Inspection Period ”) to inspect, or cause to have inspected by a Third Party designated by Paratek, any shipment of Products to determine whether such shipment conforms to Specifications or otherwise breaches CIPAN’s warranties set forth in this Agreement.  Paratek shall give CIPAN notice of

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rejection (“ Rejection Notice ”) of any shipment of Products that, in whole or part, failed to meet Specifications or which otherwise breached CIPAN’s warranties set forth in this Agreement, in each case at the time of delivery pursuant to Section 7.1 .

10.3.2 If Paratek determines during the Inspection Period for a Product(s) that such Product(s) did not conform to Specifications or otherwise breached CIPAN’s warranties set forth in this Agreement, in each case at the time of delivery pursuant to Section 7.1 , it shall notify CIPAN prior to [* * *].  Paratek’s failure to timely deliver a Rejection Notice shall be deemed its acceptance of the Product, unless a Latent Defect of such Product exists.   Paratek shall accompany any Rejection Notice with reasonable supporting evidence in its possession that shows that the Product delivered to Paratek by CIPAN was not Manufactured in accordance with Specifications or otherwise breaches CIPAN’s warranties set forth in this Agreement, in each case at the time of delivery pursuant to Section 7.1 .

10.4 Independent Testing .  

10.4.1 If Paratek delivers a Rejection Notice to CIPAN in respect of all or any part of a shipment of Product(s), then the Parties shall have [* * *] from the date of CIPAN’s receipt of such Rejection Notice to resolve any dispute regarding whether all or any part of such shipment of the Product(s) was Manufactured in conformance with Specifications and CIPAN’s warranties set forth in this Agreement.  Either Party may request, in writing, at any time within such [* * *] period that a Laboratory be used to determine whether the Product met Specifications or CIPAN’s warranties at the time of delivery and any such determination of a Laboratory shall be binding upon the Parties. [* * *]

10.4.2 If the Laboratory determines, or the Parties otherwise agree, that the Product(s) met Specifications at the time of delivery, then Paratek shall (i) pay to CIPAN the Supply Price invoiced for such Product(s) pursuant to Section 8.1 , and (ii) pay to the Laboratory the amount of the fees charged by the Laboratory for such testing, if applicable.

10.4.3 If the Laboratory determines, or the Parties otherwise agree, that the Product(s) did not meet Specifications or CIPAN’s warranties set forth in this Agreement at the time of delivery, then CIPAN shall (i) reimburse Paratek for any Supply Price previously paid by Paratek for such non-conforming Product(s), (ii) pay to the Laboratory the amount of the fees charged by the Laboratory for such testing, if applicable (iii) dispose of the non-conforming Product, at CIPAN’s expense, in accordance with Paratek’s instructions, and (iv) re-initiate Manufacturing and supply of replacement Product(s) conforming to Specifications as soon as reasonably practicable (but in no event more than [* * *] following the Laboratory’s determination).  Paratek shall pay to CIPAN the Supply Price for such replacement Product(s) in accordance with Section 8.1 .

10.5 Latent Defects .  As soon as either Party becomes aware of a Latent Defect in any Batch, such Party shall immediately notify the other Party thereof, and, at Paratek’s election, the applicable Batch shall be deemed rejected as of the date of delivery of such notice.  In such case, CIPAN shall, without limiting any other remedies available to Paratek, (a) reimburse Paratek for any Supply Price  previously paid by Paratek for such non-conforming Batch, (b) dispose of the non-conforming Batch, at CIPAN’s expense, in accordance with Paratek’s instructions, (c) Manufacture and supply of replacement Batch conforming to Specifications as soon as reasonably practicable (but in no event more than [* * *] following the discovery of the Latent Defect) and (d) reimburse Paratek for any reasonable out-of-

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pocket costs incurred by Paratek relating to the acceptance of returns from Paratek’s customers resulting from such non-conforming Batch.  At its election, Paratek may recover undisputed amounts to which it may become entitled under this paragraph by deducting such amounts from amounts then due or that may subsequently become due to CIPAN from Paratek hereunder.

10.6 Samples and Record Retention .  CIPAN shall retain records and retention samples of each Batch of Product for at least [* * *] and shall make the same available to Paratek upon request. After the required holding period, CIPAN shall provide written notice to Paratek and, at Paratek’s direction, shall either destroy or otherwise disposition such retention samples at CIPAN’s expense.  During and after the term of this Agreement, CIPAN shall assist Paratek with respect to any complaint, issue or investigation relating to Product.

10.7 Government Inspections .  Each Party shall promptly notify the other Party if such Party receives notice from a Regulatory Authority regarding a cGMP investigation or other inspection with respect to a Product.  If CIPAN receives advance notice of any such investigation, inspection or visit by any Regulatory Authority to inspect the Facility or review the Manufacture of a Product, CIPAN shall permit, to the extent permitted by applicable law, Paratek or its representatives to be present during such visit, at Paratek’s expense.  Upon Paratek’s request, CIPAN shall provide Paratek with a copy of any report issued by such Regulatory Authority following such visit.  

10.8 Recalls and Seizure .  

10.8.1 Each Party shall keep the other Party promptly and fully informed of any notification or other information whether received directly or indirectly which might result in the Recall or Seizure of Paratek Product(s).  If either Party determines that it is necessary to Recall any Paratek Product, it shall immediately notify the other Party and CIPAN will collaborate with Paratek in connection with any Recall or Seizure.  In any such situation, Paratek shall have the right to make all final decisions regarding a Recall or Seizure of Paratek Products.  

10.8.2 CIPAN shall be liable for the out-of-pocket costs and expenses actually incurred by Paratek as a result of any Recall or Seizure (including any Supply Price paid for the Product incorporated in the relevant Paratek Product and any in-process or finished Product that cannot be shipped due to the Recall or Seizure), to the extent such Recall or Seizure results from [* * *].

10.8.3 Paratek shall be liable for the out-of-pocket costs and expenses actually incurred by CIPAN as a result of any Recall or Seizure to the extent such Recall or Seizure results from [* * *].

11.

MANUFACTURING CHANGES

11.1 Voluntary Changes .  

11.1.1 Paratek may propose any change to the Manufacturing process, the Manufacturing equipment, the Specifications, the Materials, the sources of Materials or the Methods of Analysis  by delivering a written notice to CIPAN of such proposed change.  Within ten (10) Business Days of receiving such notice, CIPAN shall inform Paratek of any and all reasonable costs associated with implementing such change and if Paratek agrees to reimburse CIPAN for such costs, CIPAN shall

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implement such change as promptly as practicable in consultation in Paratek; provided , however , that, if CIPAN notifies Paratek that it has determined in good faith that such change is not in compliance with applicable laws or regulations (including cGMP), the Parties shall submit such dispute to a Third Party expert for resolution.

11.1.2 CIPAN shall not make any changes to the Manufacturing process, the Manufacturing equipment, the Specifications, the Materials, the sources of Materials or the Methods of Analysis without the prior written consent of Paratek.  

11.2 Required Changes .  If FDA or any other Regulatory Authority requests or requires any change in the Manufacturing process, the Manufacturing equipment, the Specifications, the Materials, the source of Materials or Methods of Analysis with respect to any Product, the Parties shall promptly (but in no event more than ten (10) Business Days after receipt of the Regulatory Authority’s notice) meet and discuss an implementation plan for such change, including the allocation of any associated reasonable costs for such change.  If the Parties, after discussing the proposed change in reasonable good faith negotiations, cannot agree on the plan for implementing such change, the costs (or cost allocation) of implementing such change or CIPAN is technically or financially incapable of making such change, [* * *].  Each Party agrees to promptly forward to the other copies of any written communication received by such Party from the FDA or any other Regulatory Authority that may affect the Manufacture or supply of any Product as contemplated herein.

 

12.

INTELLECTUAL PROPERTY

12.1 Ownership .

12.1.1 Paratek shall have sole ownership of all Paratek Technology, including all Paratek Improvements, and shall have the sole right to prosecute, maintain and enforce such Paratek Technology in its sole discretion.  If, at any time before or during the Term, CIPAN owns (solely or jointly) any Paratek Improvements, CIPAN agrees to assign and does hereby assign all right, title and interest in and to such Paratek Improvements to Paratek.  CIPAN shall, and shall cause its Affiliates to, execute and deliver all requested assignments and other documents, and take such other actions as Paratek may reasonably request, in order to perfect and enforce Paratek’s rights in the Paratek Improvements.  

12.1.2 CIPAN shall have sole ownership of all CIPAN Technology, including all CIPAN Improvements, and shall have the sole right to prosecute, maintain and enforce such CIPAN Technology in its sole discretion.  If, at any time before or during the Term, Paratek owns (solely or jointly) any CIPAN Improvements, Paratek agrees to assign and does hereby assign all right, title and interest in and to such CIPAN Improvements to CIPAN.  Paratek shall, and shall cause its Affiliates to, execute and deliver all requested assignments and other documents, and take such other actions as CIPAN may reasonably request, in order to perfect and enforce CIPAN’s rights in the CIPAN Improvements.  

12.1.3 Except as expressly set forth in this Section 12.1 , each Party shall own all right, title and interest in and to: (a) any and all Inventions made solely by its or its Affiliates’ employees, staff, agents or independent contractors in connection with their activities under this Agreement; (b) any and all patent rights claiming any Invention described in clause (a) of this Section 12.1.3 ; and (c) any and all know-how embodied by or in any Invention described in clause (a) of this Section 12.1.3 .  

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Except as expressly set forth in this Section 12.1 , the Parties shall jointly own all right, title and interest in and to: (i) any and all Inventions made jointly by the Parties or their respective Affiliates or their or their Affiliates’ employees, staff, agents or independent contractors in connection with their activities under this Agreement; (ii) any and all patent rights claiming any Invention described in clause (i) of this Section 12.1.3 ; and (iii) any and all know-how embodied by or in any Invention described in clause (i) of this Section 12.1.3 (such Inventions, patent rights and know-how described in clauses (i) through (iii), the “ Joint Technology ”).  Subject to the license grants set forth in this Agreement, each Party shall be free to exploit, either itself or through the grant of licenses to Third Parties (which Third Party licenses may be further sublicensable), Joint Technology, throughout the world without restriction, without the need to obtain further consent from the other Party, and without any duty to account or payment of any compensation to the other Party.  Paratek shall have the sole right to prosecute, maintain and enforce any patent rights within the Joint Technology, in its sole discretion, provided that Paratek shall provide CIPAN with a reasonable opportunity to review and comment on any patent filings (such comments to be considered for implementation by Paratek in good faith) with respect to the Joint Technology prior to submission thereof.  Inventorship shall be determined in accordance with United States patent laws .

12.2 Licenses .

12.2.1 Subject to the terms and conditions of this Agreement, during the Term, Paratek hereby grants to CIPAN, a non-exclusive, worldwide, non-transferable, non-sublicensable, royalty-free license under the Paratek Technology, including the Paratek Improvements, solely to the extent necessary for CIPAN to perform its obligations under this Agreement and the Quality Agreement, for the sole purpose of performing such obligations.

12.2.2 CIPAN shall, and hereby does, grant to Paratek a non-exclusive, worldwide, perpetual, irrevocable, sublicensable, royalty-free license under the CIPAN Technology, including the CIPAN Improvements, (a) to the extent necessary to effect any transfer of technology pursuant to this Agreement and (b) to conduct Paratek’s business activities with respect to the Products and Paratek Products, including the Manufacture and exploitation of the Products and Paratek Products by Paratek, its Affiliates, Paratek Licensees or Third Parties; [* * *].

12.3 Technology Transfer .  Promptly following the Effective Date, and thereafter during the Term at least once per Calendar Quarter, or more often upon Paratek’s reasonable request, CIPAN shall transfer to Paratek all CIPAN Technology, Paratek Improvements and Joint Technology in CIPAN’s possession and not previously transferred to Paratek, for the purpose of enabling Paratek to exercise the license set forth in Section 12.2.2 .

12.4 [†]

12.5 Rights in Bankruptcy .  All rights and licenses granted under or pursuant to this Agreement by CIPAN are and shall otherwise be deemed to be, for purposes of Section 365(n) of the U.S. Bankruptcy Code or any analogous provisions in any other country or jurisdiction, licenses of right to “intellectual property” as defined under Section 101 of the U.S. Bankruptcy Code.  CIPAN agrees that Paratek, as licensee of such rights under this Agreement, shall retain and may fully exercise all of

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their rights and elections under the U.S. Bankruptcy Code or any analogous provisions in any other country or jurisdiction.  The Parties further agree that, in the event of the commencement of a bankruptcy proceeding by or against CIPAN under the U.S. Bankruptcy Code or any analogous provisions in any other country or jurisdiction, Paratek shall be entitled to a complete duplicate of (or complete access to, as appropriate) any such intellectual property and all embodiments of such intellectual property, which, if not already in Paratek’s possession, shall be promptly delivered to it (a) upon any such commencement of a bankruptcy proceeding upon Paratek’s written request therefor, unless CIPAN elects to continue to perform all of its obligations under this Agreement or (b) if not delivered under clause (a) above, following the rejection of this Agreement by or on behalf of CIPAN upon written request therefor by Paratek.

13.

REPRESENTATIONS, WARRANTIES And covenants

13.1 Representation and Warranties of Each Party .  Each of Paratek and CIPAN hereby represents, warrants and covenants to the other Party hereto as follows:

13.1.1 it is a corporation or entity duly organized and validly existing under the laws of the state or other jurisdiction of incorporation or formation;

13.1.2 the execution, delivery and performance of this Agreement by such Party has been duly authorized by all requisite corporate action and do not require any shareholder action or approval;

13.1.3 it has the power and authority to execute and deliver this Agreement and to perform its obligations hereunder;

13.1.4 the execution, delivery and performance by such Party of this Agreement and its compliance with the terms and provisions hereof does not and will not conflict with or result in a breach of any of the terms and provisions of or constitute a default under (i) a loan agreement, guaranty, financing agreement, agreement affecting a product or other agreement or instrument binding or affecting it or its property; (ii) the provisions of its charter or operative documents or by laws; or (iii) any order, writ, injunction or decree of any court or governmental authority entered against it or by which any of its property is bound; and

13.1.5 it shall comply with all applicable laws and regulations relating to its activities under this Agreement.

13.2 Representations and Warranties of CIPAN .  CIPAN hereby further represents and warrants to Paratek as follows:

13.2.1 each Product at the time of delivery to Paratek (i) have been Manufactured, stored and shipped in accordance with cGMP and all applicable laws, rules, regulations or requirements; (ii) conform to the Specifications, are free from defects and are merchantable; (iii) are not adulterated or misbranded within the meaning of the FD&C Act; and (iv) have been shipped and stored in accordance with the procedures set forth under this Agreement and the Quality Agreement;

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13.2.2 as of immediately prior to the delivery of each Product to Paratek, CIPAN has good and marketable title to all Products and Products are free from all liens, charges, encumbrances and security interests; and

13.2.3 CIPAN does not, at any time from and after the Effective Date, retain or use the services of (a) any person debarred under 21 U.S.C. § 335a or (b) any person who has been convicted of a crime as defined under the FD&C Act, in each case in any capacity associated with or related to the Manufacture or supply of Products or any service rendered to Paratek under this Agreement or the Quality Agreement.

13.3 Representation by Legal Counsel .  Each Party hereto represents that it has been represented by legal counsel in connection with this Agreement and acknowledges that it has participated in the drafting hereof.  In interpreting and applying the terms and provisions of this Agreement, the Parties agree that no presumption shall exist or be implied against the Party which drafted such terms and provisions.

13.4 [* * *]

14.

INDEMNIFICATION, LIMITATION OF LIABILITY AND INSURANCE

14.1 Indemnification .

14.1.1 CIPAN shall indemnify, defend and hold harmless Paratek, its directors, officers, employees and agents (collectively, the “ Paratek Representatives ”) from and against all damages, losses, liabilities, expenses, claims, demands, suits, penalties or judgments or administrative or judicial orders (including reasonable attorneys’ fees and expenses) (collectively, “ Losses ”) to, from or in favor of Third Parties to the extent resulting from or arising out of (i) the [* * *] actions or omissions of CIPAN or CIPAN Representatives; (ii) any breach by CIPAN of its representations, warranties or covenants in this Agreement; (iii) any Recall or Seizure attributable to CIPAN’s performance or failure to perform pursuant to this Agreement (including amounts Paratek may pay or credit to its customers for Products so Recalled or Seized); (iv) any assertion that the Manufacture of any Product infringe any patent, copyright or trademark or misappropriate any trade secret or other intellectual property of any Third Party, except to the extent that any such allegation relates to the Manufacturing Information; (v) the renovation or construction of the New Facility Area; and (vi) CIPAN’s failure to comply with any applicable law, regulation or order (including environmental laws, regulations and orders and any failure by CIPAN to obtain and maintain any Regulatory Approvals relating to the Manufacturing of Product and required to be obtained and maintained by CIPAN under applicable law, regulation or order); provided , however , that, in each case, CIPAN shall not be required to indemnify pursuant to this Section 14.1.1 with respect to any Losses to the extent arising from or related to the [* * *] actions or [* * *] omissions of one or more Paratek Representatives or Paratek’s breach of its representations, warranties, covenants or other obligations hereunder.  The provisions of this Section shall survive the termination or expiration of this Agreement.

14.1.2 Paratek shall indemnify, defend and hold harmless CIPAN, its directors, officers, employees and agents (collectively, the “ CIPAN Representatives ”) from and against all Losses to, from or in favor of Third Parties to the extent resulting from or arising out of (i) the [* * *] actions or

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omissions of  Paratek or Paratek Representatives; (ii) any breach by Paratek of its representations, warranties or covenants in this Agreement; or (iii) any allegation that the use of the Manufacturing Information in accordance with this Agreement infringes any patent, copyright or trademark or misappropriate any trade secret or other intellectual property of any Third Party; provided , however , that, in each case, Paratek shall not be required to indemnify pursuant to this Section 14.1.2 with respect to any Losses to the extent arising from or related to the [* * *] actions or [* * *] omissions of one or more CIPAN Representatives or CIPAN’s breach of its representations, warranties, covenants or other obligations hereunder.  The provisions of this Section shall survive the termination or expiration of this Agreement.

14.1.3 Each Party and its directors, officers, employees or agents (an “ Indemnified Party ”) shall promptly notify the other Party (the “ Indemnifying Party ”), in writing, of any claim asserted or threatened against such Indemnified Party for which such Indemnified Party is entitled to indemnification hereunder from the Indemnifying Party.  With respect to any such claim the Indemnified Party shall reasonably cooperate with and provide such reasonable assistance to such Indemnifying Party as such Indemnifying Party may reasonably request, and all reasonable out-of-pocket costs of such assistance shall be paid by the Indemnifying Party.  Such reasonable assistance may include providing copies of all relevant correspondence and other materials that the Indemnifying Party may reasonably request. The obligations of an Indemnifying Party under Sections 14.1.1 and 14.1.2 are conditioned upon the delivery of written notice to the Indemnifying Party of any asserted or threatened claim promptly after the Indemnified Party becomes aware of such claim, provided that the failure of the Indemnified Party to give such notice or any delay thereof shall not affect the Indemnified Party’s right to indemnification hereunder, except to the extent that such failure or delay impairs the Indemnifying Party’s ability to defend or contest any such claim.  The Indemnifying Party shall have the right to assume the defense of any suit or claim for which indemnification is sought. If the Indemnifying Party defends the suit or claim, the Indemnified Party may participate in (but not control) the defense thereof at its sole cost and expense. An Indemnifying Party may not settle a suit or claim, without the consent of the Indemnified Party, if such settlement would (a) impose any monetary obligation on the Indemnified Party for which indemnification is not provided hereunder, (b) not include a full release of claims with respect to the Indemnified Party (c) require the Indemnified Party to submit to an injunction or (d) otherwise limit the Indemnified Party’s rights under this Agreement. Any payment made by an Indemnifying Party to settle any such suit or claim shall be at its (or its insurer’s) own cost and expense.

14.2 EXCEPT [* * *], IN NO EVENT SHALL EITHER PARTY BE LIABLE TO THE OTHER FOR SPECIAL, INDIRECT, PUNITIVE, EXEMPLARY, INCIDENTAL OR CONSEQUENTIAL DAMAGES (INCLUDING LOST PROFITS OR REVENUES) ARISING OUT OF, OR AS A RESULT OF, THE SALE, DELIVERY, NONDELIVERY, SERVICING, USE OR LOSS OF USE OF THE PRODUCT, REGARDLESS OF WHETHER SUCH CLAIM IS BASED ON BREACH OF WARRANTY, BREACH OF CONTRACT, NEGLIGENCE, STRICT TORT OR OTHER THEORY.

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14.3 Insurance .  CIPAN shall obtain and maintain insurance adequate to cover its obligations under this Agreement, to the extent such obligations are insurable. Without limiting the foregoing, CIPAN shall obtain and maintain the following kinds of insurance with the minimum limits set forth below .

 

Kind of Insurance

Minimum Limits

 

[* * *]

[* * *]

 

[* * *]

[* * *]

 

[* * *]

 

[* * *]

 

Upon request, CIPAN shall furnish insurance certificates as directed by Paratek, satisfactory in form and substance to Paratek, showing the above coverages, and providing for at least ten (10) days’ prior written notice to Paratek by the insurance company of cancellation or modification.  Paratek shall be named as an additional insured on the CIPAN’s policies.  Coverage shall be procured with carriers [* * *].

15.

TERM AND TERMINATION

15.1 Term .  This Agreement shall commence on the Effective Date and continue, with respect to each Product, unless sooner terminated as set forth below in this Article 15 or in Article 17 , for the duration of the Initial Term and after the Initial Term, for successive Renewal Terms.  

15.2 Termination at Will .  

15.2.1 Paratek may terminate this Agreement in its entirety or with respect to a Product at any time during the Initial Term or Renewal Term with delivery of [* * *] prior written notice of such termination to CIPAN.

15.2.2 Following the first Renewal Term, CIPAN may terminate this Agreement in its entirety or with respect to a Product at any time during a Renewal Term with delivery of [* * *] prior written notice of such termination to Paratek.

15.3 Termination for Material Breach . In the event that either Party breaches any of its material obligations under this Agreement, the other Party may deliver written notice of such breach to the breaching Party.  If the breaching Party fails to cure such breach within [* * *] following its receipt of such notice, the non-breaching Party may terminate this Agreement either in its entirety or on a Product-by-Product basis with respect to the Product to which such breach relates, by written notice to the breaching Party.  

15.4 Termination for Regulatory Issues; Compliance Failures .   Paratek may, notwithstanding any cure periods set forth in Section 15.3 , immediately terminate this Agreement, in its entirety or on a Product-by-Product basis, by providing written notice of termination to CIPAN if (a) CIPAN is or becomes subject to any Regulatory Authority warning letter with respect to a Facility or any Product and

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fails to comply with or meet the standards for cure or corrective action set forth in such letter; (b) CIPAN becomes subject to a consent decree issued by a Regulatory Authority; or (c) CIPAN fails at least [* * *] to comply with Section 9.2 . Notwithstanding the foregoing, Paratek may not immediately terminate this Agreement pursuant to clause (a) of this Section 15.4 in the event that such failure by CIPAN is solely caused by CIPAN’s compliance with this Agreement and CIPAN notifies Paratek of such within [* * *] of its receipt of the relevant warning letter; provided , however , that, in such case, the Parties will use good faith efforts to amend this Agreement to comply with the requirements of the applicable warning letter but CIPAN’s failure will remain subject to Paratek’s ability to terminate this Agreement, in whole or in part, under Section 15.3 .

15.5 Termination for Insolvency .  In the event that (i) either Party is declared insolvent or bankrupt by a court of competent jurisdiction; (ii) either Party files a voluntary petition of bankruptcy in any court of competent jurisdiction or (iii) this Agreement is assigned by either Party for the benefit of creditors, then the other Party may terminate this Agreement either in its entirety or on a Product-by-Product basis by delivering written notice of termination, effective immediately.  Such termination shall not give rise to the payment of any penalty, damages or indemnity by the terminating Party.

15.6 Termination Due to Material Product Events .  In the event that either (a) a Paratek Product does not receive Regulatory Approval in the United States within the [ * * * ] following the Effective Date or (b) at any time during the Term, a Regulatory Authority requires the withdrawal of a Paratek Product from, or the cessation of sale of a Paratek Product in, the commercial market in the United States, Paratek may terminate this Agreement by [ * * * ] written notice to CIPAN.

15.7 Effects of Termination .  

15.7.1 Termination of this Agreement for any reason shall be without prejudice to the right of either Party to receive all payments accrued and unpaid at the effective date of such termination or expiration, without prejudice to the remedy of either Party in respect to any previous breach of any of the representations, warranties or covenants herein contained and without prejudice to any other provisions hereof which expressly or necessarily call for performance after such termination.  

15.7.2 Upon termination of this Agreement for any reason, (i) at Paratek’s request, CIPAN shall supply Paratek with its inventory of Materials, finished Products and/or works-in-progress and, for requested items, Paratek shall pay CIPAN [ * * * ]; (ii) all Paratek Materials and Confidential Information of Paratek shall be returned to Paratek; and (iii) at Paratek’s request, CIPAN shall return to Paratek all retention samples of Product.

15.7.3 Promptly following either Party’s delivery of a notice of termination to the other Party, CIPAN shall cooperate with Paratek to transfer and transition supply of the Products to a Third Party supplier.  Upon Paratek’s request, CIPAN shall cooperate with Paratek in the transfer of technology and know-how necessary to Manufacture Products to such Third Party supplier, including providing Paratek and the Third Party supplier with reasonable access to the Facility and consulting services related to Manufacturing of the Product.  CIPAN shall conduct such activities at [* * *] expense unless [* * * ] , in which case [* * *].

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15.7.4 Notwithstanding anything to the contrary in this Agreement, if this Agreement is terminated by Paratek for any reason, upon Paratek’s request, CIPAN shall continue to Manufacture and supply Products to Paratek pursuant to this Agreement until [ * * * ]. During such time as CIPAN is continuing to supply Products to Paratek pursuant to this Section 15.7.4 , Paratek shall continue to make payments to CIPAN for such supply in accordance with this Agreement and, for clarity, all terms of the Agreement relevant to CIPAN’s Manufacture and supply of Products shall survive termination and remain in effect.

15.8 Survival . The following provisions shall survive the expiration or termination of this Agreement: Article 1 (Definitions) (solely to the extent necessary to give meaning to other surviving sections), Section 8.4 (Payment) and Section 8.5 (Taxes and Other Charges) (in each case, solely with respect to payment obligations accruing prior to expiration or termination), Section 10.6 (Samples and Record Retention), Section 10.8 (Recalls and Seizure), Section 12.1 (Ownership of Intellectual Property), Section 12.2.2 (License to Paratek), Section Error! Reference source not found. ([* * *]), Section 12.5 (Rights in Bankruptcy), Section 14.1 (Indemnification), Section 14.2 (Third Party Liability), Section 14.3 (Insurance) (for [* * *]) following expiration or termination of this Agreement), Section 15.7 (Effects of Termination), Article 16 (Confidentiality), Article 18 (Notices) and Article 19 (General). Without limiting the foregoing, all of CIPAN’s obligations under this Agreement relating to compliance with cGMP in respect of the Materials and Products shall continue in force following expiration or termination of this Agreement according to the requirements of cGMP.

16.

CONFIDENTIALITY

16.1 Nondisclosure Obligation .  Each of CIPAN and Paratek shall use only in accordance with this Agreement and shall not disclose to any Third Party the Confidential Information received by it from the other Party pursuant to this Agreement, without the prior written consent of the other Party.  The foregoing obligations shall survive for a period of [* * *] after the termination or expiration of this Agreement.  These obligations shall not apply to Confidential Information that:

 

(i)

is known by the receiving Party at the time of its receipt, and not through a prior disclosure by the disclosing Party, as documented by business records;

 

(ii)

is at the time of disclosure or thereafter becomes published or otherwise part of the public domain without breach of this Agreement by the receiving Party;

 

(iii)

is subsequently disclosed to the receiving Party by a Third Party who has the right to make such disclosure; or

 

(iv)

is developed by the receiving Party independently of the Confidential Information received from the disclosing Party and such independent development can be documented by the receiving Party.

16.2 Permitted Disclosures .  Each Party may disclose the other Party’s Confidential Information to its employees and Affiliates on a need-to-know basis and to its agents or consultants to the extent required to accomplish the purposes of this Agreement; provided that the recipient Party obtains prior agreement from such agents and consultants to whom disclosure is to be made to hold in

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confidence and not make use of such Confidential Information for any purpose other than those permitted by this Agreement.  Each Party may also disclose the other Party’s Confidential Information as required by law, regulation, rule, act or order of any governmental authority or agency to be disclosed by a Party; provided that notice is promptly delivered to the other Party in order to provide an opportunity to seek a protective order or other similar order with respect to such Confidential Information and thereafter the disclosing Party discloses to the requesting entity only the minimum Confidential Information required to be disclosed in order to comply with the request, whether or not a protective order or other similar order is obtained by the other Party.  Each Party will use at least the same standard of care as it uses to protect proprietary or confidential information of its own to ensure that such employees, agents, consultants, and Affiliates do not disclose or make any unauthorized use of the other Party’s Confidential Information.

16.3 Disclosure of Agreement .  Neither CIPAN nor Paratek shall release to any Third Party or publish in any way any non-public information with respect to the terms of this Agreement without the prior written consent of the other Party, which consent shall not be unreasonably withheld or delayed, provided that either Party may disclose the terms of this Agreement

 

(i)

to the extent required to comply with applicable laws, including the rules and regulations promulgated by the United States Securities and Exchange Commission; provided , further , that prior to making any such disclosure, the Party intending to so disclose the terms of this Agreement shall (a) provide the non-disclosing Party with written notice of the proposed disclosure and an opportunity to review and comment on the intended disclosure which is reasonable under the circumstances and (b) shall seek confidential treatment for as much of the disclosure as is reasonable under the circumstances, including,  seeking confidential treatment of any information as may be requested by the other Party; or

 

(ii)

to one (1) or more Third Parties and/or their advisors in connection with a proposed spin-off, joint venture, divestiture, merger or other similar transaction involving all, or substantially all, of the Products, assets or business of the disclosing Party to which this Agreement relates or to lenders, investment bankers and other financial institutions of its choice solely for purposes of financing the business operations of such Party; provided , further , that either (a) the other Party has consented to such disclosure or (b) such Third Parties have signed confidentiality agreements with respect to such information on terms no less restrictive than those contained in this Article 16.

16.4 Publicity .  All publicity, press releases and other announcements relating to this Agreement or the transactions contemplated hereby shall be reviewed in advance by, and shall be subject to the approval of, both Parties.

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17.

FORCE MAJEURE

If the production, delivery, acceptance, or use of Products specified for delivery under this Agreement, or the performance of any other obligation of one of the Parties hereunder is prevented, restricted or interfered with by reason of any cause or event beyond the reasonable control of such Party and without the fault or negligence of such Party (a “ Force Majeure Event ”), the Party so affected, upon prompt notice to the other Party, shall be excused from performing such obligation during the continuance of such Force Majeure Event.  If such Force Majeure Event continues for a period of [* * *] the other Party may terminate this Agreement by notice in writing provided that such Force Majeure Event is continuing.  The affected Party as a result of a Force Majeure Event shall use all reasonable efforts, at its own expense, to eliminate the Force Majeure Event and to resume performance as soon as practicable.

18.

NOTICES

18.1 Ordinary Notices .  Correspondence, reports, documentation, and any other communication in writing between the Parties in the course of ordinary implementation of this Agreement shall be delivered by hand, sent by facsimile, overnight courier or by airmail to the employee or representative of the other Party who is designated by such other Party to receive such written communication at the address or facsimile numbers specified by such employee or representative.

18.2 Extraordinary Notices .  Extraordinary notices and communications (including notices of termination, force majeure, material breach, change of address, requests for disclosure of Confidential Information, claims or indemnification) shall be in writing and sent to each Party by prepaid registered or certified airmail, or by facsimile confirmed by prepaid registered or certified airmail letter (and shall be deemed to have been properly served to the addressee upon receipt of such written communication) to the address set forth in Section 18.3 or such other address as notified in writing by such Party to the other Party.

18.3 Addresses .

 

If to Paratek:

 

 

 

Paratek Pharmaceuticals, Inc.

 

75 Park Plaza, 4th Floor

 

Boston, MA 02116

 

Attention: Vice President of Manufacturing

 

With a copy to:

 

 

 

Paratek Pharmaceuticals, Inc.

 

75 Park Plaza, 4th Floor

 

Boston, MA 02116

 

Attention: General Counsel

 

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If to CIPAN:

 

CIPAN

 

Rua da Estação, n°42

 

2600-726 Castanheira do Ribatejo

 

Portugal

 

Attention: Chief Executive Officer

 

19.

GENERAL

19.1 Governing Law .  This Agreement shall be construed in accordance with and governed by the law of [* * *] without giving effect to its conflict of laws provisions.

19.2 Escalation of Disputes .  In the event of any dispute relating to this Agreement or the Quality Agreement, either Party may refer such dispute to the Supply and Quality Committee for resolution.  If the Supply and Quality Committee is unable to resolve such dispute within [* * *] of such referral, either Party may escalate such dispute to each Party’s senior management for resolution.  If each Party’s senior management is unable to resolve such dispute within [* * *] of such escalation, either Party may commence arbitration pursuant to Section 19.3 .

19.3 Arbitration .  Any dispute relating to this Agreement or the Quality Agreement that cannot be resolved pursuant to Section 19.2 may be referred by either Party to confidential arbitration in accordance with the ICC Rules of Arbitration.  The arbitration hearing shall be held as soon as practicable following submission to arbitration.  The arbitration hearing shall be held in London, England.  The Parties shall request that the arbitration panel render a formal, binding non-appealable resolution and award on each issue as expeditiously as possible.  In any arbitration, the prevailing Party shall be entitled to reimbursement of its reasonable attorneys’ fees and the Parties shall use all reasonable efforts to keep arbitration costs to a minimum.  Judgment upon the award may be entered by any court having jurisdiction thereof or having jurisdiction over the relevant Party or its assets.

19.4 Assignment .  This Agreement shall be binding upon and inure to the benefit of each Party and their respective heirs, successors and permitted assigns.  This Agreement shall not be assignable or transferable by either Party hereto without the prior written consent of the other Party (such consent not to be unreasonably withheld, conditioned or delayed), except that Paratek may assign this Agreement without CIPAN’s consent to an Affiliate, a Paratek Licensee or a successor in connection with the merger, consolidation, reorganization or sale of all, or substantially all, of the Products, assets or business to which this Agreement relates.  Any permitted assignee of this Agreement shall agree in writing to comply with all obligations of the assigning Party under this Agreement.  CIPAN shall not subcontract any of its work hereunder without Paratek’s prior written consent and any such consent given by Paratek shall not release CIPAN from its obligations hereunder.  For clarity, any Change of Control of CIPAN shall be deemed an assignment of this Agreement and subject to the provisions of this Section 19.4 , regardless of the structure of such Change of Control.

19.5 Change of Control . During the Term, CIPAN will notify Paratek in writing if at any time CIPAN reasonably anticipates that a Change of Control will occur in the next thirty (30) days.  [* * *]

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19.6 Performance .  Each Party agrees to perform its obligations under this Agreement, including under any Scope of Work, in a timely manner. CIPAN shall allocate adequate resources to execute its obligations under this Agreement, including under each Scope of Work.  CIPAN represents and warrants that all Services shall be performed by qualified personnel in accordance with the highest industry standards.

19.7 Further Assurances .  Each Party shall duly execute and deliver or cause to be duly executed and delivered, such further instruments and do and cause to be done such further acts, as may be necessary or appropriate in order to carry out the purposes and intent of this Agreement.

19.8 Entire Agreement .  This Agreement, all Exhibits attached hereto, and the Quality Agreement (as the same may be amended from time to time by the written agreement of the Parties) constitute the entire agreement between the Parties with respect to the subject matter hereof and supersedes, as of the Effective Date, all other documents, agreements, verbal consents, arrangements and understandings between the Parties with respect to the subject matter hereof, including that certain Non-Disclosure Agreement between the Parties dated as of March 16, 2015, that certain letter agreement between the Parties dated as of February 18, 2016 and the Original Agreement.  This Agreement shall not be amended orally, but only by an agreement in writing, signed by both Parties that states that it is an amendment to this Agreement. The Original Agreement shall be deemed terminated immediately following the effectiveness of this Agreement; however, the effectiveness of this Agreement shall be without prejudice to the rights of either Party against the other Party accrued or accruing under the Original Agreement prior to the Effective Date.

19.9 Severability .  If and to the extent that any provision (or any part thereof) of this Agreement is held to be invalid, illegal or unenforceable, in any respect in any jurisdiction, the provision (or the relevant part thereof) shall be considered severed from this Agreement and shall not serve to invalidate the remainder of such provision or any other provisions hereof.  The Parties shall make a good faith effort to replace any invalid, illegal or unenforceable provision (or any part thereof) with a valid, legal and enforceable one such that the objectives contemplated by the Parties when entering this Agreement may be realized.

19.10 Independent Contractor .  CIPAN shall act as an independent contractor and neither Party shall have any authority to represent or bind the other Party in any way.

19.11 No Waiver .  Any waiver by one Party of any right or such Party or obligation of the other Party must be in writing and shall not operate as a waiver of any subsequent right or obligation.

19.12 Equitable Relief .  CIPAN acknowledges that any breach or threatened breach by CIPAN of its obligations under this Agreement (including under any Scope of Work) will cause irreparable harm to Paratek and that money damages would not be adequate to remedy such harm.  Therefore, in addition to any other remedies available at law or in equity, Paratek shall be entitled to specific performance and injunctive or other equitable relief as a remedy to, or to prevent, any such breach, without proof of damages or posting of a bond.

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19.13 Counterparts .   This Agreement may be executed in one (1) or more counterparts, each of which shall be deemed an original, and together shall constitute one and the same agreement and shall become effective when one (1) or more counterparts have been signed by each of the Parties and delivered to the other Party, it being understood that both Parties need not sign the same counterpart.  This Agreement, following its execution, may be delivered via PDF copies or other form of electronic delivery, which shall constitute delivery of an execution original for all purposes.

[ Signature page follows. ]

 

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IN WITNESS WHEREOF , the Parties have executed this Agreement as of the Effective Date.

 

PARATEK PHARMACEUTICALS, INC.

 

By:

 

/s/ William M. Haskel

 

 

Name: William M. Haskel

 

 

Title: Senior Vice President

 

CIPAN Companhia Industrial Produtora de AntibiÓticos , S.A.

 

By:

 

/s/ Teresa Alves

 

 

Name: Teresa Alves

 

 

Title: Chief Executive Officer

 

 

 

[ Signature Page to Amended and Restated Manufacturing and Services Agreement ]


THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST.  REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

EXHIBIT A

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THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST.  REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. WHERE SEVEN PAGES OF MATERIAL HAVE BEEN OMITTED, THE REDACTED MATERIAL IS MARKED WITH [●].

 

EXHIBIT B

[●]

 

 

 


THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST.  REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

EXHIBIT C

[ * * * ]

 


THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST.  REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

EXHIBIT D

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THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST.  REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

EXHIBIT E

 

[ * * * ]

 

 

 

Exhibit 10.3

AMENDMENT NO. 5

TO

LOAN AND SECURITY AGREEMENT

 

T his Amendment No. 5 to Loan and Security Agreement (this “Amendment”) is dated as of August 1, 2018 and is entered into by and among (a) (i) PARATEK PHARMACEUTICALS, INC. (“Inc.”), a Delaware corporation, and (ii) PARATEK PHARMA, LLC, a Delaware limited liability company (“LLC”; and, together with Inc. and any of their respective subsidiaries, hereinafter collectively referred to as the “Borrower”), (b) (i) HERCULES TECHNOLOGY II, L.P., a Delaware limited partnership, (ii) HERCULES TECHNOLOGY III, L.P., a Delaware limited partnership, (iii) HERCULES CAPITAL, INC., a Maryland corporation, and (iv) the several banks and other financial institutions or entities from time to time parties to the Loan Agreement (collectively, referred to as “Lender”) and (c) HERCULES CAPITAL, INC., a Maryland corporation, in its capacity as administrative agent for itself and the Lender (in such capacity, the “Agent”).  Capitalized terms used herein without definition shall have the same meanings given them in the Loan Agreement (as defined below).

 

Recitals

A.   Borrower, Agent and Lender have entered into that certain Loan and Security Agreement dated as of September 30, 2015, as amended by that certain Amendment No. 1 to Loan and Security Agreement dated as of November 10, 2015, among Borrower, Agent and Lender, as amended by that certain Amendment No. 2 to Loan and Security Agreement dated as of December 12, 2016, among Borrower, Agent and Lender, as amended by that certain Amendment No. 3 to Loan and Security Agreement dated as of June 27, 2017, among Borrower, Agent and Lender, and as further amended by that certain Amendment No. 4 to Loan and Security Agreement dated as of April 17, 2018, among Borrower, Agent and Lender (as amended, and as may be further amended, restated, amended and restated, supplemented or otherwise modified from time to time, the “Loan Agreement”), pursuant to which Lender has agreed to extend and make available to Borrower certain advances of money.

B.   Borrower and Lender have agreed to amend the Loan Agreement upon the terms and conditions more fully set forth herein.

Agreement

NOW, THEREFORE, in consideration of the foregoing Recitals and intending to be legally bound, the parties hereto agree as follows:

1.   Amendments .

1.1   The Loan Agreement shall be amended by (i) deleting the “.” appearing at the end of Recital B and inserting in lieu thereof “;”, and (iii) inserting the following new provisions to appear as Recitals C and D thereof:

“C.  Borrower has requested Lender to make available to Borrower 2018 Term Loan Advances in an aggregate principal amount of up to Thirty Million Dollars ($30,000,000) (the “2018 Maximum Term Loan Amount”); and

  D.  Lender is willing to make the 2018 Term Loan Advances on the terms and conditions set forth in this Agreement.”

 

 


 

1.2    The Loan Agreement shall be amended by inserting the follo wing new definitions to appear in proper alphabetical order in Section 1.1 thereof (Definitions and Rules of Construction):

“2015 End of Term Charge” shall have the meaning assigned to such term in Section 2.5.

“2016 End of Term Charge” shall have the meaning assigned to such term in Section 2.5.

“2017 End of Term Charge” shall have the meaning assigned to such term in Section 2.5.

“2018 Amortization Date” means September 1, 2020; provided, however, that if Milestone Event No. 1 occurs prior to [August 31, 2020], the 2018 Amortization Date shall mean March 1, 2021; provided however, that if Milestone Event No. 2 occurs prior to February 28, 2021, the 2018 Amortization Date shall mean September 1, 2021.

“2018 End of Term Charge” shall have the meaning assigned to such term in Section 2.5.

“2018 Maximum Term Loan Amount” shall have the meaning assigned to such term in the preamble to this Agreement.

“2018 Term A Loan Advance” shall have the meaning assigned to such term in Section 2.1.1(a).

“2018 Term B Loan Advance” shall have the meaning assigned to such term in Section 2.1.1(a).

“2018 Term C Loan Advance” shall have the meaning assigned to such term in Section 2.1.1(a).

“2018 Term Loan Advance” and “2018 Term Loan Advances” shall have the meaning assigned to such terms in Section 2.1.1(a).

“2018 Term Loan Interest Rate” means for any day, a floating per annum rate equal to the greater of either (a) 7.85%, or (b) the sum of (i) 7.85%, plus (ii) the Prime Rate minus five and three quarters of one percent (5.75%).  

“2018 Term Loan Maturity Date” means August 1, 2022.

“Anti-Corruption Laws” shall mean all laws, rules, and regulations of any jurisdiction applicable to Borrower or any of its Affiliates from time to time concerning or relating to bribery or corruption, including without limitation the United States Foreign Corrupt Practices Act of 1977, as amended, the UK Bribery Act 2010 and other similar legislation in any other jurisdictions.

“Anti-Terrorism Laws” means any laws, rules, regulations or orders relating to terrorism or money laundering, including without limitation Executive Order No. 13224 (effective September 24, 2001), the USA PATRIOT Act, the laws comprising or implementing the Bank Secrecy Act, and the laws administered by OFAC.

 

 


 

“Blocked Person” means any Person:  (a) listed in the annex to, or is otherwise subject to the provisions of, Executive Order No. 13224, (b) a Person owned or controlled by, or acting for or on behalf of, any Person that is listed in the annex to, or is otherwise subject to the provisions of, Executive Order No. 13224, (c) a Person with which any Lender is prohibited from dealing or otherwise engaging in any transaction by any Anti Terrorism Law, (d) a Person that commits, threatens or conspires to commit or supports “terrorism” as defined in Executive Order No. 13224, or (e) a Person that is named a “specially designated national” or “blocked person” on the most current list published by OFAC or other similar list.

“Draw Period B” means the period of time commencing upon the occurrence of the Funding Condition and continuing through the earliest to occur of (a) June 30, 2020, or (b) an Event of Default.

“Draw Period C” means the period of time commencing upon the occurrence of the Funding Condition and continuing through the earliest to occur of (a) June 30, 2021 or (b) an Event of Default.

“Established Prepayment Date” means (i) with respect to the Term Loan Advances, January 1, 2019; provided, however, that if the Borrower achieves the Interest Only Period Extension Event, the Prepayment Date shall mean January 1, 2020, and (ii) with respect to the 2018 Term Loan Advances, January 1, 2020.

“Fifth Amendment Closing Date” means August 1, 2018.

“Fifth Amendment Facility Charge” means Fifty Thousand Dollars ($50,000.00).

“Forecast” means the projections for Borrower and its consolidated Subsidiaries, as delivered and accepted by Agent on June 1, 2018; provided that Borrower may from time to time update such projections, pursuant to Section 7.1(g) hereof or otherwise, with projections prepared in good faith by management if Borrower and Agent shall mutually agree in their respective sole discretion.

“Funding Condition” means the occurrence of all of the following: (a) Borrower has requested a 2018 Term Loan Advance, (b) Lender has received all necessary internal and credit approvals for such 2018 Term Loan Advance (based upon amongst other things, commercial traction, additional clinical, fundraising, and/or business development milestones), (c) Borrower has delivered financial and other information required by Lender, which shall be satisfactory to Lender in its sole discretion, (d) no Event of Default exists at the time the requested increase is to go into effect or would exist as a result of such 2018 Term Loan Advance, and (e) Lender has provided written approval in its sole discretion that such 2018 Term Loan Advance shall be made.  For clarity, upon satisfaction of each of the conditions in (a) through (d), the determination of whether to provide any such 2018 Term Loan Advance shall be in Lender’s sole discretion and shall in no event occur automatically.

“Milestone Event No. 1” means confirmation by Agent that, on or prior to August 15, 2020, Borrower has delivered to Agent, evidence reasonably satisfactory to Agent, that Borrower has achieved trailing six (6) month net revenue (determined in accordance with GAAP) from the sale of its Omadacycline product of no less than eighty-five percent

 

 


 

(85.0%) of the projected Omadacycline product net revenues measured as of June 30, 2020, as set forth in the Forecast .

“Milestone Event No. 2” means confirmation by Agent that, on or prior to February 15, 2021, Borrower has delivered to Agent, evidence reasonably satisfactory to Agent, that Borrower has achieved trailing twelve (12) month net revenue (determined in accordance with GAAP) from the sale of its Omadacycline product of no less than eighty-five percent (85.0%) of the projected Omadacycline product net revenues measured as of December 31, 2020, as set forth in the Forecast.

“Sanctioned Country” shall mean, at any time, a country or territory which is the subject or target of any Sanctions.

“Sanctioned Person” shall mean, at any time, (a) any Person listed in any Sanctions-related list of designated Persons maintained by the Office of Foreign Assets Control of the U.S. Department of the Treasury or the U.S. Department of State, or by the United Nations Security Council, the European Union or any EU member state, (b) any Person operating, organized or resident in a Sanctioned Country or (c) any Person controlled by any such Person.

“Sanctions” shall mean economic or financial sanctions or trade embargoes imposed, administered or enforced from time to time by (a) the U.S. government, including those administered by the Office of Foreign Assets Control of the U.S. Department of the Treasury or the U.S. Department of State, or (b) the United Nations Security Council, the European Union or Her Majesty’s Treasury of the United Kingdom.

1.3   The Loan Agreement shall be amended by deleting the following definitions appearing in Section 1.1 thereof (Definitions and Rules of Construction) and inserting in lieu thereof the following:

“Advance(s)” means a Term Loan Advance or a 2018 Term Loan Advance.

“Amortization Date” means January 1, 2019; provided, however, that if the Borrower achieves the Interest Only Period Extension Event prior to December 31, 2018, the Amortization Date shall mean January 1, 2021.

“Ineligible Subsidiary” means any Domestic Subsidiary or Foreign Subsidiary which has assets not in excess of five percent of the aggregate amount of the assets of Borrower and its Subsidiaries on a consolidated basis for each of the preceding three consecutive months; provided that at no time shall the aggregate amount of Cash held at Ineligible Subsidiaries, taken as a whole, exceed $5,000,000; provided however, if the aggregate amount of Cash held at Ineligible Subsidiaries, taken as a whole, exceeds the foregoing limitation as a result of their (or its) receipt of Cash otherwise received in the ordinary course from an unaffiliated party, it will not be deemed a breach of the foregoing limitation so long as the applicable Ineligible Subsidiaries make necessary dividends, distributions, or transfers to Borrower within 30 days after the date on which such Cash was received.

“Investment” means any beneficial ownership (including stock, partnership or limited liability company interests) of or in any Person, or any loan, advance or capital contribution to any Person, or the acquisition of all or substantially all of the assets of, a

 

 


 

commercial-stage product or clinical-stage product candidate of, or a line of business, division or operating group of, another Person.

“Prepayment Fee Percentage” is (a) with respect to the First Term Loan Advance and each Second Term Loan Advance, two percent (2.0%), (b) with respect to the Third Term Loan Advance and the Fourth Term Loan Advance, one percent (1.0%), and (c) with respect to the 2018 Term Loan Advances, two and one-half of one percent (2.5%).

“Required Lenders” means at any time, the holders of more than fifty percent (50%) of the aggregate unpaid principal amount of the Advances then outstanding.

“Secured Obligations” means Borrower’s obligations under this Agreement and any Loan Document (other than the Warrants), including any obligation to pay any amount now owing or later arising (including, without limitation, the End of Term Charge, the 2018 End of Term Charge, and the Prepayment Charge).

“Term Commitment” means as to any Lender, the obligation of such Lender, if any, to make a Term Loan Advance and/or a 2018 Term Loan Advance to Borrower in a principal amount not to exceed the amount set forth under the heading “Term Commitment” opposite such Lender’s name on Schedule 1.1.  

“Term Loan Maturity Date” means September 1, 2020; provided, however, that if the Borrower achieves the Interest Only Period Extension Event prior to December 31, 2018, the Term Loan Maturity Date shall mean September 1, 2021.

“Warrants” means (i) the Warrant Agreement dated as of even date hereof by and between Hercules Technology II, L.P. and Inc., (ii) the Warrant Agreement dated as of even date hereof by and between Hercules Technology III, L.P. and Inc., (iii) the Warrant Agreement dated as of the Second Amendment Closing Date by and between Hercules Technology II, L.P. and Inc., (iv) the Warrant Agreement dated as of the Second Amendment Closing Date by and between Hercules Technology III, L.P. and Inc., (v) the Additional Warrants, if any, and (v) the Warrant Agreement dated as of the Fifth Amendment Closing Date by and between Hercules Capital, Inc. and Inc., in each case, as may be amended, restated or modified from time to time.

1.4   The Loan Agreement is amended by deleting the definition of “ End of Term Charge Percentage” appearing in Section 1.1 thereof (Definitions and Rules of Construction) in its entirety.

1.5   The Loan Agreement shall be amended by deleting Section 2.1(d) thereof (Payment) in its entirety and inserting in lieu thereof the following:

“(d)  Borrower will pay interest on each Term Loan Advance on the first (1st) Business Day of each month, beginning the month after the Advance Date.  Commencing on the Amortization Date, and continuing on the first (1st) Business Day of each month thereafter, until the Secured Obligations are repaid, Borrower shall repay the aggregate principal balance of Term Loan Advances that are outstanding on the day immediately preceding the Amortization Date in equal monthly installments of principal and interest (mortgage style).  The entire principal balance of the Term Loan Advances and all accrued but unpaid interest hereunder, and all other Secured Obligations with respect to the Term Loan Advances, shall be due and payable on Term Loan Maturity Date.  Borrower shall make all payments

 

 


 

under this Agreement without setoff, recoupment or deduction and regardless of any counterclaim or defense. Lender will initiate debit entries to the Borrower’s account as authorized on the ACH Authorization (i) on each payment date of all periodic obligations payable to Lender under each Term Loan Advance and (ii) out-of-pocket legal fees and costs incurred by Agent or Lender in connection with Section 11.11 of this Agreement; provided that, with respect to clause (i) above, in the event that Lender or Agent informs Borrower that Lender will not initiate a debit entry to Borrower’s account for a certain amount of the periodic obligations due on a specific payment date, Borrower shall pay to Lender such amount of periodic obligations in full in immediately available funds on such payment date; provided, further, that, with respect to clause (i) above, if Lender or Agent informs Borrower that Lender will not initiate a debit entry as described above later than the date that is three (3) Business Days prior to such payment date, Borrower shall pay to Lender such amount of periodic obligations in full in immediately available funds on the date that is three (3) Business Days after the date on which Lender or Agent notifies Borrower of such; provided, further, that, with respect to clause (ii) above, in the event that Lender or Agent informs Borrower that Lender will not initiate a debit entry to Borrower’s account for certain amount of such out-of-pocket legal fees and costs incurred by Agent or Lender, Borrower shall pay to Lender such amount in full in immediately available funds within three (3) Business Days .

1.6   The Loan Agreement shall be amended by inserting the following new provision to appear as Section 2.1.1:

2.1.1  2018 Term Loan .

(a)  2018 Term Advances.  Subject to the terms and conditions of this Agreement, Lender will severally (and not jointly) make, in an amount not to exceed its respective 2018 Term Commitment, and Borrower agrees to draw, one (1) 2018 Term Loan Advance in an aggregate principal amount of Ten Million Dollars ($10,000,000) on the Fifth Amendment Closing Date (the “2018 Term A Loan Advance”).  Subject to the terms and conditions of this Agreement, during the Draw Period B, upon Borrower’s written request in accordance with this Agreement and Borrower’s payment to Lender of a fully-earned non-refundable commitment fee equal to Fifty Thousand Dollars ($50,000.00), Lender will severally (and not jointly) make in an amount not to exceed its respective 2018 Term Commitment, one (1) 2018 Term Loan Advance in a principal amount of Ten Million Dollars ($10,000,000) (the “2018 Term B Loan Advance”).  Subject to the terms and conditions of this Agreement, during the Draw Period C, upon Borrower’s written request in accordance with this Agreement and Borrower’s payment to Lender of a fully-earned non-refundable commitment fee equal to Fifty Thousand Dollars ($50,000.00), Lender will severally (and not jointly) make in an amount not to exceed its respective 2018 Term Commitment, one (1) 2018 Term Loan Advance in a principal amount of Ten Million Dollars ($10,000,000) (the “2018 Term C Loan Advance”).  The 2018 Term A Loan Advance, the 2018 Term B Loan Advance, and the 2018 Term C Loan Advance are hereinafter referred to singly as the “2018 Term Loan Advance” and collectively as the “2018 Term Loan Advances.”  The aggregate outstanding 2018 Term Loan Advances shall not exceed the 2018 Maximum Term Loan Amount.  Proceeds of any 2018 Term Loan Advance shall be deposited into an account that is subject to a first priority perfected security interest in favor of Agent perfected by an Account Control Agreement.

(b)  Advance Request.  To obtain a 2018 Term Loan Advance, Borrower shall complete, sign and deliver to Agent an Advance Request (at least three (3) Business Days

 

 


 

before the Advance Date other than the Fifth Amendment Closing Date, which shall be at least one (1) Business Day).  Lende r shall fund each 2018 Term Loan Advance in the manner requested by the Advance Request provided that each of the conditions precedent to such 2018 Term Loan Advance is satisfied as of the requested Advance Date.

(c)  Interest.  The principal balance of each 2018 Term Loan Advance shall bear interest thereon from such Advance Date at the 2018 Term Loan Interest Rate based on a year consisting of 360 days, with interest computed daily based on the actual number of days elapsed.  The 2018 Term Loan Interest Rate will float and change on the day the Prime Rate changes from time to time.

(d)  Payment.  Borrower will pay interest on each 2018 Term Loan Advance on the first (1st) Business Day of each month, beginning the month after the Advance Date.  Borrower shall repay the aggregate 2018 Term Loan Advances principal balance that is outstanding on the day immediately preceding the 2018 Amortization Date, in equal monthly installments of principal and interest (mortgage style) beginning on the 2018 Amortization Date and continuing on the first Business Day of each month thereafter until the Secured Obligations (other than inchoate indemnity obligations) are repaid.  The entire 2018 Term Loan Advances principal balance and all accrued but unpaid interest hereunder, shall be due and payable on the 2018 Term Loan Maturity Date. Borrower shall make all payments under this Agreement without setoff, recoupment or deduction and regardless of any counterclaim or defense. Lender will initiate debit entries to the Borrower’s account as authorized on the ACH Authorization (i) on each payment date of all periodic obligations payable to Lender under each Term Advance and (ii) out-of-pocket legal fees and costs incurred by Agent or Lender in connection with Section 11.11 of this Agreement; provided that, with respect to clause (i) above, in the event that Lender or Agent informs Borrower that Lender will not initiate a debit entry to Borrower’s account for a certain amount of the periodic obligations due on a specific payment date, Borrower shall pay to Lender such amount of periodic obligations in full in immediately available funds on such payment date; provided, further, that, with respect to clause (i) above, if Lender or Agent informs Borrower that Lender will not initiate a debit entry as described above later than the date that is three (3) Business Days prior to such payment date, Borrower shall pay to Lender such amount of periodic obligations in full in immediately available funds on the date that is three (3) Business Days after the date on which Lender or Agent notifies Borrower of such; provided, further, that, with respect to clause (ii) above, in the event that Lender or Agent informs Borrower that Lender will not initiate a debit entry to Borrower’s account for certain amount of such out-of-pocket legal fees and costs incurred by Agent or Lender, Borrower shall pay to Lender such amount in full in immediately available funds within three (3) Business Days.”

1.7   The Loan Agreement shall be amended by deleting the second sentence appearing in Section 2.2 thereof in its entirety and inserting in lieu thereof the following:

“If a court of competent jurisdiction shall finally determine that Borrower has actually paid to Lender an amount of interest in excess of the amount that would have been payable if all of the Secured Obligations had at all times borne interest at the Maximum Rate, then such excess interest actually paid by Borrower shall be applied as follows:  first, to the payment of the Secured Obligations consisting of the outstanding principal amount of the Term Loan Advances and the 2018 Term Loan Advances; second, after all principal is repaid, to the payment of Lender’s accrued interest, costs, expenses, professional fees and

 

 


 

any other Secured Obligations; and third, after all Secured Obligations are repaid, the excess (if any) shall be refunded to Borrower.”

1.8   The Loan Agreement shall be amended by deleting Section 2.4 thereof (Prepayment) in its entirety and inserting in lieu thereof the following:

“At its option, Borrower may at any time prepay all or a portion of the outstanding Advances by paying the entire principal balance (or such portion thereof), all accrued and unpaid interest with respect to the principal balance being prepaid, together with a prepayment charge equal to the following percentage of the Advance amount being repaid: subject to the second succeeding sentence, if such Advance amounts are prepaid prior to the Prepayment Date, the applicable Prepayment Fee Percentage of the then outstanding principal amount of each Advance being prepaid; and on or after the Established Prepayment Date, zero percent (0.0%) of the then outstanding amount of the Advances being prepaid (each, a “Prepayment Charge”). For the avoidance of doubt, any Advance amounts which are prepaid shall be applied to the outstanding principal amount of the Advances as directed by Borrower.  Borrower agrees that the Prepayment Charge is a reasonable calculation of Lender’s lost profits in view of the difficulties and impracticality of determining actual damages resulting from an early repayment of the Advances.  Borrower shall prepay the outstanding amount of all principal and accrued interest through the prepayment date and the Prepayment Charge upon the occurrence of a Change in Control. Notwithstanding the foregoing, Agent and Lender agree to waive the Prepayment Charge if Agent and Lender (in its sole and absolute discretion) agree in writing to refinance the Advances prior to the Term Loan Maturity Date and/or 2018 Term Loan Maturity Date, as applicable.”

1.9   The Loan Agreement shall be amended by deleting Section 2.5 thereof (End of Term Charge) in its entirety and inserting in lieu thereof the following:

“On the earliest to occur of (i) September 1, 2020, (ii) the date that Borrower prepays the outstanding Secured Obligations (other than any inchoate indemnity obligations and any other obligations which, by their terms, are to survive the termination of this Agreement) in full, or (iii) the date that the Secured Obligations become due and payable, Borrower shall pay Lender, with respect to each Term Loan Advance, charges equal to the sum of (a) One Million Eight Hundred Thousand Dollars ($1,800,000) (the “2015 End of Term Charge”), (b) Four Hundred Fifty Thousand Dollars ($450,000) (the “2016 End of Term Charge”), and (c) Two Hundred Twenty-Five Thousand Dollars ($225,000) (the “2017 End of Term Charge” and, together with the 2015 End of Term Charge and 2016 End of Term Charge, collectively, the “End of Term Charge”). On the earliest to occur of (i) the 2018 Term Loan Maturity Date, (ii) the date that Borrower prepays the outstanding Secured Obligations (other than any inchoate indemnity obligations and any other obligations which, by their terms, are to survive the termination of this Agreement) in full, or (iii) the date that the Secured Obligations become due and payable, Borrower shall pay Lender, with respect to each 2018 Term Loan Advance, a charge equal to 6.95%, multiplied by the original principal amount of such 2018 Term Loan Advance extended by Lender (the “2018 End of Term Charge”). Notwithstanding the required payment date of such charge, the 2015 End of Term Charge shall be deemed earned by Lender as of the Closing Date, the 2016 End of Term Charge shall be deemed earned by Lender as of the Second Amendment Closing Date, the 2017 End of Term Charge shall be deemed earned by Lender as of the Third Amendment Closing Date and the 2018 End of Term Charge shall be deemed earned by Lender as of the Fifth Amendment Closing Date.”

 

 


 

1.10   The Loan Agreement shall be amended by deleting Section 2. 7 thereof ( Pro Rata Treatment ) in its entirety and inserting in lieu thereof the following :

“Each payment (including prepayment) on account of any fee and any reduction of the Advances shall be made pro rata according to the Term Commitments and 2018 Term Commitments of the relevant Lender.”

 

1.11   The Loan Agreement shall be amended by inserting the following new paragraphs to appear at the end of Section 5.6 (Laws) thereof:

“Neither Borrower nor any of its Subsidiaries is an “investment company” or a company “controlled” by an “investment company” under the Investment Company Act of 1940, as amended.  Neither Borrower nor any of its Subsidiaries is engaged as one of its important activities in extending credit for margin stock (under Regulations X, T and U of the Federal Reserve Board of Governors).  Borrower and each of its Subsidiaries has complied in all material respects with the Federal Fair Labor Standards Act.  Neither Borrower nor any of its Subsidiaries is a “holding company” or an “affiliate” of a “holding company” or a “subsidiary company” of a “holding company” as each term is defined and used in the Public Utility Holding Company Act of 2005.  Neither Borrower’s nor any of its Subsidiaries’ properties or assets has been used by Borrower or such Subsidiary or, to Borrower’s Knowledge, by previous Persons, in disposing, producing, storing, treating, or transporting any hazardous substance other than in material compliance with applicable laws.  Borrower and each of its Subsidiaries has obtained all consents, approvals and authorizations of, made all declarations or filings with, and given all notices to, all Governmental Authorities that are necessary to continue their respective businesses as currently conducted, except where the failure to obtain such consent, approval or authorization, or make such declaration or filing or give such notice would not reasonably be expected to have a Material Adverse Effect.

 

None of Borrower, any of its Subsidiaries, or any of Borrower’s or its Subsidiaries’ Affiliates or any of their respective agents acting or benefiting in any capacity in connection with the transactions contemplated by this Agreement is (i) in violation of any Anti-Terrorism Law, (ii) engaging in or conspiring to engage in any transaction that evades or avoids, or has the purpose of evading or avoiding or attempts to violate, any of the prohibitions set forth in any Anti-Terrorism Law, or (iii) is a Blocked Person.  None of Borrower, any of its Subsidiaries, or to the knowledge of Borrower and any of their Affiliates or agents, acting or benefiting in any capacity in connection with the transactions contemplated by this Agreement, (x) conducts any business or engages in making or receiving any contribution of funds, goods or services to or for the benefit of any Blocked Person, or (y) deals in, or otherwise engages in any transaction relating to, any property or interest in property blocked pursuant to Executive Order No. 13224, any similar executive order or other Anti-Terrorism Law.  None of the funds to be provided under this Agreement will be used, directly or indirectly, (a) for any activities in violation of any applicable anti-money laundering, economic sanctions and anti-bribery laws and regulations laws and regulations or (b) for any payment to any governmental official or employee, political party, official of a political party, candidate for political office, or anyone else acting in an official capacity, in order to obtain, retain or direct business or obtain any improper advantage, in violation of the United States Foreign Corrupt Practices Act of 1977, as amended.”

 

 

 


 

1.12    The Loan Agreement shall be amended by inserting the following new provision to appear as Section 5.15 thereof:

5.15  Foreign Subsidiary Voting Rights . No decision or action in any governing document of any Foreign Subsidiary (other than an Eligible Foreign Subsidiary) requires a vote of greater than 50.1% of the Equity Interests or voting rights of such Foreign Subsidiary.”

1.13   The Loan Agreement shall be amended by inserting the following sentence to appear at the end of Section 6.2 thereof:

“Borrower shall provide Agent with copies of each insurance policy, and upon entering or amending any insurance policy required hereunder, Borrower shall provide Agent with copies of such policies and shall deliver to Agent updated insurance certificates with respect to such policies within 30 days of such updates.”

1.14   The Loan Agreement shall be amended by inserting the following sentence to appear at the end of Section 6.3 thereof:

“This Section 6.3 shall survive the repayment of the Secured Obligations under, and otherwise shall survive the expiration or other termination of, the Loan Agreement.”

1.15   The Loan Agreement shall be amended by deleting the following number appearing in Section 7.1(g): “60” and inserting in lieu thereof the following: “90”.

1.16   The Loan Agreement shall be amended by deleting Section 7.13 thereof (Subsidiary) in its entirety and inserting in lieu thereof the following:

7.13  Subsidiary .  Borrower shall notify Agent of each Subsidiary formed subsequent to the Closing Date and, within 30 days of formation, shall cause any such Qualified Subsidiary to execute and deliver to Agent a Joinder Agreement.  In addition, Borrower shall cause any Ineligible Subsidiary that ceases to qualify as an Ineligible Subsidiary to execute and deliver to Agent a Joinder Agreement and grant and pledge to Agent a perfected security interest in the shares of such former Ineligible Subsidiary and execute and deliver any and all documents necessary in connection with such grant and pledge, each in form and substance acceptable to Agent.”

1.17   The Loan Agreement shall be amended by inserting the following new provisions to appear as Section 7.18, 7.19, 7.20 and 7.21 thereof:

7.18  Financial Covenant - Minimum Cash/Net Revenue.   Prior to the occurrence of the Interest Only Period Extension Event, tested at all times, Borrower shall maintain unrestricted and unencumbered Cash in amount of at least Twenty-Five Million Dollars ($25,000,000.00) in an account that is subject to an Account Control Agreement in favor of Agent (“Minimum Cash Covenant”).  Upon the occurrence of the Interest Only Period Extension Event, Borrower shall either: (i) comply with the Minimum Cash Covenant, or (ii) achieve, calculated on a trailing six (6) month basis and tested as of the last day of each calendar quarter, net revenue (determined in accordance with GAAP) from the sale of its Omadacycline product of no less than eighty-five percent (85.0%) of the projected net revenues set forth in the Forecast.

 

 


 

7.19    Foreign Subsidiary Voting Rights . Borrower shall not, and shall not permit any Subsidiary, to amend or modify any governing document of any Foreign Subsidiary of Borrower (other than an Eligible Foreign Subsidiary) the effect of which is to require a vote of greater than 50.1% of the Equity Interests or voting rights of such entity for any dec ision or action of such entity.

7.20  Use of Proceeds .  Borrower agrees that the proceeds of the Advances shall be used solely to pay related fees and expenses in connection with this Agreement and for working capital and general corporate purposes.  The proceeds of the Advances will not be used in violation of Anti-Corruption Laws or applicable Sanctions.”

7.21  Compliance with Laws .

Borrower shall maintain, and shall cause its Subsidiaries to maintain, compliance in all material respect with all applicable laws, rules or regulations (including any law, rule or regulation with respect to the making or brokering of loans or financial accommodations), and shall, or cause its Subsidiaries to, obtain and maintain all required material governmental authorizations, approvals, licenses, franchises, permits or registrations reasonably necessary in connection with the conduct of Borrower’s business.

Neither Borrower nor any of its Subsidiaries shall, nor shall Borrower or any of its Subsidiaries permit any Affiliate to, directly or indirectly, knowingly enter into any documents, instruments, agreements or contracts with any Person listed on the OFAC Lists.  Neither Borrower nor any of its Subsidiaries shall, nor shall Borrower or any of its Subsidiaries, permit any Affiliate to, directly or indirectly, (i) conduct any business or engage in any transaction or dealing with any Blocked Person, including, without limitation, the making or receiving of any contribution of funds, goods or services to or for the benefit of any Blocked Person, (ii) deal in, or otherwise engage in any transaction relating to, any property or interests in property blocked pursuant to Executive Order No. 13224 or any similar executive order or other Anti‑Terrorism Law, or (iii) engage in or conspire to engage in any transaction that evades or avoids, or has the purpose of evading or avoiding, or attempts to violate, any of the prohibitions set forth in Executive Order No. 13224 or other Anti‑Terrorism Law.

Borrower shall implement and maintain policies and procedures designed to ensure compliance by the Borrower, its Subsidiaries and their respective directors, officers, employees and agents with Anti-Corruption Laws and applicable Sanctions, and Borrower, its Subsidiaries and their respective officers and employees and to the knowledge of Borrower its directors and agents, shall be in compliance with Anti-Corruption Laws and applicable Sanctions in all material respects.

Borrower shall ensure that none of Borrower, any of its Subsidiaries or any of their respective directors, officers or employees, or to the knowledge of Borrower, any agent for Borrower or its Subsidiaries that will act in any capacity in connection with or benefit from the credit facility established hereby, is a Sanctioned Person.”

1.18   The Loan Agreement shall be amended by deleting Section 9.2 in its entirety and inserting in lieu thereof the following:

9.2  Covenants .  Borrower breaches or defaults in the performance of any covenant or Secured Obligation under this Agreement, or any of the other Loan Documents or any other

 

 


 

agreement among Borrower, Agent and Lender, and (a) with respect to a default under any covenant under this Agreement (other than under Sections 6, 7.4, 7.5, 7.6, 7.7, 7.8, 7.9, 7.14, 7.15, 7.16, 7.17, 7.18 , 7.19 , 7.20 and 7.21 ), any other Loan Document or any other agreement among Borrower, Agent and Lender, such default continues for more than ten (10) days after the earlier of the date on which (i) Agent or Lender has given notice of such default to Borrower and (ii) Borrower has actual knowledge of such default or (b) with respect to a default under any of Sections 6, 7.4, 7.5, 7.6, 7.7, 7.8, 7.9, 7.14, 7.15, 7.16, 7.17, 7.18 , 7.19 , 7.20 and 7.21 the occurrence of such default; or

1.19   The Loan Agreement shall be amended by deleting Section 11.19 in its entirety and inserting in lieu thereof the following:

11.19  Multiple Borrowers .

(a)  Borrower’s Agent.  Each of the Borrowers hereby irrevocably appoints Inc. as its agent, attorney-in-fact and legal representative for all purposes, including requesting disbursement of the Term Loan and receiving account statements and other notices and communications to Borrowers (or any of them) from the Agent or any Lender.  The Agent may rely, and shall be fully protected in relying, on any request for the Term Loan, disbursement instruction, report, information or any other notice or communication made or given by Inc., whether in its own name or on behalf of one or more of the other Borrowers, and the Agent shall not have any obligation to make any inquiry or request any confirmation from or on behalf of any other Borrower as to the binding effect on it of any such request, instruction, report, information, other notice or communication, nor shall the joint and several character of the Borrowers’ obligations hereunder be affected thereby.

(b)  Waivers.  Each Borrower hereby waives:  (i) any right to require the Agent to institute suit against, or to exhaust its rights and remedies against, any other Borrower or any other person, or to proceed against any property of any kind which secures all or any part of the Secured Obligations, or to exercise any right of offset or other right with respect to any reserves, credits or deposit accounts held by or maintained with the Agent or any Indebtedness of the Agent or any Lender to any other Borrower, or to exercise any other right or power, or pursue any other remedy the Agent or any Lender may have; (ii) any defense arising by reason of any disability or other defense of any other Borrower or any guarantor or any endorser, co-maker or other person, or by reason of the cessation from any cause whatsoever of any liability of any other Borrower or any guarantor or any endorser, co-maker or other person, with respect to all or any part of the Secured Obligations, or by reason of any act or omission of the Agent or others which directly or indirectly results in the discharge or release of any other Borrower or any guarantor or any other person or any Secured Obligations or any security therefor, whether by operation of law or otherwise; (iii) any defense arising by reason of any failure of the Agent to obtain, perfect, maintain or keep in force any Lien on, any property of any Borrower or any other person; (iv) any defense based upon or arising out of any bankruptcy, insolvency, reorganization, arrangement, readjustment of debt, liquidation or dissolution proceeding commenced by or against any other Borrower or any guarantor or any endorser, co-maker or other person, including without limitation any discharge of, or bar against collecting, any of the Secured Obligations (including without limitation any interest thereon), in or as a result of any such proceeding.  Until all of the Secured Obligations have been paid, performed, and discharged in full, nothing shall discharge or satisfy the liability of any Borrower hereunder except the full performance and payment of all of the Secured Obligations.  If any claim is ever made upon the Agent for repayment or recovery of any

 

 


 

amount or amounts received by the Agent in payment of or on account of any of the Secured Obligations, because of any claim that any such payment constituted a preferential transfer or fraudulent conveyance, or for any other reason whatsoever, and the Agent repays all or part of said amount by reason of any judgment, decree or order of any court or administrative body having jurisdiction over the Agent or any of its property, or by reason of any settlement or compromise of any such claim effected by the Agent with any such claimant (including without limitation the any other Borrower), then and in any such event, each Borrower agrees that any such judgment, decree, order, settlement and compromise shall be binding upon such Borrower, notwithstanding any revocation or release of this Agreement or the cancellation of any note or other instrument evidencing any of the Secured Obligations, or any release of any of the Secured Obligations, and each Borrower shall be and remain liable to the Agent and the Lenders under this Agreement for the amount so repaid or recovered, to the same extent as if such amount had never originally been received by the Agent or any Lender, and the provisions of this sentence shall survive, and continue in effect, notwithstanding any revocation or release of this Agreement.  Each Borrower hereby expressly and unconditionally waives all rights of subrogation, reimbursement and indemnity of every kind against any other Borrower, and all rights of recourse to any assets or property of any other Borrower, and all rights to any collateral or security held for the payment and performance of any Secured Obligations, including (but not limited to) any of the foregoing rights which Borrower may have under any present or future document or agreement with any other Borrower or other person, and including (but not limited to) any of the foregoing rights which any Borrower may have under any equitable doctrine of subrogation, implied contract, or unjust enrichment, or any other equitable or legal doctrine.

(c)  Consents.  Each Borrower hereby consents and agrees that, without notice to or by Borrower and without affecting or impairing in any way the obligations or liability of Borrower hereunder, the Agent may, from time to time before or after revocation of this Agreement, do any one or more of the following in its sole and absolute discretion:  (i) accept partial payments of, compromise or settle, renew, extend the time for the payment, discharge, or performance of, refuse to enforce, and release all or any parties to, any or all of the Secured Obligations; (ii) grant any other indulgence to any Borrower or any other Person in respect of any or all of the Secured Obligations or any other matter; (iii) accept, release, waive, surrender, enforce, exchange, modify, impair, or extend the time for the performance, discharge, or payment of, any and all property of any kind securing any or all of the Secured Obligations or any guaranty of any or all of the Secured Obligations, or on which the Agent at any time may have a Lien, or refuse to enforce its rights or make any compromise or settlement or agreement therefor in respect of any or all of such property; (iv) substitute or add, or take any action or omit to take any action which results in the release of, any one or more other Borrowers or any endorsers or guarantors of all or any part of the Secured Obligations, including, without limitation one or more parties to this Agreement, regardless of any destruction or impairment of any right of contribution or other right of Borrower; (v) apply any sums received from any other Borrower, any guarantor, endorser, or co-signer, or from the disposition of any Collateral or security, to any Indebtedness whatsoever owing from such person or secured by such Collateral or security, in such manner and order as the Agent determines in its sole discretion, and regardless of whether such Indebtedness is part of the Secured Obligations, is secured, or is due and payable.  Each Borrower consents and agrees that the Agent shall be under no obligation to marshal any assets in favor of Borrower, or against or in payment of any or all of the Secured Obligations.  Each Borrower further consents and agrees that the Agent shall have no duties or responsibilities whatsoever with respect to any property securing

 

 


 

any or all of the Secured Obligations.  Without limiting the generality of the foregoing, the Agent shall have no obligation to monitor, verify, audit, examine, or obtain or maintain any insurance with respect to, any property securing any or all of the Secured Obligations.

(d)  Independent Liability.  Each Borrower hereby agrees that one or more successive or concurrent actions may be brought hereon against such Borrower, in the same action in which any other Borrower may be sued or in separate actions, as often as deemed advisable by Agent. Each Borrower is fully aware of the financial condition of each other Borrower and is executing and delivering this Agreement based solely upon its own independent investigation of all matters pertinent hereto, and such Borrower is not relying in any manner upon any representation or statement of the Agent or any Lender with respect thereto.  Each Borrower represents and warrants that it is in a position to obtain, and each Borrower hereby assumes full responsibility for obtaining, any additional information concerning any other Borrower’s financial condition and any other matter pertinent hereto as such Borrower may desire, and such Borrower is not relying upon or expecting the Agent to furnish to it any information now or hereafter in the Agent’s possession concerning the same or any other matter.

(e)  Subordination.  All Indebtedness of a Borrower now or hereafter arising held by another Borrower is subordinated to the Secured Obligations and the Borrower holding the Indebtedness shall take all actions reasonably requested by Agent to effect, to enforce and to give notice of such subordination.”

1.20   Exhibit F (Compliance Certificate) is hereby amended and restated in its entirety with the Exhibit F appearing as Schedule 1 hereto.

1.21   Schedule 1.1 is hereby amended and restated in its entirety with the Schedule 1.1 appearing as Schedule 2 hereto.

2.   Borrower’s Representations And Warranties .  Borrower represents and warrants that:

2.1   Immediately upon giving effect to this Amendment (i) the representations and warranties contained in the Loan Documents are true, accurate and complete except to the extent such representations and warranties relate to an earlier date, in which case they are true and correct as of such date, after giving effect in all cases to any standard(s) of materiality contained in the Loan Agreement as to such representations and warranties and (ii) no Event of Default has occurred and is continuing with respect to which Borrower has not been notified in writing by Agent or Lender.

2.2   Borrower has the corporate power and authority to execute and deliver this Amendment and to perform its obligations under the Loan Agreement, as amended by this Amendment.

2.3   The certificate of incorporation, bylaws and other organizational documents of Borrower delivered to Agent and/or Lender on the Fifth Amendment Closing Date are true, accurate and complete and have not been amended, supplemented or restated and are and continue to be in full force and effect.

 

 


 

2.4    The execution and delivery by Borrower of this Amendment and the performance by Borrower of its obligations under the Loan Agreement, as amended by this Amendment, have been duly authorized by all necessary corporate action on the part of Borrower.

2.5   This Amendment has been duly executed and delivered by Borrower and is the binding obligation of Borrower, enforceable against it in accordance with its terms, except as such enforceability may be limited by bankruptcy, insolvency, reorganization, liquidation, moratorium or other similar laws of general application and equitable principles relating to or affecting creditors’ rights.

2.6   As of the date hereof, it has no defenses against the obligations to pay any amounts under the Secured Obligations.  

Borrower acknowledges that each of Agent and Lender has acted in good faith and has conducted in a commercially reasonable manner its relationships with Borrower in connection with this Amendment and in connection with the Loan Documents.  Borrower understands and acknowledges that each of Agent and Lender is entering into this Amendment in reliance upon, and in partial consideration for, the above representations and warranties, and agrees that such reliance is reasonable and appropriate.

3.   Limitation .  The amendments set forth in this Amendment shall be limited precisely as written and shall not be deemed (a) to be a waiver or modification of any other term or condition of the Loan Agreement or of any other instrument or agreement referred to therein or to prejudice any right or remedy which Agent and/or Lender may now have or may have in the future under or in connection with the Loan Agreement (as amended hereby) or any instrument or agreement referred to therein; or (b) to be a consent to any future amendment or modification or waiver to any instrument or agreement the execution and delivery of which is consented to hereby, or to any waiver of any of the provisions thereof.  Except as expressly amended hereby, the Loan Agreement shall continue in full force and effect.

4.   Effectiveness .  This Amendment shall become effective upon the satisfaction of all the following conditions precedent:

4.1  Amendment .  Borrower, Agent and Lender shall have duly executed and delivered this Amendment to Lender and such other documents as Agent may reasonably request.

4.2  Warrant .  Each Lender shall have received the Warrant.

4.3  Borrowing Resolutions .  A certified copy of resolutions of Borrower’s Board evidencing approval of (i) this Amendment and other transactions evidenced by the Loan Documents; and (ii) the Warrant.

4.4  Certificates of Good Standing .  A certificate of good standing for each Borrower from its state of incorporation and similar certificates from all other jurisdictions in which such Borrower does business and where the failure to be qualified would have a Material Adverse Effect.

4.5  Fifth Amendment Facility Charge .  Borrower shall have paid to Agent the Fifth Amendment Facility Charge.

4.6  Payment of Lender Expenses.   Borrower shall have paid all reasonable and invoiced Lender expenses (including all reasonable attorneys' fees and reasonable expenses) incurred through the date of this Amendment.

 

 


 

5.    POST- CLOSING DELIVERABLES .  Borrower shall deliver to Agent, on or before thirty (30) days after the Fifth Amendment Closing Date (the “Post-Closing Delivery Date”), (i) certificates of insurance on the Acord 25 and Acord 28, (ii) endorsements to the Borrower’s property and liability policies, which endorsements shall name Agent as lender loss payee and additional insured , and (iii) copies of all insurance policies.

6.   Release .   In consideration of the agreements of Agent and each Lender contained herein and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, Borrower, on behalf of itself and its successors, assigns, and other legal representatives, hereby fully, absolutely, unconditionally and irrevocably releases, remises and forever discharges Agent and each Lender, and its successors and assigns, and its present and former shareholders, affiliates, subsidiaries, divisions, predecessors, directors, officers, attorneys, employees, agents and other representatives (Agent, Lenders and all such other persons being hereinafter referred to collectively as the “Releasees” and individually as a “Releasee”), of and from all demands, actions, causes of action, suits, covenants, contracts, controversies, agreements, promises, sums of money, accounts, bills, reckonings, damages and any and all other claims, counterclaims, defenses, rights of set-off, demands and liabilities whatsoever of every name and nature, both at law and in equity, which Borrower, or any of its successors, assigns, or other legal representatives may have actual knowledge of or be reasonably expected to know that they own, hold, have or claim to have against the Releasees or any of them for, upon, or by reason of any circumstance, action, cause or thing whatsoever which arises at any time on or prior to the day and date of this Amendment, for or on account of, or in relation to, or in any way in connection with the Loan Agreement, or any of the other Loan Documents or transactions thereunder or related thereto.  Borrower understands, acknowledges and agrees that the release set forth above may be pleaded as a full and complete defense and may be used as a basis for an injunction against any action, suit or other proceeding which may be instituted, prosecuted or attempted in breach of the provisions of such release.  Borrower agrees that no fact, event, circumstance, evidence or transaction which Borrower has actual knowledge of or would reasonably be expected to know could now be asserted or shall affect in any manner the final, absolute and unconditional nature of the release set forth above.

7.   Counterparts .  This Amendment may be signed in any number of counterparts, and by different parties hereto in separate counterparts, with the same effect as if the signatures to each such counterpart were upon a single instrument.  All counterparts shall be deemed an original of this Amendment. This Amendment may be executed by facsimile, portable document format (.pdf) or similar technology signature, and such signature shall constitute an original for all purposes.

8.   Incorporation By Reference.  The provisions of Section 11 of the Loan Agreement, as amended hereby, shall be deemed incorporated herein by reference, mutatis mutandis .

 

              [Signature Page Follows]

 


 

 


 

In Witness Whereof , the parties have duly authorized and caused this Amendment to be executed as of the date first written above.

BORROWER:

PARATEK PHARMACEUTICALS, INC.

BORROWER:

 

PARATEK PHARMACEUTICALS, INC.

Signature:     /s/ Douglas W. Pagán

Print Name:   Douglas W. Pagán

Title:              Chief Financial Officer

 

PARATEK PHARMA, LLC.

Signature:     /s/ Douglas W. Pagán

Print Name:   Douglas W. Pagán

Title:              Chief Financial Officer

 

 

Accepted in Palo Alto, California:

 

AGENT:

HERCULES CAPITAL, INC.

Signature:     /s/ Jennifer Choe

Print Name:   Jennifer Choe

Title:              Assistant General Counsel

 

LENDER:

 

HERCULES TECHNOLOGY II, L.P. ,

a Delaware limited partnership

 

By: Hercules Technology SBIC Management, LLC,

its General Partner

 

By: HERCULES CAPITAL, INC.,

its Manager

 

 


 

 

Signature:     /s/ Jennifer Choe

Print Name:   Jennifer Choe

Title:              Assistant General Counsel

 

HERCULES TECHNOLOGY III, L.P. ,

a Delaware limited partnership

 

By: Hercules Technology SBIC Management, LLC,

its General Partner

By: HERCULES CAPITAL, INC.,

its Manager

 

Signature:     /s/ Jennifer Choe

Print Name:   Jennifer Choe

Title:              Assistant General Counsel

 

HERCULES CAPITAL, INC.

 

Signature:     /s/ Jennifer Choe    

Print Name:   Jennifer Choe

Title:              Assistant General Counsel


 

 


 

Schedule 1

 

EXHIBIT F

COMPLIANCE CERTIFICATE

Hercules Capital, Inc.
400 Hamilton Avenue, Suite 310
Palo Alto, CA 94301

Reference is made to that certain Loan and Security Agreement dated September 30, 2015 and the Loan Documents (as defined therein) entered into in connection with such Loan and Security Agreement all as may be amended from time to time (hereinafter referred to collectively as the “Loan Agreement”) by and among Hercules Capital, Inc., the several banks and other financial institutions or entities from time to time party thereto (collectively, the “Lender”) and Hercules Capital, Inc., as agent for the Lender (the “Agent”) and Paratek Pharmaceuticals, Inc. and Paratek Pharma, LLC (individually and collectively, jointly and severally, the “Borrower”) as Borrower. All capitalized terms not defined herein shall have the same meaning as defined in the Loan Agreement.

The undersigned is an Officer of Borrower, knowledgeable of all Borrower financial matters, and is authorized to provide certification of information regarding Borrower; hereby certifies, in such capacity, that in accordance with the terms and conditions of the Loan Agreement, except as set forth below, (i) Borrower is in compliance for the period ending ___________ of all covenants, conditions and terms and (ii) hereby reaffirms that all representations and warranties contained therein are true and correct on and as of the date of this Compliance Certificate with the same effect as though made on and as of such date, except to the extent such representations and warranties expressly relate to an earlier date, after giving effect in all cases to any standard(s) of materiality contained in the Loan Agreement as to such representations and warranties.  Attached are the required documents supporting the above certification.  The undersigned further certifies that these are prepared in accordance with GAAP (except for the absence of footnotes with respect to unaudited financial statement and subject to normal year end adjustments) and are consistent from one period to the next except as explained below.

EXCEPTION(S):______________________________________________________________________

____________________________________________________________________________________

____________________________________________________________________________________

 

 

 


 

REPORTING REQUIREMENT

REQUIRED

CHECK IF ATTACHED

Interim Financial Statements

Monthly within 30 days

 

Interim Financial Statements

Quarterly within 45 days

 

Audited Financial Statements

FYE within 90 days

 

 

 

 

FINANCIAL COVENANT

REQUIRED

ACTUAL

Liquidity

Lesser of (i) one (1) times the outstanding Secured Obligations of Borrower to Lender or (ii) one hundred percent (100%) of all cash of Borrower and its Subsidiaries (other than cash held in (a) Excluded Accounts or (b) other accounts in an aggregate amount not in excess of One Hundred Thousand Dollars ($100,000.00)).

 

 

Minimum Cash (prior the occurrence of the Interest Only Period Extension Event)

($25,000,000) in an account subject to an Account Control Agreement in favor of Agent, tested at all times

 

Minimum Cash/Net Revenue (after the occurrence of the Interest Only Period Extension Event)

 

Either (i) ($25,000,000) in an account subject to an Account Control Agreement in favor of Agent, tested at all times, or (ii) achieve, calculated on a trailing six (6) month basis and tested as of the last day of each calendar quarter, net revenue (determined in accordance with GAAP) from the sale of its Omadacycline product of no less than eighty-five percent (85.0%) of the projected net revenues set forth in the Forecast.

 

 

 

 

INELIGIBLE SUBSIDIARIES

 

 

Name of Ineligible Subsidiary

Value of Assets

Annual Revenue

 

 

 

 

 

 

 

 

 

 

 


 

 

 

 

 

Depository AC #

Financial Institution

Account Type (Depository / Securities)

Last Month Ending Account Balance

Purpose of Account

BORROWER Name/Address:

 

 

1

 

 

 

 

 

2

 

 

 

 

 

3

 

 

 

 

 

4

 

 

 

 

 

5

 

 

 

 

 

6

 

 

 

 

 

7

 

 

 

 

 

 

BORROWER SUSIDIARY / AFFILIATE COMPANY Name/Address

 

 

1

 

 

 

 

 

2

 

 

 

 

 

3

 

 

 

 

 

4

 

 

 

 

 

5

 

 

 

 

 

6

 

 

 

 

 

7

 

 

 

 

 

 

 

 

Very Truly Yours,

 

PARATEK PHARMACEUTICALS, INC.

By:   _______________________________

Name:   _____________________________

Title:   ______________________________

 

PARATEK PHARMA, LLC

By:   _______________________________

Name:   _____________________________

Title:   ______________________________

 


 

 


 

 

 

Schedule 2

SCHEDULE 1.1

COMMITMENTS

 

TERM LOAN ADVANCES

 

LENDER

TERM COMMITMENT

HERCULES TECHNOLOGY II, L.P.

$10,000,000

HERCULES TECHNOLOGY III, L.P.

$20,000,000

HERCULES CAPITAL, INC.

$30,000,000

TOTAL COMMITMENTS

$60,000,000

 

2018 TERM LOAN ADVANCES

 

LENDER

TRANCHE

TERM COMMITMENT

HERCULES CAPITAL, INC.

2018 Term A Loan

$10,000,000

HERCULES CAPITAL, INC.

2018 Term B Loan

$10,000,000*

HERCULES CAPITAL, INC.

2018 Term C Loan

$10,000,000*

TOTAL COMMITMENTS

 

$30,000,000

 

*Funding of the 2018 Term B Loan Advance and Term C Loan Advance is in Lender’s sole discretion.  

 

(27955.50)

2346924.6\27955.00050

 

 

 

Exhibit 31.1

CERTIFICATION OF CHIEF EXECUTIVE OFFICER PURSUANT TO

SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002

I, Michael F. Bigham, certify that:

 

1.

I have reviewed this Form 10-Q of Paratek Pharmaceuticals, Inc.;

 

2.

Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

 

3.

Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;

 

4.

The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:

 

 

(a)

Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;

 

 

(b)

Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision; to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;

 

 

(c)

Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

 

 

(d)

Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and

 

5.

The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):

 

 

(a)

All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and

 

 

(b)

Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.

 

 

/s/ MICHAEL F. BIGHAM

 

Michael F. Bigham

Chief Executive Officer

August 1, 2018

 

 

Exhibit 31.2

CERTIFICATION OF PRINCIPAL FINANCIAL OFFICER PURSUANT TO

SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002

I, Douglas W. Pagán, certify that:

 

1.

I have reviewed this Form 10-Q of Paratek Pharmaceuticals, Inc.;

 

2.

Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

 

3.

Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;

 

4.

The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:

 

 

(a)

Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;

 

 

(b)

Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision; to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;

 

 

(c)

Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

 

 

(d)

Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and

 

5.

The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):

 

 

(a)

All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and

 

 

(b)

Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.

 

 

/s/ DOUGLAS W. PAGAN

 

Douglas W. Pagán

Chief Financial Officer

August 1, 2018

 

 

Exhibit 32.1

CERTIFICATION OF CHIEF EXECUTIVE OFFICER PURSUANT TO

SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002

Pursuant to the requirement set forth in Rule 13a-14(b) of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), and Section 1350 of Chapter 63 of Title 18 of the United States Code (18 U.S.C. §1350), Michael F. Bigham, Chief Executive Officer of Paratek Pharmaceuticals, Inc. (the “Company”), hereby certifies that, to the best of his knowledge:

 

1.

The Company’s Quarterly Report on Form 10-Q for the period ended June 30, 2018 (the “Quarterly Report”), to which this Certification is attached as Exhibit 32.1 fully complies with the requirements of Section 13(a) or Section 15(d), of the Exchange Act; and

 

2.

The information contained in the Quarterly Report fairly presents, in all material respects, the financial condition and results of operations the Company.

In Witness Whereof, the undersigned has set his hand hereto as of the 1 st day of August, 2018.

 

/s/ MICHAEL F. BIGHAM

 

Michael F. Bigham

Chief Executive Officer

This certification accompanies the Form 10-Q to which it relates, is not deemed filed with the Securities and Exchange Commission and is not to be incorporated by reference into any filing of Paratek Pharmaceuticals, Inc. under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended (whether made before or after the date of the Form 10-Q), irrespective of any general incorporation language contained in such filing.

 

Exhibit 32.2

CERTIFICATION OF PRINCIPAL FINANCIAL OFFICER PURSUANT TO

SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002

Pursuant to the requirement set forth in Rule 13a-14(b) of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), and Section 1350 of Chapter 63 of Title 18 of the United States Code (18 U.S.C. §1350), Douglas W. Pagán, Chief Financial Officer of Paratek Pharmaceuticals, Inc. (the “Company”), hereby certifies that, to the best of his knowledge:

 

1.

The Company’s Quarterly Report on Form 10-Q for the period ended June 30, 2018 (the “Quarterly Report”), to which this Certification is attached as Exhibit 32.2 fully complies with the requirements of Section 13(a) or Section 15(d) of the Exchange Act; and

 

2.

The information contained in the Quarterly Report fairly presents, in all material respects, the financial condition and results of operations of the Company.

In Witness Whereof, the undersigned has set his hand hereto as of the 1 st day of August, 2018.

 

/s/ DOUGLAS W. PAGÁN

 

Douglas W. Pagán

Chief Financial Officer

This certification accompanies the Form 10-Q to which it relates, is not deemed filed with the Securities and Exchange Commission and is not to be incorporated by reference into any filing of Paratek Pharmaceuticals, Inc. under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended (whether made before or after the date of the Form 10-Q), irrespective of any general incorporation language contained in such filing.